what research design is a feasibility study

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How We Design Feasibility Studies

Public health is moving toward the goal of implementing evidence-based interventions. To accomplish this, there is a need to select, adapt, and evaluate intervention studies. Such selection relies, in part, on making judgments about the feasibility of possible interventions and determining whether comprehensive and multilevel evaluations are justified. There exist few published standards and guides to aid these judgments. This article describes the diverse types of feasibility studies conducted in the field of cancer prevention, using a group of recently funded grants from the National Cancer Institute. The grants were submitted in response to a request for applications proposing research to identify feasible interventions for increasing the utilization of the Cancer Information Service among underserved populations.

Introduction

The field of health promotion and disease prevention is moving toward the goal of implementing evidence-based interventions that have been rigorously evaluated and found to be both efficacious and effective. This will encourage the evaluation of the efficacy of additional interventions, using standards of the sort applied in the evidence reviews conducted by the Cochrane Collaboration ( www.cochrane.org ) and the Task Force on Community Preventive Services ( www.thecommunityguide.org ).

By intervention is meant any program, service, policy, or product that is intended to ultimately influence or change people’s social, environmental, and organizational conditions as well as their choices, attitudes, beliefs, and behaviors. Both early conceptual models of health education 1 and more modern versions of health promotion 2 indicate that interventions should focus on changeable behaviors and objectives; be based on critical, empirical evidence linking behavior to health; be relevant to the target populations; and have the potential to meet the intervention’s goals. In cancer prevention and control, intervention efficacy has been defined as meeting the intended behavioral outcomes under ideal circumstances. In contrast, effectiveness studies can be viewed as evaluating success in real-world, non-ideal conditions. 3

Clearly, because of resource constraints, not all interventions can be tested for both efficacy and effectiveness. Guidelines are needed to help evaluate and prioritize those interventions with the greatest likelihood of being efficacious. Feasibility studies are relied on to produce a set of findings that help determine whether an intervention should be recommended for efficacy testing. The published literature does not propose standards to guide the design and evaluation of feasibility studies. This gap in the literature and in common practice needs to be filled as the fields of evidence-based behavioral medicine and public health practice mature.

This article presents ideas for designing a feasibility study. Included are descriptions of feasibility studies from all phases of the original cancer-control continuum: from basic social science to determine the best variables to target, through methods development, to efficacy and effectiveness studies, to dissemination research. The term feasibility study is used more broadly than usual to encompass any sort of study that can help investigators prepare for full-scale research leading to intervention. It is hoped that this article can prove useful both to researchers when they consider their own intervention design and to reviewers of intervention-related grants.

Employing Feasibility Studies

Feasibility studies are used to determine whether an intervention is appropriate for further testing; in other words, they enable researchers to assess whether or not the ideas and findings can be shaped to be relevant and sustainable. Such research may identify not only what—if anything—in the research methods or protocols needs modification but also how changes might occur. For example, a feasibility study may be in order when researchers want to compare different research and recruitment strategies. Gustafson 4 found that African-American women report more mistrust of medical establishments than do white women. A feasibility study might qualitatively examine women’s reactions to a specific intervention handout that attempted to promote the trustworthiness in a medical institution. If women’s reactions were positive and in line with increased trust in the institution, the feasibility study would have served as a precursor to testing the effects of that handout in recruiting women to a randomized prevention trial. 5

Performing a feasibility study may be indicated when:

• community partnerships need to be established, increased, or sustained;
• there are few previously published studies or existing data using a specific intervention technique;
• prior studies of a specific intervention technique in a specific population were not guided by in-depth research or knowledge of the population’s socio-cultural health beliefs; by members of diverse research teams; or by researchers familiar with the target population and in partnership with the targeted communities;
• the population or intervention target has been shown empirically to need unique consideration of the topic, method, or outcome in other research; or
• previous interventions that employed a similar method have not been successful, but improved versions may be successful; or previous interventions had positive outcomes but in different settings than the one of interest.

Appropriate Areas of Focus

It is proposed that there are eight general areas of focus addressed by feasibility studies. Each is described below and summarized in Table 1 .

• Acceptability . This relatively common focus looks at how the intended individual recipients—both targeted individuals and those involved in implementing programs—react to the intervention.
• Demand . Demand for the intervention can be assessed by gathering data on estimated use or by actually documenting the use of selected intervention activities in a defined intervention population or setting.
• Implementation . This research focus concerns the extent, likelihood, and manner in which an intervention can be fully implemented as planned and proposed, 6 often in an uncontrolled design.
• Practicality . This focus explores the extent to which an intervention can be delivered when resources, time, commitment, or some combination thereof are constrained in some way.
• Adaptation . Adaptation focuses on changing program contents or procedures to be appropriate in a new situation. It is important to describe the actual modifications that are made to accommodate the context and requirements of a different format, media, or population. 7
• Integration . This focus assesses the level of system change needed to integrate a new program or process into an existing infrastructure or program. 8 The documentation of change that occurs within the organizational setting or the social/physical environment as a direct result of integrating the new program can help to determine if the new venture is truly feasible.
• Expansion . This focus examines the potential success of an already-successful intervention with a different population or in a different setting.
• Limited-efficacy testing . Many feasibility studies are designed to test an intervention in a limited way. Such tests may be conducted in a convenience sample, with intermediate rather than final outcomes, with shorter follow-up periods, or with limited statistical power.

Key areas of focus for feasibility studies and possible outcomes

Relating to the Real World

Green and Glasgow 9 have pointed out the incongruity between increasing demands for evidence-based practice and the fact that most evidence-based recommendations for behavioral interventions are derived from highly controlled efficacy trials. The highly controlled nature of efficacy research is good in that it is likely more possible to draw causal inferences from the designs used (often randomized trials). But this focus on internal validity can reduce external relevance, and generalizability can decrease, limiting dissemination. Practitioners call for more studies to be conducted in settings where community constraints, for example, are prioritized over optimal conditions and settings—specifically testing the fit of interventions in real-world settings. Feasibility studies should be especially useful in helping to fill this important gap in the research literature, and new criteria and measures have been proposed (e.g., Reach, Efficacy/Effectiveness, Adoption, Implementation, Maintenance [RE-AIM]) to evaluate the relevant outcomes. 10

To ensure that feasibility studies indeed reflect the realities of community and practice settings, it is essential that practitioners and community members be involved in meaningful ways in conceptualizing and designing feasibility research. Adhering to published principles of community-based participatory research 11 , 12 should help in this regard, with the added benefit of helping to determine whether interventions are truly acceptable to their intended audience.

Design Options for Feasibility Studies

The choice of an optimal research design depends upon the selected area of focus. This premise holds equally for feasibility studies and for other kinds of research. As the knowledge base and needs for an intervention progress, different questions come to the fore. In the initial phase of developing an intervention, Can it work? is usually the main question. Given some evidence that a treatment might work, the next question is generally Does it work? , and does it do so under ideal or actual conditions compared to other practices. Those are the questions addressed by efficacy and effectiveness studies. Finally, given evidence that an intervention is efficacious and effective, the question Will it work? is applied to the myriad contexts, settings, and cultures that might translate the intervention into practice. Table 2 outlines possible intervention designs according to the focus of the performed feasibility study.

Sample study designs: phases of intervention development by area of focus

Can It Work?

A variety of different research designs can address appropriately the Can it work? question. Sometimes the idea for an intervention derives from observations of actual practice. A practice-derived treatment hypothesis may be able to be refined efficiently by conducting a case-control feasibility study. Such a study might examine retrospectively whether better outcomes are associated with being exposed versus not being exposed to a tobacco policy. Or the same question might be addressed prospectively via a cohort study. A cohort feasibility study would follow and compare the outcomes of individuals who did or did not hear about the policy. The advantage of the cohort design, compared to the case-control design, is that it establishes the timing and directionality of effects. The disadvantage is that the need for follow-up means that cohort studies take longer to complete. Compared to an RCT, the cohort study’s main disadvantage is that participants are not assigned randomly to treatment. Thus, their outcomes may differ not because of the intervention but because the participants or their circumstances were inherently different from the outset.

Practice-derived research hypotheses are sometimes described as originating trench to bench. The other major pipeline of intervention development proceeds bench to trench by deriving hypotheses about active intervention mechanisms from basic research. Often the study involves a laboratory context that mimics or is analogous to the treatment context. For example, messages may be seen on a computer screen rather than on the ultimately intended billboard. Stated intentions to seek cancer screening may be the outcome instead of the actual performance of screening behaviors.

The drawback of experimental feasibility studies is that they have relatively limited external validity. On balance, however, they have two great advantages. First, experiments permit random or unbiased assignment to intervention conditions. Therefore, some comparison to an unbiased control from the same population is available. Second, experiments afford a very time- and cost-effective means of testing whether an intervention could work. It is the authors’ opinion that the experiment is a vastly underutilized research design for feasibility studies. Small-scale experiments that more closely approximate the clinical or community context of an RCT can also be used to test other aspects of intervention feasibility. Questions about safety; optimal dose (treatment intensity, frequency, duration); and the sequencing of treatment all can be tested efficiently in experiments before the launching of a full-scale clinical trial.

Does It Work?

Eventually preliminary positive results can suggest that an intervention is ready to be tested in a full-scale trial whose results should influence health practice. At that juncture, a variety of new feasibility questions must be addressed. One concern is whether the outcome can be measured reliably and validly. Psychometric studies of test-instrument development and validation could be the kind of feasibility research needed to address that question. In-depth qualitative assessments may be an asset to measure development. A second question is whether the intervention can be clarified and conveyed in a disseminatable format (e.g., a manual or brochure) that permits replication of the treatment.

A major feasibility issue that precedes the mounting of a full evaluation trial is the need to derive an effect-size estimate for the treatment. A small-scale randomized trial that mirrors the intended efficacy study may be valuable here. Such feasibility studies are sometimes called Phase-I or Phase-II clinical trials. Usually the design is an RCT because that study design affords the greatest internal validity (i.e., it maximizes confidence that changes in outcomes can be attributed causally to the treatment). Typically, the Phase-I or -II trial entails a smaller sample size than a full Phase-III efficacy/effectiveness trial. Earlier-phase trials are used, in part, to estimate effect size, power, and sample size for a full Phase-III trial.

Will It Work?

Ideally, a treatment will have been shown to be both efficacious and effective before being implemented broadly. New feasibility questions now arise, as interest shifts to disseminating and implementing broadly the intervention in diverse practice systems. It becomes critical to understand the perspectives of different stakeholders who will affect and be affected by the revised intervention. Those stakeholders form a system whose gears must mesh smoothly for the intervention to be taken up and integrated into practice. Qualitative research methods offer especially useful tools for understanding institutional and community cultures. 13

Other kinds of feasibility questions that may be salient at the dissemination or implementation stage concern the potential extrapolation of the intervention beyond the populations and modalities in which it was studied originally. A frequent feasibility question is whether the treatment can be used for a new demographic subgroup—new in terms of ethnicity, culture, SES, geography, or ethnicity. That question often incorporates two sub-questions. One is whether the treatment will be found acceptable to the new population—a feasibility question best approached through qualitative research. The other sub-question asks whether the treatment retains its efficacy in the new population, in new settings, or with new health outcomes. Sometimes a completely distinct and unintended treatment or intervention emerges from such initial feasibility research and warrants additional study.

A final and commonly posed feasibility question is whether a new treatment-delivery channel or intervention method will work. For instance, relevant questions can concern whether the intervention is able to be delivered in group versus individual format, over the telephone instead of face-to-face, or in web- or PDA-based formats. There may be questions about whether paraprofessionals or peers or a computer can deliver the intervention as intended. Usually, these feasibility questions and others will be addressed initially through qualitative interviewing and surveys, followed by experimentation.

This article identifies the construct feasibility as a series of questions and methods. For an intervention to be worthy of testing for efficacy, it must address the relevant questions within feasibility. It is also important to discard or modify those interventions that do not seem to be feasible as a result of data collected during the feasibility-study phase. Using feasibility research in the intervention-research process as a determinant for accepting or discarding an intervention approach is a key way to advance only those interventions that are worth testing (i.e., have a high probability of efficacy).

Scientists who propose feasibility studies are encouraged to do so while keeping in mind the research questions outlined in this article. As with any research, an investigator should choose the area of focus that best matches the needs of the situation. Methodologies to address each area may vary and can be creatively combined to form a package appropriate to the setting, community, or population under study. Reviewers of grants, as well as investigators and grants officials, will also want to pay attention to the varied areas of focus that fall under the umbrella of feasibility. Smaller studies with mixed methods might yield more innovative feasibility results.

Acknowledgments

The projects described were supported by the following six grants from the National Cancer Institute: 1R21CA126325-01, 1R21CA126390-01, 1R21CA126326-01, 1R21CA126373-01, 1R21CA126450-01, and 1R21CA126321-01. The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

No financial disclosures were reported by the authors of this paper.

What Is a Feasibility Study and How to Conduct It? (+ Examples)

Appinio Research · 26.09.2023 · 28min read

Are you ready to turn your project or business idea into a concrete reality but unsure about its feasibility? Whether you're a seasoned entrepreneur or a first-time project manager, understanding the intricate process of conducting a feasibility study is vital for making informed decisions and maximizing your chances of success.

This guide will equip you with the knowledge and tools to navigate the complexities of market, technical, financial, and operational feasibility studies. By the end, you'll have a clear roadmap to confidently assess, plan, and execute your project.

What is a Feasibility Study?

A feasibility study is a systematic and comprehensive analysis of a proposed project or business idea to assess its viability and potential for success. It involves evaluating various aspects such as market demand, technical feasibility, financial viability, and operational capabilities. The primary goal of a feasibility study is to provide you with valuable insights and data to make informed decisions about whether to proceed with the project.

Why is a Feasibility Study Important?

Conducting a feasibility study is a critical step in the planning process for any project or business. It helps you:

• Minimize Risks: By identifying potential challenges and obstacles early on, you can develop strategies to mitigate risks.
• Optimize Resource Allocation: A feasibility study helps you allocate your resources more efficiently, including time and money.
• Enhance Decision-Making: Armed with data and insights, you can make well-informed decisions about pursuing the project or exploring alternative options.
• Attract Stakeholders: Potential investors, lenders, and partners often require a feasibility study to assess the project's credibility and potential return on investment.

Now that you understand the importance of feasibility studies, let's explore the various types and dive deeper into each aspect.

Types of Feasibility Studies

Feasibility studies come in various forms, each designed to assess different aspects of a project's viability. Let's delve into the four primary types of feasibility studies in more detail:

1. Market Feasibility Study

Market feasibility studies are conducted to determine whether there is a demand for a product or service in a specific market or industry. This type of study focuses on understanding customer needs, market trends, and the competitive landscape. Here are the key elements of a market feasibility study:

• Market Research and Analysis: Comprehensive research is conducted to gather market size, growth potential , and customer behavior data. This includes both primary research (surveys, interviews) and secondary research (existing reports, data).
• Target Audience Identification: Identifying the ideal customer base by segmenting the market based on demographics, psychographics, and behavior. Understanding your target audience is crucial for tailoring your product or service.
• Competitive Analysis : Assessing the competition within the market, including identifying direct and indirect competitors, their strengths, weaknesses, and market share.
• Demand and Supply Assessment: Analyzing the balance between the demand for the product or service and its supply. This helps determine whether there is room for a new entrant in the market.

2. Technical Feasibility Study

Technical feasibility studies evaluate whether the project can be developed and implemented from a technical standpoint. This assessment focuses on the project's design, technical requirements, and resource availability. Here's what it entails:

• Project Design and Technical Requirements: Defining the technical specifications of the project, including hardware, software, and any specialized equipment. This phase outlines the technical aspects required for project execution.
• Technology Assessment: Evaluating the chosen technology's suitability for the project and assessing its scalability and compatibility with existing systems.
• Resource Evaluation: Assessing the availability of essential resources such as personnel, materials, and suppliers to ensure the project's technical requirements can be met.
• Risk Analysis: Identifying potential technical risks, challenges, and obstacles that may arise during project development. Developing risk mitigation strategies is a critical part of technical feasibility.

3. Financial Feasibility Study

Financial feasibility studies aim to determine whether the project is financially viable and sustainable in the long run. This type of study involves estimating costs, projecting revenue, and conducting financial analyses. Key components include:

• Cost Estimation: Calculating both initial and ongoing costs associated with the project, including capital expenditures, operational expenses, and contingency funds.
• Revenue Projections: Forecasting the income the project is expected to generate, considering sales, pricing strategies, market demand, and potential revenue streams.
• Investment Analysis: Evaluating the return on investment (ROI), payback period, and potential risks associated with financing the project.
• Financial Viability Assessment: Analyzing the project's profitability, cash flow, and financial stability to ensure it can meet its financial obligations and sustain operations.

4. Operational Feasibility Study

Operational feasibility studies assess whether the project can be effectively implemented within the organization's existing operational framework. This study considers processes, resource planning, scalability, and operational risks. Key elements include:

• Process and Workflow Assessment: Analyzing how the project integrates with current processes and workflows, identifying potential bottlenecks, and optimizing operations.
• Resource Planning: Determining the human, physical, and technological resources required for successful project execution and identifying resource gaps.
• Scalability Evaluation: Assessing the project's ability to adapt and expand to meet changing demands and growth opportunities, including capacity planning and growth strategies.
• Operational Risks Analysis: Identifying potential operational challenges and developing strategies to mitigate them, ensuring smooth project implementation.

Each type of feasibility study serves a specific purpose in evaluating different facets of your project, collectively providing a comprehensive assessment of its viability and potential for success.

How to Prepare for a Feasibility Study?

Before you dive into the nitty-gritty details of conducting a feasibility study, it's essential to prepare thoroughly. Proper preparation will set the stage for a successful and insightful study. In this section, we'll explore the main steps involved in preparing for a feasibility study.

1. Identify the Project or Idea

Identifying and defining your project or business idea is the foundational step in the feasibility study process. This initial phase is critical because it helps you clarify your objectives and set the direction for the study.

• Problem Identification: Start by pinpointing the problem or need your project addresses. What pain point does it solve for your target audience?
• Project Definition: Clearly define your project or business idea. What are its core components, features, or offerings?
• Goals and Objectives: Establish specific goals and objectives for your project. What do you aim to achieve in the short and long term?
• Alignment with Vision: Ensure your project aligns with your overall vision and mission. How does it fit into your larger strategic plan?

Remember, the more precisely you can articulate your project or idea at this stage, the easier it will be to conduct a focused and effective feasibility study.

2. Assemble a Feasibility Study Team

Once you've defined your project, the next step is to assemble a competent and diverse feasibility study team. Your team's expertise will play a crucial role in conducting a thorough assessment of your project's viability.

• Identify Key Roles: Determine the essential roles required for your feasibility study. These typically include experts in areas such as market research, finance, technology, and operations.
• Select Team Members: Choose team members with the relevant skills and experience to fulfill these roles effectively. Look for individuals who have successfully conducted feasibility studies in the past.
• Collaboration and Communication: Foster a collaborative environment within your team. Effective communication is essential to ensure everyone is aligned on objectives and timelines.
• Project Manager: Designate a project manager responsible for coordinating the study, tracking progress, and meeting deadlines.
• External Consultants: In some cases, you may need to engage external consultants or specialists with niche expertise to provide valuable insights.

Having the right people on your team will help you collect accurate data, analyze findings comprehensively, and make well-informed decisions based on the study's outcomes.

3. Set Clear Objectives and Scope

Before you begin the feasibility study, it's crucial to establish clear and well-defined objectives. These objectives will guide your research and analysis efforts throughout the study.

Steps to Set Clear Objectives and Scope:

• Objective Clarity: Define the specific goals you aim to achieve through the feasibility study. What questions do you want to answer, and what decisions will the study inform?
• Scope Definition: Determine the boundaries of your study. What aspects of the project will be included, and what will be excluded? Clarify any limitations.
• Resource Allocation: Assess the resources needed for the study, including time, budget, and personnel. Ensure that you allocate resources appropriately based on the scope and objectives.
• Timeline: Establish a realistic timeline for the feasibility study. Identify key milestones and deadlines for completing different phases of the study.

Clear objectives and a well-defined scope will help you stay focused and avoid scope creep during the study. They also provide a basis for measuring the study's success against its intended outcomes.

4. Gather Initial Information

Before you delve into extensive research and data collection, start by gathering any existing information and documents related to your project or industry. This initial step will help you understand the current landscape and identify gaps in your knowledge.

• Document Review: Review any existing project documentation, market research reports, business plans, or relevant industry studies.
• Competitor Analysis: Gather information about your competitors, including their products, pricing, market share, and strategies.
• Regulatory and Compliance Documents: If applicable, collect information on industry regulations, permits, licenses, and compliance requirements.
• Market Trends: Stay informed about current market trends, consumer preferences, and emerging technologies that may impact your project.
• Stakeholder Interviews: Consider conducting initial interviews with key stakeholders, including potential customers, suppliers, and industry experts, to gather insights and feedback.

By starting with a strong foundation of existing knowledge, you'll be better prepared to identify gaps that require further investigation during the feasibility study. This proactive approach ensures that your study is comprehensive and well-informed from the outset.

How to Conduct a Market Feasibility Study?

The market feasibility study is a crucial component of your overall feasibility analysis. It focuses on assessing the potential demand for your product or service, understanding your target audience, analyzing your competition, and evaluating supply and demand dynamics within your chosen market.

Market Research and Analysis

Market research is the foundation of your market feasibility study. It involves gathering and analyzing data to gain insights into market trends, customer preferences, and the overall business landscape.

• Data Collection: Utilize various methods such as surveys, interviews, questionnaires, and secondary research to collect data about the market. This data may include market size, growth rates, and historical trends.
• Market Segmentation: Divide the market into segments based on factors such as demographics, psychographics , geography, and behavior. This segmentation helps you identify specific target markets .
• Customer Needs Analysis: Understand the needs, preferences, and pain points of potential customers . Determine how your product or service can address these needs effectively.
• Market Trends: Stay updated on current market trends, emerging technologies, and industry innovations that could impact your project.
• SWOT Analysis: Conduct a SWOT (Strengths, Weaknesses, Opportunities, Threats) analysis to identify internal and external factors that may affect your market entry strategy.

In today's dynamic market landscape, gathering precise data for your market feasibility study is paramount. Appinio offers a versatile platform that enables you to swiftly collect valuable market insights from a diverse audience.

With Appinio, you can employ surveys, questionnaires, and in-depth analyses to refine your understanding of market trends, customer preferences, and competition.

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Target Audience Identification

Knowing your target audience is essential for tailoring your product or service to meet their specific needs and preferences.

• Demographic Analysis: Define the age, gender, income level, education, and other demographic characteristics of your ideal customers.
• Psychographic Profiling: Understand the psychographics of your target audience, including their lifestyle, values, interests, and buying behavior.
• Market Segmentation: Refine your target audience by segmenting it further based on shared characteristics and behaviors.
• Needs and Pain Points: Identify your target audience's unique needs, challenges, and pain points that your product or service can address.
• Competitor's Customers: Analyze the customer base of your competitors to identify potential opportunities for capturing market share.

Competitive Analysis

Competitive analysis helps you understand the strengths and weaknesses of your competitors, positioning your project strategically within the market.

• Competitor Identification: Identify direct and indirect competitors within your industry or market niche.
• Competitive Advantage: Determine the unique selling points (USPs) that set your project apart from competitors. What value can you offer that others cannot?
• SWOT Analysis for Competitors: Conduct a SWOT analysis for each competitor to assess their strengths, weaknesses, opportunities, and threats.
• Market Share Assessment: Analyze each competitor's market share and market penetration strategies.
• Pricing Strategies: Investigate the pricing strategies employed by competitors and consider how your pricing strategy will compare.

Leveraging the power of data collection and analysis is essential in gaining a competitive edge. With Appinio , you can efficiently gather critical insights about your competitors, their strengths, and weaknesses. Seamlessly integrate these findings into your market feasibility study, empowering your project with a strategic advantage.

Demand and Supply Assessment

Understanding supply and demand dynamics is crucial for gauging market sustainability and potential challenges.

• Market Demand Analysis: Estimate the current and future demand for your product or service. Consider factors like seasonality and trends.
• Supply Evaluation: Assess the availability of resources, suppliers, and distribution channels required to meet the expected demand.
• Market Saturation: Determine whether the market is saturated with similar offerings and how this might affect your project.
• Demand Forecasting: Use historical data and market trends to make informed projections about future demand.
• Scalability: Consider the scalability of your project to meet increased demand or potential fluctuations.

A comprehensive market feasibility study will give you valuable insights into your potential customer base, market dynamics, and competitive landscape. This information will be pivotal in shaping your project's direction and strategy.

How to Conduct a Technical Feasibility Study?

The technical feasibility study assesses the practicality of implementing your project from a technical standpoint. It involves evaluating the project's design, technical requirements, technological feasibility, resource availability, and risk analysis. Let's delve into each aspect in more detail.

1. Project Design and Technical Requirements

The project design and technical requirements are the foundation of your technical feasibility study. This phase involves defining the technical specifications and infrastructure needed to execute your project successfully.

• Technical Specifications: Clearly define the technical specifications of your project, including hardware, software, and any specialized equipment.
• Infrastructure Planning: Determine the physical infrastructure requirements, such as facilities, utilities, and transportation logistics.
• Development Workflow: Outline the workflow and processes required to design, develop, and implement the project.
• Prototyping: Consider creating prototypes or proof-of-concept models to test and validate the technical aspects of your project.

2. Technology Assessment

A critical aspect of the technical feasibility study is assessing the technology required for your project and ensuring it aligns with your goals.

• Technology Suitability: Evaluate the suitability of the chosen technology for your project. Is it the right fit, or are there better alternatives?
• Scalability and Compatibility: Assess whether the chosen technology can scale as your project grows and whether it is compatible with existing systems or software.
• Security Measures: Consider cybersecurity and data protection measures to safeguard sensitive information.
• Technical Expertise: Ensure your team or external partners possess the technical expertise to implement and maintain the technology.

3. Resource Evaluation

Resource evaluation involves assessing the availability of the essential resources required to execute your project successfully. These resources include personnel, materials, and suppliers.

• Human Resources: Evaluate whether you have access to skilled personnel or if additional hiring or training is necessary.
• Material Resources: Identify the materials and supplies needed for your project and assess their availability and costs.
• Supplier Relationships: Establish relationships with reliable suppliers and consistently assess their ability to meet your resource requirements.

4. Risk Analysis

Risk analysis is a critical component of the technical feasibility study, as it helps you anticipate and mitigate potential technical challenges and setbacks.

• Identify Risks: Identify potential technical risks, such as hardware or software failures, technical skill gaps, or unforeseen technical obstacles.
• Risk Mitigation Strategies: Develop strategies to mitigate identified risks, including contingency plans and resource allocation for risk management.
• Cost Estimation for Risk Mitigation: Assess the potential costs associated with managing technical risks and incorporate them into your project budget.

By conducting a thorough technical feasibility study, you can ensure that your project is technically viable and well-prepared to overcome technical challenges. This assessment will also guide decision-making regarding technology choices, resource allocation, and risk management strategies.

How to Conduct a Financial Feasibility Study?

The financial feasibility study is a critical aspect of your overall feasibility analysis. It focuses on assessing the financial viability of your project by estimating costs, projecting revenue, conducting investment analysis, and evaluating the overall financial health of your project. Let's delve into each aspect in more detail.

1. Cost Estimation

Cost estimation is the process of calculating the expenses associated with planning, developing, and implementing your project. This involves identifying both initial and ongoing costs.

• Initial Costs: Calculate the upfront expenses required to initiate the project, including capital expenditures, equipment purchases, and any development costs.
• Operational Costs: Estimate the ongoing operating expenses, such as salaries, utilities, rent, marketing, and maintenance.
• Contingency Funds: Allocate funds for unexpected expenses or contingencies to account for unforeseen challenges.
• Depreciation: Consider the depreciation of assets over time, as it impacts your financial statements.

2. Revenue Projections

Revenue projections involve forecasting the income your project is expected to generate over a specific period. Accurate revenue projections are crucial for assessing the project's financial viability.

• Sales Forecasts: Estimate your product or service sales based on market demand, pricing strategies, and potential growth.
• Pricing Strategy: Determine your pricing strategy, considering factors like competition, market conditions, and customer willingness to pay.
• Market Penetration: Analyze how quickly you can capture market share and increase sales over time.
• Seasonal Variations: Account for any seasonal fluctuations in revenue that may impact your cash flow.

3. Investment Analysis

Investment analysis involves evaluating the potential return on investment (ROI) and assessing the attractiveness of your project to potential investors or stakeholders.

• Return on Investment (ROI): Calculate the expected ROI by comparing the project's net gains against the initial investment.
• Payback Period: Determine how long it will take for the project to generate sufficient revenue to cover its initial costs.
• Risk Assessment: Consider the level of risk associated with the project and whether it aligns with investors' risk tolerance.
• Sensitivity Analysis: Perform sensitivity analysis to understand how changes in key variables, such as sales or costs, affect the investment's profitability.

4. Financial Viability Assessment

A financial viability assessment evaluates the project's ability to sustain itself financially in the long term. It considers factors such as profitability, cash flow, and financial stability.

• Profitability Analysis: Assess whether the project is expected to generate profits over its lifespan.
• Cash Flow Management: Analyze the project's cash flow to ensure it can cover operating expenses, debt payments, and other financial obligations.
• Break-Even Analysis: Determine the point at which the project's revenue covers all costs, resulting in neither profit nor loss.
• Financial Ratios: Calculate key financial ratios, such as debt-to-equity ratio and return on equity, to evaluate the project's financial health.

By conducting a comprehensive financial feasibility study, you can gain a clear understanding of the project's financial prospects and make informed decisions regarding its viability and potential for success.

How to Conduct an Operational Feasibility Study?

The operational feasibility study assesses whether your project can be implemented effectively within your organization's operational framework. It involves evaluating processes, resource planning, scalability, and analyzing potential operational risks.

1. Process and Workflow Assessment

The process and workflow assessment examines how the project integrates with existing processes and workflows within your organization.

• Process Mapping: Map out current processes and workflows to identify areas of integration and potential bottlenecks.
• Workflow Efficiency: Assess the efficiency and effectiveness of existing workflows and identify opportunities for improvement.
• Change Management: Consider the project's impact on employees and plan for change management strategies to ensure a smooth transition.

2. Resource Planning

Resource planning involves determining the human, physical, and technological resources needed to execute the project successfully.

• Human Resources: Assess the availability of skilled personnel and consider whether additional hiring or training is necessary.
• Physical Resources: Identify the physical infrastructure, equipment, and materials required for the project.
• Technology and Tools: Ensure that the necessary technology and tools are available and up to date to support project implementation.

3. Scalability Evaluation

Scalability evaluation assesses whether the project can adapt and expand to meet changing demands and growth opportunities.

• Scalability Factors: Identify factors impacting scalability, such as market growth, customer demand, and technological advancements.
• Capacity Planning: Plan for the scalability of resources, including personnel, infrastructure, and technology.
• Growth Strategies: Develop strategies for scaling the project, such as geographic expansion, product diversification, or increasing production capacity.

4. Operational Risk Analysis

Operational risk analysis involves identifying potential operational challenges and developing mitigation strategies.

• Risk Identification: Identify operational risks that could disrupt project implementation or ongoing operations.
• Risk Mitigation: Develop risk mitigation plans and contingency strategies to address potential challenges.
• Testing and Simulation: Consider conducting simulations or testing to evaluate how the project performs under various operational scenarios.
• Monitoring and Adaptation: Implement monitoring and feedback mechanisms to detect and address operational issues as they arise.

Conducting a thorough operational feasibility study ensures that your project aligns with your organization's capabilities, processes, and resources. This assessment will help you plan for a successful implementation and minimize operational disruptions.

How to Write a Feasibility Study?

The feasibility study report is the culmination of your feasibility analysis. It provides a structured and comprehensive document outlining your study's findings, conclusions, and recommendations. Let's explore the key components of the feasibility study report.

1. Structure and Components

The structure of your feasibility study report should be well-organized and easy to navigate. It typically includes the following components:

• Executive Summary: A concise summary of the study's key findings, conclusions, and recommendations.
• Introduction: An overview of the project, the objectives of the study, and a brief outline of what the report covers.
• Methodology: A description of the research methods , data sources, and analytical techniques used in the study.
• Market Feasibility Study: Detailed information on market research, target audience, competitive analysis, and demand-supply assessment.
• Technical Feasibility Study: Insights into project design, technical requirements, technology assessment, resource evaluation, and risk analysis.
• Financial Feasibility Study: Comprehensive information on cost estimation, revenue projections, investment analysis, and financial viability assessment.
• Operational Feasibility Study: Details on process and workflow assessment, resource planning, scalability evaluation, and operational risks analysis.
• Conclusion: A summary of key findings and conclusions drawn from the study.

Recommendations: Clear and actionable recommendations based on the study's findings.

2. Write the Feasibility Study Report

When writing the feasibility study report, it's essential to maintain clarity, conciseness, and objectivity. Use clear language and provide sufficient detail to support your conclusions and recommendations.

• Be Objective: Present findings and conclusions impartially, based on data and analysis.
• Use Visuals: Incorporate charts, graphs, and tables to illustrate key points and make the report more accessible.
• Cite Sources: Properly cite all data sources and references used in the study.
• Include Appendices: Attach any supplementary information, data, or documents in appendices for reference.

3. Present Findings and Recommendations

When presenting your findings and recommendations, consider your target audience. Tailor your presentation to the needs and interests of stakeholders, whether they are investors, executives, or decision-makers.

• Highlight Key Takeaways: Summarize the most critical findings and recommendations upfront.
• Use Visual Aids: Create a visually engaging presentation with slides, charts, and infographics.
• Address Questions: Be prepared to answer questions and provide additional context during the presentation.
• Provide Supporting Data: Back up your findings and recommendations with data from the feasibility study.

4. Review and Validation

Before finalizing the feasibility study report, conducting a thorough review and validation process is crucial. This ensures the accuracy and credibility of the report.

• Peer Review: Have colleagues or subject matter experts review the report for accuracy and completeness.
• Data Validation: Double-check data sources and calculations to ensure they are accurate.
• Cross-Functional Review: Involve team members from different disciplines to provide diverse perspectives.
• Stakeholder Input: Seek input from key stakeholders to validate findings and recommendations.

By following a structured approach to creating your feasibility study report, you can effectively communicate the results of your analysis, support informed decision-making, and increase the likelihood of project success.

Feasibility Study Examples

Let's dive into some real-world examples to truly grasp the concept and application of feasibility studies. These examples will illustrate how various types of projects and businesses undergo the feasibility assessment process to ensure their viability and success.

Example 1: Local Restaurant

Imagine you're passionate about opening a new restaurant in a bustling urban area. Before investing significant capital, you'd want to conduct a thorough feasibility study. Here's how it might unfold:

• Market Feasibility: You research the local dining scene, identify target demographics, and assess the demand for your cuisine. Market surveys reveal potential competitors, dining preferences, and pricing expectations.
• Technical Feasibility: You design the restaurant layout, plan the kitchen setup, and assess the technical requirements for equipment and facilities. You consider factors like kitchen efficiency, safety regulations, and adherence to health codes.
• Financial Feasibility: You estimate the initial costs for leasing or purchasing a space, kitchen equipment, staff hiring, and marketing. Revenue projections are based on expected foot traffic, menu pricing, and seasonal variations.
• Operational Feasibility: You create kitchen and service operations workflow diagrams, considering staff roles and responsibilities. Resource planning includes hiring chefs, waitstaff, and kitchen personnel. Scalability is evaluated for potential expansion or franchising.
• Risk Analysis: Potential operational risks are identified, such as food safety concerns, labor shortages, or location-specific challenges. Risk mitigation strategies involve staff training, quality control measures, and contingency plans for unexpected events.

Example 2: Software Development Project

Now, let's explore the feasibility study process for a software development project, such as building a mobile app:

• Market Feasibility: You analyze the mobile app market, identify your target audience, and assess the demand for a solution in a specific niche. You gather user feedback and conduct competitor analysis to understand the competitive landscape.
• Technical Feasibility: You define the technical requirements for the app, considering platforms (iOS, Android), development tools, and potential integrations with third-party services. You evaluate the feasibility of implementing specific features.
• Financial Feasibility: You estimate the development costs, including hiring developers, designers, and ongoing maintenance expenses. Revenue projections are based on app pricing, potential in-app purchases, and advertising revenue.
• Operational Feasibility: You map out the development workflow, detailing the phases from concept to deployment. Resource planning includes hiring developers with the necessary skills, setting up development environments, and establishing a testing framework.
• Risk Analysis: Potential risks like scope creep, technical challenges, or market saturation are assessed. Mitigation strategies involve setting clear project milestones, conducting thorough testing, and having contingency plans for technical glitches.

These examples demonstrate the versatility of feasibility studies across diverse projects. Whatever type of venture or endeavor you want to embark on, a well-structured feasibility study guides you toward informed decisions and increased project success.

In conclusion, conducting a feasibility study is a crucial step in your project's journey. It helps you assess the viability and potential risks, providing a solid foundation for informed decision-making. Remember, a well-executed feasibility study not only enables you to identify challenges but also uncovers opportunities that can lead to your project's success.

By thoroughly examining market trends, technical requirements, financial aspects, and operational considerations, you are better prepared to embark on your project confidently. With this guide, you've gained the knowledge and tools needed to navigate the intricate terrain of feasibility studies.

How to Conduct a Feasibility Study in Minutes?

Speed and precision are paramount for feasibility studies, and Appinio delivers just that. As a real-time market research platform, Appinio empowers you to seamlessly conduct your market research in a matter of minutes, putting actionable insights at your fingertips.

Here's why Appinio stands out as the go-to tool for feasibility studies:

• Rapid Insights: Appinio's intuitive platform ensures that anyone, regardless of their research background, can effortlessly navigate and conduct research, saving valuable time and resources.
• Lightning-Fast Responses: With an average field time of under 23 minutes for 1,000 respondents, Appinio ensures that you get the answers you need when you need them, making it ideal for time-sensitive feasibility studies.
• Global Reach: Appinio's extensive reach spans over 90 countries, allowing you to define the perfect target group from a pool of 1,200+ characteristics and gather insights from diverse markets.

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How to conduct a feasibility study: Template and examples

Opportunities are everywhere. Some opportunities are small and don’t require many resources. Others are massive and need further analysis and evaluation.

One of your key responsibilities as a product manager is to evaluate the potential success of those opportunities before investing significant money, time, and resources. A feasibility study, also known as a feasibility assessment or feasibility analysis, is a critical tool that can help product managers determine whether a product idea or opportunity is viable, feasible, and profitable.

So, what is a feasibility analysis? Why should product managers use it? And how do you conduct one?

What is a feasibility study?

A feasibility study is a systematic analysis and evaluation of a product opportunity’s potential to succeed. It aims to determine whether a proposed opportunity is financially and technically viable, operationally feasible, and commercially profitable.

A feasibility study typically includes an assessment of a wide range of factors, including the technical requirements of the product, resources needed to develop and launch the product, the potential market gap and demand, the competitive landscape, and economic and financial viability.

Based on the analysis’s findings, the product manager and their product team can decide whether to proceed with the product opportunity, modify its scope, or pursue another opportunity and solve a different problem.

Conducting a feasibility study helps PMs ensure that resources are invested in opportunities that have a high likelihood of success and align with the overall objectives and goals of the product strategy .

What are feasibility analyses used for?

Feasibility studies are particularly useful when introducing entirely new products or verticals. Product managers can use the results of a feasibility study to:

• Assess the technical feasibility of a product opportunity — Evaluate whether the proposed product idea or opportunity can be developed with the available technology, tools, resources, and expertise
• Determine a project’s financial viability — By analyzing the costs of development, manufacturing, and distribution, a feasibility study helps you determine whether your product is financially viable and can generate a positive return on investment (ROI)
• Evaluate customer demand and the competitive landscape — Assessing the potential market size, target audience, and competitive landscape for the product opportunity can inform decisions about the overall product positioning, marketing strategies, and pricing
• Identify potential risks and challenges — Identify potential obstacles or challenges that could impact the success of the identified opportunity, such as regulatory hurdles, operational and legal issues, and technical limitations
• Refine the product concept — The insights gained from a feasibility study can help you refine the product’s concept, make necessary modifications to the scope, and ultimately create a better product that is more likely to succeed in the market and meet users’ expectations

How to conduct a feasibility study

The activities involved in conducting a feasibility study differ from one organization to another. Also, the threshold, expectations, and deliverables change from role to role.

For a general set of guidelines to help you get started, here are some basic steps to conduct and report a feasibility study for major product opportunities or features.

1. Clearly define the opportunity

Imagine your user base is facing a significant problem that your product doesn’t solve. This is an opportunity. Define the opportunity clearly, support it with data, talk to your stakeholders to understand the opportunity space, and use it to define the objective.

2. Define the objective and scope

Each opportunity should be coupled with a business objective and should align with your product strategy.

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Determine and clearly communicate the business goals and objectives of the opportunity. Align those objectives with company leaders to make sure everyone is on the same page. Lastly, define the scope of what you plan to build.

3. Conduct market and user research

Now that you have everyone on the same page and the objective and scope of the opportunity clearly defined, gather data and insights on the target market.

Include elements like the total addressable market (TAM) , growth potential, competitors’ insights, and deep insight into users’ problems and preferences collected through techniques like interviews, surveys, observation studies, contextual inquiries, and focus groups.

4. Analyze technical feasibility

Suppose your market and user research have validated the problem you are trying to solve. The next step should be to, alongside your engineers, assess the technical resources and expertise needed to launch the product to the market.

Dig deeper into the proposed solution and try to comprehend the technical limitations and estimated time required for the product to be in your users’ hands.

5. Assess financial viability

If your company hasa product pricing team, work closely with them to determine the willingness to pay (WTP) and devise a monetization strategy for the new feature.

Conduct a comprehensive financial analysis, including the total cost of development, revenue streams, and the expected return on investment (ROI) based on the agreed-upon monetization strategy.

6. Evaluate potential risks

Now that you have almost a complete picture, identify the risks associated with building and launching the opportunity. Risks may include things like regulatory hurdles, technical limitations, and any operational risks.

7. Decide, prepare, and share

Based on the steps above, you should end up with a report that can help you decide whether to pursue the opportunity or not. Either way, prepare your findings, including any recommended modifications to the product scope, and present your final findings and recommendations to your stakeholders.

Make sure to prepare an executive summary for your C-suite; they will be the most critical stakeholders and the decision-makers at the end of the meeting.

Feasibility study example

Imagine you’re a product manager at a digital software company that specializes in building project management tools.

Your team has identified a potential opportunity to expand the product offering by developing a new AI-based feature that can automatically prioritize tasks for users based on their deadlines, workload, and importance.

To assess the viability of this opportunity, you can conduct a feasibility study. Here’s how you might approach it according to the process described above:

• Clearly define the opportunity — In this case, the opportunity is the development of an AI-based task prioritization feature within the existing project management software
• Define the objective and scope — The business objective is to increase user productivity and satisfaction by providing an intelligent task prioritization system. The scope includes the integration of the AI-based feature within the existing software, as well as any necessary training for users to understand and use the feature effectively
• Conduct market and user research — Investigate the demand for AI-driven task prioritization among your target audience. Collect data on competitors who may already be offering similar features and determine the unique selling points of your proposed solution. Conduct user research through interviews, surveys, and focus groups to understand users’ pain points regarding task prioritization and gauge their interest in the proposed feature
• Analyze technical feasibility — Collaborate with your engineering team to assess the technical requirements and challenges of developing the AI-based feature. Determine whether your team has the necessary expertise to implement the feature and estimate the time and resources required for its development
• Assess financial viability — Work with your pricing team to estimate the costs associated with developing, launching, and maintaining the AI-based feature. Analyze the potential revenue streams and calculate the expected ROI based on various pricing models and user adoption rates
• Evaluate potential risks — Identify any risks associated with the development and implementation of the AI-based feature, such as data privacy concerns, potential biases in the AI algorithm, or the impact on the existing product’s performance
• Decide, prepare, and share — Based on your analysis, determine whether the AI-based task prioritization feature is a viable opportunity for your company. Prepare a comprehensive report detailing your findings and recommendations, including any necessary modifications to the product scope or implementation plan. Present your findings to your stakeholders and be prepared to discuss and defend your recommendations

Feasibility study template

The following feasibility study template is designed to help you evaluate the feasibility of a product opportunity and provide a comprehensive report to inform decision-making and guide the development process.

Remember that each study will be unique to your product and market, so you may need to adjust the template to fit your specific needs.

• Briefly describe the product opportunity or feature you’re evaluating
• Explain the problem it aims to solve or the value it will bring to users
• Define the business goals and objectives for the opportunity
• Outline the scope of the product or feature, including any key components or functionality
• Summarize the findings from your market research, including data on the target market, competitors, and unique selling points
• Highlight insights from user research, such as user pain points, preferences, and potential adoption rates
• Detail the technical requirements and challenges for developing the product or feature
• Estimate the resources and expertise needed for implementation, including any necessary software, hardware, or skills
• Provide an overview of the costs associated with the development, launch, and maintenance of the product or feature
• Outline potential revenue streams and calculate the expected ROI based on various pricing models and user adoption rates
• Identify any potential risks or challenges associated with the development, implementation, or market adoption of the product or feature
• Discuss how these risks could impact the success of the opportunity and any potential mitigation strategies
• Based on your analysis, recommend whether to proceed with the opportunity, modify the scope, or explore other alternatives
• Provide a rationale for your recommendation, supported by data and insights from your research
• Summarize the key findings and recommendations from your feasibility study in a concise, easily digestible format for your stakeholders

Overcoming stakeholder management challenges

The ultimate challenge that faces most product managers when conducting a feasibility study is managing stakeholders .

Stakeholders may interfere with your analysis, jumping to conclude that your proposed product or feature won’t work and deeming it a waste of resources. They may even try to prioritize your backlog for you.

Here are some tips to help you deal with even the most difficult stakeholders during a feasibility study:

• Use hard data to make your point — Never defend your opinion based on your assumptions. Always show them data and evidence based on your user research and market analysis
• Learn to say no — You are the voice of customers, and you know their issues and how to monetize them. Don’t be afraid to say no and defend your team’s work as a product manager
• Build stakeholder buy-in early on — Engage stakeholders from the beginning of the feasibility study process by involving them in discussions and seeking their input. This helps create a sense of ownership and ensures that their concerns and insights are considered throughout the study
• Provide regular updates and maintain transparency — Keep stakeholders informed about the progress of the feasibility study by providing regular updates and sharing key findings. This transparency can help build trust, foster collaboration, and prevent misunderstandings or misaligned expectations
• Leverage stakeholder expertise — Recognize and utilize the unique expertise and knowledge that stakeholders bring to the table. By involving them in specific aspects of the feasibility study where their skills and experience can add value, you can strengthen the study’s outcomes and foster a more collaborative working relationship

Final thoughts

A feasibility study is a critical tool to use right after you identify a significant opportunity. It helps you evaluate the potential success of the opportunity, analyze and identify potential challenges, gaps, and risks in the opportunity, and provides a data-driven approach in the market insights to make an informed decision.

By conducting a feasibility study, product teams can determine whether a product idea is profitable, viable, feasible, and thus worth investing resources into. It is a crucial step in the product development process and when considering investments in significant initiatives such as launching a completely new product or vertical.

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• Number 5 / September 2018

Feasibility Studies: What They Are, How They Are Done, and What We Can Learn From Them

Anne M. Kolenic

Nursing clinical research is a growing field, and as more nurses become engaged in conducting clinical research, feasibility studies may be their first encounter. Understanding what they are, how to conduct them, and the importance of properly reporting their outcomes is vital to the continued advancement of nursing science.

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Many interventions, practices, and processes exist in the nursing field that are grounded in evidence; however, problems that do not appear to be linked to any strong evidence are encountered in daily practice. Nurses are left questioning, “Why do we do it this way?” or “Is there a better way to provide this intervention?” Sometimes these questions may be answered by performing a literature search and realizing that a novel approach exists to implement into their practice; however, if the literature search does not yield any results for an evidence-based practice change, then conducting research could be the next step. Conducting a large, well-designed study can be overwhelming and expensive and may require funding; it also may not be the appropriate first step in the research process (Morris & Rosenbloom, 2017). A feasibility study may be the appropriate first step to help identify whether a larger research study is warranted.

A feasibility study is often a critical step to be taken prior to conducting a larger study. The primary aim of a feasibility study is to assess the feasibility of conducting future conclusive randomized, controlled trials (RCTs) (Eldridge et al., 2016a). Feasibility studies do not have a primary focus on effectiveness or efficacy (Eldridge et al., 2016a); they can be viewed as a dry run to identify problems that may hinder or prevent success of a subsequent larger trial (Conn, Algase, Rawl, Zerwic, & Wyman, 2010). Feasibility studies can demonstrate that a research design is achievable and that recruitment for an anticipated larger study is possible (Morris & Rosenbloom, 2017). They also can supply data that often are required to receive funding and support for a larger RCT to demonstrate that the study approach is feasible and to make a case that the proposed study will answer the question that is being posed (Morris & Rosenbloom, 2017). They also permit testing of sampling strategies, intervention content, delivery methods, data collection, and analysis (Conn et al., 2010). The article “Nurse-Delivered Symptom Assessment for Individuals With Advanced Lung Cancer” (Flannery et al., 2018) provides an example of how a nurse took a clinical question and moved it into the research arena by conducting a feasibility study to assess an intervention strategy.

A feasibility study’s focus is not on efficacy or effectiveness, but the publication of the findings is beneficial and important to the development of science and must follow high standards, just as definitive trials do (Conn et al., 2010; Eldridge et al., 2016a). The Consolidated Standards of Reporting Trials (CONSORT) statement, last updated in 2010, is a guideline designed to improve the transparency and quality of the reporting of RCTs (Eldridge et al., 2016a). Eldridge et al. (2016a) presented an extension to that statement for randomized pilot and feasibility trials conducted in advance of a future definitive RCT. The development was motivated by the increasing number of studies that were described as pilot or feasibility studies and by research that identified weaknesses in the way they were being conducted and in their reporting (Eldridge et al., 2016b). Eldridge et al. (2016b) recognized that, although much of the information to be reported in these trials was similar to RCTs, key differences also were seen, and the CONSORT standards and checklists needed to be adapted to assist in improving the reporting of pilot and feasibility studies (Eldridge et al., 2016a). When conducting and reporting a feasibility study, of importance is that the guidelines, flowchart, and checklists provided in the 2016 extension of the CONSORT 2010 statement are used by the researcher to promote transparency and to improve the quality and standardization of the reporting (Eldridge et al., 2016a).

Many terms are used interchangeably to describe preliminary studies that are done before a larger study, but consensus is growing in the field of research that distinctions among them should be recognized and more consistently used (Morris & Rosenbloom, 2017). The rationale for needing increased consistency in usage is because the way terms are defined determines the necessary components of the study (Eldridge et al., 2016b; Morris & Rosenbloom, 2017). For example, the terms feasibility studies, pilot studies, pilot RCTs, pilot trials, and pilot work are used by many authors to reference a study done in advance of a future definitive RCT and whose primary aim is to assess feasibility (Eldridge et al., 2016b; Morris & Rosenbloom, 2017). This can be confusing when reading and searching the literature. Eldridge et al. (2016b) proposed the following definitions, which may be helpful when reading articles or when a researcher is deciding on which type of study to perform:

•  Feasibility study: Research conducted to determine whether something can or should be done and, if so, how

•  Randomized pilot study: A small-scale feasibility study, conducted with randomization of participants, that evaluates the practicability of carrying out all or part of an intervention and other processes to be undertaken in a future larger study; may or may not include alternative approaches

•  Nonrandomized pilot study: A small-scale feasibility study, conducted without randomization of participants, that evaluates the practicability of carrying out all or part of an intervention—and, possibly, other processes—to be undertaken in a future larger study

•  Feasibility study that is not a pilot study: A feasibility study that does not incorporate the intervention or other processes to be undertaken in a future trial but may address the development of interventions or processes

Regardless of the type of feasibility study that will be done, they all start the same way, with a question or a problem that a clinician has come up with, followed by a literature search. After that, the researcher must identify gaps in knowledge and in the literature, followed by revision and refinement of the original question into a specific research question. Next, the reasons for conducting the preliminary research need to be considered and then the form it should take determined. The focus of feasibility studies can be on any aspect of research, including the following (Morris & Rosenbloom, 2007):

•  Processes: Informed consent procedures, recruitment approaches, nonadherence

•  Resources: Budget allocation, equipment, data collection time, time requirements

•  Management: Data management, ease of data entry, overall study feasibility, and reporting procedures

•  Science: Treatment safety, dose levels and responses, and variance of treatment effect

After the focus and form are decided, the researcher must design the study, collaborate with stakeholders, carry out the study, and analyze the results. Finally, the researcher must relate the findings to plans for a future study and disseminate the findings.

The publication of feasibility studies provides important information to the scientific community. The results of feasibility studies focus on the value of outcomes for subsequent studies rather than on specific findings (Morris & Rosenbloom, 2017). These studies can provide detailed information that often is omitted from reports of large-scale trials because of space considerations, such as changes to the protocol or other modifications that were done because of findings during the pilot (Conn et al., 2010). Often, a larger trial does not happen after the pilot study is completed for one reason or another, so publication of the pilot results may be the only publicly available record that the intervention was tested (Conn et al., 2010). Flannery et al. (2018) reported that although delivering the intervention with fidelity was possible, the feasibility findings did not warrant intervention replication. This is an important finding to report because it will prevent additional researchers from wasting their time and resources testing that same intervention and process. So, even though these findings did not support the plan to conduct a future larger study, they still provide vital information concerning this vulnerable population. This article provides detailed information on how the feasibility study was designed and conducted, allowing future researchers to change the approach and test different interventions and delivery to this population to promote their well-being.

Feasibility studies are extremely important to advance the science of nursing because they allow for the planning of subsequent larger trials. Nurses often think of ideas and solutions to everyday clinical problems and issues but are challenged to move that idea into a full-scale study. Taking that idea or solution and conducting a feasibility study may be a first step into the area of research for many nurses.

About the Author(s)

Anne M. Kolenic, DNP, APRN, AOCNS®, is an ambulatory clinical nurse specialist at the University Hospitals Seidman Cancer Center in Cleveland, OH. No financial relationships to disclose. Kolenic can be reached at [email protected] , with copy to [email protected] .

Conn, V.S., Algase, D.L., Rawl, S.M., Zerwic, J.J., & Wyman, J.F. (2010). Publishing pilot intervention work. Western Journal of Nursing Research, 32, 994–1010. https://doi.org/10.1177/0193945910367229

Eldridge, S.M., Chan, C.L., Campbell, M.J., Bond, C.M., Hopewell, S., Thabane, L., & Lancaster, G.A. (2016a). CONSORT 2010 statement: Extension to randomised pilot and feasibility trials. Pilot and Feasibility Studies, 2, 64.

Eldridge, S.M., Lancaster, G.A., Campbell, M.J., Thabane, L., Hopewell, S., Coleman, C.L., & Bond, C.M. (2016b). Defining feasibility and pilot studies in preparation for randomized controlled trials: Development of a conceptual framework. PLOS ONE, 11(3), e0150205. https://doi.org/10.1371/journal.pone.0150205

Flannery, M., Stein, K.F., Dougherty, D.W., Mohile, S., Guido, J., & Wells, N. (2018). Nurse-delivered symptom assessment for individuals with advanced lung cancer. Oncology Nursing Forum, 45, 619–630. https://doi.org/10.1188/18.ONF.619-630

Morris, N.S., & Rosenbloom, D.A. (2017). CE: Defining and understanding pilot and other feasibility studies. American Journal of Nursing, 117(3), 38–46.

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Feasibility Study

Yarilet Perez is an experienced multimedia journalist and fact-checker with a Master of Science in Journalism. She has worked in multiple cities covering breaking news, politics, education, and more. Her expertise is in personal finance and investing, and real estate.

What Is a Feasibility Study?

A feasibility study is a detailed analysis that considers all of the critical aspects of a proposed project in order to determine the likelihood of it succeeding.

Success in business may be defined primarily by return on investment , meaning that the project will generate enough profit to justify the investment. However, many other important factors may be identified on the plus or minus side, such as community reaction and environmental impact.

Although feasibility studies can help project managers determine the risk and return of pursuing a plan of action, several steps should be considered before moving forward.

Key Takeaways

• A company may conduct a feasibility study when it’s considering launching a new business, adding a new product line, or acquiring a rival.
• A feasibility study assesses the potential for success of the proposed plan or project by defining its expected costs and projected benefits in detail.
• It’s a good idea to have a contingency plan on hand in case the original project is found to be infeasible.

Lara Antal / Investopedia

Understanding a Feasibility Study

A feasibility study is an assessment of the practicality of a proposed plan or project. A feasibility study analyzes the viability of a project to determine whether the project or venture is likely to succeed. The study is also designed to identify potential issues and problems that could arise while pursuing the project.

As part of the feasibility study, project managers must determine whether they have enough of the right people, financial resources, and technology. The study must also determine the return on investment, whether this is measured as a financial gain or a benefit to society, the latter in the case of a nonprofit project.

The feasibility study might include a cash flow analysis, measuring the level of cash generated from revenue vs. the project’s operating costs . A risk assessment must also be completed to determine whether the return is enough to offset the risk of undergoing the venture.

When doing a feasibility study, it’s always good to have a contingency plan that is ready to test as a viable alternative if the first plan fails.

Benefits of a Feasibility Study

There are several benefits to feasibility studies, including helping project managers discern the pros and cons of undertaking a project before investing a significant amount of time and capital into it.

Feasibility studies can also provide a company’s management team with crucial information that could prevent them from entering into a risky business venture.

Such studies help companies determine how they will grow. They will know more about how they will operate, what the potential obstacles are, who the competition is, and what the market is.

Feasibility studies also help convince investors and bankers that investing in a particular project or business is a wise choice.

How to Conduct a Feasibility Study

The exact format of a feasibility study will depend on the type of organization that requires it. However, the same factors will be involved even if their weighting varies.

Preliminary Analysis

Although each project can have unique goals and needs, there are some best practices for conducting any feasibility study:

• Conduct a preliminary analysis, which involves getting feedback about the new concept from the appropriate stakeholders.
• Analyze and ask questions about the data obtained in the early phase of the study to make sure that it’s solid.
• Conduct a market survey or market research to identify the market demand and opportunity for pursuing the project or business.
• Write an organizational, operational, or business plan, including identifying the amount of labor needed, at what cost, and for how long.
• Prepare a projected income statement, which includes revenue, operating costs, and profit .
• Prepare an opening day balance sheet .
• Identify obstacles and any potential vulnerabilities, as well as how to deal with them.
• Make an initial “go” or “no-go” decision about moving ahead with the plan.

Suggested Components

Once the initial due diligence has been completed, the real work begins. Components that are typically found in a feasibility study include the following:

• Executive summary : Formulate a narrative describing details of the project, product, service, plan, or business.
• Technological considerations : Ask what will it take. Do you have it? If not, can you get it? What will it cost?
• Existing marketplace : Examine the local and broader markets for the product, service, plan, or business.
• Marketing strategy : Describe it in detail.
• Required staffing : What are the human capital needs for this project? Draw up an organizational chart.
• Schedule and timeline : Include significant interim markers for the project’s completion date.
• Project financials
• Findings and recommendations : Break down into subsets of technology, marketing, organization, and financials.

Examples of a Feasibility Study

Below are two examples of a feasibility study. The first involves expansion plans for a university. The second is a real-world example conducted by the Washington State Department of Transportation with private contributions from Microsoft Inc.

A University Science Building

Officials at a university were concerned that the science building—built in the 1970s—was outdated. Considering the technological and scientific advances of the last 20 years, they wanted to explore the cost and benefits of upgrading and expanding the building. A feasibility study was conducted.

In the preliminary analysis, school officials explored several options, weighing the benefits and costs of expanding and updating the science building. Some school officials had concerns about the project, including the cost and possible community opposition. The new science building would be much larger, and the community board had earlier rejected similar proposals. The feasibility study would need to address these concerns and any potential legal or zoning issues.

The feasibility study also explored the technological needs of the new science facility, the benefits to the students, and the long-term viability of the college. A modernized science facility would expand the school’s scientific research capabilities, improve its curriculum, and attract new students.

Financial projections showed the cost and scope of the project and how the school planned to raise the needed funds, which included issuing a bond to investors and tapping into the school’s endowment . The projections also showed how the expanded facility would allow more students to be enrolled in the science programs, increasing revenue from tuition and fees.

The feasibility study demonstrated that the project was viable, paving the way to enacting the modernization and expansion plans of the science building.

Without conducting a feasibility study, the school administrators would never have known whether its expansion plans were viable.

A High-Speed Rail Project

The Washington State Department of Transportation decided to conduct a feasibility study on a proposal to construct a high-speed rail that would connect Vancouver, British Columbia, Seattle, Washington, and Portland, Oregon. The goal was to create an environmentally responsible transportation system to enhance the competitiveness and future prosperity of the Pacific Northwest.

The preliminary analysis outlined a governance framework for future decision making. The study involved researching the most effective governance framework by interviewing experts and stakeholders, reviewing governance structures, and learning from existing high-speed rail projects in North America. As a result, governing and coordinating entities were developed to oversee and follow the project if it was approved by the state legislature.

A strategic engagement plan involved an equitable approach with the public, elected officials, federal agencies, business leaders, advocacy groups, and Indigenous communities. The engagement plan was designed to be flexible, considering the size and scope of the project and how many cities and towns would be involved. A team of the executive committee members was formed and met to discuss strategies, as well as lessons learned from previous projects, and met with experts to create an outreach framework.

The financial component of the feasibility study outlined the strategy for securing the project’s funding, which explored obtaining funds from federal, state, and private investments. The project’s cost was estimated to be $24 billion to $42 billion. The revenue generated from the high-speed rail system was estimated to be $160 million to $250 million.

The report bifurcated the money sources between funding and financing. Funding referred to grants, appropriations from the local or state government, and revenue. Financing referred to bonds issued by the government, loans from financial institutions, and equity investments, which are essentially loans against future revenue that need to be paid back with interest.

The sources for the capital needed were to vary as the project moved forward. In the early stages, most of the funding would come from the government, and as the project developed, funding would come from private contributions and financing measures. Private contributors included Microsoft Inc., which donated more than $570,000 to the project.

The benefits outlined in the feasibility report show that the region would experience enhanced interconnectivity, allowing for better management of the population and increasing regional economic growth by $355 billion. The new transportation system would provide people with access to better jobs and more affordable housing. The high-speed rail system would also relieve congested areas from automobile traffic.

The timeline for the study began in 2016, when an agreement was reached with British Columbia to work together on a new technology corridor that included high-speed rail transportation. The feasibility report was submitted to the Washington State Legislature in December 2020.

What Is the Main Objective of a Feasibility Study?

A feasibility study is designed to help decision makers determine whether or not a proposed project or investment is likely to be successful. It identifies both the known costs and the expected benefits.

In business, “successful” means that the financial return exceeds the cost. In a nonprofit, success may be measured in other ways. A project’s benefit to the community it serves may be worth the cost.

What Are the Steps in a Feasibility Study?

A feasibility study starts with a preliminary analysis. Stakeholders are interviewed, market research is conducted, and a business plan is prepared. All of this information is analyzed to make an initial “go” or “no-go” decision.

If it’s a go, the real study can begin. This includes listing the technological considerations, studying the marketplace, describing the marketing strategy, and outlining the necessary human capital, project schedule, and financing requirements.

Who Conducts a Feasibility Study?

A feasibility study may be conducted by a team of the organization’s senior managers. If they lack the expertise or time to do the work internally, it may be outsourced to a consultant.

What Are the 4 Types of Feasibility?

The study considers the feasibility of four aspects of a project:

Technical : A list of the hardware and software needed, and the skilled labor required to make them work

Financial : An estimate of the cost of the overall project and its expected return

Market : An analysis of the market for the product or service, the industry, competition, consumer demand, sales forecasts, and growth projections

Organizational : An outline of the business structure and the management team that will be needed

The Bottom Line

Feasibility studies help project managers determine the viability of a project or business venture by identifying the factors that can lead to its success. The study also shows the potential return on investment and any risks to the success of the venture.

A feasibility study contains a detailed analysis of what’s needed to complete the proposed project. The report may include a description of the new product or venture, a market analysis, the technology and labor needed, and the sources of financing and capital. The report will also include financial projections, the likelihood of success, and ultimately, a “go” or “no-go” decision.

Washington State Department of Transportation. “ Ultra-High-Speed Rail Study .”

Washington State Department of Transportation. “ Cascadia Ultra High Speed Ground Transportation: Framework for the Future .”

Washington State Department of Transportation. “ Ultra-High-Speed Rail Study: Outcomes .”

Washington State Department of Transportation. “ Ultra-High-Speed Ground Transportation Business Case Analysis ,” Page ii (Page 3 of PDF).

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Pilot Study in Research: Definition & Examples

Julia Simkus

Editor at Simply Psychology

BA (Hons) Psychology, Princeton University

Julia Simkus is a graduate of Princeton University with a Bachelor of Arts in Psychology. She is currently studying for a Master's Degree in Counseling for Mental Health and Wellness in September 2023. Julia's research has been published in peer reviewed journals.

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Saul Mcleod, PhD

Editor-in-Chief for Simply Psychology

BSc (Hons) Psychology, MRes, PhD, University of Manchester

Saul Mcleod, PhD., is a qualified psychology teacher with over 18 years of experience in further and higher education. He has been published in peer-reviewed journals, including the Journal of Clinical Psychology.

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Associate Editor for Simply Psychology

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On This Page:

A pilot study, also known as a feasibility study, is a small-scale preliminary study conducted before the main research to check the feasibility or improve the research design.

Pilot studies can be very important before conducting a full-scale research project, helping design the research methods and protocol.

How Does it Work?

Pilot studies are a fundamental stage of the research process. They can help identify design issues and evaluate a study’s feasibility, practicality, resources, time, and cost before the main research is conducted.

It involves selecting a few people and trying out the study on them. It is possible to save time and, in some cases, money by identifying any flaws in the procedures designed by the researcher.

A pilot study can help the researcher spot any ambiguities (i.e., unusual things), confusion in the information given to participants, or problems with the task devised.

Sometimes the task is too hard, and the researcher may get a floor effect because none of the participants can score at all or can complete the task – all performances are low.

The opposite effect is a ceiling effect, when the task is so easy that all achieve virtually full marks or top performances and are “hitting the ceiling.”

This enables researchers to predict an appropriate sample size, budget accordingly, and improve the study design before performing a full-scale project.

Pilot studies also provide researchers with preliminary data to gain insight into the potential results of their proposed experiment.

However, pilot studies should not be used to test hypotheses since the appropriate power and sample size are not calculated. Rather, pilot studies should be used to assess the feasibility of participant recruitment or study design.

By conducting a pilot study, researchers will be better prepared to face the challenges that might arise in the larger study. They will be more confident with the instruments they will use for data collection.

Multiple pilot studies may be needed in some studies, and qualitative and/or quantitative methods may be used.

To avoid bias, pilot studies are usually carried out on individuals who are as similar as possible to the target population but not on those who will be a part of the final sample.

Feedback from participants in the pilot study can be used to improve the experience for participants in the main study. This might include reducing the burden on participants, improving instructions, or identifying potential ethical issues.

Experiment Pilot Study

In a pilot study with an experimental design , you would want to ensure that your measures of these variables are reliable and valid.

You would also want to check that you can effectively manipulate your independent variables and that you can control for potential confounding variables.

A pilot study allows the research team to gain experience and training, which can be particularly beneficial if new experimental techniques or procedures are used.

Questionnaire Pilot Study

It is important to conduct a questionnaire pilot study for the following reasons:

• Check that respondents understand the terminology used in the questionnaire.
• Check that emotive questions are not used, as they make people defensive and could invalidate their answers.
• Check that leading questions have not been used as they could bias the respondent’s answer.
• Ensure that the questionnaire can be completed in a reasonable amount of time. If it’s too long, respondents may lose interest or not have enough time to complete it, which could affect the response rate and the data quality.

By identifying and addressing issues in the pilot study, researchers can reduce errors and risks in the main study. This increases the reliability and validity of the main study’s results.

Assessing the practicality and feasibility of the main study

Testing the efficacy of research instruments

Identifying and addressing any weaknesses or logistical problems

Collecting preliminary data

Estimating the time and costs required for the project

Determining what resources are needed for the study

Identifying the necessity to modify procedures that do not elicit useful data

Adding credibility and dependability to the study

Pretesting the interview format

Enabling researchers to develop consistent practices and familiarize themselves with the procedures in the protocol

Addressing safety issues and management problems

Limitations

Require extra costs, time, and resources.

Do not guarantee the success of the main study.

Contamination (ie: if data from the pilot study or pilot participants are included in the main study results).

Funding bodies may be reluctant to fund a further study if the pilot study results are published.

Do not have the power to assess treatment effects due to small sample size.

• Viscocanalostomy: A Pilot Study (Carassa, Bettin, Fiori, & Brancato, 1998)
• WHO International Pilot Study of Schizophrenia (Sartorius, Shapiro, Kimura, & Barrett, 1972)
• Stephen LaBerge of Stanford University ran a series of experiments in the 80s that investigated lucid dreaming. In 1985, he performed a pilot study that demonstrated that time perception is the same as during wakefulness. Specifically, he had participants go into a state of lucid dreaming and count out ten seconds, signaling the start and end with pre-determined eye movements measured with the EOG.
• Negative Word-of-Mouth by Dissatisfied Consumers: A Pilot Study (Richins, 1983)
• A pilot study and randomized controlled trial of the mindful self‐compassion program (Neff & Germer, 2013)
• Pilot study of secondary prevention of posttraumatic stress disorder with propranolol (Pitman et al., 2002)
• In unstructured observations, the researcher records all relevant behavior without a system. There may be too much to record, and the behaviors recorded may not necessarily be the most important, so the approach is usually used as a pilot study to see what type of behaviors would be recorded.
• Perspectives of the use of smartphones in travel behavior studies: Findings from a literature review and a pilot study (Gadziński, 2018)

Further Information

• Lancaster, G. A., Dodd, S., & Williamson, P. R. (2004). Design and analysis of pilot studies: recommendations for good practice. Journal of evaluation in clinical practice, 10 (2), 307-312.
• Thabane, L., Ma, J., Chu, R., Cheng, J., Ismaila, A., Rios, L. P., … & Goldsmith, C. H. (2010). A tutorial on pilot studies: the what, why and how. BMC Medical Research Methodology, 10 (1), 1-10.
• Moore, C. G., Carter, R. E., Nietert, P. J., & Stewart, P. W. (2011). Recommendations for planning pilot studies in clinical and translational research. Clinical and translational science, 4 (5), 332-337.

Carassa, R. G., Bettin, P., Fiori, M., & Brancato, R. (1998). Viscocanalostomy: a pilot study. European journal of ophthalmology, 8 (2), 57-61.

Gadziński, J. (2018). Perspectives of the use of smartphones in travel behaviour studies: Findings from a literature review and a pilot study. Transportation Research Part C: Emerging Technologies, 88 , 74-86.

In J. (2017). Introduction of a pilot study. Korean Journal of Anesthesiology, 70 (6), 601–605. https://doi.org/10.4097/kjae.2017.70.6.601

LaBerge, S., LaMarca, K., & Baird, B. (2018). Pre-sleep treatment with galantamine stimulates lucid dreaming: A double-blind, placebo-controlled, crossover study. PLoS One, 13 (8), e0201246.

Leon, A. C., Davis, L. L., & Kraemer, H. C. (2011). The role and interpretation of pilot studies in clinical research. Journal of psychiatric research, 45 (5), 626–629. https://doi.org/10.1016/j.jpsychires.2010.10.008

Malmqvist, J., Hellberg, K., Möllås, G., Rose, R., & Shevlin, M. (2019). Conducting the Pilot Study: A Neglected Part of the Research Process? Methodological Findings Supporting the Importance of Piloting in Qualitative Research Studies. International Journal of Qualitative Methods. https://doi.org/10.1177/1609406919878341

Neff, K. D., & Germer, C. K. (2013). A pilot study and randomized controlled trial of the mindful self‐compassion program. Journal of Clinical Psychology, 69 (1), 28-44.

Pitman, R. K., Sanders, K. M., Zusman, R. M., Healy, A. R., Cheema, F., Lasko, N. B., … & Orr, S. P. (2002). Pilot study of secondary prevention of posttraumatic stress disorder with propranolol. Biological psychiatry, 51 (2), 189-192.

Richins, M. L. (1983). Negative word-of-mouth by dissatisfied consumers: A pilot study. Journal of Marketing, 47 (1), 68-78.

Sartorius, N., Shapiro, R., Kimura, M., & Barrett, K. (1972). WHO International Pilot Study of Schizophrenia1. Psychological medicine, 2 (4), 422-425.

Teijlingen, E. R; V. Hundley (2001). The importance of pilot studies, Social research UPDATE, (35)

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What Is a Feasibility Study? How to Conduct One for Your Project

Table of Contents

What is a feasibility study, what’s the importance of a feasibility study, what is included in a feasibility study report, types of feasibility study.

• 7 Steps To Do a Feasibility Study

Feasibility Study Examples

Why is a feasibility study so important in project management? For one, the feasibility study or feasibility analysis is the foundation upon which your project plan resides. That’s because the feasibility analysis determines the viability of your project. Now that you know the importance, read on to learn what you need to know about feasibility studies.

A feasibility study is simply an assessment of the practicality of a proposed project plan or method. This is done by analyzing technical, economic, legal, operational and time feasibility factors. Just as the name implies, you’re asking, “Is this feasible?” For example, do you have or can you create the technology that accomplishes what you propose? Do you have the people, tools and resources necessary? And, will the project get you the ROI you expect?

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Feasibility study template

Use this free Feasibility Study Template for Word to manage your projects better.

A project feasibility study should be done during the project management life cycle after the business case has been completed. So, that’s the “what” and the “when” but how about the “why?” Why is it important to conduct a feasibility study?

An effective feasibility study points a project in the right direction by helping decision-makers have a holistic view of the potential benefits, disadvantages, barriers and constraints that could affect its outcome. The main purpose of a feasibility study is to determine whether the project can be not only viable but also beneficial from a technical, financial, legal and market standpoint.

The findings of your project feasibility study are compiled in a feasibility report that usually includes the following elements.

• Executive summary
• Description of product/service
• Technology considerations
• Product/service marketplace
• Marketing strategy
• Organization/staffing
• Financial projections
• Findings and recommendations

Free Feasibility Study Template

Use this free feasibility study template for Word to begin your own feasibility study. It has all the fundamental sections for you to get started, and it’s flexible enough to adapt to your specific needs. Download yours today.

There are many things to consider when determining project feasibility, and there are different types of feasibility studies you might conduct to assess your project from different perspectives.

Pre-Feasibility Study

A pre-feasibility study, as its name suggests, it’s a process that’s undertaken before the feasibility study. It involves decision-makers and subject matter experts who will prioritize different project ideas or approaches to quickly determine whether the project has fundamental technical, financial, operational or any other evident flaws. If the project proposal is sound, a proper feasibility study will follow.

Technical Feasibility Study

A technical feasibility study consists in determining if your organization has the technical resources and expertise to meet the project requirements . A technical study focuses on assessing whether your organization has the necessary capabilities that are needed to execute a project, such as the production capacity, facility needs, raw materials, supply chain and other inputs. In addition to these production inputs, you should also consider other factors such as regulatory compliance requirements or standards for your products or services.

Economic Feasibility Study

Also called financial feasibility study, this type of study allows you to determine whether a project is financially feasible. Economic feasibility studies require the following steps:

• Before you can start your project, you’ll need to determine the seed capital, working capital and any other capital requirements, such as contingency capital. To do this, you’ll need to estimate what types of resources will be needed for the execution of your project, such as raw materials, equipment and labor.
• Once you’ve determined what project resources are needed, you should use a cost breakdown structure to identify all your project costs.
• Identify potential sources of funding such as loans or investments from angel investors or venture capitalists.
• Estimate the expected revenue, profit margin and return on investment of your project by conducting a cost-benefit analysis , or by using business forecasting techniques such as linear programming to estimate different future outcomes under different levels of production, demand and sales.
• Estimate your project’s break-even point.
• Conduct a financial benchmark analysis with industrial averages and specific competitors in your industry.
• Use pro forma cash flow statements, financial statements, balance sheets and other financial projection documents.

Legal Feasibility Study

Your project must meet legal requirements including laws and regulations that apply to all activities and deliverables in your project scope . In addition, think about the most favorable legal structure for your organization and its investors. Each business legal structure has advantages and disadvantages when it comes to liability for business owners, such as limited liability companies (LLCs) or corporations, which reduce the liability for each business partner.

Market Feasibility Study

A market feasibility study determines whether your project has the potential to succeed in the market. To do so, you’ll need to analyze the following factors:

• Industry overview: Assess your industry, such as year-over-year growth, identify key direct and indirect competitors, availability of supplies and any other trends that might affect the future of the industry and your project.
• SWOT analysis: A SWOT analysis allows organizations to determine how competitive an organization can be by examining its strengths, weaknesses and the opportunities and threats of the market. Strengths are the operational capabilities or competitive advantages that allow an organization to outperform its competitors such as lower costs, faster production or intellectual property. Weaknesses are areas where your business might be outperformed by competitors. Opportunities are external, such as an underserved market, an increased demand for your products or favorable economic conditions. Threats are also external factors that might affect your ability to do well in the market such as new competitors, substitute products and new technologies.
• Market research: The main purpose of market research is to determine whether it’s possible for your organization to enter the market or if there are barriers to entry or constraints that might affect your ability to compete. Consider variables such as pricing, your unique value proposition, customer demand, new technologies, market trends and any other factors that affect how your business will serve your customers. Use market research techniques to identify your target market, create buyer personas, assess the competitiveness of your niche and gauge customer demand, among other things.

7 Steps to Do a Feasibility Study

If you’re ready to do your own feasibility study, follow these 7 steps. You can use this free feasibility study template to help you get started.

1. Conduct a Preliminary Analysis

Begin by outlining your project plan . You should focus on an unserved need, a market where the demand is greater than the supply and whether the product or service has a distinct advantage. Then, determine if the feasibility factors are too high to clear (i.e. too expensive, unable to effectively market, etc.).

2. Prepare a Projected Income Statement

This step requires working backward. Start with what you expect the income from the project to be and then what project funding is needed to achieve that goal. This is the foundation of an income statement. Factor in what services are required and how much they’ll cost and any adjustments to revenues, such as reimbursements, etc.

Related: Free Project Management Templates

3. Conduct a Market Survey or Perform Market Research

This step is key to the success of your feasibility study, so make your market analysis as thorough as possible. It’s so important that if your organization doesn’t have the resources to do a proper one, then it is advantageous to hire an outside firm to do so.

Market research will give you the clearest picture of the revenues and return on investment you can realistically expect from the project. Some things to consider are the geographic influence on the market, demographics, analyzing competitors, the value of the market and what your share will be and if the market is open to expansion (that is, in response to your offer).

4. Plan Business Organization and Operations

Once the groundwork of the previous steps has been laid, it’s time to set up the organization and operations of the planned project to meet its technical, operational, economic and legal feasibility factors. This isn’t a superficial, broad-stroke endeavor. It should be thorough and include start-up costs, fixed investments and operating costs.

These costs address things such as equipment, merchandising methods, real estate, personnel, supply availability, overhead, etc.

5. Prepare an Opening Day Balance Sheet

This includes an estimate of the assets and liabilities, one that should be as accurate as possible. To do this, create a list that includes items, sources, costs and available financing. Liabilities to consider are such things as leasing or purchasing land, buildings and equipment, financing for assets and accounts receivables.

6. Review and Analyze All Data

All of these steps are important, but the review and analysis are especially important to ensure that everything is as it should be and that nothing requires changing or tweaking. Take a moment to look over your work one last time.

Reexamine your previous steps, such as the income statement, and compare them with your expenses and liabilities. Is it still realistic? This is also the time to think about risk and come up with any contingency plans .

7. Make a Go/No-Go Decision

You’re now at the point to make a decision about whether or not the project is feasible. That sounds simple, but all the previous steps lead to this decision-making moment. A couple of other things to consider before making that binary choice are whether the commitment is worth the time, effort and money and whether it aligns with the organization’s strategic goals and long-term aspirations.

Here are some simple feasibility study examples so you have a better idea of what a feasibility study is used for in different industries.

Construction Feasibility Study

For this construction feasibility study example, let’s imagine a large construction company that’s interested in starting a new project in the near future to generate profits.

• Pre-Feasibility Study: The first step is to conduct a preliminary feasibility study. It can be as simple as a meeting where decision-makers will prioritize projects and discuss different project ideas to determine which poses a bigger financial benefit for the organization.
• Technical Feasibility Study: Now it’s time to estimate what resources are needed to execute the construction project, such as raw materials, equipment and labor. If there’s work that can’t be executed by the company with its current resources, a subcontractor will be hired to fill the gap.
• Economic Feasibility Study: Once the construction project management team has established what materials, equipment and labor are needed, they can estimate costs. Cost estimators use information from past projects, construction drawings and documents such as a bill of quantities to come up with an accurate cost estimate. Then, based on this estimate, a profit margin and financial forecasts will be analyzed to determine if there’s economic feasibility.
• Legal Feasibility Study: Now the company needs to identify all potential regulations, building codes and laws that might affect the project. They’ll need to ask for approval from the local government so that they can begin the construction project .
• Market Feasibility Study: Market feasibility will be determined depending on the nature of the project. For this feasibility example, let’s assume a residential construction project will be built. To gauge market potential, they’ll need to analyze variables such as the average income of the households in the city, crime rate, population density and any trends in state migration.

Manufacturing Feasibility Study

Another industry that uses feasibility studies is manufacturing. It’s a test run of the steps in the manufacturing production cycle to ensure the process is designed properly. Let’s take a look at what a manufacturing feasibility study example would look like.

• Feasibility Study: The first step is to look at various ideas and decide which is the best one to pursue. You don’t want to get started and have to stop. That’s a waste of time, money and effort. Look at what you intend to manufacture, does it fill an unserved need, is the market able to support competition and can you manufacture a quality product on time and within your budget?
• Financial Feasibility Study: Find out if your estimated income from the sale of this product is going to cover your costs, both direct and indirect costs. Work backward from the income you expect to make and the expenses you’ll spend for labor, materials and production to determine if the manufacturing of this product is financially feasible.
• Market Feasibility Study: You’ve already determined that there’s a need that’s not being served, but now it’s time to dig deeper to get realistic projections of revenue. You’ll want to define your target demographic, analyze the competitive landscape, determine the total market volume and what your market share will be and estimate what market expansion opportunities there are.
• Technical Feasibility Study: This is where you’ll explore the production , such as what resources you’ll need to produce your product. These findings will inform your financial feasibility study as well as labor, material, equipment, etc., costs have to be within your budget. You’ll also figure out the processes you’ll use to produce and deliver your product to the market, including warehousing and retail distribution.

There could be other feasibility studies you’ll have to make depending on the product and the market, but these are the essential ones that all manufacturers have to look at before they can make an educated decision as to whether to go forward or abandon the idea.

Best Practices for a Feasibility Study

• Use project management software like ProjectManager to organize your data and work efficiently and effectively
• Use templates or any data and technology that gives you leverage
• Involve the appropriate stakeholders to get their feedback
• Use market research to further your data collection
• Do your homework and ask questions to make sure your data is solid

If your project is feasible, then the real work begins. ProjectManager helps you plan more efficiently. Our online Gantt chart organizes tasks, sets deadlines, adds priority and links dependent tasks to avoid delays. But unlike other Gantt software, we calculate the critical path for you and set a baseline to measure project variance once you move into the execution phase.

Watch a Video on Feasibility Studies

There are many steps and aspects to a project feasibility study. If you want yours to be accurate and forecast correctly whether your project is doable, then you need to have a clear understanding of all its moving parts.

Jennifer Bridges, PMP, is an expert on all aspects of project management and leads this free training video to help you get a firm handle on the subject.

Here’s a screenshot for your reference!

Pro tip: When completing a feasibility study, it’s always good to have a contingency plan that you test to make sure it’s a viable alternative.

ProjectManager Improves Your Feasibility Study

A feasibility study is a project, so get yourself a project management software that can help you execute it. ProjectManager is an award-winning software that can help you manage your feasibility study through every phase.

Once you have a plan for your feasibility study, upload that task list to our software and all your work is populated in our online Gantt chart. Now you can assign tasks to team members, add costs, create timelines, collect all the market research and attach notes at the task level. This gives people a plan to work off of, and a collaborative platform to collect ideas and comments.

If you decide to implement the project, you already have it started in our software, which can now help you monitor and report on its progress. Try it for yourself with this free 30-day trial.

Transcription

Today we’re talking about How to Conduct A Feasibility Study, but first of all, I want to start with clarifying what a feasibility study is.

Feasibility Analysis Definition

Basically, it’s an assessment of the practicality of a proposed plan or method. Basically, we’ll want to want to know, is this feasible. Some of the questions that may generate this or we can hear people asking are, “Do we have or can we create the technology to do this? Do we have the people resource who can produce this and will we get our ROI, our Return On Investment?”

When to Do a Feasibility Study

So when do we do the feasibility study? So it’s done during a project lifecycle and it’s done after the business case because the business case outlines what we’re proposing. Is it a product or service that we’re proposing?

So why do we do this? The reason we do this is that we need to determine the factors that will make the business opportunity a success.

How to Conduct a Feasibility Study

Well, let’s talk about a few steps that we do in order to conduct the feasibility study.

Well, first of all, we conduct a preliminary analysis of what all’s involved in the business case and what we’re analyzing and what we’re trying to determine is feasible.

Then we prepare a projected income statement. We need to know what are the income streams, how are we gonna make money on this. Where’s the revenue coming from? We also need to conduct a market survey.

We need to know, is this a demand? Is there a market for this? Are customers willing to use this product or use this service?

The fourth one is to plan the business organization and operations. What is the structure, what kind of resources do we need? What kind of staffing requirements do we have?

We also want to prepare an opening day balance sheet. What are the…how again, what are the expenses, what’s the revenue and to ensure that being able to determine if we’re gonna make our ROI.

So we want to review and analyze all of the data that we have and with that, we’re going to determine, we’re going to make a go, no-go decision. Meaning, are we going to do this project or this business opportunity or not.

Well, here are some of the best practices to use during your feasibility study.

One is to use templates, tools and surveys that exist today. The great news is, data is becoming more and more prevalent. There are all kinds of technologies. There are groups that they do nothing but research. Things that we can leverage today.

We want to involve the appropriate stakeholders to ensure that input is being considered from the different people involved.

We also want to use again the market research to ensure we’re bringing in good, reliable data.

Do your homework, meaning act like is if this is your project, if it’s your money. So do your homework and do it well and make sure you give credible data.

What Is a Feasibility Report?

So ultimately in the end what we’re doing is, we’re producing and we’re providing a feasibility report. So in that report, think of this is like a template.

So what you’re gonna do is give it an executive summary of the business opportunity that you’re evaluating and the description of the product or the service.

You want to look at different technology considerations. Is it technology that you’re going to use? Are you going to build the technology?

What kind of product and service marketplace and being able again, to identify the specific market you’re going to be targeting? Also, what is the marketing strategy you’re going to use to target the marketplace?

And also what’s the organizational structure? What are the staffing requirements? What people do you need to deliver the product or service and even support it?

So also we want to know the schedule to be able to have the milestones to ensure that as we’re building things, that as we’re spending money that we’re beginning to bring in income to pay and knowing when we’re going to start recuperating some of the funding. Again, which also ties into the financial projections.

Ultimately in this report, you’re going to provide the findings and the recommendations.

Again, we’ll probably talk about technology. Are you going to build it? Are you going to buy it? What are the marketing strategies for the specific marketplace organization? You may have some recommendations for whether you’re going to insource the staff, maybe you are going to outsource some staff and what that looks like and also financial recommendation.

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Research Design | Step-by-Step Guide with Examples

Published on 5 May 2022 by Shona McCombes . Revised on 20 March 2023.

A research design is a strategy for answering your research question  using empirical data. Creating a research design means making decisions about:

• Your overall aims and approach
• The type of research design you’ll use
• Your sampling methods or criteria for selecting subjects
• Your data collection methods
• The procedures you’ll follow to collect data
• Your data analysis methods

A well-planned research design helps ensure that your methods match your research aims and that you use the right kind of analysis for your data.

Table of contents

Step 1: consider your aims and approach, step 2: choose a type of research design, step 3: identify your population and sampling method, step 4: choose your data collection methods, step 5: plan your data collection procedures, step 6: decide on your data analysis strategies, frequently asked questions.

• Introduction

Before you can start designing your research, you should already have a clear idea of the research question you want to investigate.

There are many different ways you could go about answering this question. Your research design choices should be driven by your aims and priorities – start by thinking carefully about what you want to achieve.

The first choice you need to make is whether you’ll take a qualitative or quantitative approach.

Qualitative research designs tend to be more flexible and inductive , allowing you to adjust your approach based on what you find throughout the research process.

Quantitative research designs tend to be more fixed and deductive , with variables and hypotheses clearly defined in advance of data collection.

It’s also possible to use a mixed methods design that integrates aspects of both approaches. By combining qualitative and quantitative insights, you can gain a more complete picture of the problem you’re studying and strengthen the credibility of your conclusions.

Practical and ethical considerations when designing research

As well as scientific considerations, you need to think practically when designing your research. If your research involves people or animals, you also need to consider research ethics .

• How much time do you have to collect data and write up the research?
• Will you be able to gain access to the data you need (e.g., by travelling to a specific location or contacting specific people)?
• Do you have the necessary research skills (e.g., statistical analysis or interview techniques)?
• Will you need ethical approval ?

At each stage of the research design process, make sure that your choices are practically feasible.

Prevent plagiarism, run a free check.

Within both qualitative and quantitative approaches, there are several types of research design to choose from. Each type provides a framework for the overall shape of your research.

Types of quantitative research designs

Quantitative designs can be split into four main types. Experimental and   quasi-experimental designs allow you to test cause-and-effect relationships, while descriptive and correlational designs allow you to measure variables and describe relationships between them.

With descriptive and correlational designs, you can get a clear picture of characteristics, trends, and relationships as they exist in the real world. However, you can’t draw conclusions about cause and effect (because correlation doesn’t imply causation ).

Experiments are the strongest way to test cause-and-effect relationships without the risk of other variables influencing the results. However, their controlled conditions may not always reflect how things work in the real world. They’re often also more difficult and expensive to implement.

Types of qualitative research designs

Qualitative designs are less strictly defined. This approach is about gaining a rich, detailed understanding of a specific context or phenomenon, and you can often be more creative and flexible in designing your research.

The table below shows some common types of qualitative design. They often have similar approaches in terms of data collection, but focus on different aspects when analysing the data.

Your research design should clearly define who or what your research will focus on, and how you’ll go about choosing your participants or subjects.

In research, a population is the entire group that you want to draw conclusions about, while a sample is the smaller group of individuals you’ll actually collect data from.

Defining the population

A population can be made up of anything you want to study – plants, animals, organisations, texts, countries, etc. In the social sciences, it most often refers to a group of people.

For example, will you focus on people from a specific demographic, region, or background? Are you interested in people with a certain job or medical condition, or users of a particular product?

The more precisely you define your population, the easier it will be to gather a representative sample.

Sampling methods

Even with a narrowly defined population, it’s rarely possible to collect data from every individual. Instead, you’ll collect data from a sample.

To select a sample, there are two main approaches: probability sampling and non-probability sampling . The sampling method you use affects how confidently you can generalise your results to the population as a whole.

Probability sampling is the most statistically valid option, but it’s often difficult to achieve unless you’re dealing with a very small and accessible population.

For practical reasons, many studies use non-probability sampling, but it’s important to be aware of the limitations and carefully consider potential biases. You should always make an effort to gather a sample that’s as representative as possible of the population.

Case selection in qualitative research

In some types of qualitative designs, sampling may not be relevant.

For example, in an ethnography or a case study, your aim is to deeply understand a specific context, not to generalise to a population. Instead of sampling, you may simply aim to collect as much data as possible about the context you are studying.

In these types of design, you still have to carefully consider your choice of case or community. You should have a clear rationale for why this particular case is suitable for answering your research question.

For example, you might choose a case study that reveals an unusual or neglected aspect of your research problem, or you might choose several very similar or very different cases in order to compare them.

Data collection methods are ways of directly measuring variables and gathering information. They allow you to gain first-hand knowledge and original insights into your research problem.

You can choose just one data collection method, or use several methods in the same study.

Survey methods

Surveys allow you to collect data about opinions, behaviours, experiences, and characteristics by asking people directly. There are two main survey methods to choose from: questionnaires and interviews.

Observation methods

Observations allow you to collect data unobtrusively, observing characteristics, behaviours, or social interactions without relying on self-reporting.

Observations may be conducted in real time, taking notes as you observe, or you might make audiovisual recordings for later analysis. They can be qualitative or quantitative.

Other methods of data collection

There are many other ways you might collect data depending on your field and topic.

If you’re not sure which methods will work best for your research design, try reading some papers in your field to see what data collection methods they used.

Secondary data

If you don’t have the time or resources to collect data from the population you’re interested in, you can also choose to use secondary data that other researchers already collected – for example, datasets from government surveys or previous studies on your topic.

With this raw data, you can do your own analysis to answer new research questions that weren’t addressed by the original study.

Using secondary data can expand the scope of your research, as you may be able to access much larger and more varied samples than you could collect yourself.

However, it also means you don’t have any control over which variables to measure or how to measure them, so the conclusions you can draw may be limited.

As well as deciding on your methods, you need to plan exactly how you’ll use these methods to collect data that’s consistent, accurate, and unbiased.

Planning systematic procedures is especially important in quantitative research, where you need to precisely define your variables and ensure your measurements are reliable and valid.

Operationalisation

Some variables, like height or age, are easily measured. But often you’ll be dealing with more abstract concepts, like satisfaction, anxiety, or competence. Operationalisation means turning these fuzzy ideas into measurable indicators.

If you’re using observations , which events or actions will you count?

If you’re using surveys , which questions will you ask and what range of responses will be offered?

You may also choose to use or adapt existing materials designed to measure the concept you’re interested in – for example, questionnaires or inventories whose reliability and validity has already been established.

Reliability and validity

Reliability means your results can be consistently reproduced , while validity means that you’re actually measuring the concept you’re interested in.

For valid and reliable results, your measurement materials should be thoroughly researched and carefully designed. Plan your procedures to make sure you carry out the same steps in the same way for each participant.

If you’re developing a new questionnaire or other instrument to measure a specific concept, running a pilot study allows you to check its validity and reliability in advance.

Sampling procedures

As well as choosing an appropriate sampling method, you need a concrete plan for how you’ll actually contact and recruit your selected sample.

That means making decisions about things like:

• How many participants do you need for an adequate sample size?
• What inclusion and exclusion criteria will you use to identify eligible participants?
• How will you contact your sample – by mail, online, by phone, or in person?

If you’re using a probability sampling method, it’s important that everyone who is randomly selected actually participates in the study. How will you ensure a high response rate?

If you’re using a non-probability method, how will you avoid bias and ensure a representative sample?

Data management

It’s also important to create a data management plan for organising and storing your data.

Will you need to transcribe interviews or perform data entry for observations? You should anonymise and safeguard any sensitive data, and make sure it’s backed up regularly.

Keeping your data well organised will save time when it comes to analysing them. It can also help other researchers validate and add to your findings.

On their own, raw data can’t answer your research question. The last step of designing your research is planning how you’ll analyse the data.

Quantitative data analysis

In quantitative research, you’ll most likely use some form of statistical analysis . With statistics, you can summarise your sample data, make estimates, and test hypotheses.

Using descriptive statistics , you can summarise your sample data in terms of:

• The distribution of the data (e.g., the frequency of each score on a test)
• The central tendency of the data (e.g., the mean to describe the average score)
• The variability of the data (e.g., the standard deviation to describe how spread out the scores are)

The specific calculations you can do depend on the level of measurement of your variables.

Using inferential statistics , you can:

• Make estimates about the population based on your sample data.
• Test hypotheses about a relationship between variables.

Regression and correlation tests look for associations between two or more variables, while comparison tests (such as t tests and ANOVAs ) look for differences in the outcomes of different groups.

Your choice of statistical test depends on various aspects of your research design, including the types of variables you’re dealing with and the distribution of your data.

Qualitative data analysis

In qualitative research, your data will usually be very dense with information and ideas. Instead of summing it up in numbers, you’ll need to comb through the data in detail, interpret its meanings, identify patterns, and extract the parts that are most relevant to your research question.

Two of the most common approaches to doing this are thematic analysis and discourse analysis .

There are many other ways of analysing qualitative data depending on the aims of your research. To get a sense of potential approaches, try reading some qualitative research papers in your field.

A sample is a subset of individuals from a larger population. Sampling means selecting the group that you will actually collect data from in your research.

For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

Statistical sampling allows you to test a hypothesis about the characteristics of a population. There are various sampling methods you can use to ensure that your sample is representative of the population as a whole.

Operationalisation means turning abstract conceptual ideas into measurable observations.

For example, the concept of social anxiety isn’t directly observable, but it can be operationally defined in terms of self-rating scores, behavioural avoidance of crowded places, or physical anxiety symptoms in social situations.

Before collecting data , it’s important to consider how you will operationalise the variables that you want to measure.

The research methods you use depend on the type of data you need to answer your research question .

• If you want to measure something or test a hypothesis , use quantitative methods . If you want to explore ideas, thoughts, and meanings, use qualitative methods .
• If you want to analyse a large amount of readily available data, use secondary data. If you want data specific to your purposes with control over how they are generated, collect primary data.
• If you want to establish cause-and-effect relationships between variables , use experimental methods. If you want to understand the characteristics of a research subject, use descriptive methods.

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Guidance on applying for feasibility studies

Published: 01 February 2021

Version: 4.0 - November 2023

A study designed to help prepare the ground for a larger, more definitive piece of research should either improve the chances of the subsequent study producing valuable evidence, or help to avoid wasting resource on large studies that are unlikely to answer the intended research question.

Studies of this type funded by the Research for Patient Benefit (RfPB) programme  are usually intended to inform a randomised controlled trial (RCT), but we also welcome proposals for studies in preparation for other research designs such as surveys, data linkage studies, or investigations of how best to access seldom heard groups.

When applying to RfPB for studies in preparation for a RCT to evaluate an intervention, applicants need to demonstrate the promise of the proposed intervention and identify the specific uncertainties that need to be addressed before the main study. RfPB funding committees will assess applications against these criteria, paying particular attention to the rationale for the specific uncertainties and the robustness of the plan to address them.

This document presents revised guidance for applying for funding for feasibility studies, for applicants to the RfPB programme.

Definitions

A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale.

As a subset of feasibility research, pilot studies may or may not be randomised. In a randomised pilot the future RCT design is first conducted on a smaller scale. This is intended to check that the study processes (e.g. recruitment, randomisation, treatment, follow-up assessments) all run smoothly. In some cases, this will be the first phase of the main study, and data from the pilot phase may contribute to the final analysis; this is referred to as an internal pilot. A non-randomised pilot has similar aims but without randomisation of participants.

These definitions are agreed by the Programme Grants for Applied Research (PGfAR), Efficacy and Mechanism Evaluation (EME), Health Technology Assessment (HTA) and RfPB programmes. This is in line with MRC guidance and follows Eldridge et al (2016) . 

The promise of the intervention

When applying for studies in preparation for an RCT of an intervention, applicants will be required to demonstrate, at Stage 1, that there is convincing evidence making a case to support the promise of the particular intervention. This might include:

• existing trials of effectiveness included in systematic reviews of small underpowered trials
• existing trials of efficacy
• observational, and before and after studies
• a convincing explanation for how an intervention might produce the postulated effect
• evidence that the intervention is being used in practice, in the NHS or elsewhere
• a promising signal that the intervention may be more cost effective than current practice

The programme acknowledges the potential challenge in generating a case for the promise of some complex interventions or for underrepresented groups. Judgements about the extent to which an intervention is ready for RfPB evaluation are made on a case-by case basis and are proportional to likely impact, importance to patients and the NHS, and potential costs of the feasibility work. However, applicants should be aware that even if preparatory work suggests that the proposed study design for a definitive trial is broadly feasible, funding is unlikely if a convincing case for the promise of the intervention has not been marshalled to support that wider-scale and costly research.

The specific uncertainties

All preparatory research, be it a pilot, feasibility study, proof-of-concept or exploratory qualitative research, assesses uncertainties in relation to the conduct of a larger study including whether the full study is likely to be possible. Depending on the nature of the specific uncertainties that need to be resolved, different research designs may be appropriate. For example, interviews or observations might ascertain the acceptability of an intervention, willingness to take part or be randomised, or to refine particular components of an intervention.

RfPB considers pre-RCT preparatory studies to be good value for money, as they improve the chances of success for a full RCT. However, after funding a substantial number of feasibility studies, we observe that ‘formulaic’ designs may not be efficient in resolving the uncertainties that really matter. We therefore require that preparatory work should identify the uncertainties for the conduct of the particular RCT and address them in the appropriate field and settings.

For example, uncertainty could concern:

• Acceptability of the intervention to the users
• Adherence to an intervention
• Ways to ensure representative recruitment and engagement
• The willingness of patients to be randomised
• The willingness of clinicians to randomise patients
• The choice of primary outcomes and their characteristics
• The choice of an adequate comparator
• Follow-up rates, response rates to questionnaires, adherence/compliance rates, ICCs in cluster trials, etc.
• The time needed to collect, clean and analyse data
• Practicality of delivering the intervention(s) in the proposed setting(s)
• Variation in use or delivery of the intervention in each setting

If the applicant team considers that there are no, or very few, uncertainties to be resolved, and it Is thought that the remaining uncertainties could be addressed in an internal pilot then it may be appropriate to apply directly for a RCT and plan an internal pilot, with minor feasibility questions as part of the stated progression criteria.

Here we provide examples from previously funded RfPB studies on how uncertainty can be addressed.

Testing the acceptability of the intervention in the setting

A study used mixed methods to test the feasibility of conducting a cluster randomised RCT of a fall prevention intervention in care homes. The research team tested uncertainties relating to acceptability (would enough care homes be willing to take part?), tolerability and adherence (would enough residents take part? Would they tolerate the techniques involved?) as well as implementation facilitators and barriers for the intervention. The study also explored whether it would be possible to collect valid and reliable data.

Funding awarded: £143,322

Testing the feasibility of implementing an intervention

A study in preparation for a large evaluation assessed whether a problem solving intervention for people at risk of self-harm and suicidal behaviour could be implemented in prisons and what length of follow up would be possible after the participants were released from prison. Interviews were conducted to assess the acceptability of the intervention while an interrupted time series analysis was used to examine whether an evaluation was feasible.

Funding awarded: £248,635

Testing the safety of an intervention and the feasibility of collecting data

A cohort study tested the tolerance of intravenous iron administration in patients with cystic fibrosis in preparation for a multicentre RCT. The study also tested the feasibility of collecting and measuring preliminary data on patient-focused clinical outcomes and informing sample size calculations.

Funding awarded: £148,367

Testing the acceptability of the intervention to the users

A preparatory study built on findings from a previous trial of training videos for first time users of hearing aids. The research team used a mixed-methods approach, including semi-structured interviews, to address uncertainties about adaptation of the intervention (including greater personalisation) for use with mobile technologies. Usability, delivery, accessibility, acceptability and adherence were assessed to inform the development of a definitive multi-centre RCT.

Funding awarded: £149,906

Testing the willingness of patients and clinicians to participate in a trial

A preparatory study informed the development of a fully powered RCT of treatment for patients with Barret’s Oesophagus. Qualitative interviews with a purposive sample were used to examine acceptability, to patients and clinicians, of a trial comparing surgery to endotherapy. Uncertainties included barriers to recruitment and retention and how to ensure equivalent treatment and histology interpretation in the different centres.

Funding awarded: £224,773

Pathway to RCT

RfPB Committees consider the pathway to a RCT as part of their assessment. Therefore, a clear route (e.g. progression criteria) should be included in the research plan. Applicants are expected to identify the potential funder and the anticipated time frame to the subsequent RCT. To encourage faster progression into RCTs, applicants are expected to include writing the proposal for the RCT, if shown to be feasible, within the timeframe of the RfPB feasibility study. Where the full trial is not considered to be feasible the results should be submitted for publication within the study time frame.

RfPB does fund full RCTs, although it is recognised that our current limit of £500,000 will preclude many multi-centre studies. RfPB has occasionally fast tracked preparatory studies to consideration for a full RCT within the programme and we work closely with other NIHR programmes that fund larger studies. RfPB feasibility studies have led to RCT funding from HTA, PGfAR, RfPB, EME, PHR, HS&DR, and NIHR Academy Fellowships and also from charity and other funders. Each funding programme has a specific remit. Advice about programme remits are available on their websites. Applying for funding is, or course, a highly competitive process and while our programme managers (and colleagues in the Research Support Service) will help guide applicant teams there are no guarantees of future funding, even for those preparatory studies that appear promising.

For HTA studies that undertake national evaluations of the effectiveness and cost-effectiveness of interventions, NIHR has published guidance on whether an intervention ready for HTA researcher-led evaluation . Generally, an intervention is ready for HTA evaluation if:

• There is a reasonable chance that it will be effective
• It has already been tested in a typical NHS or social care setting
• There is a reasonable chance it will be used across the NHS if shown to be effective.

HTA evaluation may also be appropriate if the intervention is already widely used in the NHS, but evidence of benefit and harms is lacking.

RfPB policy on funding studies in preparation for future research

RfPB welcomes applications for preparatory work resolving uncertainties in relation to RCTs and other large studies. Depending on their complexity and the scale of the uncertainties most studies would cost less than £300,000, while those that test an individual uncertainty (e.g. identifying a core outcome set) would cost less than £200,000. Costs higher than this will need to be fully justified with a strong case for the trajectory to patient benefit.

RfPB continues to welcome proposals for studies in preparation for future research. We are looking for a clear statement of the specific uncertainties, a sound justification for the preparatory study design and an indication that the intervention (where applicable) has promise. By funding more appropriately designed preparatory work RfPB envisages that the programme can improve the transition to large studies, including RCTs for promising interventions, within NIHR and to other funders.

Further information

Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, et al. (2016) Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework . PLoS ONE 11(3): e0150205. 

Many of the RfPB preparatory studies seek funding for follow on studies from the HTA programme . NIHR has published guidance on  whether an intervention ready for HTA researcher-led evaluation  and hints and tips for a good HTA study design . For more information, contact [email protected] .

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What is the difference between feasibility studies and pilot testing?

Feasibility study: "Feasibility studies are pieces of research done before a main study to answer the question ‘Can this study be done?’ They are used to estimate important parameters that are needed to design the main study” [1] . Data collected would not be analyzed or included in publications.

• Going to a potential site to see if the research is possible
• Checking to see what is the best approach to the research
• Going through a consent process with friends to see if the information is comprehensible
• Sending your survey instrument to a few experts in the field for their feedback as to whether or not the questions are appropriate for the topic and/or cohort of the research
• Feedback from colleagues and peers about research design
• Student researcher designs questionnaire for their study’s target population and asks someone from a different population to test the questionnaire

A researcher planning to conduct interviews regarding landowner perspectives of land use regulations contacts the US Forest Service to ask how they have typically approached land owners in the past and asks for feedback on their planned questions.

Pilot testing: “A small scale-study conducted prior to conducting an actual experiment; designed to test and refine procedures.”

• Checking to see if the designed tool works
• Asking people to complete a survey to find out whether a question results in the requested information
• Testing the intervention with four people before trying it with 60 people
• Asking people to complete your survey and then revising the questions based on their responses
• Revising the study after analyzing preliminary data and determining that the data do not address their research question
• Student researcher designs questionnaire for their study’s target population, asks the population to try out the questionnaire, and the questions are revised based on the responses

A researcher planning to conduct interviews regarding landowner perspectives of land use regulations conducts interviews with 5 people to test the questions and see if they get answers that make sense. The researchers may revise their interview guides based on the initial data collected.

Q: Does my feasibility study/pilot testing require IRB Review?

A: The federal regulations indicate that pilot testing meets the definition of research involving human subjects and requires IRB review. However, feasibility studies typically do not meet the definition of research involving human subjects and therefore would not require IRB review.

In order for the IRB to determine whether your activities constitute a feasibility study or pilot testing, and subsequently, whether they require IRB review, please complete and submit the initial sections of the HRPP application and protocol form in Cayuse. Instructions can be found on the " Preparing an Initial Submission " page. In this form, it is helpful to note with whom the study or testing is going to be done and how the data will be used.

[1] National Institute for Health Research; https://www.nihr.ac.uk/glossary/

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What Is a Feasibility Study? How to Conduct One for Your Project

Before allocating sources, a feasibility study is a crucial tool for determining whether or not the project is feasible. To confirm whether the project is technically, financially, and operationally feasible, it includes evaluating a variety of factors.

Table of Content

What is a Feasibility Study?

What’s the importance of a feasibility study, what is included in a feasibility study report, types of feasibility study, 7 steps to do a feasibility study, feasibility study examples, how to manufacturing feasibility study, best practices for a feasibility study, conclusion: feasibility study, faqs: feasibility study.

A Feasibility Study in Project Management is a comprehensive analysis conducted to determine the practicality and viability of a proposed project . It assesses various aspects such as technical, economic, legal, operational, and scheduling feasibility to ascertain if the project can be successfully completed within defined constraints. The study helps stakeholders make informed decisions about whether to proceed with the project or explore alternative options based on the identified risks, costs, benefits, and potential outcomes.

• Cost-Benefit Analysis: It permits the interested parties to carry out an exhaustive evaluation of costs and advantages to envision
• Project Viability: Evaluating the general viability and feasibility of a proposed project is critical because it enables stakeholders to determine if the project is profitable.
• Market Demand and Competition: A feasibility study gives insights into the possible purchaser base, marketplace possibilities, and competitive surroundings by analyzing market demands, trends, and opposition.
• Making Decisions: Feasibility studies provide stakeholders the information and understanding they need to decide whether or not to move ahead with the task, exchange its scope or technique, or scrap it entirely.
• Executive Summary: A executive summary is a quick assessment of the feasibility study’s important conclusions, guidelines, and findings.
• Introduction: A summary of the goals and goals to be carried out, along with the reason and scope of the feasibility study.
• Background and Context: Details about the project or business endeavors under attention, such as its heritage, purpose, and justification for conducting a feasibility study.
• Market Analysis: Market study is the process of examining the target market’s size, trends, potential for growth, customer demographics, and competitive environment. This section explores possible opportunities and difficulties as well as evaluates the demand for the suggested good or service.
• Financial Analysis: A thorough financial analysis that includes ROI calculations, cost estimates, revenue forecasts, and cash flow projections. This part evaluates the project’s prospective profitability as well as its financial viability.
• Risk assessment: It is the process of identifying and evaluating the project’s possible risks and difficulties, such as financial, technical, commercial, and regulatory concerns. The methods for decreasing and controlling those risks are described in this phase.
• Resource Requirements: Plans for allocating sources and an estimate of it’s expenses are supplied in this segment.
• Conclusion and Recommendations: An evaluate of the feasibility study’s essential conclusions and findings, together with suggestions for decision-makers.
• Appendices: Extra data, charts, tables, references, and supporting documents that give the feasibility study more context or information.
• Technical Feasibility Study: This type of feasibility take a look at evaluating a project’s technical capabilities, consisting of the accessibility of the resources, technology, and knowledge had to deliver it out efficiently. It assesses whether or not the project may be technically finished on time.
• Economic Feasibility Study: Economic feasibility studies examine a project’s expenses and feasible benefits to determine whether or not it’s financially viable. This entails comparing the project’s effect on income, charges, and profitability as well as doing cost-benefit analysis and calculating return on funding (ROI).
• Operational Feasibility Study: Operational feasibility research determine a assignment’s operational factors, which include its workflows, organizational structure, and strategies. They evaluate how successfully and efficiently the project can be performed and integrated into the current operations.
• Social Feasibility Study: It evaluates how a task will have an effect on stakeholders, neighborhood communities, and society as a whole on a social and cultural stage. To decide if the project is socially possible and suitable, they determine variables like social acceptance, stakeholder participation, community effect, and company social responsibility.
• Step1: Specify the goals and scope of the assignmentClearly state the project’s goals , objectives, and motive. Comprehending the project’s scale is critical in directing the feasibility study methodology.
• Step2: Collect relevant details and dataGather all the project-related data and information that is required. This could contain financial information, industry analysis, legal needs, technological considerations, market research, and any other elements that could have an impact on the project’s success.
• Step3 : Analyze the marketAnalyze the product or service’s potential and market demand. Examine consumer demands and preferences, market developments, rivalry, and possible entry hurdles.
• Step4: Determine Technical FeasibilityDetermine the technical specifications and capacities required to carry out the project. This involves figuring out if the infrastructure, generation, manpower, and expertise needed to create and offer the coolest or carrier are with ease available.
• Step5: Assessing the Financial ViabilityTo determine the viability and profitability of the project, do a detailed economic study. Compute the projected revenue, persevering with prices, one-time investment charges, and feasible return on investment (ROI). To ascertain whether or not the project is financially feasible, compute essential economic indicators such net present value (NPV), internal rate of run (IRR), and payback duration.
• Step6: Analyze Organizational and Operational FeasibilityExamine the project’s operational and organizational feasibility by conducting an organizational and operational feasibility analysis. Evaluate the organization’s ability and potential to carry out the project successfully. Take into account elements including the amount of workers needed, the management structure, the operating procedures, and any potential hazards or limitations.
• Step7: Compile Results and Offer RecommendationsCreate a thorough report by compiling the feasibility study’s results. Include a SWOT analysis of the main conclusions, highlighting the benefits, risks, possibilities, and threats. Provide tips approximately about the project’s viability primarily based on the study, along with whether or not to move ahead, make changes, or scrap the idea altogether.

1. Real-Estate Development Feasibility Study

Objective: The aim of this study is to assess the viability of creating a mixed-use residential and business complex at a given site.

Components:

• Market Analysis: Analyze the market to determine target demographics, the level of competition, and the demand for residential and commercial real estate in the area.
• Financial analysis: Compute the total cost of development, taking into account permits, building, and land acquisition. Determine the expected revenue from the sale or rental of real estate and evaluate the project’s profitability.
• Technical analysis : To ascertain whether development is feasible, assess the site’s characteristics, the availability of infrastructure, and zoning laws.

2. Technology Implementation Feasibility Study

Objective: The aim of this study is to evaluate the viability of integrating a novel technological solution into an enterprise.

• Technical analysis : Assess the hardware, software, and infrastructural requirements as well as the technical specifications of the technology solution. Evaluate potential integration problems as well as compatibility with current systems.
• Organizational analysis : Evaluate how well-equipped the company is to use technology, taking into account the training and skill gaps in the workforce, possible effects on daily operations, and alignment with strategic objectives.
• Financial analysis: Calculate the expenses related to the purchase, deployment, and continuing upkeep of technology. Determine whether implementing the technology will result in cost savings or increased income.
• Define the Objectives: Clearly state the aim and objectives of the manufacturing feasibility study, with an emphasis on the product to be produced and the intended results.
• Gather information: To help with the feasibility evaluation, gather information on the following topics: market demand, competitors, materials, production techniques, product specifications, and regulatory needs.
• Analyze Technical Feasibility: Determine whether the technology, tools, and information required for manufacturing are simply available. You should also look for areas where the manufacturing process might be optimized and faced with obstacles.
• Assessing Financial Feasibility : To ascertain the profitability and financial viability of producing the product, estimate the original investment and ongoing costs. Then, examine revenue estimates.
• Evaluate Operational Feasibility: To guarantee effective product production and distribution, compare labor availability, deliver chain logistics, and operational processes.
• Evaluate the Issues of Regulation and Compliance: Recognize and abide through applicable laws and regulations, securing the required licenses and certifications to guarantee ethical and steady production strategies.
• Compile Results and Offer Recommendations: Combine results into a report that emphasizes important factors and offers suggestions on whether or not the product can be manufactured, along with any necessary modifications or mitigations.
• Include Crucial Stakeholders: To assure support and obtain a variety of viewpoints, involve decision-makers, subject matter experts, and end users at every stage of the feasibility study.
• Complete Data Collection: To support the feasibility evaluation, compile accurate and thorough data from a variety of sources, such as industry reports, financial predictions, market research, and expert opinions.
• Clear Communication: Clearly and simply convey to all stakeholders the results, conclusions, and suggestions of the feasibility study. Charts, graphs, and other visual aids can help with comprehension.
• Practical Suggestions : Based on the results of the feasibility study, make practical suggestions that specify the measures that must be done in order to overcome obstacles or seize possibilities.

Related Articles:

• Phases of Project Management Process
• Characteristics of Project – Project Management

In conclusion, feasibility study helps stakeholders in decision-making by offering insightful information about the project’s likelihood of success. You can carry out an in-depth feasibility study to assess the viability of your project and raise the possibility of its success by following the steps listed and taking important variables like market demand, technical requirements, and financial feasibility into account.

1. Who carries out a feasibility study?

Project managers , business analysts, or consultants with experience in the appropriate field or industry usually carry out feasibility studies. To obtain data and insights, they might entail working together with stakeholders, subject matter experts, and other important parties.

2. What restrictions apply to a feasibility study?

Feasibility studies are subject to various constraints, such as the inability to accurately predict future conditions, dependence on assumptions and estimations, and the possibility of unanticipated hazards or external variables impacting the project’s viability . Furthermore, while feasibility studies offer a well-informed assessment of a project’s potential viability, they cannot ensure that it will succeed.

3. What is the duration of a feasibility study?

The complexity of the project, the accessibility of information and resources, and the extent of the analysis can all affect how long a feasibility study takes. The duration of feasibility studies might range from a few weeks to many months.

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• Published: 14 May 2024

Can on-line gait training improve clinical practice? Study protocol for feasibility randomised controlled trial of an on-line educational intervention to improve clinician’s gait-related decision-making in ambulant children and young people with cerebral palsy

• Anna Hebda-Boon   ORCID: orcid.org/0000-0002-7091-2828 1 ,
• Adam P. Shortland 2 ,
• Aleksandra Birn-Jeffery 3 &
• Dylan Morrissey 1 , 4  

Pilot and Feasibility Studies volume  10 , Article number:  76 ( 2024 ) Cite this article

Metrics details

Instrumented gait analysis (IGA) is an assessment and research tool with proven impacts on clinical decision-making for the management of ambulant children and young people with cerebral palsy (CYPwCP) but is underused and variably understood by relevant clinicians. Clinicians’ difficulties in gaining expertise and confidence in using IGA are multifactorial and related to access for clinical decision-making, limited training opportunities and inability to translate this training into clinical practice.

The primary aim of this study is to test the feasibility of an educational intervention to advance clinicians’ application of gait analysis in CYPwCP, to inform a definitive trial. The secondary aim is to measure the effect that appropriate IGA training has on physiotherapists’ knowledge, skills, confidence and behaviours. This will be a two-arm feasibility randomised controlled trial with an experimental and control group. The 6-week on-line intervention uses a multicomponent approach grounded in behavioural change techniques. A repeated measures design will be adopted, whereby participants will complete outcome measures at baseline, immediately after the intervention and at 4 months. The primary outcome measures (trial feasibility-related outcomes) are recruitment and engagement. The secondary outcome measures (trial research-related outcomes) are knowledge, skills, confidence and practice change. Outcome measures will be collected via online questionnaires and during observed skill assessments. Analysis of data will use descriptive statistics, two-way mixed ANOVA model and qualitative content analysis.

This study will determine feasibility of the definitive randomised control trial of educational intervention delivered to advance clinicians’ application of gait analysis in CYPwCP. This study offers the shift in emphasis from regarding IGA as a tool to a focus on clinicians’ requirements for access, training and a well-defined role to optimise utilisation of IGA. The impact of this should be better engagement with IGA and clinical practice change. This study will contribute to a body of educational research into clinical education of healthcare professionals and IGA training offering insight into high levels of evaluation evidence including clinical behaviour change.

Trial registration

Protocol has been registered with the Open Science Framework (osf.io/nweq6) in June 2023.

Peer Review reports

The National Institute for Clinical Excellence (NICE) refers to instrumented gait analysis (IGA) assessment as a preferable choice prior to gait-improving orthopaedic surgery [ 1 ]. The impact of IGA on decision-making in treatment planning and treatment outcomes for ambulant CYPwCP has been broadly debated in the literature particularly in areas of orthopaedic decision-making [ 2 , 3 , 4 , 5 ] and individually tailored nonsurgical treatments [ 6 , 7 ]. Generally, single event multilevel surgeries (SEMLS) are performed after IGA is conducted as the IGA results can help to determine which specific soft-tissue or bony surgical procedures should be performed [ 8 ]. Furthermore, studies show that use of IGA for treatment decision-making has potential to improve patient outcomes — authors indicate the positive gait-related outcomes and improvement in gait parameters when treatment matches IGA recommendations [ 9 , 10 , 11 ]. Despite this, more standardised access pathways for CYPwCP to IGA are yet to be established [ 7 , 12 ], and access to the IGA for other professionals involved in gait management such as physiotherapists or orthotists and their formal IGA education remains limited [ 13 ]. As a science, gait analysis brings a wide spectrum of knowledge and skills, making it hard to educate and successfully integrate it into undergraduate curricula [ 14 ]. Clinicians’ difficulties in gaining expertise and confidence in using IGA are multifactorial and can be related to lack of IGA access for clinical decision-making, limited training opportunities and inability to translate this training into clinical practice [ 15 ].

According to research, clinician-centred factors such as IGA training and affiliation to IGA laboratory [ 16 ] are shown to influence engagement with IGA-derived recommendations and may therefore impact on patient outcomes [ 17 ].

This indicates a required shift in emphasis from regarding IGA as a tool providing 3rd party recommendations to a focus on clinicians’ requirements for access, training and a well-defined role to optimise utilisation of IGA [ 17 ]. This is essential to address in order to improve inequity of access and patient outcomes. Findings of our previous research [ 15 , 17 ] provided context for the design and delivery of a feasibility randomised controlled trial (RCT) of an educational intervention to improve clinicians’ engagement with the IGA.

Study aims and objectives

The primary aim of this study is to determine the feasibility of an educational intervention to advance clinicians’ application of instrumented gait analysis in children and young people with cerebral palsy, to inform the design of a full trial. Objectives are as follows:

To establish the feasibility of a future randomised controlled trial of educational intervention.

Assess the rate of participant enrolment, retention and compliance with intervention.

Assess whether the inclusion and exclusion criteria for participants are appropriate.

Assess whether the duration of intervention is appropriate.

Assess whether intervention delivery in a virtual learning environment is feasible and acceptable.

Explore if the outcome measures are appropriate for the study aims.

Define the sample size for a definitive trial.

Explore the fidelity of intervention delivery.

Further understand the barriers and facilitators of the intervention.

The secondary aim is to measure the effect that appropriate IGA training and its delivery has on physiotherapists’ knowledge, skills and attitudes.

This feasibility trial protocol follows the SPIRIT statement on defining standard protocol items for clinical trials and its checklist [ 18 ] and the CONSORT statement extension to randomised pilot and feasibility trials and its checklist [ 19 ].

Trial design

This will be a two-arm feasibility randomised controlled trial with an experimental and control group. The 6-week on-line intervention delivered as part of the trial is a stand-alone, post-graduate level educational course called Virtual Gait Analysis Course for Paediatric Physiotherapists (VGAPP). Eligible physiotherapists who consent to take part in the study will be randomly allocated into experimental and control groups. A repeated measures design will be adopted, whereby participants will complete outcome measures at baseline, immediately after the intervention, and at 4 months. This will include collection of feedback as part of a full process evaluation.

The trial will be determined feasible if a priori set criteria based on primary outcome measures and included in the process evaluation will be achieved at or above agreed levels (see the ‘ Outcome measures ’ section of ‘ Methods ’). After conducting and reviewing outcomes of the full evaluation process, the decision about delivery of the definitive trial will be made.

Figure  1 shows the study flow diagram, and Table  1 indicates the schedule of enrolment, intervention, and outcome measures [ 18 ].

Study flow diagram

Participants

Study setting.

This study will be conducted virtually using Queen Mary University of London (QMUL) virtual learning environment (VLE), online questionnaires (SurveyMonkey), and Microsoft Teams, eradicating the need for participants to travel, reducing both cost and participants’ time. Participating clinicians will be working in a variety of settings (acute and community, special schools, both national health service and private settings) within the UK, where the data will be collected. Each participant’s data will be collected under their unique student number. To ensure anonymity, once data collection is complete, student numbers will be additionally coded.

Eligibility criteria

The aim of the inclusion and exclusion criteria is to ensure that participants are actively involved in assessment and treatment of ambulant CYPwCP and have currently available opportunities to apply the taught knowledge and skills in their workplace. The eligibility criteria were reviewed during the stakeholder focus groups including both clinicians and educators. Focus groups found inclusion and exclusion criteria appropriate for the feasibility trial (see Supplementary material).

Inclusion criteria are as follows:

18 years of age or older

Physiotherapists currently providing assessment and treatment to ambulant children and young people with cerebral palsy

Practicing within the UK (any National Health Service or private practice setting)

Exclusion criteria are as follows:

Outside of UK

Not currently employed as physiotherapist or on a career break

In rotational posts, where they could rotate to specialty not managing ambulant CYPwCP

Intervention

Design and refinement.

This educational intervention uses a multicomponent approach grounded in behavioural change techniques (BCTs). The overall aim of the intervention is to improve gait-related clinical practice.

Intervention (VGAPP) will be delivered via QMUL VLE and will comprise of pre-course resources and a 6-week course. Content of the VGAPP course has been developed based on evidence from the scientific literature, current best practice and informed by the scoping review [ 17 ], qualitative study [ 15 ] and results from a national survey of paediatric physiotherapists in the UK (unpublished, in review). Stakeholder engagement has been integral to the research and intervention design, delivery and evaluation process and included Patient and Families (PPI-A) interviews and Clinicians and Educators Focus Groups (PPI-B) (Fig.  2 ). PPI-A included children, young people and their families who have a lived experience of cerebral palsy and received IGA as part of management of their condition. PPI-A was involved in the design of intervention prior to involving clinicians in order to ensure that the project is centred around the needs of patients and to ensure that the practice behaviour change, and transfer of knowledge will directly benefit patients and their families. Themes, subthemes and illustrative quotes from patients and parents’ interviews and changes applied to the intervention and evaluation content are available in the Supplementary Table  1 . PPI-B were representatives from all UK nations, with a variety of paediatric physiotherapy specialisms, experience levels and from different work settings, thus providing invaluable insight and the opportunity for further refinement of the intervention design (in the areas of recruitment, eligibility criteria, sample size, control group intervention), content, delivery and evaluation methods. Themes, subthemes, and illustrative quotes from clinicians and educators focus groups and changes applied to intervention and evaluation content are available in the Supplementary Table  2 .

Stakeholder engagement

Through this process, several changes were implemented to the intervention content and assessment process in areas of communication, patient/family perspectives, orthotics, and linking elements of gait-related practice to the ICF domains. A detailed PPI involvement report, including the educational intervention refinement process is available from the corresponding author on reasonable request.

Pre-intervention resources

Pre-intervention resources will include the pre-course manual, ‘meet and greet’ forum and the reading list. Participants will be able to complete a self-diagnostic tool to identify and reflect on their current IGA engagement and barriers to confident gait-related practice.

Intervention components

The intervention will be a stand-alone, post-graduate level educational event delivered fully on-line. It will employ the delivery of weekly on-line plenary sessions incorporating active learning — synchronous on-line problem-based learning sessions and seminars integrating elements of experimental learning within the learning community. These sessions will be delivered by experienced educators and clinicians working in the instrumented gait analysis laboratories, with a track record of delivering education within the field of gait analysis and paediatric neurodisability. Educators will be approached via email by the lead researcher. Content of the intervention will encompass an array of gait analysis methods and an overview of equipment currently used in the clinical practice. This will include but will not be limited to clinical outcome measures, measurement software, videography techniques and setup, 3-dimensional motion laboratory equipment, and laboratory setup (examples of Vicon and Codamotion Systems). Intervention will comprise of weekly tasks (asynchronous) to facilitate revision and application in practice and formative assessment/feedback opportunities (short knowledge quizzes, open questions within the discussion forum) to support learning autonomy and facilitate participant’s recall and self-regulation. Table 2 provides an indicative number of hours for each activity to give an overall picture of the workload a participant would be expected to undertake.

The intended learning outcomes (ILOs) have been designed and benchmarked against the QAA Statements Physiotherapy (2001) Academic Content.

Academic content is as follows:

Demonstrates an understanding of the interdisciplinary knowledge that underpins gait analysis practice including elements of human anatomy, biomechanics, and gross motor development: C1

Demonstrates an understanding of the principles of typical gait pattern and how movement patterns are likely to be affected by some of the childhood diseases: C1

Demonstrates an understanding of the available measurement technologies and the principles on which they are based: C1

Disciplinary skills are as follows:

Applies variety of gait assessment methods in context of own practice and service delivery: B1 and C2

Uses the gait analysis outputs in clinical practice to aid treatment decision-making and measurement — in line with clinical reasoning paradigms and evidence-based practice: A1, B1, and C2

Communicates assessment findings and gait-related decision-making effectively with multidisciplinary team, patients, and families: A2, A3, B2, and C2

Attributes are as follows:

Cultivates an individualised, patient-centred approach to assessment and treatment planning: B2

Reflects on own practice to identify the needs within own role and wider aspects of service delivery: A3, A4, and B2 (health and social care equivalent B4)

Demonstrates a creative drive to implement the knowledge and skills, improve own practice, and support development of others: A3, A4, and B2 (health and social care equivalent B3)

Behaviour change techniques (BCT)

Utilisation of the BCT taxonomy [ 20 ] will support refinement of the targeted behaviours. It will also support the process evaluation analysis to gain understanding of how the change is expected to take place [ 21 ] and related barriers and facilitators of implementing the feasibility trial. To support knowledge transfer, several behaviour change techniques will be used in the intervention content.

Prior to the course, participants will gain access to a diagnostic session to identify potential internal and/or external barriers to their gait-related practice. They will be encouraged to set their personal and service goals and will be supported in making plans for delivery. Participants will share their plans and progress as part of the evaluation process.

A variety of synchronous (problem-based learning sessions) and asynchronous resources (lectures, reading links and podcasts) will incorporate instruction on how to perform new or refined gait-related practice behaviours. These resources will also support shaping of the participant’s knowledge through instruction and demonstration on how to perform the behaviours and setting clinically oriented practical tasks focusing on the behaviour. Throughout the course, participants will be provided strategies to support behaviours through associations such as regular prompts and cues, ideas on restructuring of their clinical environment to improve their gait assessment quality and techniques, or through objects which could be added into their environment (such as outcome measure templates — digital and/or printed). A virtual learning community, created through group chats and discussion forums, will aim to support emergence of the identity associated with changed behaviours.

Figure  3 outlines the simplified logic model of the study.

Feasibility RCT study logic model

Control group intervention

To compare the effects of the intervention against usual practice, participants allocated into the control group will be asked to continue with their usual practice. At the point of enrolment, the control group will gain access to the virtual learning environment and receive basic orientation resources, but no training or guidance will be offered during this time. Participants in the control group will be asked to complete the same measurements as those in the intervention group and at the same timepoints (Table  1 ). The control group will be offered the full intervention after the completion of the third round of assessments. Provision of educational content and its timing in the control group were reviewed during the stakeholder focus groups including of clinicians and educators.

Outcome measures

Outcome measures were grouped as primary outcome measures (trial feasibility-related outcomes) and secondary outcome measures (trial research-related outcomes) collated in Table  3 .

Recruitment will be determined as feasible if study is able to recruit 24 participants within 4 months [ 22 , 23 ]. Retention rates will be considered at two stages: (1) from expression of interest to consent — it will be deemed feasible if greater than 50%, and (2) from consent to course completion — it will be deemed feasible if greater than 75% [ 24 , 25 ]. Additionally, engagement (participants’ interactions with an online system) data will be collected during intervention via the analytics tools in the QMUL Virtual Learning Environment which log the detail of activity access, time, and completion for each component. These analytic tools are part of the general-purpose dashboard and provide an algorithmic representation of student online behaviours based on whether the behaviour occurred and for how long, rather than quality of these behaviours. Previous studies show that these analytics have been positively correlated with student performance [ 26 , 27 , 28 ]. It will be deemed feasible if the average proportion of completed learning sessions and tasks will be ≥ 66%.

Secondary outcomes are as follows: knowledge, skills, attitudes, and satisfaction will be collected via online questionnaires (SurveyMonkey) and during skill tests (OSCE). Knowledge, skills, and attitudes will be collected at three timepoints (Table  1 ).

Baseline (pre-intervention)

Questionnaire including background (demographics, current gait analysis practice, access to IGA equipment, barriers to gait analysis practice), attitudes (reasons for joining the study, anticipated changes in practice after the intervention, beliefs), confidence (self-rated), and knowledge (self-rated and multiple-choice question test)

Objective structured clinical examination (OSCE) of a patient case: Assessment will be delivered on-line, recorded and scored against a standardised scoring sheet including gait-related clinical reasoning and treatment planning based on evidence and findings, problem-solving, systematicity of approach, ability to link various types of gait-related information, confidence in engagement with gait data, analysis of gait graphs, communication (including use of gait-related terminology, providing lay explanations to a parent), and implementation of biopsychosocial model or ICF to decision-making

Post intervention (immediately after 6-week intervention)

Questionnaire including attitudes (planning practice change, implemented practice change, beliefs), confidence (self-rated), knowledge (self-rated and multiple-choice question test), and satisfaction (experimental group only)

OSCE of a different patient case (scored against the same criteria as at baseline)

Re-test (4-month post-intervention)

Questionnaire attitudes (planning practice change, implemented practice change, beliefs), confidence (self-rated), and knowledge (self-rated and multiple-choice question test)

Knowledge and skills retention as well as attitudes will be measured between timepoints, with a focus on changes between baseline and immediately post intervention and at 4-month follow-up. Satisfaction questionnaire will contain 28 items, each assessed on a 5-point Likert scale, related to the relevance and scientific quality of the content, the educational structure, and delivery. Satisfaction feedback will be collected immediately after intervention delivery (experimental group).

Sample size

Considering the study objectives and recommendations, the target sample size will be of a minimum 12 participants per trial arm; therefore, a minimum of 24 in total is anticipated. Guidance from the National Institute for Health Research (NIHR) indicates that a sample size of 30 is appropriate to answer the questions posed by a feasibility trial [ 23 ]. A lower number of participants will be better suited for an educational intervention for clinicians — it will ensure delivery of a high-quality learning experience and allow for active engagement with tutors during problem-based learning within the experimental group. Furthermore, the stakeholder focus groups including of clinicians and educators reviewed the proposed sample size and reported it as appropriate for the feasibility trial.

Recruitment

Participants will be recruited via the largest national paediatric physiotherapy network (Association of Chartered Paediatric Physiotherapists) using bulletins, social media, and targeted emails to team leads across the UK. The advertisement will provide general information about the intervention and the research study together with inclusion and exclusion criteria. Upon expression of interest, participants will be screened against eligibility criteria, and the participant’s information sheet and consent form will be sent to prospective participants via email. Participants will return signed consent forms electronically to the research lead. In line with advice from the Clinician and Educator Focus Group (PPI-B), the recruitment of study participants will commence early to ensure that participants are able to make suitable arrangements in the workplace, such as request study leave and ‘block time’ to attend synchronous sessions etc.

Participant timeline

Time schedule of enrolment, intervention, and assessments is presented in Table  1 . After the eligibility criteria screen and receipt of their written informed consent, 24 participants will be enrolled to the study. After random allocation to the trial arms, participants will receive access to the password-protected online platform hosted by Queen Mary University of London. All participants will be asked to complete the baseline assessment including the questionnaire (background, attitudes, knowledge, and skills) and objective structured clinical examination (OSCE) of a patient case (assessment will be delivered on-line, recorded, and scored against standardised scoring sheet). After completing the baseline assessment, participants assigned to the experimental arm will gain access to the pre-course learning resources (6 weeks prior to start of the course). The experimental group will commence the 6 week blocks of intervention including pre-recorded resources, problem-based learning tasks, discussion forums, and live sessions. At 6 weeks, participants from both arms will be asked to complete the second assessment including the questionnaire (attitudes, knowledge and skills, and satisfaction scores in experimental group only) and the second OSCE of a patient case. Four months after the intervention, participants in both trial arms will be asked to complete the third assessment including the questionnaire (attitudes, knowledge, and skills) and the OSCE of a patient case. Once all the data is collected, participants in the control group will gain access to the prereading resources and start the 6-weekly intervention sessions.

Assignment of intervention

Allocation, concealment mechanism, and implementation.

Participants who meet the inclusion criteria and return the consent form will be assigned an ID number in the Microsoft Excel spreadsheet. Participants will be assigned to groups randomly. In case there are more eligible physiotherapists than spaces, participants will be chosen by the number generation software which will be used in the allocation process. This will be conducted by an external person not related to the study or the research team. To avoid contamination, participants from the same healthcare trusts will be randomised to the same group.

Information about group randomisation will be provided in the participant’s information sheet. Participants in this study will not be blinded to the group allocation or deceived. This was discussed in the stakeholder focus groups who agreed that in the context of clinical practice, deceiving participants could mean a loss of their study/annual leave if pre-booked specifically to attend the intervention as well as potential cancelations of clinics in the control group. Participants will be informed about their allocation at the time of receiving instructions with the QMUL VLE platform access. At this time, the control group will be informed about timings of gaining their access to the full intervention and all resources provided to the experimental group after final assessments are completed. Participants will be informed that they are free to withdraw at any time without needing to provide a reason and with no penalties or detrimental effects.

Data collection, management, and analysis

In line with accepted practice for feasibility studies, no power analysis will be conducted, and all analyses will be exploratory only [ 29 ]. Data analysis will be performed after the last trial participant has completed final assessments (outcomes at 4 months post intervention). Data will be managed initially in Microsoft Excel software and analysed using IBM SPSS statistics software. Table 3 provides a summary of outcome measures, hypotheses, and analysis planned in the study.

Data management and research governance

A baseline table (descriptive statistics and frequencies) will compare the demographic and clinical characteristics including gender, age, experience, education, practice setting, contract type, study leave availability to participate in intervention, access to equipment, and gait analysis training. The primary outcomes will be reported using descriptive statistics. The quantitative variables will be presented as means and standard deviations.

A preliminary analysis of between-group differences will be conducted to determine the range of potential effect sizes from repeated measures ANOVA. Feasibility outcomes will be presented as number of participants meeting the a priori definitions. Kendall’s tau-b ( τ b ) correlation coefficient will be used to measure of the strength and direction of association that exists between two variables measured on at least an ordinal scale. To explore the extent and patterns of missing outcome data, we will report the proportion of missing values per item and the proportion of participants who will complete all items on the questionnaires. The proportion of missing data will also be reported for the other key outcomes and compared between the participants from intervention and control groups.

Qualitative data will be analysed according to the framework approach [ 30 ], a realist approach located within an interpretivist frame. The opinions and experiences of participants will be explored to understand any barriers and facilitators related to running of the educational intervention. During active familiarisation, the textual data will be coded, and codes will be organised into themes and subthemes to construct a thematic framework to aid indexing. To ensure rigour and consistency, the analysis process will undergo investigator triangulation. In this process, different observers, examiners, and analysts will compare and check data collection and/or interpretation [ 30 , 31 ]. Qualitative data will be presented as quotes and descriptive summaries.

Process evaluation and implementation outcomes

The process evaluation has been informed by Medical Research Council guidance on process evaluation of complex interventions [ 32 , 33 ] and the Implementation Outcome Framework (IOF) [ 34 ]. Proctor et al. described eight implementation outcomes in the IOF: acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration (or coverage), and sustainability. Each of these implementation outcomes aligns with important considerations for trial design and implementation; however, the ‘adoption’ outcome does not directly align with process evaluation of our current feasibility trial design and delivery, as it is not offered by other educational providers. Therefore, seven out of eight implementation outcomes will be included in this process evaluation. Acceptability of the intervention and of the assessments will include data on the duration, content, and delivery methods (including satisfaction scores). Synthesis of satisfaction scores, feedback, and reports on participants’ logistics related to taking part in the trial (protected study time, ensuring opportunities in practice, assessment burden) will be carried out. The findings will be supplemented with observations made by the researchers, educators, administrative staff, and examiners throughout the implementation of the intervention. Collectively, these will provide information on the acceptability of the trial measurements and the intervention. Feasibility measures will include participant recruitment rate, retention, and engagement thresholds as described in the ‘ Methods ’ section. The process evaluation will include analysis of proportion of eligible participants being offered trial and, if possible, proportion of participants in the population represented by eligibility criteria (coverage).

Baseline comparisons will be conducted to detect any substantial differences between participants recruited from the control and intervention arms. Sample size and anticipated effect size defined for the definitive trial will be reviewed and assessed for feasibility. Participant withdrawals and number of participants lost to follow-up (and where possible reasons and participants’ key baseline characteristics) will be analysed. The study protocol adherence will be reviewed within the research team. Fidelity to the trial protocol including follow-up, dosage of the intervention, crossover between study arms, and adherence to intervention delivery plan will be assessed against study protocol and participant timelines. Any changes to the protocol will be reported.

Furthermore, appropriateness of the trial design for the trial aim, inclusion and exclusion criteria, outcome measures, and intervention components will undergo an exploratory analysis of participants’ outcomes, engagement with content, and assessments, together with qualitative analysis of participants and educators’ feedback. Sustained participant interest throughout the trial period and sustained staffing levels to deliver and facilitate participants’ learning journey during intervention will be explored to inform the sustainability criteria for the definitive trial. The implementation cost analysis will be explored with the aim to inform the design of a full cost-utility analysis alongside a future definitive trial. Implementation cost will include the cost of administration involved in running the trial and cost related to production and delivery of the intervention and assessment components — such as speaker fees, and OSCE examiners and moderators will be reviewed.

In addition, the COM-B model and the behaviour change techniques taxonomy (BCTT) [ 35 ], widely used frameworks in behaviour change and implementation research, will support the process evaluation analysis and an in-depth exploration of the barriers and facilitators of implementing the feasibility trial.

This article describes the protocol of a study evaluating the feasibility of conducting definitive RCT of the educational intervention for paediatric physiotherapists working with ambulant CYPwCP in the UK. This feasibility study was designed to assess predefined criteria related to the evaluation design (such as reducing uncertainty around recruitment, retention, choice of outcomes, analysis) and the intervention (its content and delivery, acceptability, adherence, cost-effectiveness, etc.) in line with the current guidance [ 32 , 33 ].

The educational intervention planned for this trial intends to integrate the complexity of knowledge, skills within the realities of clinicians’ practice to support knowledge translation to influence the practice behaviour change. Due to its complexity, the design of the study was preceded by in-depth research studies of the intervention’s context and implementation factors within the clinical practice reality of paediatric physiotherapists. This included close collaboration with stakeholders — patients and their families, clinicians, and clinical educators [ 33 ].

The need for gait analysis training was clearly identified in previous study of physiotherapists in the UK [ 13 ]. Despite extensive gait-related practice [ 36 , 37 ], evidence of how paediatric physiotherapists engage with instrumentation or access the IGA training is sparse. There are currently many gait-related courses available world-wide delivered by a variety of providers specifically targeting this clinical group (CMAS workshop 2023). Although there is a rich training offer, the impact of training on skills and behaviour, evaluation of needs, and barriers to knowledge transfer are not addressed in the current literature showing an evidence gap (CMAS 2023 education workshop). The impact of existing educational interventions is rarely reported [ 38 , 39 ] and concerns low levels of evaluation evidence, omitting evaluation clinical behaviour change or organisational impact. Our previous studies show that transfer of gait-related knowledge from the classroom to the clinic room also poses challenges to clinicians at different levels of practice expertise [ 15 ]. The lack of institutional resources (financial, such as availability of funding for staff’s training or limited study leave), spatial and temporal to promote implementation of new procedural skills and motivation to engage with learning, may also influence low uptake of professional training.

One of the main challenges will be associated with possible low uptake in the study and high drop-out rate. High work pressures and limited time to study may result in reduced opportunity or willingness to participate in the intervention and multiple assessments.

Limitations

Participants in this trial will not be blinded to allocation. After discussions within the research team and stakeholder focus groups, it was decided that if a participant secures study leave to take part in the 6-week intervention (potentially taking time off clinical work which may lead to cancellation of clinics) and would not receive the intervention due to allocation to the control group — this may result in loss of study leave and could have a potentially negative impact on the patient’s care by added waiting time.

The intervention lead is a paediatric physiotherapist experienced in gait-related practice which may be a source of potential bias. To mitigate this risk, multiple educators and clinical experts will be appointed to co-deliver the intervention, and additional examiners and moderators will be blinded to participants’ allocation. The intervention lead will keep a reflective diary and will have access to de-brief meetings within the research team [ 40 ]. Involvement of a considerable number of experts co-delivering the content of the intervention may pose risk to intervention integrity. To mitigate this risk, the intervention lead will be providing detailed 1:1 briefing about the study, targeted behaviours, session aims, and ILOs.

Generalisability

A relatively small sample planned for this feasibility study may pose questions regarding the applicability of findings to the future definitive trial and other studies. To ensure that the feasibility sample is representative of the UK paediatric physiotherapists, the study will be broadly advertised to reach therapists in all four UK countries and across the healthcare sectors.

Despite the extensive context research, a wide array of primary and secondary outcome measures planned to be used in the process evaluation, there may be factors influential to the trial but not be captured by the feasibility testing. Use of MRC guidance on process evaluation of complex interventions [ 32 , 33 ] and the IOF [ 34 ] will ensure thorough investigation of the change mechanisms and how the effects will occur [ 32 , 41 ]. Furthermore, the COM-B model and BCTT [ 35 ] are useful tools to characterise the targeted behaviours and content of educational interventions focused on continuing professional development in healthcare [ 42 ]. These were used throughout design of the study and will support the process evaluation to further advance understanding of their mechanisms of action.

With the detailed planning of this protocol and careful consideration of challenges and limitations, this study will offer essential preliminary data about the feasibility of implementing the VGAPP intervention to improve gait-related practice of paediatric physiotherapists in the UK. Study findings will provide a comprehensive understanding of whether a full randomised control trial is viable and identify any areas which could be enhanced. Furthermore, this study will contribute to a body of educational research into clinical training of healthcare professionals and IGA training.

Availability of data and materials

Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.

Abbreviations

Behaviour change techniques taxonomy

Clinical Movement Analysis Society

Capability, opportunity, motivation, behaviour model

Consolidated Standards of Reporting Trials for Pilot and Feasibility trials

Children and young people with cerebral palsy

International Classification of Functioning, Disability and Health

• Instrumented gait analysis

Intended learning outcomes

Implementation Outcome Framework

Medical Research Council

National Institute for Clinical Excellence

Objective structured clinical examination

Patient and public involvement

Standard Protocol Items: Recommendations for Interventional Trials

Virtual gait analysis course for paediatric physiotherapists

Virtual learning environment

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This study is funded by Private Physiotherapy Education Fund grant.

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Hebda-Boon, A., Shortland, A.P., Birn-Jeffery, A. et al. Can on-line gait training improve clinical practice? Study protocol for feasibility randomised controlled trial of an on-line educational intervention to improve clinician’s gait-related decision-making in ambulant children and young people with cerebral palsy. Pilot Feasibility Stud 10 , 76 (2024). https://doi.org/10.1186/s40814-024-01477-5

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Using the Design-Based Research Approach to Develop and Evaluate a New Study Module about Knowledge Acquisition in Science

Jana Biedenbach 1 and Verena Spatz 1

Published under licence by IOP Publishing Ltd Journal of Physics: Conference Series , Volume 2727 , 3rd World Conference on Physics Education 13/12/2021 - 16/12/2021 Hanoi, Vietnam Citation Jana Biedenbach and Verena Spatz 2024 J. Phys.: Conf. Ser. 2727 012007 DOI 10.1088/1742-6596/2727/1/012007

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1 Technical University of Darmstadt Hochschulstraße 12, 64289 Darmstadt, Germany

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The research approach design-based research has become more popular in recent years, also in the field of science didactics. Representatives of this field usually explicitly distinguish themselves from evaluation. In contrast, we have formed a synthesis of both research approaches for our development and evaluation project. By conducting the development and evaluation according to a design-based research process, we are able to take advantage of the added value of the design-based research approach. This article describes the philosophy of our research with the image of the didactic engineer and gives an insight into the implementation through the concrete description of our project, the development and evaluation of a new study module on knowledge acquisition in science for pre-service teachers. Finally, we discuss the added value of the elements of design-based Research compared to a pure evaluation and where the limits lie regarding the claims of design-based research.

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Peer-reviewed

Research Article

Feasibility, acceptability and equity of a mobile intervention for Upscaling Participatory Action and Videos for Agriculture and Nutrition (m-UPAVAN) in rural Odisha, India

Roles Conceptualization, Data curation, Formal analysis, Investigation, Project administration, Writing – original draft, Writing – review & editing

* E-mail: [email protected]

Affiliation Department of Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom

Roles Conceptualization, Investigation, Writing – review & editing

Affiliation DCOR Consulting Pvt. Ltd., Bhubaneswar, India

Roles Conceptualization, Writing – review & editing

Roles Conceptualization, Investigation

Roles Conceptualization, Investigation, Project administration

Affiliation Voluntary Association for Rural Reconstruction and Appropriate Technology (VARRAT), Kendrapara, India

Affiliation Digital Green, New Delhi, India

Roles Formal analysis

Roles Formal analysis, Writing – review & editing

Affiliation Institute for Global Health, University College London, London, United Kingdom

Roles Supervision, Writing – review & editing

Affiliation Independent Consultant, Valencia, Spain

Roles Investigation, Software

Affiliation Emergency Nutrition Network (ENN), Oxford, United Kingdom

Roles Investigation, Project administration

Roles Methodology

Affiliation Ekjut, Chakradharpur, India

Roles Methodology, Writing – review & editing

Affiliation JSI Research & Training Institute, Inc. Arlington, Virginia, United States of America

Affiliation Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, United Kingdom

•  [ ... ],

Roles Conceptualization, Funding acquisition, Project administration, Supervision, Writing – review & editing

• [ view all ]
• [ view less ]
• Emily Fivian, 
• Manoj Parida, 
• Helen Harris-Fry, 
• Satyanarayan Mohanty, 
• Shibanath Padhan, 
• Ronali Pradhan, 
• Pranay Das, 
• Gladys Odhiambo, 
• Audrey Prost, 

• Published: May 14, 2024
• https://doi.org/10.1371/journal.pgph.0003206
• Peer Review
• Reader Comments

Addressing undernutrition requires strategies that remove barriers to health for all. We adapted an intervention from the ‘UPAVAN’ trial to a mobile intervention (m-UPAVAN) during the COVID-19 pandemic in rural Odisha, India. In UPAVAN, women’s groups viewed and discussed participatory videos on nutrition-specific and nutrition-sensitive agricultural (NSA) topics. In m-UPAVAN, weekly videos and audios on the same topics were disseminated via WhatsApp and an interactive voice response system. We assessed feasibility, acceptability, and equity of m-UPAVAN using a convergent parallel mixed-methods design. m-UPAVAN ran from Mar-Sept 2021 in 133 UPAVAN villages. In Feb-Mar 2021, we invited 1000 mothers of children aged 0–23 months to participate in a sociodemographic phone survey. Of those, we randomly sampled 200 mothers each month for five months for phone surveys to monitor progress against targets. Feasibility targets were met if >70% received videos/audios and >50% watched/listened at least once. Acceptability targets were met if >75% of those watching/listening liked the videos/audios and <20% opted out of the intervention. We investigated mothers’ experiences of the intervention, including preferences for m-UPAVAN versus UPAVAN, using in-person, semi-structured interviews ( n = 38). Of the 810 mothers we reached, 666 provided monitoring data at least once. Among these mothers, feasibility and acceptability targets were achieved. m-UPAVAN engaged whole families, which facilitated family-level discussions around promoted practices. Women valued the ability to access m-UPAVAN content on demand. This advantage did not apply to many mothers with limited phone access. Mothers highlighted that the UPAVAN interventions’ in-person participatory approaches and longer videos were more conducive to learning and inclusive, and that mobile approaches provide important complementarity. We conclude that mobile NSA interventions are feasible and acceptable, can engage families, and reinforce learning. However, in-person participatory approaches remain essential for improving equity of NSA interventions. Investments are needed in developing and testing hybrid NSA interventions.

Citation: Fivian E, Parida M, Harris-Fry H, Mohanty S, Padhan S, Pradhan R, et al. (2024) Feasibility, acceptability and equity of a mobile intervention for Upscaling Participatory Action and Videos for Agriculture and Nutrition (m-UPAVAN) in rural Odisha, India. PLOS Glob Public Health 4(5): e0003206. https://doi.org/10.1371/journal.pgph.0003206

Editor: Jyoti Sharma, IIPHs: Indian Institutes of Public Health, INDIA

Received: October 2, 2023; Accepted: April 14, 2024; Published: May 14, 2024

Copyright: © 2024 Fivian et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: The de-identified participant quantitative data analyzed during the current study are available for ethically approved research from the LSHTM Data Compass, an open access institutional research data repository: https://doi.org/10.17037/DATA.00003635 . The qualitative data analyzed during the current study contains unique participant experiences that may risk revealing participants' identities, even after the removal of common identifiers. Given the nature of the discussions, this may risk jeopardizing participant safety. Data are available from the corresponding author, or the data management team at the London School of Hygiene and Tropical Medicine via email ( [email protected] ) for specific lines of enquiry that do not jeopardize the participants’ anonymity and safety, and subject to ethical approval.

Funding: This work was co-funded by the Bill & Melinda Gates Foundation and the Foreign Commonwealth Development Office of the UK Government (award number OPP1136656) to EF, MP, HHF, SM SP, RP, PD, GO, AP, SB, PJ, NKM, SuR, NN, ShR, PKB, HD, EA, and SK. Additionally, funding of author HH-F was provided by a Sir Henry Wellcome Fellowship (grant 210894/Z/18/Z). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests. AP declares receiving funding from the Children’s Investment Fund Foundation, The UK Medical Research Council, and The UK Economic & Social Research Council; payment for grant reviews from the Research Council of Norway; payment for guest lecturing at the London School of Hygiene and Tropical Medicine; and being the Chair of Climate Change Working Group as part of the Children in All Policies (CAP2030) Initiative. These competing interests will not alter adherence to PLOS Global Public Health policies on sharing data and materials. No other authors have competing interests to declare.

Introduction

Maternal and child undernutrition remains a leading cause of death and disability in low- and middle-income countries [ 1 ]. In India, decades of government programmes have aimed to address this burden, yet millions still suffer. The UN Global Strategy for Women’s and Children’s Health expresses the need to implement and scale up existing cost-effective, evidence-based interventions and for innovative strategies that eliminate barriers to these interventions [ 2 ]. Innovative strategies include mobile technologies that could increase access and efficiency of health care delivery, especially in resource-constrained, remote settings [ 3 , 4 ]. However, a prerequisite for mobile health interventions to reach and benefit people is that participants have mobile phone access. This means that mHealth risks widening inequalities in access to health services rather than improving them. While mobile phone access is almost universal among men in India, around half of women do not have access and those that do tend to access lower quality phones, such as feature phones rather than smartphones [ 5 ]. Women’s phone access is also constrained by gendered social barriers that affect their phone usage, yet women are often key targets for health interventions due to specific antenatal and maternity healthcare needs and the role they commonly play in ensuring children’s healthcare access [ 6 ]. Additionally, the feasibility of mHealth in resource-constrained areas may also be challenged by poor network connectivity, digital illiteracy, misinformation and cybercrimes, phone numbers changing frequently and the economic inability of poor households to recharge phones [ 7 , 8 ].

Alongside potential challenges, mobile approaches may present opportunities to overcome barriers that arise from face-to-face approaches. For example, mobile interventions that are accessible from home and on-demand can overcome time-related barriers (e.g., travel times to health centres or women’s groups, and time away from domestic responsibilities and livelihood activities), restrictions to women’s physical mobility [ 9 ], and reluctance to access services when heavily pregnant or with children [ 10 ]. Further, mobile approaches may be more convenient for other family members to engage with, which may enhance the adoption of promoted practices compared with interventions solely targeting women [ 6 ]. Despite mobile interventions being increasingly used to improve healthcare delivery in India, there is a lack of well-designed user acceptability and efficacy studies [ 11 ]. Additionally, little is known about whether mHealth intervention coverage and engagement would be sufficient and the trade-offs between mobile and in-person approaches. Therefore, a better understanding of the feasibility, acceptability, inclusivity and equity implications of adapting effective health interventions to mHealth delivery is needed.

One type of effective intervention that may be conducive to mHealth adaptation are the nutrition-sensitive agriculture (NSA) interventions tested in the four-arm cluster-randomised controlled trial, UPAVAN [ 12 ]. The UPAVAN interventions used combinations of women’s group facilitated viewings and discussions on locally made participatory NSA and nutrition-specific videos, and a cycle of participatory learning and action meetings. The trial was conducted in 148 clusters (village and surrounding hamlets) in four blocks of Keonjhar district, Odisha, India. Keonjhar is a heavily forested landlocked district where 45% of the population belongs to historically disadvantaged groups, Scheduled Tribes, who endure high rates of poverty and undernutrition [ 13 , 14 ]. The UPAVAN study arms included:

AGRI: Fortnightly women’s group meetings using NSA participatory videos;

AGRI-NUT: Fortnightly women’s group meetings using NSA videos once per month and nutrition-specific participatory videos once per month;

AGRI-NUT+PLA: Women’s group meetings using participatory NSA videos once per month and nutrition-specific participatory learning and action meetings or videos once per month;

Control: Standard government services only.

The interventions ran for 32 months between 2016–19. The impact evaluation showed a higher proportion of children achieving minimum dietary diversity in AGRI-NUT and AGRI-NUT+PLA compared to the control group, and a higher proportion of mothers achieving minimum dietary diversity in AGRI and AGRI-NUT+PLA compared to the control group [ 12 ]. Since UPAVAN’s completion in Oct 2019, the COVID-19 pandemic caused disruptions to livelihoods and many essential face-to-face nutrition and health services [ 15 ]. These developments provided an urgent impetus to learn how communities can continue to benefit from agriculture and nutrition interventions despite the challenges posed by the pandemic.

Given this and community demand for the continuation of UPAVAN, we designed a behaviour change intervention retaining the core UPAVAN model with locally made NSA and nutrition-specific videos but adapted for mobile delivery (m-UPAVAN). The design of the m-UPAVAN intervention was informed by considering several of these potential opportunities and barriers, in addition to key learnings from the UPAVAN process evaluation [ 10 ]. Our study objectives were:

• To assess the feasibility and acceptability of the m-UPAVAN intervention among mothers with a child 0–23 months.
• To assess the extent to which the m-UPAVAN intervention was equitable by assessing feasibility and acceptability across specific subgroups.
• To understand mothers’ receptivity of m-UPAVAN contrasted against the face-to-face group-based UPAVAN approach.

Materials and methods

Ethical statement.

Our study was approved by the London School of Hygiene and Tropical Medicine Ethics Board ( # 22800) and Sigma Institutional Review Board, New Delhi ( # 10039 and #10036). All implementation and research activities were conducted in concordance with local government guidance related to COVID-19.

Sampling participants

m-UPAVAN included a subset of 99 (133 villages) of the 148 UPAVAN clusters in all four blocks of the UPAVAN trial (Ghatgaon, Harichandanpur, Patna, and Keonjhar Sadar) in Keonjhar district, Odisha, India. All 37 UPAVAN control clusters were included and intervention clusters with a higher proportion of Scheduled Tribe households were prioritised.

Local intervention facilitators visited households in all 133 villages between Dec 2020 and Jan 2021 to obtain data on phone ownership and phone numbers and identify eligible participants for feasibility and acceptability assessment (women with a child under 2 years and intra-household phone access). Facilitators sought consent to share phone numbers with the implementation and research teams. All women in m-UPAVAN villages were invited to participate in m-UPAVAN using their own phone, a neighbour’s, or a facilitator’s phone when COVID-19 restrictions allowed.

Quantitative phone survey sampling.

First, from the list of eligible participants, women and their spouses were randomly selected and invited to participate in a phone-based sociodemographic baseline survey between Feb 16 and March 7, 2021. Our target sample size was 1,000 mothers and their spouses. Next, following rollout of the m-UPAVAN intervention, a random sample of mothers was drawn each month from those who participated in the baseline survey between May and September 2021. These mothers were invited to participate in phone-based monitoring surveys designed to assess intervention feasibility and acceptability. Our target sample size was 200 mothers each month. Sampling from the baseline enabled us to link cases and avoid repetition of demographic questions. Following local government guidance on COVID-19, all but the first monthly surveys were conducted via phone. Therefore, we excluded the first month’s survey (conducted in April) from analyses to avoid bias arising from different data collection methods. For phone surveys, data collectors sought informed verbal consent from participants, which was recorded and documented by DCOR–this was approved by the Institutional Review Boards. All participant selection was stratified by cluster-level distance to the nearest town (<10 km or ≥10 km) and proportion of Scheduled Caste and Scheduled Tribe households (<30%, 30% to 69%, ≥70%).

The number of intervention clusters and sample sizes for quantitative surveys was determined by budget and feasibility and deemed sufficient by our research team to describe feasibility and acceptability.

Qualitative interview sampling.

After the intervention, between Oct 11 and 20, 2021, we recruited 38 women with a child under 2 years for qualitative interviews using purposive sampling to reflect the caste and tribe diversity of the population and varying phone access to enable us to explore a variety of responses to the intervention. Thirty-three women were sampled from those participating in monitoring surveys and, therefore, had intrahousehold phone access, of which we ensured at least 10 of these women had exposure to the previous UPAVAN interventions. Five women without intrahousehold phone access were also selected. Our qualitative sample characteristics are shown in S1 Table . Qualitative interviews were administered in-person, and data collectors sought participants’ written (signature or thumbprint) informed consent.

The m-UPAVAN intervention.

Digital Green, an international NGO, produced the intervention content. Voluntary Association for Rural Reconstruction and Appropriate Technology (VARRAT), an Odisha-based NGO, was responsible for implementing the intervention in m-UPAVAN villages. Ekjut and JSI provided technical assistance. UCL advised on the intervention content and study design. DCOR led the data collection and data coding. LSHTM led the entire study. These same organisations were partners in the UPAVAN trial.

The m-UPAVAN intervention was centred around weekly WhatsApp videos and audio messages on agriculture and nutrition topics, coordinated by intervention facilitators. The key components of the intervention are as follows:

• 1. Recruitment and training of facilitators

Intervention facilitators, most of whom were facilitators in the UPAVAN trial, were recruited at the village level. They were trained through Digital Green’s Virtual Training Institute, a compilation of training resources to orient all staff on the essential nutrition, agriculture, and health topics addressed in the intervention. Facilitators were responsible for community sensitisation, encouraging participation, and managing WhatsApp groups for video dissemination.

• 2. Dissemination of re-purposed UPAVAN videos through WhatsApp

The UPAVAN interventions built upon a participatory video-based approach to agriculture extension designed by Digital Green but made ‘nutrition-sensitive’ (i.e., promoting practices that address the underlying causes of undernutrition and incorporating specific nutrition goals) and integrating nutrition-specific video topics [ 16 ]. In m-UPAVAN, Digital Green reproduced videos covering NSA and nutrition-specific topics based on those used in the original UPAVAN trial but shortened for sharing and viewing via WhatsApp groups. Topics were sequenced based on season and community preference, as informed by experience from the UPAVAN trial [ 12 ]. On average, videos were 4 minutes long, with critical messages (‘knowledge recall points’) written in the local language (Odiya) at key points in videos, and 49 seconds of COVID-19 guidelines were included at the end of each video. Facilitators formed village-level WhatsApp groups for disseminating videos and ‘WhatsApp viewers groups’ where women who owned a smartphone were grouped with women who did not own a smartphone to watch videos together. Facilitators shared one video per week on Wednesdays over 6 months.

• 3. Interactive Voice Response (IVR)

For those owning a feature phone only, the same content as in the weekly videos was scripted as audio and disseminated every Sunday through a toll-free IVR system. Each audio was available to listen to until the next was shared the following week. Users could respond to the audio or ask questions by submitting a voice recording.

• 4. Promotional activities and interactive learning

Facilitators shared short video advertisements through WhatsApp before each video dissemination, which highlighted the constraints that each topic addressed. Village-wise posters advertised the toll-free IVR system ( S1 Appendix ), and text messages were sent each Sunday to remind registered users to listen to the audio messages. Facilitators encouraged participants to watch or listen to m-UPAVAN messages and to watch with their families via WhatsApp group chat or in-person, depending on COVID-19 restrictions. Facilitators helped community members with queries and encouraged them to adopt new practices. After each video dissemination, a quiz with multiple-choice questions took place in WhatsApp groups. Participants who selected the correct answers received an appreciation message, whilst facilitators encouraged those who got the wrong answer to re-watch the video. Facilitators also encouraged women to share photos of families watching or listening together and of them implementing the recommended practices.

Facilitators contacted all mothers with children under two years of age and a random selection of households with a phone at least once per month to ascertain if they were watching or listening, receive feedback on the content for future dissemination, and update phone numbers.

Quantitative outcomes.

Our four key quantitative outcomes were: 1) proportion of women receiving at least one video or audio in the last month (coverage); 2) proportion of women watching or listening to at least one video or audio in the last month (uptake); 3) proportion of women that watched or listened who reported liking the messages (acceptability), and 4) proportion of women opting-out of from receiving m-UPAVAN messages, as indicated by the implementation team (attrition).

A priori, we determined that feasibility would be confirmed with a coverage rate of >70% and uptake rate of >50%, and acceptability confirmed with an acceptability rate of >75% and attrition rate of <20%. Our research and implementation team arrived at a consensus for targets by considering: 1) exposure to the original UPAVAN interventions, which ranged from 50–58% [ 12 ] and reflects our m-UPAVAN intervention uptake target (proportion of women watching or listening to at least one video or audio in the last month) of >50%; 2) potential logistical constraints, and 3) what the implementation team considered realistic, achievable and would warrant further investment, based on their >30 years of experience in implementing development interventions in our study district. As suggested by Avery and colleagues [ 17 ], indicators falling below our prespecified targets would be reviewed by the implementation team to assess whether further investment in the intervention was still warranted but with caution and or/modifications, or whether the indicators suggest intractable issues with the intervention that are irremediable.

Other outcomes included intensity of uptake, proportion of spouses or senior family members also watching or listening, and proportion of women discussing content with an adult family member.

Equity was assessed by analysing differences in all outcomes across well-known proxies of socioeconomic position in Odisha: whether participants reported belonging to Scheduled Tribes (ST) or other caste groups (non-ST), whether women had or had not completed primary school, and also by mother’s personal phone ownership, and whether there was a smartphone in the household.

Qualitative interviews.

Interviews were conducted to understand women’s experiences of the intervention, factors that affected its feasibility and acceptability, and the potential for realising change in NSA and nutrition-specific practices. Participants from the UPAVAN intervention areas were asked whether they participated in the UPAVAN interventions, and if so, questions on preferences for m-UPAVAN vs UPAVAN were additionally administered. All in-depth interviews were semi-structured, with open-ended questions and relevant prompts. Interview guides were piloted and refined, as necessary, and were conducted in Odiya at participants’ homes by five experienced qualitative researchers from DCOR (see S2 Appendix for interview guides). Interview recordings were translated and transcribed verbatim into the English language by DCOR before analysis.

Quantitative data analysis.

Quantitative analyses were conducted in Stata/SE 17.0. Participants’ characteristics are presented using descriptive statistics (frequency (%) and means (standard deviation)). We calculated coverage, uptake, and acceptability to assess achievements against the pre-specified feasibility and acceptability targets across all monitoring surveys using mixed-effects logistic or linear regression to obtain percentages or means (95% CI). To assess equity, we calculated adjusted percentage point (pp) differences across characteristics and phone access using mixed-effect logistic regression models followed by Wald tests for differences in post-estimation average adjusted marginal predictions, and mean differences in outcomes using mixed-effect linear regression models. Models included random effects to account for repeated measures within individuals and within clusters.

Qualitative data analysis.

NVivo 10 was used to manage and analyse qualitative data. We analysed interview data using deductive thematic analysis and used an adapted version of Normalised Process Theory (NPT) as a theoretical lens to assist with analysis and to organise and code the data. NPT “identifies, characterises and explains key mechanisms that promote and inhibit the implementation, embedding and integration of a new health technique, technologies and other complex intervention ” [ 18 ]. NPT is primarily used to evaluate intervention implementation or feasibility focusing on the agency of those involved in the implementation. Therefore, we adapted the four main constructs (coherence, cognitive participation, collective action, and reflexive monitoring) to reflect participants’ experiences [ 19 ]. We divided interview transcripts among three researchers (MP, PD, GO). A fourth researcher (EF) double-coded one in three transcripts; EF reviewed inconsistencies, which were discussed with the team and resolved.

Integration of quantitative and qualitative data.

To understand the feasibility and acceptability of the intervention beyond what we would from the qualitative and quantitative components separately, we used a convergent parallel mixed-method design [ 20 ]. We assessed concordance between the quantitative and qualitative findings and used the qualitative to explain the quantitative findings. We report findings using a narrative-weaving approach.

Reflexivity and positionality statement.

This research was primarily undertaken by academic researchers based in the UK and researchers based in and from India. These researchers all have first-hand-contextual experience of the study setting and academic knowledge that likely preconditioned beliefs related to participant realities, which may have influenced interactions with participants during qualitative interviews and interpretations of the data. By acknowledging the diverse positionalities and perspectives within our research team and in relation to our study participants throughout the research processes, we strived to ensure a respectful representation of the lived experiences of the study participants.

Inclusivity in global research.

Additional information regarding the ethical, cultural, and scientific considerations specific to inclusivity in global research is included in the ( S1 Checklist ).

In the 133 villages enrolled in m-UPAVAN, facilitators formed one WhatsApp group per village. All women in the villages owning a smartphone ( n = 3,099) formed video viewing groups with 7–8 women without a smartphone ( n = 18,679). 5,667 households were registered to receive IVR audio services. Intervention activities were delivered as planned. An overview of the intervention’s content with video links is shown in S2 Table .

Fig 1 shows the study flow diagram, and Table 1 shows the characteristics of the quantitative survey participants. We identified 3,012 women with a child aged under 2 years in intervention villages. Of these, 27% ( n = 808) were not eligible for quantitative surveys due to not having intra-household phone access. Of those that did have intra-household phone access, 1043 mothers provided data at baseline (cohort for monitoring surveys); 61% ( n = 632) belonged to households owning a smartphone, and 67% ( n = 694) of mothers owned their own phone (whether feature or smartphone).

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All quantitative surveys were administered by phone; qualitative interviews were administered in-person. Mothers randomly selected and invited to participate in monthly monitoring phone surveys indicate the total number of mothers that were randomly drawn and contacted at least once across five months of sampling.

https://doi.org/10.1371/journal.pgph.0003206.g001

https://doi.org/10.1371/journal.pgph.0003206.t001

Between May and September 2021, 810 mothers out of 1043 who provided data at baseline were randomly drawn to participate in monitoring surveys at least once. Of these, 666 mothers provided data (981 total responses). Differences existed between those who responded to monthly monitoring surveys and those who did not ( n = 114). Compared with non-respondents, a larger proportion of respondents had a smartphone in the household (percentage point (pp) difference: 19.8) and owned ≥2.5 acres of land (pp difference 14.1).

Pooled descriptive results for outcomes across the five monthly monitoring phone surveys are provided in Table 2 . No one opted out of receiving the intervention (attrition).

https://doi.org/10.1371/journal.pgph.0003206.t002

Feasibility

The proportion reporting receiving at least one video or audio message in the last month was 72.8% (95% CI 69.1, 76.6), meeting our coverage target of 70%. Two qualitative themes emerged to explain the high coverage: trust in facilitators and perceived value of the intervention. Respondents were willing to participate in the intervention due to their trust and respect for the facilitators who informed them about the intervention, which assured participants that the intervention was worthwhile and relevant to them.

Respondent [R]: [ … ] As this program is good and Madam [facilitator] recommended to join I did the same . I didn’t have to ask anyone’s permission . R: I asked them [facilitators] where will the videos be sent and why . Then they answered that videos related to pregnant mothers and related to agriculture would be sent […]. I got attracted because we are farmers so if they will send videos related to agriculture it will be beneficial to us as we can learn new things .

Table 3 shows that coverage was higher among those with smartphones in the household than those without (adjusted pp difference (95% CI): 9.4, 3.2, 15.6) and among women owning their own phones than women not owning their own (adjusted pp difference: 9.5, 2.7, 16.3). Qualitative findings revealed that whilst some spouses were keen to participate in the intervention and receive the m-UPAVAN messages on their phones, others needed more convincing.

https://doi.org/10.1371/journal.pgph.0003206.t003

Interviewer [I]: What was your husband’s reaction regarding you watching the videos on his phone? R: He is very happy to receive the videos on his phone . He says that after I finish all my house chores, we both should watch it together . R: First they [spouse and mother - in - law] were very sceptical about it [m-UPAVAN] but later when I explained to them that it is important, then they accepted .

The proportion reporting watching or listening at least once in the last month was 70.9% (95% CI 66.7, 75.1), satisfying our prespecified target for uptake of 50%. Women generally displayed agency in accessing and using phones. When women had to ask permission, they were rarely denied. Furthermore, spouses and other household members tended to support women’s participation and facilitated their access to the m-UPAVAN content.

I: You have to ask for the mobile phone from your husband? R: No, no. He himself says that a message has come and I have to listen . I don’t have to ask . I: Is he present at home when the message comes? R: Wherever he is, he comes home in the evening and says that message has come”

The proportion of respondents watching or listening at least once in the last month was 7.2 (95% CI 0.28, 14.1) pp higher among women who owned a phone than women who did not ( Table 3 ) but did not vary across other characteristics explored. One woman described her exchange with her spouse, explaining how his taking of the only phone for his work limited her access to the intervention–this was a common occurrence for women not owning their own phone.

R: Not able to listen to that [m-UPAVAN audios] . Husband takes and goes away. If want to listen to that thing a little, husband takes and goes away . So, at that time I get problems while listening to that .

Other emerging themes showed that women were motivated to watch or listen due to curiosity about what future information videos or audios may entail, encouragement by facilitators, and eagerness to participate in the quizzes that followed each weekly video or audio dissemination. In contrast, some women expressed being nervous or fearful of participating in quizzes, either due to a lack of confidence using the phone or concern over what others may think if they were to respond.

I: What motivated you to reply [to quizzes]? R: As I found the videos helpful I gave a reply . Madam [facilitator] also encouraged me to give a reply […] when I know the answer to a question then I get excited to reply […] . R: I wanted to press those buttons 1 or 2 or 3 but was unable to do that I: Why were you unable to do that? R: Because I do not know how to do that . I: […] Why did you not ask anyone if you were not able to understand? […] R: I have asked once. She [facilitator] told me to press the button and to talk with them…I have not done that. I: Is there any reason why you have not? R: […] Because of some fear I have not tried .

Acceptability

All respondents who watched or listened reported liking the m-UPAVAN messages. A favoured aspect was the mobile delivery platform, which enabled women to gain information from the comfort of their homes and at a convenient time. Women highlighted how the ability to re-watch the videos to reinforce their learning was also important to them. However, this benefit was less applicable to the audios, as audios were only available for a week.

R: […] Thanks to mobile and WhatsApp, I can take part in all those, right? If it needed us to go somewhere then we couldn’t have gone that much . As the mobile is there, everything comes on WhatsApp, there’s more interest, we can watch it all and learn it all .

The content of the m-UPAVAN messages was praised highly by respondents, who often mentioned their favourite topics, which varied from nutrition-specific videos to ivy gourd farming, with the video on making pot manure fertiliser most frequently highlighted. The content revealed popularity due to the associated monetary benefits, as the promoted agriculture practices aimed to improve productivity and diversity. Frequently, though, monetary benefits were framed as desirable because they contributed towards improving the nutrition and health of women and their families. Several respondents also highlighted how the intervention content helped address taboos around women and children consuming certain foods.

I: What are the effects of this [m-UPAVAN] on you , your family and your kids ? […] R: […] We are farming ourselves and then giving them [crops] to our kids and are eating ourselves . We a re staying healthy . We are farming small amounts and selling them to buy essentials . We are eating all that . And both mother and kids are remaining healthy . R: I got to know that we [pregnant women] can eat anything we want. The elders used to say that we shouldn’t eat more during pregnancy . But now we have got to know that we can eat more, and we should not do heavy work during pregnancy . We should take rest .

Additionally, respondents felt the knowledge they gained was unique, and otherwise inaccessible if they did not watch the videos or listen to the audio messages. Respondents felt empowered with this knowledge.

I : What was your first reaction after watching videos for the first time? R: I became happy after watching . We generally have no idea regarding this, but due to this program we got to know about many things like plantation, health, nutrition, proper food for pregnant woman .

Intensity of uptake

Whilst 71% of respondents watched or listened to at least one video or audio in the past month, women only watched or listened to a mean of 1.61 (95% CI 1.50, 1.72), out of a maximum of 4 messages per month and women listened to fewer audios (0.52, 95% CI 0.45, 0.59) than videos (1.36, 95% CI 1.25, 1.47) ( Table 2 ). Intensity of uptake overall (videos and audios) only varied between women owning a phone vs not (adjusted mean difference (95% CI): 0.25, 0.07, 0.43) ( Table 3 ) . Qualitative findings explained how, whilst women without their own phones could engage with the intervention occasionally, it was too infrequent, not at their convenience, and they were not able to re-watch the content as they wished.

R: I watch as per my free time, but I cannot watch as much as I want . I: Why? R: Because it is their mobile, right? Will they always give me to watch on their mobile? I watch it once, but even if I am interested to watch it a second time I do not get to watch it on mobile .

Engaging family members

The mobile platform of the m-UPAVAN intervention offered an opportunity to engage whole families, and facilitators played a critical role in encouraging this. One woman explained the encouragement she received from her local facilitator:

R: He’d [facilitator] say: “[ … ] show those videos to your family members and observe whether they are getting interested or not and you should also make them understand what is explained in the video because they will think “watching these videos, what will I get?” but you have to make them understand that it will be beneficial, tell them what benefits you have got by watching these videos so that they will also watch the videos” like this he used to encourage us .

Quantitative findings showed the facilitators’ encouragement was successful. Of those who watched or listened, 60.8% (95% CI 56.3, 65.3) reported their spouses or other senior household members also watching or listening. Whilst families engaging with content was higher among women from smartphone-owning households (adjusted pp difference: 9.9, 1.8, 18.0) ( Table 3 ) , over 50% of women from households without a smartphone still reported their spouses or senior family members listening. Women expressed how it was important for their families to learn directly from the videos and audios to ensure they received accurate information and could subsequently support women in implementing new behaviours.

R: They [respondent’s family] like the videos . If I had seen the videos alone, I might not have been able to share everything. They wouldn’t have been able to know everything . I: Do you think that they should participate in the m-UPAVAN program? R: Yes . I: Why so? R: Because they will understand it better and will help me in doing those things. Their health will also be good .

Around half of the women watching or listening also reported discussing the content with other family members ( Table 2 ), and whether these discussions took place did not vary across different characteristics and phone ownership ( Table 3 ). The respondents explained that family members learning from m-UPAVAN messages directly helped ease family-level discussions and negotiations around the agriculture and nutrition practices promoted and facilitated cooperation among family members.

I : So do you find explaining it [information from the videos] to your family members to be easy or difficult? R: It is easy as they themselves see the video . R: I learnt how to send a message on the phone and how to discuss things with family members . We got to know all these through listening to the talks in m-UPAVAN . R: All the videos were doable . We don’t need to invest a lot of money to implement those videos. It just needs cooperation of family members .

Preference for in-person UPAVAN or mobile-based m-UPAVAN

Overall, most participants highlighted various aspects that they liked about both the mobile and face-to-face intervention, with only a few participants providing a definite answer of their ‘favourite.’ Aspects of m-UPAVAN that were preferred related to being able to learn from the comfort of their own homes, with little opportunity cost concerning time trade-offs, and being able to refer back to messages for ‘revision’. Simultaneously, participants found the longer video format in UPAVAN more conducive to learning and easier to understand, especially for those with less education and digital literacy.

R: In [m-UPAVAN] we can listen to it at our convenience and after 2–3 days if we forget anything we can listen to it again if we want . But in UPAVAN , [facilitator] would come and show us and then the next time there will be a new video . R: In UPAVAN among 20 mothers , we watch [and discuss] videos for around 1 to 1 . 5 hours . The videos in m-UPAVAN are for short duration so I don’t like it much . If they would start UPAVAN again I will like it .

Additionally, the mobile intervention did not adequately replace other aspects of the UPAVAN face-to-face group-based approach. Many women highlighted the importance of discussing in a group, sharing opinions with other women, and the enjoyment they felt from social interactions. Women who had taken part in the participatory learning and action meetings of UPAVAN often referred fondly to the elements designed for collective problem-solving and action. Further, equity concerns about m-UPAVAN were commonly expressed, as the opportunity to learn was unequal between women with and without phone access and with smartphones versus feature phones.

R : In UPAVAN we get to watch the videos , and after that , they conduct the meeting as well and everyone gets to share their opinions . That’s why I like UPAVAN , even they make us play games […] Now there is no one to discuss with and everything remains within our family members , if [UPAVAN] is conducted again , all of us mothers would be happy […] For m-UPAVAN not everyone has a phone , they can only get to know through others . R: In UPAVAN we are shown the videos in a very easy way but in m-UPAVAN to see the video one has to have a smartphone and data pack all the time . But not everyone can afford that. So UPAVAN is a lot better and more effective in that way .

Despite this, the same woman quoted above who liked UPAVAN more acknowledged that m-UPAVAN motivated her more to implement the methods, and was important for enabling her family to learn too. Yet, not all women felt this way. Some women expressed how UPAVAN was necessary for understanding ‘properly’ and then subsequently being able to implement what was learned.

I: Which one did motivate you to implement the methods ? UPAVAN or m-UPAVAN ? R: m-UPAVAN [because] in m-UPAVAN we can watch the video and implement it simultaneously . We can watch the video again and again . Once , I was watching a video on diarrhoea of children . My older son saw that and asked me about it and I explained to him . He is very curious to know different things . So are my family members . So , in m-UPAVAN , not only do I get to know , but the whole family learns . My husband also supports this program as it gives a lot of information . I: [ … ] Which program will you recommend to people to participate in [m-UPAVAN or UPAVAN]? R : I will recommend participating in UPAVAN . I : Why? R: In UPAVAN they will see directly, they will understand it and they can apply it after understanding it properly , so I will suggest they watch UPAVAN .

Collectively, women’s reflections pointed towards the necessity of both intervention modalities.

R: I like both [m-UPAVAN and UPAVAN] . Both are important and enjoyable in their own dimensions . R: I wish UPAVAN could be started again but still m-UPAVAN is helpful as we can watch the video again and again in case we forget any procedure . So both are interesting .

We aimed to understand whether delivering NSA and nutrition-specific social behaviour change communication in the form of participatory WhatsApp videos and IVR audios offers a potential approach for improving agriculture and maternal and child nutrition in rural Odisha, India. During and since COVID-19, there has been an increased need and interest in remote delivery of agriculture, nutrition and health services [ 21 , 22 ]. However, to our knowledge, this is the first study to examine how a mobile adaptation of an NSA intervention that improved maternal and child diets could work in rural, disadvantaged, agrarian communities.

Among the mothers that had intra-household phone access, m-UPAVAN was demonstrated as a feasible and acceptable NSA intervention with our pre-specified targets for coverage, uptake, and acceptability met. We found that the interpersonal communication provided by the well-trained and trusted local intervention facilitators was integral for community mobilisation and engaging women and their families with the intervention. A wider body of research demonstrates that mobilising communities and delivering quality services requires eliciting and sustaining trust between those delivering the health services, e.g., community health workers and the community [ 23 , 24 ]. Our study showed how this continues to remain of critical importance even when using digital approaches. This finding is consistent with that from a digital messaging intervention in Telangana, India, delivered during COVID-19, which showed how digital approaches offer opportunity to improve the reach and consistency of behaviour change communication but complement rather than replace in-person approaches [ 25 ].

Throughout COVID-19, as mobile phones became the pivotal platform for information sharing and delivering health interventions, the need for flexible intervention delivery platforms became increasingly important. This and other studies taught us that, whilst mobile approaches are feasible, equity issues cannot be overlooked [ 5 ]. Social norms regarding women accessing and using phones are concerns for mHealth services in low-middle-income countries [ 26 ]. Whilst we found that women generally displayed agency using phones, digital gender inequality was greater among households that owned just one phone as men’s phone usage was prioritised, restricting women’s access to the intervention. Although we only found feasibility and acceptability outcomes to vary by phone ownership type, it is well known that the most marginalised groups and least educated, those with the greatest needs for nutrition and health services, have worse phone access [ 27 ]. Further, the most vulnerable women were likely among the 30% of women excluded from our quantitative feasibility and acceptability assessment due to no phone access. Additionally, whilst our objective was not to compare feasibility and acceptability between m-UPAVAN videos and audios, the lower engagement with the audio messages than videos implies the audio messages were a less feasible intervention strategy. This may have been due to the audios being less engaging than the videos and the more active participation required (women had to call to receive audios, whilst videos were automatically sent to them). As such, women who only have access to a feature phone, likely poorer and more nutritionally vulnerable groups [ 27 ], may benefit less from the intervention than those with access to a smartphone.

Despite these findings, our study revealed how mobile interventions can overcome barriers related to face-to-face approaches. A favourite aspect of m-UPAVAN was the time women saved from travelling and the ability to learn on-demand. A family-centric virtual counselling mHealth intervention tested in Nepal demonstrates the importance of the on-demand nature of m-UPAVAN [ 28 ]. In addition to other barriers related to poor network connectivity and digital literacy, the evaluation found that scheduling the counselling services was challenging for some women due to their competing time demands, and family members were hard to engage due to working outside of the home [ 28 ]. Whether women are able to participate in NSA programmes and thus benefit from them may be influenced by time trade-offs [ 29 ], and the time to participate in programmes is not equally available to all women [ 30 ]. As such, the time poverty of women must not be overlooked when designing interventions for marginalised communities, especially as poorer women tend to be more affected [ 31 ]. On-demand mobile interventions may offer opportunities to alleviate some of these concerns, albeit unlikely for the most marginalised groups. Additionally, although we found that the longer videos and facilitated discussions of the UPAVAN interventions were more conducive to learning, women expressed how the ability to refer back to videos to revise the content minimised information loss, which may enhance the likelihood of implementing promoted practices. Taken together, these findings suggest a need for a hybrid intervention that offers interpersonal interaction and participatory elements to promote peer-to-peer learning and sharing approaches, whilst also offering flexibility, being considerate of women’s limited time, and giving opportunities to revise and retain knowledge through the mHealth approach.

A further benefit of the mobile platform was the successful engagement of whole families. Lack of family support is a key barrier to accessing nutrition interventions and adopting promoted behaviours in low and middle-income countries [ 32 ] and family support and cooperation were identified as important enabling factors in the UPAVAN trial [ 10 , 33 ]. Following this, m-UPAVAN actively promoted watching and listening with family members via phone messages and with facilitators after COVID-19 restrictions eased. Over 60% of women engaging with m-UPAVAN content reported their spouse or another senior family member also doing so, and around half discussed the content with their families. Engaging whole families enabled discussions and negotiations around agriculture and nutrition practices promoted in the videos, which mothers believed facilitated their learning and adoption of behaviours. More active and deliberate engagement with other family members could help further increase the effectiveness of interventions [ 34 , 35 ]. For example, mobile interventions in India have proved successful in improving men’s knowledge of maternal health through text messaging [ 36 ]. Further research is needed to understand whether approaches that include other household members yield greater agriculture and nutrition impacts than those predominantly focused on women and the potential mediating mechanisms. However, strategies that engage whole families inclusively, i.e., not excluding those without phone access, also need developing and testing.

Whilst making interventions more family-centric may be key to enhancing nutritional impacts, women’s group-based learning remains important and was often highlighted as why mothers preferred UPAVAN over m-UPAVAN. Group-based approaches focused on social interactions create spaces for women to share experiences and gain confidence, where new behaviours are learnt and collectively adopted [ 37 ]. In India, women’s self-help groups and participatory learning and action groups (including those used in UPAVAN), to which learning and action-based interpersonal social interactions are central and empowering to communities, have proven effective at improving diets and other health outcomes [ 38 – 41 ].

The design of the m-UPAVAN intervention incorporated key learnings from the UPAVAN process evaluation, which found that lack of time, water, land, and family support meant that many families only adopted a limited number of practices, despite the intervention addressing these [ 10 ]. As such, to ensure participants could gauge the relevance of the upcoming messages, m-UPAVAN facilitators actively promoted the audio and videos before they were disseminated including providing information on the various constraints that the messages addressed (e.g., lack of time, water or land). To alleviate barriers arising from a lack of family support, facilitators actively encouraged women to watch or listen with their family members. Resulting, we found that m-UPAVAN was highly accepted, with participants expressing that the promoted practices were useful and feasible based on available resources. However, whilst this positive feedback suggests a need to evaluated the impact of the mobile intervention on agriculture and nutrition outcomes, it is important to note that our study sample likely represents a better-off portion of the population. m-UPAVAN was initiated during the COVID-19 lockdown in Odisha when only phone surveys were feasible. As such, over a quarter of women belonging to households without phones were excluded from our quantitative surveys. Therefore, our study sample may generally face fewer constraints in adopting promoted practices relative to the wider population.

Our study’s findings underpin the necessity of addressing inequities in phone access and use to optimise mHealth interventions’ potential in low- and middle-income settings. Training and capacity building on phone and mobile app usage in rural communities could help increase the uptake of mHealth interventions and alleviate gender-based social norms in phone usage [ 42 ]. Many policy initiatives are being implemented across low and middle-income settings [ 43 , 44 ], including in India [ 45 , 46 ], to improve access to digital technologies in rural and disadvantaged communities. Future mHealth interventions and policy approaches should work closely with relevant initiatives to increase their uptake and effectiveness. mHealth interventions that incorporate a microcredit component to help certain individuals purchase phones may also be a feasible approach to reducing inequities in mHealth [ 42 ]. Future research must explicitly evaluate the effects of digital inequality on the efficacy and equity of future mHealth interventions.

Limitations and strengths

A limitation of our study is sampling bias and non-response bias. As women without a phone were excluded from quantitative surveys and monitoring survey respondents were economically better off than non-respondents, the reported feasibility and acceptability of the intervention may have been inflated relative to a sample representative of all women with a child under 2 years in study villages. Whilst unfeasible at the time of our study due to COVID-19 restrictions, evaluations of future digital interventions should aim to use the most inclusive methods available for recruiting and interviewing participants to overcome these biases, such as in-person interviews or using on-the-ground resource persons to help facilitate the participation of harder-to-reach groups in mobile surveys. Additionally, social desirability may have resulted in respondents overreporting positive attitudes towards the intervention. However, quantitative surveys administered by an independent data collection firm, which was not involved in the intervention, aimed to minimise this risk. A key strength is our mixed-methods approach, which enabled us to understand intervention feasibility and acceptability and unpack the factors that explained it. Second, delivering the adapted intervention in the same study area and within a short time frame of the original intervention provided a unique opportunity to understand preferences regarding the in-person vs . mobile-based intervention.

Mobile phones can provide a feasible and acceptable way to deliver NSA interventions among those with phone, especially smartphone, access, and can overcome several barriers related to in-person approaches: provide NSA services on demand, reinforce learning, and engage whole families. However, despite mobile coverage growing rapidly in rural India [ 47 ], equity issues remain. Participatory face-to-face approaches continue to be essential for improving the equity of NSA interventions and are more conducive to learning. There is a need to develop and test the effectiveness of hybrid NSA interventions that incorporate the complementary strengths of both mobile and face-to-face interventions for improving agricultural and nutrition outcomes.

Supporting information

S1 checklist. inclusivity in global research..

https://doi.org/10.1371/journal.pgph.0003206.s001

S1 Table. Characteristics of purposely sampled qualitative interview participants ( N = 38).

Participants in UPAVAN study areas who confirmed they participated in the UPAVAN interventions were administered open-ended questions regarding preferences for m-UPAVAN vs UPAVAN. All mothers, besides those belonging to a household without a phone, were recruited from those who participated in monthly monitoring surveys.

https://doi.org/10.1371/journal.pgph.0003206.s002

S2 Table. Nutrition-sensitive agriculture and nutrition-specific topics disseminated in m-UPAVAN.

https://doi.org/10.1371/journal.pgph.0003206.s003

S1 Appendix. Village-wise poster that advertised the toll-free line for accessing m-UPAVAN audios.

https://doi.org/10.1371/journal.pgph.0003206.s004

S2 Appendix. Semi-structured interview guides used in qualitative interviews.

https://doi.org/10.1371/journal.pgph.0003206.s005

Acknowledgments

The authors would like to thank all the women and their families who participated in the interventions, responded to surveys, and took part in qualitative interviews. We also thank the Voluntary Association for Rural Reconstruction and Appropriate Technology field staff, who dedicated their time to delivering the interventions, and DCOR survey staff for collecting quantitative data and conducting qualitative interviews.

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This paper is in the following e-collection/theme issue:

Published on 15.5.2024 in Vol 8 (2024)

An Internet-Based Intervention to Increase the Ability of Lesbian, Gay, and Bisexual People to Cope With Adverse Events: Single-Group Feasibility Study

Authors of this article:

Original Paper

• Andreea Bogdana Isbășoiu 1, 2 , PhD   ; 
• Florin Alin Sava 1 , PhD   ; 
• Torill M B Larsen 3 , PhD   ; 
• Norman Anderssen 4 , PhD   ; 
• Tudor-Stefan Rotaru 5 , PhD   ; 
• Andrei Rusu 1 , PhD   ; 
• Nastasia Sălăgean 1 , PhD   ; 
• Bogdan Tudor Tulbure 1 , PhD  

1 Department of Psychology, West University of Timisoara, Timisoara, Romania

2 Department of Psychology and Educational Sciences, Transilvania University of Brasov, Brasov, Romania

3 Department of Health Promotion and Development, University of Bergen, Bergen, Norway

4 Department of Psychosocial Science, University of Bergen, Bergen, Norway

5 Department of Bioethics, University of Medicine and Pharmacy “Gr. T. Popa” Iași, Iasi, Romania

Corresponding Author:

Florin Alin Sava, PhD

Department of Psychology

West University of Timisoara

4 Vasile Parvan Bvd.

Timisoara, 300223

Phone: 40 256592270

Fax:40 256592311

Email: [email protected]

Background: Lesbian, gay, bisexual, transgender, and queer (LGBTQ+) people are at higher risk of mental health problems due to widespread hetero- and cisnormativity, including negative public attitudes toward the LGBTQ+ community. In addition to combating social exclusion at the societal level, strengthening the coping abilities of young LGBTQ+ people is an important goal.

Objective: In this transdiagnostic feasibility study, we tested a 6-week internet intervention program designed to increase the ability of nonclinical LGBTQ+ participants to cope with adverse events in their daily lives. The program was based on acceptance and commitment therapy principles.

Methods: The program consists of 6 web-based modules and low-intensity assistance for homework provided by a single care provider asynchronously. The design was a single-group assignment of 15 self-identified LGB community members who agreed to participate in an open trial with a single group (pre- and postintervention design).

Results: Before starting the program, participants found the intervention credible and expressed high satisfaction at the end of the intervention. Treatment adherence, operationalized by the percentage of completed homework assignments (32/36, 88%) was also high. When we compared participants’ pre- and postintervention scores, we found a significant decrease in clinical symptoms of depression (Cohen d =0.44, 90% CI 0.09-0.80), social phobia ( d =0.39, 90% CI 0.07-0.72), and posttraumatic stress disorder ( d =0.30, 90% CI 0.04-0.55). There was also a significant improvement in the level of self-acceptance and behavioral effectiveness ( d =0.64, 90% CI 0.28-0.99) and a significant decrease in the tendency to avoid negative internal experiences ( d =0.38, 90% CI 0.09-0.66). The level of general anxiety disorder ( P =.11; d =0.29, 90% CI –0.10 to 0.68) and alcohol consumption ( P =.35; d =–0.06, 90% CI –0.31 to 0.19) were the only 2 outcomes for which the results were not statistically significant.

Conclusions: The proposed web-based acceptance and commitment therapy program, designed to help LGBTQ+ participants better manage emotional difficulties and become more resilient, represents a promising therapeutic tool. The program could be further tested with more participants to ensure its efficacy and effectiveness.

Trial Registration: ClinicalTrials.gov NCT05514964; https://clinicaltrials.gov/study/NCT05514964

Introduction

Social inclusion of lesbian, gay, bisexual, and transgender (LGBT) individuals varies within and between countries (eg, measures of public acceptance of homosexuality and same-sex family rights) [ 1 ]. However, the LGBT groups are, on average, at a higher risk for mental health problems [ 2 , 3 ] as a result of various types of marginalization and discrimination working through processes of minority stress [ 4 ]. This includes repeated experiences of adverse social events that can lead to internalized homo-, bi-, and transphobia. For example, the vulnerability of gay men to developing symptoms of depression and anxiety is explained by the stress of being part of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+) community. This type of stress includes experiences of discrimination and bullying, as well as the internalization of negative social attitudes. However, some research suggests that promoting self-acceptance may be beneficial in reducing self-stigma related to sexual orientation. This study examined how a specially tailored internet intervention program might help improve self-acceptance among LGB individuals.

Scientific Background

The literature in this area includes studies of various types of interventions conducted to support the LGBTQ+ community, such as a camp intervention for LGBTQ+ youth to reduce depressive symptoms [ 5 ], a cognitive behavioral therapy (CBT) intervention for body image, and self-care for gay men living with HIV [ 6 ], an affirmative CBT intervention for depression caused by sexual orientation discrimination [ 7 ], an identity-affirming web app to cope with minority stress [ 8 ], an intensive outpatient group program tailored form LGBTQIA+ to reduce depression and anxiety [ 9 ], a rejection sensitivity model used to extend minority stress theory to improve mental health [ 10 ], and even a socially assistive robot to be used by young LGBTQ+ at risk for self-harm [ 11 ]. All of these and others, including this study, have been designed and implemented by psychologists who have shown an interest in improving the quality of life for the LGBTQ+ community.

Digital interventions such as those delivered through web platforms or smartphones are highly relevant for the LGBTQ+ population, as many people prefer to conceal their identity, particularly in countries with high levels of homophobia and transphobia. A recent systematic review [ 12 ] on digital health interventions for LGBTQ+ participants concluded that there were more interventions aiming at reducing sexually transmitted diseases than for other health concerns and that more targeted interventions are needed to cover mental health difficulties.

This study aims to design and preliminary test a stand-alone digital intervention tailored for LGBTQ+ participants that originates from the acceptance and commitment theory [ 13 - 15 ]. Several studies have emphasized the protective role of psychological processes related to acceptance. Acceptance implies psychological flexibility, from which 2 essential resources are derived [ 13 - 15 ]. One resource is the ability to accept the experience of the present moment as it is rather than avoid unpleasant events. A crucial rule is to accept the diversity of emotional experiences, not just the positive ones. One strategy for achieving this goal is to view unpleasant events as external events rather than overidentifying with these difficulties and blaming oneself. While avoidance is a coping strategy often used by LGBTQ+ people to deal with adverse events [ 16 ], there is also evidence to suggest that this emotional regulation strategy is associated with poor mental health [ 17 ]. Experiential avoidance, viewed by Hayes et al [ 18 ] as the opposite of acceptance, is a stronger predictor of depression than internalized homophobia. It also mediates the relationship between internalized homophobia and the severity of depressive symptoms [ 19 ]. In a recent systematic review, there was a call for action for researchers to provide evidence for the effectiveness of acceptance and commitment therapy (ACT) in treating mental health issues expressed by the LGBT community [ 20 ] in the absence of methodologically robust studies on this topic. An exception outside the ACT area [ 21 ] provided evidence for the effectiveness of an online single session in reducing internalized stigma and slightly increasing identity pride. Increasing the number of sessions from 1 to 6 and focusing on ACT principles to increase self-acceptance may increase the effectiveness of an online intervention tailored to the mental health needs of LGBTQ+ adults.

Goals of This Study

The main objective was to design and implement an internet-delivered (digital) psychological program based on ACT principles to help LGBTQ+ individuals become more resilient.

This study (NCT05514964) had three aims: (1) to tailor a prevention program based on ACT principles to the specific needs of the LGBTQ+ community; (2) to assess the feasibility of the program operationalized as treatment acceptability and treatment satisfaction among participants; and (3) to preliminary test the impact of the intervention program on participants’ levels of psychological flexibility, anxiety, and depression. Together with an increased sense of personal agency—that is, the ability to make changes in one’s life and control one’s destiny—we expect that LGBTQ+ individuals will be better equipped to cope with potential adverse events, including discrimination. The premises for an online intervention for LGBTQ+ participants are favorable because such interventions are more appropriate for LGBTQ+ people who are closeted and can cover more geographical locations, including areas outside of major cities where face-to-face psychological services are less available.

We hypothesized that the ACT-based mental health prevention program tailored for the specific needs of the LGBTQ+ community would be perceived as being (1) credible (logical) in comparison with a neutral point on a not logical–very logical continuum and (2) will lead to beneficiaries’ satisfaction in comparison with a neutral point on a totally unsatisfied–very satisfied continuum. Likewise, we hypothesized significant improvements in the (3) level of anxiety, (4) social anxiety, (5) depression, and (6) alcohol consumption between the pretest and posttest as evidence in favor of treatment feasibility for these primary outcomes.

Recruitment and Procedure

Participants were recruited using a variety of advertising methods targeting the LGBTQ+ community. We used online postings supported by several local NGOs (Accept, MozaiQ, Identity Education, and Campus Pride). The official description of the program was posted on the project website and social media (Facebook [Meta] and Grindr [Joel Simkhai]), and posters were printed for LGBTQ+ nightclubs. A brief description of the program was included in a newsletter, and one of the authors presented the program to potentially interested participants during a Campus Pride event.

Participants were invited to log in to a psychotherapy platform using a personal email account to participate in the study. Before registering, participants were encouraged to create a new email account to maintain anonymity. Registered participants were asked to complete a series of screening questionnaires to assess their eligibility. Based on these descriptions, computer and internet literacy was expected from participants in the study.

Treatment credibility was also assessed before the program. Inclusion criteria were being older than 18 years; fluent in Romanian; and being gay, lesbian, bisexual, or transgender. All eligible participants in the study should also have low or moderate symptoms on at least one of the following self-report scales: General Anxiety Disorder-7 (GAD-7; a score between 5 and 14) for generalized anxiety, Social Phobia Inventory (SPIN; a score between 21 and 40) for social anxiety, Patient Health Questionnaire (PHQ-9; a score between 5 and 14) for depression, and Alcohol Use Disorders Identification Test (AUDIT; a score between 8 and 14) for alcohol use. The exclusion criteria were suicidal ideation (ie, exceeding a score of 1 on suicide item 9 from PHQ-9), changes in psychotropic medication dosage in the past month (if present), bipolar disorder or psychosis (according to medication status), severe alcohol abuse or dependence (AUDIT score ≥15), clinical levels of anxiety or depression (exceeding the previously mentioned thresholds), current participation in other psychological treatment, and an obvious barrier to participation (eg, no current internet access, extended travel plans during the treatment period).

Enrolled participants were asked to read the first intervention module and complete homework assignments. No bug fixes or unexpected events occurred in the functionality of the platform. Finally, after the 6-week intervention, participants were invited to complete the postintervention assessment measures, which self-assessed their levels of anxiety, depression, and alcohol use through online questionnaires. Treatment satisfaction data were collected after the intervention to measure whether participants were satisfied with the intervention through online self-assessed questionnaires.

Participants

While the intervention was active online, 169 individuals expressed interest in the study by accessing the web platform. Of these, 65 completed all or most of the screening questionnaires, and 15 were eligible for inclusion in the study ( Table 1 shows the demographics). All these 15 participants successfully completed the program.

The Program

The current prevention program is based on a previously tested intervention based on ACT principles [ 22 ] and reported according to the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth) checklist [ 23 ]. However, this intervention was initially designed for the general population, and the original version of the program did not include specific references to sexual orientation. Therefore, our team decided to make the program LGBTQ+ friendly and tailor the content to the particular needs of this community. The tailoring process was theoretically informed by the American Psychological Association’s general recommendations for psychological practice with lesbian, gay, and bisexual clients [ 24 ]. These guidelines provide a general framework for psychological services with the LGBTQ+ community, systematically addressing the important issues and pertinent features that may arise in this context. We have also incorporated other suggestions from the literature [ 25 , 26 ], where comparable interventions have been successfully tested with the LGBTQ+ community. Finally, we thoroughly discussed the tailoring process and the new content to be added to the program with several members of the local LGBTQ+ communities. Some of these members were actively involved in various local LGBTQ+ organizations, some had professional training in psychology, and some were community members. The tailoring process took about 6 months, during which feedback was collected, discussed, and ultimately incorporated into the final version of the program. As a result, 6 customized modules adapted for the online environment were finally uploaded to a psychotherapy web platform.

The 6 modules covered six different topics: (1) introduction to minority stress and the current program, (2) defusion, (3) coming out and the acceptance process, (4) personal values, (5) committed action, and (6) compassion and self in context. The recommended time for each module was 1 week, so the total length of the program was 6 weeks. Participants were asked to complete approximately 6 homework assignments per module (36 for the entire program). At the end of each week, an online therapist provided written feedback to each participant on the platform. To ensure confidentiality, the content of the messages was securely stored on encrypted software. Participants received only a notification when a new written message was delivered to them within the psychotherapy platform, but their registered email was not used to provide any sensitive data. The content of the 6 modules is available for replicability or upscaling studies at the LGBT Inclusion website [ 27 ]. Human involvement was limited to providing asynchronous written feedback and reminders for homework. The assistance was provided by a single care provider (research assistant).

Treatment Credibility, Satisfaction, and Adherence Measures

Participants were asked to complete a measure of treatment credibility before the program began and a measure of treatment satisfaction immediately after the intervention to assess their overall perceptions of the program. A total of 5 standard questions on operationalized treatment credibility were scored on a 10-point Likert scale (ie, the program: 0=does not seem logical to 10=seems very logical). After the intervention, we assessed participants’ satisfaction with the program by asking them to complete a series of quantitative and qualitative items, that is, overall satisfaction with treatment (1=totally unsatisfied vs 5=very satisfied). More details on treatment credibility and satisfaction questions are presented in the Results section.

Treatment adherence (the intensity or dose of the intervention) was estimated by the number of homework assignments completed for each participant.

Outcome Measures

Primary outcome measures.

The SPIN [ 28 ] was designed to measure the participant’s level of social phobia. The scale is unidimensional, and the total score ranges from 0 to 68, with high scores associated with high levels of social phobia. In this study, the internal consistency was adequate α=.87.

The PHQ-9 [ 29 ] was designed to measure the participant’s level of depression, with high scores associated with high levels of depression. In this study, the internal consistency was α=.84.

The GAD-7 [ 30 ] was designed to measure the participants’ level of anxiety or worry. The total score ranges from 0 to 21, with high scores associated with high levels of worry. The instrument has demonstrated adequate psychometric properties [ 31 , 32 ], and in our sample, the internal consistency was α=.87.

The AUDIT [ 33 ] consists of 10 items measuring alcohol use. In this study, internal consistency for this scale was α=.73.

Secondary Outcome Measures

The Acceptance and Action Questionnaire 2 [ 34 ] assessed psychological flexibility. In this study, the internal consistency was α=.81.

The Brief Multidimensional Experiential Avoidance Questionnaire [ 35 ] was designed to measure the participants’ avoidance tendencies. The internal consistency in this study was α=.84.

The Diagnostic and Statistical Manual-5 Post-Traumatic Stress Disorder Checklist (PCL-5) [ 36 ] was used to measure symptoms of posttraumatic stress disorder (PTSD). For this study, the internal consistency of the PCL-5 was (α=.91).

Additional measures were used during the screening process related to how participants experience their lives as members of the LGB community. These three additional measures were (1) the Short Internalized Homonegativity Scale [ 37 ], (2) the Sexual Orientation Concealment Scale [ 38 ], and (3) the Daily Heterosexist Experiences Questionnaire [ 39 ].

Ethical Considerations

The study was approved by the Ethics Committee of the West University of Timisoara, Romania (4137/27.01.2021) and was registered on ClinicalTrials.gov as NCT05514964. Written informed consent was obtained from all participants by surface email.

Treatment Credibility, Satisfaction, and Adherence

Table 2 shows the mean scores for the included participants. The scores for all items were significantly above chance (set at 5 on the 10-point scale, all P <.001), as participants reported that the program seemed trustworthy.

As shown in Table 3 , participants completed most of the modules and seemed satisfied with the intervention. The fact that most participants remained active throughout the program and completed the postintervention assessment proves that the program was perceived as useful despite the time (3.6 hours per week) and effort required to complete it.

Treatment adherence (the intensity or dose of the intervention) was estimated by the number of homework assignments completed for each participant. On average, participants completed 5.3 weekly assignments (out of a maximum of 6). More specifically, the 15 participants completed, on average, 32 out of a maximum of 36 assignments (88%), representing high adherence.

Treatment Outcomes

Subsequently, we assessed the impact of the program by comparing participants’ levels of anxiety, depression, and alcohol use before and after completing the program. Table 4 shows us that participants improved on most outcome measures, except the AUDIT and GAD-7. Participants’ alcohol consumption seems to remain unaffected by the program while their anxiety and depression levels decrease. We also found that participants’ psychological flexibility increased significantly (Cohen d =0.83).

We found a significant improvement in participants’ psychological flexibility (Acceptance and Action Questionnaire 2, Cohen d =0.64), the primary goal of any ACT-based intervention. We also found significant reductions in clinical symptoms of depression ( d =0.44), social phobia ( d =0.39), and PTSD ( d =0.30). However, participants’ levels of general anxiety disorder and alcohol use were the only 2 outcomes for which the results were not statistically significant.

a AUDIT: The Alcohol Use Disorders Identification Test.

b PHQ-9: Patient Health Questionnaire-9.

c GAD-7: Generalized Anxiety Disorder-7.

d SPIN: Social Phobia Inventory.

e AAQ-2: Acceptance and Action Questionnaire 2.

f B-MEAQ: Brief-Multidimensional Experiential Avoidance Questionnaire.

g PCL5: Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5.

Principal Results

In this study, we examined the feasibility of an internet-delivered prevention program tailored for LGBTQ+ individuals at risk for developing emotional disorders due to minority stress (eg, being discriminated against, not being accepted by their families, etc). The intervention was designed to increase personal agency and foster acceptance among LGB individuals. Overall, the intervention was perceived as credible based on participants’ involvement in the program and generated high levels of satisfaction at the end of the program. Participants also demonstrated a high level of treatment adherence, completing 88% (32/36) of the homework assignments. In terms of impact, we found significant reductions in clinical symptoms of depression, social phobia, and PTSD following the intervention. There was also a substantial improvement in self-acceptance and a considerable decrease in the avoidance of negative experiences.

This was the first online transdiagnostic prevention program targeting the LGB group based on the ACT framework. Despite previous calls to use standard ACT [ 40 ] or affirmative ACT [ 41 ] for LGBTQ+ communities, this is the first ACT-inspired open trial tailored for LGBTQ+ people. It is not, however, the first mental health program tailored to the LGBTQ+ community. For example, Pachankis et al [ 26 ] used a 10-session LGBTQ+ tailored CBT. They found reductions in a wide range of symptoms such as depression, anxiety, and co-occurring health risks (ie, alcohol use and condomless sex) among young adult gay and bisexual men. It should be noted, however, that this intervention was based on face-to-face sessions with experienced CBT therapists.

Considering the privacy issues, the shortage of trained mental health professionals in Romania and internationally, and the fact that even those who exist may not have sufficient knowledge or experience working with sexual minorities, an internet-delivered program looks pretty suitable for LGBTQ+ participants. They are more reluctant to participate in such programs, preferring to hide their identity. The challenge is to make evidence-based interventions available to underserved populations, such as LGBTQ+ people with emotional difficulties.

Internet-delivered or computerized interventions may address the above limitations by becoming an attractive alternative in a stepped-care approach for those seeking treatment for mild to moderate symptoms [ 42 ]. The internet-based treatment format has the potential to reduce many of the barriers that currently impede access to mental health care: the small number of competent psychotherapists, geographic distance, and the high cost of face-to-face programs. However, many internet-delivered studies have not been implemented for the LGBTQ+ community, with one exception: the computerized CBT-Rainbow SPARX (Smart, Positive, Active, Realistic, X-Factor Thoughts), aimed at reducing depression symptoms in adolescents who manifested same-sex attraction [ 43 ]. However, the program was designed primarily for adolescents in a gamified form. Participants had to use avatars to collect all 6 gems for a shield. This strategy limits its applicability to adults, who are less likely to participate in a gamified psychosocial intervention.

Mental health issues in the LGBTQ+ community are multifaceted and have a significant impact on the psychological and physical well-being of those affected. Several studies have documented that people who are part of the LGBTQ+ community are vulnerable to various status inequalities related to income disparities, treatment in the workplace, and social and legal discrimination [ 44 , 45 , 46 ], as same-sex unions are not recognized. Targeting and changing such societal processes requires several long-term structural changes. An online intervention program targeting personal acceptance, identity, engagement, and coping strategies is only one of several strategies to reach the LGB and LGBTQ+ communities.

Limitations

This feasibility study provided us with experience in making relevant changes in different parts of the procedures and the program. First, we observed that several potential participants did not join the program because of too many measurements, including too many instruments that asked in great detail about the participants’ lives and intruded too much into their privacy, which scared them, considering that we are in a country where this category of the population is very discriminated against. To diminish the risk that the research process itself could be seen as tiring and intrusive, as it involves revealing aspects of their lives that are stigmatized, we suggest dropping out some measures to reduce the burden of participants and advertising the call to potential beneficiaries only after establishing a direct contact with them to decrease their mistrust level. Second, the study did not include follow-up measurements. Future studies should include follow-up measurements to decide whether the intervention has significant long-term effects. This would involve providing incentives for their long-term participation, including sharing the progress or preliminary results, to help participants notice their contribution is meaningful and valuable. Third, as with any feasibility study, an underpowered study undermines some potential conclusions. It may be that relying solely on increasing the sample size would be sufficient to decrease the generalized anxiety symptoms significantly. Or perhaps an extension from a 6-week to a 9-week program would be required to reduce the anxiety symptoms significantly. Similarly, the current program focuses extensively on internalizing problems, so a program redesign is needed when targeting externalizing problems such as alcohol use.

Conclusions

The 6-week online transdiagnostic program based on ACT, specifically designed for the LGBT community, is a promising intervention because the treatment is credible and results in beneficiaries’ satisfaction. In addition, the dynamics of the pre- and posttest data suggest clinical improvement in most of the measured outcomes, including depression, PTSD, and social phobia, as well as in the potential related mechanisms of change from an ACT perspective. The online program is particularly appropriate for use in countries where beneficiaries are less likely to disclose themselves and where there is a shortage of therapists due to geographic or other barriers.

Acknowledgments

The research leading to these results has received funding from the NO grants 2014-2021, under project contract 17/2020 (RO-NO-2019-0412; project title: The Social Inclusion of Lesbian, Gay, Bisexual, and Transgender People. Public Attitudes and Evidence-Based Interventions to Increase Their Quality of Life.

Conflicts of Interest

None declared.

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Abbreviations

Edited by A Mavragani; submitted 09.01.24; peer-reviewed by ASW Chan; comments to author 15.03.24; revised version received 05.04.24; accepted 09.04.24; published 15.05.24.

©Andreea Bogdana Isbășoiu, Florin Alin Sava, Torill M B Larsen, Norman Anderssen, Tudor-Stefan Rotaru, Andrei Rusu, Nastasia Sălăgean, Bogdan Tudor Tulbure. Originally published in JMIR Formative Research (https://formative.jmir.org), 15.05.2024.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Formative Research, is properly cited. The complete bibliographic information, a link to the original publication on https://formative.jmir.org, as well as this copyright and license information must be included.

Black & Veatch delivers feasibility study of AET LNG project (Colombia)

Black & Veatch has completed a feasibility study for the Andes Energy Terminal (AET) LNG regasification terminal and power plant, located near the port city of Buenaventura on Colombia’s Pacific coast. The study assessed site suitability, project design requirements, capital and operating costs, financial viability, financing options, climate resilience, and implementation and construction plans. The AET project comprises an LNG import terminal, a land-based regasification plant, an LNG truck loading terminal, a power plant, and associated gas and electrical transmission infrastructure. 

The AET project is being developed by the Colombian energy planning agency UPME with the aim of avoiding the risk of a gas shortage forecasted in the coming years, particularly in the south-west of the country. The project’s Phase I includes a 270 MW SCGT to be upgraded to a 400 MW CCGT in Phase II.

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