Using qualitative evidence in decision making for health and social interventions: an approach to assess confidence in findings from qualitative evidence syntheses (GRADE-CERQual). They can explain the mechanisms by which interventions, evaluated within trials, might achieve their effect. BMC Medical Research Methodology 2011; 11: 124. Explicit reporting standards have been developed. (Booth et al 2016). We would like to thank the previous Chapter 20 authors Jennie Popay and Alan Pearson. Themes are then integrated within the quantitative synthesis. For all reviews, it is important to define criteria such as the population, intervention, comparison and outcomes, and to identify potential risks of bias. Harden A, Thomas J, Cargo M, Harris J, Pantoja T, Flemming K, Booth A, Garside R, Hannes K, Noyes J. Cochrane Qualitative and Implementation Methods Group guidance series-paper 5: methods for integrating qualitative and implementation evidence within intervention effectiveness reviews. Tools not meeting the criterion of focusing on assessment of methodological strengths and limitations include those that integrate assessment of the quality of reporting (such as scoring of the title and abstract, etc) into an overall assessment of methodological strengths and limitations. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. Cochrane Database of Systematic Reviews 2010; 3: CD004015. London: National Institute for Health and Care Excellence (NICE); 2012. Journal of Clinical Epidemiology 2018; 99: 41-52. Elements of this chapter draw on previous supplemental guidance produced by the Cochrane Qualitative and Implementation Methods Group Convenors, to which Simon Lewin contributed. Qualitative research is not statistically representative. Authors should distinguish between assessment of study quality and assessment of risk of bias by focusing on assessment of methodological strengths and limitations as a marker of study rigour (what we term a ‘risk to rigour’ approach (Noyes et al 2019)). No room for reflexivity? A systematic review with qualitative syntheses was performed (CRD42017065149). A qualitative evidence synthesis (commonly referred to as QES) can add value by providing decision makers with additional evidence to improve understanding of intervention complexity, contextual variations, implementation, and stakeholder preferences and experiences. Authors will typically find that they cannot select an appropriate synthesis method until the pool of available qualitative evidence has been thoroughly scoped. Meta-ethnography: synthesizing qualitative studies. Cochrane, 2020. The benefits and challenges of using systematic reviews in international development research ... tive and/or qualitative data, in order to synthesise the evidence. Decisions on whether to include all studies or to select a sample of studies depend on a range of general and review specific criteria that Noyes and colleagues (Noyes et al (2019) outline in detail. Meta-analysis of continuous outcomes combining individual patient data and aggregate data. Nevertheless, filters may facilitate efficient retrieval by study type (e.g. Dixon-Woods M. Using framework-based synthesis for conducting reviews of qualitative studies. Depending on the field, a meta-analysis is often used to combine and directly compare quantitative results. Time frame – consider what type of qualitative evidence synthesis will be feasible and manageable within the time frame available (Booth et al 2016). Does the approach to question formulation, the scope of the review and the intended outputs meet their needs? Its pur-pose is to introduce fundamental concepts and basic methodologies to both readers and researchers, who may have already encountered qualitative synthesis within systematic reviews of the literature. More work is needed to determine how CERQual can be applied to theoretical findings. One component of this approach requires an appraisal of the methodological limitations of studies contributing data to a review finding. These different forms of social theory can be used to visualize and map the research question, its context, components, influential factors and possible outcomes (Noyes et al 2016a, Rehfuess et al 2018). BMJ Global Health 2019; 4 (Suppl 1): e000899. However, within systematic reviews and evidence syntheses it is considered essential, even when studies are not to be excluded on the basis of quality (Carroll et al 2013). In the absence of an explicit programme theory and detail of how implementation relates to outcomes, an a priori realist review, meta-ethnography or meta-interpretive review can be undertaken (Booth et al 2016). BMC Medical Research Methodology 2016; 16: 21. Adapted from Noyes et al (2019) and Alvesson and Sköldberg (2009). We will Qualitative systematic reviews or qualitative evidence syntheses (QES) are increasingly recognised as a way to enhance the value of systematic reviews (SRs) of clinical trials. The framework allows a clear mechanism for integration of qualitative and quantitative evidence in an aggregative way – see Noyes et al (2018a). Some features of the site may not work correctly. BMJ Global Health 2019; 4: e000882. Resources – consider whether the ambition of the review matches the available resources. Methods for qualitative evidence synthesis are complex and continue to develop. Sandelowski M, Barroso J. Booth A, Noyes J, Flemming K, Gehardus A, Wahlster P, Jan van der Wilt G, Mozygemba K, Refolo P, Sacchini D, Tummers M, Rehfuess E. Structured methodology review identified seven (RETREAT) criteria for selecting qualitative evidence synthesis approaches. This involves conducting a sensitive topic search without any study design filter (Harden et al 1999), and identifying all study designs of interest during the screening process. Another key decision is whether to use study filters or simply to conduct a topic-based search where qualitative studies are identified at the study selection stage. Booth A, Carroll C. How to build up the actionable knowledge base: the role of 'best fit' framework synthesis for studies of improvement in healthcare. A strong understanding of how an intervention is thought to work, and how it should be implemented in practice, will enable a critical consideration of whether any observed lack of effect might be due to a poorly conceptualized intervention (i.e. They can investigate differences in effects between different population groups. Theoretical findings may combine empirical evidence, expert opinion and conjecture to form hypotheses. Process evaluation of complex interventions: Medical Research Council guidance. A range of methods and tools is available for data integration or mixed-method synthesis (Harden et al 2018, Noyes et al 2019). France EF, Cunningham M, Ring N, Uny I, Duncan EAS, Jepson RG, Maxwell M, Roberts RJ, Turley RL, Booth A, Britten N, Flemming K, Gallagher I, Garside R, Hannes K, Lewin S, Noblit G, Pope C, Thomas J, Vanstone M, Higginbottom GMA, Noyes J. Kneale D, Thomas J, Harris K. Developing and Optimising the Use of Logic Models in Systematic Reviews: Exploring Practice and Good Practice in the Use of Programme Theory in Reviews. We encourage review authors to discuss the studies and their assessments of ‘risk to rigour’ for each paper and how the study’s methodological limitations may affect review findings (Noyes et al 2019). BMJ 2017; 356: j80. Data extraction is not sequential and linear; often, it involves moving backwards and forwards between review stages. BMJ 2007; 335: 858. Ames HM, Glenton C, Lewin S. Parents' and informal caregivers' views and experiences of communication about routine childhood vaccination: a synthesis of qualitative evidence. women’s conceptualization of what good antenatal care looks like); identifying associations between the broader environment within which people live and the interventions that are implemented; increasing understanding of the values and attitudes toward, and experiences of, health conditions and interventions by those who implement or receive them; and. In relation to the woman’s perceptions and experiences? The second potential problem with qualitative research is that a particular problem could go unnoticed (Bowen 2006). Irrespective of the review type and choice of synthesis method, we consider it best practice to extract detailed contextual and methodological information on each study and to report this information in a table of ‘Characteristics of included studies’ (see Table 21.11.a). More detailed guidance is provided by Cargo and colleagues (Cargo et al (2018). Kahwati L, Jacobs S, Kane H, Lewis M, Viswanathan M, Golin CE. Candy B, King M, Jones L, Oliver S. Using qualitative synthesis to explore heterogeneity of complex interventions. Jane Noyes, Andrew Booth, Margaret Cargo, Kate Flemming, Angela Harden, Janet Harris, Ruth Garside, Karin Hannes, Tomás Pantoja, James Thomas. Risk of simplistically forcing data into a framework for expedience. Qualitative: In this type of systematic review, the results of relevant studies are summarized but not statistically combined. Upper Saddle River (NJ): Pearson Prentice Hall; 2005. One such purpose is their use, alongside reviews of effectiveness, to inform guidelines and other decisions, with the first Cochrane qualitative evidence synthesis published in 2013 . Systematic Reviews 2014; 3: 67. Bonell C, Jamal F, Harden A, Wells H, Parry W, Fletcher A, Petticrew M, Thomas J, Whitehead M, Campbell R, Murphy S, Moore L. Public Health Research. From Noyes et al (2019). The BeHEMoTh approach has been developed for identifying explicit use of theory (Booth and Carroll 2015). Systematic Reviews 2016; 5: 82. Both can provide useful information, with trial sibling studies obviously closer in terms of their precise contexts to the included trials (Moore et al 2015), and non-sibling studies possibly contributing perspectives not present in the trials (Noyes et al 2016b). (Squires et al 2013, Kelly et al 2017). Review teams will need regular meetings to discuss and further interrogate the evidence and thereby achieve a shared understanding. When thinking about qualitative evidence, specific terminology is used to describe the level of conceptual and contextual detail. Qualitative findings may take the form of quotations from participants, subthemes and themes identified by the study’s authors, explanations, hypotheses or new theory, or observational excerpts and author interpretations of these data (Sandelowski and Barroso 2002). In: Facey K, editor. Important elements of study context, relevant to addressing the review question and locating the context of the primary study; for example, the study setting, population characteristics, participants and participant characteristics, the intervention delivered (if appropriate), etc. Irrespective of whether the qualitative synthesis is sequential or convergent to the intervention review, we recommend that qualitative and quantitative evidence be synthesized separately using appropriate methods before integration (Harden et al 2018). Lewin S, Booth A, Glenton C, Munthe-Kaas H, Rashidian A, Wainwright M, Bohren MA, Tuncalp O, Colvin CJ, Garside R, Carlsen B, Langlois EV, Noyes J. Pros: Most accessible form of synthesis. Also, recommendations are made to improve the conducting and reporting of this type of review. Like all systematic reviews, optimal methods for reviewing qualitative research are still evolving, however published reviews demonstrate considerable variability in their approach. Poor indexing of qualitative studies makes citation searching (forward and backward) and the Related Articles features of electronic databases particularly useful (Cooper et al 2017). Findings may be presented as a narrative, or summarized and displayed as tables, infographics or logic models and potentially located in any part of the paper (Noyes et al 2019). Principal considerations when planning a search for qualitative studies, and the evidence that underpins them, have been characterized using a 7S framework from Sampling and Sources through Structured questions, Search procedures, Strategies and filters and Supplementary strategies to Standards for Reporting (Booth et al 2016). Meta-analysis of data from the six primary prevention trials of cardiovascular events using aspirin. Methods for qualitative data extraction vary according to the synthesis method selected. Glenton C, Colvin CJ, Carlsen B, Swartz A, Lewin S, Noyes J, Rashidian A. Available from www.training.cochrane.org/handbook. Types of systematic reviews. Systematic review of the effects of schools and school environment interventions on health: evidence mapping and synthesis. Integrating qualitative research with trials in systematic reviews. A systematic review. Aggregate data meta-analysis with time-to-event outcomes. Research Synthesis Methods 2017; 8: 303-311. Assessment of the methodological strengths and limitations of qualitative research remains contested within the primary qualitative research community (Garside 2014). BMC Medical Research Methodology 2009; 9: 59. The intervention Complexity Assessment Tool for Systematic Reviews iCAT_SR (Lewin et al 2017) may be helpful in classifying complexity in interventions and developing associated questions. Vaccine 2011; 29: 9588-9599. There are two main designs for synthesizing qualitative evidence with evidence of the effects of interventions: It is increasingly common for sequential and convergent reviews to be conducted by some or all of the same authors; if not, it is critical that authors working on the qualitative evidence synthesis and intervention review work closely together to identify and create sufficient points of integration to enable a third synthesis that integrates the two reviews, or the conduct of a mixed-method review (Noyes et al 2018a) (see Figure 21.2.a).
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