ࡱ> bjbjVV o_<</CE  t tY"#"$$$z9z9z94֡~B9^z9BB$$ҜJJJB$$JBJJ.+Hw$m1Js@0TJ.TwwTz9J<JL>?z9z9z9Jz9z9z9BBBBTz9z9z9z9z9z9z9z9z9 :Chapter 6: Supplemental Guidance on Selecting a Method of Qualitative Evidence Synthesis, and Integrating Qualitative Evidence with Cochrane Intervention Reviews This chapter should be cited as: Noyes J & Lewin S. Chapter 6: Supplemental Guidance on Selecting a Method of Qualitative Evidence Synthesis, and Integrating Qualitative Evidence with Cochrane Intervention Reviews. In: Noyes J, Booth A, Hannes K, Harden A, Harris J, Lewin S, Lockwood C (editors), Supplementary Guidance for Inclusion of Qualitative Research in Cochrane Systematic Reviews of Interventions. Version 1 (updated August 2011). Cochrane Collaboration Qualitative Methods Group, 2011. Available from URL HYPERLINK "http://cqrmg.cochrane.org/supplemental-handbook-guidance"http://cqrmg.cochrane.org/supplemental-handbook-guidance Key points This document provides supplementary guidance to section 20.3.2.4 of the Cochrane Intervention Handbook. This Guidance is primarily for those authors wishing to synthesise qualitative evidence to inform, enhance or extend a Cochrane intervention review. The methods for qualitative evidence synthesis are still evolving and there are a number of unanswered questions regarding which synthesis methods are most appropriate: for a particular kind of review (e.g. to inform, enhance or extend a Cochrane review) for particular types of studies (ethnographies, phenomenological studies etc.) for particular review questions (e.g. experiences of the intervention, implementation, effectiveness, and broader issues beyond effectiveness). There are blurred boundaries between the different qualitative synthesis methods, with a proliferation of different approaches. Qualitative evidence syntheses tend to take an iterative approach to the sampling, extraction and synthesis of qualitative data. To some extent, this differs from the more linear processes underlying the Cochrane intervention reviews of quantitative data. The choice of synthesis method should be informed by: whether the research question is more exploratory in nature or highly focused and specific the nature of the evidence identified, for example whether evidence is largely descriptive or highly theorized or conceptual whether there is an established theoretical framework or model in place for the phenomenon that is being explored. Where a well accepted explanatory model is available it may not be necessary to develop one through the synthesis and an aggregative approach to data synthesis may be sufficient. In contrast, where no accepted explanatory framework exits, a more inductive synthesis approach would be justified The expertise of the team and available resources. Introduction Chapter 20 of the Cochrane Intervention handbook outlines four ways that qualitative research can potentially contribute to Cochrane Intervention reviews, including: o Informing reviews by using evidence from qualitative research to help define and refine the question and to ensure the review includes appropriate studies and addresses important outcomes; o Enhancing reviews by synthesising evidence from qualitative research identified whilst looking for evidence of effectiveness; o Extending reviews by undertaking a search to specifically seek out evidence from qualitative studies to address questions directly related to the effectiveness review; and o Supplementing reviews by synthesising qualitative evidence within a stand-alone, but complementary, qualitative review to address questions on aspects other than effectiveness. Although there are growing numbers of published high quality qualitative evidence syntheses, at present the Cochrane Collaboration is not able to support stand alone supplementary qualitative reviews. Methodological developments within the Collaboration are currently constrained by the focus on the effectiveness of interventions and the associated limitations of the software (RevMan), which has been designed as a platform for quantitative intervention reviews. Currently review groups and authors may opt to use qualitative evidence to inform, enhance or extend a Cochrane intervention review. It is up to individuals to decide which titles and topics are most likely to gain significant additional value and utility by the addition of a qualitative evidence synthesis. See chapter 3 for further guidance on question development and application of qualitative evidence. Choosing an appropriate synthesis method As outlined in section 20.3.2.4 of the Cochrane Intervention handbook, the choice of method for inclusion of qualitative evidence in a Cochrane intervention review will depend on a number of factors, including the: Type and scope of the review and review question(s); Pool of available evidence and the extent to which there are existing theoretical or conceptual frameworks within this literature; Expertise of the team, and; Available resources. In the Cochrane Intervention handbook, we previously recommended that any high quality method of qualitative evidence synthesis may be used that is best suited to the type of intervention review. In this additional guidance we signpost authors to named approaches that may be appropriate to use for particular kinds of questions and evidence. The choice of approach rests with the authors, but the Cochrane Qualitative Research Methods Group is happy to advise. Different types of synthesis approaches Methodologists tend to define and organise synthesis approaches on a spectrum from integrative/aggregative/summative to interpretive and theory generating, as summarised in Table 1. Table 1: Different approaches to evidence synthesis (Adapted from Dixon-Woods et al. 2005b) Integration/Aggregation/SummationInterpretation and theory developmentAimTo assemble and pool dataTo develop concepts and theories that integrate the themes described in the primary qualitative studiesSimilarities and differencesMay use techniques such as meta-analysis, and require a basic comparability between phenomena so that the data can be aggregated for analysis. Their defining characteristics are a focus on summarising data, and an assumption that the concepts (or variables) under which those data are to be summarised are largely secure and well specified. Key concepts are defined at an early stage in the review and form the categories under which the data from empirical studies are to be summarised. In an interpretive review, concepts are generally not specified in advance of the synthesis. Rather, these emerge as a product of the interpretive analysis. The output of the synthesis is not aggregations of data, but theory that is grounded in the data from the studies included in the review. ExamplesCochrane intervention reviews of effect JBI QARI approach of meta-aggregation (Pearson 2004)Meta-ethnography (Noblit and Hare 1988) Critical Interpretive synthesis (Dixon-Woods et al. 2006) Realist review (Pawson et al. 2005) Factors to consider when selecting an appropriate qualitative evidence synthesis method to inform, enhance or extend a Cochrane Intervention review Key messages: In choosing an evidence synthesis method it is important to consider what value would be added by the method in terms of informing, enhancing or extending a Cochrane review. The question(s) that the synthesis aims to address should inform the choice of synthesis method see figure 1 for a decision flow chart. If the synthesis aims to develop new theory regarding, for example, why an intervention did not work, more interpretive or constructivist approaches such as meta-ethnography may be appropriate (Pound et al. 2005). The outputs of reviews using these methods tend to be more conceptual, and perhaps less useful in answering specific practice questions (Barnett-Page & Thomas 2009). In contrast, if the synthesis aims to define or refine a Cochrane review question by summarizing the range of views expressed by consumers regarding a health issue or intervention, more aggregative approaches such as thematic analysis or meta-aggregation may be suitable. The type of data available for the synthesis should also inform the choice of synthesis approach. For example, if the available qualitative studies include only thin description then it may not be useful to attempt to use meta-ethnography. Meta-ethnography is better suited to interpretation than to aggregation and relies on primary studies that include thick description. Similarly, synthesis approaches such as thematic analysis would be more suitable than meta-ethnography if the evidence synthesis was focused on aggregating the findings of process evaluations conducted alongside trials included in a Cochrane review. Familiarity with the evidence synthesis method and its underlying techniques is essential. If the review team has not used the synthesis method before, training and support should be sought. In summary, the evidence synthesis method chosen needs to be fit for purpose, i.e. suitable for the research question; the available primary study data; and the review teams expertise and epistemological standpoint. Figure 1. Decision flow chart  SHAPE \* MERGEFORMAT  Qualitative evidence synthesis approaches that fit with the Cochrane context. Table 2 outlines the range of approaches to qualitative evidence synthesis viewed by the Cochrane Qualitative Research Methods Group as most useful within the context of Cochrane Intervention reviews Table 2: Potential qualitative evidence synthesis methods that fit with a Cochrane Intervention review Approach Meta-ethnography Adapted from primary method of data analysisThematic analysis A variety of thematic approaches adapted from primary method of data analysisMeta-aggregation Grounded theory A variety of grounded approaches adapted from primary method of data analysisDescription/ Theoretical framework or assumptions Reciprocal translational analysis (RTA) identifies key themes in each study, then seeks to translate these into context of each other study. Themes with the best overall fit/explanatory power are adopted. The approach may then distil these translations into a higher order interpretation, which may be a "line of argument" synthesis (a broader picture of the phenomenon) or a refutational synthesis, which examines contradictions between the findings of individual studies. (Dixon-Woods et al. 2005b). Identification of major / recurrent themes in the studies identified; summary of findings of primary studies under these thematic headings (Dixon-woods et al. 2005b). A group of approaches all use thematic analysis as the basis for, or as part of, the synthesis. The web-based Qualitative Assessment and Review Instrument (QARI) includes a number of processes that lead to the development of synthesized findings from the included studies: Translating the results from each study into QARI findings a conclusion reached by the researchers and presented as a metaphor or theme. These QARI findings are illustrated using text from the papers as quotes, or by summarizing illustrative text. QARI findings are then grouped into categories and combined to create synthesized themes. These, in turn, allow the recommendations for practice to be generated. (Pearson 2004)Constant comparative method identifies patterns and interrelations in primary data. Sampling responds to analysis, until theoretical saturation reached. (Dixon woods 2005a) Synthesis approachInterpretiveInterpretive / IntegrativeIntegrativeInterpretiveApplication alongside Cochrane reviewsLikely to be most useful in supplementing, informing and extending Cochrane reviews (see introduction for an explanation of these different purposes)Likely to be useful in informing, enhancing, extending and supplementing Cochrane reviewsLikely to be useful in informing, enhancing, extending and supplementing Cochrane reviewsLikely to be useful in informing, enhancing, extending and supplementing Cochrane reviewsAvailable guidance Noblit & Hare 1988. More explicit guidance in the application of this method still needs to be developed. There are multiple approaches (Pope et al. 2007). Some examples are listed below. The Joanna Briggs Institute Reviewers Manual, 2008 Edition SUMARI User guide, 2008, Version 4.0Glaser and Strauss 1967; Strauss and Corbin 1998ExamplesThere are now many published examples, including: Campbell et al. 2003; Merten et al. 2010; Munro et al. 2007; Pound et al. 2005; Schumm et al. 2010Carlsen 2007 McInnes and Arskie 2004 Noyes and Popay 2007 Briggs and Flemming 2007 Lamb et al. 2008 Eaves 2001 Finfgeld 1999 Kearney 2001 Published examples within a Cochrane context Munro et als review on TB adherence (2007,2008) was undertaken to explore questions raised by a Cochrane review on directly observed therapy. A review is underway on perceived impacts and experiences of peer support in chronic disease (Embuldeniya 2010). This will extend the update of a Cochrane review on peer support strategies for people with chronic diseases (Doull et al. 2005).Noyes and Popay (2007) provide a worked example of how qualitative synthesis may be used to enhance, extend and supplement a Cochrane review on directly observed therapy. McInnes et al (2004) examined the views, preferences and experiences of older people in relation to falls prevention strategies, alongside a Cochrane effects review on falls prevention. No published examples of the use of this approach within the Cochrane context. No published examples of the use of this approach within the Cochrane context.  Strengths and weaknesses of the different approaches to qualitative evidence synthesis in the context of Cochrane reviews Dixon-Woods et al. (2005b) and Pope et al. (2007) provide an overview of the comparative strengths and challenges of different methods for evidence synthesis. This is summarized in Table 3 below. Key points to note include: There are increasing numbers of published high quality qualitative and mixed method syntheses, which provide descriptions of methods and processes used. It is particularly important that reports of reviews within a Cochrane context include a detailed description of how the synthesis methods were applied; the key analytic and methodological choices made; and the challenges experienced. This will improve the transparency of the review process by providing an audit trail for the reader. Approaches that aim to produce higher order interpretations of included evidence require considerable expertise in qualitative methods; may also require a greater investment of resources; and may not be suitable for syntheses in which large numbers of primary studies need to be included. Most approaches do not provide detailed guidance on the sampling of studies for inclusion in the review or on how the quality of included studies should be appraised. Review authors will need to select from among the range of quality assessment tools available, bearing in mind the strengths and weaknesses of the different quality appraisal approaches (see Chapter 6). Table 3: Strengths and challenges of different methods for qualitative evidence synthesis (Dixon-Woods et al. 2005b; Pope et al. 2007: Briggs and Flemming 2007) ApproachMeta-ethnography Thematic analysis Meta-aggregation Grounded theory StrengthsSystematic approach combined with the potential for preserving the interpretive properties of the primary data.Allows clear identification of prominent themes, and organised and structured ways of dealing with a large volume of literature under these themes. It allows some flexibility by accommodating large volumes of literature Can accommodate studies using a wide range of methodologies and philosophical perspectives Provides a transparent and auditable pathway for the synthesis process The generation of higher order themes as a means of synthesis encourages reflexivity on the part of the reviewer while preserving the interpretive properties of the underlying data. Grounded theory, and the notions of theoretical saturation and theoretical sampling, also offers a means of limiting the number of papers that need be reviewed, especially where the emphasis is on conceptual robustness rather than on completeness of data.Challenges Requires high level of expertise Offers no guidance on sampling or appraisal Is solely a means of synthesis It is demanding and laborious, and might benefit from the development of suitable software or the use of existing software packages The process of qualitative synthesis cannot be reduced to a set of mechanistic tasks, and meta-ethnography thus runs into the usual problems of transparency No steer on which order the papers should be synthesised for reciprocal translational analysis. Other difficulties arise when a large number of reports need to be synthesised, because reciprocal translational analysis (RTA) appears to be most suitable for small stable sets of papers. Also, because RTA provides summaries in terms that have already been used in the literature, there is a danger that it will tend towards conservatism. Thematic analysis can be either data driven driven by the themes identified in the literature itself - or theory driven oriented to evaluation of particular themes through interrogation of the literature. The failure of much writing on thematic analysis to distinguish adequately between these two approaches has resulted in a lack of transparency There is lack of clarity about exactly what thematic analysis involves and the processes by which it can be achieved; for example, there is a lack of explicitness about procedures and aims, including the extent to which thematic analyses should be descriptive or interpretive. It is unclear whether the structure of the analysis should reflect the frequency with which particular themes are reported, or whether the analysis should be weighted towards themes that appear to have a high level of explanatory value. If thematic analysis is limited to summarising themes reported in primary studies, it offers little by way of theoretical structure within which to develop higher order thematic categories beyond those identified from the literature. Includes all findings from a paper regardless of whether they support a specific viewpoint or whether they are supported by direct quotes, therefore can result in large numbers of findings Finding are rated based on linkage with the text i.e. unequivocal, credible, unsupported Progressing single findings through categorisation to synthesised findings Does not generate third order interpretationsRequires a high level of expertise As an interpretive method it inherently lacks transparency No advice is offered on how to appraise studies for inclusion in a review There are several important epistemological issues to be resolved, including the status of the accounts offered in the studies and how to deal with the varying credibility of these accounts Tensions exist between grounded theory communities leading to development of convergent approaches  Using principles or adapting an approach Whilst the CQRMG have made some recommendations in this guidance about appropriate qualitative evidence synthesis methods to use within a Cochrane context, we acknowledge that methods continue to be adapted for different contexts and uses. For example Greenhalgh et al.s realist review of school feeding programmes (Greenhalgh et al. 2007) was undertaken to enhance a Cochrane review of school feeding for improving health outcomes among disadvantaged elementary school children (Kristjansson et al. 2007). Although realist review methodology is designed to incorporate different types of evidence, Greenhalgh et al. adapted the approach to only synthesise evidence from process evaluations conducted alongside included trials in the published Cochrane intervention review. They then applied the theoretical principles and processes of realist synthesis and created context, mechanism and outcome chains to consider what worked for whom and in what contexts. The product of this review provides a clear explanation about the theoretical adequacy of interventions and a theory as to why the poorest children did not benefit sufficiently from the intervention. Review authors may of course work independently of Cochrane and choose this type of adapted approach and, like Greenhalgh et al., publish the product in a high ranking journal, and include an explicit link with the Cochrane intervention review. CQRMG members will develop and amend this guidance as and when qualitative synthesis methods evolve and more high quality exemplars are available within a Cochrane framework. Approaches to incorporating or juxtaposing qualitative evidence syntheses with or alongside Cochrane intervention reviews of effects At present authors who wish to enhance or extend a Cochrane intervention review are compelled to undertake an approach that involves a separate qualitative evidence synthesis rather than a truly integrated mixed-method approach to managing different types of evidence. In the context of a Cochrane intervention review, the qualitative evidence synthesis will at some stage need to be integrated with the quantitative intervention effects review to explore and explain issues of interest, such as the heterogeneity of trial results. Section 20.3.2.5 of the Cochrane intervention handbook outlines two broad approaches that can be used to integrate qualitative and quantitative findings: Multi-level, simultaneous syntheses Qualitative evidence (synthesis 1) and quantitative evidence (synthesis 2) are each conducted as separate streams or separate, but linked, reviews. The product of each synthesis is then combined (synthesis 3). This approach mirrors the EPPI approach for integrating qualitative and quantitative evidence. For example, in a review of barriers and facilitators to healthy eating, Thomas et al. conducted both a synthesis of effectiveness findings from outcome evaluations (2004) and a synthesis of childrens views studies (2003) (See figure 2). A cross study synthesis drew together the findings from these two reviews by comparing interventions studied through outcome evaluations to the key findings from the childrens views studies. In doing so, the cross study synthesis identified both areas where issues raised in the views studies had been addressed by outcome evaluations and areas where gaps between views and outcomes studies existed (Thomas et al. 2003). Work underway by Leiknes et al. on integrated qualitative and effectiveness reviews on electroconvulsive therapy for depression will use a similar approach (see footnote 2).  SHAPE \* MERGEFORMAT  Figure 2. EPPI approach multi-layered syntheses Parallel syntheses Qualitative evidence (synthesis 1) and quantitative evidence (synthesis 2) can be conducted as separate streams or separate but linked reviews. These reviews might be undertaken by the same team or by two separate teams and may be undertaken simultaneously or sequentially. The qualitative synthesis findings can then be used in parallel and juxtaposed alongside the quantitative synthesis findings to aid the interpretation of the synthesized trials. (See for example Noyes & Popay 2007; and the work underway by Embuldeniya on peer support in chronic disease Table 2). 2.1 Adding a post-hoc parallel synthesis of qualitative evidence to a published Cochrane intervention review. Many published Cochrane reviews now call for a synthesis of qualitative evidence to help explain why an intervention has or has not worked, or to incorporate stakeholders views about the intervention or its impacts (see Figure 3). When adding to a published intervention review, the qualitative review authors have the benefit of knowing the quantitative review outcomes or issues of interest at the outset.  Figure 3. Integrating a new synthesis of qualitative evidence with a published Cochrane Intervention review. For example, Noyes and Popay (2007) selected a published Cochrane intervention review on Directly Observed Therapy and TB (Volmink and Garner 2006), and set out to use qualitative evidence to help explain the complex variations in trial outcomes and identify the facilitators and barriers to accessing and complying with the various types of directly observed therapy tested. In this post-hoc analysis, the authors of the qualitative review noted that the ways in which directly observed therapy was delivered was important in understanding the effects on cure rates of a particular type of observed therapy. The qualitative review also suggested that social and economic factors, as well as the considerable physical side-effects of the treatment, affected both treatment seeking behaviour for tuberculosis and treatment adherence (Noyes and Popay 2007; Noyes et al. 2008). If considering a post-hoc qualitative synthesis, and the qualitative team has no previous connection with the published Cochrane quantitative intervention review or its authors, it may be courteous to contact the original authors at the outset to signal your intention to add a qualitative synthesis to the quantitative review. This may also provide impetus or an additional opportunity for the quantitative team to update their review at the same time. In addition, the processes for publishing qualitative evidence syntheses alongside, or integrated with, published Cochrane intervention reviews have yet to be worked out. Therefore establishing a relationship with the quantitative review team may be important if additional qualitative evidence needs to be integrated with, and published alongside, another teams review. Working with a quantitative review team to inform, enhance or extend a new Cochrane intervention review The CQRMG is increasingly receiving enquiries from quantitative and qualitative teams who wish to work together and undertake a new Cochrane intervention review with an additional qualitative evidence synthesis in a concurrent process. With this approach, both review teams could potentially work together as appropriate and use qualitative evidence at various stages to aid understanding of quantitative outcomes and phenomena (see Figure 4).  SHAPE \* MERGEFORMAT  Figure 4. Undertaking quantitative and qualitative reviews as a concurrent and interactive processes Multiple level and parallel syntheses both require a separate systematic review of evidence from qualitative studies, which at some stage is synthesized with, or juxtaposed alongside, the synthesis of trials. Guidance on the conduct of narrative synthesis (Popay et al, 2006), contains a toolkit for bringing together findings from different study designs within different methods and approaches. Further methodological work is required on the processes by which evidence from studies using different qualitative methods and generating a range of types of evidence can be synthesized and combined with quantitative findings on effect without compromising the need to minimize bias (Lucas et al. 2007). Resources Many software packages designed for the analysis of primary qualitative evidence can be used for synthesis of secondary published qualitative evidence. Examples are listed in Table 5. Table 5: Examples of available qualitative synthesis software packages NvivoQARIATLAS. tiEPPI-ReviewerProduced byQSR International HYPERLINK "http://www.qsrinternational.com/"www.qsrinternational.com/ Joanna Briggs Institute HYPERLINK "http://www.joannabriggs.edu.au/services/sumari_info.php"www.joannabriggs.edu.au/services/sumari_info.php ATLAS.ti Scientific Software Development HYPERLINK "http://www.atlasti.de"www.atlasti.deEPPI Centre, Institute of Education, University of London HYPERLINK "http://eppi.ioe.ac.uk/cms/Default.aspx?tabid=1913&language=en-US"eppi.ioe.ac.uk/cms/Default.aspx?tabid=1913&language=en-USFree to downloadNoYesNoNo Publishing the qualitative evidence synthesis in the Cochrane library Processes have yet to be developed for publishing the product of the qualitative evidence synthesis and/or the product of the integrated quantitative and qualitative synthesis in the Cochrane library. Additional guidance on this will follow as these processes are established. Where conducting a qualitative synthesis within a Cochrane context does not seem appropriate For some review teams, the limitations of synthesizing and integrating qualitative evidence within a Cochrane context may appear too constraining to address fully the proposed review questions. After careful consideration, authors may feel that it is more appropriate to continue developing their review outside of a Cochrane context with less focus on the effectiveness of interventions and the freedom to use a mixed method approach. Outside of a Cochrane context, a number of synthesis approaches allow qualitative and quantitative evidence to be considered within one process rather than only in parallel. For example, Critical Interpretive Synthesis (Dixon-Woods et al. 2006), Realist Synthesis and the comparative case study approach (Agranoff and Radin 1991). For information, these approaches are summarized in Additional Table 1. References Agranoff R, Radin BA (1991). 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(2007) Synthesizing qualitative and quantitative health research. Oxford: Oxford University Press. Pound P, Britten N, Morgan M, Yardley L, Pope C, Daker-White G, Campbell R. (2005) Resisting medicines: a synthesis of qualitative studies of medicine taking. Social Science & Medicine. 6: 133-155 Roberts K, Dixon-Woods M, Fitzpatrick R, Abrams K, Jones D. (2002) Factors affecting uptake of childhood immunisation: a Bayesian synthesis of qualitative and quantitative evidence. The Lancet. 360 (9345): 1596-1599. Schumm K, Skea Z, McKee L, N'Dow J. (2020) 'They're doing surgery on two people': a meta-ethnography of the influences on couples' treatment decision making for prostate cancer. Health Expect. 13(4): 335-49. Spiegelhalter DJ, Myles JP, Jones DR, Abrams KR. (2000) Bayesian methods in health technology assessment: a review. Health Technol Assess. 4(38). Strauss A, Corbin J. (1998) Basics of qualitative research: techniques and procedures for developing grounded theory. 2nd ed. Thousand Oaks, Ca: Sage. Sutton AJ, Abrams KR. (2001) Bayesian methods in meta-analysis and evidence synthesis. Stat Methods Med Res. 10: 277303. Thomas J, Harden A, Oakley A, Oliver S, Sutcliffe K, Rees R, Brunton G, Kavanagh F. (2004) Integrating Qualitative Research with trials in systematic reviews: an example review from public health shows how integration is possible and some potential benefits. BMJ 328: 1010-12 Thomas J, Sutcliffe K, Harden A, Oakley A, Oliver S, Rees R, Brunton G, Kavanagh J. (2003) Children and Healthy Eating: A systematic review of barriers and facilitators. London: EPPI-Centre, Social Science Research Unit, Institute of Education, University of London. Available at: HYPERLINK "http://eppi.ioe.ac.uk/EPPIWebContent/hp/reports/healthy_eating02/Final_report_web.pdf"http://eppi.ioe.ac.uk/EPPIWebContent/hp/reports/healthy_eating02/Final_report_web.pdf Thomas J, Harden A. (2008) Methods for the thematic synthesis of qualitative research in systematic reviews. BMC Med Res Methodol. 8:45. Volmink J, Garner P. (2006) Directly observed therapy for treating tuberculosis. Cochrane Database of Systematic Reviews. Issue 4. Art No: CD003343. Additional Table 1: Mixed method approaches to synthesis of quantitative and qualitative evidence in common use outside of a Cochrane context Approach EPPI approachNarrative synthesis JBI approach Realist synthesis BayesianCritical Interpretive Inquiry Description, Theoretical Framework or Assumptions Usually includes a mapping or scoping review followed by refinement of the review question. Meta-analysis of the data extracted from trials is then conducted in parallel with thematic analysis to synthesise the textual data extracted from qualitative studies. The findings from the qualitative synthesis are then integrated with those from the quantitative meta-analysis i.e. one review with three syntheses. Tool box of approaches for the synthesis of qualitative and quantitative data. The framework includes: Developing a theory of how the intervention works, why and for whom Developing a preliminary synthesis of findings of included studies Exploring relationships in the data Assessing the robustness of the synthesis. . Integration / aggregation using comprehensive and exhaustive search strategies, a standardized approach to critical appraisal, data extraction and data synthesis as described in an a priori protocol. Data synthesis using the QARI software is process based, commencing with the identification of findings, categorization of findings and development of synthesized findings that are representative of the primary research they are drawn from. Synthesised findings are used as the basis for generalisable statements related to an intervention or phenomena of interest, specifically to inform practitioners. Realist synthesis is a model for synthesizing plural forms of evidence that are generated through the complex interactions between processes (mechanisms). The model draws on the methodological logic of realistic evaluation and applies it to the synthesis of plural forms of evidence. (McCormack et al. 2006)Bayesian analysis begins with beliefs that are temporally or logically prior to the main data, formally expressed as a probability distribution, and updates these beliefs using the main data to produce an assessment of current evidence. It allows the integration of qualitative and quantitative forms of evidence, and explicitly allows qualitative evidence to contribute to meta-analysis by identifying variables to be included and providing evidence about effect sizes. (Dixon-Woods et al. 2005a)This method does not take a sequential approach to review but rather sees question formulation, searching, selection, data extraction, critique and synthesis as iterative processes. (Dixon-Woods et al.2006) Synthesis approachInterpretiveInterpretiveAggregativeInterpretiveInterpretiveInterpretiveGuidance and examplesThomas & Harden (2008) describes the approach used in EPPI reviews, including data extraction, coding and synthesis Thomas et al. (2003) review on children and healthy eating Several other examples described in Harden et al. 2004 Popay et al - ESRC guidance 2006 Arai et al. (2005) review on the use of domestic smoke detectors The Joanna Briggs Institute Reviewers Manual, 2008 Edition, SUMARI User guide, 2008, Version 4.0 Pearson et al (2005) Pawson 2006; Pawson and Boaz 2004; Pawson et al 2004; Pawson & Tilley 1997 Greenhalgh et al.s re- interpretation of a Cochrane review of childrens feeding programmes (2007); McCormack et al. (2006) review on practice development Sutton et al. 2001; Spiegelhalter et al. 2000; Roberts et al 2002 Dixon-Woods et al 2006 on access to healthcare by vulnerable groups; Flemming 2010 on the use of morphine to treat cancer-related pain  A number of titles and protocols are in development for qualitative reviews within the Cochrane framework, including the following: Protocol: Lins S et al. Telephone counselling for informal carers of people with dementia. Cochrane Dementia & Cognitive Improvement Group. Protocol: Leiknes KA et al. Electroconvulsive therapy for depression. Cochrane Depression, Anxiety and Neurosis Group. Title: Cracknell J. Factors which impact on the use of weaning protocols for reducing the duration of mechanical ventilation in adults and children: a qualitative evidence synthesis. Cochrane Airways Review Group. Title: Cassidy T et al. Psychosocial and cultural interventions to reduce alcohol consumption during lactation. Cochrane Drugs and Alcohol Group.     Version 1. 23 December 2010 PAGE  PAGE 1 Decision to conduct a qualitative evidence synthesis To aggregate / summarise / integrate qualitative data to address specific questions in relation to a Cochrane intervention review To interpret synthesised qualitative evidence and develop explanatory theory or models Primarily to integrate and interpret qualitative and quantitative evidence within a single approach or integrated model Can be used to develop explanatory theory Purpose of the additional qualitative synthesis Thematic analysis without theory generation Meta-aggregation Meta-summary Realist review EPPI approach Narrative synthesis Bayesian synthesis Critical interpretive synthesis Meta-ethnography Thematic analysis with theory generation Grounded theory Product Explanatory theory, analytical or conceptual framework or interpretative framework/ mechanism Product Aggregated findings from source papers Cochrane Intervention Review Qualitative Evidence Synthesis Research Question(s) Synthesis of Qualitative and Quantitative Studies Cochrane Intervention Review Qualitative Evidence Synthesis  "#$9:X~x : Ϸ÷ϷkkTkMEAEhnjhnU h_hXfF-h_hXfF0J06B*fHphq *h_hXfF0J0B*fHphq $hXfF0J0B*fHphq 0h_hXfF0J05B*\fHphq hXfFhXfF0J05hXfFhZg5CJ aJ hXfFhj%5CJ aJ hXfFhaa5CJ aJ hXfFh%u5CJ aJ hXfFh"95CJ aJ hXfFhXfF5CJ aJ $' ( ) 4 5 5 6 5 } & F 88^8gdXfF & F hh^hgdXfF & F he^e`gdXfF hh7$8$H$^h`gdXfF & F he7$8$H$^e`gdXfF$a$gdXfF & F[$\$gdXfFgdXfF % & ' ( ) 4 5 B C e n v y ! 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