literature review sampling methods

Methodological Approaches to Literature Review

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• Dennis Thomas 2 ,
• Elida Zairina 3 &
• Johnson George 4  

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The literature review can serve various functions in the contexts of education and research. It aids in identifying knowledge gaps, informing research methodology, and developing a theoretical framework during the planning stages of a research study or project, as well as reporting of review findings in the context of the existing literature. This chapter discusses the methodological approaches to conducting a literature review and offers an overview of different types of reviews. There are various types of reviews, including narrative reviews, scoping reviews, and systematic reviews with reporting strategies such as meta-analysis and meta-synthesis. Review authors should consider the scope of the literature review when selecting a type and method. Being focused is essential for a successful review; however, this must be balanced against the relevance of the review to a broad audience.

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Centre of Excellence in Treatable Traits, College of Health, Medicine and Wellbeing, University of Newcastle, Hunter Medical Research Institute Asthma and Breathing Programme, Newcastle, NSW, Australia

Dennis Thomas

Department of Pharmacy Practice, Faculty of Pharmacy, Universitas Airlangga, Surabaya, Indonesia

Elida Zairina

Centre for Medicine Use and Safety, Monash Institute of Pharmaceutical Sciences, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, VIC, Australia

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Thomas, D., Zairina, E., George, J. (2023). Methodological Approaches to Literature Review. In: Encyclopedia of Evidence in Pharmaceutical Public Health and Health Services Research in Pharmacy. Springer, Cham. https://doi.org/10.1007/978-3-030-50247-8_57-1

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A literature review surveys prior research published in books, scholarly articles, and any other sources relevant to a particular issue, area of research, or theory, and by so doing, provides a description, summary, and critical evaluation of these works in relation to the research problem being investigated. Literature reviews are designed to provide an overview of sources you have used in researching a particular topic and to demonstrate to your readers how your research fits within existing scholarship about the topic.

Fink, Arlene. Conducting Research Literature Reviews: From the Internet to Paper . Fourth edition. Thousand Oaks, CA: SAGE, 2014.

Importance of a Good Literature Review

A literature review may consist of simply a summary of key sources, but in the social sciences, a literature review usually has an organizational pattern and combines both summary and synthesis, often within specific conceptual categories . A summary is a recap of the important information of the source, but a synthesis is a re-organization, or a reshuffling, of that information in a way that informs how you are planning to investigate a research problem. The analytical features of a literature review might:

• Give a new interpretation of old material or combine new with old interpretations,
• Trace the intellectual progression of the field, including major debates,
• Depending on the situation, evaluate the sources and advise the reader on the most pertinent or relevant research, or
• Usually in the conclusion of a literature review, identify where gaps exist in how a problem has been researched to date.

Given this, the purpose of a literature review is to:

• Place each work in the context of its contribution to understanding the research problem being studied.
• Describe the relationship of each work to the others under consideration.
• Identify new ways to interpret prior research.
• Reveal any gaps that exist in the literature.
• Resolve conflicts amongst seemingly contradictory previous studies.
• Identify areas of prior scholarship to prevent duplication of effort.
• Point the way in fulfilling a need for additional research.
• Locate your own research within the context of existing literature [very important].

Fink, Arlene. Conducting Research Literature Reviews: From the Internet to Paper. 2nd ed. Thousand Oaks, CA: Sage, 2005; Hart, Chris. Doing a Literature Review: Releasing the Social Science Research Imagination . Thousand Oaks, CA: Sage Publications, 1998; Jesson, Jill. Doing Your Literature Review: Traditional and Systematic Techniques . Los Angeles, CA: SAGE, 2011; Knopf, Jeffrey W. "Doing a Literature Review." PS: Political Science and Politics 39 (January 2006): 127-132; Ridley, Diana. The Literature Review: A Step-by-Step Guide for Students . 2nd ed. Los Angeles, CA: SAGE, 2012.

Types of Literature Reviews

It is important to think of knowledge in a given field as consisting of three layers. First, there are the primary studies that researchers conduct and publish. Second are the reviews of those studies that summarize and offer new interpretations built from and often extending beyond the primary studies. Third, there are the perceptions, conclusions, opinion, and interpretations that are shared informally among scholars that become part of the body of epistemological traditions within the field.

In composing a literature review, it is important to note that it is often this third layer of knowledge that is cited as "true" even though it often has only a loose relationship to the primary studies and secondary literature reviews. Given this, while literature reviews are designed to provide an overview and synthesis of pertinent sources you have explored, there are a number of approaches you could adopt depending upon the type of analysis underpinning your study.

Argumentative Review This form examines literature selectively in order to support or refute an argument, deeply embedded assumption, or philosophical problem already established in the literature. The purpose is to develop a body of literature that establishes a contrarian viewpoint. Given the value-laden nature of some social science research [e.g., educational reform; immigration control], argumentative approaches to analyzing the literature can be a legitimate and important form of discourse. However, note that they can also introduce problems of bias when they are used to make summary claims of the sort found in systematic reviews [see below].

Integrative Review Considered a form of research that reviews, critiques, and synthesizes representative literature on a topic in an integrated way such that new frameworks and perspectives on the topic are generated. The body of literature includes all studies that address related or identical hypotheses or research problems. A well-done integrative review meets the same standards as primary research in regard to clarity, rigor, and replication. This is the most common form of review in the social sciences.

Historical Review Few things rest in isolation from historical precedent. Historical literature reviews focus on examining research throughout a period of time, often starting with the first time an issue, concept, theory, phenomena emerged in the literature, then tracing its evolution within the scholarship of a discipline. The purpose is to place research in a historical context to show familiarity with state-of-the-art developments and to identify the likely directions for future research.

Methodological Review A review does not always focus on what someone said [findings], but how they came about saying what they say [method of analysis]. Reviewing methods of analysis provides a framework of understanding at different levels [i.e. those of theory, substantive fields, research approaches, and data collection and analysis techniques], how researchers draw upon a wide variety of knowledge ranging from the conceptual level to practical documents for use in fieldwork in the areas of ontological and epistemological consideration, quantitative and qualitative integration, sampling, interviewing, data collection, and data analysis. This approach helps highlight ethical issues which you should be aware of and consider as you go through your own study.

Systematic Review This form consists of an overview of existing evidence pertinent to a clearly formulated research question, which uses pre-specified and standardized methods to identify and critically appraise relevant research, and to collect, report, and analyze data from the studies that are included in the review. The goal is to deliberately document, critically evaluate, and summarize scientifically all of the research about a clearly defined research problem . Typically it focuses on a very specific empirical question, often posed in a cause-and-effect form, such as "To what extent does A contribute to B?" This type of literature review is primarily applied to examining prior research studies in clinical medicine and allied health fields, but it is increasingly being used in the social sciences.

Theoretical Review The purpose of this form is to examine the corpus of theory that has accumulated in regard to an issue, concept, theory, phenomena. The theoretical literature review helps to establish what theories already exist, the relationships between them, to what degree the existing theories have been investigated, and to develop new hypotheses to be tested. Often this form is used to help establish a lack of appropriate theories or reveal that current theories are inadequate for explaining new or emerging research problems. The unit of analysis can focus on a theoretical concept or a whole theory or framework.

NOTE : Most often the literature review will incorporate some combination of types. For example, a review that examines literature supporting or refuting an argument, assumption, or philosophical problem related to the research problem will also need to include writing supported by sources that establish the history of these arguments in the literature.

Baumeister, Roy F. and Mark R. Leary. "Writing Narrative Literature Reviews."  Review of General Psychology 1 (September 1997): 311-320; Mark R. Fink, Arlene. Conducting Research Literature Reviews: From the Internet to Paper . 2nd ed. Thousand Oaks, CA: Sage, 2005; Hart, Chris. Doing a Literature Review: Releasing the Social Science Research Imagination . Thousand Oaks, CA: Sage Publications, 1998; Kennedy, Mary M. "Defining a Literature." Educational Researcher 36 (April 2007): 139-147; Petticrew, Mark and Helen Roberts. Systematic Reviews in the Social Sciences: A Practical Guide . Malden, MA: Blackwell Publishers, 2006; Torracro, Richard. "Writing Integrative Literature Reviews: Guidelines and Examples." Human Resource Development Review 4 (September 2005): 356-367; Rocco, Tonette S. and Maria S. Plakhotnik. "Literature Reviews, Conceptual Frameworks, and Theoretical Frameworks: Terms, Functions, and Distinctions." Human Ressource Development Review 8 (March 2008): 120-130; Sutton, Anthea. Systematic Approaches to a Successful Literature Review . Los Angeles, CA: Sage Publications, 2016.

Structure and Writing Style

I.  Thinking About Your Literature Review

The structure of a literature review should include the following in support of understanding the research problem :

• An overview of the subject, issue, or theory under consideration, along with the objectives of the literature review,
• Division of works under review into themes or categories [e.g. works that support a particular position, those against, and those offering alternative approaches entirely],
• An explanation of how each work is similar to and how it varies from the others,
• Conclusions as to which pieces are best considered in their argument, are most convincing of their opinions, and make the greatest contribution to the understanding and development of their area of research.

The critical evaluation of each work should consider :

• Provenance -- what are the author's credentials? Are the author's arguments supported by evidence [e.g. primary historical material, case studies, narratives, statistics, recent scientific findings]?
• Methodology -- were the techniques used to identify, gather, and analyze the data appropriate to addressing the research problem? Was the sample size appropriate? Were the results effectively interpreted and reported?
• Objectivity -- is the author's perspective even-handed or prejudicial? Is contrary data considered or is certain pertinent information ignored to prove the author's point?
• Persuasiveness -- which of the author's theses are most convincing or least convincing?
• Validity -- are the author's arguments and conclusions convincing? Does the work ultimately contribute in any significant way to an understanding of the subject?

II.  Development of the Literature Review

Four Basic Stages of Writing 1.  Problem formulation -- which topic or field is being examined and what are its component issues? 2.  Literature search -- finding materials relevant to the subject being explored. 3.  Data evaluation -- determining which literature makes a significant contribution to the understanding of the topic. 4.  Analysis and interpretation -- discussing the findings and conclusions of pertinent literature.

Consider the following issues before writing the literature review: Clarify If your assignment is not specific about what form your literature review should take, seek clarification from your professor by asking these questions: 1.  Roughly how many sources would be appropriate to include? 2.  What types of sources should I review (books, journal articles, websites; scholarly versus popular sources)? 3.  Should I summarize, synthesize, or critique sources by discussing a common theme or issue? 4.  Should I evaluate the sources in any way beyond evaluating how they relate to understanding the research problem? 5.  Should I provide subheadings and other background information, such as definitions and/or a history? Find Models Use the exercise of reviewing the literature to examine how authors in your discipline or area of interest have composed their literature review sections. Read them to get a sense of the types of themes you might want to look for in your own research or to identify ways to organize your final review. The bibliography or reference section of sources you've already read, such as required readings in the course syllabus, are also excellent entry points into your own research. Narrow the Topic The narrower your topic, the easier it will be to limit the number of sources you need to read in order to obtain a good survey of relevant resources. Your professor will probably not expect you to read everything that's available about the topic, but you'll make the act of reviewing easier if you first limit scope of the research problem. A good strategy is to begin by searching the USC Libraries Catalog for recent books about the topic and review the table of contents for chapters that focuses on specific issues. You can also review the indexes of books to find references to specific issues that can serve as the focus of your research. For example, a book surveying the history of the Israeli-Palestinian conflict may include a chapter on the role Egypt has played in mediating the conflict, or look in the index for the pages where Egypt is mentioned in the text. Consider Whether Your Sources are Current Some disciplines require that you use information that is as current as possible. This is particularly true in disciplines in medicine and the sciences where research conducted becomes obsolete very quickly as new discoveries are made. However, when writing a review in the social sciences, a survey of the history of the literature may be required. In other words, a complete understanding the research problem requires you to deliberately examine how knowledge and perspectives have changed over time. Sort through other current bibliographies or literature reviews in the field to get a sense of what your discipline expects. You can also use this method to explore what is considered by scholars to be a "hot topic" and what is not.

III.  Ways to Organize Your Literature Review

Chronology of Events If your review follows the chronological method, you could write about the materials according to when they were published. This approach should only be followed if a clear path of research building on previous research can be identified and that these trends follow a clear chronological order of development. For example, a literature review that focuses on continuing research about the emergence of German economic power after the fall of the Soviet Union. By Publication Order your sources by publication chronology, then, only if the order demonstrates a more important trend. For instance, you could order a review of literature on environmental studies of brown fields if the progression revealed, for example, a change in the soil collection practices of the researchers who wrote and/or conducted the studies. Thematic [“conceptual categories”] A thematic literature review is the most common approach to summarizing prior research in the social and behavioral sciences. Thematic reviews are organized around a topic or issue, rather than the progression of time, although the progression of time may still be incorporated into a thematic review. For example, a review of the Internet’s impact on American presidential politics could focus on the development of online political satire. While the study focuses on one topic, the Internet’s impact on American presidential politics, it would still be organized chronologically reflecting technological developments in media. The difference in this example between a "chronological" and a "thematic" approach is what is emphasized the most: themes related to the role of the Internet in presidential politics. Note that more authentic thematic reviews tend to break away from chronological order. A review organized in this manner would shift between time periods within each section according to the point being made. Methodological A methodological approach focuses on the methods utilized by the researcher. For the Internet in American presidential politics project, one methodological approach would be to look at cultural differences between the portrayal of American presidents on American, British, and French websites. Or the review might focus on the fundraising impact of the Internet on a particular political party. A methodological scope will influence either the types of documents in the review or the way in which these documents are discussed.

Other Sections of Your Literature Review Once you've decided on the organizational method for your literature review, the sections you need to include in the paper should be easy to figure out because they arise from your organizational strategy. In other words, a chronological review would have subsections for each vital time period; a thematic review would have subtopics based upon factors that relate to the theme or issue. However, sometimes you may need to add additional sections that are necessary for your study, but do not fit in the organizational strategy of the body. What other sections you include in the body is up to you. However, only include what is necessary for the reader to locate your study within the larger scholarship about the research problem.

Here are examples of other sections, usually in the form of a single paragraph, you may need to include depending on the type of review you write:

• Current Situation : Information necessary to understand the current topic or focus of the literature review.
• Sources Used : Describes the methods and resources [e.g., databases] you used to identify the literature you reviewed.
• History : The chronological progression of the field, the research literature, or an idea that is necessary to understand the literature review, if the body of the literature review is not already a chronology.
• Selection Methods : Criteria you used to select (and perhaps exclude) sources in your literature review. For instance, you might explain that your review includes only peer-reviewed [i.e., scholarly] sources.
• Standards : Description of the way in which you present your information.
• Questions for Further Research : What questions about the field has the review sparked? How will you further your research as a result of the review?

IV.  Writing Your Literature Review

Once you've settled on how to organize your literature review, you're ready to write each section. When writing your review, keep in mind these issues.

Use Evidence A literature review section is, in this sense, just like any other academic research paper. Your interpretation of the available sources must be backed up with evidence [citations] that demonstrates that what you are saying is valid. Be Selective Select only the most important points in each source to highlight in the review. The type of information you choose to mention should relate directly to the research problem, whether it is thematic, methodological, or chronological. Related items that provide additional information, but that are not key to understanding the research problem, can be included in a list of further readings . Use Quotes Sparingly Some short quotes are appropriate if you want to emphasize a point, or if what an author stated cannot be easily paraphrased. Sometimes you may need to quote certain terminology that was coined by the author, is not common knowledge, or taken directly from the study. Do not use extensive quotes as a substitute for using your own words in reviewing the literature. Summarize and Synthesize Remember to summarize and synthesize your sources within each thematic paragraph as well as throughout the review. Recapitulate important features of a research study, but then synthesize it by rephrasing the study's significance and relating it to your own work and the work of others. Keep Your Own Voice While the literature review presents others' ideas, your voice [the writer's] should remain front and center. For example, weave references to other sources into what you are writing but maintain your own voice by starting and ending the paragraph with your own ideas and wording. Use Caution When Paraphrasing When paraphrasing a source that is not your own, be sure to represent the author's information or opinions accurately and in your own words. Even when paraphrasing an author’s work, you still must provide a citation to that work.

V.  Common Mistakes to Avoid

These are the most common mistakes made in reviewing social science research literature.

• Sources in your literature review do not clearly relate to the research problem;
• You do not take sufficient time to define and identify the most relevant sources to use in the literature review related to the research problem;
• Relies exclusively on secondary analytical sources rather than including relevant primary research studies or data;
• Uncritically accepts another researcher's findings and interpretations as valid, rather than examining critically all aspects of the research design and analysis;
• Does not describe the search procedures that were used in identifying the literature to review;
• Reports isolated statistical results rather than synthesizing them in chi-squared or meta-analytic methods; and,
• Only includes research that validates assumptions and does not consider contrary findings and alternative interpretations found in the literature.

Cook, Kathleen E. and Elise Murowchick. “Do Literature Review Skills Transfer from One Course to Another?” Psychology Learning and Teaching 13 (March 2014): 3-11; Fink, Arlene. Conducting Research Literature Reviews: From the Internet to Paper . 2nd ed. Thousand Oaks, CA: Sage, 2005; Hart, Chris. Doing a Literature Review: Releasing the Social Science Research Imagination . Thousand Oaks, CA: Sage Publications, 1998; Jesson, Jill. Doing Your Literature Review: Traditional and Systematic Techniques . London: SAGE, 2011; Literature Review Handout. Online Writing Center. Liberty University; Literature Reviews. The Writing Center. University of North Carolina; Onwuegbuzie, Anthony J. and Rebecca Frels. Seven Steps to a Comprehensive Literature Review: A Multimodal and Cultural Approach . Los Angeles, CA: SAGE, 2016; Ridley, Diana. The Literature Review: A Step-by-Step Guide for Students . 2nd ed. Los Angeles, CA: SAGE, 2012; Randolph, Justus J. “A Guide to Writing the Dissertation Literature Review." Practical Assessment, Research, and Evaluation. vol. 14, June 2009; Sutton, Anthea. Systematic Approaches to a Successful Literature Review . Los Angeles, CA: Sage Publications, 2016; Taylor, Dena. The Literature Review: A Few Tips On Conducting It. University College Writing Centre. University of Toronto; Writing a Literature Review. Academic Skills Centre. University of Canberra.

Writing Tip

Break Out of Your Disciplinary Box!

Thinking interdisciplinarily about a research problem can be a rewarding exercise in applying new ideas, theories, or concepts to an old problem. For example, what might cultural anthropologists say about the continuing conflict in the Middle East? In what ways might geographers view the need for better distribution of social service agencies in large cities than how social workers might study the issue? You don’t want to substitute a thorough review of core research literature in your discipline for studies conducted in other fields of study. However, particularly in the social sciences, thinking about research problems from multiple vectors is a key strategy for finding new solutions to a problem or gaining a new perspective. Consult with a librarian about identifying research databases in other disciplines; almost every field of study has at least one comprehensive database devoted to indexing its research literature.

Frodeman, Robert. The Oxford Handbook of Interdisciplinarity . New York: Oxford University Press, 2010.

Another Writing Tip

Don't Just Review for Content!

While conducting a review of the literature, maximize the time you devote to writing this part of your paper by thinking broadly about what you should be looking for and evaluating. Review not just what scholars are saying, but how are they saying it. Some questions to ask:

• How are they organizing their ideas?
• What methods have they used to study the problem?
• What theories have been used to explain, predict, or understand their research problem?
• What sources have they cited to support their conclusions?
• How have they used non-textual elements [e.g., charts, graphs, figures, etc.] to illustrate key points?

When you begin to write your literature review section, you'll be glad you dug deeper into how the research was designed and constructed because it establishes a means for developing more substantial analysis and interpretation of the research problem.

Hart, Chris. Doing a Literature Review: Releasing the Social Science Research Imagination . Thousand Oaks, CA: Sage Publications, 1 998.

Yet Another Writing Tip

When Do I Know I Can Stop Looking and Move On?

Here are several strategies you can utilize to assess whether you've thoroughly reviewed the literature:

• Look for repeating patterns in the research findings . If the same thing is being said, just by different people, then this likely demonstrates that the research problem has hit a conceptual dead end. At this point consider: Does your study extend current research?  Does it forge a new path? Or, does is merely add more of the same thing being said?
• Look at sources the authors cite to in their work . If you begin to see the same researchers cited again and again, then this is often an indication that no new ideas have been generated to address the research problem.
• Search Google Scholar to identify who has subsequently cited leading scholars already identified in your literature review [see next sub-tab]. This is called citation tracking and there are a number of sources that can help you identify who has cited whom, particularly scholars from outside of your discipline. Here again, if the same authors are being cited again and again, this may indicate no new literature has been written on the topic.

Onwuegbuzie, Anthony J. and Rebecca Frels. Seven Steps to a Comprehensive Literature Review: A Multimodal and Cultural Approach . Los Angeles, CA: Sage, 2016; Sutton, Anthea. Systematic Approaches to a Successful Literature Review . Los Angeles, CA: Sage Publications, 2016.

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• Open access
• Published: 18 February 2016

The use of purposeful sampling in a qualitative evidence synthesis: A worked example on sexual adjustment to a cancer trajectory

• Charlotte Benoot 1 ,
• Karin Hannes 2 &
• Johan Bilsen 1  

BMC Medical Research Methodology volume  16 , Article number:  21 ( 2016 ) Cite this article

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An increasing number of qualitative evidence syntheses papers are found in health care literature. Many of these syntheses use a strictly exhaustive search strategy to collect articles, mirroring the standard template developed by major review organizations such as the Cochrane and Campbell Collaboration. The hegemonic idea behind it is that non-comprehensive samples in systematic reviews may introduce selection bias. However, exhaustive sampling in a qualitative evidence synthesis has been questioned, and a more purposeful way of sampling papers has been proposed as an alternative, although there is a lack of transparency on how these purposeful sampling strategies might be applied to a qualitative evidence synthesis. We discuss in our paper why and how we used purposeful sampling in a qualitative evidence synthesis about ‘sexual adjustment to a cancer trajectory’, by giving a worked example.

We have chosen a mixed purposeful sampling, combining three different strategies that we considered the most consistent with our research purpose: intensity sampling, maximum variation sampling and confirming/disconfirming case sampling.

The concept of purposeful sampling on the meta-level could not readily been borrowed from the logic applied in basic research projects. It also demands a considerable amount of flexibility, and is labour-intensive, which goes against the argument of many authors that using purposeful sampling provides a pragmatic solution or a short cut for researchers, compared with exhaustive sampling.

Opportunities of purposeful sampling were the possible inclusion of new perspectives to the line-of-argument and the enhancement of the theoretical diversity of the papers being included, which could make the results more conceptually aligned with the synthesis purpose.

Conclusions

This paper helps researchers to make decisions related to purposeful sampling in a more systematic and transparent way. Future research could confirm or disconfirm the hypothesis of conceptual enhancement by comparing the findings of a purposefully sampled qualitative evidence synthesis with those drawing on an exhaustive sample of the literature.

Peer Review reports

An increasing number of qualitative evidence synthesis papers are appearing in the health care literature [ 1 , 2 ]. Qualitative evidence synthesis methods have the potential to generate answers to complex questions that provide us with novel and valuable insights for theory development and clinical practice, hereby moving beyond review questions only related to the effectiveness of interventions and causation [ 3 , 4 ].

Over 20 different approaches to qualitative evidence synthesis have been developed [ 5 ]. Meta ethnography developed by Noblit and Hare (1988) is currently one of the most commonly used synthesis approaches [ 2 , 6 , 7 ]. Meta-ethnography enables a systematic and detailed understanding of how studies are related, through the comparison of findings within and across studies, ultimately providing an interpretation of the whole body of research [ 7 ]. It has known a considerable uptake in the field of healthcare [ 8 , 9 ]. Furthermore, it has the capacity to generate hypotheses for future testing or comparison with trial outcomes [ 10 ]. In our review project, we opted for a meta-ethnographic approach to synthesize findings on the sexual adjustment of cancer patients and their partners across a number of qualitative studies. It was expected that this would allow us to generate a comprehensive model to understand patients and their partners’ sexual adaptation after cancer.

We noticed that many of the meta-ethnographies published adopt a linear approach to synthesizing the literature, mirroring the standard template developed by major review organizations such as the Cochrane and Campbell Collaboration. Consequently, in most meta- ethnographic synthesis projects, a strictly exhaustive search and information retrieval strategy is used to collect data and relevant studies are assessed for quality before being included in the synthesis. The idea to work with comprehensive samples of the literature is strongly influenced by the risk of bias discourse, suggesting that non-comprehensive samples may introduce a selection bias in systematic reviews, for example [ 11 – 13 ].

However, the usefulness of the review strategy promoted by organizations such as Cochrane and Campbell, and thus of exhaustive search techniques and sampling, has been questioned by a substantial proportion of members of the qualitative research community. It has been argued that exhaustive sampling is a highly rigorous and formalistic approach that risks to be too time consuming because the searches often retrieve very large data sets that are impractical to screen [ 14 , 15 ]. Moreover, exhaustive sample risks to produce rather superficial synthesis findings, with a large number of studies that fail to go beyond the level of description [ 16 ].

Consequently, some authors are proposing a more purposeful way of sampling papers as an alternative for exhaustive sampling [ 17 ].

Purposeful sampling techniques for primary research have been well described by Patton (2002, p. 230) who has provided a definition of what purposeful sampling means [ 16 ].

“The logic and power of purposeful sampling lie in selecting information-rich cases for study in depth. Information-rich cases are those from which one can learn a great deal about issues of central importance to the purpose of the inquiry, thus the term purposeful sampling. Studying information-rich cases yields insights and in-depth understanding rather than empirical generalizations.”

Applied to the meta-level, purposeful sampling in a qualitative evidence synthesis has often been promoted as a solution for pragmatic constraints of time, resources, access to information and expertise [ 5 , 15 ]. However, several review authors specializing in qualitative evidence synthesis have also provided a more theoretical background to the choice for purposeful sampling. One of the core arguments supporting a purposeful sampling approach is that it is not meant to be comprehensive in terms of screening all potentially relevant papers, mainly because the interest of the authors is not in seeking a single ‘correct’ answer, but rather in examining the complexity of different conceptualizations. It follows that these types of reviews require variation to enable new conceptual understandings to be generated [ 11 , 17 , 18 ]. Booth (2011) further claims that authors of qualitative evidence syntheses are mainly concerned with ‘aiming to find sufficient cases to explore patterns and so are not necessarily attempting to be exhaustive in their searching’ [ 19 ]. To guarantee a sufficient level of conceptual richness, review directions may be divergent and iterative, rather than linear [ 20 ]. This thus contradicts the classic prospective approach of exhaustive searching [ 1 ].

Although several qualitative researchers have recommended purposeful sampling in the context of qualitative evidence synthesis, the published literature holds sparse discussion on how these strategies might be applied to a qualitative evidence synthesis [ 15 ]. Suri (2011) has made a worthwhile attempt to address this issue by examining the adaptability of the 16 purposeful sampling strategies in primary research described by Patton (2002) to the process of qualitative evidence synthesis (see Table  1 ).

Despite this promising effort by Suri (2011) to theoretically present the different options of sampling for synthesis, researchers who claim to have used a purposeful sampling approach often fail to create a transparent audit trail on the review process. In addition, early pioneers such as Campbell and colleagues (2003) who explored purposeful sampling remain close to a positivist sampling strategy, opting for an arbitrary, random sampling technique to select a subset of papers to extract [ 21 ]. Noblit and Hare (1988), the initiators of the meta-ethnographic approach, introduce the idea of sampling purposefully without developing it further [ 7 ].

This indicates that there is a unilateral focus on exhaustive sampling methods, as well as a lack of transparency on how to effectively use and report on purposeful sampling techniques. Therefore, we discuss in this paper why and how we have used purposeful sampling in our qualitative evidence synthesis. The following issues will be addressed: (a) how purposeful sampling procedures have been integrated into our review procedure; (b) how this purposeful sampling has led to the development of a line-of-argument, and (c) what sort of challenges and opportunities we encountered in the instrumental outline of the procedure.

We used Suri’s (2011) description of 16 possible purposeful sampling strategies for qualitative evidence synthesis as a starting point for deciding on which type of sampling strategy we would apply in our synthesis (see Table  1 ) [ 15 ]. Suri (2011) urges authors to carefully identify sampling strategies that are conceptually aligned with the synthesis purpose, that are credible, that sufficiently address the synthesis purpose, and that are feasible, ethical and efficient.

However, we found that Suri did not offer a ‘grab and go’ option that was the perfect match for building a theoretical model, which was the aim in our qualitative evidence synthesis about sexual adjustment after cancer. Little guidance is thus available for the practical implementation of theoretical sampling. Following the example of theoretical sampling guides in primary research, we choose to see theoretical sampling as an umbrella approach, i.e. a combination of different purposeful sampling techniques [ 22 , 23 ].

We have therefore chosen a combination consisting of (a) intensity sampling at first, then a (b) maximum variation sampling and finally (c) disconfirming case sampling. This combination of sampling techniques was chosen as these aligned with the different steps of analysing towards a theoretical construct, and in accordance with Corbin and Strauss, who also connected specific sampling strategies to different types of analysing [ 24 ].

In what follows, we describe and discuss how these sampling procedures have been integrated into our review procedure. As well we describe why we used the specific sampling technique in alliance with a specific step in the analysis.

Scoping review

Initially, we compiled a database of potentially relevant articles based on a scoping review. Scoping is an exploratory and systematic way of mapping the literature available on a topic [ 17 ]. Scoping exercises are perceived as the ideal way of doing preparatory work for an exhaustive systematic review. In our case, we have used them for building an archive of data for our qualitative evidence synthesis.

We searched 4 major databases: Medline, Psychinfo, Cinahl and Dissertation Abstracts. A search string was developed for each database with the support of a specialized team. For each database we added a methodological filter to these search strings in order to extract qualitative research articles [ 25 – 27 ]. For example, the research string we used in Medline was ((interview* or qualitative or experience*) and (cancer and sexual*). Studies included had to be written in English and be carried out between 1994 and 2014, for pragmatic reasons.

The qualitative studies retrieved were qualitative studies matched against the following inclusion criteria.

Type of studies

We considered all sorts of qualitative designs. Opinion pieces and editorials were excluded. The study reports should be qualitative in nature.

Phenomenon of interest

Studies should (partially) focus on the relational aspects of sexuality, namely the sexual intimacy of patient and partner, in a context of a cancer diagnosis.

Type of participants

We included articles where the cancer patient and/or the partner was the unit of analysis.

First one researcher (CB) applied the inclusion and exclusion criteria to the retrieved abstracts. A full text was requested for each of the relevant studies. These studies were further assessed by the same researcher, rechecking them against the same inclusion and exclusion criteria. As can be seen in Fig.  1 , a total of 58 articles were included in our pool/archive of data.

Flow chart of the scoping review

The quality of the 58 studies was appraised using the CASP (Critical Appraisal Skills Program) tool, as this proved to be the most feasible instrument to appraise qualitative studies (Hannes, Lockwood, & Pearson, 2010). The appraisal of the quality of the research articles was not meant as an inclusion tool in scoping, but was used later on as a parameter for intensity sampling (see further).

The pool of 58 data was used to initiate purposeful sampling –i.e. (a) intensity sampling, (b) maximum variation sampling, and (c) confirming/disconfirming case sampling (see Fig.  2 ).

Overview figure of the purposeful sampling guidance

In order to prepare for the purposeful sampling phase, we constructed a standardized extraction form for each of the 58 articles to highlight the specific characteristics identified, i.e. the data collection, method, research question/goal, sampling characteristics and main theoretical arguments. By summarizing the methodological and theoretical basis of the primary studies we could easily compare the differences between studies. This facilitated our choice in purposefully sampling papers. Table  2 shows an example of a descriptive data extraction sheet of one of the studies included.

• Purposeful sampling

Intensity sampling

“Intensity sampling in a research synthesis would involve selecting studies that are ‘excellent or rich examples of the phenomenon of interest, but not highly unusual cases [ 16 ]”.

The reason why we chose this sampling technique as the first technique is because we believed that the starting point of the literature synthesis would influence the further analysis, so it was important to choose rich examples of the phenomenon of interest, but not highly unusual cases.

The first task was to translate the theoretical definition of intensity sampling into some concrete inclusion factors. The first factor was the degree of overlap between the research question of the article and those of the qualitative evidence synthesis, because the content of the article had to parallel the intended content of our meta-ethnography closely. The second factor was the methodological quality of the paper, evaluated by means of the CASP. High-quality articles are usually more likely to provide rich, textual accounts to draw information from [ 28 ]. A third factor we assessed was the conceptual clarity of the article [ 29 ]. Conceptual clarity means the presence and clarity of concepts for translation, and is integral to a meta-ethnography which requires clear concepts as data.

We did this intensity sampling until a “jumping off point” was reached [ 30 ]. This point is reached when the concepts and categories emerging from the papers are saturated, meaning that no new concepts are derived from reading further articles. We retrieved this jumping off point after including 6 articles (see Fig.  2 ). From that point on, we wanted to deepen the concepts further by investigating the relation between the different concepts, by means of maximum variation sampling.

Maximum variation sampling

“A maximum variation sample is constructed by identifying key dimensions of variations and then finding cases that vary from each other as much as possible. This sampling yields: ‘(1) high-quality, detailed descriptions of each case, which are useful for documenting uniqueness, and (2) important shared patterns that cut across cases and derive their significance from having emerged out of heterogeneity [ 16 ].

Presuming that different study characteristics illuminate different aspects of a phenomenon, maximum variation sampling can be utilized to construct a holistic understanding of the phenomenon by synthesizing studies that differ in their study designs on several dimensions [ 15 ]. This type of sampling fits the stage of analysis as the aim is to uncover a many different key dimensions as possible.

The different concepts derived from the intensity sampling, defined the key dimensions that served as a basis for selecting additional papers. These papers vary from each other in these particular dimensions, e.g. theoretical underpinning of the articles (see further for an example of these key dimensions). Maximum variation sampling led us to the construction of a preliminary line-of-argument, after including 7 more articles (see Fig.  2 ) which was then further refined by using confirming/disconfirming case sampling.

disconfirming case sampling

“The disconfirming case sampling contains a selection of articles that do not fit [ the emerging patterns]. They are a source of rival interpretations as well as a way of placing boundaries around confirmed findings” [ 15 ].

Disconfirming case sampling fits this stage of analysis, as we want to verify and deepen the preliminary line of argument.

We selected new articles based on deviant theoretical assumptions. Disconfirming articles were thus also selected through the data extraction sheets of each paper, namely by reading through the main theoretical aspects of the studies. Papers that featured theories and concepts opposing the ones we had already included in our preliminary line-of-argument were further considered for in-depth analysis. We included 3 more articles for this sampling technique, which makes the total number of included articles 16 (see Fig.  2 ).

We have now addressed how to potentially introduce purposeful sampling into a review project. However, it has been suggested that a purposeful sampling procedure is subject to a permanent dialogue with the analysis of the data [ 31 , 32 ]. In what follows, we will discuss what sort of contribution purposeful sampling has made to our findings and the model we have developed, by means of a worked example.

Results: Illustration of the purposeful sampling techniques using a worked example

In a meta-ethnography, a popular way of analysing data is the translation of the concepts or metaphors of one study into another, while preserving the structure of relationships between concepts within any given study [ 33 ]. We will thus show how we sampled different studies and how this influenced the translation exercise based on an example of three example concepts from three articles included in our review. Note that the decision to work with three concepts only was taken to increase the clarity of the procedures we describe in this paper, not to describe all the actual results and complete line-of-argument.

First step: Arriving at a “jumping off point” through intensity sampling

We will illustrate these decisions of intensity sampling by describing the inclusion of 3 articles [ 34 – 36 ] which - according to our parameters described above - have a great degree of overlap with the research goal, a high methodological quality and strong conceptual clarity.

On the articles that were included through intensity sampling, we performed a reciprocal translation of the concepts, which is the translation of one study’s findings into another, using metaphors and overarching concepts. [ 7 ] In what follows, we give a worked example of how we did this reciprocal translation for 3 concepts identified in the initial set of studies considered for the synthesis, as this is a necessary step towards the illustration of the subsequent sampling methodology. In order to be explicit about how the concepts compared to one another, we created a table into which we placed and compared the concepts of each paper (See Table  3 ). Each row of the table represents a key concept. In the left collumn, we labelled the rows with concepts that encompassed all the relevant concepts from each paper.

The first concept we retrieved through intensity sampling is “sexual struggling”, encompassing the different ways of struggling with the sexual changes due to cancer. In Walker’s study (2011) it is formulated as having a sense of loss [ 35 ]. In the study of Gilbert (2013), this is formulated as patients having an altered body image [ 36 ]. In Juraskova’s study (2013) it is formulated as “reduced vaginal lubrification” [ 34 ].

Another overarching concept that we retrieved was “exacerbation of struggling”, encompassing strategies, situations, characteristics that were leading to an increasing struggling with the sexual changes. In Gilbert’s study (2013), this is formulated as “sticking to the coital imperative”, which means that intercourse is the most normal and natural form of heterosexuality, and condemns those who cannot perform as dysfunctional. In Walker’s study (2012), this is formulated as avoidance of communication about the sexual changes. In Juraskova (2003), exacerbation of struggling is the case when the patients are “ Receiving radiotherapy combined with external radiation and brachytherapy”.

A third overarching concept we found was the “sexual adjustment” to changes due to having cancer, encompassing the different ways of adaptation to sexual changes. Gilbert’s study (2010) describes that there is “a renegociation of the practices of sexual intimacy”, which means that the couple included sexual practices that had previously been marginalized in relation to sexual intercourse. Walker (2011) formulates this adjustment as “accepting the decision to stop sexuality”. Juraskove (2003) formulates it as “sexual adjustment and quality of life”.

The articles were sampled by the main author, but all articles included by intensity sampling were read and analysed by two authors (CB and MS). After a certain point which we call the “jumping off point”, we began to discover certain key dimensions of variation between the studies, which we explored further through maximum variation sampling. In the worked example that we explain here was the discovery that the studies varied on the scientific approach they took on, resulting in a different interpretation of the overarching concepts. To illustrate this: Gilbert (2010) used a social-constructionist lens to investigate sexual adjustment, Walker (2011) used a more psychological approach to investigate the subject, and Juraskova (2003) underscores more the biological aspects of sexual changes after cancer. Through the maximum variation sampling, we thus want to further explore how these different approaches lead to different interpretations of the phenomenon.

Second step: Apply a maximum variation sampling strategy to construct a preliminary line of argument

To explore the consequence of variation on the key dimension, we used maximum variation sampling to include studies that varied on the above cited dimension (i.e. scientific approach, socio-, psycho, or biological perspective). In this worked example, we show through the inclusion of three more papers [ 37 – 39 ] how we arrived – through comparison of the papers- at a preliminary line of argument.

The sampling was also done by one researcher, but the articles were read and analysed by 2 researchers. As a result of this maximum variation sampling and constant comparison between the papers, could develop relationships between the different concepts and constructing a preliminary line of argument (see Table  4 ).

First, with regard to the concept of struggling, we found that articles who work with a psychological approach, describe the concept of struggling on an emotional level, analog with the stages of grief (anger, depression,..) while the sociological articles describe it more on a level of identity, analog with the theory of biographical disruption. Articles who have a more biological approach reduce the struggling on a level of sexual dysfunction.

Second, with regard to the concept of exacerbation of struggling, articles who work with a psychological approach again describe a stage of the grief theory, which is denial. Sociological oriented articles work with the adherence to hegemonic discourses, and biological oriented articles use certain characteristics of the cancer treatment as barriers towards adjustment.

Third, with regard to the concept of sexual adjustment, articles who are psychological oriented again use a stage of the grief theory to encompass this adjustment, which is acceptance. Sociological oriented article worked with a “rediscovery” of what sexuality is. The changes are thus not merely accepted, rather they are incorporated in a new definition of the self and sexuality. Biological oriented articles worked with “sexual recovery”, which –in contrast to the sociological oriented articles- means that there is no difference in what sexuality means , but a reuptake of sexual activity , similar to what it was before the cancer.

Our preliminary line of argument consisted of three different pathways the articles worked with. First, there are articles following the grief theory to describe the adjustment process In this case, sexual changes are depicted in terms of losses, and the adjustment occurs through the process of grief and mourning.

Second, there are articles following the “restructuring theory” during illness. Unlike the case of grief theory, where the patient and partner are working through some emotional stages, in the restructuring pathway patient and partner are more cognitively dealing with sexuality after cancer through the development of a new sexual paradigm. Flexibility is the central aspect of this adjustment.

Thirdly, there are articles following the pathway of sexual rehabilitation. This pathway is embedded in a more positivistic paradigm where the adaptation does not emphasize psychological changes or cognitive restructuring, but sexual changes as a bodily dysfunction that needs treatment and behavioural strategies.

Refining the preliminary line of argument by means of disconfirming case sample.

To test, refine, and deepening our preliminary line-of-argument, , we included 3 articles out of the pool of 58 articles that consist of a theory and concepts opposing the preliminary line-of argument. We will give an example with including 1 article (see Table  5 ).

In this phase of sampling, we worked together with a researcher who was not involved in the analysis process before (JB). This is because we wanted to have a fresh and “unambiguous view” of our line of argument. This researcher, together with the first researcher, read the articles and tested them against the line of argument.

In our preliminary line-of-argument, we assumed that the three pathways of adjustment all followed a linear pattern from the struggling towards the adjustment. However, Ramirez (2009) counter argues this linear approach by stating that patients could refine their definition of sexuality, but could also return to it at a certain moment [ 40 ]. These disconfirming findings led us to re-analyse the included articles, where we came eventually to the conclusion that the sexual adjustment as a cognitive restructuring process does not have a linear pattern with an endpoint, but rather makes on oscillating movement between following hegemonic definitions of sexuality, and challenging them.

Challenges and opportunities

In the process of conducting a qualitative evidence synthesis through purposeful sampling, we encountered several challenges. But this process also created a few opportunities that would not have occurred if we had used an exhaustive sampling and analysis strategy. In what follows, we discuss how we have bridged obstacles and maximized benefits in terms of the opportunities arising.

First, it proved to be difficult to define what exactly to look for, since the concept of e.g. an intensity sample on the meta-level could not readily been borrowed from the logic applied in basic research projects. In an original research project, as opposed to a qualitative evidence synthesis project, purposeful sampling can often easily be conducted, for example by using a brief questionnaire as a screening tool to search for participants with specific characteristics [ 41 ]. However, with research reports, this is more difficult in practice. We chose to search for literature by means of electronic databases with the use of search strings. Finding a specific search string to detect a specific information-rich research report which meets the sampling criteria would be difficult, because the search terms are usually based on population and setting characteristics as well as the topic of interest, rather than on conceptual or theoretically interesting leads.

Therefore we decided to conduct a scoping of the literature prior to applying a purposeful sampling technique. The scoping review was intended to create a pool/or archive of primary research reports that are easily accessible and can be used later as material for purposeful sampling. In fact, our purposeful sampling strategy did not start at the level of data-collection. It was initiated at the level of data extraction and analysis. The consequence of this decision was that the sampling procedure was rather labour-intensive as we had to perform a scoping review before the actual mixed purposeful sampling could start.

We illustrated through our worked example that using purposeful sampling techniques also has several advantages.

First of all, although some researchers argued that reducing the number of included articles by means of purposeful sampling could result in neglecting important data [ 18 , 42 ], we showed throughout this worked example that the opposite can be true. With the use of this combination of three purposeful sampling techniques – intensity sampling, maximum variation sampling and confirming/disconfirming case sampling - we arrived at a line-of-argument.

Because of this emphasis on conceptual robustness instead of generalization of the data, we were more sensitive to “deviant data”, i.e. data that may not have been picked up when synthesizing information from an exhaustive sample of the literature, because review authors are generally more focused on detecting commonalities between articles. When using an exhaustive sampling technique, researchers will arrive at results that describe the “greatest common devisor” of all included papers.

Furthermore, deviant data that has been derived through maximum variation sampling and confirming/disconfirming case sampling may add new perspectives or a new space of understanding to the line-of-argument, while sampling randomly may run the risk of preventing enhanced insight and knowledge.

Moreover, the combination of sampling techniques – instead of a random sample or just one method of purposeful sampling- could enhance the quality and diversity of the papers being included, and could make the results more conceptually aligned with the synthesis purpose. This would further enhance the possible impact a qualitative evidence synthesis could have on informing healthcare practice [ 43 ].

Such an approach, however, demands a considerable amount of flexibility from review authors, mainly because inclusion criteria may change progressively during the process. This fact, together with the experience described above of doing a labour-intensive scope of the literature, goes against the argument of many authors [ 5 ] that using purposeful sampling provides a pragmatic solution or a short cut for reviewers who have limited time for searching and screening. However, we felt we did gain some time in the analytical process, since the number of articles from which data were extracted was modest in number. This strategy is therefore recommended for authors who are left with a high number of relevant articles after screening for inclusion.

However, the choice of using this particular combination of sampling techniques should also be motivated from a theoretical perspective. Authors who want to build a theoretical model out of the qualitative evidence synthesis could use this scheme of sampling methods, as it aligns well with the different stages of analysis, and is parallel to what Corbin and Strauss suggested for primary research [ 24 ].

In this paper, we addressed two different needs:

Firstly, we met the need for a transparent worked example of how to apply purposeful sampling techniques to a qualitative evidence synthesis. We believe that this paper can help other researchers to make decisions related to purposeful sampling in a more systematic and transparent way.

Secondly, we gave evidence for the beneficial effects of using purposeful sampling techniques in a qualitative evidence synthesis. Although purposeful sampling is a time-consuming activity that requires a lot of resources and flexibility from the researchers, it creates potential to arrive at a rich conceptual model that can be useful for clinical practice. Future research could confirm or disconfirm the hypothesis of conceptual enhancement by comparing the findings of a purposefully sampled qualitative evidence synthesis with those drawing on an exhaustive sample of the literature.

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Acknowledgements

We would like to thank Drs. Marlies Saelaert for making substantial contributions to the analysis and interpretation of the data of our meta-synthesis. We also would like to acknowledge the Flemish fund for Scientific research (FWO) for financially supporting this study.

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CB carried out the qualitative evidence synthesis and wrote the first draft. KH guided the philosophic discussion that contributed to the methodological development of the paper. JB conceived of the study, participated in its design and helped to draft the manuscript. All authors read and approved the final manuscript.

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Benoot, C., Hannes, K. & Bilsen, J. The use of purposeful sampling in a qualitative evidence synthesis: A worked example on sexual adjustment to a cancer trajectory. BMC Med Res Methodol 16 , 21 (2016). https://doi.org/10.1186/s12874-016-0114-6

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Developing practical strategies to reduce addiction-related stigma and discrimination in public addiction treatment centers: a mixed-methods study protocol

• Maryam Khazaee-Pool   ORCID: orcid.org/0000-0002-2587-3460 1 ,
• Seyed Abolhassan Naghibi 1 ,
• Tahereh Pashaei 2 &
• Koen Ponnet 3  

Addiction Science & Clinical Practice volume  19 , Article number:  40 ( 2024 ) Cite this article

Metrics details

People with substance use disorders (SUDs) have restricted engagement with health-care facilities and describe repeated experiences of stigma, discrimination, and mistreatment when receiving care at health-care and public addiction treatment centers (PATCs). The purpose of the current study is to design practical cultural-based strategies to reduce addiction-related stigma and discrimination at PATCs.

Methods/design

The present study will use a mixed-methods design with an explanatory sequential approach. Phase 1 of the study will combine a cluster sampling technique combined with a cross-sectional survey of Patients with Substance Use Disorders (SUDs) in Mazandaran, Iran. A total of three hundred and sixty individuals with SUDs will be selected to assess their experiences of stigma and factors predicting stigma. Phase 2 will involve qualitative study aimed at exploring participants’ perceptions regarding the aspects and determinants of their stigma experience. The participants will include two groups: people with SUDs and staff/health-care providers at PATCs. Participants for Phase 2 will be purposively sampled from those involved in Phase 1.Qualitative data will be collected using in-depth semi-structured interviews and focus group discussions and analyzed using content analysis with a conventional approach. Phase 3 will focus on the development of new strategies to reduce the experiences of stigma among people with SUDs at PATCs. These strategies will be formulated based on the findings derived from the qualitative and quantitative data obtained in Phases 1 and 2, a comprehensive review of the literature, and expert opinions gathered using the nominal group technique.

This is one of the few studies conducted within the domain of stigma pertaining to individuals who use drugs within the context of Iranian culture employing a mixed-methods approach, this study aims to develop culturally sensitive strategies to reduce such problems from the perspective of Iranian people who use drugs. It is anticipated that the study will yield evidence-based insights and provide practical strategies to reduce the stigma and discrimination experienced by people who use drugs at PATCs. Such outcomes are important for informing policymaking and designing healthcare interventions tailored to the needs of individuals grappling with substance dependency.

Introduction

Substance use disorders (SUDs) represent complex illnesses that disrupt brain activity and function resulting in significant personal and societal repercussions [ 1 , 2 , 3 , 4 ]. Recognizing the detrimental impact of SUD-related stigma, The National Institute on Drug Abuse has prioritized efforts to understand and diminish this stigma [ 5 ]. Research on mental illness stigma has consistently revealed its association with adverse outcomes, including exacerbated symptoms and impaired social functioning [ 6 ]. With the increasing prevalence of SUDs within the general population [ 1 , 2 , 3 , 4 , 7 ] and the necessity to inform policymakers and allocate legislative resources effectively [ 8 , 9 ], it becomes crucial to raise awareness about the stigma surrounding SUDs in society. Studies investigating SUD-related stigma have documented various forms of prejudice and discrimination experienced by people who use drugs, particularly from healthcare providers, which are correlated with detrimental health outcomes, including mental health disorders and compromised physical health [ 10 , 11 , 12 , 13 , 14 ].

Part of the stigmatization faced by healthcare providers stems from the inaction of public health leaders [ 15 ], while another part arises from the lack of training among healthcare workers in SUD treatment [ 16 , 17 ], both of which contribute to inadequate implementation of effective remedies. Numerous studies have demonstrated the persistent and entrenched nature of stigma, often rooted in the misconception that drug addiction reflects a personal choice, indicating a lack of self-control and moral failure. Stigma and discrimination levels are notably high both within the general population and among professions that interact with individuals with SUDs, such as the healthcare industry. Some studies have demonstrated that stigma and prejudice harm SUD patients’ health and cause delays in the delivery of high-quality care in venues for public addiction treatment. Individuals with SUDs frequently encounter stigma and discrimination across all levels of care at public addiction treatment centers (PATCs) [ 17 , 18 , 19 , 20 , 21 , 22 ].

The World Health Organization is working with several countries to train medical professionals in screening, brief intervention, and referral to treatment (SBIRT) [ 23 , 24 , 25 , 26 , 27 ]. SBIRT is a treatment strategy that encourages all medical professionals to identify patients who are taking drugs at statistically dangerous levels, provide brief interventions to promote drug use reduction, and then refer patients who meet criteria for drug use or addiction for more intensive treatments. According to some studies, screening and brief interventions (SBI) have the greatest effect on reducing the use of psychoactive substances [ 20 , 23 , 26 , and 28 ]. SBI is a simple, quick advisory intervention that stresses several types of specific behavior. It may be used by professionals in a variety of situations [ 29 ].

Unfortunately, societal acceptability of evidence-based initiatives does not always come easily [ 30 ]. The allocation of healthcare interventions is influenced by various factors, including the novelty of characteristics, healthcare worker attitudes, and the stigma associated with a health condition. Research has consistently demonstrated that negative attitudes among healthcare professionals can impede the adoption of innovative practices, the quality of services provided, and clients’ adherence to preventive and therapeutic measures [ 31 , 32 , 33 , 34 , 35 , 36 ]. Therefore, education and training programs should prioritize the modification of attitudes and beliefs among healthcare providers to promote the uptake of SBI for drug addiction [ 37 , 38 ].

Research in health has linked stigma from service providers at care or treatment centers with poor utilization of preventive programs and reduced accessibility for stigmatized individuals to access effective interventions [ 39 , 40 ]. Efforts to mitigate stigmatization are underway, particularly for individuals living with mental health conditions [ 40 , 41 ]. Studies have identified three main approaches: (i) providing educational interventions to dispel misconceptions about mental illnesses, (ii) facilitating interactions between individuals with mental illnesses and the community to challenge community attitudes, and (iii) exposing stigmatizing beliefs and behaviors in the hope of eliciting public condemnation and reducing their acceptance [ 41 , 42 , 43 ]. Although anti-stigma strategies are sometimes inaccessible or unproven, the aforementioned techniques aim to change community perceptions of people facing such circumstances [ 39 , 41 ].

To reduce the stigma associated with mental illness, several national and international strategies have been developed, and the range of programs continues to expand. However, stigma and discrimination against individuals with SUDs remain poorly understood [ 44 , 45 ]. Moreover, there has been limited research investigating the creation and execution of practices or interventions aimed at reducing SUD-related stigma and discrimination among people who use drugs by PHC professionals [ 46 , 47 , 48 , 49 , 50 ]. When developing anti-stigma strategies, it is essential to consider the cultural norms and different behaviors of specific groups, including healthcare professionals, youth, police, and policymakers [ 14 , 38 , 40 , 45 , 49 ].

For many years, stigma related to SUDs has posed challenges in Iran [ 51 , 52 , 53 ]. One of the most significant obstacles to improving the well-being and health of individuals with SUDs is the stigmatization and discrimination they face within the healthcare system [ 52 , 54 ]. This results in disparities in healthcare facilities, including limited availability, accessibility, and quality of services for individuals with SUDs [ 54 ]. Stigmatization negatively impacts help-seeking behavior from official healthcare facilities, leading to poorer outcomes and perpetuating the misconception that SUDs are untreatable. individuals with SUDs may be more prone to engaging in unhealthy behaviors, refusing treatment, non-compliance with prescription instructions, weakened immune systems, and experiencing adverse consequences [ 55 ].

Comprehensive plans for the promotion, prevention, treatment, and recovery of individuals with substance use disorders (SUDs) should consider numerous socioeconomic variables. Adopting a “health-in-all policies” approach is crucial in addressing these challenges. Strategies to increase access to treatment and reduce stigma and discrimination towards individuals with SUDs may involve integrating SUD care and fostering collaboration between primary care clinicians and other healthcare providers [ 22 , 38 , 39 , 40 , 53 ]. International efforts to combat addiction-related stigma have emphasized the importance of lowering barriers to a variety of health treatments for individuals with SUDs. Despite this emphasis and the widespread consensus that reducing stigma associated with SUDs is important, progress in this area has been slow [ 40 , 49 , 56 , 57 , 58 ]. While strategies to reduce SUD-related stigma have gained traction in Western industrial nations in recent years [ 59 , 60 ]. They remain largely absent from national and government policies, information, and healthcare plans in many parts of the world [ 40 , 42 , 44 , 53 , 58 , 61 ].

Longitudinal data on behavior changes in response to stigma and discrimination related to SUDs in Iran are lacking, making it challenging to develop effective strategies to reduce such stigma, especially in PATCs. The most widely recognized solutions are those that are acceptable, suitable, and adaptable across cultural contexts. Further research and needs assessments are required to identify additional strategies for addressing addiction-related stigma [ 42 , 47 , 56 ]. To address the stigma associated with addiction, it is necessary to study the effectiveness and feasibility of stigma-reducing interventions [ 55 , 58 , 62 ].

In Iran, as in many other countries, there is a lack of comprehensive strategies aimed at reducing stigma related to SUDs. Additionally, there is a dearth of studies providing practical strategies, both quantitative and qualitative, to address addiction-related stigma and discrimination specifically within PATCs for individuals with SUDs in Iran. Mixed-method analyses focusing on this issue are also lacking. While there have been some studies conducted in Iran to explore stigma toward individuals with SUDs, none have offered strategies or methods to mitigate stigma within public treatment settings. Although limited, existing data from small-scale qualitative studies in Iranian healthcare settings indicate the prevalence of discriminatory attitudes toward people with SUDs, manifesting as care refusal, substandard care, excessive precautions, physical distancing, humiliation, and blame [ 30 , 51 , 52 , 55 , 62 , 63 , 64 ].

Iran’s unique cultural characteristics [ 65 ] including demographic factors [ 66 ], cultural norms [ 67 ], ethnic identity [ 68 ], social customs, traditions, peer relationships, and poverty [ 69 ] shape the societal landscape and perceptions surrounding behaviors, including those related to SUDs. Consequently, addressing addiction-related stigma and its impact on individuals who use drugs in Iran requires sensitivity to these cultural nuances [ 64 , 70 ]. In Iran, SUDs are not solely viewed as medical issues but also as a socio-cultural problem. This perspective can lead to delays in treatment and pose significant challenges for patients and their families. Consequently, reducing stigma and discrimination associated with the rising prevalence of addiction among Iranians has been identified as a pressing priority within the healthcare system [ 70 ].

In Iranian society, plays a significant role in shaping perceptions and experiences of SUD across various demographic groups, including differences related to age, gender, socioeconomic status, and education level [ 64 ]. Research in Iran has extensively explored how cultural influences manifest in SUDs, examining factors such as demographic characteristics, regional prevalence patterns, gender dynamics, religious beliefs, and the stigma associated with drug use. These studies highlight the complex interplay between cultural norms, individual behaviors, and societal attitudes toward SUDs within the Iranian context [ 66 , 67 , 68 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 ].

Of course, the stigma surrounding drug addiction in Iran exhibits variations based on factors such as gender, the specific type of drug used, and residential location [ 81 , 82 ]. Interestingly, a study examining literary works in Iran reveals a historical acceptance of opium as a medicinal remedy by prominent Iranian poets. Opium has been portrayed positively, with references to its purported benefits such as regulating blood pressure and relieving pain [ 83 ]. This cultural perspective reflects a nuanced view of drug consumption in Iranian society, indicating that stigma surrounding certain drugs may not be uniform. Rather, stigma appears to evolve dynamically within social contexts, presenting new challenges that may differ from those associated with more entrenched forms of stigma.

Although previous qualitative studies have provided valuable insights into the experiences of individuals with SUD interacting with healthcare professionals, our understanding of SUD-related stigma within the Iranian healthcare system remains limited. A comprehensive, multiphase study employing a mixed-methods approach is needed to systematically assess the experiences of Iranian people who use drugs regarding stigma and to develop evidence-based guidelines and strategies for reducing stigma and discrimination against individuals with SUDs at PATCs. The importance and the impact of stigma and discrimination related to SUDs within Iranian culture as well as the influence of cultural differences on patients’ healthcare-seeking attitudes and the support services provided by the healthcare system, form the foundation of this mixed-method study. Given these considerations, it is imperative to address cultural factors associated with substance use disorders and the stigma stemming from substance consumption in Iranian society. This is because the cultural, economic, and social variations across different societies warrant an examination of human experiences within each unique cultural context. Therefore, the aim of this study is to explore comprehensive and culturally sensitive strategies in order to reduce addiction-related stigma and discrimination at PATCs.

The study aims

This mixed-methods study aims to identify strategies to reduce stigma and discrimination against Iranian people who use drugs at PATCs. The specific objectives of the study can be categorized into three phases as follows:

To measure the perceived stigma score among people with substance use disorders (SUDs) who were referred to PATCs in Mazandaran, Iran.

To evaluate professionals’ attitudes towards people with SUDs receiving treatment at PATCs in Mazandaran, Iran.

To measure the social distance score towards people with substance use disorders seeking treatment at PATCs in Mazandaran, Iran.

To examine the relationship between socio-demographic characteristics and perceived stigma among individuals with substance use disorders.

To investigate the relationship between perceived stigma, social distance, and professionals’ attitudes toward people with SUDs.

To explore the perspectives and experiences of people who use drugs concerning the various aspects and determinants of stigma and discrimination stemming from the community, healthcare centers, or PATCs due to drug use.

To examine healthcare providers’ perspectives on stigma against individuals who use drugs.

To develop evidence-based cultural strategies aimed at diminishing stigma and discrimination at PATCs against Iranian people who use drugs faced health challenges.

Study design

This study will employ a mixed-methods technique with an explanatory sequential approach for data collection and analysis. Grounded in pragmatic principles and logic, the mixed-methods paradigm combines quantitative and qualitative methodologies to provide a comprehensive understanding of the research questions. In this methodology, the researcher first gathers quantitative data to identify patterns or trends requiring further exploration. Subsequently, qualitative data are collected from individuals who can offer insights to enhance the understanding and interpretation of the quantitative findings [ 84 ]. According to this paradigm, merging qualitative and quantitative methods results in a deeper comprehension of the issue [ 85 , 86 ].

This study will be conducted in three phases. The first phase will be a quantitative study, during which, quantitative data will be gathered. The second phase of this project will be a more detailed exploratory qualitative study of participants’ experiences regarding SUD-related stigma toward and discrimination against people who use drugs at PATCs. At the end of the second phase, the qualitative and quantitative findings will be integrated. The third phase of the study will involve the development of evidence-based and culturally sensitive strategies based on a literature review, the results of Phases 1 and 2, and experts’ opinions using the nominal group technique (NGT) (Fig.  1 ). Full explanations of each part of the study are provided below.

Study visual diagram

Phase 1: quantitative study

The quantitative phase will be a descriptive-analytic cross-sectional study conducted among Iranian people with SUDs living in Mazandaran, Iran. In this phase, we will assess perceived stigma experiences and their relationship with social distance, perceived dangerousness, experts’ discrimination or acceptance, and sociodemographic characteristics among the participants. The target population will consist of people who are referred to PATCs in Mazandaran, Iran. The Perceived Stigma of Addiction Scale (PSAS), Health Professionals’ Attitude Towards Substance Abusers Scale (HPA-SAS), and Social Distance Scale (SDS) will be used. These scales will be validated for use among Iranian people.

Sample size and sampling method

There is no shortage of research on stigma toward and discrimination against people with SUDs at PATCs and other health-care settings in Iran. Therefore, the sample size is calculated based on Matsumoto’s study [ 87 ]. Following Matsumoto et al. [ 87 ], the calculated sample size is 240, based on the largest standard deviation related to the sub dimension of stigma (SD = 12.39), with a precision (d) of 0.05 around the mean (m = 35.01), and α = 0.05. In most cases, the design effect’s numerical value is about 1.5–2. In this study, we will apply 1.5, and the final sample size will be increased to 360 substance users, based on cluster sampling.

For this project, fifteen PATCs in Mazandaran will be selected. A cluster sampling method will be employed, with each cluster comprising a comparable number of respondents. Mazandaran will be divided into three areas (west, central, and east). All PATCs within these areas will be enumerated, and five PATCs will be randomly chosen from each area. Individuals with SUDs who are referred to the PATCs will be invited to participate in the project.

The participants will be offered comprehensive explanations of the goals and methods of the research. The sociodemographic questions, the PSAS, HPA-SAS, and SDS will be administered in a “quiet setting” [questionnaire will be presented while maintaining patient privacy] by a research group member and then collected in person. The investigator will fill out the scales to ensure that the same data collection method is used for all individuals. Informed consent will be obtained from the individuals prior to the data collection.

Inclusion criteria

Individuals will be eligible for the current project if they are adults (aged 20 years or older), reside in Mazandaran province, have a history of any kind of substance use, and have no severe mental difficulties that prevent them from answering the items in the questionnaires.

Exclusion criteria

The exclusion criteria for participants will be: having a mental disability, having psychiatry history like active bipolar disease, depression with psychosis, or schizophrenia, being deaf or mute, showing unwillingness to continue participating in the study, and not fully completing the questionnaires.

Questionnaires and data collection

Quantitative data will be collected utilizing sociodemographic variables and the PSAS, HPA-SAS, and SDS scales. The sociodemographic section will include questions on age, gender, occupation, duration of employment, and education. The PSAS comprises eight items to measure the perceived stigma towards individuals with substance use disorders. Initially developed and validated among patients undergoing treatment for substance use–related issues in the United States [ 88 ]. he items were adapted from a study conducted by Link and colleagues on perceived discrimination-devaluation processes, Content validity was established through review by stigma professionals in the substance use field the PSAS was related to adopted shame, self-concealment, adopted stigma, and depression [ 89 ]. The PSAS employs a four-point Likert scale ranging from “strongly disagree” to “strongly agree” for participants to rate their agreement or disagreement with each item. Scores range from 8 to 32, with higher scores indicating greater perceived stigma. The PSAS has demonstrated good reliability, with a Cronbach’s alpha of 0.71 and a reliability coefficient of 0.79 based on the test-retest method in American society [ 88 ]. In an Iranian study, the reliability of the PSAS was found to be 0.85, with a test-retest correlation coefficient of 0.81 [ 90 ].

The HPA-SAS consists of 10 items, with questions addressing the attitudes and/or views of health professionals toward people with SUD, their knowledge of addiction, and their training in substance use. The constructs of attitudes will focus on discrimination and acceptance towards people who use drugs. The HPA-SAS was developed utilizing a Likert scale format, with each item offering four response options: (1) strongly disagree (2), disagree (3), agree, and (4) strongly agree, resulting in total scores ranging from 10 to 40. The validity and reliability of the HPA-SAS were established through research conducted by a team of psychological counseling and medical care professionals. The overall Cronbach’s alpha of the original HPA-SAS has been reported as 0.79 [ 91 ]. In this study, the validity and reliability of the questionnaire were assessed prior to data collection with a sample of Iranian people who use drugs. The overall Cronbach’s alpha of the HPA-SAS was found to be 0.76, and the test–retest correlation coefficient of this scale was 0.74.

The seven-item SDS, which was created by Bogardus et al. (1925) [ 92 ] and then modified by Link et al. (1987) [ 89 ], measures the social distance that interviewees wish to keep toward a person with a particular condition (diverse social, ethnic, or racial backgrounds). This scale focuses on respondents’ willingness to engage in a relationship with someone who is dependent on illegal substances. In particular, it measures people’s willingness to take part in a variety of social contacts with a particular group. The SDS consists of seven items presented as multiple-choice questions, which assess social distance by probing the respondent’s willingness to engage in various social interactions with stigmatized individuals: These interactions include scenarios such as being a sub-lessee, neighbor, co-worker, spouse of a family member, caretaker of one’s child, and member of the same social group. Participants will be asked to rate their level of willingness or unwillingness for each item using a four-point Likert scale with the following options: (0) definitely willing [ 1 ], willing [ 2 ], unwilling, and [ 3 ] definitely unwilling. The total score ranges from 0 to 21; scores higher than the mean identify higher social distance. The overall Cronbach’s alpha of the original SDS is 0.75 [ 89 ]. The Iranian version of the SDS has found to have a Cronbach’s alpha value of 0.92. The test–retest reliability coefficient for the SDS was 0.89, and the content validity coefficient was 0.75 [ 90 ].

Data analysis

The data from the first phase of the study will be analyzed using SPSS Statistics Version 26.0 for Windows (IBM Inc., Armonk, NY, USA). In the cross-sectional phase, descriptive statistics will be applied to describe the sociodemographic factors and perceived stigma of addiction, experts’ attitudes toward people with SUD, and social distance. Univariate analytical statistics will be used to test the correlation between the sociodemographic variables and perceived stigma, experts’ attitudes toward people with SUD, and social distance. Variables with a correlation of p  < 0.1 in the univariate analysis will be included in the multivariable logistic model. All statistical tests will be two-tailed, and a p -value < 0.05 will be considered statistically significant. To ensure data quality during this phase of the study, measures such as double data entry and range checks for data values will be implemented.

Phase 2: qualitative study

In Phase 2, an exploratory qualitative study will be conducted utilizing a conventional content analysis method to explore the experiences of people who use drugs regarding stigma and discrimination stemming from the community, health-care centers, or PATCs as a result of drug use. Additionally, this phase will aim to gain insight into healthcare providers’ perspectives on stigma against people who use drugs in greater detail. Given the objectives of the project’s qualitative phase, employing this method will enable the investigator to gain a comprehensive understanding of the situation, facilitating the clarification of the impact of stigma and discrimination on Iranian people who use drugs at PATCs.

Participants and sampling method

A purposive sampling approach will be used in the second phase of the study. The target population will consist of two groups of people, namely, those who have experienced drug use and staff members at PATCs. The first group of participants (people who use drugs) will be selected from those willing to participate in the quantitative phase of the study and will be based on the mean total score of the stigma experience, which will be collected in Phase 1 of the study. People with 10% upper and lower stigma experience scores will be selected as extreme cases, and will be retained for the next phase. We will seek to interview people with either a stigma or discrimination experience in order to collect more comprehensive information about their stigma experiences and its related factors. Efforts will be made to have variety in terms of gender, level of education, religion, age, socioeconomic situation, and the use of different types of drugs.

The second group of participants will consist of health-care workers and providers at PATCs. This sample will include agents from (i) PATC management, (ii) clinical and medical teams, (iii) health-care program teams and (iv)others according to the setting (e.g., finance). Health-care workers will be enlisted using purposive sampling methods. Four of them will be contacted through education programs with a specific focus on staff involved in drug treatment. The retained persons will be invited to register, and a member of the research team will be in touch to schedule an interview. Health-care workers in specific treatment centers will also receive direct invitations from the investigation team.

Data analysis will commence after the first interview, focusing on elucidating the intricacies and interactions among key concepts and categories derived from the exploration of the primary data. Consequently, the selection of participants will persist until theoretical saturation is achieved, ensuring a comprehensive understanding of the relationships between the study concepts and components [ 93 ]. In the current study, sampling will continue until the investigator determines that no further data can be garnered through data analysis and coding, signifying theoretical saturation. However, it is recommended by experts that a minimum of 12 participants be interviewed for a qualitative study to ensure a robust and comprehensive analysis [ 94 ].

Data collection

Data will be collected by two methods: in-depth interviews with individuals with SUDs and focus group discussions with PATC staff members.

Semi-structured, in-depth interviews

Individual, in-depth, semi-structured interviews featuring open-ended questions will be employed to gather data. These interviews will focus on exploring participants’ perspectives and experiences related to stigma and discrimination against individuals with (SUDs within healthcare settings. The target group for this part of the study will consist of people who use drugs who have been referred to PATCs in Mazandaran, Iran. Before the qualitative phase of the study, the interview protocol questions will be prepared based on the results of the first phase of the study as well as the literature review. Interviews will be held in locations, such as clinics, where respondents will feel safe and relaxed. All individual in-depth interviews will be recorded using a digital tape recorder after the applicant’s permission. In addition to the audio recordings, the interviewer will take notes. If participants decline to be audio-recorded, only notes will be employed for data gathering. Furthermore, non-verbal cues, such as facial expressions, tone of voice, and the respondents’ state, will also be noted by the interviewer, together with the date and place of the interview.

All interviews will be conducted by the first author of this study, who is familiar with qualitative research methods and the topic, and who has conducted similar studies on addiction,. Participants will be encouraged to discuss their experiences related to strategies to reduce addiction-related stigma and discrimination in public addiction treatment centers. Further, they will be encouraged to discuss sociocultural and ecological components that might have had an effect on the level of using these strategies in this regard.

The interviews will be focused on the following three main questions:

How was the experience with stigma toward and discrimination in health-care settings?

What strategy and procedure have they applied to reduce and cope with stigma and discrimination in health-care settings?

How have the strategies and procedures affected their coping strategies in this regard?

Based on the responses to these questions, follow-up questions will be asked. After each question, participants will be invited to explain more thoroughly their answer, by probing questions such as “What do you mean?” or “can you explain this more”.

Interviews will be performed during a single meeting with each participant and is estimated to last between 40 and 60 min, although this can differ slightly based on the experiences of each participant. The investigator will start with explaining the significance of the study in order to gain their confidence. All interview questions will be reviewed after the first interview, and all interviews will be taped. Data collection will be continued until saturation is reached.

Focus group discussions

Following semi-structured interviews, the principal researcher (first author), who is an expert in qualitative studies, an expert in qualitative studies, will conduct focus group discussions with staff members at Patients with Substance Use Disorders Treatment Centers (PATCs), which comprise the second target group of this phase of the study. These focus group discussions aim to validate the emerging themes from the individual interviews and gain deeper insights into the identified themes. The focus group discussions will be guided by the two main research questions: (i) What is providers’ understanding of stigma towards and discrimination against persons with SUDs? and [ 2 ] What are the providers’ opinions regarding a response to stigma and discrimination? Furthermore, more detailed investigative questions will be incorporated, such as: What types of SUDs do your clients typically present with? Are there any other community-level factors that could influence experiences of stigma and discrimination against individuals with SUDs?

Immediately following data collection, the coding process will be initiated, and the data will be analyzed. The main themes will be identified using a conventional content analysis method of Graneheim and Lundman [ 95 ], in which themes and subthemes are identified to reveal participants’ perceptions and experiences toward stigma and discrimination against Iranian people who use drugs at PATCs. This process will employ inductive reasoning, which introduces concepts and categories via a detailed exploration of the data by the researcher.

In Graneheim and Lundman’s method, qualitative content analysis addresses the obvious content of an interview, along with explanations of content that can be construed or added from the interview but are not obviously detailed in the transcript [ 95 ]. Further, coding classifications are derived directly from the transcription data. Without laying on preset themes or prior theoretical opinions to categorize extracted codes from interviews, the conventional content analysis method is a suitable technique for advancing coding categorizations from the raw interview transcripts.

In this method, data analysis begins with a comprehensive reading of the entire text to ensure a thorough understanding. Subsequently, the text is examined word by word to extract codes, initially identifying specific words that may encapsulate the main concepts. These texts are derived from notes documenting the initial opinions of the interviewees and the preliminary analysis conducted. Codes that are indicative of more than one main thought are tagged and then categorized based on their dissimilarities and similarities. The greatest benefit of a conventional content analysis is attaining data directly from the study without imposing preplanned and defined categories, themes, or theories. However, one problem with this kind of analysis is that it interjects with other qualitative methods (i.e., grounded theory or phenomenology). While these approaches share similarities with initial analysis, they are emphasized for their relevance to theory advancement. Additionally, they hold significance for model development. To evaluate the trustworthiness of the results in this phase of the study, four criteria —reliability, portability, credibility, and verifiability— will be employed [ 96 ]. MAXQDA software will be used for data processing.

Phase three: integration of quantitative and qualitative data and the development of strategies

In this phase, cultural evidence-based strategies aimed at reducing stigma and discrimination associated with substance use of Iranian people at PATCs will be developed This will involve integrating insights from the literature review, the findings of the preceding study phases, and input from experts. The target group for this aspect of the study will comprise PATC experts residing in Mazandaran, Iran.

Upon completion of the second phase of the study, the quantitative and qualitative results will be merged to glean additional insights that will inform the design and implementation of appropriate strategies to mitigate stigma and discrimination against individuals with SUDs at PATCs. Three techniques can be employed to integrate the quantitative and qualitative findings: combining the data into a discussion, utilizing a matrix for combination, or employing a side-by-side display and transformation. n this study, the data will be combined into a discussion format. Some researchers often commence this approach with a section outlining the quantitative findings, followed by a section detailing the qualitative findings. Alternatively, researchers may present the quantitative findings while substantiating claims with quotes extracted from them. Another less common technique involves initially presenting the quantitative results and subsequently confirming and validating them with descriptive qualitative findings [ 97 , 98 ].

To develop strategies for reducing stigma and discrimination against people who use drugs at PATCs, the research team will start with formulating guidelines after a comprehensive review of the available literature. Systematic review and interventional studies will be conducted to find approaches. The search will encompass English-language databases (including Cochrane Library, APA PsycNET, MEDLINE, Web of Science, Embase, Scopus, ProQuest) as well as Persian databases (such as Magiran, Irandoc, SID, and Barakat). No restrictions will be imposed, particularly with regard to publication dates, to ensure comprehensive coverage of relevant studies. A uniform search strategy will be applied across all databases, utilizing the intersection of three fields via the Boolean AND operator. To define search terms, the Medical Subject Headings (MeSH) dictionary will be referenced. Upon identification of relevant documents, their quality will be assessed using the GRADE approach, followed by evidence analysis. Insights gleaned from the literature review will also be incorporated. Subsequently, the recommended strategies developed will be offered to Nominal Group Technique (NGT) experts.

NGT will be applied will be employed to devise and implement effective strategies aimed at diminishing stigma and discrimination against individuals with SUDs at PATCs. NGT is a structured, group-based method utilized to achieve consensus. Participants are encouraged to independently generate viewpoints based on predetermined and organized questions facilitated by a moderator [ 99 ]. To initiate the NGT process, primary strategies will be extracted from the findings of the first and second phases of the study, in addition to insights gathered from a literature review and examination of relevant rules and regulations A meeting will then be held with the experts who must meet the inclusion criteria of being residents of Mazandaran, Iran, possessing a minimum of one year of relevant work experience, having comprehensive familiarity with Iranian culture and customs, and being employed in a clinic associated with the treatment of people who use drugs. During this meeting, specialists will be invited to share their opinions on the developed strategies in relation to the key study questions, with all ideas and suggestions being meticulously recorded. Subsequently, these suggestions will be organized and prioritized to formulate consensus-driven strategies for effectively reducing stigma and discrimination against Iranian individuals with SUDs.

Ethical approval

The Ethics Committee of the Mazandaran University of Medical Sciences in Mazandaran, Sari, Iran, has approved the protocol for the present study [code number: IR.MAZUMS.REC.1401.192]. Informed written consent will be obtained from all participants during the quantitative and qualitative stages. Participants will be assured of the confidentiality of their data and identities. Additionally, they will be informed that they have the right to withdraw from the project at any phase of the intervention, and that their decision to refuse participation at any time will not impact or alter the quality of services provided to them.

The study is still ongoing, and no results have yet been generated. We will wait until the completion of our first data collection before disseminating any findings.

This article outlines the protocol for a mixed-method study aimed at identifying and formulating appropriate strategies to mitigate addiction-related stigma and discrimination at PATCs. The study will offer comprehensive insights into the stigma encountered by a cohort of Iranian people who use drugs and the factors influencing their experiences. The findings of this study will be utilized to develop and implement culturally tailored strategies geared towards reducing stigma and discrimination associated with substance use among Iranian people who use drugs attending PATCs.

While stigma and discrimination linked with drug addiction is a global concern, their nature and expression are contingent upon the religious, social, and cultural frameworks prevalent in various societies. Operating as a multilevel phenomenon, stigma arises when harm resulting from unfavorable status, labeling, or discrimination transpires within a power structure that perpetuates and reinforces social inequalities among those labeled [ 100 ]. Stigma toward substance use can profoundly impact an individual’s social and personal connections, often resulting in feelings of worthlessness. Such stigma may provoke negative responses and behaviors from various organizations and individuals towards the affected person [ 101 , 102 ]. These behaviors can impede access to treatment for individuals with substance use disorders. Moreover, they contribute to social, financial, and health discrimination within these communities, fostering the perception that individuals with SUDs are undeserving of the opportunity to address their condition [ 103 ].

Stigma significantly impacts the spectrum of care for individuals with SUDs, influencing aspects such as treatment seeking, preference, maintenance, and adherence, consequently leading to poorer health outcomes within this population or ever, stigma may exacerbate disparities in accessing medical and health services, as individuals with SUDs may be hesitant to pursue and adhere to health-oriented measures [ 104 ].

Studies evaluating the stigma experiences of persons with SUDs are mainly qualitative in nature [ 21 , 52 , 62 , 98 , 105 , 106 ]. The present study will be one of the few studies addressing addiction-related stigma in Iran that applies a mixed-methods technique to identify suitable strategies to reduce addiction-related stigma and discrimination at PATCs from the perspective of Iranian people who use drugs. It is expected that the current work, by using quantitative and qualitative methods, will offer valid data regarding suitable cultural strategies to reduce stigma against persons with SUDs at health-care and treatment centers.

The findings of the current study hold potential significance for healthcare specialists and policymakers shedding light on the pivotal role of cultural strategies in mitigating stigma against individuals with SUDs within healthcare and treatment settings employing a culturally sensitive approach Furthermore, the study aims to elucidate the needs of individuals with SUDs and provide insights into the factors influencing addiction-related stigma that require attention. Effective strategies emerging from this research may encompass interventions geared towards enhancing the health outcomes of Iranian people who use drugs and their families, as well as those from other nationalities and countries sharing similar cultural contexts with Iran. Additionally, the study’s findings are anticipated to inform stigma-reduction education and healthcare support initiatives tailored to the Iranian population, underpinned by a culture-based approach.

Potential strengths of the study

This study has several advantages. The results will potentially fill some of the gaps in research on people with SUDs who encounter stigma and discrimination at PATCs thus holding significant clinical implications. By employing a mixed-methods approach, this study facilitates the integration of diverse approaches and methodologies. The collection of both qualitative and quantitative data will provide a comprehensive understanding of. People who use drugs’ experiences of stigma and discrimination at PATCs. Moreover, the qualitative component of the study involves various participants directly or indirectly associated with this phenomenon, including individuals with SUDs and staff/clinicians. Conducting interviews with substance users and clinicians will enable a deeper understanding of how the phenomenon is perceived by those directly affected by stigma/discrimination, as well as by individuals closely involved in the patients’ daily lives and clinicians, who play a crucial role in both the phenomenon and its treatment.

Potential limitations of the study

The researchers acknowledge several limitations in the current study although the developed strategies will be evaluated upon achievement to ascertain their suitability and effectiveness, detailed descriptions will be necessary to design appropriate interventions and allow for generalization in similar contexts. One limitation is related to the sampling, which will be conducted in only one province in Iran. To mitigate this weakness, we will try to use maximum variation in the study phases. Another limitation is the possibility that the participants will not cooperate and drop out before the end of the study. Additionally, the scarcity of research and literature reviews regarding the stigma experienced by this population at PATCs poses a challenge. Furthermore, there is limited available data on how stigma varies among different subgroups, such as based on gender, race, religion, or socioeconomic status. These limitations will be considered during the interpretation of the study results and may influence the generalizability of findings to broader contexts.

The stigma and discrimination faced by individuals’ with SUDs experience persist not only in the community but also within PATCs, and medical settings. This Stigmatization adversely affects the accessibility and acceptability of care, as the lack of anonymity limits the willingness of this population to seek SUD treatment. The present study aims to provide comprehensive insights into the development of appropriate strategies to reduce addiction-related stigma and discrimination at PATCs. By incorporating evidence-based practice principles, insights from people who use drugs’ experiences, and input from PATC staff, these strategies can offer valuable guidance for healthcare professionals, policymakers, and managers seeking to enhance the quality of care for individuals with a history of drug use worldwide. Furthermore, the strategies developed may serve as a blueprint for adapting interventions for patients with SUDs in various settings, including other healthcare treatment centers, clinics, and within the broader public community.

Data availability

Not applicable.

Abbreviations

substance use disorder

public addiction treatment centers

Perceived Stigma of Addiction Scale

Professional’s Discrimination, Acceptance, Attitude, and Training toward Substance Abusers

Social Distance Scale

focus group discussions

screening, brief intervention and referral to treatment

in-depth interviews

nominal group technique

standard deviation

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Maryam Khazaee-Pool & Seyed Abolhassan Naghibi

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MK designed the project, and will collect and analyze the data. Mk wrote the first draft of this manuscript. TP and SAN will participate in the analyses of data. MK and KP critically revised the final version of this article. All authors read and approved the final manuscript.

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Khazaee-Pool, M., Naghibi, S.A., Pashaei, T. et al. Developing practical strategies to reduce addiction-related stigma and discrimination in public addiction treatment centers: a mixed-methods study protocol. Addict Sci Clin Pract 19 , 40 (2024). https://doi.org/10.1186/s13722-024-00472-8

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Unused, expired pharmaceuticals and their disposal practices among the general public in Burdur-Türkiye: a cross-sectional study

• Serkan Köksoy 1  

BMC Public Health volume  24 , Article number:  1303 ( 2024 ) Cite this article

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Unused pharmaceuticals are currently a public health problem. This study aimed to identify unused pharmaceuticals, research practices about the disposal methods, classify the medicines according to Anatomical Therapeutic Chemical codes (ATC) and, to determine the number of unused medicines.

The study was designed as a cross-sectional study. Data were collected between April and August 2023 in Burdur-Türkiye by non-probability sampling technique (convenience method). Pharmaceuticals were classified according to ATC. Statistical Package for Social Science SPSS (V.24) package program was used for data analysis.

A total of 1120 people, 1005 in the first sample group and 115 in the second sample group, participated in the study. Findings of first sample group: A total of 4097 boxes of unused pharmaceuticals (4.7 ± 4.3 boxes/per capita) were detected. It was found that pharmaceuticals were stored in areas such as kitchens (59.1%) and refrigerators (38.6%), the reason for keeping them was reuse (41%), and the disposal practice was household garbage (81%). Paracetamol (648 boxes), Other cold preparation (303 boxes), Dexketoprofen (239 boxes), Diclofenac (218 boxes), Amoxicillin and beta-lactamase inhibitor ( 190 boxes) were found to be the most frequently unused pharmaceuticals. Using the unused medicines at home without consulting a physician was 94.1% (self-medication). Findings of second sample group: Of the 6189 dosage forms in 265 boxes pharmaceutical, 3132(50.6%) dosage forms were used and 3057(49.4%) were found to be unused.

There is a significant amount and number of unused medicines in households, and self-medication is common. Medicines are not properly disposed of and some of them expire. Public information is needed. A “drug take-back system” for unused medicines can be useful in solving this problem.

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Introduction

Drugs are agents used in the treatment of diseases and are prescribed by physicians based on the patient’s diagnosis. For home treatment, medications prescribed by physicians are obtained from the pharmacy and used for treatment. However, patients may prematurely discontinue home drug treatment for various reasons. The main reasons for early discontinuation include the early recovery from disease, a change in diagnosis, a decrease in or loss of faith in the treatment, side effects of the medication, and the patient non-compliance with treatment, among others [ 1 ]. When the patients discontinue drug treatment for any reason, they may contribute to the accumulation of unused medicines in the household. The unused pharmaceuticals that accumulate in the household can be reused at different times to alleviate the symptoms of various diseases, can be given to another person, or kept on hand until the expiration date [ 2 ]. If there is lack of knowledge about the medicines that accumulate in the household, the expiration dates of the medicines may expire, which can lead to health problems when these medicines are used [ 3 ].

Several epidemiological studies have been conducted on unused pharmaceuticals. In a study conducted in Saudi Arabia, it was reported that about half of the participants accumulated unused pharmaceuticals in their households, the main reason for accumulation was to cure illness, they disposed of the pharmaceuticals by throwing them in the garbage, and a significant number of participants were uneducated about pharmaceutical disposal practices [ 4 ]. In a study conducted by Woldeyohanins et al. (2021), it was reported that more than half of the participants had unused pharmaceuticals in their homes, about 59.2% checked the expiration date, and the household trash can was used as a method of pharmaceutical disposal practices [ 5 ]. In a similar study, people were reported to have unused medicines at homes, to store them because they might need them later, and to dispose of them inappropriately [ 6 ].

While this is the case in the general public, similar findings have been reported among student in health professions (medicine, nursing, pharmacy, etc.). For example, a previous study reported that 95.7% of pharmacy students had unused medications, some of which were expired and not properly disposed [ 7 , 8 ]. Improper disposal of pharmaceuticals posed an environmental hazard. The presence of pharmaceutical waste in wastewater treatment plants was indicative of this problem. A study reported that pharmaceutical metabolites and active ingredients were detected in drinking water facilities, even if at low levels [ 9 ].

There are numerous studies in the literature on unused medicines. These studies summarize data from different countries, cultures, geographies, and levels of development. In generel, these studies categorize the unused medicines by mechanism of action (antibiotics, analgesics, etc.) rather than by Anatomical Therapeutic Chemical classification (ATC). In addition, it has been observed that the number of studies reporting the amount of used and unused medicines is extremely limited. This gap in the literature needs to be addressed. Therefore, this study aimed to identify unused medications, classify them according to the ATC, research participants’ practices about these medications, and determine how much of medications such as tablets, capsules and dragees with a given quantity are used and how much is unused.

Study design

The study was designed as a cross-sectional study. Data were collected between April 1 and August 31, 2023 in Burdur-Türkiye. This study consists of two sample groups, the first sample group and the second sample group. The data of both groups were collected by a non-probability sampling technique (convenience method). While the online method (Google form) was used to collect the data in the first sample, the face-to-face method was used in the second sample. For first sample size, proportionally based sampling with the double design effect method was used. For second sample size, certain percentage of the calculated number of participants in the first sample group was taken as a basis. The purpose of the second sample was to determine the quantity of unused pharmaceuticals, to strengthen the findings and to enhance the literature. For some reasons, the data collected from the first sample were not collected from the second sample (Private life/privacy, protection of personal data, difficulty of voluntary participation, similar personal characteristics.etc.).

Participant criteria

Participant criteria were determined to participate in the study. These were determined as not having any chronic disease at the time of data collection and not taking medication for any disease, having appropriate equipment for online data (computer, smartphone, tablet), living at home due to the question types, being literate (for face-to-face data collection), not being given partial or incomplete information, being above the age of 18 years and giving consent. Participant exclusion criteria were defined as not having the above-mentioned conditions and not having unused medicines.

First sample size

A formula ( n = Z 2 x p(1-p)/d 2 x DEFF ( n: sample size, Z:confidence interval, p:expected proportion, d:margin of error and DEFF: design effect) ) was used to calculate this sample size [ 10 ]. According to this formula ( 1.96 2  × 0.5(1–0.5)/0.05 2  × 2n=754 × 0.1 ), it was needed that at least 830 people participate in the study. Sociodemographic data, practices on unused medicines, disposal methods, number of unused medicines and generic names of medicines were collected from these sample group.

Second sample size

For the quantity analysis, 10% ( n  = 83) of the first sample size ( n  = 830) was taken as a basis [ 11 ]. Only the generic name of pharmaceutical and quantity of unused drugs (dosage forms) were collected from this sample.

As a result, it was calculated that at least 913 people participated in the study.

Data collection tool

Since the research consisted of two separate sample groups, two separate forms were used. The data collection form collected from the first sample included the sociodemographic characteristics of the participants, their practices about unused drugs, disposal method, generic names of drugs and the number of unused drugs. In the second sample group data collection form, only data on the quantity of unused medicines such as tablets, dragees and capsules were collected.

Description of unused drug: It is called the leftover part of the drug after treatment. This description was sent as a video to the group for online data collection. It was explained verbally to the face-to-face data collection group.

The data collection form of the first sample group

In order to obtain data from the first sample group of the study, a questionnaire was developed based on the questions of previous studies [ 11 , 12 , 13 , 14 ]. The content of this form includes socio-demographics, practices about on unused medicines, disposal practices, number of unused medicines and generic names of medicines. The data collected through this form were collected online by using a Google form. The Google form was turned into a link. This link and the explanation video of the research (purpose, participant criteria, data filling examples, etc.) were sent to people as text messages via WhatsApp. In particular, groups with a large number of people registered (groups such as school, work, etc.) were targeted.

The data collection form of the second sample group

This was a data collection form in which quantity of unused medicines in the medicines box (tablets, dragees, capsules, etc.) was recorded. The number of dosage forms of these medicines was obtained by simple subtraction (Number of dosage forms of unused medicines = number of dosage forms of medicines - number of dosage forms of medicines used). Data used for quantity analysis were collected face-to-face by using a written data collection form.

Classification of Pharmaceuticals

Pharmaceuticals were classified according to the ATC/DDD Index 2023. This index is a very useful resource published by WHO and WHO Collaborating Centre for Drug Statistics Methodology and includes Anatomical Therapeutic Chemical (ATC) classification, Defined Daily Dose (DDD) values, codes [ 15 ].

Data Analysis

SPSS (V.24) package program was used for data analysis. Descriptive parameters were summarized as (n) and percentage (%) where relevant [n(%)]. Mean (X̅) and standard deviation (S) were summarized as X̅±S. The relationship between the number of pharmaceuticals in the households and sociodemographic variables was tested with non-parametric tests (Mann Whitney U, Kruskal Wallis, Tamhanes T2). Statistical significance level was taken as p  < 0.05.

A total of 1172 people participated in the study, 1057 in the first sample group (52 people were excluded) and 115 in the second sample group. The study was completed with 1120 participants.

The findings of the first sample group ( n  = 1005)

Some people data were not included in the study due to exclusion criteria ( n  = 24, 2.3%). The number of people with unused pharmaceuticals was found to be 28(2.6%) (97.4% of participants have unused medicines). Therefore, study was completed with 1005 participants (Age mean 36.9 ± 12.3 years). A total of 4097 boxes of unused pharmaceuticals were observed (4.7 ± 4.3 boxes/per capita).

When evaluating the number of unused pharmaceuticals and the sociodemographic characteristics of the participants ( n  = 1005), no statistical difference was observed in gender variable ( p  = 0.089). However, statistical differences were observed in marital status (lower in singles), place of residence (lower in rural areas), and economic status (Income < Expense) ( p  < 0.001, p  < 0.001, p  < 0.001, respectively) as shown in Table  1 .

It was found that the options of kitchen (59.1%) as the room where pharmaceuticals were kept at home, refrigerator (38.6%) as the place where pharmaceuticals were stored, family health center (42.2%) as the health facility where most pharmaceuticals were prescribed, reuse (41%) as the reason for keeping pharmaceuticals in household, family physician (48.7%) as the specialty branch where most pharmaceuticals were prescribed, were selected more than other options. The options of checking the expiry date of pharmaceuticals (72.1%), reading the package insert (56.7%) and not buying pharmaceuticals without a prescription (58.7%) were more chosen ones by the participants. Keeping pharmaceuticals in household until the expiry date (44.6%), throwing expired pharmaceuticals in the garbage (81%), thinking that improper disposal of pharmaceuticals pollutes the environment (74.8%), and The Ministry of Health is responsible for raising awareness on medicines (41.7%) were the options that were more frequently marked by the participants. Using the unused medicines at home without consulting a physician was 94.1% (self-medication). (Table  2 ).

The most unused drugs by ATC class were Lansoprozole, Folic Acid, Propranolol, Other Cicatrizants, Levothyroxine Sodium, Amoxicillin and beta lactamase inhibitor, Dexketoprofen, Paracetamol, Metronidazole, Other Cold Medicines . In terms of number of boxes, it was “ Paracetamol, Other Cold Medicines, Dexketoprofen, Diclofenac, Amoxicillin and beta lactamase inhibitor, Pseudoephedrine combination, Lansoprazole and Acetylsalicylic acid ” (Table  3 ).

n = number of pharmaceuticals (box), %=percentage of the number of pharmaceuticals. Pharmaceuticals with fewer than 10 were given as “others” in the table. Pharmaceuticals in the Others section was summarized separately as ATC name, ATC code and number of pharmaceuticals (For example: Zinc sulfate(A12CB01):9). A-Others( n  = 80):Benzidamine(A01AD02):9, Lactulose(A06AD11):9, Zinc sulfate(A12CB01):9, Nifuroxazide(A07AX03):8, Tioctic acid(A16AX01):7, Pinaverium(A03AX04):6, Sodium fluoride(A01AA01):6, Famotidine(A02BA03):5, Orlistat(A08AB01):3, Rabeprazole(A02BC04):3, Multivitamins and other minerals, incl. combinations(A11AA03):2, Otilonium bromide(A03AB06):2, Multienzymes(lipase, protease etc.)(A09AA02):2, Dexpanthenol(A11HA30):1, Domperidone(A03FA03):1, Glibenclamide(A10BB01):1, Glibornuride(A10BB04):1, Glycerol(A06AG04):1, Magnesium hydroxide(A02AA04):1, Mebeverine(A03AA04):1, Various(A01AD11):1, Pyridoxine(A11HA02):1. B-Others( n  = 24):Cyanocobalamin(B03BA01):8, Ferrous amino acid complex and folic acid(B03AD01):7, Clopidogrel(B01AC04):3, Ticagrelor(B01AC24):1, Apixaban(B01AF02):1, Tranexamic acid(B02AA02):1, Ferrous glycine sulfate(B03AA01):1, Ferrous fumarate(B03AA02):1, Cyanocobalamin, combinations(B03BB51):1. C-Others( n  = 46):Doxazosin(C02CA04):7, Rosuvastatin(C10AA07):6, Candesartan(C09CA06):4, Nebivolol(C07AB12):3, Amlodipine(C08CA01):2, Captopril(C09AA01):2, Lercanidipine(C08CA13):2, Digoxin(C01AA05):2, Atenolol(C07AB03):1, Benidipin(C08CA15):1, Calcium Dobesilat(C05BX01):1, Organo-heparinoid(C05BA01):1, Hydrocortisone(C05AA01):1, Quinapril and diuretics(C09BA06):1, Lisinopril(C09AA03):1, Losartan and diuretics(C09DA01):1, Olmesartan mdeoxomil and amlodipine(C09DB02):1, Pentoxifylline(C04AD03):1, Pitavastatin(C10AA08):1, Other preparations, combinations(C05AX03):1, Spironolactone(C03DA01):1, Hydrochlorothiazide combinations(C03AX01):1, Torasemide(C03CA04):1, Trimetazidine(C01EB15):1, Valsartan and diuretics(C09DA03):1, Zofenopril(C09AA15):1. D-Others( n  = 51):Silver sulfadiazine(D06BA01):8, Centella asiatica herba(D03AX14):7, Carbamide combinations(D02AE51):5, Clobetasol(D07AD01):3, Oxytetracycline(D06AA03):3, Sertaconazole(D01AC14):3, Terbinafine(D01BA02):3, Diphenhydramine(D04AA32):2, Nadifloxacin(D10AF05):2, Wart and anti-corn preparations (D11AF):2, Acyclovir(D06BB03):1, Other antibiotics for topical use (D06AX):1, Betamethasone(D07AC01):1, Butenafine(D01AE23):1, Hydroquinone(D11AX11):1, Hydrocortisone(D07AA02):1, Isotretinoin combinations(D10AD54):1, Clobetasone(D07AB01):1, Methylprednisolone aceponate(D07AC14):1, Mometasone(D07AC13):1, Naftifine(D01AE22):1, Terbinafine(D01AE15):1, Oxiconazole(D01AC11):1. G-Others( n  = 9):Clotrimazole(G01AF02):2, Progesterone(G03DA04):2, Dydrogesteron(G03DB01):2, Imidazole derivates and corticosteroids(G01BF):1, Estradiol(G03CA03):1, Darifenacin(G04BD10):1. H-Others( n  = 12):Dexamethasone(H02AB02):6, Prednisolone(H02AB06):5, Betamethasone(H02AB01):1. J-Others( n  = 31):Cefaclor(J01DC04):8, Azithromycin(J01FA10):5, Clarithromycin(J01FA09):4, Cefixime(J01DD08):3, Doxycycline(J01AA02):2, Cefprozil(J01DC10):1, Sulfamethoxazole and trimethoprim (J01EE01):1, Lincomycin(J01FF02):1, Levofloxacin(J01MA12):1, Fusidic acid(J01XC01):1, Fluconazole(J02AC01):1, Rifamycin(J04AB03):1, Aciclovir(J05AB01):1, Valaciclovir(J05AB11):1. L-Others( n  = 1):Leflunamide(L04AA13):1 M-Others( n  = 37):Acemetacin(M01AB11):7, Thiocolchicoside, combinations(M03BX55):7, Preparations with salicylic acid derivatives(M02AC):5, Colchicine(M04AC01):5, Phenprobamate, combinations excl. psycholeptics(M03BA51):2, Thiocolchicoside(M03BX05):2, Indomethacin(M01AB01):2, Meloxicam(M01AC06):2, Benzidamine(M02AA05):1, Etofenamate(M02AA06):1, Piroxicam(M02AA07):1, Methocarbamol, combinations excl. psycholeptics(M03BA53):1, Tizanidine(M03BX02):1. N-Others( n  = 34):Paracetamol, combinations with psycholeptics(N02BE71):8, Sertraline(N06AB06):5, Eletriptan(N02CC06):3, Frovatriptan(N02CC07):2, Paroxetine(N06AB05):2, Methylphenidate(N06BA04):2, Flunarizine(N07CA03):2, Acetylsalicylic acid, combinations excl. psycholeptics(N02BA51):1, Ergotamine(N02CA02):1, Topiramate(N03AX11):1, Gabapentin(N0BF01):1, Lacosamide(N03AX18):1, Diazepam(N05BA01):1, Escitalopram(N06AB10):1, Trazodone(N06AX05):1, Duloxetine(N06AX21):1, Lamotrigine(N03AX09):1. R-Others( n  = 52):Oxymetazoline(R01AA05):10, Salbutamol and sodium cromoglicate (R03AK04):7, Cyproheptadine(R06AX02):4, Oxolamine(R05DB07):3, Rupatadine(R06AX28):3, Diphenhydramine(R06AA2):2, Beclomethasone(R01AD01):2, Mometasone(R01AD09):2, Fluticasone(R03BA05):2, Theophylline(R03DA04):2, Montelukast(R03DC03):2, Ebastine(R06AX22):2, Fexofenadine(R06AX26):2, Levodropropizine(R05DB27):2, Xylometazoline(R01AA07):1, Azelastine(R01AC03):1, Pseudoephedrine(R01BA02):1, Formoterol and budesonide(R03AK07):1, Formoterol and beclometasone(R03AK08):1, Doxylamine(R06AA09):1, Bilastine(R06AX29):1. S-Others( n  = 13):Fusidic acid(S01AA13):3, Ketotifen(S01GX08):3, Tobramycin(S01AA12):2, Artificial tears and other indifferent preparations(S01XA20):2, Gentamicin(S03AA06):2, Corticosteroids and antiinfectives in combination(S01CA01):1 (Table  3 )

The findings of the second sample group ( n  = 115)

It was found that there were 265 boxes (6189 dosage forms in the boxes) of unused pharmaceuticals (3.8 ± 5 boxes/per capita) in in households of these participants. Of the 265 boxes medicines, 74(27.9%) were found to be expired. The most Pseudoephedrine combination (23 boxes) and Other cold preparation (23 boxes) and Dexketoprofen (20 boxes) drugs were found to be unused drugs. The percentage of unused drugs was highest in class D(79%), P(55.4%) and N(54.6%), while used drugs were in class G(76.9%), C(69.6%) and A(53.9%) (Table  4 ).

Among the prescribed pharmaceuticals, pharmaceuticals in “Class G” were the most commonly used (76.9%), while pharmaceuticals in “Class D” were the least used (21%). The highest number of unused pharmaceuticals was found to be in “Class R” (929 dosage forms), followed by “Class M” drugs (682 dosage forms). Of the pharmaceuticals prescribed to the participants (6189 dosage forms), 3132(50.6%) were used and 3057(49.4%) were unused (Table  4 ).

Many studies have been conducted on unused medicines and their disposal practices. According to the findings of these studies, there is a serious public health problem and lack of policy. This study presents the current situation in Türkiye. In our study, there was a statistical difference between the number of unused drugs and some sociodemographic characteristics such as marriage, education, economic status etc. In the literature search, studies researching socio-demographic characteristics and the number of pharmaceuticals are very limited. A previous study found that medication disposal practice was found to be associated with some sociodemographic variables such as gender, age, marital status, and residence [ 16 ]. In another study, it was reported that parameters such as gender, education level, and place of residence were associated with drug keeping at home [ 17 ]. Therefore, it is possible to say that some sociodemographic characteristics are effective on the dependent variables.

According to the findings obtained from the participants’ practices on unused pharmaceuticals, it was found that pharmaceuticals were generally stored in the kitchen and refrigerator, and most of the pharmaceuticals were prescribed by primary health care facilities and family physicians. Addition, it was found that the most important reason for having unused pharmaceuticals in their households was reuse (for treatment), 44.6% kept them in household until the expiration date, 72.1% checked the expiration date, 56.7% read the package insert, and 41.3% purchased pharmaceuticals without a prescription. The findings that expired pharmaceuticals were thrown away, that improper disposal of pharmaceuticals polluted the environment and that the awareness on pharmaceuticals should be raised by the Ministry of Health came to the forefront. In a study reported by Manocha et al. (2020), it was reported that a significant proportion of participants had unused pharmaceuticals in their households and threw away expired pharmaceuticals [ 18 ]. In a study conducted by Althagafi et al. (2022), it was shown that about half of the participants were found pharmaceuticals in their households and that these pharmaceuticals were mainly stored in the refrigerator [ 4 ]. In another study researching the storage conditions of pharmaceuticals, it was shown that pharmaceuticals were stored in many different places, but especially in the kitchen [ 19 ]. In a study conducted by Gidey et al. (2020), it was reported that improper disposal of pharmaceuticals might be harmful to the environment and 77.4% disposed of pharmaceuticals by throwing them in household garbage [ 20 ]. In another study on medication disposal, it was reported that participants mostly disposed of medicines by throwing them in household garbage [ 21 ]. The dominant view was that unused pharmaceuticals were generally accumulated in households, expired pharmaceuticals were thrown in household garbage, pharmaceuticals were stored in the kitchen, and improper disposal harmed the environment in literature. When we compare the findings in the literature with our study findings, it is possible to say that the findings are similar. We think that the variation in the findings of behaviors towards unused medicines (storage, disposal, etc.) may be related to the type of study, number of participants, participant characteristics, culture, region and development level of the country.

According to the findings of our study, there were unused drugs in almost all ATC classes. In addition, the most prominent drugs in the quantity of leftover drugs were analgesics (paracetamol, etc.), cold medicines, NSAIDs (dexketoprofen, etc.), antibiotics (amoxicillin, etc.) and proton pump inhibitors (lansoprazole, etc.). According to various studies conducted based on the classification of the mechanism of action, drugs such as analgesics and pain relievers [ 22 ], antipyretics, analgesics, antispasmodics, antibiotics, antacids, and vitamins [ 23 ], antibiotics and pain-spasm relievers [ 24 ], antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs) [ 12 ], antibiotics and analgesics [ 2 ], NSAIDs, antibiotics, and vitamins [ 13 ], were reported. In studies conducted in Mexico and Saudi Arabia, which are located in two different geographies, NSAIDs came to the forefront [ 25 , 26 ]. It is seen that the findings of studies based on the mechanism of action of unused pharmaceuticals in the literature are similar to each other. In our study, ATC classification was performed and it can be said that the Turkish context also supports the existing literature.

According to the findings of our study, 50.6% of the total number of dosage forms of pharmaceuticals were used but 49.4% were unused. Patients should follow the treatment procedure prescribed by the physician. However, in some cases, medication may be stopped early by the patient. Some studies have reported that the most important reason for having unused or expired pharmaceuticals in household is recovery [ 1 , 27 ]. Other reported reasons were a change in treatment by the doctor and feeling well [ 28 ]. In our study, we showed that approximately half of the medicines were not used. The presence of unused medicines in households might be related to self-medication. In our study the prevalence of self-medication was 94.1%. Analgesics, common cold and muscle relaxants of the pharmaceuticals were found to be the most commonly used pharmaceuticals without consulting a physician. This finding was reported by Kumar et al. (2013) as 78.6% [ 29 ], by Niromand et al. (2020) as 72% [ 30 ], by Abdi et al. (2018) as 89.6% [ 31 ], and by Bahzadifar et al. (2020) as 70.1%. In the same study, it was reported as 97.2% in medical students and 44.7% in non-medical students [ 32 ]. According to the findings of a local study, the prevalence of self-medication was 64.3%, and it was found that analgesics, antibiotics and cold pharmaceuticals were mostly used in this way [ 33 ]. In another study, analgesics, antibiotics and antacid pharmaceuticals came to the forefront [ 34 ]. When we compare the findings of previous studies with our finding, it is possible to say that a finding similar to the literature has emerged when the number and quantity of unused pharmaceuticals at home are taken into consideration and that the prevalence related to self-medication is one of the highest findings in the literature.

According to findings, there is a significant quantity and number of unused pharmaceuticals with various active ingredients in households. It was observed that the unused pharmaceuticals were used without consulting a physician, were not disposed of properly, and some of them had expired. Considering the conditions associated with pharmaceuticals, this situation points to a significant public health problem for both people and environment. The public urgently needs to be informed about the use of pharmaceuticals. The accumulation resulting from any discontinuation of pharmaceutical therapy needs to be monitored and updated public health policies and legislation are required. In addition, a “drug take-back system” for unused pharmaceuticals may be useful in solving this problem.

Limits of the study

This study has some limitations. The limitations of this study included the fact that a significant portion of the study data was collected by online method, that it was based on the statements and practices of the participants, and that some pharmaceuticals might not be reported by the participants considering that they were related to privacy and research data were collected from a single center.

Data availability

The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.

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SK Carried out the study design and execution of the research work and writing of the initial draft of the manuscript. SK Writing and expert review of the manuscript. SK Reviewed the statistical analysis for appropriate writing of the manuscript and expert review of the manuscript. All authors read and approved the final version of the manuscript.

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Ethical approval for this study was taken from Burdur Mehmet Akif Ersoy University Non-Invasive Clinical Trials Ethics Committee (2023 − 210). Informed consents were obtained according to the conditions accepted by the ethics committee. For data collected online, it was obtained in the form of a checkbox on the first opening screen of the link and before proceeding to the study questions (First sample group). In face-to-face data collection, it was read directly to the participant and their written informed consent was obtained (Second sample group). The Declaration of Helsinki was followed at every stage of the study.

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Köksoy, S. Unused, expired pharmaceuticals and their disposal practices among the general public in Burdur-Türkiye: a cross-sectional study. BMC Public Health 24 , 1303 (2024). https://doi.org/10.1186/s12889-024-18788-0

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DOI : https://doi.org/10.1186/s12889-024-18788-0

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