document research methodology

Document Analysis

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This chapter describes the document analysis approach. As a qualitative method, document analysis entails a systematic procedure for reviewing and evaluating documents through finding, selecting, appraising (making sense of), and synthesizing data contained within them. This chapter outlines the brief history, method and use of document analysis, provides an outline of its process, strengths and limitations, and application, and offers further readings, resources, and suggestions for student engagement activities.

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Additional Reading

Kutsyuruba, B. (2017). Examining education reforms through document analysis methodology. In I. Silova, A. Korzh, S. Kovalchuk, & N. Sobe (Eds.), Reimagining Utopias: Theory and method for educational research in post-socialist contexts (pp. 199–214). Sense.

Kutsyuruba, B., Christou, T., Heggie, L., Murray, J., & Deluca, C. (2015). Teacher collaborative inquiry in Ontario: An analysis of provincial and school board policies and support documents. Canadian Journal of Educational Administration and Policy, 172 , 1–38.

Kutsyuruba, B., Godden, L., & Tregunna, L. (2014). Curbing the early-career attrition: A pan-Canadian document analysis of teacher induction and mentorship programs. Canadian Journal of Educational Administration and Policy, 161 , 1–42.

Segeren, A., & Kutsyuruba, B. (2012). Twenty years and counting: An examination of the development of equity and inclusive education policy in Ontario (1990–2010). Canadian Journal of Educational Administration and Policy, 136 , 1–38.

Online Resources

Document Analysis: A How To Guide (12:27 min) https://www.youtube.com/watch?v=vOsE9saR_ck

Document Analysis with Philip Adu (1:16:40 min) https://youtu.be/bLKBffW5JPU

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Kutsyuruba, B. (2023). Document Analysis. In: Okoko, J.M., Tunison, S., Walker, K.D. (eds) Varieties of Qualitative Research Methods. Springer Texts in Education. Springer, Cham. https://doi.org/10.1007/978-3-031-04394-9_23

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Article Contents

Introduction, what is document analysis, the read approach, supplementary data, acknowledgements.

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Document analysis in health policy research: the READ approach

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Sarah L Dalglish, Hina Khalid, Shannon A McMahon, Document analysis in health policy research: the READ approach, Health Policy and Planning , Volume 35, Issue 10, December 2020, Pages 1424–1431, https://doi.org/10.1093/heapol/czaa064

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Document analysis is one of the most commonly used and powerful methods in health policy research. While existing qualitative research manuals offer direction for conducting document analysis, there has been little specific discussion about how to use this method to understand and analyse health policy. Drawing on guidance from other disciplines and our own research experience, we present a systematic approach for document analysis in health policy research called the READ approach: (1) ready your materials, (2) extract data, (3) analyse data and (4) distil your findings. We provide practical advice on each step, with consideration of epistemological and theoretical issues such as the socially constructed nature of documents and their role in modern bureaucracies. We provide examples of document analysis from two case studies from our work in Pakistan and Niger in which documents provided critical insight and advanced empirical and theoretical understanding of a health policy issue. Coding tools for each case study are included as Supplementary Files to inspire and guide future research. These case studies illustrate the value of rigorous document analysis to understand policy content and processes and discourse around policy, in ways that are either not possible using other methods, or greatly enrich other methods such as in-depth interviews and observation. Given the central nature of documents to health policy research and importance of reading them critically, the READ approach provides practical guidance on gaining the most out of documents and ensuring rigour in document analysis.

Rigour in qualitative research is judged partly by the use of deliberate, systematic procedures; however, little specific guidance is available for analysing documents, a nonetheless common method in health policy research.

Document analysis is useful for understanding policy content across time and geographies, documenting processes, triangulating with interviews and other sources of data, understanding how information and ideas are presented formally, and understanding issue framing, among other purposes.

The READ (Ready materials, Extract data, Analyse data, Distil) approach provides a step-by-step guide to conducting document analysis for qualitative policy research.

The READ approach can be adapted to different purposes and types of research, two examples of which are presented in this article, with sample tools in the Supplementary Materials .

Document analysis (also called document review) is one of the most commonly used methods in health policy research; it is nearly impossible to conduct policy research without it. Writing in early 20th century, Weber (2015) identified the importance of formal, written documents as a key characteristic of the bureaucracies by which modern societies function, including in public health. Accordingly, critical social research has a long tradition of documentary review: Marx analysed official reports, laws, statues, census reports and newspapers and periodicals over a nearly 50-year period to come to his world-altering conclusions ( Harvey, 1990 ). Yet in much of social science research, ‘documents are placed at the margins of consideration,’ with privilege given to the spoken word via methods such as interviews, possibly due to the fact that many qualitative methods were developed in the anthropological tradition to study mainly pre-literate societies ( Prior, 2003 ). To date, little specific guidance is available to help health policy researchers make the most of these wells of information.

The term ‘documents’ is defined here broadly, following Prior, as physical or virtual artefacts designed by creators, for users, to function within a particular setting ( Prior, 2003 ). Documents exist not as standalone objects of study but must be understood in the social web of meaning within which they are produced and consumed. For example, some analysts distinguish between public documents (produced in the context of public sector activities), private documents (from business and civil society) and personal documents (created by or for individuals, and generally not meant for public consumption) ( Mogalakwe, 2009 ). Documents can be used in a number of ways throughout the research process ( Bowen, 2009 ). In the planning or study design phase, they can be used to gather background information and help refine the research question. Documents can also be used to spark ideas for disseminating research once it is complete, by observing the ways those who will use the research speak to and communicate ideas with one another.

Documents can also be used during data collection and analysis to help answer research questions. Recent health policy research shows that this can be done in at least four ways. Frequently, policy documents are reviewed to describe the content or categorize the approaches to specific health problems in existing policies, as in reviews of the composition of drowning prevention resources in the United States or policy responses to foetal alcohol spectrum disorder in South Africa ( Katchmarchi et al. , 2018 ; Adebiyi et al. , 2019 ). In other cases, non-policy documents are used to examine the implementation of health policies in real-world settings, as in a review of web sources and newspapers analysing the functioning of community health councils in New Zealand ( Gurung et al. , 2020 ). Perhaps less frequently, document analysis is used to analyse policy processes, as in an assessment of multi-sectoral planning process for nutrition in Burkina Faso ( Ouedraogo et al. , 2020 ). Finally, and most broadly, document analysis can be used to inform new policies, as in one study that assessed cigarette sticks as communication and branding ‘documents,’ to suggest avenues for further regulation and tobacco control activities ( Smith et al. , 2017 ).

This practice paper provides an overarching method for conducting document analysis, which can be adapted to a multitude of research questions and topics. Document analysis is used in most or all policy studies; the aim of this article is to provide a systematized method that will enhance procedural rigour. We provide an overview of document analysis, drawing on guidance from disciplines adjacent to public health, introduce the ‘READ’ approach to document analysis and provide two short case studies demonstrating how document analysis can be applied.

Document analysis is a systematic procedure for reviewing or evaluating documents, which can be used to provide context, generate questions, supplement other types of research data, track change over time and corroborate other sources ( Bowen, 2009 ). In one commonly cited approach in social research, Bowen recommends first skimming the documents to get an overview, then reading to identify relevant categories of analysis for the overall set of documents and finally interpreting the body of documents ( Bowen, 2009 ). Document analysis can include both quantitative and qualitative components: the approach presented here can be used with either set of methods, but we emphasize qualitative ones, which are more adapted to the socially constructed meaning-making inherent to collaborative exercises such as policymaking.

The study of documents as a research method is common to a number of social science disciplines—yet in many of these fields, including sociology ( Mogalakwe, 2009 ), anthropology ( Prior, 2003 ) and political science ( Wesley, 2010 ), document-based research is described as ill-considered and underutilized. Unsurprisingly, textual analysis is perhaps most developed in fields such as media studies, cultural studies and literary theory, all disciplines that recognize documents as ‘social facts’ that are created, consumed, shared and utilized in socially organized ways ( Atkinson and Coffey, 1997 ). Documents exist within social ‘fields of action,’ a term used to designate the environments within which individuals and groups interact. Documents are therefore not mere records of social life, but integral parts of it—and indeed can become agents in their own right ( Prior, 2003 ). Powerful entities also manipulate the nature and content of knowledge; therefore, gaps in available information must be understood as reflecting and potentially reinforcing societal power relations ( Bryman and Burgess, 1994 ).

Document analysis, like any research method, can be subject to concerns regarding validity, reliability, authenticity, motivated authorship, lack of representativity and so on. However, these can be mitigated or avoided using standard techniques to enhance qualitative rigour, such as triangulation (within documents and across methods and theoretical perspectives), ensuring adequate sample size or ‘engagement’ with the documents, member checking, peer debriefing and so on ( Maxwell, 2005 ).

Document analysis can be used as a standalone method, e.g. to analyse the contents of specific types of policy as they evolve over time and differ across geographies, but document analysis can also be powerfully combined with other types of methods to cross-validate (i.e. triangulate) and deepen the value of concurrent methods. As one guide to public policy research puts it, ‘almost all likely sources of information, data, and ideas fall into two general types: documents and people’ ( Bardach and Patashnik, 2015 ). Thus, researchers can ask interviewees to address questions that arise from policy documents and point the way to useful new documents. Bardach and Patashnik suggest alternating between documents and interviews as sources as information, as one tends to lead to the other, such as by scanning interviewees’ bookshelves and papers for titles and author names ( Bardach and Patashnik, 2015 ). Depending on your research questions, document analysis can be used in combination with different types of interviews ( Berner-Rodoreda et al. , 2018 ), observation ( Harvey, 2018 ), and quantitative analyses, among other common methods in policy research.

The READ approach to document analysis is a systematic procedure for collecting documents and gaining information from them in the context of health policy studies at any level (global, national, local, etc.). The steps consist of: (1) ready your materials, (2) extract data, (3) analyse data and (4) distil your findings. We describe each of these steps in turn.

Step 1. Ready your materials

At the outset, researchers must set parameters in terms of the nature and number (approximately) of documents they plan to analyse, based on the research question. How much time will you allocate to the document analysis, and what is the scope of your research question? Depending on the answers to these questions, criteria should be established around (1) the topic (a particular policy, programme, or health issue, narrowly defined according to the research question); (2) dates of inclusion (whether taking the long view of several decades, or zooming in on a specific event or period in time); and (3) an indicative list of places to search for documents (possibilities include databases such as Ministry archives; LexisNexis or other databases; online searches; and particularly interview subjects). For difficult-to-obtain working documents or otherwise non-public items, bringing a flash drive to interviews is one of the best ways to gain access to valuable documents.

For research focusing on a single policy or programme, you may review only a handful of documents. However, if you are looking at multiple policies, health issues, or contexts, or reviewing shorter documents (such as newspaper articles), you may look at hundreds, or even thousands of documents. When considering the number of documents you will analyse, you should make notes on the type of information you plan to extract from documents—i.e. what it is you hope to learn, and how this will help answer your research question(s). The initial criteria—and the data you seek to extract from documents—will likely evolve over the course of the research, as it becomes clear whether they will yield too few documents and information (a rare outcome), far too many documents and too much information (a much more common outcome) or documents that fail to address the research question; however, it is important to have a starting point to guide the search. If you find that the documents you need are unavailable, you may need to reassess your research questions or consider other methods of inquiry. If you have too many documents, you can either analyse a subset of these ( Panel 1 ) or adopt more stringent inclusion criteria.

Exploring the framing of diseases in Pakistani media

In Table 1 , we present a non-exhaustive list of the types of documents that can be included in document analyses of health policy issues. In most cases, this will mean written sources (policies, reports, articles). The types of documents to be analysed will vary by study and according to the research question, although in many cases, it will be useful to consult a mix of formal documents (such as official policies, laws or strategies), ‘gray literature’ (organizational materials such as reports, evaluations and white papers produced outside formal publication channels) and, whenever possible, informal or working documents (such as meeting notes, PowerPoint presentations and memoranda). These latter in particular can provide rich veins of insight into how policy actors are thinking through the issues under study, particularly for the lucky researcher who obtains working documents with ‘Track Changes.’ How you prioritize documents will depend on your research question: you may prioritize official policy documents if you are studying policy content, or you may prioritize informal documents if you are studying policy process.

Types of documents that can be consulted in studies of health policy

During this initial preparatory phase, we also recommend devising a file-naming system for your documents (e.g. Author.Date.Topic.Institution.PDF), so that documents can be easily retrieved throughout the research process. After extracting data and processing your documents the first time around, you will likely have additional ‘questions’ to ask your documents and need to consult them again. For this reason, it is important to clearly name source files and link filenames to the data that you are extracting (see sample naming conventions in the Supplementary Materials ).

Step 2. Extract data

Data can be extracted in a number of ways, and the method you select for doing so will depend on your research question and the nature of your documents. One simple way is to use an Excel spreadsheet where each row is a document and each column is a category of information you are seeking to extract, from more basic data such as the document title, author and date, to theoretical or conceptual categories deriving from your research question, operating theory or analytical framework (Panel 2). Documents can also be imported into thematic coding software such as Atlas.ti or NVivo, and data extracted that way. Alternatively, if the research question focuses on process, documents can be used to compile a timeline of events, to trace processes across time. Ask yourself, how can I organize these data in the most coherent manner? What are my priority categories? We have included two different examples of data extraction tools in the Supplementary Materials to this article to spark ideas.

Case study Documents tell part of the story in Niger

Document analyses are first and foremost exercises in close reading: documents should be read thoroughly, from start to finish, including annexes, which may seem tedious but which sometimes produce golden nuggets of information. Read for overall meaning as you extract specific data related to your research question. As you go along, you will begin to have ideas or build working theories about what you are learning and observing in the data. We suggest capturing these emerging theories in extended notes or ‘memos,’ as used in Grounded Theory methodology ( Charmaz, 2006 ); these can be useful analytical units in themselves and can also provide a basis for later report and article writing.

As you read more documents, you may find that your data extraction tool needs to be modified to capture all the relevant information (or to avoid wasting time capturing irrelevant information). This may require you to go back and seek information in documents you have already read and processed, which will be greatly facilitated by a coherent file-naming system. It is also useful to keep notes on other documents that are mentioned that should be tracked down (sometimes you can write the author for help). As a general rule, we suggest being parsimonious when selecting initial categories to extract from data. Simply reading the documents takes significant time in and of itself—make sure you think about how, exactly, the specific data you are extracting will be used and how it goes towards answering your research questions.

Step 3. Analyse data

As in all types of qualitative research, data collection and analysis are iterative and characterized by emergent design, meaning that developing findings continually inform whether and how to obtain and interpret data ( Creswell, 2013 ). In practice, this means that during the data extraction phase, the researcher is already analysing data and forming initial theories—as well as potentially modifying document selection criteria. However, only when data extraction is complete can one see the full picture. For example, are there any documents that you would have expected to find, but did not? Why do you think they might be missing? Are there temporal trends (i.e. similarities, differences or evolutions that stand out when documents are ordered chronologically)? What else do you notice? We provide a list of overarching questions you should think about when viewing your body of document as a whole ( Table 2 ).

Questions to ask your overall body of documents

HIV and viral hepatitis articles by main frames (%). Note: The percentage of articles is calculated by dividing the number of articles appearing in each frame for viral hepatitis and HIV by the respectivenumber of sampled articles for each disease (N = 137 for HIV; N = 117 for hepatitis). Time frame: 1 January 2006 to 30 September 2016

Representations of progress toward Millennium Development Goal 4 in Nigerien policy documents. Sources: clockwise from upper left: ( WHO 2006 ); ( Institut National de la Statistique 2010 ); ( Ministè re de la Santé Publique 2010 ); ( Unicef 2010 )

In addition to the meaning-making processes you are already engaged in during the data extraction process, in most cases, it will be useful to apply specific analysis methodologies to the overall corpus of your documents, such as policy analysis ( Buse et al. , 2005 ). An array of analysis methodologies can be used, both quantitative and qualitative, including case study methodology, thematic content analysis, discourse analysis, framework analysis and process tracing, which may require differing levels of familiarity and skills to apply (we highlight a few of these in the case studies below). Analysis can also be structured according to theoretical approaches. When it comes to analysing policies, process tracing can be particularly useful to combine multiple sources of information, establish a chronicle of events and reveal political and social processes, so as to create a narrative of the policy cycle ( Yin, 1994 ; Shiffman et al. , 2004 ). Practically, you will also want to take a holistic view of the documents’ ‘answers’ to the questions or analysis categories you applied during the data extraction phase. Overall, what did the documents ‘say’ about these thematic categories? What variation did you find within and between documents, and along which axes? Answers to these questions are best recorded by developing notes or memos, which again will come in handy as you write up your results.

As with all qualitative research, you will want to consider your own positionality towards the documents (and their sources and authors); it may be helpful to keep a ‘reflexivity’ memo documenting how your personal characteristics or pre-standing views might influence your analysis ( Watt, 2007 ).

Step 4. Distil your findings

You will know when you have completed your document review when one of the three things happens: (1) completeness (you feel satisfied you have obtained every document fitting your criteria—this is rare), (2) out of time (this means you should have used more specific criteria), and (3) saturation (you fully or sufficiently understand the phenomenon you are studying). In all cases, you should strive to make the third situation the reason for ending your document review, though this will not always mean you will have read and analysed every document fitting your criteria—just enough documents to feel confident you have found good answers to your research questions.

Now it is time to refine your findings. During the extraction phase, you did the equivalent of walking along the beach, noticing the beautiful shells, driftwood and sea glass, and picking them up along the way. During the analysis phase, you started sorting these items into different buckets (your analysis categories) and building increasingly detailed collections. Now you have returned home from the beach, and it is time to clean your objects, rinse them of sand and preserve only the best specimens for presentation. To do this, you can return to your memos, refine them, illustrate them with graphics and quotes and fill in any incomplete areas. It can also be illuminating to look across different strands of work: e.g. how did the content, style, authorship, or tone of arguments evolve over time? Can you illustrate which words, concepts or phrases were used by authors or author groups?

Results will often first be grouped by theoretical or analytic category, or presented as a policy narrative, interweaving strands from other methods you may have used (interviews, observation, etc.). It can also be helpful to create conceptual charts and graphs, especially as this corresponds to your analytical framework (Panels 1 and 2). If you have been keeping a timeline of events, you can seek out any missing information from other sources. Finally, ask yourself how the validity of your findings checks against what you have learned using other methods. The final products of the distillation process will vary by research study, but they will invariably allow you to state your findings relative to your research questions and to draw policy-relevant conclusions.

Document analysis is an essential component of health policy research—it is also relatively convenient and can be low cost. Using an organized system of analysis enhances the document analysis’s procedural rigour, allows for a fuller understanding of policy process and content and enhances the effectiveness of other methods such as interviews and non-participant observation. We propose the READ approach as a systematic method for interrogating documents and extracting study-relevant data that is flexible enough to accommodate many types of research questions. We hope that this article encourages discussion about how to make best use of data from documents when researching health policy questions.

Supplementary data are available at Health Policy and Planning online.

The data extraction tool in the Supplementary Materials for the iCCM case study (Panel 2) was conceived of by the research team for the multi-country study ‘Policy Analysis of Community Case Management for Childhood and Newborn Illnesses’. The authors thank Sara Bennett and Daniela Rodriguez for granting permission to publish this tool. S.M. was supported by The Olympia-Morata-Programme of Heidelberg University. The funders had no role in the decision to publish, or preparation of the manuscript. The content is the responsibility of the authors and does not necessarily represent the views of any funder.

Conflict of interest statement . None declared.

Ethical approval. No ethical approval was required for this study.

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Documentary Research: What it is, methodology & free examples

Social scientists often conduct documentary research. Its primary use is to assess various documents in the interest of social or historical value. Researchers also conduct documentary research to study multiple documents surrounding events or individuals.

What is documentary research?

Documentary research is the research conducted through the use of official documents or personal documents as the source of information.

Documents can include anything from the following: 

• Directories
• Government statistical publications
• Gramophone records
• Photographs
• Computer files

The above may not fit the traditional bill of a “document”, but companies can use them towards documentary research since they contain information.

Documentary research is similar to content analysis, which involves studying existing information recorded in media, texts, and physical items. Here, data collection from people is not required to conduct research. Hence, this is a prime example of secondary research.

It is essential to consider the quality of the documents while using it as evidence on social relations and social meanings. Keep in mind that, unlike surveys and research interviews, the records are originally published/generated without keeping the purpose of research in mind. It is good practice to cross-verify documents against other similar documents before reaching a decision.

Documentary research examples

Bellow, we can find a few real-life examples of documentary research applied to companies’ daily events.

1. Social research studies

Although documentary research is not used extensively today, it is the go-to research method to conduct social research studies. For example, Karl Marx and Emile Durkheim used documentary research extensively for their research.

Karl Marx used documents like:

• Her Majesty Inspectors of Factories Reports
• Royal Commission
• Inland Revenue Reports

There’s also a record of his use of reports by the Medical Officer of the Privy Council, reports on children’s employment in factories, the Corn-laws, the Banking Acts, and Census Reports for Wales and England to name a few.

Durkheim, one of the founders of Sociology, wrote a book on suicide, which is recognized as the first modern example of a methodical and consistent use of documents for social research.

2. Archival inquiry

The field of sociology has a popular, longstanding tradition of documentary inquiry. Many historians refer to and rely on primary documents for their research. Historians give historical documents more emphasis while conducting research. Of course, as we evolve, virtual documents like emails will play a significant role in research activities conducted by these researchers.

3. Aesthetic interpretation

Documentary research is not limited to text only. Pictures, paintings, videos, audio files, monuments are also used to conduct research. Documentary researchers use these tools in addition to texts while studying social sciences. The use of these tools adds to the authenticity of the textual research, or may very well point out deviations in the findings.

This deviation suggests that investigators research more to draw accurate conclusions.

Documentary research methodology

Documentary research, if conducted thoroughly, can help develop a hypothesis or prove or disprove an existing theory. This of course depends on the methodology applied and the depth of research conducted. The researcher must conduct his/her own secondary research to analyze the contents before extracting it. They must handle the data scientifically.

Follow this four-step approach to control the quality of the content:

The authenticity of the documents

The credibility of the documents

Representativeness of the documents

The meaning derived from the documents

Let’s take a look at these in detail.

Authenticity implies whether the document’s origin is reliable, is the evidence genuine, are the intentions sincere, and what were the commitments to creating the document. The authenticity of the source is the primary criterion of documentary research.

Credibility means the subjective and objective components that make one believe the source of information and whether the data is free from distortion and error. The information must be trustworthy and must have some level of expertise.

Representativeness refers to whether the document represents a more extensive collection of the data point, and it is an aggregation of the topic being studied. That said, documents get distorted with time due to the inclusion of new factors, and a check has to be made to ensure the documents are representative.

Meaning means whether the findings are understandable and clear to be called evidence. The goal of examining documents is to understand its significance and meaning. Researchers must find out whether the document fits within the historical context or not.

Advantages of documentary study

Here are the advantages of the documentary research method:

• Data readily available: Data is readily available in various sources. You only need to know where to look and how to use it. The data is available in different forms, and harnessing it is the real challenge.
• Inexpensive and economical: The data for research is already collected and published in either print or other forms. The researcher does not need to spend money and time like they do to collect market research insights and gather data. They need to search for and compile the available data from different sources.
• Saves time: Conducting market research is time-consuming. Responses will not come in quickly as expected, and gathering global responses will take a huge amount of time. If you have all the reference documents available (or you know where to find them), research is relatively quick.
• Non-bias: Primary data collection tends to be biased. This bias depends on a lot of factors like the age of the respondents, the time they take the survey, their mentality while taking the survey, their gender, their feelings towards certain ideas, to name a few. The list goes on and on when it comes to surveying bias.
• A researcher is not necessary during data collection: The researcher doesn’t need to be present during data collection. It is practically impossible for the researcher to be present at every point of the data source, especially thinking about the various data sources.
• Useful for hypothesis: Use historical data to draw inferences of the current or future events. Conclusions can be drawn from the experience of past events and data available for them. 

Disadvantages of the method

Here are the disadvantages of the documentary research method:

• Limited data: Data is not always available, especially when you need to cross-verify a theory or strengthen your argument based on different forms of data.
• Inaccuracies: As the data is historical and published, there is almost no way of ascertaining if the data is accurate or not. 
• Incomplete documents: Often, documents can be incomplete, and there is no way of knowing if there are additional documents to refer to on the subject.
• Data out of context: The data that the researcher refers to may be out of context and may not be in line with the concept the researcher is trying to study. Its because the research goal is not thought of when creating the original data. Often, researchers have to make do with the available data at hand.

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The Basics of Document Analysis

Document analysis is the process of reviewing or evaluating documents both printed and electronic in a methodical manner. The document analysis method, like many other qualitative research methods, involves examining and interpreting data to uncover meaning, gain understanding, and come to a conclusion.

What is Meant by Document Analysis?

Document analysis pertains to the process of interpreting documents for an assessment topic by the researcher as a means of giving voice and meaning. In Document Analysis as a Qualitative Research Method by Glenn A. Bowen , document analysis is described as, “... a systematic procedure for reviewing or evaluating documents—both printed and electronic (computer-based and Internet-transmitted) material. Like other analytical methods in qualitative research, document analysis requires that data be examined and interpreted in order to elicit meaning, gain understanding, and develop empirical knowledge.”

During the analysis of documents, the content is categorized into distinct themes, similar to the way transcripts from interviews or focus groups are analyzed. The documents may also be graded or scored using a rubric.

Document analysis is a social research method of great value, and it plays a crucial role in most triangulation methods, combining various methods to study a particular phenomenon.

>> View Webinar: How-To’s for Data Analysis

Documents fall into three main categories:

• Personal Documents: A personal account of an individual's beliefs, actions, and experiences. The following are examples: e-mails, calendars, scrapbooks, Facebook posts, incident reports, blogs, duty logs, newspapers, and reflections or journals.
• Public Records: Records of an organization's activities that are maintained continuously over time. These include mission statements, student transcripts, annual reports, student handbooks, policy manuals, syllabus, and strategic plans.
• Physical Evidence: Artifacts or items found within a study setting, also referred to as artifacts. Among these are posters, flyers, agendas, training materials, and handbooks.

The qualitative researcher generally makes use of two or more resources, each using a different data source and methodology, to achieve convergence and corroboration. An important purpose of triangulating evidence is to establish credibility through a convergence of evidence. Corroboration of findings across data sets reduces the possibility of bias, by examining data gathered in different ways.

It is important to note that document analysis differs from content analysis as content analysis refers to more than documents. As part of their definition for content analysis, Columbia Mailman School of Public Health states that, “Sources of data could be from interviews, open-ended questions, field research notes, conversations, or literally any occurrence of communicative language (such as books, essays, discussions, newspaper headlines, speeches, media, historical documents).

How Do You Do Document Analysis?

In order for a researcher to obtain reliable results from document analysis, a detailed planning process must be undertaken. The following is an outline of an eight-step planning process that should be employed in all textual analysis including document analysis techniques.

• Identify the texts you want to analyze such as samples, population, participants, and respondents.
• You should consider how texts will be accessed, paying attention to any cultural or linguistic barriers.
• Acknowledge and resolve biases.
• Acquire appropriate research skills.
• Strategize for ensuring credibility.
• Identify the data that is being sought.
• Take into account ethical issues.
• Keep a backup plan handy.

Researchers can use a wide variety of texts as part of their research, but the most common source is likely to be written material. Researchers often ask how many documents they should collect. There is an opinion that a wide selection of documents is preferable, but the issue should probably revolve more around the quality of the document than its quantity.

Why is Document Analysis Useful?

Different types of documents serve different purposes. They provide background information, indicate potential interview questions, serve as a mechanism for monitoring progress and tracking changes within a project, and allow for verification of any claims or progress made.

You can triangulate your claims about the phenomenon being studied using document analysis by using multiple sources and other research gathering methods.

Below are the advantages and disadvantages of document analysis

• Document analysis may assist researchers in determining what questions to ask your interviewees, as well as provide insight into what to watch out for during your participant observation.
• It is particularly useful to researchers who wish to focus on specific case studies
• It is inexpensive and quick in cases where data is easily obtainable.
• Documents provide specific and reliable data, unaffected by researchers' presence unlike with other research methods like participant observation.

Disadvantages

• It is likely that the documents researchers obtain are not complete or written objectively, requiring researchers to adopt a critical approach and not assume their contents are reliable or unbiased.
• There may be a risk of information overload due to the number of documents involved. Researchers often have difficulties determining what parts of each document are relevant to the topic being studied.
• It may be necessary to anonymize documents and compare them with other documents.

How NVivo Can Help with Document Analysis

Analyzing copious amounts of data and information can be a daunting and time-consuming prospect. Luckily, qualitative data analysis tools like NVivo can help!

NVivo’s AI-powered autocoding text analysis tool can help you efficiently analyze data and perform thematic analysis . By automatically detecting, grouping, and tagging noun phrases, you can quickly identify key themes throughout your documents – aiding in your evaluation.

Additionally, once you start coding part of your data, NVivo’s smart coding can take care of the rest for you by using machine learning to match your coding style. After your initial coding, you can run queries and create visualizations to expand on initial findings and gain deeper insights.

These features allow you to conduct data analysis on large amounts of documents – improving the efficiency of this qualitative research method. Learn more about these features in the webinar, NVivo 14: Thematic Analysis Using NVivo.

>> Watch Webinar NVivo 14: Thematic Analysis Using NVivo

Learn More About Document Analysis

Watch Twenty-Five Qualitative Researchers Share How-To's for Data Analysis

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Research Methodologies Guide

• Action Research
• Bibliometrics
• Case Studies
• Content Analysis
• Digital Scholarship This link opens in a new window
• Documentary
• Ethnography
• Focus Groups
• Grounded Theory
• Life Histories/Autobiographies
• Longitudinal
• Participant Observation
• Qualitative Research (General)
• Quasi-Experimental Design
• Usability Studies

Documentary Research

According to Scott & Marshall (2015), Documentary Research is

" Research that uses personal and official documents as a source material. Documents... may include such things as newspapers, diaries, stamps, directories, handbills, maps, government statistical publications, photographs, paintings, gramophone records, tapes, and computer files. "

Documentary research is often conducted by social scientists to assess a set of documents for historical or social value, or to create a larger narrative through the study of multiple documents surrounding an event or individual. 

Documentary research is often related to Content Analysis research methodologies. 

For more information, browse the selected resources below:

Books and articles

• Documentary Research in the Social Sciences by Malcolm Tight Publication Date: 2019 From diaries and letters to surveys and interview transcripts, documents are a cornerstone of social science research. This book guides you through the documentary research process, from choosing the best research design, through data collection and analysis, to publishing and sharing research findings.
• Documentary Research by Gary McCulloch Publication Date: 2004 Documentary sources have become increasingly neglected in education and the social sciences. This book seeks to emphasise their potential value and importance for an understanding of modern societies, while also recognising their limitations, and explores their relationship with other research strategies.
• An Introduction to Documentary Research A brief introduction to documentary research from the American Educational Research Association.
• Documentary Research [Reference] An encyclopedia entry on Documentary Research from the Encyclopedia of Curriculum Studies.
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• Next: Ethnography >>
• Last Updated: Dec 19, 2023 2:12 PM
• URL: https://instr.iastate.libguides.com/researchmethods

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Please note you do not have access to teaching notes, document analysis as a qualitative research method.

Qualitative Research Journal

ISSN : 1443-9883

Article publication date: 3 August 2009

This article examines the function of documents as a data source in qualitative research and discusses document analysis procedure in the context of actual research experiences. Targeted to research novices, the article takes a nuts‐and‐bolts approach to document analysis. It describes the nature and forms of documents, outlines the advantages and limitations of document analysis, and offers specific examples of the use of documents in the research process. The application of document analysis to a grounded theory study is illustrated.

• Content analysis
• Grounded theory
• Thematic analysis
• Triangulation

Bowen, G.A. (2009), "Document Analysis as a Qualitative Research Method", Qualitative Research Journal , Vol. 9 No. 2, pp. 27-40. https://doi.org/10.3316/QRJ0902027

Emerald Group Publishing Limited

Copyright © 2009, Emerald Group Publishing Limited

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• Documentary Research: Definition, Types, Applications & Examples

Introduction

Over the years, social scientists have used documentary research to understand series of events that have occurred or happened in the past. Here, they explore available recovered or existing documents and material to get information and gain insight into a research question or particular topic.

In this article, we would define the concept of documentary research, the various types of documentary research, its applications, and some valid examples.

Let’s dive right in.

What is Documentary Research?

In simple terms, documentary research is a form of research that uses records to get accurate information about a particular subject. It is a systematic investigation and analysis of existing records or documents. These documents can be in written forms, visual/audio materials, photographs, videos books, etc.

Documentary research is a valuable approach used in exploring historical events, cultural phenomena, and societal trends to get deep insight into a topic, subject or research question.

Documentary research is somewhat similar to content analysis, which also entails studying existing information/documents.

One of the most vital considerations when using documentary research is the quality of the material being utilized, hence the danger of falling into the single-story phenomenon. 

To forestall this, the documents being reviewed must be assessed thoroughly before it is used. (see John Scott, A Matter of Record, 1990). The criteria for authenticity involves checking the documents thoroughly to ensure their genuineness.

List of Documentary Research Methods

• Social Research Studies: This form of documentary research is commonly used in social research studies. For instance, Karl Max used documentary research extensively for his research and the documents he used include The Royal Commission, Inland revenue reports, and Her Majesty Inspectors of Factory reports, to mention a few. Emile Durkheim one of the founders of sociology authored a book on suicide and his work was recognized as the first modern example of consistent use of documents for social research.
• Archival Inquiry: This is a field of sociology explored in documentary research. It entails using primary source documents stored in archives. This form of research is popular amongst historians and the archival documents are referred to as references in their research.
• Content Analysis: This method involves the examination and interpretation of content in documents like articles, books, and speeches in other to find a connection, verify events, and identify patterns or trends.
• Historical Analysis: This is the study and analysis of occurrences that took place in the past, but were documented in records like newspapers, government records, and diaries to understand past events accurately and use the information to understand the present.
• Textual Analysis: This form of analysis is focused on printed texts, in a bid to understand pictures, symbols, and language in other to understand events or occurrences that happened in the lives of the subject.
• Oral Tradition : Oral history involves gathering information via oral summations of people who had direct experience of the events or subject being researched. These interviews are recorded and transcribed, and then analyzed as documents.
• Ethnographic Research: This form of research involves documenting the daily experiences of people in their natural environment, in other to understand how interactions in their personal space affect or impacts their experiences.
• Comparative Analysis: Comparative analysis entails comparing documents from multiple sources to understand context, and periods and uncover any similarities or differences. The goal is to understand cultural or political variations.
• Cross-Sectional Analysis: Cross-sectional analysis involves reviewing documents from multiple perspectives to understand changes, trends, or developments over a specific period.
• Aesthetic Interpretation: This is analyzing visual documents, like paintings, photographs, and footage from videos. This is often used as a supplement to text to authenticate discoveries uncovered in text documents.

Understanding the Documentary Research Methodology

Documentary research involves several key steps, such as defining the objective or research question, identifying relevant resources, revising them, and drawing up a well-informed and accurate conclusion based on fact.

Here are some key points to help you understand the documentary research methodology:

• Purpose: The essence of documentary research is to review existing documents to have insight into a research problem or question. The documents reviewed include written texts, such as books, articles, letters, diaries, newspapers, official reports, government publications, and archival materials, and non-written materials like videos, audio recordings,  photographs, and digital documents.
• Data Collection: This phase is when researchers gather relevant documents required for the research topic. These documents are evaluated carefully based on credibility and relevance. 

Explore – Data Collection Methods: Definition + Steps to Do It

• Data Analysis: Here, the gathered documents are analyzed systematically using relevant document research methodologies. This involves reading, grouping similar resources, and extracting information based on similarities, trends, etc.
• Interpretation: After data analysis, the discoveries are interpreted and the answers are applied to the research question or objective.

Read More: What is Data Interpretation? + [Types, Methods & Tools]

• Ethical Considerations: Ethical principles should be considered when carrying out documentary research. Copyright and intellectual property rights should be respected and all necessary permissions should be obtained before using confidential materials.
• Strengths and Limitations: The documentary research methodology has several advantages. One of which is that it helps researchers study past events by providing relevant documentation that sheds light. It also offers rich and detailed insights into social, cultural, and historical contexts. However, as with every good thing, there are limitations, such as some form of biases in the selected documents, which could emanate from the author or source of the document, missing data, and validity of the findings.

Related: What are Ethical Practices in Market Research?

Applications of Documentary Research

The documentary research methodology has a broad range of applications across various disciplines. They include:

• Historical Research : Documentary research is used extensively in historical studies to explore past events, in other to predict the future. Researchers review historical documents, like letters, diaries, government records, newspapers, and photographs, to better understand historical narratives, social and cultural contexts, and see how individuals or communities conducted their activities in the past.
• Social Sciences: In social sciences, documentary research helps investigate social concepts and trends. Documents like surveys, census data, and organization records are studied and analyzed, in other to understand public opinion, social inequality, and organizational behavior.
• Legal Research: Documentary research plays a vital role in legal studies. Lawyers, legal scholars, policymakers, etc analyze legal documents, regulations, court cases, and legal antecedents all in a bid to understand the legal framework and ways in which law evolves. Documentary research can support legal arguments, influence the development of legal theories, and inform policy-making.
• Education Research: Documentary research is used to understand educational policies, curriculum development, and teaching practices. Researchers review educational documents, such as textbooks,  educational policies, and assessment materials, to access educational systems, approaches, and the effect of these on learning outcomes.

Examples of Documentary Research

• The Russian Revolution (1891 – 1924), With the aid of newspaper documents and personal diaries Orlando Figes, a British historian narrated the most important milestones of the revolution in that period and proffered a comprehensive portrait of everyday occurrences as it occurred then the book Figes. depicts how the Russian Revolution was a historical process that changed the lives of its people and had its influence globally.
• The Vietnam War . The 990 minutes audiovisual documentary by Ken Burns narrates the Vietnam War (1955-1975). Throughout 10 episodes, the military operations of the Vietnam War were addressed, as well as the opposition to the war by the US.
• Bios . Lives that marked yours: Luis Alberto Spinetta. This two-hour audiovisual documentary, produced by National Geographic, intimate and deeply details the life of  Luis Alberto Spineta, an artist referred to as one of the fathers of Argentine rock. His family was part of the production,the100 hours documentary was directed by Catarina Spinetta and she used recordings, and testimonies from family members to review her father’s childhood until his final moments.
• The Secret Decrees of the Dictatorship . This publication was released between March and May 2019, and more than 7000 secret decrees issued by the Military Juntas in Argentina between 1976-1983 were reviewed by the Data Unit of the news portal. These decrees signed by different dictators focused on deportations, the prohibition of books, and the sale of weapons. All of these materials were analyzed and presented along with eight notes, published in 2019.
• World War II in Photographs, David Boyle . This book is an example of aesthetic documentary research. 900 high-quality photographs from various sources were used to portray World War II (1939–1945). The images uncover the scenarios as the warfare took place. The images were arranged in chronological order with images of the steppes of Russia, the deserts of Africa, the jungles of the South Pacific, and the seas of the Arctic and each one of them has a detailed explanation of the course of events.
• The Silence of the Others . This documentary by the Spanish Pedro Almodóvar took 7 years to produce and over 450 hours of review of materials to uncover the crimes carried out during the Franco regime and the plight of the victims seeking justice. 
• The Berlin Wall . The border through a city, Thomas Flemming. This is another example of documentary research, with documents, photos, and illustrations, this book illustrates the history of the Berlin Wall. The daily life of the people who lived to the west and east of the city was portrayed in the book as well as the events that led to the fall of the border in 1989.

Purpose of Documentary Research

The purpose of documentary research is to gather verifiable evidence, that can help researchers understand clearly events that occurred in the past/present and also uncover new knowledge by analyzing existing documents and materials. It aids researchers in exploring topics that are difficult to decipher through other research methods and proffers a historical or contextual perspective on the subject being studied.

When to Use Documentary Research

Documentary research is best when researching events that occurred in the past, especially in instances where direct observation is not applicable. Here are some instances where documentary research is particularly useful:

• Historical Studies: Documentary research is ideal when conducting historical research. Researchers can then analyze historical records or documents left behind to better understand past events, chronologically.
• Exploratory Research: In cases where there are gaps in research studies. documentary research can serve as an exploratory method to fill gaps in knowledge by exploring different perspectives that can uncover new knowledge.
• Policy Analysis : Documentary research is useful in examining policies and similar regulations. By analyzing policy documents, over a period, researchers can measure the impact policies had or have on a particular subject. Based on their review of existing documents, they can make recommendations and supervise their implementation. This method is particularly useful in fields such as public policy, education, healthcare, and social welfare.
• Comparative Studies: Documentary research is useful for comparative analysis. Researchers can analyze documents from different sources and geographical locations to identify patterns, verify results or simply identify contradictions and uncover areas that require further investigation.

Characteristics of Documentary Research

• Uses Existing Documents: Documentary research is based on existing documents as a primary source of data. These documents can be written(letters, diaries, articles, books)or unwritten documents(videos, photographs, inscriptions). These documents are analyzed to gain insight and understanding into a specific phenomenon. 
• Non-Experimental In Nature: Documentary research does not involve manipulated variables, meaning that the researcher can not change the outcomes by directly intervening in the research. All the results derived are based on phenomena that have d occurred, which have documented records to attest to their occurrence. 
• Data Analysis: Documentary research involves rigorous data analysis, as researchers have to carefully read, extract relevant information, categorize data, and use qualitative/quantitative analysis to derive results.
• Interpretation of Findings: After data analysis. The findings of the research must be interpreted in a way that gives insight and deep understanding to anyone reading about the subject being researched. The interpretation phase involves synthesizing and relating the findings to the research questions or objectives.
• Contextual Understanding : Documentary research emphasizes the importance of understanding the social, cultural, and historical, events in the context, in which the documents were recorded, reviewed, and analyzed.By context we mean, the period, cultural norms, political climate, socio-economic factors, etc where the events being studied took place and under what circumstances. This contextual understanding helps to interpret the findings and draw accurate conclusions.
• Cross Reference and Validation: Documentary research is characterized by cross-referencing or triangulation, which involves using multiple sources or methods to corroborate findings. The combination of documentary research with other research methods strengthens the validity and reliability of their findings. This enhances the robustness of the research and helps minimize potential biases or inaccuracies.
• Ethical Considerations: Documentary research requires that researchers respect ethical guidelines and principles. Copyright and intellectual property laws must be adhered to and necessary permissions obtained when using sensitive or confidential documents, as well as the privacy and anonymity of individuals mentioned in the documents. 

Advantages of Documentary Research

• Access to Existing Data: In documentary research, existing data is readily available for review and analysis. There is no need to collect new data, via surveys and the like which can take time or require intensive resources. This makes documentary research a cost-effective and efficient method.
• Rich and Dynamic Data: Documents and materials used in documentary research offer a rich pool of information and insights. This method covers a wide range of topics, periods, and perspectives. There is access to primary sources, such as original letters or historical documents, as well as secondary sources like scholarly articles or reports. This variety of data allows for a comprehensive and clear understanding of the research topic.
• Longitudinal and Historical Perspectives: Documentary research allows researchers to study phenomena over extended periods and explore historical contexts. By examining documents spanning different periods, researchers can analyze patterns, trends, changes, and continuity across social, cultural, or organizational aspects. 
• Non-Intrusive Method : Since documentary research relies on existing documents, there is no direct involvement with research subjects or settings. Hence there is no need to disturb or manipulate the research environment or intrude on the lives of individuals. This makes it an ethical and practical method, especially for sensitive or personal topics.
• Exploration of Inaccessible or Historical Data: Documentary research allows researchers to access data that cannot be duplicated anymore due to timelapse and changing circumstances. For instance, researchers can analyze archived documents, historical records, or rare texts which provide unique insights into the past or specific contexts. 
• Large-Scale Data Analysis : Documentary research deals with or involves large volumes of data. Numerous documents, texts, or media materials to identify patterns, themes, or trends can be examined. This exposure to extensive data sets enables comprehensive analysis and enhances the reliability of research findings.

Limitations of Documentary Research

• The Danger of Biased Perspectives: The documents used in documentary research are subject to bias, as they could reflect the perspectives, agendas, or limitations of the authors or organizations that produced them. Critical evaluation is necessary to ensure the credibility of the documents.
• No Control Over Data Collection : Documentary research relies on existing data that may not have been aimed at the research question it is being applied to. As researchers have limited control over the collection process, there is the potential for missing or incomplete information.
• Subjective Interpretation: Documents analyzed require interpretation of findings, which can be subjective as different researchers can interpret the same document differently, leading to variations in findings and conclusions.

Documentary research is a valuable form of research methodology as it provides access to existing documents and materials for analysis and interpretation. There are many advantages of these methods, such as diverse sources of data, historical perspectives, and access to large volumes of data from analysis.

However, there are also limitations like biases based on the author’s perspective, no control over data collection, and challenges in interpretation. A clear understanding of the pros and cons of this research method would help users make informed decisions on how to apply documentary research to their subject of study.

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• cross-sectional study
• data analysis
• data collection methods
• data interpretation
• documentary research
• Angela Kayode-Sanni

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How to use and assess qualitative research methods

Loraine busetto.

1 Department of Neurology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany

Wolfgang Wick

2 Clinical Cooperation Unit Neuro-Oncology, German Cancer Research Center, Heidelberg, Germany

Christoph Gumbinger

Associated data.

Not applicable.

This paper aims to provide an overview of the use and assessment of qualitative research methods in the health sciences. Qualitative research can be defined as the study of the nature of phenomena and is especially appropriate for answering questions of why something is (not) observed, assessing complex multi-component interventions, and focussing on intervention improvement. The most common methods of data collection are document study, (non-) participant observations, semi-structured interviews and focus groups. For data analysis, field-notes and audio-recordings are transcribed into protocols and transcripts, and coded using qualitative data management software. Criteria such as checklists, reflexivity, sampling strategies, piloting, co-coding, member-checking and stakeholder involvement can be used to enhance and assess the quality of the research conducted. Using qualitative in addition to quantitative designs will equip us with better tools to address a greater range of research problems, and to fill in blind spots in current neurological research and practice.

The aim of this paper is to provide an overview of qualitative research methods, including hands-on information on how they can be used, reported and assessed. This article is intended for beginning qualitative researchers in the health sciences as well as experienced quantitative researchers who wish to broaden their understanding of qualitative research.

What is qualitative research?

Qualitative research is defined as “the study of the nature of phenomena”, including “their quality, different manifestations, the context in which they appear or the perspectives from which they can be perceived” , but excluding “their range, frequency and place in an objectively determined chain of cause and effect” [ 1 ]. This formal definition can be complemented with a more pragmatic rule of thumb: qualitative research generally includes data in form of words rather than numbers [ 2 ].

Why conduct qualitative research?

Because some research questions cannot be answered using (only) quantitative methods. For example, one Australian study addressed the issue of why patients from Aboriginal communities often present late or not at all to specialist services offered by tertiary care hospitals. Using qualitative interviews with patients and staff, it found one of the most significant access barriers to be transportation problems, including some towns and communities simply not having a bus service to the hospital [ 3 ]. A quantitative study could have measured the number of patients over time or even looked at possible explanatory factors – but only those previously known or suspected to be of relevance. To discover reasons for observed patterns, especially the invisible or surprising ones, qualitative designs are needed.

While qualitative research is common in other fields, it is still relatively underrepresented in health services research. The latter field is more traditionally rooted in the evidence-based-medicine paradigm, as seen in " research that involves testing the effectiveness of various strategies to achieve changes in clinical practice, preferably applying randomised controlled trial study designs (...) " [ 4 ]. This focus on quantitative research and specifically randomised controlled trials (RCT) is visible in the idea of a hierarchy of research evidence which assumes that some research designs are objectively better than others, and that choosing a "lesser" design is only acceptable when the better ones are not practically or ethically feasible [ 5 , 6 ]. Others, however, argue that an objective hierarchy does not exist, and that, instead, the research design and methods should be chosen to fit the specific research question at hand – "questions before methods" [ 2 , 7 – 9 ]. This means that even when an RCT is possible, some research problems require a different design that is better suited to addressing them. Arguing in JAMA, Berwick uses the example of rapid response teams in hospitals, which he describes as " a complex, multicomponent intervention – essentially a process of social change" susceptible to a range of different context factors including leadership or organisation history. According to him, "[in] such complex terrain, the RCT is an impoverished way to learn. Critics who use it as a truth standard in this context are incorrect" [ 8 ] . Instead of limiting oneself to RCTs, Berwick recommends embracing a wider range of methods , including qualitative ones, which for "these specific applications, (...) are not compromises in learning how to improve; they are superior" [ 8 ].

Research problems that can be approached particularly well using qualitative methods include assessing complex multi-component interventions or systems (of change), addressing questions beyond “what works”, towards “what works for whom when, how and why”, and focussing on intervention improvement rather than accreditation [ 7 , 9 – 12 ]. Using qualitative methods can also help shed light on the “softer” side of medical treatment. For example, while quantitative trials can measure the costs and benefits of neuro-oncological treatment in terms of survival rates or adverse effects, qualitative research can help provide a better understanding of patient or caregiver stress, visibility of illness or out-of-pocket expenses.

How to conduct qualitative research?

Given that qualitative research is characterised by flexibility, openness and responsivity to context, the steps of data collection and analysis are not as separate and consecutive as they tend to be in quantitative research [ 13 , 14 ]. As Fossey puts it : “sampling, data collection, analysis and interpretation are related to each other in a cyclical (iterative) manner, rather than following one after another in a stepwise approach” [ 15 ]. The researcher can make educated decisions with regard to the choice of method, how they are implemented, and to which and how many units they are applied [ 13 ]. As shown in Fig.  1 , this can involve several back-and-forth steps between data collection and analysis where new insights and experiences can lead to adaption and expansion of the original plan. Some insights may also necessitate a revision of the research question and/or the research design as a whole. The process ends when saturation is achieved, i.e. when no relevant new information can be found (see also below: sampling and saturation). For reasons of transparency, it is essential for all decisions as well as the underlying reasoning to be well-documented.

Iterative research process

While it is not always explicitly addressed, qualitative methods reflect a different underlying research paradigm than quantitative research (e.g. constructivism or interpretivism as opposed to positivism). The choice of methods can be based on the respective underlying substantive theory or theoretical framework used by the researcher [ 2 ].

Data collection

The methods of qualitative data collection most commonly used in health research are document study, observations, semi-structured interviews and focus groups [ 1 , 14 , 16 , 17 ].

Document study

Document study (also called document analysis) refers to the review by the researcher of written materials [ 14 ]. These can include personal and non-personal documents such as archives, annual reports, guidelines, policy documents, diaries or letters.

Observations

Observations are particularly useful to gain insights into a certain setting and actual behaviour – as opposed to reported behaviour or opinions [ 13 ]. Qualitative observations can be either participant or non-participant in nature. In participant observations, the observer is part of the observed setting, for example a nurse working in an intensive care unit [ 18 ]. In non-participant observations, the observer is “on the outside looking in”, i.e. present in but not part of the situation, trying not to influence the setting by their presence. Observations can be planned (e.g. for 3 h during the day or night shift) or ad hoc (e.g. as soon as a stroke patient arrives at the emergency room). During the observation, the observer takes notes on everything or certain pre-determined parts of what is happening around them, for example focusing on physician-patient interactions or communication between different professional groups. Written notes can be taken during or after the observations, depending on feasibility (which is usually lower during participant observations) and acceptability (e.g. when the observer is perceived to be judging the observed). Afterwards, these field notes are transcribed into observation protocols. If more than one observer was involved, field notes are taken independently, but notes can be consolidated into one protocol after discussions. Advantages of conducting observations include minimising the distance between the researcher and the researched, the potential discovery of topics that the researcher did not realise were relevant and gaining deeper insights into the real-world dimensions of the research problem at hand [ 18 ].

Semi-structured interviews

Hijmans & Kuyper describe qualitative interviews as “an exchange with an informal character, a conversation with a goal” [ 19 ]. Interviews are used to gain insights into a person’s subjective experiences, opinions and motivations – as opposed to facts or behaviours [ 13 ]. Interviews can be distinguished by the degree to which they are structured (i.e. a questionnaire), open (e.g. free conversation or autobiographical interviews) or semi-structured [ 2 , 13 ]. Semi-structured interviews are characterized by open-ended questions and the use of an interview guide (or topic guide/list) in which the broad areas of interest, sometimes including sub-questions, are defined [ 19 ]. The pre-defined topics in the interview guide can be derived from the literature, previous research or a preliminary method of data collection, e.g. document study or observations. The topic list is usually adapted and improved at the start of the data collection process as the interviewer learns more about the field [ 20 ]. Across interviews the focus on the different (blocks of) questions may differ and some questions may be skipped altogether (e.g. if the interviewee is not able or willing to answer the questions or for concerns about the total length of the interview) [ 20 ]. Qualitative interviews are usually not conducted in written format as it impedes on the interactive component of the method [ 20 ]. In comparison to written surveys, qualitative interviews have the advantage of being interactive and allowing for unexpected topics to emerge and to be taken up by the researcher. This can also help overcome a provider or researcher-centred bias often found in written surveys, which by nature, can only measure what is already known or expected to be of relevance to the researcher. Interviews can be audio- or video-taped; but sometimes it is only feasible or acceptable for the interviewer to take written notes [ 14 , 16 , 20 ].

Focus groups

Focus groups are group interviews to explore participants’ expertise and experiences, including explorations of how and why people behave in certain ways [ 1 ]. Focus groups usually consist of 6–8 people and are led by an experienced moderator following a topic guide or “script” [ 21 ]. They can involve an observer who takes note of the non-verbal aspects of the situation, possibly using an observation guide [ 21 ]. Depending on researchers’ and participants’ preferences, the discussions can be audio- or video-taped and transcribed afterwards [ 21 ]. Focus groups are useful for bringing together homogeneous (to a lesser extent heterogeneous) groups of participants with relevant expertise and experience on a given topic on which they can share detailed information [ 21 ]. Focus groups are a relatively easy, fast and inexpensive method to gain access to information on interactions in a given group, i.e. “the sharing and comparing” among participants [ 21 ]. Disadvantages include less control over the process and a lesser extent to which each individual may participate. Moreover, focus group moderators need experience, as do those tasked with the analysis of the resulting data. Focus groups can be less appropriate for discussing sensitive topics that participants might be reluctant to disclose in a group setting [ 13 ]. Moreover, attention must be paid to the emergence of “groupthink” as well as possible power dynamics within the group, e.g. when patients are awed or intimidated by health professionals.

Choosing the “right” method

As explained above, the school of thought underlying qualitative research assumes no objective hierarchy of evidence and methods. This means that each choice of single or combined methods has to be based on the research question that needs to be answered and a critical assessment with regard to whether or to what extent the chosen method can accomplish this – i.e. the “fit” between question and method [ 14 ]. It is necessary for these decisions to be documented when they are being made, and to be critically discussed when reporting methods and results.

Let us assume that our research aim is to examine the (clinical) processes around acute endovascular treatment (EVT), from the patient’s arrival at the emergency room to recanalization, with the aim to identify possible causes for delay and/or other causes for sub-optimal treatment outcome. As a first step, we could conduct a document study of the relevant standard operating procedures (SOPs) for this phase of care – are they up-to-date and in line with current guidelines? Do they contain any mistakes, irregularities or uncertainties that could cause delays or other problems? Regardless of the answers to these questions, the results have to be interpreted based on what they are: a written outline of what care processes in this hospital should look like. If we want to know what they actually look like in practice, we can conduct observations of the processes described in the SOPs. These results can (and should) be analysed in themselves, but also in comparison to the results of the document analysis, especially as regards relevant discrepancies. Do the SOPs outline specific tests for which no equipment can be observed or tasks to be performed by specialized nurses who are not present during the observation? It might also be possible that the written SOP is outdated, but the actual care provided is in line with current best practice. In order to find out why these discrepancies exist, it can be useful to conduct interviews. Are the physicians simply not aware of the SOPs (because their existence is limited to the hospital’s intranet) or do they actively disagree with them or does the infrastructure make it impossible to provide the care as described? Another rationale for adding interviews is that some situations (or all of their possible variations for different patient groups or the day, night or weekend shift) cannot practically or ethically be observed. In this case, it is possible to ask those involved to report on their actions – being aware that this is not the same as the actual observation. A senior physician’s or hospital manager’s description of certain situations might differ from a nurse’s or junior physician’s one, maybe because they intentionally misrepresent facts or maybe because different aspects of the process are visible or important to them. In some cases, it can also be relevant to consider to whom the interviewee is disclosing this information – someone they trust, someone they are otherwise not connected to, or someone they suspect or are aware of being in a potentially “dangerous” power relationship to them. Lastly, a focus group could be conducted with representatives of the relevant professional groups to explore how and why exactly they provide care around EVT. The discussion might reveal discrepancies (between SOPs and actual care or between different physicians) and motivations to the researchers as well as to the focus group members that they might not have been aware of themselves. For the focus group to deliver relevant information, attention has to be paid to its composition and conduct, for example, to make sure that all participants feel safe to disclose sensitive or potentially problematic information or that the discussion is not dominated by (senior) physicians only. The resulting combination of data collection methods is shown in Fig.  2 .

Possible combination of data collection methods

Attributions for icons: “Book” by Serhii Smirnov, “Interview” by Adrien Coquet, FR, “Magnifying Glass” by anggun, ID, “Business communication” by Vectors Market; all from the Noun Project

The combination of multiple data source as described for this example can be referred to as “triangulation”, in which multiple measurements are carried out from different angles to achieve a more comprehensive understanding of the phenomenon under study [ 22 , 23 ].

Data analysis

To analyse the data collected through observations, interviews and focus groups these need to be transcribed into protocols and transcripts (see Fig.  3 ). Interviews and focus groups can be transcribed verbatim , with or without annotations for behaviour (e.g. laughing, crying, pausing) and with or without phonetic transcription of dialects and filler words, depending on what is expected or known to be relevant for the analysis. In the next step, the protocols and transcripts are coded , that is, marked (or tagged, labelled) with one or more short descriptors of the content of a sentence or paragraph [ 2 , 15 , 23 ]. Jansen describes coding as “connecting the raw data with “theoretical” terms” [ 20 ]. In a more practical sense, coding makes raw data sortable. This makes it possible to extract and examine all segments describing, say, a tele-neurology consultation from multiple data sources (e.g. SOPs, emergency room observations, staff and patient interview). In a process of synthesis and abstraction, the codes are then grouped, summarised and/or categorised [ 15 , 20 ]. The end product of the coding or analysis process is a descriptive theory of the behavioural pattern under investigation [ 20 ]. The coding process is performed using qualitative data management software, the most common ones being InVivo, MaxQDA and Atlas.ti. It should be noted that these are data management tools which support the analysis performed by the researcher(s) [ 14 ].

From data collection to data analysis

Attributions for icons: see Fig. ​ Fig.2, 2 , also “Speech to text” by Trevor Dsouza, “Field Notes” by Mike O’Brien, US, “Voice Record” by ProSymbols, US, “Inspection” by Made, AU, and “Cloud” by Graphic Tigers; all from the Noun Project

How to report qualitative research?

Protocols of qualitative research can be published separately and in advance of the study results. However, the aim is not the same as in RCT protocols, i.e. to pre-define and set in stone the research questions and primary or secondary endpoints. Rather, it is a way to describe the research methods in detail, which might not be possible in the results paper given journals’ word limits. Qualitative research papers are usually longer than their quantitative counterparts to allow for deep understanding and so-called “thick description”. In the methods section, the focus is on transparency of the methods used, including why, how and by whom they were implemented in the specific study setting, so as to enable a discussion of whether and how this may have influenced data collection, analysis and interpretation. The results section usually starts with a paragraph outlining the main findings, followed by more detailed descriptions of, for example, the commonalities, discrepancies or exceptions per category [ 20 ]. Here it is important to support main findings by relevant quotations, which may add information, context, emphasis or real-life examples [ 20 , 23 ]. It is subject to debate in the field whether it is relevant to state the exact number or percentage of respondents supporting a certain statement (e.g. “Five interviewees expressed negative feelings towards XYZ”) [ 21 ].

How to combine qualitative with quantitative research?

Qualitative methods can be combined with other methods in multi- or mixed methods designs, which “[employ] two or more different methods [ …] within the same study or research program rather than confining the research to one single method” [ 24 ]. Reasons for combining methods can be diverse, including triangulation for corroboration of findings, complementarity for illustration and clarification of results, expansion to extend the breadth and range of the study, explanation of (unexpected) results generated with one method with the help of another, or offsetting the weakness of one method with the strength of another [ 1 , 17 , 24 – 26 ]. The resulting designs can be classified according to when, why and how the different quantitative and/or qualitative data strands are combined. The three most common types of mixed method designs are the convergent parallel design , the explanatory sequential design and the exploratory sequential design. The designs with examples are shown in Fig.  4 .

Three common mixed methods designs

In the convergent parallel design, a qualitative study is conducted in parallel to and independently of a quantitative study, and the results of both studies are compared and combined at the stage of interpretation of results. Using the above example of EVT provision, this could entail setting up a quantitative EVT registry to measure process times and patient outcomes in parallel to conducting the qualitative research outlined above, and then comparing results. Amongst other things, this would make it possible to assess whether interview respondents’ subjective impressions of patients receiving good care match modified Rankin Scores at follow-up, or whether observed delays in care provision are exceptions or the rule when compared to door-to-needle times as documented in the registry. In the explanatory sequential design, a quantitative study is carried out first, followed by a qualitative study to help explain the results from the quantitative study. This would be an appropriate design if the registry alone had revealed relevant delays in door-to-needle times and the qualitative study would be used to understand where and why these occurred, and how they could be improved. In the exploratory design, the qualitative study is carried out first and its results help informing and building the quantitative study in the next step [ 26 ]. If the qualitative study around EVT provision had shown a high level of dissatisfaction among the staff members involved, a quantitative questionnaire investigating staff satisfaction could be set up in the next step, informed by the qualitative study on which topics dissatisfaction had been expressed. Amongst other things, the questionnaire design would make it possible to widen the reach of the research to more respondents from different (types of) hospitals, regions, countries or settings, and to conduct sub-group analyses for different professional groups.

How to assess qualitative research?

A variety of assessment criteria and lists have been developed for qualitative research, ranging in their focus and comprehensiveness [ 14 , 17 , 27 ]. However, none of these has been elevated to the “gold standard” in the field. In the following, we therefore focus on a set of commonly used assessment criteria that, from a practical standpoint, a researcher can look for when assessing a qualitative research report or paper.

Assessors should check the authors’ use of and adherence to the relevant reporting checklists (e.g. Standards for Reporting Qualitative Research (SRQR)) to make sure all items that are relevant for this type of research are addressed [ 23 , 28 ]. Discussions of quantitative measures in addition to or instead of these qualitative measures can be a sign of lower quality of the research (paper). Providing and adhering to a checklist for qualitative research contributes to an important quality criterion for qualitative research, namely transparency [ 15 , 17 , 23 ].

Reflexivity

While methodological transparency and complete reporting is relevant for all types of research, some additional criteria must be taken into account for qualitative research. This includes what is called reflexivity, i.e. sensitivity to the relationship between the researcher and the researched, including how contact was established and maintained, or the background and experience of the researcher(s) involved in data collection and analysis. Depending on the research question and population to be researched this can be limited to professional experience, but it may also include gender, age or ethnicity [ 17 , 27 ]. These details are relevant because in qualitative research, as opposed to quantitative research, the researcher as a person cannot be isolated from the research process [ 23 ]. It may influence the conversation when an interviewed patient speaks to an interviewer who is a physician, or when an interviewee is asked to discuss a gynaecological procedure with a male interviewer, and therefore the reader must be made aware of these details [ 19 ].

Sampling and saturation

The aim of qualitative sampling is for all variants of the objects of observation that are deemed relevant for the study to be present in the sample “ to see the issue and its meanings from as many angles as possible” [ 1 , 16 , 19 , 20 , 27 ] , and to ensure “information-richness [ 15 ]. An iterative sampling approach is advised, in which data collection (e.g. five interviews) is followed by data analysis, followed by more data collection to find variants that are lacking in the current sample. This process continues until no new (relevant) information can be found and further sampling becomes redundant – which is called saturation [ 1 , 15 ] . In other words: qualitative data collection finds its end point not a priori , but when the research team determines that saturation has been reached [ 29 , 30 ].

This is also the reason why most qualitative studies use deliberate instead of random sampling strategies. This is generally referred to as “ purposive sampling” , in which researchers pre-define which types of participants or cases they need to include so as to cover all variations that are expected to be of relevance, based on the literature, previous experience or theory (i.e. theoretical sampling) [ 14 , 20 ]. Other types of purposive sampling include (but are not limited to) maximum variation sampling, critical case sampling or extreme or deviant case sampling [ 2 ]. In the above EVT example, a purposive sample could include all relevant professional groups and/or all relevant stakeholders (patients, relatives) and/or all relevant times of observation (day, night and weekend shift).

Assessors of qualitative research should check whether the considerations underlying the sampling strategy were sound and whether or how researchers tried to adapt and improve their strategies in stepwise or cyclical approaches between data collection and analysis to achieve saturation [ 14 ].

Good qualitative research is iterative in nature, i.e. it goes back and forth between data collection and analysis, revising and improving the approach where necessary. One example of this are pilot interviews, where different aspects of the interview (especially the interview guide, but also, for example, the site of the interview or whether the interview can be audio-recorded) are tested with a small number of respondents, evaluated and revised [ 19 ]. In doing so, the interviewer learns which wording or types of questions work best, or which is the best length of an interview with patients who have trouble concentrating for an extended time. Of course, the same reasoning applies to observations or focus groups which can also be piloted.

Ideally, coding should be performed by at least two researchers, especially at the beginning of the coding process when a common approach must be defined, including the establishment of a useful coding list (or tree), and when a common meaning of individual codes must be established [ 23 ]. An initial sub-set or all transcripts can be coded independently by the coders and then compared and consolidated after regular discussions in the research team. This is to make sure that codes are applied consistently to the research data.

Member checking

Member checking, also called respondent validation , refers to the practice of checking back with study respondents to see if the research is in line with their views [ 14 , 27 ]. This can happen after data collection or analysis or when first results are available [ 23 ]. For example, interviewees can be provided with (summaries of) their transcripts and asked whether they believe this to be a complete representation of their views or whether they would like to clarify or elaborate on their responses [ 17 ]. Respondents’ feedback on these issues then becomes part of the data collection and analysis [ 27 ].

Stakeholder involvement

In those niches where qualitative approaches have been able to evolve and grow, a new trend has seen the inclusion of patients and their representatives not only as study participants (i.e. “members”, see above) but as consultants to and active participants in the broader research process [ 31 – 33 ]. The underlying assumption is that patients and other stakeholders hold unique perspectives and experiences that add value beyond their own single story, making the research more relevant and beneficial to researchers, study participants and (future) patients alike [ 34 , 35 ]. Using the example of patients on or nearing dialysis, a recent scoping review found that 80% of clinical research did not address the top 10 research priorities identified by patients and caregivers [ 32 , 36 ]. In this sense, the involvement of the relevant stakeholders, especially patients and relatives, is increasingly being seen as a quality indicator in and of itself.

How not to assess qualitative research

The above overview does not include certain items that are routine in assessments of quantitative research. What follows is a non-exhaustive, non-representative, experience-based list of the quantitative criteria often applied to the assessment of qualitative research, as well as an explanation of the limited usefulness of these endeavours.

Protocol adherence

Given the openness and flexibility of qualitative research, it should not be assessed by how well it adheres to pre-determined and fixed strategies – in other words: its rigidity. Instead, the assessor should look for signs of adaptation and refinement based on lessons learned from earlier steps in the research process.

Sample size

For the reasons explained above, qualitative research does not require specific sample sizes, nor does it require that the sample size be determined a priori [ 1 , 14 , 27 , 37 – 39 ]. Sample size can only be a useful quality indicator when related to the research purpose, the chosen methodology and the composition of the sample, i.e. who was included and why.

Randomisation

While some authors argue that randomisation can be used in qualitative research, this is not commonly the case, as neither its feasibility nor its necessity or usefulness has been convincingly established for qualitative research [ 13 , 27 ]. Relevant disadvantages include the negative impact of a too large sample size as well as the possibility (or probability) of selecting “ quiet, uncooperative or inarticulate individuals ” [ 17 ]. Qualitative studies do not use control groups, either.

Interrater reliability, variability and other “objectivity checks”

The concept of “interrater reliability” is sometimes used in qualitative research to assess to which extent the coding approach overlaps between the two co-coders. However, it is not clear what this measure tells us about the quality of the analysis [ 23 ]. This means that these scores can be included in qualitative research reports, preferably with some additional information on what the score means for the analysis, but it is not a requirement. Relatedly, it is not relevant for the quality or “objectivity” of qualitative research to separate those who recruited the study participants and collected and analysed the data. Experiences even show that it might be better to have the same person or team perform all of these tasks [ 20 ]. First, when researchers introduce themselves during recruitment this can enhance trust when the interview takes place days or weeks later with the same researcher. Second, when the audio-recording is transcribed for analysis, the researcher conducting the interviews will usually remember the interviewee and the specific interview situation during data analysis. This might be helpful in providing additional context information for interpretation of data, e.g. on whether something might have been meant as a joke [ 18 ].

Not being quantitative research

Being qualitative research instead of quantitative research should not be used as an assessment criterion if it is used irrespectively of the research problem at hand. Similarly, qualitative research should not be required to be combined with quantitative research per se – unless mixed methods research is judged as inherently better than single-method research. In this case, the same criterion should be applied for quantitative studies without a qualitative component.

The main take-away points of this paper are summarised in Table ​ Table1. 1 . We aimed to show that, if conducted well, qualitative research can answer specific research questions that cannot to be adequately answered using (only) quantitative designs. Seeing qualitative and quantitative methods as equal will help us become more aware and critical of the “fit” between the research problem and our chosen methods: I can conduct an RCT to determine the reasons for transportation delays of acute stroke patients – but should I? It also provides us with a greater range of tools to tackle a greater range of research problems more appropriately and successfully, filling in the blind spots on one half of the methodological spectrum to better address the whole complexity of neurological research and practice.

Take-away-points

Acknowledgements

Abbreviations, authors’ contributions.

LB drafted the manuscript; WW and CG revised the manuscript; all authors approved the final versions.

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The authors declare no competing interests.

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Document research method refers to the analysis of documents that contains information about the scenario or event under consideration. It is used to investigate, categorize and analyze physical sources, most commonly written documents, in the social, public or digital world. This research method is just as good as and sometimes even more cost effective than the surveys, in-depth interviews or other observation based methods such as ethnography.

Quick details: Document Research

Structure: Structured

Preparation: Documents to be researched

Deliverables: Research notes, Documentation, Insights

More about Document Research

A document is defined as written text. Documents can be files, statistical data, records of official or unofficial nature providing an account of an event, images, other written material that can be accessed in a social, public or digital context. For example, institutional memoranda and reports, census publications, government pronouncements and proceedings, diaries and other written, visual and pictorial sources in different forms and so on are socially, publically or digitally accessible either openly or on request.

Document research is not a standalone method; it is usually used in conjunction with other design methods. Document research is employed when the researcher has questions to which they seek answers. It is not as helpful in an open inquiry to determine patterns as the number of documents that would need to be investigated can be huge, turning the researcher’s task into a never-ending exercise. Therefore, This research method is often used only as a supplement to the other research methods.

Along with surveys and ethnography, document research is one of the three major types of social research and arguably has been the most widely used of the three, to study needs, behavior and expectations of user groups. The analysis of the documents in document research is either quantitative or qualitative analysis (or both). The key issues surrounding types of documents and our ability to use them as reliable sources of evidence on the user groups must be considered by all who use documents in their research.

Advantages of Document Research

1. availability.

Document research method uses documents that are public or can be accessed on request if private.

2. Time & Cost effective

As the phenomenon being investigated is clearly defined before the method is exercised, the research is focused and closed. This saves a lot of time for the researcher and also costs that would have been incurred if an expert was consulted for the study.

3. Unbiased Collection Process

As the collection process doesn’t involve direct interaction of the researcher with the user groups or author of the documents, the chances of introducing bias stays low. Again, if the document is of the statistical record type, then the data being collected is based on facts that can be verified and cross-checked for errors.

4. Researcher Presence

The researcher is not required to be present at the time of data collection.

Disadvantages of Document Research

1. limited by available data.

As the data or documents that are available on the phenomenon being investigated as the primary resources for the study, the findings will be based on only the data that is documented on the subject.

2. Errors in written material

If there are errors in the documents being referred, these errors will render erroneous findings as well .

3. Out of context

If the documents studied are out of context, they will not contribute meaning to the study or will not lead to an insightful findings.

4. Preparation before analysis

The preparation required before document analysis is performed is a task in itself. The efforts are usually directed toward recruiting the researchers, identifying sources, shortlisting the material to be researched and analyzed, among others.

Think Design's recommendation

More often than not, any design project starts with some kind of Document Research or the other. It is predominantly a secondary research method; however, the researcher/ designer is using the documented material for his own understanding of the context. 

Do not use document research as a stand-alone method and do not proceed with your design assuming that the documents you studied have provided you with all the answers. This method compliments other methods and is usually a good starting point.

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Related methods.

• Audio/ Video Analysis
• Heatmap Analysis
• Social Network Mapping
• Time Lapse Video
• Trend Analysis
• Usage Analytics

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What’s Included: Methodology Template

This template covers all the core components required in the research methodology chapter or section of a typical dissertation or thesis, including:

• The opening section
• Research philosophy
• Research type
• Research strategy
• Time horizon
• Sampling strategy
• Data collection methods
• Data analysis methods
• Conclusion & summary

The purpose of each section is explained in plain language, followed by an overview of the key elements that you need to cover. The template also includes practical examples to help you understand exactly what’s required, along with links to additional free resources (articles, videos, etc.) to help you along your research journey.

The cleanly-formatted Google Doc can be downloaded as a fully editable MS Word Document (DOCX format), so you can use it as-is or convert it to LaTeX.

PS – if you’d like a high-level template for the entire thesis, you can we’ve got that too .

What format is the template (DOC, PDF, PPT, etc.)?

The methodology chapter template is provided as a Google Doc. You can download it in MS Word format or make a copy to your Google Drive. You’re also welcome to convert it to whatever format works best for you, such as LaTeX or PDF.

What types of dissertations/theses can this template be used for?

The methodology template follows the standard format for academic research projects, which means it will be suitable for the vast majority of dissertations and theses (especially those within the sciences), whether they adopt a qualitative, quantitative, or mixed-methods approach. The template is loosely based on Saunders’ research onion , which is recommended as a methodological framework by many universities.

Keep in mind that the exact requirements for the methodology chapter/section will vary between universities and degree programs. These are typically minor, but it’s always a good idea to double-check your university’s requirements before you finalize your structure.

Is this template for an undergrad, Master or PhD-level thesis?

This template can be used for a dissertation, thesis or research project at any level of study. Doctoral-level projects typically require the methodology chapter to be more extensive/comprehensive, but the structure will typically remain the same.

How long should the methodology chapter be?

This can vary a fair deal, depending on the level of study (undergrad, Master or Doctoral), the field of research, as well as your university’s specific requirements. Therefore, it’s best to check with your university or review past dissertations from your program to get an accurate estimate. 

How detailed should my methodology be?

As a rule of thumb, you should provide enough detail for another researcher to replicate your study. This includes clear descriptions of procedures, tools, and techniques you used to collect and analyse your data, as well as your sampling approach.

How technical should my language be in this chapter?

In the methodology chapter, your language should be technical enough to accurately convey your research methods and processes, but also clear and precise to ensure it’s accessible to readers within your field.

Aim for a balance where the technical aspects of your methods are thoroughly explained without overusing jargon or overly complex language.

Should I include a pilot study in my methodology?

If you conducted a pilot study, you can include it in the methodology to demonstrate the feasibility and refinement of your methods. Be sure to obtain the necessary permissions from your research advisor before conducting any pilot studies, though. 

Can I share this template with my friends/colleagues?

Yes, you’re welcome to share this template in its original format (no editing allowed). If you want to post about it on your blog or social media, we kindly request that you reference this page as your source.

Do you have templates for the other chapters?

Yes, we do. We are constantly developing our collection of free resources to help students complete their dissertations and theses. You can view all of our template resources here .

Can Grad Coach help me with my methodology?

Yes, we can assist with your methodology chapter (or any other chapter) on a coaching basis. If you’re interested, feel free to get in touch to discuss our private coaching services .

• Research Data Lifecycle Guide

Developing a Data Management Plan

This section breaks down different topics required for the planning and preparation of data used in research at Case Western Reserve University. In this phase you should understand the research being conducted, the type and methods used for collecting data, the methods used to prepare and analyze the data, addressing budgets and resources required, and have a sound understanding of how you will manage data activities during your research project.

Many federal sponsors of Case Western Reserve funded research have required data sharing plans in research proposals since 2003. As of Jan. 25, 2023, the National Institutes of Health has revised its data management and sharing requirements. 

This website is designed to provide basic information and best practices to seasoned and new investigators as well as detailed guidance for adhering to the revised NIH policy.  

Basics of Research Data Management

What is research data management?

Research data management (RDM) comprises a set of best practices that include file organization, documentation, storage, backup, security, preservation, and sharing, which affords researchers the ability to more quickly, efficiently, and accurately find, access, and understand their own or others' research data.

Why should you care about research data management?

RDM practices, if applied consistently and as early in a project as possible, can save you considerable time and effort later, when specific data are needed, when others need to make sense of your data, or when you decide to share or otherwise upload your data to a digital repository. Adopting RDM practices will also help you more easily comply with the data management plan (DMP) required for obtaining grants from many funding agencies and institutions.

Does data need to be retained after a project is completed?

Research data must be retained in sufficient detail and for an adequate period of time to enable appropriate responses to questions about accuracy, authenticity, primacy and compliance with laws and regulations governing the conduct of the research. External funding agencies will each have different requirements regarding storage, retention, and availability of research data. Please carefully review your award or agreement for the disposition of data requirements and data retention policies.

A good data management plan begins by understanding the sponsor requirements funding your research. As a principal investigator (PI) it is your responsibility to be knowledgeable of sponsors requirements. The Data Management Plan Tool (DMPTool) has been designed to help PIs adhere to sponsor requirements efficiently and effectively. It is strongly recommended that you take advantage of the DMPTool.  

CWRU has an institutional account with DMPTool that enables users to access all of its resources via your Single Sign On credentials. CWRU's DMPTool account is supported by members of the Digital Scholarship team with the Freedman Center for Digital Scholarship. Please use the RDM Intake Request form to schedule a consultation if you would like support or guidance regarding developing a Data Management Plan.

Some basic steps to get started:

• Sign into the  DMPTool site  to start creating a DMP for managing and sharing your data. 
• On the DMPTool site, you can find the most up to date templates for creating a DMP for a long list of funders, including the NIH, NEH, NSF, and more. 
• Explore sample DMPs to see examples of successful plans .

Be sure that your DMP is addressing any and all federal and/or funder requirements and associated DMP templates that may apply to your project. It is strongly recommended that investigators submitting proposals to the NIH utilize this tool. 

The NIH is mandating Data Management and Sharing Plans for all proposals submitted after Jan. 25, 2023.  Guidance for completing a NIH Data Management Plan has its own dedicated content to provide investigators detailed guidance on development of these plans for inclusion in proposals. 

A Data Management Plan can help create and maintain reliable data and promote project success. DMPs, when carefully constructed and reliably adhered to, help guide elements of your research and data organization.

A DMP can help you:

Document your process and data.

• Maintain a file with information on researchers and collaborators and their roles, sponsors/funding sources, methods/techniques/protocols/standards used, instrumentation, software (w/versions), references used, any applicable restrictions on its distribution or use.
• Establish how you will document file changes, name changes, dates of changes, etc. Where will you record of these changes? Try to keep this sort of information in a plain text file located in the same folder as the files to which it pertains.
• How are derived data products created? A DMP encourages consistent description of data processing performed, software (including version number) used, and analyses applied to data.
• Establish regular forms or templates for data collection. This helps reduce gaps in your data, promotes consistency throughout the project.

Explain your data

• From the outset, consider why your data were collected, what the known and expected conditions may be for collection, and information such as time and place, resolution, and standards of data collected.
• What attributes, fields, or parameters will be studied and included in your data files? Identify and describe these in each file that employs them.
• For an overview of data dictionaries, see the USGS page here: https://www.usgs.gov/products/data-and-tools/data-management/data-dictionaries

DMP Requirements

Why are you being asked to include a data management plan (DMP) in your grant application? For grants awarded by US governmental agencies, two federal memos from the US Office of Science and Technology Policy (OSTP), issued in 2013 and 2015 , respectively, have prompted this requirement. These memos mandate public access to federally- (and, thus, taxpayer-) funded research results, reflecting a commitment by the government to greater accountability and transparency. While "results" generally refers to the publications and reports produced from a research project, it is increasingly used to refer to the resulting data as well.

Federal research-funding agencies  have responded to the OSTP memos by issuing their own guidelines and requirements for grant applicants (see below), specifying whether and how research data in particular are to be managed in order to be publicly and properly accessible.

• NSF—National Science Foundation "Proposals submitted or due on or after January 18, 2011, must include a supplementary document of no more than two pages labeled 'Data Management Plan'. This supplementary document should describe how the proposal will conform to NSF policy on the dissemination and sharing of research results." Note: Additional requirements may apply per Directorate, Office, Division, Program, or other NSF unit.
• NIH—National Institutes of Health "To facilitate data sharing, investigators submitting a research application requesting $500,000 or more of direct costs in any single year to NIH on or after October 1, 2003 are expected to include a plan for sharing final research data for research purposes, or state why data sharing is not possible."
• NASA—National Aeronautics and Space Administration "The purpose of a Data Management Plan (DMP) is to address the management of data from Earth science missions, from the time of their data collection/observation, to their entry into permanent archives."
• DOD—Department of Defense "A Data Management Plan (DMP) describing the scientific data expected to be created or gathered in the course of a research project must be submitted to DTIC at the start of each research effort. It is important that DoD researchers document plans for preserving data at the outset, keeping in mind the potential utility of the data for future research or to support transition to operational or other environments. Otherwise, the data is lost as researchers move on to other efforts. The essential descriptive elements of the DMP are listed in section 3 of DoDI 3200.12, although the format of the plan may be adjusted to conform to standards established by the relevant scientific discipline or one that meets the requirements of the responsible Component"
• Department of Education "The purpose of this document is to describe the implementation of this policy on public access to data and to provide guidance to applicants for preparing the Data Management Plan (DMP) that must outline data sharing and be submitted with the grant application. The DMP should describe a plan to provide discoverable and citable dataset(s) with sufficient documentation to support responsible use by other researchers, and should address four interrelated concerns—access, permissions, documentation, and resources—which must be considered in the earliest stages of planning for the grant."
• " Office of Scientific and Technical Information (OSTI) Provides access to free, publicly-available research sponsored by the Department of Energy (DOE), including technical reports, bibliographic citations, journal articles, conference papers, books, multimedia, software, and data.

Data Management Best Practices

As you plan to collect data for research, keep in mind the following best practices. 

Keep Your Data Accessible to You

• Store your temporary working files somewhere easily accessible, like on a local hard drive or shared server.
• While cloud storage is a convenient solution for storage and sharing, there are often concerns about data privacy and preservation. Be sure to only put data in the cloud that you are comfortable with and that your funding and/or departmental requirements allow.
• For long-term storage, data should be put into preservation systems that are well-managed. [U]Tech provides several long-term data storage options for cloud and campus. 
• Don't keep your original data on a thumb drive or portable hard drive, as it can be easily lost or stolen.
• Think about file formats that have a long life and that are readable by many programs. Formats like ascii, .txt, .csv, .pdf are great for long term  preservation.
• A DMP is not a replacement for good data management practices, but it can set you on the right path if it is consistently followed. Consistently revisit your plan to ensure you are following it and adhering to funder requirements.

Preservation

• Know the difference between storing and preserving your data. True preservation is the ongoing process of making sure your data are secure and accessible for future generations. Many sponsors have preferred or recommended data repositories. The DMP tool can help you identify these preferred repositories. 
• Identify data with long-term value. Preserve the raw data and any intermediate/derived products that are expensive to reproduce or can be directly used for analysis. Preserve any scripted code that was used to clean and transform the data.
• Whenever converting your data from one format to another, keep a copy of the original file and format to avoid loss or corruption of your important files.
• Leverage online platforms like OSF can help your group organize, version, share, and preserve your data, if the sponsor hasn’t specified a specific platform.
• Adhere to federal sponsor requirements on utilizing accepted data repositories (NIH dbGaP, NIH SRA, NIH CRDC, etc.) for preservation. 

Backup, Backup, Backup

• The general rule is to keep 3 copies of your data: 2 copies onsite, 1 offsite.
• Backup your data regularly and frequently - automate the process if possible. This may mean weekly duplication of your working files to a separate drive, syncing your folders to a cloud service like Box, or dedicating a block of time every week to ensure you've copied everything to another location.

Organization

• Establish a consistent, descriptive filing system that is intelligible to future researchers and does not rely on your own inside knowledge of your research.
• A descriptive directory and file-naming structure should guide users through the contents to help them find whatever they are looking for.

Naming Conventions

• Use consistent, descriptive filenames that reliably indicate the contents of the file.
• If your discipline requires or recommends particular naming conventions, use them!
• Do not use spaces between words. Use either camelcase or underscores to separate words
• Include LastnameFirstname descriptors where appropriate.
• Avoid using MM-DD-YYYY formats
• Do not append vague descriptors like "latest" or "final" to your file versions. Instead, append the version's date or a consistently iterated version number.

Clean Your Data

• Mistakes happen, and often researchers don't notice at first. If you are manually entering data, be sure to double-check the entries for consistency and duplication. Often having a fresh set of eyes will help to catch errors before they become problems.
• Tabular data can often be error checked by sorting the fields alphanumerically to catch simple typos, extra spaces, or otherwise extreme outliers. Be sure to save your data before sorting it to ensure you do not disrupt the records!
• Programs like OpenRefine  are useful for checking for consistency in coding for records and variables, catching missing values, transforming data, and much more.

What should you do if you need assistance implementing RDM practices?

Whether it's because you need discipline-specific metadata standards for your data, help with securing sensitive data, or assistance writing a data management plan for a grant, help is available to you at CWRU. In addition to consulting the resources featured in this guide, you are encouraged to contact your department's liaison librarian.

If you are planning to submit a research proposal and need assistance with budgeting for data storage and or applications used to capture, manage, and or process data UTech provides information and assistance including resource boilerplates that list what centralized resources are available. 

More specific guidance for including a budget for Data Management and Sharing is included on this document: Budgeting for Data Management and Sharing . 

Custody of Research Data

The PI is the custodian of research data, unless agreed on in writing otherwise and the agreement is on file with the University, and is responsible for the collection, management, and retention of research data. The PI should adopt an orderly system of data organization and should communicate the chosen system to all members of a research group and to the appropriate administrative personnel, where applicable. Particularly for long-term research projects, the PI should establish and maintain procedures for the protection and management of essential records.

CWRU Custody of Research Data Policy  

Data Sharing

Many funding agencies require data to be shared for the purposes of reproducibility and other important scientific goals. It is important to plan for the timely release and sharing of final research data for use by other researchers.  The final release of data should be included as a key deliverable of the DMP. Knowledge of the discipline-specific database, data repository, data enclave, or archive store used to disseminate the data should also be documented as needed. 

The NIH is mandating Data Management and Sharing Plans for all proposals submitted after Jan. 25, 2023. Guidance for completing a NIH Data Management and Sharing Plan  has its own dedicated content to provide investigators detailed guidance on development of these plans for inclusion in proposals.

An EEG-based Seizure Recognition Method using dynamic routing

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Harvey Cushing/John Hay Whitney Medical Library

Sharing libraries and collaborating on research papers, ways to share endnote desktop library, 1. endnote   group sharing.

You can share your EndNote library (or groups) through EndNote Desktop

• Pros : Read/write access, easy
• Cons : The sharer can only share (sync) one library, the share-ee can have multiple libraries shared with them, make sure to finish syncing before closing the library, everyone needs to have an EndNote online account  

2. Compress and send an EndNote library (or group) through email or Box

Compress and send your library

How to: File > Compressed Library (.enlx)

• Pros : PDFs can be included in the EndNote library
• Cons : X9.3 isn't backward compatible. If this happens send an RIS file but note, all Groups and Group Sets will be lost, changes made by one user won’t be reflected in other users’ files.  

3. Send your EndNote library embedded within the Word Document you've been editing with EndNote.

Your Word document contains a "Traveling Library" comprising all references cited using EndNote. This enables you to collaborate with your colleagues on the same document without having to have the same EndNote library.

• Pros : Easy
• Cons : No pdfs, metadata incomplete, required that everyone has EndNote Desktop  

Ways to Collaborate on a Paper (Pros and Cons)

1. microsoft word or google docs.

One person makes the edits. One person has access to the EndNote library and has control over the master document.  All others collaborate on the manuscript, editing and marking where a reference goes (use author, year). The person with the master document uses the edited document to add the new references to EndNote and then references into the master document.

• Pros : less prone to error
• Cons : complicated  

2. Google Docs Method

There is no EndNote Cite While You Write tool available for Google Docs.

• Pros : Highly collaborative
• Cons : Complicated

Directions :

• Highlight the references in EndNote
• Drag and drop the references into your Google Doc. This will create an unformatted citation, (it will have curly brackets { }).
• Alternatively, manually insert unformatted citations in the format {first authors surname, year #record number}. To see the record number, in EndNote, right click on the display fields shown in the middle panel and tick Record Number to add it to the display.
• When the manuscript is completed, download the Google Doc as a .docx file
• Open in Word
• Make sure you have a completed EndNote library from which the Word document will pull the references from. If you have people contributing from personal EndNote libraries, the library at the end needs to have all the references in it. If you don't have a copy, ask the person (people) to compress and email their citations.
• Turn on Instant Formatting. If the reference number don't match, Word will prompt you to clarify which reference you mean.

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• Volume 83, Issue 6
• EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update
• Article Text
• Article info
• Citation Tools
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• http://orcid.org/0000-0002-4528-310X Laure Gossec 1 , 2 ,
• http://orcid.org/0000-0002-6685-8873 Andreas Kerschbaumer 3 ,
• http://orcid.org/0000-0002-2517-0247 Ricardo J O Ferreira 4 , 5 ,
• http://orcid.org/0000-0003-2108-0030 Daniel Aletaha 3 ,
• http://orcid.org/0000-0002-9475-9362 Xenofon Baraliakos 6 ,
• Heidi Bertheussen 7 ,
• Wolf-Henning Boehncke 8 ,
• http://orcid.org/0000-0001-5331-8221 Bente Appel Esbensen 9 , 10 ,
• Iain B McInnes 11 ,
• Dennis McGonagle 12 , 13 ,
• http://orcid.org/0000-0002-3892-6947 Kevin L Winthrop 14 ,
• Andra Balanescu 15 ,
• Peter V Balint 16 ,
• http://orcid.org/0000-0001-7518-1131 Gerd R Burmester 17 ,
• http://orcid.org/0000-0003-2606-0573 Juan D Cañete 18 , 19 ,
• Pascal Claudepierre 20 , 21 ,
• http://orcid.org/0000-0002-1473-1715 Lihi Eder 22 ,
• http://orcid.org/0000-0003-4229-6818 Merete Lund Hetland 23 , 24 ,
• http://orcid.org/0000-0001-5592-724X Annamaria Iagnocco 25 ,
• Lars Erik Kristensen 26 , 27 ,
• Rik Lories 28 , 29 ,
• http://orcid.org/0000-0002-8418-7145 Rubén Queiro 30 , 31 ,
• http://orcid.org/0000-0002-9022-8863 Daniele Mauro 32 ,
• http://orcid.org/0000-0002-9683-3407 Helena Marzo-Ortega 12 , 13 ,
• http://orcid.org/0000-0002-6620-0457 Philip J Mease 33 , 34 ,
• http://orcid.org/0000-0002-2571-788X Peter Nash 35 ,
• Wendy Wagenaar 36 , 37 ,
• Laura Savage 38 ,
• http://orcid.org/0000-0001-8740-9615 Georg Schett 39 ,
• http://orcid.org/0000-0002-9441-5535 Stephanie J W Shoop-Worrall 40 ,
• http://orcid.org/0000-0002-0807-7139 Yoshiya Tanaka 41 ,
• http://orcid.org/0000-0002-3561-5932 Filip E Van den Bosch 42 ,
• Annette van der Helm-van Mil 43 ,
• http://orcid.org/0000-0002-0573-464X Alen Zabotti 44 ,
• http://orcid.org/0000-0002-5781-158X Désirée van der Heijde 43 ,
• Josef S Smolen 3
• 1 INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique , Sorbonne Universite , Paris , France
• 2 APHP, Rheumatology Department , Hopital Universitaire Pitie Salpetriere , Paris , France
• 3 Division of Rheumatology, Department of Medicine 3 , Medical University of Vienna , Vienna , Austria
• 4 Nursing Research, Innovation and Development Centre of Lisbon (CIDNUR) , Higher School of Nursing of Lisbon , Lisbon , Portugal
• 5 Rheumatology Department , Centro Hospitalar e Universitário de Coimbra EPE , Coimbra , Portugal
• 6 Rheumazentrum Ruhrgebiet , Ruhr University Bochum , Herne , Germany
• 7 EULAR Patient Research Partner , EULAR , Oslo , Norway
• 8 Dermatology and Venereology , Geneva University Hospitals , Geneva , Switzerland
• 9 Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics , Rigshospitalet , Glostrup , Denmark
• 10 Department of Clinical Medicine , University of Copenhagen , Copenhagen , Denmark
• 11 College of Medical Veterinary and Life Sciences , University of Glasgow , Glasgow , UK
• 12 LTHT , NIHR Leeds Biomedical Research Centre , Leeds , UK
• 13 Leeds Institute of Rheumatic and Musculoskeletal Medicine , University of Leeds , Leeds , UK
• 14 Division of Infectious Diseases, School of Medicine, School of Public Health , Oregon Health & Science University , Portland , Oregon , USA
• 15 Sf Maria Hospital , University of Medicine and Pharmacy Carol Davila Bucharest , Bucharest , Romania
• 16 Medical Imaging Centre, Semmelweis University, 3rd Rheumatology Department, National Institute of Musculoskeletal Diseases , Budapest , Hungary
• 17 Department of Rheumatology and Clinical Immunology, Freie Universität Berlin and Humboldt-Universität zu Berlin , Charité Universitätsmedizin Berlin , Berlin , Germany
• 18 Arthritis Unit, Department of Rheumatology , Hospital Clínic Barcelona , Barcelona , Spain
• 19 FCRB , IDIBAPS , Barcelona , Spain
• 20 Rheumatology , AP-HP, Henri Mondor University Hospital , Creteil , France
• 21 EA Epiderme , UPEC , Creteil , France
• 22 Department of Medicine, University of Toronto , Women's College Hospital , Toronto , Toronto , Canada
• 23 The Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics , Rigshospitalet Glostrup , Glostrup , Denmark
• 24 Department of Clinical Medicine, Faculty of Health and Medical Sciences , University of Copenhagen , Copenhagen , Denmark
• 25 Academic Rheumatology Centre, Dipartimento Scienze Cliniche Biologiche , Università di Torino - AO Mauriziano Torino , Turin , Italy
• 26 The Parker Institute , Bispebjerg , Denmark
• 27 Frederiksberg Hospital , Copenhagen University , Copenhagen , Denmark
• 28 Laboratory of Tissue Homeostasis and Disease, Skeletal Biology and Engineering Research Center , KU Leuven , Leuven , Belgium
• 29 Division of Rheumatology , University Hospitals Leuven , Leuven , Belgium
• 30 Rheumatology , Hospital Universitario Central de Asturias , Oviedo , Spain
• 31 Translational Immunology Division, Biohealth Research Institute of the Principality of Asturias , Oviedo University School of Medicine , Oviedo , Spain
• 32 Department of Precision Medicine , University of Campania Luigi Vanvitelli , Naples , Italy
• 33 Rheumatology Research , Providence Swedish , Seattle , Washington , USA
• 34 University of Washington School of Medicine , Seattle , Washington , USA
• 35 School of Medicine , Griffith University , Brisbane , Queensland , Australia
• 36 Tranzo, Tilburg School of Social and Behavioral Sciences , Tilburg University , Tilburg , The Netherlands
• 37 Young PARE Patient Research Partner , EULAR , Zurich , Switzerland
• 38 School of Medicine and Dermatology, Leeds Teaching Hospitals NHS Trust , University of Leeds , Leeds , UK
• 39 Department of Internal Medicine 3, Rheumatology and Immunology and Universitätsklinikum Erlangen , Friedrich-Alexander-Universität Erlangen-Nürnberg , Erlangen , Germany
• 40 Children and Young Person’s Rheumatology Research Programme, Centre for Musculoskeletal Research , The University of Manchester , Manchester , UK
• 41 First Department of Internal Medicine , University of Occupational and Environmental Health, Japan , Kitakyushu , Japan
• 42 Department of Internal Medicine and Pediatrics, VIB Center for Inflammation Research , Ghent University , Gent , Belgium
• 43 Rheumatology , Leiden University Medical Center , Leiden , The Netherlands
• 44 Department of Medical and Biological Sciences , Azienda sanitaria universitaria Friuli Centrale , Udine , Italy
• Correspondence to Laure Gossec, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Universite, Paris, France; laure.gossec{at}aphp.fr

Objective New modes of action and more data on the efficacy and safety of existing drugs in psoriatic arthritis (PsA) required an update of the EULAR 2019 recommendations for the pharmacological treatment of PsA.

Methods Following EULAR standardised operating procedures, the process included a systematic literature review and a consensus meeting of 36 international experts in April 2023. Levels of evidence and grades of recommendations were determined.

Results The updated recommendations comprise 7 overarching principles and 11 recommendations, and provide a treatment strategy for pharmacological therapies. Non-steroidal anti-inflammatory drugs should be used in monotherapy only for mild PsA and in the short term; oral glucocorticoids are not recommended. In patients with peripheral arthritis, rapid initiation of conventional synthetic disease-modifying antirheumatic drugs is recommended and methotrexate preferred. If the treatment target is not achieved with this strategy, a biological disease-modifying antirheumatic drug (bDMARD) should be initiated, without preference among modes of action. Relevant skin psoriasis should orient towards bDMARDs targeting interleukin (IL)-23p40, IL-23p19, IL-17A and IL-17A/F inhibitors. In case of predominant axial or entheseal disease, an algorithm is also proposed. Use of Janus kinase inhibitors is proposed primarily after bDMARD failure, taking relevant risk factors into account, or in case bDMARDs are not an appropriate choice. Inflammatory bowel disease and uveitis, if present, should influence drug choices, with monoclonal tumour necrosis factor inhibitors proposed. Drug switches and tapering in sustained remission are also addressed.

Conclusion These updated recommendations integrate all currently available drugs in a practical and progressive approach, which will be helpful in the pharmacological management of PsA.

• Psoriatic Arthritis
• Biological Therapy
• Biosimilar Pharmaceuticals

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https://doi.org/10.1136/ard-2024-225531

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Introduction

Psoriatic arthritis (PsA) is a disease which has benefited from notable progress over recent years. Concepts have evolved, such as very early diagnosis and pre-PsA, as well as defining treatment targets and applying a holistic approach to comorbidity management. 1–4 Pharmacological options have extended, with the approval of new agents targeting various modes of action for PsA (as well as skin psoriasis). Drugs licensed for PsA now include (1) conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), sulfasalazine and leflunomide; (2) biological (b) DMARDs targeting tumour necrosis factor (TNF), the interleukin (IL)-12/23 or IL-23 pathway, and the IL-17A and IL-17A/F pathway; and (3) targeted synthetic (ts) DMARDs that inhibit Janus kinases (JAKs) or phosphodiesterase 4 (PDE4) ( table 1 ). 5 New safety data have emerged in inflammatory arthritis, particularly a worldwide cautionary comment regarding JAK inhibitors (JAKis), following a large randomised controlled trial (RCT) of tofacitinib in rheumatoid arthritis (RA). 6–8 Since the last EULAR recommendations for the pharmacological management of PsA in 2019, the field has changed significantly. 9–12 An update of the EULAR PsA management recommendations was therefore timely. 9

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Disease-modifying treatment options for psoriatic arthritis in 2023

This update addresses the non-topical, pharmacological management of PsA, with a specific focus on musculoskeletal (MSK) manifestations, while also addressing the spectrum of PsA, including how skin psoriasis, extra-MSK manifestations and comorbidities should influence treatment choices.

In accordance with the EULAR updated standardised operating procedures, 13 the process leading to this update included a data-driven approach and expert opinion.

After approval for an update by the EULAR Council in September 2022, taskforce members were selected by the convenor (JSS) and the methodologist (LG), to include more than one-third of new members, as well as country and gender representation. For the first time, experts from Australia, Japan and North America participated. Representatives from the health professionals in rheumatology (HPR) committee, patient research partners from PARE (People with Arthritis/Rheumatism) and young colleagues from the EMEUNET (EMerging EUlar NETwork) were included. Five members were recruited through an open call to EULAR countries via a competitive application process.

In October 2022, the steering group had its first meeting. The steering group consisted of seven rheumatologists (including the convenor, the methodologist and the fellow: JSS, LG, AK, DA, XB, IBM and DGM), a dermatologist (W-HB), an infectious disease specialist (KLW), an experienced fellow rheumatologist (AK), a patient research partner (HB) and two health professionals (BAE and RJOF, the latter acting in the capacity of a junior methodologist). Questions were then defined and addressed through a systematic literature review (SLR), performed by the fellow (AK) between November 2022 and April 2023, for the literature pertaining to pharmacological treatments of PsA and published since the previous SLR (ie, since the end of 2018). 5

The taskforce comprised the steering group and 23 other experts; members came from 19 different countries (of which 15 were EULAR countries), and included 27 rheumatology specialists, 2 dermatologists, 1 infectious disease specialist, 2 people affected with PsA acting as patient research partners, 2 HPRs and 3 rheumatology/epidemiology fellows/trainees. Overall, 47% of the taskforce members had not participated in the previous update in 2019. In April 2023, the taskforce met for a physical meeting to develop the updated bullet points. Each point was discussed in detail both in smaller (breakout) groups and in plenary sessions until consensus was reached. Group approval was sought through votes (by raised hands) for each bullet point; the limit for acceptance of individual recommendations was set at ≥75% majority among the taskforce for the first voting round; then (after discussions and potential reformulations) at ≥67% majority; and finally, if required, the last round of votes was accepted with >50% acceptance or else a proposal was rejected. 13

Although the SLR was a strong component of the discussions, the process was not only evidence-based but also experience-based and consensus-based, and included consideration of safety, efficacy, cost and long-term data. The levels of evidence (LoE) and grades of recommendation (GoR) were determined for each recommendation based on the Oxford Evidence Based System. 13 14 In May 2023, an anonymised email-based voting on the level of agreement (LoA) among the taskforce members was performed on a 0–10 scale (with 10 meaning full agreement) allowing calculation of mean LoA.

These recommendations address non-topical pharmacological treatments with a main focus on MSK manifestations. These recommendations concern stakeholders, such as experts involved in the care of patients with PsA, particularly rheumatologists and other health professionals (such as rheumatology nurses), general practitioners, dermatologists and other specialists; and also people with PsA as well as other stakeholders, for example, government and hospital officials, patient organisations, regulatory agencies and reimbursement institutions.

The overarching principles (OAPs) and recommendations are shown in table 2 , with LoE, GoR and LoA. The updated recommendations include 7 OAPs (vs 6 in 2019) and 11 recommendations (vs 12 in 2019, due to merges). Of the 11 recommendations, only 4 are unchanged compared with 2019 (the modifications compared with the 2019 recommendations are represented in table 3 ).

2023 updated EULAR recommendations for the pharmacological management of psoriatic arthritis

Comparison of the 2019 and 2023 EULAR recommendations for the management of psoriatic arthritis

Overarching principles

Of the seven OAPs, three remain unchanged, three were reworded and one has been added (overarching principle G). For more information on the thought process leading to the OAPs (unchanged or slightly changed), please refer to the 2015 and 2019 recommendations manuscripts. 9 15 Key points from the discussion of the OAPs are addressed in the following:

A. Psoriatic arthritis is a heterogeneous and potentially severe disease, which may require multidisciplinary treatment (unchanged) .

Although PsA is potentially severe, not all patients will develop severe forms. 16 17 Multidisciplinary management is helpful for many patients, through collaboration between physicians of different specialties and HPRs with the appropriate expertise. 18 19

B. Treatment of psoriatic arthritis patients should aim at the best care and must be based on a shared decision between the patient and the rheumatologist, considering efficacy, safety, patient preferences and costs.

This OAP was modified from 2019 to add patient preferences as an element to be considered and emphasise the importance of shared decision-making to maximise treatment adherence and efficacy while at the same time minimise complications driven by uncontrolled (active) disease as well as potential side effects of pharmacological drugs. 20 21

C. Rheumatologists are the specialists who should primarily care for the musculoskeletal manifestations of patients with psoriatic arthritis; in the presence of clinically relevant skin involvement, a rheumatologist and a dermatologist should collaborate in diagnosis and management.

We consider that rheumatology experts provide the best care for patients with PsA, given their experience with the many drugs used to treat these and other rheumatic and musculoskeletal diseases (RMDs), including the important aspects of safety and comorbidities. Consultation with dermatologists and sometimes other specialists may be helpful in individual clinical scenarios (see also overarching principles F and G). A very slight rewording was performed to discuss skin involvement as ‘clinically relevant’ rather than ‘clinically significant’ for more homogeneity with other bullet points. This bullet point does not address the role of HPRs, who are usually not prescribers in EULAR countries.

D. The primary goal of treating patients with psoriatic arthritis is to maximise health-related quality of life, through control of symptoms, prevention of structural damage, normalisation of function and social participation; abrogation of inflammation is an important component to achieve these goals (unchanged).

For more details, please see the 2019 update of these recommendations. 9

E. In managing patients with psoriatic arthritis, consideration should be given to each musculoskeletal manifestation and treatment decisions made accordingly (unchanged).

For more details, please refer to the 2019 update. 9

F. When managing patients with psoriatic arthritis, non-musculoskeletal manifestations (skin, eye and gastrointestinal tract) should be taken into account; comorbidities such as obesity, metabolic syndrome, cardiovascular disease or depression should also be considered.

The wording ‘such as obesity’ was added, since obesity is frequent in PsA and can influence outcomes. 22 23 Obesity concerns excess body fat, while metabolic syndrome is a collection of risk factors that increase the likelihood of developing cardiovascular disease and type 2 diabetes. Obesity is a significant contributor to the development of metabolic syndrome. The taskforce members discussed if other comorbidities should be added, but it was felt that the term ‘such as’ entails that comorbidities overall should be considered, without a need to list them. Depression and potentially other mental health issues may influence treatment choice. Central sensitisation to pain perception is frequent in PsA and also influences outcomes; this may lead to difficulties in disease management. 24 25 Bone health and malignancies were also specifically highlighted. The management of comorbidities poses specific issues, in particular as to who is responsible for managing distinct disease domains. Solutions need to be applied according to the individual patient, each country’s specific setting and healthcare system organisation.

G. The choice of treatment should take account of safety considerations regarding individual modes of action to optimise the benefit–risk profile (new).

Given new data on the safety of different modes of action, the taskforce proposed this new OAP to emphasise the importance of taking into account safety considerations for each patient. 6 The taskforce was aware that this item is somewhat redundant with overarching principle B but wished to emphasise the importance of benefit–risk assessment when considering the use of specific agents.

Recommendations

Of note, these recommendations are centred on non-topical pharmacological treatments; topical and non-pharmacological treatments are also important in PsA but are outside our scope. Figure 1 shows a summarised algorithm of the treatment proposals.

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2023 EULAR recommendations algorithm for the management of PsA. bDMARD, biological disease-modifying antirheumatic drug; csDMARD, conventional synthetic disease-modifying antirheumatic drug; IBD, inflammatory bowel disease; L, interleukin; JAK, Janus kinase inhibitor; JAKi, Janus kinase inhibitor; NSAID, non-steroidal anti-inflammatory drugs; TNF, tumour necrosis factor; TNFI, tumour necrosis factor inhibitor.

Some safety issues will be briefly addressed, but for a full picture of the adverse event profile of different drugs the package inserts should be consulted.

Recommendation 1

Treatment should be aimed at reaching the target of remission or, alternatively, low disease activity, by regular disease activity assessment and appropriate adjustment of therapy.

This (unchanged) recommendation is in keeping with the principles of treating-to-target. 26 27 Given the lack of new data to support treat-to-target in PsA, the LoE and GoR are also unchanged. The use of instruments to assess disease activity has been addressed in the treat-to-target recommendations. 26 The definition of remission in PsA remains a subject of debate. 28–30 For the context of these recommendations, remission should be seen as an abrogation of inflammation.

The taskforce members emphasised that disease activity should be regularly assessed across individual involved manifestations (eg, joints, skin, enthesitis, dactylitis, axial disease), and that treatment adjustments will depend on the predominant manifestation of the disease at a given moment. 31

Recommendation 2

Non-steroidal anti-inflammatory drugs may be used to relieve musculoskeletal signs and symptoms; local injections of glucocorticoids may be considered as adjunctive therapy.

This recommendation deals with the short-term use of symptomatic treatment. It was developed by merging the two previous recommendations 2 and 3, which dealt separately with non-steroidal anti-inflammatory drugs (NSAIDs) and glucocorticoids, as both only serve to relieve symptoms in the short term. It was decided to no longer allude to systemic glucocorticoids in a bullet point, since the data underlying the prescription of systemic glucocorticoids in PsA are scarce. Moreover, glucocorticoids harbour many potential safety issues, in particular when taking into account the high prevalence of comorbidities and cardiovascular risk factors in PsA. 3 32 However, the taskforce members agreed that, in some selected cases, systemic glucocorticoid therapy may be helpful for some patients, especially for polyarticular forms and/or as bridging therapy.

NSAIDs offer symptomatic relief to patients with MSK involvement, but have not shown any efficacy in psoriasis. NSAIDs and local glucocorticoid injections are useful to relieve symptoms and local inflammation temporarily, and may be used combined with DMARDs as needed (please see recommendation 3). However, the safety aspects of (potentially long-term) NSAID use have to be taken into account.

The taskforce emphasised that the vast majority of patients should not be treated with NSAIDs alone (without DMARDs), in keeping with a proactive treat-to-target approach to PsA. Only patients with very mild peripheral disease, or with predominant entheseal or axial disease, may sufficiently benefit from NSAIDs as monotherapy. Even in these cases, it is proposed that the use of symptomatic treatments alone should usually be short term, for example, limited to 4 weeks or so. In peripheral arthritis, this duration is based on the opinion of the group; in predominant axial disease, it is in keeping with the Assesment of Spondyloarthritis International Society (ASAS)/EULAR recommendations for axial spondyloarthritis (axSpA) whereby persistent disease after 4 weeks of treatment is considered a failure of NSAIDs. 33 On the other hand, for patients with predominant axial disease who experience significant improvement in clinical symptoms, continuous NSAID use may be proposed if needed to control symptoms, always taking the risks and benefits into account. Of note, data regarding the efficacy of NSAIDs in enthesitis are limited.

Recommendation 3

In patients with polyarthritis or those with monoarthritis/oligoarthritis and poor prognostic factors (eg, structural damage, elevated acute phase reactants, dactylitis or nail involvement), a csDMARD should be initiated rapidly, with methotrexate preferred in those with clinically relevant skin involvement.

Among patients with peripheral arthritis, 34 35 a distinction is made according to the number of swollen joints and according to prognostic factors. 36 In 2019, polyarthritis and monoarthritis/oligoarthritis with poor prognostic markers were addressed in separate bullet points, which were merged for clarity in this update ( table 3 ). Oligoarticular disease is defined as arthritis (swollen joints) of up to four (included) joints. 9 This definition applies to clinical detection (rather than imaging). The prognostic factors have also been previously defined 9 17 and are unchanged.

We recommend rapid csDMARD start, concomitant (or close) with the initiation of symptomatic therapy, for both patients with polyarticular disease and patients with oligoarticular disease and poor prognostic factors. Patients with oligoarticular disease and lack of poor prognostic factors should also receive a csDMARD, but there is less urgency for these patients given the more favourable long-term prognosis. The latter may receive csDMARDs after a longer delay, and potentially a period of symptomatic treatment alone (see recommendation 2). Since there is a lack of strong evidence to support this approach of rapid treatment introduction, this recommendation was mainly based on expert opinion.

Of note, there is no specific recommendation for dactylitis. We consider dactylitis as an association of (oligo)synovitis, tenosynovitis and enthesitis. Patients with isolated dactylitis should be treated similarly to patients with oligoarthritis; this includes the use of joint glucocorticoid injections and csDMARDs, which have shown efficacy in relieving dactylitis. 37

The first DMARD should be a csDMARD (meaning MTX, leflunomide or sulfasalazine). The decision concerning the first-line DMARD is important and led to much taskforce discussion, and has been put as an element for further research in the research agenda ( table 4 ). The continued prioritisation of csDMARDs reflects consensual expert opinion within the taskforce that favoured the benefit–risk–cost balance of csDMARDs and in particular MTX over targeted drugs. The absence of new data indicating the superiority of a b/tsDMARD as first-line, and in the presence of new data on MTX, was seen as confirming the efficacy of this drug in PsA. 5 37–39

Research agenda indicating priorities for future research in PsA

Since the EULAR recommendations adhere to a treat-to-target (T2T) approach which implies a reduction of disease activity by at least 50% within 3 months and reaching the treatment target within 6 months, a csDMARD should not be continued if these therapeutic goals are not attained. On csDMARD inefficacy, another DMARD, such as a bDMARD (see recommendation 4), can be rapidly instituted. Generally speaking, we recommend assessing the efficacy of the csDMARD and deciding if it should be pursued as monotherapy or not, after 12 weeks, in line with the T2T recommendations. 26 Although MTX use in PsA has typically been founded on evidence from other immune-mediated diseases such as RA and psoriasis, 40 there is also evidence for its efficacy in PsA, with recent confirmatory data both from observational data sources and from a randomised trial indicating that a proportion of patients will respond to escalation of doses of MTX. 39 41–43 The efficacy–safety balance of MTX should be assessed regularly, given the general metabolic profile of patients with PsA which can put them at a higher risk for adverse events such as hepatotoxicity. 42–44 The MTX dose should be sufficient, that is, usually between 20 mg and 25 mg weekly (about 0.3 mg/kg), and use of folate supplementation is recommended to reduce the adverse effects of MTX. 45

Other csDMARDs (ie, leflunomide and sulfasalazine) are potential treatment options and have demonstrated efficacy in PsA peripheral arthritis. 15 A recent trial of the combination of MTX with leflunomide indicated a low efficacy to safety ratio; thus, this association is not recommended. 38

Recommendation 4

In patients with peripheral arthritis and an inadequate response to at least one csDMARD, therapy with a bDMARD should be commenced.

This recommendation is relevant to patients with peripheral arthritis and therefore is meant to include both those with monoarticular/oligoarticular and those with polyarticular disease. However, where peripheral involvement is limited and without poor prognostic factors, it is not unreasonable to apply a second csDMARD course before initiating a bDMARD/tsDMARD, when this decision is agreed by the prescriber and the patient.

After failure of at least one csDMARD, the taskforce proposed as next step one of the many available bDMARDs ( table 1 ). 5

JAKi is efficacious in PsA, but the taskforce decided that at present the efficacy–safety balance, costs and long-term experience with many bDMARDs clearly favour their recommendation over JAKi. Relevant comorbidities in many patients with PsA also favour bDMARD selection.

Regarding bDMARDs, no order of preference is given since no bDMARD has demonstrated superiority for joint involvement over other bDMARDs ( table 1 ). 46–48 Herein they are listed in numeric order of the targeted cytokine, and not in order of preference. However, in the context of the present recommendation, CTLA4 (cytotoxic T-lymphocyte–associated antigen 4) inhibition is not considered a good option due to its limited efficacy in clinical trials. 49 The GoR is high for this bullet point, reflecting robust accrued data. 50

Unlike MSK manifestations, non-MSK domains of PsA allow differential order of bDMARD recommendation (se recommendation 9). 5 Two head-to-head trials of bDMARDs in PsA, both comparing an IL-17A inhibitor with adalimumab, showed similar efficacy for IL-17A inhibition and TNF inhibition, as regards efficacy on the joints, while skin responses are better with the former. 46 47 We also note that there is evidence on the better efficacy of a bDMARD compared with MTX in skin psoriasis (and evidence for differences between bDMARDs, please see recommendation 9). 51 52

All bDMARDs and JAKi showed efficacy regarding inhibition of radiographic progression; such data are lacking for apremilast.

The safety of the different available categories of bDMARDs appears acceptable in our SLR. 5 All bDMARDs increase the risk of infections. 5 The risks of TNF inhibitors (TNFis) are well known. Candidiasis (usually mucocutaneous) is more frequent with IL-17A and IL-17A/F inhibition, particularly the latter. 53 54 While IL-23-p19i is a more recent addition to the armament, its safety appears satisfactory, in line with ustekinumab which also interferes with IL-23 (p40 chain) whose adverse event profile is well known and appears satisfactory. 5

As a general rule, safety and comorbidities need to be taken into account when a decision to start a new drug is taken. More complete information regarding the safety aspects of bDMARDs is provided in the individual drug’s product information. Costs should also be taken into account, but these may vary at the country level; cost savings will occur in many countries due to the availability of biosimilar TNF blockers and potentially other biosimilars in due course. Personalised medicine, to facilitate an optimal choice of the first bDMARD, is currently difficult due to the lack of individualised predictors of response to treatment. 55 As previously discussed, it is of key importance to take into account the patient phenotype and potential extra-MSK features ( figure 1 ). Comorbidities are also to be considered. 23 56 More research is needed on the predictors of drug response, including the effect of sex. 57 58

Combination of a bDMARD with a csDMARD

First-line bDMARDs are often given in combination with csDMARDs, such as MTX. 41 59 However, there are conflicting data regarding the added benefit of concomitant MTX with targeted DMARDs in patients with peripheral disease and no evidence of a benefit of MTX in patients with axial symptoms. 33 60 61

MTX combination with bDMARDs has been explored mainly for TNFi; studies have generally found similar efficacy with or without concomitant MTX, although with increased drug survival when using MTX, in some studies. 41 59 62 A recent large study reported increased remission rates with TNFi plus MTX combination therapy. 59 With other modes of action, there is a lack of data to support comedication. Overall, the taskforce proposed to combine a first bDMARD with the previously prescribed csDMARD, in all cases where such a treatment has already been tolerated by the patient and in particular when the first bDMARD is a TNFi. For other modes of action, given the lack of data, we cannot recommend comedication, although the usual practice would be to continue a csDMARD when initiating a bDMARD (doses of the csDMARD can be diminished if needed).

Recommendation 5

In patients with peripheral arthritis and an inadequate response to at least one bDMARD, or when a bDMARD is not appropriate, a JAKi may be considered, taking safety considerations into account.

This recommendation elicited much debate. On the one hand, since 2019, new data have accrued on JAKis in terms of efficacy, such as the publication of positive trials on upadacitinib in PsA. 63 On the other hand, there is currently a worldwide cautionary statement issued by both the Food and Drug Administration and the European Medicine Agency restricting the use of JAKis in all diseases including PsA, based on an increased risk of cardiovascular and malignancy events observed with tofacitinib in older patients with RA with cardiovascular risk factors. 6–8 JAKis lead to increased general infection rates of similar magnitude to bDMARDs, but higher for herpes zoster infections. 5 Drug safety for the JAKis tofacitinib and upadacitinib in the specific context of PsA was recently reported and appeared reassuring; however, follow-up was short and further data are warranted. 64 65 While currently long-term extension data do not show increased cardiovascular/cancer risk related to JAKi use in PsA, there are no RCTs similar to the ORAL-Surveillance trial available at present in PsA. Therefore, the taskforce felt that the precautions related to RA also have to be taken for PsA, especially since various comorbidities important for the JAKi risk profile may be more prevalent in PsA than in RA (eg, obesity and cardiovascular risk factors). On the other hand, controlling inflammation is important to decrease cardiovascular risk.

Safety of JAKis should be carefully considered 66 ; we propose in table 2 and figure 1 a shortened version of the EMA warning/limitation to use, which includes age, smoking status and other cardiovascular/venous/cancer risk factors. 7 8

After much discussion, we considered that the efficacy–safety balance of JAKis did not justify putting JAKis on the same level as bDMARDs for order of choice (ie, proposing JAKis as usual treatment after insufficient response and/or intolerance to csDMARD treatment).

Therefore, JAKis are proposed usually as second-line targeted therapies (or third-line DMARDs). Of note, we recognise that, for some patients, JAKis may be a relevant option after a csDMARD; this is reflected in the wording of the bullet point (‘when a bDMARD is not appropriate’). This ‘non-appropriateness’ may include contraindications to bDMARDs, practical issues leading to a strong preference for oral administrations (eg, lack of proper conservation at regulated temperatures) and patient preferences, including risk of non-adherence to injections (in accordance with the first OAP concerning shared decision-making). Nevertheless, patients will have to weigh their preferences against potential risks.

The GoR was low for this recommendation, in particular regarding safety considerations, since the data are sparse in PsA and we had to rely on data taken from RA. The taskforce suggests using JAKi after bDMARDs have failed because several new bDMARDs with excellent effects on skin involvement and relatively good safety data are now available (IL-23, IL-17 inhibitors) and more long-term data on JAKi efficacy and safety are needed in PsA. The efficacy to safety ratio of JAKis was also put into the research agenda ( table 4 ).

Currently, drugs from the tyrosine kinase 2 (TYK2) pathway inhibition are being assessed in PsA 5 ; they are not currently licensed for use, and indeed the data are at this point limited in particular for safety (including in psoriasis where such therapy is licensed). Thus, we did not include TYK2 inhibition in the current recommendations.

Recommendation 6

In patients with mild disease and an inadequate response to at least one csDMARD, in whom neither a bDMARD nor a JAKi is appropriate, a PDE4 inhibitor may be considered.

This recommendation is unchanged from 2019, with unchanged LoE. ‘Mild disease’ is defined as oligoarticular or entheseal disease without poor prognostic factors and limited skin involvement. 9 67 The FOREMOST trial recently confirmed the efficacy of apremilast compared with placebo in oligoarticular PsA. 67 Nevertheless, the reason to place apremilast differently from bDMARDs or other tsDMARDs is not only based on its consistently relatively low efficacy, but also on the lack of structural efficacy data (thus putting the term ‘DMARD’ at risk since there are no data on inhibition of damage progression).

This recommendation received the lowest LoA within the taskforce, reflecting that more than a quarter of the taskforce participants were in favour of only discussing apremilast in the text without a specific bullet point.

The use of apremilast in combination with TNFi is off-label, and is a more costly drug combination with no supporting data and cannot be recommended.

Recommendation 7

In patients with unequivocal enthesitis and an insufficient response to NSAIDs or local glucocorticoid injections, therapy with a bDMARD should be considered.

This bullet point remains unchanged. Unequivocal enthesitis refers (as in 2019) to definite entheseal inflammation (which might need additional diagnostic imaging) to avoid overtreatment of entheseal pain not related to PsA (eg, in the context of widespread pain syndrome or repetitive mechanical stress). 68 69 In terms of treatment options, the taskforce discussed the recent data indicating indirectly some efficacy for MTX in enthesitis. 5 38 39 However, it was felt that the data for MTX were not sufficiently strong to propose MTX in the bullet point. We do acknowledge that, for some patients with enthesitis, MTX may be an option ( figure 1 ).

For unequivocal predominant enthesitis, the proposal is to introduce a bDMARD (without a preference for a specific mode of action) since all currently approved bDMARDs have demonstrated efficacy on enthesitis, with similar magnitudes of response, although head-to-head trials are missing ( figure 1 ). 5 Here, costs may be important, but other manifestations will also have to be taken into account (see recommendations 8 and 9). Of note, although tsDMARDs are not mentioned specifically in the bullet point, they are an option in some cases of enthesitis (always considering benefit to risk ratios, in particular for JAKis). 7 8

Recommendation 8

In patients with clinically relevant axial disease with an insufficient response to NSAIDs, therapy with an IL-17Ai, a TNFi, an IL-17 A/Fi or a JAKi should be considered.

The formulation for axial disease was modified from predominant to clinically relevant. For axial disease, in agreement also with the recently updated ASAS/EULAR axSpA recommendations, 33 we continue to judge csDMARDs as not relevant. bDMARDs targeting TNF and IL-17A and IL-17A/F as well as tsDMARDs targeting JAK are recommended. For JAKis, safety issues should be considered. Of note, we propose a choice between the drugs, not a combination of the drugs.

For this recommendation, the order of the drugs listed is of relevance, meaning that IL-17A inhibition has been put first due to the availability of currently only one trial specifically investigating axial PsA and using secukinumab (the MAXIMISE trial), 70 with the other drugs listed thereafter. Thus, the LoE is stronger for IL-17A inhibition than for the other drugs, where the data are derived from axial SpA. 33

The other drugs are listed with TNF inhibition first due to long-term safety data, then IL-17 A/F inhibition which has been recently licensed for axial SpA and JAK inhibition as an option taking into account safety. JAKis are here proposed in the same recommendation as bDMARDs, also reflecting that comorbidity profiles of patients with predominant or isolated axial PsA may be more comparable to patients with axial SpA and therefore may have a more favourable safety profile with respect to cardiovascular and cancer risks than many patients with predominant peripheral arthritis. The taskforce discussed the circumstantial evidence that IL-23 inhibition may be efficacious for axial PsA; however, given negative trials for IL-12/23 inhibition in axSpA, the IL-23 pathway is not recommended here. 33 71–73 Axial PsA remains a challenging form of PsA in terms of definition and differences with axial SpA; thus, this phenotype is part of the research agenda ( table 4 ).

Recommendation 9

The choice of the mode of action should reflect non-musculoskeletal manifestations related to PsA; with clinically relevant skin involvement, preference should be given to an IL-17A or IL-17A/F or IL-23 or IL-12/23 inhibitor; with uveitis to an anti-TNF monoclonal antibody; and with IBD to an anti-TNF monoclonal antibody or an IL-23 inhibitor or IL-12/23 inhibitor or a JAKi.

This is a new recommendation to clarify more visibly than in 2019 ( table 3 ) that the choice of drug should take into account not only the MSK PsA phenotype but also extra-MSK manifestations.

The first extra-MSK manifestation of interest in PsA is skin psoriasis. Although most patients with PsA present with skin psoriasis or have a personal history of skin psoriasis, registry data indicate that many patients with PsA have mild skin involvement. 74 However, even limited skin psoriasis can be troublesome, since relevant skin involvement is defined as either extensive (body surface area involvement >10%), or as important to the patient, that is, impacting negatively their quality of life (such as is the case with face or genital involvement). 9 For these patients, we recommend preferentially considering drugs targeting the IL-17A, IL-17A/F or IL-23 pathway (here, the order between drugs is cited in order of numbered cytokine, not preference). There are strong data, including head-to-head trials, in the field of skin psoriasis showing that drugs targeting the IL-23 and IL-17 pathways are superior to TNFis and to JAKis for skin psoriasis. 51 52 75–78 This justified proposing these modes of action preferentially in case of relevant skin involvement. This is in keeping with psoriasis recommendations. 79

Uveitis is not as frequent in PsA as it is in axial SpA; the prevalence is reported around 5%. 80 However, uveitis can be severe and should influence treatment decisions. Currently, the only mode of action with direct proof of efficacy on uveitis is TNF inhibition through monoclonal antibodies (ie, adalimumab and infliximab). Thus, for patients with uveitis, an anti-TNF monoclonal antibody is preferred.

Inflammatory bowel disease (IBD) concerns 2%–4% of patients with PsA. 80 The armamentarium for IBD has widened recently, and this recommendation reflects this fact, proposing that one of the modes of action currently licensed for IBD should be prescribed when it coexists with PsA. No order of preference is given here and prescribers are urged to adhere to EMA authorisations for IBD and take into account safety. For informative purposes, as of mid-2023, drugs authorised for IBD include anti-TNF monoclonal antibodies (ie, adalimumab and infliximab), the IL-12/23i ustekinumab, the IL-23i risankizumab (for Crohn’s disease) and two JAKis (one of which, tofacitinib, only for Crohn’s disease). 81–85 IL-17is (both A and A/F) are not recommended in case of active IBD, given indications of a heightened risk of flares. 86–88

Decisions for patients presenting with major skin involvement, with uveitis or with IBD should be discussed with the relevant specialist colleagues, as needed.

In all cases, the prescriber must refer to current drug authorisations and take into account safety and comorbidities.

To present an order for choosing drugs, we propose that the first element to take into account is the PsA subtype, then as a second element extra-MSK manifestations (always considering safety and comorbidities).

Recommendation 10

In patients with an inadequate response or intolerance to a bDMARD or a JAKi, switching to another bDMARD or JAKi should be considered, including one switch within a class.

This recommendation is unchanged from 2019, with unchanged LoE. 9 After failing one targeted drug, it is logical to switch to another targeted drug; there are currently no strong data to prefer a switch with a change in mode of action to a switch within the same mode of action. Of note, this recommendation does not limit the total number of switches for a given patient. It also does not necessarily mean that more switches within a class could not be done, but the taskforce felt that a switch should not necessarily be done after one drug of a class has failed. Switches can be made, as appropriate, between bDMARDs, or between bDMARDs and JAKis. We include abatacept as a treatment option ( table 1 ), 49 but note that it demonstrated modest efficacy and hence this is an option to be used only after failing one or more other targeted drugs. The efficacy of bimekizumab, the dual IL-17 A/F inhibitor, appeared similar in TNF-naïve and TNF-experienced populations; this will warrant confirmation. 53 54 Finally, a combination of bDMARDs is being explored, but cannot be recommended at this time.

Recommendation 11

In patients in sustained remission, tapering of DMARDs may be considered.

This bullet point is unchanged. However, more data have accrued on tapering, leading to a higher grade of recommendation. 89–91 By tapering we mean ‘dose reduction’ not drug discontinuation since the latter usually leads to flares. Drug tapering is a logical step when patients are doing well over time, from a safety and a cost perspective (tapering is often performed by the patient himself/herself alone). On the other hand, long-term data are missing and currently drug tapering is off-label. For all of these reasons, the taskforce kept the tentative wording of ‘may be considered’ (to ensure it is not made mandatory) and of course in the context of a shared decision with the patient (as is the case also for the other treatment decisions).

Research agenda

The taskforce felt that many issues needed more data, and an extensive research agenda was developed ( table 4 ).

This paper presents updated recommendations for the management of PsA, a treatment algorithm and a research agenda. This update addresses all currently available drugs and modes of action, and recommends an order to their use, taking into account the phenotype of the MSK and the non-MSK manifestations.

These elements should be helpful in the management of individual patients, but also in the advocacy for better access to care and for research.

This 2023 update is a major update since most of the recommendations were modified substantially. The EULAR standardised operating procedures propose a voting system for updates which discourages minor modifications for rewordings. 13 Since 2019, many new drugs have become available in PsA; the choice of which drug to prescribe to which patients rests on data related to efficacy, clinical phenotype, adverse event risk profile, tolerance, long-term data, cost and access. While laboratory biomarkers for stratified treatment approaches are lacking, the taskforce used clinical markers to develop clinical phenotypic preferences for specific drugs. In these updated recommendations, the taskforce applied expert opinion to the available data, to propose a pragmatic, logical order of a step-up approach to targeted treatments of PsA. The taskforce felt that proposing an order is helpful both for clinicians and to advocate for access to drugs for patients with PsA.

The drug options considered in these recommendations are currently licensed for PsA. We are aware that other drugs are being tested, or are available in other related conditions, especially skin psoriasis; however, these drugs are considered out of the scope of the present recommendations. Brodalumab was at the time of these recommendations only approved for psoriasis; TYK2 inhibitors such as deucravacitinib and brepocitinib have also been developed or in development for skin psoriasis and PsA; izokibep is a novel antibody mimetic, a small IL-17i currently undergoing testing; and an oral IL-23i is also in development. 5

The taskforce had extensive discussions on the positioning of JAKi in the recommendations. 63 92 We as a group feel that it is important to make haste slowly , and to uphold high safety standards when promoting drugs with only short-to-medium-term experience and for which long-term data are lacking—not least in PsA. In fact, this cautious attitude was also adhered to in the 2019 recommendations, and further safety developments have later confirmed that this attitude was appropriate. 7 8 It is of key importance to continue monitoring the drugs and, ideally, perform controlled trials, as only hard and high-level data can be reassuring.

Costs are also an important aspect in patient management, and it is generally recommended to prescribe the cheaper drug if two agents have similar efficacy and safety. Of note, even if one mode of action may have somewhat better efficacy on certain manifestations, a less expensive agent could still be preferred as long as it does not bear much lesser efficacy in that disease domain. Biosimilars are available for several TNFis and have led to significant reduction in expenditure and more use in many countries, while their price is not much lower than that of originators in many other ones. Tofacitinib will soon become generic, and the same is true for apremilast, which should also lower the costs for these agents and allow wider application especially in less affluent countries. Thus, overall, the taskforce felt that the prescription of drugs would account for the relationships between efficacy, safety and cost, in line with the OAPs and the 11 recommendations which are summarised in the algorithm ( figure 1 ). Many points are still to be confirmed in the management of PsA, leading to an extensive research agenda. 93

In conclusion, the updated 2023 recommendations should be helpful to clinicians but also to health professionals and patients when discussing treatment options. They can also be helpful to promote access to optimal care. As new data become available and new drugs are authorised in PsA, these recommendations should be again updated.

Ethics statements

Patient consent for publication.

Not required.

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Handling editor Dimitrios T Boumpas

X @LGossec, @FerreiraRJO, @lihi_eder, @dranielmar, @drpnash, @sshoopworrall

Contributors All authors have contributed to this work and approved the final version.

Funding Supported by EULAR (QoC016).

Competing interests No support to any author for the present work. Outside the submitted work: LG: research grants: AbbVie, Biogen, Lilly, Novartis, UCB; consulting fees: AbbVie, Amgen, BMS, Celltrion, Janssen, Lilly, MSD, Novartis, Pfizer, UCB; non-financial support: AbbVie, Amgen, Galapagos, Janssen, MSD, Novartis, Pfizer, UCB; membership on an entity’s Board of Directors or advisory committees: EULAR Treasurer. AK: speakers bureau, consultancy: AbbVie, Amgen, Galapagos, Janssen, Eli Lilly, MSD, Novartis, Pfizer, UCB. RJOF: research grants: Medac, Lilly; consulting fees: Sanofi. DA: research grants: Galapagos, Lilly; consulting fees: AbbVie, Gilead, Janssen, Lilly, Merck, Novartis, Sanofi. XB: research grants: AbbVie, MSD, Novartis; consultancies: AbbVie, Amgen, Celltrion, Chugai, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche, Sandoz, UCB; membership on an entity’s Board of Directors or advisory committees: ASAS President, EULAR President Elect. W-HB: honoraria: AbbVie, Almirall, BMS, Janssen, Leo, Eli Lilly, Novartis, UCB; expert testimony: Novartis; participation on a Data Safety Monitoring Board or Advisory Board: AbbVie, Almirall, BMS, Janssen, Leo, Eli Lilly, Novartis, UCB. IBM: honoraria/consultation fees non-exec roles: NHS GGC Board Member, Evelo Board of Directors, Versus Arthritis Trustee Status; stock or stock options: Evelo, Cabaletta, Compugen, Causeway Therapeutics, Dextera. DGM: research grants: Janssen, AbbVie, Lilly, Novartis, UCB, BMS, Moonlake; consulting fees: Janssen, AbbVie, Lilly, Novartis, UCB, BMS, Moonlake, Celgene; honoraria: Janssen, AbbVie, Lilly, Novartis, UCB, BMS, Moonlake. KLW: research grants: BMS, Pfizer; consulting: Pfizer, AbbVie, AstraZeneca, BMS, Eli Lilly, Galapagos, GlaxoSmithKline (GSK), Gilead, Novartis, Moderna, Regeneron, Roche, Sanofi, UCB Pharma. AB: speakers fees: AbbVie, Amgen, AlphaSigma, AstraZeneca, Angelini, Biogen, BMS, Berlin-Chemie, Boehringer Ingelheim, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, Teva, UCB, Zentiva; consultancies: Akros, AbbVie, Amgen, AlphaSigma, Biogen, Boehringer Ingelheim, Lilly, Mylan, MSD, Novartis, Pfizer, Roche, Sandoz, Sobi, UCB. PVB: consulting fees: AbbVie, Janssen-Cilag, Pfizer; honoraria: AbbVie, Bausch Health, Celltrion Healthcare, Eli Lilly, Gedeon Richter, IBSA Pharma, Infomed, Janssen-Cilag, Novartis, Pfizer, Sandoz; payment for expert testimony: Gedeon Richter; other: President, Hungarian Association of Rheumatologists. GRB: honoraria and/or speaker fees: AbbVie, BMS, Janssen, Lilly, Novartis, Pfizer. JDC: honoraria: UCB. PC: research grants: AbbVie, Amgen, Biogen, Jansen, Lilly, Novartis, UCB; consulting fees: AbbVie, Amgen, Celltrion, Janssen, Lilly, MSD, Novartis, Pfizer, UCB. LE: consultation fee/advisory board: AbbVie, Novartis, Janssen, UCB, BMS, Eli Lilly; research/educational grants: AbbVie, Fresenius Kabi, Janssen, Amgen, UCB, Novartis, Eli Lilly, Sandoz, Pfizer. MLH: grant support: AbbVie, Biogen, BMS, Celltrion, Eli Lilly, Janssen Biologics BV, Lundbeck Foundation, MSD, Pfizer, Roche, Samsung Bioepis, Sandoz, Novartis, Nordforsk; honoraria: Pfizer, Medac, Sandoz; advisory board: AbbVie; past-chair of the steering committee of the Danish Rheumatology Quality Registry (DANBIO, DRQ), which receives public funding from the hospital owners and funding from pharmaceutical companies; cochair of EuroSpA, partly funded by Novartis. AI: research grants from AbbVie, Pfizer, Novartis; honoraria for lectures, presentations, speakers bureaus from AbbVie, Alfasigma, BMS, Celgene, Celltrion, Eli Lilly, Galapagos, Gilead, Janssen, MSD, Novartis, Pfizer, Sanofi Genzyme, Sobi; EULAR Board Member; EULAR Congress Committee, Education Committee and Advocacy Committee Advisor; EULAR Past President. LEK: consultancies: AbbVie, Amgen, Biogen, BMS, Celgene, Eli Lilly, Pfizer, UCB, Sanofi, GSK, Galapagos, Forward Pharma, MSD, Novartis, Janssen; has been representing rheumatology FOREUM scientific chair. RQ: consultancy and/or speaker’s honoraria from and/or participated in clinical trials and/or research projects sponsored by AbbVie, Amgen-Celgene, Eli Lilly, Novartis, Janssen, Pfizer, MSD, UCB. DM: honoraria: UCB, Janssen, GSK, AstraZeneca, AbbVie; support to meetings: Janssen. HM-O: grant support: Janssen, Novartis, UCB; honoraria and/or speaker fees: AbbVie, Biogen, Eli Lilly, Janssen, Moonlake, Novartis, Pfizer, Takeda, UCB. PJM: grant support: AbbVie, Acelyrin, Amgen, Bristol Myers Squibb, Eli Lilly, Genascence, Janssen, Novartis, Pfizer, UCB; consulting fees: AbbVie, Acelyrin, Aclaris, Alumis, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Genascence, Inmagene, Janssen, Moonlake, Novartis, Pfizer, Takeda, UCB, Ventyx, Xinthera; honoraria: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, UCB. PN: consulting fees and honoraria: AbbVie, Amgen, BMS, Lilly, Janssen, GSK, Novartis, UCB, Servatus; boards: Amgen, BMS, Janssen, GSK, Novartis, UCB; GRAPPA Steering Committee, Chair ASMPOC, ARA. LS: consulting fees: AbbVie, Almirall, Novartis, Janssen, Lilly, UCB, Pfizer, Bristol Myers Squibb, Boehringer Ingelheim; honoraria: AbbVie, Almirall, Novartis, Janssen, UCB, Pfizer, Takeda, Galderma, Biogen, Celgene, Celltrion, Lilly, Sanofi, Bristol Myers Squibb, Boehringer Ingelheim; support to attending meetings: AbbVie, Janssen, Lilly, Novartis, UCB, Galderma, Bristol Myers Squibb, Boehringer Ingelheim; participation in boards: AbbVie, Almirall, Novartis, Janssen, UCB, Pfizer, Galderma, Biogen, Lilly, Sanofi, Bristol Myers Squibb, Boehringer Ingelheim; GRAPPA Executive Board (elected), British Society for Medical Dermatology (BSMD) Committee. GS: honoraria: Novartis, Janssen. SJWS-W: grant support: Medical Research Council (MR/W027151/1). YT: research grants from Mitsubishi Tanabe, Eisai, Chugai, Taisho; speaking fees and/or honoraria from Eli Lilly, AstraZeneca, AbbVie, Gilead, Chugai, Boehringer Ingelheim, GlaxoSmithKline, Eisai, Taisho, Bristol Myers, Pfizer, Taiho. FEVdB: consultancy honoraria from AbbVie, Amgen, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, UCB. AZ: speakers bureau: AbbVie, Novartis, Janssen, Lilly, UCB, Amgen; paid instructor for AbbVie, Novartis, UCB. DvdH: consulting fees AbbVie, Argenx, Bayer, BMS, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer, Takeda, UCB Pharma; Director of Imaging Rheumatology bv; Associate Editor for Annals of the Rheumatic Diseases ; Editorial Board Member for Journal of Rheumatology and RMD Open ; Advisor Assessment Axial Spondyloarthritis International Society. JSS: research grants from AbbVie, AstraZeneca, Lilly, Galapagos; royalties from Elsevier (textbook); consulting fees from AbbVie, Galapagos/Gilead, Novartis-Sandoz, BMS, Samsung, Sanofi, Chugai, R-Pharma, Lilly; honoraria from Samsung, Lilly, R-Pharma, Chugai, MSD, Janssen, Novartis-Sandoz; participation in advisory board from AstraZeneca.

Provenance and peer review Not commissioned; externally peer reviewed.

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