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Critically appraising qualitative research

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Peer review
Ayelet Kuper , assistant professor 1 ,
Lorelei Lingard , associate professor 2 ,
Wendy Levinson , Sir John and Lady Eaton professor and chair 3
1 Department of Medicine, Sunnybrook Health Sciences Centre, and Wilson Centre for Research in Education, University of Toronto, 2075 Bayview Avenue, Room HG 08, Toronto, ON, Canada M4N 3M5
2 Department of Paediatrics and Wilson Centre for Research in Education, University of Toronto and SickKids Learning Institute; BMO Financial Group Professor in Health Professions Education Research, University Health Network, 200 Elizabeth Street, Eaton South 1-565, Toronto
3 Department of Medicine, Sunnybrook Health Sciences Centre
Correspondence to: A Kuper ayelet94{at}post.harvard.edu

Six key questions will help readers to assess qualitative research

Summary points

Appraising qualitative research is different from appraising quantitative research

Qualitative research papers should show appropriate sampling, data collection, and data analysis

Transferability of qualitative research depends on context and may be enhanced by using theory

Ethics in qualitative research goes beyond review boards’ requirements to involve complex issues of confidentiality, reflexivity, and power

Over the past decade, readers of medical journals have gained skills in critically appraising studies to determine whether the results can be trusted and applied to their own practice settings. Criteria have been designed to assess studies that use quantitative methods, and these are now in common use.

In this article we offer guidance for readers on how to assess a study that uses qualitative research methods by providing six key questions to ask when reading qualitative research (box 1). However, the thorough assessment of qualitative research is an interpretive act and requires informed reflective thought rather than the simple application of a scoring system.

Box 1 Key questions to ask when reading qualitative research studies

Was the sample used in the study appropriate to its research question.

Were the data collected appropriately?

Were the data analysed appropriately?

Can I transfer the results of this study to my own setting?

Does the study adequately address potential ethical issues, including reflexivity?

Overall: is what the researchers did clear?

One of the critical decisions in a qualitative study is whom or what to include in the sample—whom to interview, whom to observe, what texts to analyse. An understanding that qualitative research is based in experience and in the construction of meaning, combined with the specific research question, should guide the sampling process. For example, a study of the experience of survivors of domestic violence that examined their reasons for not seeking help from healthcare providers might focus on interviewing a …

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Step-by-step guide to critiquing research. Part 2: Qualitative research

Affiliation.

1 School of Nursing and Midwifery, University of Dublin, Trinity College, Dublin, Ireland, UK.
PMID: 17851363
DOI: 10.12968/bjon.2007.16.12.23726

As with a quantitative study, critical analysis of a qualitative study involves an in-depth review of how each step of the research was undertaken. Qualitative and quantitative studies are, however, fundamentally different approaches to research and therefore need to be considered differently with regard to critiquing. The different philosophical underpinnings of the various qualitative research methods generate discrete ways of reasoning and distinct terminology; however, there are also many similarities within these methods. Because of this and its subjective nature, qualitative research it is often regarded as more difficult to critique. Nevertheless, an evidenced-based profession such as nursing cannot accept research at face value, and nurses need to be able to determine the strengths and limitations of qualitative as well as quantitative research studies when reviewing the available literature on a topic.

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Qualitative Research Methods: A Critical Analysis

11 Pages Posted: 13 May 2021

Northern Caribbean University

Enid F. Newell-McLymont

Date Written: May 13, 2021

Creswell (2014) noted that qualitative research is an approach for exploring and understanding the meaning individuals or groups ascribe to a social or human problem. The article embodies a critical analysis of chapters one to twelve of Stake (2010). In chapter one, Qualitative research: How things work is seen as qualitative, is based on a comprehensive aim seeking to answer the questions why and how. It analyzes actions and interactions, taking into account the intentions of the actors. An analytic perspective on the interpretation of the Person as an instrument is the thrust of chapter two. Chapter three examines the experiential understanding: Most qualitative study is experiential, in this chapter stake (2010) discusses two common research approaches, qualitative and quantitative methods. Chapter four Stating the Problem: Questioning How This Thing Works. Chapter five deals with the Methods-Gatherings Data, while chapter six illuminates the Review of Literature: Zooming to See the Problem. In chapter seven, the author implores the evidence: Bolstering Judgment and Reconnoitering. Chapter eight propels Analysis and Synthesis: How Things Work. Chapter nine acts as a mirror that invites the researcher to examine their action research and Self-Evaluation: Finding our Own How our Place Works. Finally, in chapters ten to twelve, the author compels Storytelling: Illustrating How Things Work, Writing the Final Report: An Iterative Convergence, and Advocacy and Ethics: Making Things Work Better. This work is expected to guide future researchers in developing their research in qualitative research.

Keywords: Qualitative Research, The Thing, Review of Literature, Evidence, Triangulation, Bias

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Northern caribbean university ( email ), do you have a job opening that you would like to promote on ssrn, paper statistics, related ejournals, engineering education ejournal.

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Critical Appraisal for Health Students

Critical Appraisal of a qualitative paper
Critical Appraisal: Help
Critical Appraisal of a quantitative paper
Useful resources

Appraisal of a Qualitative paper : Top tips

Introduction

Critical appraisal of a qualitative paper

This guide aimed at health students, provides basic level support for appraising qualitative research papers. It's designed for students who have already attended lectures on critical appraisal. One framework for appraising qualitative research (based on 4 aspects of trustworthiness) is provided and there is an opportunity to practise the technique on a sample article.

Support Materials

Framework for reading qualitative papers
Critical appraisal of a qualitative paper PowerPoint

To practise following this framework for critically appraising a qualitative article, please look at the following article:

Schellekens, M.P.J. et al (2016) 'A qualitative study on mindfulness-based stress reduction for breast cancer patients: how women experience participating with fellow patients', Support Care Cancer , 24(4), pp. 1813-1820.

Critical appraisal of a qualitative paper: practical example.

Credibility
Transferability
Dependability
Confirmability

How to use this practical example

Using the framework, you can have a go at appraising a qualitative paper - we are going to look at the following article:

Step 1. take a quick look at the article, step 2. click on the credibility tab above - there are questions to help you appraise the trustworthiness of the article, read the questions and look for the answers in the article. , step 3. click on each question and our answers will appear., step 4. repeat with the other aspects of trustworthiness: transferability, dependability and confirmability ., questioning the credibility:, who is the researcher what has been their experience how well do they know this research area, was the best method chosen what method did they use was there any justification was the method scrutinised by peers is it a recognisable method was there triangulation ( more than one method used), how was the data collected was data collected from the participants at more than one time point how long were the interviews were questions asked to the participants in different ways, is the research reporting what the participants actually said were the participants shown transcripts / notes of the interviews / observations to ‘check’ for accuracy are direct quotes used from a variety of participants, how would you rate the overall credibility, questioning the transferability, was a meaningful sample obtained how many people were included is the sample diverse how were they selected, are the demographics given, does the research cover diverse viewpoints do the results include negative cases was data saturation reached, what is the overall transferability can the research be transferred to other settings , questioning the dependability :, how transparent is the audit trail can you follow the research steps are the decisions made transparent is the whole process explained in enough detail did the researcher keep a field diary is there a clear limitations section, was there peer scrutiny of the researchwas the research plan shown to peers / colleagues for approval and/or feedback did two or more researchers independently judge data, how would you rate the overall dependability would the results be similar if the study was repeated how consistent are the data and findings, questioning the confirmability :, is the process of analysis described in detail is a method of analysis named or described is there sufficient detail, have any checks taken place was there cross-checking of themes was there a team of researchers, has the researcher reflected on possible bias is there a reflexive diary, giving a detailed log of thoughts, ideas and assumptions, how do you rate the overall confirmability has the researcher attempted to limit bias, questioning the overall trustworthiness :, overall how trustworthy is the research, further information.

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Qualitative research has an important place within evidence-based health care (EBHC), contributing to policy on patient safety and quality of care, supporting understanding of the impact of chronic illness, and explaining contextual factors surrounding the implementation of interventions. However, the question of whether, when and how to critically appraise qualitative research persists. Whilst there is consensus that we cannot - and should not – simplistically adopt existing approaches for appraising quantitative methods, it is nonetheless crucial that we develop a better understanding of how to subject qualitative evidence to robust and systematic scrutiny in order to assess its trustworthiness and credibility. Currently, most appraisal methods and tools for qualitative health research use one of two approaches: checklists or frameworks. We have previously outlined the specific issues with these approaches (Williams et al 2019). A fundamental challenge still to be addressed, however, is the lack of differentiation between different methodological approaches when appraising qualitative health research. We do this routinely when appraising quantitative research: we have specific checklists and tools to appraise randomised controlled trials, diagnostic studies, observational studies and so on. Current checklists for qualitative research typically treat the entire paradigm as a single design (illustrated by titles of tools such as ‘CASP Qualitative Checklist’, ‘JBI checklist for qualitative research’) and frameworks tend to require substantial understanding of a given methodological approach without providing guidance on how they should be applied. Given the fundamental differences in the aims and outcomes of different methodologies, such as ethnography, grounded theory, and phenomenological approaches, as well as specific aspects of the research process, such as sampling, data collection and analysis, we cannot treat qualitative research as a single approach. Rather, we must strive to recognise core commonalities relating to rigour, but considering key methodological differences. We have argued for a reconsideration of current approaches to the systematic appraisal of qualitative health research (Williams et al 2021), and propose the development of a tool or tools that allow differentiated evaluations of multiple methodological approaches rather than continuing to treat qualitative health research as a single, unified method. Here we propose a workshop for researchers interested in the appraisal of qualitative health research and invite them to develop an initial consensus regarding core aspects of a new appraisal tool that differentiates between the different qualitative research methodologies and thus provides a ‘fit for purpose’ tool, for both, educators and clinicians.

https://doi.org/10.1136/ebm-2022-EBMLive.36

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BMC Med Res Methodol

Methods for the synthesis of qualitative research: a critical review

Elaine barnett-page.

1 Evidence for Policy and Practice Information and Co-ordinating (EPPI-) Centre, Social Science Research Unit, 18 Woburn Square, London WC1H 0NS, UK

James Thomas

Associated data.

In recent years, a growing number of methods for synthesising qualitative research have emerged, particularly in relation to health-related research. There is a need for both researchers and commissioners to be able to distinguish between these methods and to select which method is the most appropriate to their situation.

A number of methodological and conceptual links between these methods were identified and explored, while contrasting epistemological positions explained differences in approaches to issues such as quality assessment and extent of iteration. Methods broadly fall into 'realist' or 'idealist' epistemologies, which partly accounts for these differences.

Methods for qualitative synthesis vary across a range of dimensions. Commissioners of qualitative syntheses might wish to consider the kind of product they want and select their method – or type of method – accordingly.

The range of different methods for synthesising qualitative research has been growing over recent years [ 1 , 2 ], alongside an increasing interest in qualitative synthesis to inform health-related policy and practice [ 3 ]. While the terms 'meta-analysis' (a statistical method to combine the results of primary studies), or sometimes 'narrative synthesis', are frequently used to describe how quantitative research is synthesised, far more terms are used to describe the synthesis of qualitative research. This profusion of terms can mask some of the basic similarities in approach that the different methods share, and also lead to some confusion regarding which method is most appropriate in a given situation. This paper does not argue that the various nomenclatures are unnecessary, but rather seeks to draw together and review the full range of methods of synthesis available to assist future reviewers in selecting a method that is fit for their purpose. It also represents an attempt to guide the reader through some of the varied terminology to spring up around qualitative synthesis. Other helpful reviews of synthesis methods have been undertaken in recent years with slightly different foci to this paper. Two recent studies have focused on describing and critiquing methods for the integration of qualitative research with quantitative [ 4 , 5 ] rather than exclusively examining the detail and rationale of methods for the synthesis of qualitative research. Two other significant pieces of work give practical advice for conducting the synthesis of qualitative research, but do not discuss the full range of methods available [ 6 , 7 ]. We begin our Discussion by outlining each method of synthesis in turn, before comparing and contrasting characteristics of these different methods across a range of dimensions. Readers who are more familiar with the synthesis methods described here may prefer to turn straight to the 'dimensions of difference' analysis in the second part of the Discussion.

Overview of synthesis methods

Meta-ethnography.

In their seminal work of 1988, Noblit and Hare proposed meta-ethnography as an alternative to meta-analysis [ 8 ]. They cited Strike and Posner's [ 9 ] definition of synthesis as an activity in which separate parts are brought together to form a 'whole'; this construction of the whole is essentially characterised by some degree of innovation, so that the result is greater than the sum of its parts. They also borrowed from Turner's theory of social explanation [ 10 ], a key tenet of which was building 'comparative understanding' [[ 8 ], p22] rather than aggregating data.

To Noblit and Hare, synthesis provided an answer to the question of 'how to "put together" written interpretive accounts' [[ 8 ], p7], where mere integration would not be appropriate. Noblit and Hare's early work synthesised research from the field of education.

Three different methods of synthesis are used in meta-ethnography. One involves the 'translation' of concepts from individual studies into one another, thereby evolving overarching concepts or metaphors. Noblit and Hare called this process reciprocal translational analysis (RTA). Refutational synthesis involves exploring and explaining contradictions between individual studies. Lines-of-argument (LOA) synthesis involves building up a picture of the whole (i.e. culture, organisation etc) from studies of its parts. The authors conceptualised this latter approach as a type of grounded theorising.

Britten et al [ 11 ] and Campbell et al [ 12 ] have both conducted evaluations of meta-ethnography and claim to have succeeded, by using this method, in producing theories with greater explanatory power than could be achieved in a narrative literature review. While both these evaluations used small numbers of studies, more recently Pound et al [ 13 ] conducted both an RTA and an LOA synthesis using a much larger number of studies (37) on resisting medicines. These studies demonstrate that meta-ethnography has evolved since Noblit and Hare first introduced it. Campbell et al claim to have applied the method successfully to non-ethnographical studies. Based on their reading of Schutz [ 14 ], Britten et al have developed both second and third order constructs in their synthesis (Noblit and Hare briefly allude to the possibility of a 'second level of synthesis' [[ 8 ], p28] but do not demonstrate or further develop the idea).

In a more recent development, Sandelowski & Barroso [ 15 ] write of adapting RTA by using it to ' integrate findings interpretively, as opposed to comparing them interpretively' (p204). The former would involve looking to see whether the same concept, theory etc exists in different studies; the latter would involve the construction of a bigger picture or theory (i.e. LOA synthesis). They also talk about comparing or integrating imported concepts (e.g. from other disciplines) as well as those evolved 'in vivo'.

Grounded theory

Kearney [ 16 ], Eaves [ 17 ] and Finfgeld [ 18 ] have all adapted grounded theory to formulate a method of synthesis. Key methods and assumptions of grounded theory, as originally formulated and subsequently refined by Glaser and Strauss [ 19 ] and Strauss and Corbin [ 20 , 21 ], include: simultaneous phases of data collection and analysis; an inductive approach to analysis, allowing the theory to emerge from the data; the use of the constant comparison method; the use of theoretical sampling to reach theoretical saturation; and the generation of new theory. Eaves cited grounded theorists Charmaz [ 22 ] and Chesler [ 23 ], as well as Strauss and Corbin [ 20 ], as informing her approach to synthesis.

Glaser and Strauss [ 19 ] foresaw a time when a substantive body of grounded research should be pushed towards a higher, more abstract level. As a piece of methodological work, Eaves undertook her own synthesis of the synthesis methods used by these authors to produce her own clear and explicit guide to synthesis in grounded formal theory. Kearney stated that 'grounded formal theory', as she termed this method of synthesis, 'is suited to study of phenomena involving processes of contextualized understanding and action' [[ 24 ], p180] and, as such, is particularly applicable to nurses' research interests.

As Kearney suggested, the examples examined here were largely dominated by research in nursing. Eaves synthesised studies on care-giving in rural African-American families for elderly stroke survivors; Finfgeld on courage among individuals with long-term health problems; Kearney on women's experiences of domestic violence.

Kearney explicitly chose 'grounded formal theory' because it matches 'like' with 'like': that is, it applies the same methods that have been used to generate the original grounded theories included in the synthesis – produced by constant comparison and theoretical sampling – to generate a higher-level grounded theory. The wish to match 'like' with 'like' is also implicit in Eaves' paper. This distinguishes grounded formal theory from more recent applications of meta-ethnography, which have sought to include qualitative research using diverse methodological approaches [ 12 ].

Thematic Synthesis

Thomas and Harden [ 25 ] have developed an approach to synthesis which they term 'thematic synthesis'. This combines and adapts approaches from both meta-ethnography and grounded theory. The method was developed out of a need to conduct reviews that addressed questions relating to intervention need, appropriateness and acceptability – as well as those relating to effectiveness – without compromising on key principles developed in systematic reviews. They applied thematic synthesis in a review of the barriers to, and facilitators of, healthy eating amongst children.

Free codes of findings are organised into 'descriptive' themes, which are then further interpreted to yield 'analytical' themes. This approach shares characteristics with later adaptations of meta-ethnography, in that the analytical themes are comparable to 'third order interpretations' and that the development of descriptive and analytical themes using coding invoke reciprocal 'translation'. It also shares much with grounded theory, in that the approach is inductive and themes are developed using a 'constant comparison' method. A novel aspect of their approach is the use of computer software to code the results of included studies line-by-line, thus borrowing another technique from methods usually used to analyse primary research.

Textual Narrative Synthesis

Textual narrative synthesis is an approach which arranges studies into more homogenous groups. Lucas et al [ 26 ] comment that it has proved useful in synthesising evidence of different types (qualitative, quantitative, economic etc). Typically, study characteristics, context, quality and findings are reported on according to a standard format and similarities and differences are compared across studies. Structured summaries may also be developed, elaborating on and putting into context the extracted data [ 27 ].

Lucas et al [ 26 ] compared thematic synthesis with textual narrative synthesis. They found that 'thematic synthesis holds most potential for hypothesis generation' whereas textual narrative synthesis is more likely to make transparent heterogeneity between studies (as does meta-ethnography, with refutational synthesis) and issues of quality appraisal. This is possibly because textual narrative synthesis makes clearer the context and characteristics of each study, while the thematic approach organises data according to themes. However, Lucas et al found that textual narrative synthesis is 'less good at identifying commonality' (p2); the authors do not make explicit why this should be, although it may be that organising according to themes, as the thematic approach does, is comparatively more successful in revealing commonality.

Paterson et al [ 28 ] have evolved a multi-faceted approach to synthesis, which they call 'meta-study'. The sociologist Zhao [ 29 ], drawing on Ritzer's work [ 30 ], outlined three components of analysis, which they proposed should be undertaken prior to synthesis. These are meta-data-analysis (the analysis of findings), meta-method (the analysis of methods) and meta-theory (the analysis of theory). Collectively, these three elements of analysis, culminating in synthesis, make up the practice of 'meta-study'. Paterson et al pointed out that the different components of analysis may be conducted concurrently.

Paterson et al argued that primary research is a construction; secondary research is therefore a construction of a construction. There is need for an approach that recognises this, and that also recognises research to be a product of its social, historical and ideological context. Such an approach would be useful in accounting for differences in research findings. For Paterson et al, there is no such thing as 'absolute truth'.

Meta-study was developed to study the experiences of adults living with a chronic illness. Meta-data-analysis was conceived of by Paterson et al in similar terms to Noblit and Hare's meta-ethnography (see above), in that it is essentially interpretive and seeks to reveal similarities and discrepancies among accounts of a particular phenomenon. Meta-method involves the examination of the methodologies of the individual studies under review. Part of the process of meta-method is to consider different aspects of methodology such as sampling, data collection, research design etc, similar to procedures others have called 'critical appraisal' (CASP [ 31 ]). However, Paterson et al take their critique to a deeper level by establishing the underlying assumptions of the methodologies used and the relationship between research outcomes and methods used. Meta-theory involves scrutiny of the philosophical and theoretical assumptions of the included research papers; this includes looking at the wider context in which new theory is generated. Paterson et al described meta-synthesis as a process which creates a new interpretation which accounts for the results of all three elements of analysis. The process of synthesis is iterative and reflexive and the authors were unwilling to oversimplify the process by 'codifying' procedures for bringing all three components of analysis together.

Meta-narrative

Greenhalgh et al [ 32 ]'s meta-narrative approach to synthesis arose out of the need to synthesise evidence to inform complex policy-making questions and was assisted by the formation of a multi-disciplinary team. Their approach to review was informed by Thomas Kuhn's The Structure of Scientific Revolutions [ 33 ], in which he proposed that knowledge is produced within particular paradigms which have their own assumptions about theory, about what is a legitimate object of study, about what are legitimate research questions and about what constitutes a finding. Paradigms also tend to develop through time according to a particular set of stages, central to which is the stage of 'normal science', in which the particular standards of the paradigm are largely unchallenged and seen to be self-evident. As Greenhalgh et al pointed out, Kuhn saw paradigms as largely incommensurable: 'that is, an empirical discovery made using one set of concepts, theories, methods and instruments cannot be satisfactorily explained through a different paradigmatic lens' [[ 32 ], p419].

Greenhalgh et al synthesised research from a wide range of disciplines; their research question related to the diffusion of innovations in health service delivery and organisation. They thus identified a need to synthesise findings from research which contains many different theories arising from many different disciplines and study designs.

Based on Kuhn's work, Greenhalgh et al proposed that, across different paradigms, there were multiple – and potentially mutually contradictory – ways of understanding the concept at the heart of their review, namely the diffusion of innovation. Bearing this in mind, the reviewers deliberately chose to select key papers from a number of different research 'paradigms' or 'traditions', both within and beyond healthcare, guided by their multidisciplinary research team. They took as their unit of analysis the 'unfolding "storyline" of a research tradition over time' [[ 32 ], p417) and sought to understand diffusion of innovation as it was conceptualised in each of these traditions. Key features of each tradition were mapped: historical roots, scope, theoretical basis; research questions asked and methods/instruments used; main empirical findings; historical development of the body of knowledge (how have earlier findings led to later findings); and strengths and limitations of the tradition. The results of this exercise led to maps of 13 'meta-narratives' in total, from which seven key dimensions, or themes, were identified and distilled for the synthesis phase of the review.

Critical Interpretive Synthesis

Dixon-Woods et al [ 34 ] developed their own approach to synthesising multi-disciplinary and multi-method evidence, termed 'critical interpretive synthesis', while researching access to healthcare by vulnerable groups. Critical interpretive synthesis is an adaptation of meta-ethnography, as well as borrowing techniques from grounded theory. The authors stated that they needed to adapt traditional meta-ethnographic methods for synthesis, since these had never been applied to quantitative as well as qualitative data, nor had they been applied to a substantial body of data (in this case, 119 papers).

Dixon-Woods et al presented critical interpretive synthesis as an approach to the whole process of review, rather than to just the synthesis component. It involves an iterative approach to refining the research question and searching and selecting from the literature (using theoretical sampling) and defining and applying codes and categories. It also has a particular approach to appraising quality, using relevance – i.e. likely contribution to theory development – rather than methodological characteristics as a means of determining the 'quality' of individual papers [ 35 ]. The authors also stress, as a defining characteristic, critical interpretive synthesis's critical approach to the literature in terms of deconstructing research traditions or theoretical assumptions as a means of contextualising findings.

Dixon-Woods et al rejected reciprocal translational analysis (RTA) as this produced 'only a summary in terms that have already been used in the literature' [[ 34 ], p5], which was seen as less helpful when dealing with a large and diverse body of literature. Instead, Dixon-Woods et al adopted a lines-of-argument (LOA) synthesis, in which – rejecting the difference between first, second and third order constructs – they instead developed 'synthetic constructs' which were then linked with constructs arising directly from the literature.

The influence of grounded theory can be seen in particular in critical interpretive synthesis's inductive approach to formulating the review question and to developing categories and concepts, rejecting a 'stage' approach to systematic reviewing, and in selecting papers using theoretical sampling. Dixon-Woods et al also claim that critical interpretive synthesis is distinct in its 'explicit orientation towards theory generation' [[ 34 ], p9].

Ecological Triangulation

Jim Banning is the author of 'ecological triangulation' or 'ecological sentence synthesis', applying this method to the evidence for what works for youth with disabilities. He borrows from Webb et al [ 36 ] and Denzin [ 37 ] the concept of triangulation, in which phenomena are studied from a variety of vantage points. His rationale is that building an 'evidence base' of effectiveness requires the synthesis of cumulative, multi-faceted evidence in order to find out 'what intervention works for what kind of outcomes for what kind of persons under what kind of conditions' [[ 38 ], p1].

Ecological triangulation unpicks the mutually interdependent relationships between behaviour, persons and environments. The method requires that, for data extraction and synthesis, 'ecological sentences' are formulated following the pattern: 'With this intervention, these outcomes occur with these population foci and within these grades (ages), with these genders ... and these ethnicities in these settings' [[ 39 ], p1].

Framework Synthesis

Brunton et al [ 40 ] and Oliver et al [ 41 ] have applied a 'framework synthesis' approach in their reviews. Framework synthesis is based on framework analysis, which was outlined by Pope, Ziebland and Mays [ 42 ], and draws upon the work of Ritchie and Spencer [ 43 ] and Miles and Huberman [ 44 ]. Its rationale is that qualitative research produces large amounts of textual data in the form of transcripts, observational fieldnotes etc. The sheer wealth of information poses a challenge for rigorous analysis. Framework synthesis offers a highly structured approach to organising and analysing data (e.g. indexing using numerical codes, rearranging data into charts etc).

Brunton et al applied the approach to a review of children's, young people's and parents' views of walking and cycling; Oliver et al to an analysis of public involvement in health services research. Framework synthesis is distinct from the other methods outlined here in that it utilises an a priori 'framework' – informed by background material and team discussions – to extract and synthesise findings. As such, it is largely a deductive approach although, in addition to topics identified by the framework, new topics may be developed and incorporated as they emerge from the data. The synthetic product can be expressed in the form of a chart for each key dimension identified, which may be used to map the nature and range of the concept under study and find associations between themes and exceptions to these [ 40 ].

'Fledgling' approaches

There are three other approaches to synthesis which have not yet been widely used. One is an approach using content analysis [ 45 , 46 ] in which text is condensed into fewer content-related categories. Another is 'meta-interpretation' [ 47 ], featuring the following: an ideographic rather than pre-determined approach to the development of exclusion criteria; a focus on meaning in context; interpretations as raw data for synthesis (although this feature doesn't distinguish it from other synthesis methods); an iterative approach to the theoretical sampling of studies for synthesis; and a transparent audit trail demonstrating the trustworthiness of the synthesis.

In addition to the synthesis methods discussed above, Sandelowski and Barroso propose a method they call 'qualitative metasummary' [ 15 ]. It is mentioned here as a new and original approach to handling a collection of qualitative studies but is qualitatively different to the other methods described here since it is aggregative; that is, findings are accumulated and summarised rather than 'transformed'. Metasummary is a way of producing a 'map' of the contents of qualitative studies and – according to Sandelowski and Barroso – 'reflect [s] a quantitative logic' [[ 15 ], p151]. The frequency of each finding is determined and the higher the frequency of a particular finding, the greater its validity. The authors even discuss the calculation of 'effect sizes' for qualitative findings. Qualitative metasummaries can be undertaken as an end in themselves or may serve as a basis for a further synthesis.

Dimensions of difference

Having outlined the range of methods identified, we now turn to an examination of how they compare with one another. It is clear that they have come from many different contexts and have different approaches to understanding knowledge, but what do these differences mean in practice? Our framework for this analysis is shown in Additional file 1 : dimensions of difference [ 48 ]. We have examined the epistemology of each of the methods and found that, to some extent, this explains the need for different methods and their various approaches to synthesis.

Epistemology

The first dimension that we will consider is that of the researchers' epistemological assumptions. Spencer et al [ 49 ] outline a range of epistemological positions, which might be organised into a spectrum as follows:

Subjective idealism : there is no shared reality independent of multiple alternative human constructions

Objective idealism : there is a world of collectively shared understandings

Critical realism : knowledge of reality is mediated by our perceptions and beliefs

Scientific realism : it is possible for knowledge to approximate closely an external reality

Naïve realism : reality exists independently of human constructions and can be known directly [ 49 , 45 , 46 ].

Thus, at one end of the spectrum we have a highly constructivist view of knowledge and, at the other, an unproblematized 'direct window onto the world' view.

Nearly all of positions along this spectrum are represented in the range of methodological approaches to synthesis covered in this paper. The originators of meta-narrative synthesis, critical interpretive synthesis and meta-study all articulate what might be termed a 'subjective idealist' approach to knowledge. Paterson et al [ 28 ] state that meta-study shies away from creating 'grand theories' within the health or social sciences and assume that no single objective reality will be found. Primary studies, they argue, are themselves constructions; meta-synthesis, then, 'deals with constructions of constructions' (p7). Greenhalgh et al [ 32 ] also view knowledge as a product of its disciplinary paradigm and use this to explain conflicting findings: again, the authors neither seek, nor expect to find, one final, non-contestable answer to their research question. Critical interpretive synthesis is similar in seeking to place literature within its context, to question its assumptions and to produce a theoretical model of a phenomenon which – because highly interpretive – may not be reproducible by different research teams at alternative points in time [[ 34 ], p11].

Methods used to synthesise grounded theory studies in order to produce a higher level of grounded theory [ 24 ] appear to be informed by 'objective idealism', as does meta-ethnography. Kearney argues for the near-universal applicability of a 'ready-to-wear' theory across contexts and populations. This approach is clearly distinct from one which recognises multiple realities. The emphasis is on examining commonalities amongst, rather than discrepancies between, accounts. This emphasis is similarly apparent in most meta-ethnographies, which are conducted either according to Noblit and Hare's 'reciprocal translational analysis' technique or to their 'lines-of-argument' technique and which seek to provide a 'whole' which has a greater explanatory power. Although Noblit and Hare also propose 'refutational synthesis', in which contradictory findings might be explored, there are few examples of this having been undertaken in practice, and the aim of the method appears to be to explain and explore differences due to context, rather than multiple realities.

Despite an assumption of a reality which is perhaps less contestable than those of meta-narrative synthesis, critical interpretive synthesis and meta-study, both grounded formal theory and meta-ethnography place a great deal of emphasis on the interpretive nature of their methods. This still supposes a degree of constructivism. Although less explicit about how their methods are informed, it seems that both thematic synthesis and framework synthesis – while also involving some interpretation of data – share an even less problematized view of reality and a greater assumption that their synthetic products are reproducible and correspond to a shared reality. This is also implicit in the fact that such products are designed directly to inform policy and practice, a characteristic shared by ecological triangulation. Notably, ecological triangulation, according to Banning, can be either realist or idealist. Banning argues that the interpretation of triangulation can either be one in which multiple viewpoints converge on a point to produce confirming evidence (i.e. one definitive answer to the research question) or an idealist one, in which the complexity of multiple viewpoints is represented. Thus, although ecological triangulation views reality as complex, the approach assumes that it can be approximately knowable (at least when the realist view of ecological triangulation is adopted) and that interventions can and should be modelled according to the products of its syntheses.

While pigeonholing different methods into specific epistemological positions is a problematic process, we do suggest that the contrasting epistemologies of different researchers is one way of explaining why we have – and need – different methods for synthesis.

Variation in terms of the extent of iteration during the review process is another key dimension. All synthesis methods include some iteration but the degree varies. Meta-ethnography, grounded theory and thematic synthesis all include iteration at the synthesis stage; both framework synthesis and critical interpretive synthesis involve iterative literature searching – in the case of critical interpretive synthesis, it is not clear whether iteration occurs during the rest of the review process. Meta-narrative also involves iteration at every stage. Banning does not mention iteration in outlining ecological triangulation and neither do Lucas or Thomas and Harden for thematic narrative synthesis.

It seems that the more idealist the approach, the greater the extent of iteration. This might be because a large degree of iteration does not sit well with a more 'positivist' ideal of procedural objectivity; in particular, the notion that the robustness of the synthetic product depends in part on the reviewers stating up front in a protocol their searching strategies, inclusion/exclusion criteria etc, and being seen not to alter these at a later stage.

Quality assessment

Another dimension along which we can look at different synthesis methods is that of quality assessment. When the approaches to the assessment of the quality of studies retrieved for review are examined, there is again a wide methodological variation. It might be expected that the further towards the 'realism' end of the epistemological spectrum a method of synthesis falls, the greater the emphasis on quality assessment. In fact, this is only partially the case.

Framework synthesis, thematic narrative synthesis and thematic synthesis – methods which might be classified as sharing a 'critical realist' approach – all have highly specified approaches to quality assessment. The review in which framework synthesis was developed applied ten quality criteria: two on quality and reporting of sampling methods, four to the quality of the description of the sample in the study, two to the reliability and validity of the tools used to collect data and one on whether studies used appropriate methods for helping people to express their views. Studies which did not meet a certain number of quality criteria were excluded from contributing to findings. Similarly, in the example review for thematic synthesis, 12 criteria were applied: five related to reporting aims, context, rationale, methods and findings; four relating to reliability and validity; and three relating to the appropriateness of methods for ensuring that findings were rooted in participants' own perspectives. Studies which were deemed to have significant flaws were excluded and sensitivity analyses were used to assess the possible impact of study quality on the review's findings. Thomas and Harden's use of thematic narrative synthesis similarly applied quality criteria and developed criteria additional to those they found in the literature on quality assessment, relating to the extent to which people's views and perspectives had been privileged by researchers. It is worth noting not only that these methods apply quality criteria but that they are explicit about what they are: assessing quality is a key component in the review process for both of these methods. Likewise, Banning – the originator of ecological triangulation – sees quality assessment as important and adapts the Design and Implementation Assessment Device (DIAD) Version 0.3 (a quality assessment tool for quantitative research) for use when appraising qualitative studies [ 50 ]. Again, Banning writes of excluding studies deemed to be of poor quality.

Greenhalgh et al's meta-narrative review [ 32 ] modified a range of existing quality assessment tools to evaluate studies according to validity and robustness of methods; sample size and power; and validity of conclusions. The authors imply, but are not explicit, that this process formed the basis for the exclusion of some studies. Although not quite so clear about quality assessment methods as framework and thematic synthesis, it might be argued that meta-narrative synthesis shows a greater commitment to the concept that research can and should be assessed for quality than either meta-ethnography or grounded formal theory. The originators of meta-ethnography, Noblit and Hare [ 8 ], originally discussed quality in terms of quality of metaphor, while more recent use of this method has used amended versions of CASP (the Critical Appraisal Skills Programme tool, [ 31 ]), yet has only referred to studies being excluded on the basis of lack of relevance or because they weren't 'qualitative' studies [ 8 ]. In grounded theory, quality assessment is only discussed in terms of a 'personal note' being made on the context, quality and usefulness of each study. However, contrary to expectation, meta-narrative synthesis lies at the extreme end of the idealism/realism spectrum – as a subjective idealist approach – while meta-ethnography and grounded theory are classified as objective idealist approaches.

Finally, meta-study and critical interpretive synthesis – two more subjective idealist approaches – look to the content and utility of findings rather than methodology in order to establish quality. While earlier forms of meta-study included only studies which demonstrated 'epistemological soundness', in its most recent form [ 51 ] this method has sought to include all relevant studies, excluding only those deemed not to be 'qualitative' research. Critical interpretive synthesis also conforms to what we might expect of its approach to quality assessment: quality of research is judged as the extent to which it informs theory. The threshold of inclusion is informed by expertise and instinct rather than being articulated a priori.

In terms of quality assessment, it might be important to consider the academic context in which these various methods of synthesis developed. The reason why thematic synthesis, framework synthesis and ecological triangulation have such highly specified approaches to quality assessment may be that each of these was developed for a particular task, i.e. to conduct a multi-method review in which randomised controlled trials (RCTs) were included. The concept of quality assessment in relation to RCTs is much less contested and there is general agreement on criteria against which quality should be judged.

Problematizing the literature

Critical interpretive synthesis, the meta-narrative approach and the meta-theory element of meta-study all share some common ground in that their review and synthesis processes include examining all aspects of the context in which knowledge is produced. In conducting a review on access to healthcare by vulnerable groups, critical interpretive synthesis sought to question 'the ways in which the literature had constructed the problematics of access, the nature of the assumptions on which it drew, and what has influenced its choice of proposed solutions' [[ 34 ], p6]. Although not claiming to have been directly influenced by Greenhalgh et al's meta-narrative approach, Dixon-Woods et al do cite it as sharing similar characteristics in the sense that it critiques the literature it reviews.

Meta-study uses meta-theory to describe and deconstruct the theories that shape a body of research and to assess its quality. One aspect of this process is to examine the historical evolution of each theory and to put it in its socio-political context, which invites direct comparison with meta-narrative synthesis. Greenhalgh et al put a similar emphasis on placing research findings within their social and historical context, often as a means of seeking to explain heterogeneity of findings. In addition, meta-narrative shares with critical interpretive synthesis an iterative approach to searching and selecting from the literature.

Framework synthesis, thematic synthesis, textual narrative synthesis, meta-ethnography and grounded theory do not share the same approach to problematizing the literature as critical interpretive synthesis, meta-study and meta-narrative. In part, this may be explained by the extent to which studies included in the synthesis represented a broad range of approaches or methodologies. This, in turn, may reflect the broadness of the review question and the extent to which the concepts contained within the question are pre-defined within the literature. In the case of both the critical interpretive synthesis and meta-narrative reviews, terminology was elastic and/or the question formed iteratively. Similarly, both reviews placed great emphasis on employing multi-disciplinary research teams. Approaches which do not critique the literature in the same way tend to have more narrowly-focused questions. They also tend to include a more limited range of studies: grounded theory synthesis includes grounded theory studies, meta-ethnography (in its original form, as applied by Noblit and Hare) ethnographies. The thematic synthesis incorporated studies based on only a narrow range of qualitative methodologies (interviews and focus groups) which were informed by a similarly narrow range of epistemological assumptions. It may be that the authors of such syntheses saw no need for including such a critique in their review process.

Similarities and differences between primary studies

Most methods of synthesis are applicable to heterogeneous data (i.e. studies which use contrasting methodologies) apart from early meta-ethnography and synthesis informed by grounded theory. All methods of synthesis state that, at some level, studies are compared; many are not so explicit about how this is done, though some are. Meta-ethnography is one of the most explicit: it describes the act of 'translation' where terms and concepts which have resonance with one another are subsumed into 'higher order constructs'. Grounded theory, as represented by Eaves [ 17 ], is undertaken according to a long list of steps and sub-steps, includes the production of generalizations about concepts/categories, which comes from classifying these categories. In meta-narrative synthesis, comparable studies are grouped together at the appraisal phase of review.

Perhaps more interesting are the ways in which differences between studies are explored. Those methods with a greater emphasis on critical appraisal may tend (although this is not always made explicit) to use differences in method to explain differences in finding. Meta-ethnography proposes 'refutational synthesis' to explain differences, although there are few examples of this in the literature. Some synthesis methods – for example, thematic synthesis – look at other characteristics of the studies under review, whether types of participants and their context vary, and whether this can explain differences in perspective.

All of these methods, then, look within the studies to explain differences. Other methods look beyond the study itself to the context in which it was produced. Critical interpretive synthesis and meta-study look at differences in theory or in socio-economic context. Critical interpretive synthesis, like meta-narrative, also explores epistemological orientation. Meta-narrative is unique in concerning itself with disciplinary paradigm (i.e. the story of the discipline as it progresses). It is also distinctive in that it treats conflicting findings as 'higher order data' [[ 32 ], p420], so that the main emphasis of the synthesis appears to be on examining and explaining contradictions in the literature.

Going 'beyond' the primary studies

Synthesis is sometimes defined as a process resulting in a product, a 'whole', which is more than the sum of its parts. However, the methods reviewed here vary in the extent to which they attempt to 'go beyond' the primary studies and transform the data. Some methods – textual narrative synthesis, ecological triangulation and framework synthesis – focus on describing and summarising their primary data (often in a highly structured and detailed way) and translating the studies into one another. Others – meta-ethnography, grounded theory, thematic synthesis, meta-study, meta-narrative and critical interpretive synthesis – seek to push beyond the original data to a fresh interpretation of the phenomena under review. A key feature of thematic synthesis is its clear differentiation between these two stages.

Different methods have different mechanisms for going beyond the primary studies, although some are more explicit than others about what these entail. Meta-ethnography proposes a 'Line of Argument' (LOA) synthesis in which an interpretation is constructed to both link and explain a set of parts. Critical interpretive synthesis based its synthesis methods on those of meta-ethnography, developing an LOA using what the authors term 'synthetic constructs' (akin to 'third order constructs' in meta-ethnography) to create a 'synthesising argument'. Dixon-Woods et al claim that this is an advance on Britten et al's methods, in that they reject the difference between first, second and third order constructs.

Meta-narrative, as outlined above, focuses on conflicting findings and constructs theories to explain these in terms of differing paradigms. Meta study derives questions from each of its three components to which it subjects the dataset and inductively generates a number of theoretical claims in relation to it. According to Eaves' model of grounded theory [ 17 ], mini-theories are integrated to produce an explanatory framework. In ecological triangulation, the 'axial' codes – or second level codes evolved from the initial deductive open codes – are used to produce Banning's 'ecological sentence' [ 39 ].

The synthetic product

In overviewing and comparing different qualitative synthesis methods, the ultimate question relates to the utility of the synthetic product: what is it for? It is clear that some methods of synthesis – namely, thematic synthesis, textual narrative synthesis, framework synthesis and ecological triangulation – view themselves as producing an output that is directly applicable to policy makers and designers of interventions. The example of framework synthesis examined here (on children's, young people's and parents' views of walking and cycling) involved policy makers and practitioners in directing the focus of the synthesis and used the themes derived from the synthesis to infer what kind of interventions might be most effective in encouraging walking and cycling. Likewise, the products of the thematic synthesis took the form of practical recommendations for interventions (e.g. 'do not promote fruit and vegetables in the same way in the same intervention'). The extent to which policy makers and practitioners are involved in informing either synthesis or recommendation is less clear from the documents published on ecological triangulation, but the aim certainly is to directly inform practice.

The outputs of synthesis methods which have a more constructivist orientation – meta-study, meta-narrative, meta-ethnography, grounded theory, critical interpretive synthesis – tend to look rather different. They are generally more complex and conceptual, sometimes operating on the symbolic or metaphorical level, and requiring a further process of interpretation by policy makers and practitioners in order for them to inform practice. This is not to say, however, that they are not useful for practice, more that they are doing different work. However, it may be that, in the absence of further interpretation, they are more useful for informing other researchers and theoreticians.

Looking across dimensions

After examining the dimensions of difference of our included methods, what picture ultimately emerges? It seems clear that, while similar in some respects, there are genuine differences in approach to the synthesis of what is essentially textual data. To some extent, these differences can be explained by the epistemological assumptions that underpin each method. Our methods split into two broad camps: the idealist and the realist (see Table Table1 1 for a summary). Idealist approaches generally tend to have a more iterative approach to searching (and the review process), have less a priori quality assessment procedures and are more inclined to problematize the literature. Realist approaches are characterised by a more linear approach to searching and review, have clearer and more well-developed approaches to quality assessment, and do not problematize the literature.

Summary table

	Idealist	Realist
Searching	Iterative	Linear
Quality assessment	Less clear, less a priori; quality of content rather than method	Clear and a priori
Problematizing the literature	Yes	No
Question	Explore	Answer
Heterogeneity	Lots	Little
Synthetic product	Complex	Clear for policy makers and practitioners

N.B.: In terms of the above dimensions, it is generally a question of degree rather than of absolute distinctions.

Mapping the relationships between methods

What is interesting is the relationship between these methods of synthesis, the conceptual links between them, and the extent to which the originators cite – or, in some cases, don't cite – one another. Some methods directly build on others – framework synthesis builds on framework analysis, for example, while grounded theory and constant comparative analysis build on grounded theory. Others further develop existing methods – meta-study, critical interpretive synthesis and meta-narrative all adapt aspects of meta-ethnography, while also importing concepts from other theorists (critical interpretive synthesis also adapts grounded theory techniques).

Some methods share a clear conceptual link, without directly citing one another: for example, the analytical themes developed during thematic synthesis are comparable to the third order interpretations of meta-ethnography. The meta-theory aspect of meta-study is echoed in both meta-narrative synthesis and critical interpretive synthesis (see 'Problematizing the literature, above); however, the originators of critical interpretive synthesis only refer to the originators of meta-study in relation to their use of sampling techniques.

While methods for qualitative synthesis have many similarities, there are clear differences in approach between them, many of which can be explained by taking account of a given method's epistemology.

However, within the two broad idealist/realist categories, any differences between methods in terms of outputs appear to be small.

Since many systematic reviews are designed to inform policy and practice, it is important to select a method – or type of method – that will produce the kind of conclusions needed. However, it is acknowledged that this is not always simple or even possible to achieve in practice.

The approaches that result in more easily translatable messages for policy-makers and practitioners may appear to be more attractive than the others; but we do need to take account lessons from the more idealist end of the spectrum, that some perspectives are not universal.

Competing interests

The authors declare that they have no competing interests.

Authors' contributions

Both authors made substantial contributions, with EBP taking a lead on writing and JT on the analytical framework. Both authors read and approved the final manuscript.

Pre-publication history

The pre-publication history for this paper can be accessed here:

http://www.biomedcentral.com/1471-2288/9/59/prepub

Supplementary Material

Dimensions of difference . Ranging from subjective idealism through objective idealism and critical realism to scientific realism to naïve realism

Acknowledgements

The authors would like to acknowledge the helpful contributions of the following in commenting on earlier drafts of this paper: David Gough, Sandy Oliver, Angela Harden, Mary Dixon-Woods, Trisha Greenhalgh and Barbara L. Paterson. We would also like to thank the peer reviewers: Helen J Smith, Rosaline Barbour and Mark Rodgers for their helpful reviews. The methodological development was supported by the Department of Health (England) and the ESRC through the Methods for Research Synthesis Node of the National Centre for Research Methods (NCRM). An earlier draft of this paper currently appears as a working paper on the National Centre for Research Methods' website http://www.ncrm.ac.uk/ .

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Critical Discourse Analysis | Definition, Guide & Examples

Critical Discourse Analysis | Definition, Guide & Examples

Published on August 23, 2019 by Amy Luo . Revised on June 22, 2023.

Critical discourse analysis (or discourse analysis) is a research method for studying written or spoken language in relation to its social context. It aims to understand how language is used in real life situations.

When you conduct discourse analysis, you might focus on:

The purposes and effects of different types of language
Cultural rules and conventions in communication
How values, beliefs and assumptions are communicated
How language use relates to its social, political and historical context

Discourse analysis is a common qualitative research method in many humanities and social science disciplines, including linguistics, sociology, anthropology, psychology and cultural studies.

What is discourse analysis used for, how is discourse analysis different from other methods, how to conduct discourse analysis, other interesting articles.

Conducting discourse analysis means examining how language functions and how meaning is created in different social contexts. It can be applied to any instance of written or oral language, as well as non-verbal aspects of communication such as tone and gestures.

Materials that are suitable for discourse analysis include:

Books, newspapers and periodicals
Marketing material, such as brochures and advertisements
Business and government documents
Websites, forums, social media posts and comments
Interviews and conversations

By analyzing these types of discourse, researchers aim to gain an understanding of social groups and how they communicate.

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Unlike linguistic approaches that focus only on the rules of language use, discourse analysis emphasizes the contextual meaning of language.

It focuses on the social aspects of communication and the ways people use language to achieve specific effects (e.g. to build trust, to create doubt, to evoke emotions, or to manage conflict).

Instead of focusing on smaller units of language, such as sounds, words or phrases, discourse analysis is used to study larger chunks of language, such as entire conversations, texts, or collections of texts. The selected sources can be analyzed on multiple levels.

Critical discourse analysis
Level of communication	What is analyzed?
Vocabulary	Words and phrases can be analyzed for ideological associations, formality, and euphemistic and metaphorical content.
Grammar	The way that sentences are constructed (e.g., , active or passive construction, and the use of imperatives and questions) can reveal aspects of intended meaning.
Structure	The structure of a text can be analyzed for how it creates emphasis or builds a narrative.
Genre	Texts can be analyzed in relation to the conventions and communicative aims of their genre (e.g., political speeches or tabloid newspaper articles).
Non-verbal communication	Non-verbal aspects of speech, such as tone of voice, pauses, gestures, and sounds like “um”, can reveal aspects of a speaker’s intentions, attitudes, and emotions.
Conversational codes	The interaction between people in a conversation, such as turn-taking, interruptions and listener response, can reveal aspects of cultural conventions and social roles.

Discourse analysis is a qualitative and interpretive method of analyzing texts (in contrast to more systematic methods like content analysis ). You make interpretations based on both the details of the material itself and on contextual knowledge.

There are many different approaches and techniques you can use to conduct discourse analysis, but the steps below outline the basic structure you need to follow. Following these steps can help you avoid pitfalls of confirmation bias that can cloud your analysis.

Step 1: Define the research question and select the content of analysis

To do discourse analysis, you begin with a clearly defined research question . Once you have developed your question, select a range of material that is appropriate to answer it.

Discourse analysis is a method that can be applied both to large volumes of material and to smaller samples, depending on the aims and timescale of your research.

Step 2: Gather information and theory on the context

Next, you must establish the social and historical context in which the material was produced and intended to be received. Gather factual details of when and where the content was created, who the author is, who published it, and whom it was disseminated to.

As well as understanding the real-life context of the discourse, you can also conduct a literature review on the topic and construct a theoretical framework to guide your analysis.

Step 3: Analyze the content for themes and patterns

This step involves closely examining various elements of the material – such as words, sentences, paragraphs, and overall structure – and relating them to attributes, themes, and patterns relevant to your research question.

Step 4: Review your results and draw conclusions

Once you have assigned particular attributes to elements of the material, reflect on your results to examine the function and meaning of the language used. Here, you will consider your analysis in relation to the broader context that you established earlier to draw conclusions that answer your research question.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

Normal distribution
Measures of central tendency
Chi square tests
Confidence interval
Quartiles & Quantiles
Cluster sampling
Stratified sampling
Thematic analysis
Cohort study
Peer review
Ethnography

Research bias

Implicit bias
Cognitive bias
Conformity bias
Hawthorne effect
Availability heuristic
Attrition bias
Social desirability bias

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Forum: Qualitative Social Research / Forum Qualitative Sozialforschung

Mapping Powerful Constellations in Childhood and Youth Research. Critical Reflections on a Participatory Research Process With Young People

Nadja Althaus Goethe-Universität Frankfurt am Main

Participatory approaches face significant scientific pressure for legitimacy, particularly in German-language childhood and youth research, and reports on studies with collaborative methods remain underrepresented. At the same time, participation of young people is becoming increasingly important, also in scientific contexts, and participatory methods are currently used more frequently. Against this background, I first report in this article on the completed Peer2Peer project, in which young people participated extensively as co-researchers. I then discuss the diverse data material of the study employing three mapping tools of situational analysis in order to enable retrospective reflection on the research process in its entirety. As a result, relational networks and constellations as well as the research ethical complexity of studies with young people become visible. The selected approach is beneficial and contributes to a power-sensitive discourse with regard to the redemption of participation rights. It also provides further critical perspectives, including on (participatory) social science research.

Author Biography

Nadja althaus, goethe-universität frankfurt am main.

Nadja ALTHAUS ist als wissenschaftliche Mitarbeiterin im Forschungsprojekt Potentiale und Grenzen von Mitbestimmung ausloten (Potentiale+). Eine prozessuale Evaluationsstudie partizipativer Beteiligungsstrukturen für Kinder und Jugendliche im Institut für Sozialpädagogik und Erwachsenenbildung am Fachbereich Erziehungswissenschaften der Goethe-Universität Frankfurt am Main (Projektleitung Prof.in Dr.in Sabine ANDRESEN) und im Verbundprojekt Diagnostische Praxis zur Feststellung sonderpädagogischen Förderbedarfs und Bundeslanddisparitäten im Kontext der UN-Behindertenrechtskonvention (FePrax) im Institut für Rehabilitationswissenschaften an der Humboldt Universität zu Berlin (Verbundprojektleitung Prof.in Dr.in Vera MOSER) tätig.

Aktuelle Forschungsschwerpunkte sind partizipative Forschungsmethoden in der Kindheits-, Jugend- und Familienforschung, Beteiligungsrechte, Prävention und Kinderschutz sowie als Querschnittsthema Inklusion.

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Althaus, Nadja (2023). Chancen und Herausforderungen partizipativer Forschung mit jungen Menschen. Erkenntnisse eines deutschsprachigen Literaturreviews. Diskurs Kindheits- und Jugendforschung/Discourse. Journal of Childhood and Adolescence Research, 18(4), 561-584.

Althaus, Nadja & Andresen, Sabine (2023). Teilhabe und Beteiligung neu denken. Kinder und Jugendliche sprechen mit! Studienbericht des partizipativen Forschungsprojekts Peer2Peer. Gütersloh: Bertelsmann Stiftung, https://www.bertelsmann-stiftung.de/de/publikationen/publikation/did/teilhabe-und-beteiligung-neu-denken-kinder-und-jugendliche-sprechen-mit?tx_rsmbstpublications_pi2%5BfilterSprache%5D%5B1%5D=1&cHash=940239928cd2b185c6c0ee2f185f8158 [Datum des Zugriffs: 10. Juni 2024].

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Published: 28 September 2024

The role of family doctors in developing primary care systems in Asia: a systematic review of qualitative research conducted in middle-income countries 2010–2020

Biyun Li 1 &
Margo Turnbull 1

BMC Primary Care volume 25 , Article number: 346 ( 2024 ) Cite this article

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The Asia Pacific Region’s middle-income countries (MICs) face unique challenges in the ongoing development of primary care (PC) systems. This development is complicated by systemic factors, including rapid policy changes and the introduction of private healthcare services, as well as the mounting challenges associated with ageing populations and increasing rates of chronic diseases. Despite the widespread acknowledgement of the importance of family doctors in the development of PC services, relatively little is known about how these roles have developed in Asian MICs. To address this gap, this systematic review presents a synthesis of recent research focused on the role of family doctors within the PC systems of MICs in the Asia Pacific Region.

We searched six electronic databases (CINAHL Complete, Embase, PsycINFO, PubMed, Web of Science, and Index Medicus for the South-East Asia Region and Western Pacific) for peer-reviewed qualitative literature published between January 2010 and December 2020. The quality of the studies was evaluated using the Critical Appraisal Skills Programme tool. Eighteen articles were included in the analysis. Findings from these articles were extracted and synthesised using qualitative thematic synthesis. We used the Rainbow Framework to analyse the interconnections within health systems at the macro, meso and micro levels.

Our analysis of the included articles showed that family doctors play a crucial role in bridging the gap between hospitals and communities. They are essential in adopting holistic approaches to health and wellbeing and are in a unique position to try and address social, psychological, and biological aspects of health. Our findings also highlight the influence of policy changes at the macro level on the role and responsibilities of family doctors at the meso (organisational) and micro (interpersonal) levels.

Conclusions

Limited research has explored the role of family doctors in the ongoing development of primary care systems in MICs in the Asia Pacific Region. The findings of this review have significant implications for policymakers and healthcare administrators involved in ongoing improvements to and strengthening of PC systems. Areas of particular concern relate to policy linked with training and workforce development, insurance systems and public awareness of what primary care services are.

Peer Review reports

The principles of primary health care (PHC) have been an international priority since the Alma-Ata Declaration in 1978 [ 1 ]. High-income countries such as Australia and the UK have made significant improvements in working towards the objectives and ways of thinking about accessible health and care at both individual and population levels [ 2 ] through the provision of primary care (PC) services including those led by family doctors [ 3 ]. Progress in low- and middle-income countries (LIC and MICs) Footnote 1 has been more limited and associated weaknesses were evident in the difficulties health systems faced during the COVID-19 pandemic [ 4 ]. Despite inconsistent progress in the development of PC services, the principles of PHC remain the most promising for addressing global health challenges including those associated with ageing populations and increases in chronic diseases [ 5 , 6 ]. The World Health Organization (WHO) has restated its support of principles of prevention, social justice, equity, solidarity and participation in healthcare in reports including “Primary health care now more than ever” [ 7 ] as well as the more recent Astana Declaration [ 5 ]. LIC and MICs governments have continued to state their commitment to strengthening the connections between health and social care systems that facilitate the transition from reliance on hospital-level care to services delivered to individuals through community-based services [ 8 ].

Research in countries with highly developed healthcare systems has consistently highlighted the key role of family doctors (also referred to as General Practitioners; this review uses ‘family doctor’ throughout for consistency) [ 9 ] in the provision of community-based PC services. Family doctors serve as gatekeepers into health systems [ 10 ] and play a crucial role in coordinating and responding to the needs of local communities [ 11 ]. In well-functioning systems, high levels of public awareness allow family doctors to actively cultivate positive and ongoing relationships with service users [ 2 ]. These relationships have various effects on system development including promoting access to services, continuity of care, and the effective management of physical and mental health [ 11 ]. This holistic approach can contribute to the potential alleviation of poor health outcomes associated with poverty and structural inequality [ 12 , 13 ].

From a global perspective, MICs face particular challenges in the development of PC systems [ 14 ]. These locations may now be caught in the ‘double-bind’ of contending with high rates of infectious diseases while also being confronted with rapid growth in chronic diseases [ 14 ]. Additionally, individual access to services may be curtailed by limited or uneven public health insurance systems [ 15 ]. To date, most reviews of PC development have focused on variables of income status [ 14 , 16 ] with little attention directed towards regional sociocultural factors that may shape responses to the development of PC.

In this systematic review, we focus on what is known about family doctors’ perceptions and experiences of their role in PC systems in MICs located in the Asia Pacific Region Footnote 2 . This region is densely populated, socially and culturally diverse and characterised by uneven economic development [ 16 , 17 ]. Additionally, services within the region have shown a slow transition from hospital to community-based services despite the increasing pressures associated with rapidly ageing populations [ 18 ]. Recent research within the region has primarily focused on the macro context of policy or programme innovations in single locations [ 19 ] with limited attention directed towards exploring broader social and systemic factors that promote or limit PC development [ 20 ]. In response to this lacuna, our review presents a synthesis of recently published empirical qualitative research articles based on research conducted in MICs in the Asia Pacific Region. Research published between 2010 and 2020 was selected for inclusion as this period reflects a key time of regional policy development linked with relevant WHO initiatives and before the severe disruption to PC services caused by the COVID-19 pandemic [ 21 ]. To facilitate an in-depth and cross-cutting analysis, the Rainbow Framework [ 22 ] was used to examine the interconnections within health systems at the macro (societal and policy context), meso (organisational and managerial factors), and micro (patient and provider interactions) levels. The findings of this review will inform policymakers and healthcare administrators engaged in the development of PC systems including the strengthening of initiatives associated with public awareness, education and workforce development.

This systematic review was registered prospectively with PROSPERO (CRD42023439032) and this entry has been updated periodically. Findings are reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2020) guidelines [ 23 ].

Inclusion and exclusion criteria

To be eligible for inclusion, articles needed to report on original, empirical, and qualitative research published in international peer-reviewed journals between January 2010 and December 2020. Data needed to be collected from locations within the Asia Pacific Region with research questions primarily focused on family doctors’ perceptions of their role in the development of PC services. These inclusion criteria are summarised in Table 1 . Articles were excluded if research questions and data collection focused on hospital settings (secondary/tertiary care), non-doctor health workers in PC settings, medical students or trainees, perspectives of patients and/or policymakers, or evaluations of training programs for family doctors.

Six electronic databases (CINAHL Complete, Embase, PsycINFO, PubMed, Web of Science, and Index Medicus for the South-East Asia Region and Western Pacific) were searched manually for relevant peer-reviewed literature published between January 2010 and December 2020. Print and online sources were included. No language restrictions were applied to the searches. Geographical locations were selected based on the World Bank’s country income classifications and the WHO map of regions Footnote 3 . Refer to Appendix 1 for the complete search strategy and associated rationale.

Original searches for studies published between 2010 and 2020 were run in June and August 2023. At this time, 998 articles were found and then after removal of duplications and screening, 12 articles were deemed eligible. After further input from an expert librarian and reviewers, the protocol was revised and searches were re-run in June and July 2024 using expanded search terms with the same publication timeframes (2010–2020). All other inclusion and eligibility criteria were unchanged. The re-run searches returned 13,423 articles. Following the removal of duplicates, 6,532 articles were identified for screening against the inclusion criteria by the first author (BL), and 20 full-text articles were assessed for eligibility. In total, 18 articles were identified through the search process. Both authors agreed on inclusions after evaluating each article’s eligibility against inclusion and exclusion criteria. Citation searching (forward and backward citation searching) was then conducted and no additional articles were identified.

Study quality appraisal

Methods for the appraisal of study quality in systematic reviews are contentious [ 25 , 26 ]. We followed the practice of Damarell et al. [ 27 ] and appraised the ethical and methodological choices described in each study included in the review [ 27 ]. The full texts of the eighteen articles identified were appraised by both authors using the Critical Appraisal Skills Programme (CASP) checklist [ 28 ]. In line with Noyes et al. [ 29 ], both authors engaged in discussions about the included studies, evaluating each paper’s rigour, methodological limitations and potential contributions to local knowledge and services. Authors agreed before the final appraisal that the only grounds for exclusion were inadequate or absent reporting of ethical approval. All included studies reported appropriate ethical approval and thus no articles were excluded at this stage. The results of the CASP and discussion of the potential contributions of individual articles are provided in Table 2 .

Data extraction strategy

Study information from the eighteen included articles was extracted by both authors. Extracted details included author/s and year of publication, location of data collection, research objectives, data collection method, participants, and main findings (Table 3 ).

Data synthesis and presentation

Qualitative thematic synthesis [ 47 ] was used to synthesize the findings of the included studies. Both authors independently and inductively coded the results and/or findings from all studies. This process began with line-by-line coding. Codes were then grouped into descriptive themes. Finally, analytic themes, identified by consolidating descriptive themes, were developed. Any discrepancies were addressed through ongoing discussion between the authors.

This review included eighteen empirical research articles that focused on family doctors’ perceptions and experiences of their role in PC development. Figure 1 shows the PRISMA 2020 flowchart of the searches that were re-run in June and July 2024. Despite all MICs in the Asia Pacific Region being included in the database searches, articles that were deemed eligible for inclusion in the review were based on data collected in a limited number of locations specifically Mainland China (hereafter referred to as China), Hong Kong Special Administrative Region (hereafter referred to as Hong Kong), India, Indonesia, and Malaysia. The significance of the lack of research available from other locations in the region is discussed later in this article. The five locations represented in the articles included in the review have all undergone rapid policy-led PC developments in recent years and this may have contributed to a growth in related research. For example, China’s PC system has been significantly reformed and networks of community centres and clinics have been established [ 43 ]. Hong Kong has a more established PC system, comprised of both public and private sectors. This system offers a blend of subsidised public clinics and private practices to manage a wide range of health issues [ 48 ]. Recent policy initiatives in India, Indonesia and Malaysia have focused on the development of policy and education initiatives to extend public and private PC services with family doctors increasingly positioned as key stakeholders [ 30 , 34 , 37 ].

PRISMA 2020 flow diagram of included and excluded studies from the systematic review based on results of June-July 2024 searches

Qualitative thematic synthesis identified key factors that influenced family doctors’ involvement in the development of local PC programs. In keeping with the Rainbow Framework [ 22 ], these factors were analysed across macro, meso and micro dimensions of PC systems. Although these dimensions of health systems are interconnected and porous, using this framework for analysis and discussion highlights some of the structural and systemic challenges in the region that may influence the ongoing development and strengthening of local PC services.

Macro: Health system policy and capacity for PC development

Research included in the review highlighted the influence of government policy on both the capacity of PC systems as well as the ability of family doctors to actively promote the development of the sector. Key factors were associated with (1) overarching health system policies including those related to health insurance and regulation of the sector, and (2) limited systemic refocusing/pivoting towards PC service delivery.

Overarching health system policies

Most articles acknowledged the impact of the overarching government policies that shaped the macro system in which PC was located [ 13 , 34 , 36 , 43 , 44 , 45 , 46 ]. A key issue identified in China, India, Indonesia and Malaysia related to the absence of comprehensive health insurance that restricted access to and development of PC. This lack of comprehensive insurance limited patients’ ability to access PC and, at times, led to reported increases in self-medication [ 34 ], delays in seeking necessary medical help [ 13 ], and limited access to mental health treatment [ 43 ]. A lack of policy initiatives that aimed to develop post-qualification specialist training for family doctors on key topics including mental health, men’s health and women’s sexual dysfunction were also noted as a factor that restricted the development of PC systems [ 36 , 43 , 44 , 46 ].

Limited systemic refocusing/pivoting towards PC

Research included in this review reflected broader concerns expressed by family doctors across locations about the limited refocusing or pivoting towards the development of a PC-oriented health system. Research participants claimed that this was evident in inadequate government regulation and oversight of PC services. The lack of regulation of PC systems in India was linked to limited control over the distribution of medicine, leading to patients obtaining antibiotics from unqualified prescribers or dispensers [ 34 ]. Additionally, the absence of monitoring systems in private PC services provided by midwives and nurses in Indonesia was reported to result in the provision of services beyond their professional or legal competencies [ 13 ].

A lack of regulation of professional training – including postgraduate qualifications and continuous professional development (CPD) – was also identified as restricting the development of the role of family doctors within PC systems [ 30 , 41 , 45 , 46 ]. Research participants in China noted that although there were national General Practitioners (GPs) training programs for community-based family doctors, the content was not differentiated to reflect the diverse needs of doctors working in community (rather than hospital) locations or settings [ 45 ]. In research from India, it was reported that formal training in family medicine for family doctors was only recently introduced to the medical system through government-led policy [ 40 ].

Across the included studies, family doctors reported facing constraints within the health system that limited broadening their scope of practice to include mental health and social issues related to health and well-being [ 37 , 38 , 43 , 46 ]. Despite recognising their role as the first point of contact for patients, family doctors in China, Indonesia and Malaysia reported difficulties in working to address and manage general health issues due to the absence of government policies and guidelines that specifically authorised the inclusion of these areas in the remit of their work [ 37 , 38 , 43 ]. This was evident in the low priority given to mental health in China, and the consequent underdiagnosis and limited access to appropriate treatments [ 43 , 46 ]. In Malaysia, doctors expressed an awareness of social issues such as elder abuse and neglect but did not perceive such issues as priorities during clinical consultations due to a lack of guidelines or reporting systems for these areas of care [ 37 ]. Similarly, in Indonesia, family doctors found it difficult to engage in the management of suspected violence against women as there were no standard operational procedures to direct their intervention [ 38 ].

Limited public awareness of the purpose of PC and its interaction with social and cultural norms was also widely reported to impact the work of family doctors [ 35 , 36 , 37 , 40 , 41 , 43 , 44 , 45 , 46 ]. The lack of public awareness of the role of preventative health care [ 44 ], the stigma surrounding mental health [ 43 ] and social taboos associated with issues including elder abuse [ 37 ], adolescent abortion [ 35 ], and female sexual dysfunction [ 36 ] also restricted the capacity and motivation of family doctors to engage in delivering these services. Doctors encountered sensitivity, resistance and wariness when broaching these topics due to social and cultural taboos and confusion about the role of the family doctor in the management of these issues [ 37 ]. This public misunderstanding of family medicine at multiple levels of the health care system in India was linked by research participants with a common misperception that low-cost PC was low-quality care [ 40 ].

Meso level challenges

The research included in the review highlighted how changes in the macro systems had knock-on effects at the meso (organisational) level in relation to (1) service delivery, (2) rural and urban disparities, and (3) challenges in specialist education and continuing professional development for family doctors.

Limitations in service delivery

Changes in macro systems had significant effects on the level of clinical service delivery. In addition to the low priority given to mental health and other issues, the lack of guidelines, policies, support systems and healthcare resources meant that family doctors often did not know how to deliver services in line with PC objectives [ 34 , 43 , 46 ]. For example, doctors in community healthcare centres in Shenzhen, China, identified a lack of personnel, treatment options, and consultation rooms as restricting their capacity to incorporate mental health care services into local PC service delivery [ 43 ]. Additionally, funding for medical treatment and the development of specialist facilities often remained with the hospitals rather than being devolved out to PC settings [ 43 , 46 ].

Service delivery was also limited by low levels of public health literacy and awareness of PC [ 43 , 46 ]. This was, in turn, linked with issues such as self-medication and antibiotics overuse [ 34 ], low treatment adherence [ 34 ], and limited health literacy in relation to mental health and preventative interventions [ 43 , 44 ]. Research participants discussed their ongoing work in advocating for urgent government policy change in order to promote public awareness of PC and how citizens could access services and resources [ 43 , 34 ].

Exacerbation of rural and urban disparities

Disparities in the distribution of resources between rural and urban areas and the impact on the division between primary and secondary/tertiary care settings presented various challenges to the development of the role of family doctors in PC. Research conducted in rural areas in Malaysia and Indonesia identified challenges including staff shortages, inadequate medicine supplies, a lack of essential equipment and facilities, and limitations in professional training systems [ 31 , 33 ]. Disparities in income and career development were identified by research participants in Indonesia as making local recruitment more difficult [ 33 ].

Malaysian research also described some family doctors in rural areas as devising information innovations or ‘work arounds’ to address local gaps in PC services [ 31 ]. For example, some family doctors implemented a ‘buddy system’ to seek assistance from specialists [ 31 ].

Challenges in specialist education and continuing professional development

Similar issues in relation to ongoing education were reported by family doctors in urban locations [ 39 , 41 , 43 , 46 ]. Family doctors in Shanghai and Shenzhen, China, expressed a desire and commitment to increasing their skills and knowledge in relation to mental health care in PC but reported that they lacked access to training about how to diagnose mental health issues in PC settings [ 43 , 46 ]. Some doctors in Shenzhen reported that in the absence of mental health guidelines for PC settings, they extended their own clinical practices through self-directed learning which included developing screening instruments to aid in the diagnosis of mental health conditions [ 43 ]. In Hong Kong, due to limited learning opportunities provided by formal organisations, family doctors often devised their own CPD activities in small professional groups [ 39 ]. These informal groups allowed them to establish stable peer support systems, discuss clinical practice and update their clinic knowledge by inviting specialists to give talks to the community members [ 39 ]. Likewise, some private family doctors in Malaysia formed informal peer support groups to exchange information and CPD resources [ 41 ].

Micro level challenges

Research included in this review also highlighted the limitations family doctors experienced in their everyday interactions with PC patients. These limitations at the micro level were influenced by the broader factors that shaped the meso and macro levels.

Time constraints

Family doctors highlighted the negative impact of short consultation times, which severely reduced their ability to engage in what they considered to be comprehensive PC [ 13 , 30 , 31 , 32 , 34 , 35 , 37 , 38 , 39 , 42 , 43 , 45 ]. Doctors in Malaysia reported that the high patient-to-doctor ratio led to an overwhelming workload and extremely short consultation times [ 31 , 32 ]. Doctors across the studies reported that due to heavy workloads they did not have time to inquire about patients’ family history [ 32 ], educate patients about the proper use of antibiotics [ 34 ], identify risk factors and utilise depression screening tools [ 43 ], follow-up concerns about elder abuse [ 37 ] or domestic violence [ 38 ], investigate cases of adolescent pregnancy [ 35 ], seek evidence-based answers [ 31 ], or attend CPD programs and activities [ 30 , 41 , 45 ].

Challenges to professional identity as family doctors

Family doctors reported that a lack of awareness of their specialised role within the broader healthcare environment limited their influence within the PC system and, thus, restricted the development of impactful relationships with PC patients [ 35 , 37 , 38 , 40 , 42 , 43 , 46 ]. Doctors linked this lack of professional identity with feelings of disillusionment and low levels of acknowledgement of the value of their role by the broader society [ 40 ]. Although some doctors in the research studies acknowledged their potential to be involved in the management of mental health disorders [ 43 ] or elder abuse [ 37 ], they still identified their key function as being to address the clinical presentation of patients rather than dealing with broader social issues that may impact health and wellbeing [ 37 ]. It is of significance that a number of studies highlighted participants lack of confidence in identifying and managing mental illnesses and broader health issues [ 37 , 38 , 43 , 46 ]. This lack of confidence was attributed to several factors, including limited training and experience, poor learning support structures, inadequate government guidelines, and insufficient support systems [ 37 , 43 , 46 ]. In some cases, in China, even when training schemes were available, the excessive clinical workload and lack of staffing made it difficult for doctors to attend training programs [ 43 , 46 ]. Doctors viewed these barriers to attending training as problematic as they greatly valued CPD and considered it to be an important way of staying up-to-date with the latest medical knowledge and best practices [ 39 , 41 , 45 ].

This systematic review has explored what is currently known about the role of family doctors in PC systems in MICs in the Asia Pacific Region. The family doctor is widely acknowledged as being a key point of connection between hospitals and communities and also facilitates holistic approaches to health and wellbeing as they connect across social, psychological and biological domains.

The findings of this review highlight the interconnected nature of PC systems and the significant impact of policy changes at the macro level on the role and work of family doctors at both the meso (organisational) and micro (interpersonal) levels. Research included in the review has shown that overarching policy changes often have effects that essentially limit the development of the role of the family doctor and thus stall or slow down broader improvements in PC. Limited public insurance coverage, low levels of health literacy and awareness of what PC is limit opportunities for engagement of family doctors with PC patients. Additionally, restricted education and professional development opportunities and narrow views of the role of family doctors also hinder development.

The findings of this review highlight the need for all parties involved in developing PC to recognize the interconnected nature of the macro, micro and meso levels of health care systems. For example, policy innovations may increase the number of people who are eligible to access PC services but if this is not done in tandem with changes at the levels of workforce development, professional education, local service development and public awareness raising then ongoing PC improvement will be limited.

Limitations

There are two limitations associated with this review that need to be acknowledged. Firstly, initial and potentially restrictive search terms used in 2023 were expanded for the re-running of the searches in June and July 2024 (publication time-frames and all other inclusion and eligibility criteria were unchanged). Despite this modification, searches returned literature from only a limited number of MICs within the Asian Pacific Region (China, Hong Kong, India, Indonesia, and Malaysia). This lack of representativeness limits the potential to draw inferences from the experiences of family doctors in other MICs in the region. To address this paucity of published, peer-reviewed literature from some of the MICs within the region, future research on this topic could usefully include grey literature such as government reports, policy documents and information from professional and educational institutions. The second limitation of this review relates to the potential for findings to be incorporated into policy and practice guidelines. Although the findings will be of interest to a range of PC stakeholders, it is increasingly acknowledged that confidence in the representativeness of findings of qualitative systematic reviews and therefore their potential to be incorporated into policy and practice are enhanced by the use of tools such as GRADE-CERQual [ 49 ]. It is recommended that future research on this topic makes use of such a tool in order to optimise the uptake of findings by policy makers and practitioners across locations.

The development of well-functioning PC systems in MICs in the Asia Pacific Region remains challenging. The findings of this systematic review highlight that to achieve progress in PC development, family doctors need to be actively engaged across macro, meso and micro levels of service change. Additional research is needed to explore strategies that enable family doctors to play a more effective role in the PC system during the health transition of MICs in the Asia Pacific Region.

Data availability

No datasets were generated or analysed during the current study.

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Abbreviations

Critical Appraisal Skills Programme

Continuous professional development

General Practitioner

Middle-income countries
Primary care
Primary healthcare

Preferred Reporting Items for Systematic Reviews and Meta-Analyses

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This research is funded by a grant from the Hong Kong Polytechnic University to Margo Turnbull (corresponding author) [project number P0045897].

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Li, B., Turnbull, M. The role of family doctors in developing primary care systems in Asia: a systematic review of qualitative research conducted in middle-income countries 2010–2020. BMC Prim. Care 25 , 346 (2024). https://doi.org/10.1186/s12875-024-02585-0

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Prescription drug monitoring program in Australia: a qualitative study of stakeholders’ experiences and perceptions of a state-wide implementation

Emma Tay 1 , 2 ,
Meredith Makeham 1 , 3 ,
Andrew Hargreaves 4 ,
Tracey-Lea Laba 5 &
Melissa Baysari 1

BMC Health Services Research volume 24 , Article number: 1147 ( 2024 ) Cite this article

Metrics details

Prescription Drug Monitoring Programs (PDMPs) are increasingly implemented across the globe with aims of managing and mitigating risks relating to high-risk prescription medicines. There is limited research focused on identifying strategies or processes for large-scale PDMP implementation. This study aimed to identify strategies perceived as necessary for successful state-wide implementation of a PDMP by exploring the experiences and perceptions of stakeholders responsible for the implementation in New South Wales (NSW), Australia: to identify (1) the drivers of implementation; (2) perceived strategies that worked well; (3) barriers to implementation; and (4) the elements needed for long-term success of SafeScript NSW.

This study used a qualitative descriptive design. Theoretical frameworks used to design interview questions and guide thematic analysis were the non-adoption, abandonment, scale-up, spread, and sustainability (NASSS) framework and Quadruple Aim framework. Participants were stakeholders responsible for PDMP implementation in NSW. Recruitment and data collection were completed between March and April 2022. Semi-structured interviews were audio-recorded and transcribed. Two researchers independently reviewed transcripts, generated codes from the data, and mapped these to each NASSS domain. They came together multiple times during data analysis to review the codes and grouped them into higher level themes via a discussion and consensus process. Themes were then organised according to the four objectives of the study.

Eight interviews were conducted and analysed after which thematic saturation was reached. All participants had a common understanding of the perceived benefits and drivers for PDMP implementation. Participants outlined ten key ingredients for perceived successful state-wide implementation. Strong and iterative engagement with a large number of stakeholder groups was viewed as critical, as was targeting user experience, ongoing monitoring and evaluation. These were facilitated by a phased roll-out strategy. Participants identified some barriers to implementation, particularly around poor usability and user experience of the tool.

Conclusions

This is one of the first studies focused on strategies for what was perceived to be successful state-wide implementation of PDMP. Successful implementation requires significant time and resourcing, with the design and configuration of the technology being only one component of a multi-strategy process. Knowledge and insights gained from this study may be useful for other implementations of similar digital health tools in large-scale jurisdictions.

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Contributions to the literature

Evidence on the effectiveness of prescription drug monitoring programs (PDMPs) is mixed, with poor uptake and usability issues contributing to failure to achieve desired benefits.

This is one of the first studies focused on describing strategies necessary for successful state-wide PDMP implementation, involving a multi-strategy approach involving significant time, resourcing, and careful design and configuration of the technology and its use.

Our study contributes to recognised gaps in the literature, in particular identifying factors that are crucial for successful digital health tool implementation on a large-scale.

Prescription drug monitoring programs (PDMPs) are tools that allow clinicians and health regulators to track and monitor certain high-risk or controlled prescription medicines with intended aims of managing and mitigating risks relating to these medicines. Common medications included in PDMPs are opioids, benzodiazepines, stimulants, and gabapentinoids, as these are often associated with misuse, diversion, and adverse outcomes including dependence, overdoses, and deaths [ 1 , 2 ].

A systematic review of reviews showed studies evaluating PDMPs were either outcome or process evaluation reviews [ 3 ]. Reviews summarising PDMP outcomes were focused on opioids, with the majority of the studies specifically examining PDMPs in the USA [ 3 ]. Mixed evidence with respect to the effectiveness of PDMPs in reducing opioid related use and harms was shown, likely resulting from inconsistencies in the methods and outcome measures used, varying from prescribing or dispensing events, misuse, and morbidity and mortality outcomes between studies [ 3 ]. Reviews summarising process evaluations were also variable, with most reporting barriers to PDMP use or implementation, and others including utilisation, usability, effects of knowledge and attitude on intention to use, and PDMP impact on clinical decision making [ 3 ]. Only one of seven process evaluation reviews of PDMP utilised a theoretical model or framework to inform barrier identification [ 3 ]. Evidence on PDMPs was therefore conflicting and of low overall quality [ 3 ]. This review did highlight a key factor influencing PDMP effectiveness and delivery of benefits was the uptake of the tool by intended users [ 3 ]. Underutilisation of PDMPs was often linked to barriers like poor usability and poor user satisfaction. Strategies to support PDMP implementation should therefore consider, and target identified challenges to ensure uptake and program success. There is limited research focused on identifying the strategies or processes necessary for successful PDMP implementation. Qualitative studies have shown that facilitators to implementation include integration into electronic health records [ 4 , 5 ], training and awareness [ 6 ], and collaboration across agencies and stakeholders [ 6 ], but these studies explored and reported on specific implementation conditions such as sites (for example emergency departments) and features (like mandatory access or opioid prescribing laws), not implementation strategies.

PDMP implementation across the entire state of New South Wales (NSW) provided us with a unique opportunity to examine a large-scale implementation of a PDMP. The NSW PDMP, named SafeScript NSW [ 7 ], is available to all NSW and interstate prescribing and dispensing clinicians to voluntarily register and use. SafeScript NSW provides these clinicians with access to information on prescribing and dispensing history for certain high-risk or controlled medicines for patients in NSW and can provide alerts to clinicians when certain predetermined risk criteria (such as multiple providers or concurrent harmful polypharmacy) were met [ 7 ]. The system can be accessed by the relevant clinician via the web portal, with or without an alert prompt. This study aimed to identify strategies perceived as necessary for successful state-wide implementation of this digital health tool by exploring the experiences and perceptions of stakeholders responsible for the implementation of PDMP (SafeScript NSW) across NSW. We set out to identify: (1) the drivers of implementation; (2) perceived strategies that worked well; (3) barriers to implementation; and (4) the elements needed for long-term success of SafeScript NSW.

Study design

To achieve the study’s four objectives, this study used a qualitative descriptive design.

Study setting

The healthcare system in Australia is both federal and state/territory based. A base platform for PDMP was supplied by the federal government, with each state/territory customising its system for local needs and use. The implementation of PDMPs varied, with the earliest implementation in jurisdictions of Tasmania, Australian Capital Territory, and Victoria. The ‘go live’ roll-out of SafeScript NSW (in this manuscript, used interchangeably with PDMP) took place between April 2021 and May 2022 in three phases across 10 primary health networks (PHNs) consisting of metropolitan, rural, and regional areas of NSW. Phase 1 occurred in one PHN (November 2021), Phase 2 in two PHNs (March 2022), and Phase 3 across all other PHNs and primary care services in the state (May 2022).

Study sample and recruitment

Purposive sampling was used to recruit stakeholders employed by the state health department directly responsible for all three phases of the implementation of SafeScript NSW, including those who were involved in communication, change management, partnerships, and engaging with key business representatives. These participants were chosen because they were aware of and delivered many of the strategies that support implementation. To recruit participants, email invitations, including the Participant Information Statement and Participant Consent Form, were distributed to all eligible participants by the SafeScript NSW implementation team project manager (AH) on behalf of the research team. Participants who were interested were required to contact a researcher (ET), who was independent from the program, to arrange an interview time. Written informed consent was obtained from all participants prior to commencement of their interview. Recruitment of participants ceased when saturation was reached from the data collected and no new information was gained. This was determined in one of the data analysis meetings between researchers. All interviews were completed in March and April 2022, coinciding with Phase 2 roll-out.

Data collection

Semi-structured interviews were conducted over videoconference (by ET) and were audio-recorded and transcribed. Transcripts were de-identified, and each participant was assigned a numerical code. The interview guide (Additional file 1 ) was developed by the research team, which was comprised of experts in human factors, digital health, health economics, community and primary health care, clinical pharmacology and addiction medicine, and was informed by two theoretical frameworks, described below.

Theoretical frameworks used to guide interview questions and analysis were the non-adoption, abandonment, scale-up, spread, and sustainability (NASSS) framework [ 8 ] and the Quadruple Aim framework [ 9 ]. NASSS proposes that successful implementation of a digital health technology can be explored through seven domains. The interview guide included questions to explore these seven domains: the condition (high risk medicines use and harm), technology (SafeScript NSW), value proposition (desirability, efficacy, and cost effectiveness of SafeScript NSW implementation), adopter system (healthcare providers, patients, caregivers), organisation (health system in NSW), wider context (including regulatory and societal context relating to SafeScript NSW implementation), and the embedding and adaptability of technology (SafeScript NSW) over time [ 8 ]. We used the Quadruple Aim framework [ 9 ] to further explore one NASSS domain, value proposition, and draw on participants’ perceptions of the impact of the technology on four dimensions of care: patient experience, provider experience, population health, and effectiveness and cost efficiency of health care delivery.

Data synthesis and analysis

Researchers used both inductive and deductive coding to analyse the data [ 10 ]. The interview guide was structured around the NASSS, so quotes were extracted and coded into the seven domains of the NASSS framework, but categories within each NASSS domain emerged from the data. The two researchers (ET and MB) independently reviewed transcripts, generated codes from the data, and mapped these to each NASSS domain. They came together multiple times during data analysis to review the codes and grouped them into higher level themes via a discussion and consensus process. Themes were then organised according to the four objectives of the study. That is: the drivers of implementation; strategies perceived as necessary for successful implementation; barriers to implementation; and long-term success elements.

This study was approved by the University of Sydney’s Human Research Ethics Committee. Standards for Reporting Qualitative Research is reported in Additional file 2 .

Twelve potential participants were sent the study invitation, and eight agreed to participate (67% response rate). Interviews ran for 26 to 50 min (average 42 min).

Participant demographics

Participants who took part in the study comprised a wide range of roles in the SafeScript NSW implementation team, which included management/managerial, business, change adoption, analytics, and regulatory. Their professional training background included clinical (pharmacy ( n = 3), psychology ( n = 2)) and non-clinical (information technology ( n = 2), digital health ( n = 1)). Half ( n = 4; 50%) of the participants had 1–5 years of experience in digital health, while the remainder reported more than ten years of experience.

Thematic saturation was achieved. Themes that were generated during coding process are presented in Fig. 1 as the overall study outcomes on stakeholders’ views of successful PDMP implementation.

Overall study outcomes on stakeholders’ views of successful PDMP implementation. Note. PDMP = Prescription Drug Monitoring Program

Drivers for PDMP implementation – value and impact to stakeholders

Participants were consistent in describing SafeScript NSW as a system implemented to monitor medications known to be inadvertently or deliberately misused, diverted, and involved in overdoses, emergency presentations, hospitalisations, and deaths. SafeScript NSW was identified to be both a clinical decision support and a regulatory tool. Participants were also consistent in describing benefits expected from the implementation of SafeScript NSW, with only a small number of potential negative outcomes reported.

Healthcare practitioners or clinicians

Most participants described SafeScript NSW as a clinical tool to support healthcare practitioners (prescribing and dispensing clinicians) make informed decisions about prescribing and dispensing monitored medicines.

… the practitioners of NSW can use the system and the information stored within it to supplement their existing clinical workflow and their clinical decision making. – Participant 4.

Participants reflected on the improved transparency and visibility of information relating to the use of monitored medicines with SafeScript NSW. A key reported benefit was a reduction in morbidity and mortality associated with reduced hospital presentations due to misuse, overdoses, and deaths. Participants perceived improved clinical decision-making related to prescribing and dispensing monitored medicines to be a benefit. Some participants noted SafeScript NSW could assist healthcare practitioners in identifying patients who may benefit from earlier redirection to other appropriate treatment such as pain management, mental health, or addiction services. Some participants also noted the potential added value to community prescribers (primarily general practitioners) by increasing their confidence in managing certain patients within the primary care setting.

… making it easier for doctors and pharmacists to identify people who are at risk , intervene earlier , and reduce harm and death associated with prescription meds and overdose and toxicity. – Participant 1.

However, some participants felt that SafeScript NSW may result in unintended consequences, including increasing demands on certain health or specialist services and encouraging a shift to increasing use of illicit drugs or other non-monitored medicines.

…there might be some system impacts in the sense that if there’s GPs that are identifying more patients that require specialist advice or support , it might increase referrals into pain and drug and alcohol services. So that might be an event , unintended impact of this program. And that will create kind of a system issues. – Participant 7.

Some participants discussed the value of SafeScript NSW to patients (or consumers), including improved continuity of care and relationships with healthcare practitioners, and subsequent confidence in the appropriateness of care received.

So it’s important that people have , feel confident in it , that patients feel that it’s the right thing for them that it’s actually there to help them and not hinder them. – Participant 6.

The other thing we’re hoping is that consumers will see the benefit of having a key kind of doctor , like key prescriber , but also like a key pharmacists that they go to , so that they’re going to the same health professionals and getting to know that health professionals , they’re getting that kind of continuity of care , whilst they’re being treated for you know , whether it’s pain management or , you know , or for their addiction. – Participant 7.

A participant added however a potential risk of patients denied necessary care or treatment by clinicians in response to data accessible on SafeScript NSW.

Healthcare regulators

Some participants described SafeScript NSW as a tool used by the state’s health regulatory unit to assist in monitoring prescribing and dispensing activities.

From a regulators point of view , the benefit for us of having access to SafeScript is that we really can get a pretty complete picture of what’s being prescribed and what’s being dispensed out there. – Participant 2.

Participants described SafeScript NSW data being utilised by the regulators to target investigations and perceived the tool and data as enabling proactive regulation and surveillance through improved visibility of trends in medicine use.

So the regulator can use the information inside SafeScript NSW to target their investigation and enforcement activity … it’s a really important part of the medicines regulatory framework in NSW and SafeScript NSW means that that team can be more targeted and more efficient and more effective in their activities. – Participant 1.

…the long term aim is to have capability doing some proactive surveillance , rather than purely reactive… – Participant 3.

SafeScript NSW implementation – key ingredients for successful state-wide roll-out

Participants described ten strategies that contributed to what was perceived to be successful implementation of SafeScript NSW. These are listed with illustrative quotes in Table 1 and described below.

Benefiting from experiences of others

Many participants described benefiting from the experiences and learnings of other jurisdictions that had already implemented PDMPs.

Stakeholder engagement

Good stakeholder engagement throughout all stages, which included engagement with governance, clinicians, and consumer stakeholders, were also described as crucial for successful implementation.

New and revised policies

Participants highlighted the importance of development of new policies and changes to current policies, procedures and guidelines to facilitate the implementation of PDMP. Some described amendments to the Poisons and Therapeutic Goods Act to enable the collection of information into the monitored medicines database, and others described the development of a new privacy policy that restricts access to data on SafeScript NSW to certain people and conditions.

Deciding the key features of SafeScript NSW

A critical implementation process reported was the customisation of features for the state, including medicines selected for monitoring within the tool (“monitored medicines list”), rules relating to the types of data collected, the user interface, and rules relating to alert triggers. Participants said a new monitored medicines committee was set up that looked at available evidence and made recommendations for medicines to be included in SafeScript NSW.

Determining whether use of SafeScript NSW was to be made mandatory was described by participants as an important decision, with the state opting against mandated use. Participants held the view that evidence is required prior to implementing mandated use of the tool and explained that the current non-mandated access is in keeping with many other existing clinical tools.

Phased roll-out

An important implementation approach mentioned by most participants was the phased roll-out strategy. This iterative process was perceived to help the team obtain feedback, identify issues and revise strategies to support implementation of later phases. Some participants explained that the order of roll-out to PHNs was guided by the availability of resources and the capacity of networks to manage potential increased workload for certain specialist services such as addiction and pain management services.

Promoting uptake of education and training support

Participants frequently mentioned partnerships with existing trusted professional bodies responsible for education as being key to successful implementation. These organisations delivered information and educational content relating to SafeScript NSW via subscribed channels to members. Participants perceived helpful elements of education and training for the program to be its availability online, and the incentive of them being accreditable Continued Professional Development activities for healthcare practitioners.

Providing clinical support

All participants described a key strategy to support implementation to be the development of new web-based information portals and educational material to support the upskilling of clinicians. Participants explained that a goal of education and training was to enhance primary care led interventions. Participants reported that a new telephone advice line was set up, which provides 24-hour clinical support to clinicians, however, a small number of participants alluded to low uptake of the advice line after Phase 1 implementation.

Providing technological support

Participants described information technology support being available to users of the tool via educational resources on technical usage of the system, telephone support, and online troubleshooting resources.

In addition to partnering with existing health professionals’ organisations for education, participants explained that these partnerships were also essential for communicating with healthcare practitioners about PDMP. Partnering with consumer organisations was also frequently raised by participants as valuable, utilising existing consumer channels to distribute material and information about SafeScript NSW to increase awareness and engagement.

Many participants described evaluation as a key ingredient to ensuring PDMP implementation was a success. Feedback was obtained from both clinicians and consumers following the first phase of roll-out. Participants described two methods for obtaining clinician feedback – a diary study and a survey. Feedback from consumers was obtained via a consumer survey.

Barriers to PDMP implementation

In addition to the strategies above, participants outlined a number of barriers to implementation of SafeScript NSW. Table 2 further describes these with illustrative quotes.

Competing priorities and timelines between the implementation team, PDMP vendor, and other vendors or providers of community practices operating systems was identified as an issue as these were required to build an integrated workflow for SafeScript NSW.

Participants also discussed the delay and changes to strategies to support implementation that were required because of natural disasters, including the COVID-19 pandemic and major flooding that occurred during the implementation of SafeScript NSW. A small number of participants described challenges experienced with low uptake of training resources, with feedback indicating the training and educational modules were too long for time-poor clinicians.

Another frequently reported barrier was poor user experience, which negatively impacted adoption. This included issues with variable system performance, login problems, and poor data quality. Participants explained that they had received feedback from users about the system being slow or glitching, and further work was completed to improve and enhance the system performance with the vendor of SafeScript NSW. With respect to login, participants said that users had provided feedback about the time required for multifactor login requirements. Some participants also raised concerns about data quality, with data input by clinicians affecting data output, such as the inability to access data on the system because incorrect patient details were entered.

Legal risks relating to privacy and security concerns were also reported as additional adoption barriers. These were in relation to potential consumer concerns regarding the security and privacy of their data now available on SafeScript NSW. Additionally, participants raised the prospect of medicolegal challenges and perceived clinical liability faced by clinicians where no standard of practice is in place regarding the use of SafeScript NSW, given its non-mandatory status.

Elements required for long-term successful adoption of PDMP

Participants noted that, although all NSW-registered prescribers and pharmacists on the Australian Health Practitioner Regulation Agency are invited to register and use SafeScript NSW, full uptake was not expected, as not all will prescribe or dispense the medicines monitored on SafeScript NSW.

Barriers and facilitators to long-term adoption

Of those expected to use SafeScript NSW, a barrier to adoption was reported to be the fact that registration and use of the tool in NSW was optional.

I think the obvious thing is regulatory levers to compel the use of SafeScript under certain circumstances. I think that’s probably the most logical thing that would increase the adoption rate. … we’re really hopeful that health practitioners will self-select and use the system on their own behalf and won’t be required to compel the use. – Participant 1.

A small number of participants mentioned the potential to review the optional access status to SafeScript NSW if uptake was deemed suboptimal. Although some participants also explained that mandating use of SafeScript NSW may not change behaviours of clinicians.

And also , what does mandatory use look like? …I’ve complied with the law , because I’ve looked at it. But it hasn’t actually affected my behaviour. So I don’t know that that is , in and of itself is the answer , forcing somebody to look at something is part of the success because at least you made them look at it… – Participant 2.

Participants discussed how poor user experience, particularly on first use, may deter people from using the tool again. For healthcare regulators, some participants noted a potential barrier to be the resources required to manage the increased traffic and workload introduced by SafeScript NSW’s increased data availability.

I think we always knew that there would be millions of events. … And with such a huge volume of data , you can get delays in systems. – Participant 2.

These problems were described to potentially result in negative publicity, which could negatively impact the success of implementation and limit adoption.

I think those things would undermine it and would you know , once it gets a bad name , and it loses its sort of shine , there’s a potential that they’ll just , people will just switch off and ignore it. – Participant 6.

Participants suggested positive user experience and confidence in the accuracy, robustness, and usefulness of SafeScript NSW information would be facilitators to successful ongoing implementation and uptake. Therefore, having champions within user groups and positive testimonials were identified as important strategies to aid promotion and long-term adoption of the tool.

The positive user experience , I think , and the way that they’re using the system , and that it’s , that they feel that it’s achieving something. – Participant 2.

Monitoring and evaluation

Participants described ongoing monitoring, such as reviewing rates of registration, active use, alerts generated by the system along with rates of clinicians’ viewing of alerts, would be useful for ensuring long term success. Some participants reported that evaluation of outcomes was also important, including prescription rates and patterns, and referral rates to specialists. Participants highlighted the importance of monitoring unintended consequences such as increased use of non-monitored or illicit drugs. A small number of participants described measuring system speed and effectiveness, and the impact to regulatory unit workload, such as increases in prescription authority requests.

Some participants noted that evaluation of successful implementation is complex, with most benefits not achieved immediately, but over time. The longer-term measures of success were viewed to be reductions in mortality and emergency department presentations.

Wider adoption and national integration

The majority of the participants described an indicator of success of SafeScript NSW implementation long-term being the tool becoming part of a nationally integrated information sharing system, although some participants described challenges associated with implementing a nationally integrated approach with no current plans or procedures in place. Some participants also discussed an annual review of emerging trends of other drugs that may contribute to the monitored medicines list. Having broader reach and collecting and integrating data from hospital systems were raised by participants as being part of the longer-term plans of PDMP, although some raised concerns about feasibility.

Stakeholders responsible for PDMP implementation in NSW shared a common understanding of the perceived benefits and drivers for PDMP implementation. A reduction in harms from certain high-risk prescription medications was expected, an outcome which impacts healthcare regulators, practitioners, and patients. Participants outlined ten key ingredients for successful state-wide implementation, and identified a number of barriers, particularly around poor usability and user experience of the tool. Phased roll-out, extensive and iterative consultation with stakeholders throughout implementation, and efforts targeting user experience and perceptions were important highlights.

The iterative involvement of all stakeholders, including regulatory and governance groups, healthcare practitioners, professional organisations, and consumer groups, throughout all stages of planning, roll-out, and evaluation emerged as a critical factor for successful implementation of SafeScript NSW. This involved utilising existing trusted professional bodies to consult with, disseminate information, and provide platforms for training, education, and feedback. This reflected the importance of involving clinician users and consumers, as those impacted by the implementation of the tool on successful implementation [ 11 ]. Interagency and stakeholder collaborations have been identified as important facilitators to PDMP implementation in previous research [ 6 ]. Our study adds to this by highlighting the criticality of repetitive engagement with stakeholder groups for a large-scale roll-out, and importantly, throughout stages rather than in a singular consultative occasion.

Another valuable strategy emphasised was the phased roll-out of SafeScript NSW. This provided opportunities to review stakeholder feedback, manage risks or challenges encountered, and to revise and adapt system design, usability, and implementation plans to improve roll-out and ensure success. There have been no reports or evaluations of this approach in previous PDMP-related studies, although phased roll-out has been used in previous implementations of other digital tools [ 12 , 13 ]. Our study highlights the perceived benefit of this approach for PDMP, particularly for state-wide implementations. Often facilitated by the phased roll-out, participants frequently mentioned the importance of continuous monitoring and evaluation of the implementation, in order to optimise the intervention, as has been done with other digital health tools [ 14 , 15 , 16 , 17 ]. Digital systems are not ‘set and forget’ interventions, with ongoing review and modifications needed to ensure they remain useful and appropriate as the digital landscape and skills and knowledge of users continually change.

Poor or negative user experience was perceived to be a barrier to the adoption and, therefore, user experience and associated uptake are key factors impacting PDMPs effectiveness and ability to achieve desired benefits—a finding consistent with a recent systematic review [ 3 ]. Ensuring user confidence in the PDMP data and tool contributing positively to clinical decision making was perceived as an important element to its long-term success and uptake. One concrete way of doing this as reported by participants, is to evaluate and obtain feedback from users in early phases and modify the tool to improve usability and trust in the tool, an approach used for other digital health tools, as described in literature [ 18 ].

When discussing the decision for non-mandated use of SafeScript NSW, participants reported that more evidence was required to demonstrate the benefits of mandatory access. This is in contrast to research showing that evidence plays a limited role in driving decisions to implement ‘non-mandatory’ clinical decision support tools, and likely reflects a desire to ensure benefits will be achieved, before enforcing adoption [ 19 ]. Existing literature has shown that, although mandated use of PDMPs may increase user uptake, it is associated with negative user experiences and perceptions [ 3 ], in addition to the emergence of unintended consequences such as under-prescribing for patients in need [ 20 ], and increased use of other non-monitored drugs such as pregabalin and tricyclic antidepressants [ 21 ]. Thus, the decision to make a system like PDMP mandatory is complex, and requires careful consideration regarding the impact on healthcare provision from the perspective of patients and healthcare practitioners, in addition to the interrelated regulatory and medicolegal concerns that may emerge. These considerations and decisions must be accompanied by meaningful monitoring and regulation of a mandate.

Limitations

The study was conducted during the Phase 2 roll-out of SafeScript NSW, prior to the completion of full implementation. Study participants were self-selected individuals who were likely more keen to express their views than those who did not volunteer, and so may not be representative of the entire sample. This research was conducted in a high-resourced country and may not be generalisable to other settings, although many of the lessons learnt (such as phased roll-out, wide iterative stakeholder engagement and evaluation) could still be applicable and scaled appropriately. Finally, use of the NASSS framework to guide data analysis proved challenging and time consuming, with researchers often interpreting NASSS components differently. Extensive discussion between coders was needed to ensure consistency in understandings of categories and in analysis.

Overall, this is one of the first studies focused on identifying important strategies for perceived successful large-scale state-wide implementation of PDMP. Successful implementation requires significant time and resourcing, with the design and configuration of the technology only one component of a multi-strategy process. Iterative engagement with a large number of stakeholder groups was viewed as key, as was ongoing monitoring and evaluation, facilitated by a phased roll-out. Effective and well-considered strategies to support implementation are crucial for maximising the potential for the successful uptake of such tools and the subsequent realisation of intended benefits or outcomes. The knowledge and insights gained from this study may be applied to other implementations of similar digital health tools and/or large-scale jurisdictions.

Availability of data and materials

No datasets were generated or analysed during the current study.

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Acknowledgements

The authors would like to acknowledge and thank the study participants for giving up their time to participate in this research, as well as the NSW Department of Health and SafeScript NSW implementation team for its support of this study.

ET is a recipient of the National Health and Medical Research Council Postgraduate Scholarship.

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Emma Tay, Meredith Makeham & Melissa Baysari

Drug Health Service, Western Sydney Local Health District, Sydney, Australia

Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, Australia

Meredith Makeham

Pharmaceutical Services Unit, New South Wales Ministry of Health, Sydney, Australia

Andrew Hargreaves

Centre for Health Economics Research and Evaluation, The University of Technology Sydney, Sydney, Australia

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Contributions

ET and MB conceived of the study, and all authors (ET, MB, MM, TLL, AH) contributed to the design of the study. ET conducted the data collection, ET and MB conducted data analysis, and all authors contributed to interpretation of data. AH assisted with obtaining approval from NSW Department of Health to enable the conduct of the study and led the distribution of recruitment emails to potential participants. ET wrote the initial draft manuscript and all authors (ET, MB, MM, TLL, AH) read and approved the final manuscript.

Corresponding author

Correspondence to Emma Tay .

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Ethics approval and consent to participate.

Ethics approval was obtained from The University of Sydney Human Research Ethics Committee. All participants provided written informed consent before participating in the study.

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Not applicable.

Competing interests

ET, TLL, MM, and MB have no conflict of interest to declare. AH is an employee of NSW Department of Health and was program manager of the SafeScript NSW implementation team at the time of the undertaking of this study.

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Tay, E., Makeham, M., Hargreaves, A. et al. Prescription drug monitoring program in Australia: a qualitative study of stakeholders’ experiences and perceptions of a state-wide implementation. BMC Health Serv Res 24 , 1147 (2024). https://doi.org/10.1186/s12913-024-11614-8

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Published : 29 September 2024

DOI : https://doi.org/10.1186/s12913-024-11614-8

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Methods for the synthesis of qualitative research: a critical review

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