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Background: The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual's relevance component.Methods: We developed the relevance component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual relevance component within several qualitative evidence syntheses before agreeing on the current definition and principles for application.Results: When applying CERQual, we define relevance as the extent to which the body of data from the primary studies supporting a review finding is applicable to the context (perspective or population, phenomenon of interest, setting) specified in the review question. In this paper, we describe the relevance component and its rationale and offer guidance on how to assess relevance in the context of a review finding. This guidance outlines the information required to assess relevance, the steps that need to be taken to assess relevance and examples of relevance assessments.Conclusions: This paper provides guidance for review authors and others on undertaking an assessment of relevance in the context of the CERQual approach. Assessing the relevance component requires consideration of potentially important contextual factors at an early stage in the review process. We expect the CERQual approach, and its individual components, to develop further as our experiences with the practical implementation of the approach increase. [ABSTRACT FROM AUTHOR]

Background: The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on a probable fifth component, dissemination bias. Given its exploratory nature, we are not yet able to provide guidance on applying this potential component of the CERQual approach. Instead, we focus on how dissemination bias might be conceptualised in the context of qualitative research and the potential impact dissemination bias might have on an overall assessment of confidence in a review finding. We also set out a proposed research agenda in this area.Methods: We developed this paper by gathering feedback from relevant research communities, searching MEDLINE and Web of Science to identify and characterise the existing literature discussing or assessing dissemination bias in qualitative research and its wider implications, developing consensus through project group meetings, and conducting an online survey of the extent, awareness and perceptions of dissemination bias in qualitative research.Results: We have defined dissemination bias in qualitative research as a systematic distortion of the phenomenon of interest due to selective dissemination of studies or individual study findings. Dissemination bias is important for qualitative evidence syntheses as the selective dissemination of qualitative studies and/or study findings may distort our understanding of the phenomena that these syntheses aim to explore and thereby undermine our confidence in these findings. Dissemination bias has been extensively examined in the context of randomised controlled trials and systematic reviews of such studies. The effects of potential dissemination bias are formally considered, as publication bias, within the GRADE approach. However, the issue has received almost no attention in the context of qualitative research. Because of very limited understanding of dissemination bias and its potential impact on review findings in the context of qualitative evidence syntheses, this component is currently not included in the GRADE-CERQual approach.Conclusions: Further research is needed to establish the extent and impacts of dissemination bias in qualitative research and the extent to which dissemination bias needs to be taken into account when we assess how much confidence we have in findings from qualitative evidence syntheses. [ABSTRACT FROM AUTHOR]

The GRADE-CERQual ('Confidence in the Evidence from Reviews of Qualitative research') approach provides guidance for assessing how much confidence to place in findings from systematic reviews of qualitative research (or qualitative evidence syntheses). The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. Confidence in the evidence from qualitative evidence syntheses is an assessment of the extent to which a review finding is a reasonable representation of the phenomenon of interest. CERQual provides a systematic and transparent framework for assessing confidence in individual review findings, based on consideration of four components: (1) methodological limitations, (2) coherence, (3) adequacy of data, and (4) relevance. A fifth component, dissemination (or publication) bias, may also be important and is being explored. As with the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach for effectiveness evidence, CERQual suggests summarising evidence in succinct, transparent, and informative Summary of Qualitative Findings tables. These tables are designed to communicate the review findings and the CERQual assessment of confidence in each finding. This article is the first of a seven-part series providing guidance on how to apply the CERQual approach. In this paper, we describe the rationale and conceptual basis for CERQual, the aims of the approach, how the approach was developed, and its main components. We also outline the purpose and structure of this series and discuss the growing role for qualitative evidence in decision-making. Papers 3, 4, 5, 6, and 7 in this series discuss each CERQual component, including the rationale for including the component in the approach, how the component is conceptualised, and how it should be assessed. Paper 2 discusses how to make an overall assessment of confidence in a review finding and how to create a Summary of Qualitative Findings table. The series is intended primarily for those undertaking qualitative evidence syntheses or using their findings in decision-making processes but is also relevant to guideline development agencies, primary qualitative researchers, and implementation scientists and practitioners. [ABSTRACT FROM AUTHOR]

Background: The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual's methodological limitations component.Methods: We developed the methodological limitations component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual methodological limitations component within several qualitative evidence syntheses before agreeing on the current definition and principles for application.Results: When applying CERQual, we define methodological limitations as the extent to which there are concerns about the design or conduct of the primary studies that contributed evidence to an individual review finding. In this paper, we describe the methodological limitations component and its rationale and offer guidance on how to assess methodological limitations of a review finding as part of the CERQual approach. This guidance outlines the information required to assess methodological limitations component, the steps that need to be taken to assess methodological limitations of data contributing to a review finding and examples of methodological limitation assessments.Conclusions: This paper provides guidance for review authors and others on undertaking an assessment of methodological limitations in the context of the CERQual approach. More work is needed to determine which criteria critical appraisal tools should include when assessing methodological limitations. We currently recommend that whichever tool is used, review authors provide a transparent description of their assessments of methodological limitations in a review finding. We expect the CERQual approach and its individual components to develop further as our experiences with the practical implementation of the approach increase. [ABSTRACT FROM AUTHOR]

Background: The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) working group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations; (2) coherence; (3) adequacy of data; and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual's adequacy of data component.Methods: We developed the adequacy of data component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual adequacy of data component within several qualitative evidence syntheses before agreeing on the current definition and principles for application.Results: When applying CERQual, we define adequacy of data as an overall determination of the degree of richness and the quantity of data supporting a review finding. In this paper, we describe the adequacy component and its rationale and offer guidance on how to assess data adequacy in the context of a review finding as part of the CERQual approach. This guidance outlines the information required to assess data adequacy, the steps that need to be taken to assess data adequacy, and examples of adequacy assessments.Conclusions: This paper provides guidance for review authors and others on undertaking an assessment of adequacy in the context of the CERQual approach. We approach assessments of data adequacy in terms of the richness and quantity of the data supporting each review finding, but do not offer fixed rules regarding what constitutes sufficiently rich data or an adequate quantity of data. Instead, we recommend that this assessment is made in relation to the nature of the finding. We expect the CERQual approach, and its individual components, to develop further as our experiences with the practical implementation of the approach increase. [ABSTRACT FROM AUTHOR]

Background: The GRADE-CERQual (Grading of Recommendations Assessment, Development and Evaluation-Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE working group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) relevance, (3) coherence and (4) adequacy of data. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual's coherence component.Methods: We developed the coherence component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual coherence component within several qualitative evidence syntheses before agreeing on the current definition and principles for application.Results: When applying CERQual, we define coherence as how clear and cogent the fit is between the data from the primary studies and a review finding that synthesises that data. In this paper, we describe the coherence component and its rationale and offer guidance on how to assess coherence in the context of a review finding as part of the CERQual approach. This guidance outlines the information required to assess coherence, the steps that need to be taken to assess coherence and examples of coherence assessments.Conclusions: This paper provides guidance for review authors and others on undertaking an assessment of coherence in the context of the CERQual approach. We suggest that threats to coherence may arise when the data supporting a review finding are contradictory, ambiguous or incomplete or where competing theories exist that could be used to synthesise the data. We expect the CERQual approach, and its individual components, to develop further as our experiences with the practical implementation of the approach increase. [ABSTRACT FROM AUTHOR]

Background: The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on making an overall assessment of confidence in a review finding and creating a CERQual Evidence Profile and a CERQual Summary of Qualitative Findings table.Methods: We developed this guidance by examining the methods used by other GRADE approaches, gathering feedback from relevant research communities and developing consensus through project group meetings. We then piloted the guidance on several qualitative evidence syntheses before agreeing on the approach.Results: Confidence in the evidence is an assessment of the extent to which a review finding is a reasonable representation of the phenomenon of interest. Creating a summary of each review finding and deciding whether or not CERQual should be used are important steps prior to assessing confidence. Confidence should be assessed for each review finding individually, based on the judgements made for each of the four CERQual components. Four levels are used to describe the overall assessment of confidence: high, moderate, low or very low. The overall CERQual assessment for each review finding should be explained in a CERQual Evidence Profile and Summary of Qualitative Findings table.Conclusions: Structuring and summarising review findings, assessing confidence in those findings using CERQual and creating a CERQual Evidence Profile and Summary of Qualitative Findings table should be essential components of undertaking qualitative evidence syntheses. This paper describes the end point of a CERQual assessment and should be read in conjunction with the other papers in the series that provide information on assessing individual CERQual components. [ABSTRACT FROM AUTHOR]

Background: The purpose and contribution of supplementary search methods in systematic reviews is increasingly acknowledged. Numerous studies have demonstrated their potential in identifying studies or study data that would have been missed by bibliographic database searching alone. What is less certain is how supplementary search methods actually work, how they are applied, and the consequent advantages, disadvantages and resource implications of each search method. The aim of this study is to compare current practice in using supplementary search methods with methodological guidance. Methods: Four methodological handbooks in informing systematic review practice in the UK were read and audited to establish current methodological guidance. Studies evaluating the use of supplementary search methods were identified by searching five bibliographic databases. Studies were included if they (1) reported practical application of a supplementary search method (descriptive) or (2) examined the utility of a supplementary search method (analytical) or (3) identified/explored factors that impact on the utility of a supplementary method, when applied in practice. Results: Thirty-five studies were included in this review in addition to the four methodological handbooks. Studies were published between 1989 and 2016, and dates of publication of the handbooks ranged from 1994 to 2014. Five supplementary search methods were reviewed: contacting study authors, citation chasing, handsearching, searching trial registers and web searching. Conclusions: There is reasonable consistency between recommended best practice (handbooks) and current practice (methodological studies) as it relates to the application of supplementary search methods. The methodological studies provide useful information on the effectiveness of the supplementary search methods, often seeking to evaluate aspects of the method to improve effectiveness or efficiency. In this way, the studies advance the understanding of the supplementary search methods. Further research is required, however, so that a rational choice can be made about which supplementary search strategies should be used, and when. [ABSTRACT FROM AUTHOR]

Background: Unintended repeat conceptions can result in emotional, psychological and educational harm to young women, often with enduring implications for their life chances. This study aimed to identify which young women are at the greatest risk of repeat unintended pregnancies; which interventions are effective and cost-effective; and what are the barriers to and facilitators for the uptake of these interventions.Methods: We conducted a mixed-methods systematic review which included meta-analysis, framework synthesis and application of realist principles, with stakeholder input and service user feedback to address this. We searched 20 electronic databases, including MEDLINE, Excerpta Medica database, Applied Social Sciences Index and Abstracts and Research Papers in Economics, to cover a broad range of health, social science, health economics and grey literature sources. Searches were conducted between May 2013 and June 2014 and updated in August 2015.Results: Twelve randomised controlled trials (RCTs), two quasi-RCTs, 10 qualitative studies and 53 other quantitative studies were identified. The RCTs evaluated psychosocial interventions and an emergency contraception programme. The primary outcome was repeat conception rate: the event rate was 132 of 308 (43%) in the intervention group versus 140 of 289 (48%) for the control group, with a non-significant risk ratio (RR) of 0.92 [95% confidence interval (CI) 0.78-1.08]. Four studies reported subsequent birth rates: 29 of 237 (12%) events for the intervention arm versus 46 out of 224 (21%) for the control arm, with an RR of 0.60 (95% CI 0.39-0.93). Many repeat conceptions occurred in the context of poverty, low expectations and aspirations and negligible opportunities. Qualitative and realist evidence highlighted the importance of context, motivation, future planning and giving young women a central and active role in the development of new interventions.Conclusions: Little or no evidence for the effectiveness or cost-effectiveness of any of the interventions to reduce repeat pregnancy in young women was found. Qualitative and realist evidence helped to explain gaps in intervention design that should be addressed. More theory-based, rigorously evaluated programmes need to be developed to reduce unintended repeat pregnancy in young women.Trial Registration: PROSPERO, CRD42012003168 . Cochrane registration number: i = fertility/0068. [ABSTRACT FROM AUTHOR]

Background: Medication-related adverse events have been estimated to be responsible for 5700 deaths and cost the UK £750 million annually. This burden falls disproportionately on older people. Outcomes from interventions to optimise medication management are caused by multiple context-sensitive mechanisms. The MEdication Management in Older people: REalist Approaches BAsed on Literature and Evaluation (MEMORABLE) project uses realist synthesis to understand how, why, for whom and in what context interventions, to improve medication management in older people on complex medication regimes residing in the community, work. Method: This realist synthesis uses secondary data and primary data from interviews to develop the programme theory. A realist logic of analysis will synthesise data both within and across the two data sources to inform the design of a complex intervention(s) to help improve medication management in older people. 1. Literature Review The review (using realist synthesis) contains five stages to develop an initial programme theory to understand why processes are more or less successful and under which situations: Focussing of the research question; developing the initial programme theory; developing the search strategy; selection and appraisal based on relevance and rigour; and data analysis/synthesis to develop and refine the programme theory and context, intervention, mechanism configurations. 2. Realist Interviews Realist interviews will explore and refine our understanding of the programme theory developed from the realist synthesis. Up to 30 older people and their informal carers (15 older people with multi-morbidity, 10 informal carers and 5 older people with dementia), and 20 care staff will be interviewed. 3. Developing framework for the Intervention(s) Data from the realist synthesis and interviews will be used to develop a framework for the intervention(s) to identify: the mechanisms that need to be 'triggered', and the contexts related to these mechanisms. Intervention strategies that change the contexts so the mechanisms are triggered to produce desired outcomes will be developed. Feedback on these strategies will be obtained. Discussion: This realist synthesis aims to develop a framework (underpinned by our programme theory) for a novel multi-disciplinary, multi-agency intervention(s), to improve medication management in communitydwelling older people on complex medication regimens. [ABSTRACT FROM AUTHOR]

Background: The effectiveness of complex interventions, as well as their success in reaching relevant populations, is critically influenced by their implementation in a given context. Current conceptual frameworks often fail to address context and implementation in an integrated way and, where addressed, they tend to focus on organisational context and are mostly concerned with specific health fields. Our objective was to develop a framework to facilitate the structured and comprehensive conceptualisation and assessment of context and implementation of complex interventions.Methods: The Context and Implementation of Complex Interventions (CICI) framework was developed in an iterative manner and underwent extensive application. An initial framework based on a scoping review was tested in rapid assessments, revealing inconsistencies with respect to the underlying concepts. Thus, pragmatic utility concept analysis was undertaken to advance the concepts of context and implementation. Based on these findings, the framework was revised and applied in several systematic reviews, one health technology assessment (HTA) and one applicability assessment of very different complex interventions. Lessons learnt from these applications and from peer review were incorporated, resulting in the CICI framework.Results: The CICI framework comprises three dimensions-context, implementation and setting-which interact with one another and with the intervention dimension. Context comprises seven domains (i.e., geographical, epidemiological, socio-cultural, socio-economic, ethical, legal, political); implementation consists of five domains (i.e., implementation theory, process, strategies, agents and outcomes); setting refers to the specific physical location, in which the intervention is put into practise. The intervention and the way it is implemented in a given setting and context can occur on a micro, meso and macro level. Tools to operationalise the framework comprise a checklist, data extraction tools for qualitative and quantitative reviews and a consultation guide for applicability assessments.Conclusions: The CICI framework addresses and graphically presents context, implementation and setting in an integrated way. It aims at simplifying and structuring complexity in order to advance our understanding of whether and how interventions work. The framework can be applied in systematic reviews and HTA as well as primary research and facilitate communication among teams of researchers and with various stakeholders. [ABSTRACT FROM AUTHOR]

Background: NHS England’s Five Year Forward View (NHS England, Five Year Forward View, 2014) formally introduced a strategy for new models of care driven by simultaneous pressures to contain costs, improve care and deliver services closer to home through integrated models. This synthesis focuses on a multispecialty community provider (MCP) model. This new model of care seeks to overcome the limitations in current models of care, often based around single condition-focused pathways, in contrast to patient-focused delivery (Royal College of General Practitioners, The 2022 GP: compendium of evidence, 2012) which offers greater continuity of care in recognition of complex needs and multimorbidity. Methods: The synthesis, an innovative combination of best fit framework synthesis and realist synthesis, will develop a “blueprint” which articulates how and why MCP models work, to inform design of future iterations of the MCP model. A systematic search will be conducted to identify research and practice-derived evidence to achieve a balance that captures the historical legacy of MCP models but focuses on contemporary evidence. Sources will include bibliographic databases including MEDLINE, PreMEDLINE, CINAHL, Embase, HMIC and Cochrane Library; and grey literature sources. The Best Fit synthesis methodology will be combined with a synthesis following realist principles which are particularly suited to exploring what works, when, for whom and in what circumstances. Discussion: The aim of this synthesis is to provide decision makers in health and social care with a practical evidence base relating to the multispecialty community provider (MCP) model of care. [ABSTRACT FROM AUTHOR]

Background: The importance of respecting patients' preferences when making treatment decisions is increasingly recognized. Efficiently retrieving papers from the scientific literature reporting on the presence and nature of such preferences can help to achieve this goal. The objective of this study was to create a search filter for PubMed to help retrieve evidence on patient preferences for treatment outcomes.Methods: A total of 27 journals were hand-searched for articles on patient preferences for treatment outcomes published in 2011. Selected articles served as a reference set. To develop optimal search strategies to retrieve this set, all articles in the reference set were randomly split into a development and a validation set. MeSH-terms and keywords retrieved using PubReMiner were tested individually and as combinations in PubMed and evaluated for retrieval performance (e.g. sensitivity (Se) and specificity (Sp)).Results: Of 8238 articles, 22 were considered to report empirical evidence on patient preferences for specific treatment outcomes. The best search filters reached Se of 100 % [95 % CI 100-100] with Sp of 95 % [94-95 %] and Sp of 97 % [97-98 %] with 75 % Se [74-76 %]. In the validation set these queries reached values of Se of 90 % [89-91 %] with Sp 94 % [93-95 %] and Se of 80 % [79-81 %] with Sp of 97 % [96-96 %], respectively.Conclusions: Narrow and broad search queries were developed which can help in retrieving literature on patient preferences for treatment outcomes. Identifying such evidence may in turn enhance the incorporation of patient preferences in clinical decision making and health technology assessment. [ABSTRACT FROM AUTHOR]

Background: 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. They can explain the mechanisms by which interventions, evaluated within trials, might achieve their effect. They can investigate differences in effects between different population groups. They can identify which outcomes are most important to patients, carers, health professionals and other stakeholders. QES can explore the impact of acceptance, feasibility, meaningfulness and implementation-related factors within a real world setting and thus contribute to the design and further refinement of future interventions. To produce valid, reliable and meaningful QES requires systematic identification of relevant qualitative evidence. Although the methodologies of QES, including methods for information retrieval, are well-documented, little empirical evidence exists to inform their conduct and reporting. Methods: This structured methodological overview examines papers on searching for qualitative research identified from the Cochrane Qualitative and Implementation Methods Group Methodology Register and from citation searches of 15 key papers. Results: A single reviewer reviewed 1299 references. Papers reporting methodological guidance, use of innovative methodologies or empirical studies of retrieval methods were categorised under eight topical headings: overviews and methodological guidance, sampling, sources, structured questions, search procedures, search strategies and filters, supplementary strategies and standards. Conclusions: This structured overview presents a contemporaneous view of information retrieval for qualitative research and identifies a future research agenda. This review concludes that poor empirical evidence underpins current information practice in information retrieval of qualitative research. A trend towards improved transparency of search methods and further evaluation of key search procedures offers the prospect of rapid development of search methods. [ABSTRACT FROM AUTHOR]

Background: District health managers play a key role in the effectiveness of decentralized health systems in lowand middle-income countries. Inadequate management and leadership skills often hamper their ability to improve quality of care and effectiveness of health service delivery. Nevertheless, significant investments have been made in capacity-building programmes based on site-based training, mentoring, and operational research. This systematic review aims to review the effectiveness of site-based training, mentoring, and operational research (or action research) on the improvement of district health system management and leadership. Our secondary objectives are to assess whether variations in composition or intensity of the intervention influence its effectiveness and to identify enabling and constraining contexts and underlying mechanisms. Methods: We will search the following databases: MEDLINE, PsycInfo, Cochrane Library, CRD database (DARE), Cochrane Effective Practice and Organisation of Care (EPOC) group, ISI Web of Science, Health Evidence.org, PDQEvidence, ERIC, EMBASE, and TRIP. Complementary search will be performed (hand-searching journals and citation and reference tracking). Studies that meet the following PICO (Population, Intervention, Comparison, Outcome) criteria will be included: P: professionals working at district health management level; I: site-based training with or without mentoring, or operational research; C: normal institutional arrangements; and O: district health management functions. We will include cluster randomized controlled trials, controlled before-and-after studies, interrupted time series analysis, quasi-experimental designs, and cohort and longitudinal studies. Qualitative research will be included to contextualize findings and identify barriers and facilitators. Primary outcomes that will be reported are district health management and leadership functions. We will assess risk of bias with the Cochrane Collaboration's tools for randomized controlled trials (RCT) and non RCT studies and Critical Appraisal Skills Programme checklists for qualitative studies. We will assess strength of recommendations with the GRADE tool for quantitative studies, and the CERQual approach for qualitative studies. Synthesis of quantitative studies will be performed through meta-analysis when appropriate. Best fit framework synthesis will be used to synthesize qualitative studies. Discussion: This protocol paper describes a systematic review assessing the effectiveness of site-based training (with or without mentoring programmes or operational research) on the improvement of district health system management and leadership. [ABSTRACT FROM AUTHOR]

Background: Conceptual frameworks are recommended as a way of applying theory to enhance implementation efforts. The Knowledge to Action (KTA) Framework was developed in Canada by Graham and colleagues in the 2000s, following a review of 31 planned action theories. The framework has two components: Knowledge Creation and an Action Cycle, each of which comprises multiple phases. This review sought to answer two questions: ‘Is the KTA Framework used in practice? And if so, how?’ Methods: This study is a citation analysis and systematic review. The index citation for the original paper was identified on three databases—Web of Science, Scopus and Google Scholar—with the facility for citation searching. Limitations of English language and year of publication 2006-June 2013 were set. A taxonomy categorising the continuum of usage was developed. Only studies applying the framework to implementation projects were included. Data were extracted and mapped against each phase of the framework for studies where it was integral to the implementation project. Results: The citation search yielded 1,787 records. A total of 1,057 titles and abstracts were screened. One hundred and forty-six studies described usage to varying degrees, ranging from referenced to integrated. In ten studies, the KTA Framework was integral to the design, delivery and evaluation of the implementation activities. All ten described using the Action Cycle and seven referred to Knowledge Creation. The KTA Framework was enacted in different health care and academic settings with projects targeted at patients, the public, and nursing and allied health professionals. Conclusions: The KTA Framework is being used in practice with varying degrees of completeness. It is frequently cited, with usage ranging from simple attribution via a reference, through informing planning, to making an intellectual contribution. When the framework was integral to knowledge translation, it guided action in idiosyncratic ways and there was theory fidelity. Prevailing wisdom encourages the use of theories, models and conceptual frameworks, yet their application is less evident in practice. This may be an artefact of reporting, indicating that prospective, primary research is needed to explore the real value of the KTA Framework and similar tools. [ABSTRACT FROM AUTHOR]

Background Stroke places a significant burden to all affected individuals, but it is perhaps more significant amongst members of black, minority and ethnic communities, who may experience poorer awareness of stroke symptoms than the general population. Recently, several initiatives tried to improve public awareness that symptoms of stroke need to be treated as a medical emergency. However, ethnic communities present cultural barriers, requiring tailored health promotion interventions, whose effectiveness remains uncertain. Our systematic review aimed to identify relevant published evidence, synthesize the main study components and identify evidence of the effectiveness of the interventions. Methods MEDLINE, EMBASE, CINAHL, and PsycInfo were searched for journal articles on health promotion interventions for increasing stroke awareness in ethnic minorities, published in English between 1995 and 2012. Search results were collaboratively assessed by the authors; included studies were analysed to identify their main characteristics, and a thematic analysis of their content was conducted. No meta-analysis was performed, due to the heterogeneity of results. Results Eighteen studies were included, reporting 15 interventions conducted in the US, for African- Americans or Hispanics; populations sizes differed between interventions. Interventions were mostly carried out in community settings with different educational techniques, focussing on experiential methods. Health professionals usually organized the programs, delivered by nurses, other health professionals or volunteers. The few theory-based interventions focussed on individual-level behavioural change. Practical cultural adaptation strategies were not linked to specific theoretical frameworks. Interventions widely differed as for target populations, settings, delivery methods, contents and professional roles involved. All study designs were quantitative, and the emerging evidence of effectiveness was inconclusive. Such interventions operate in very complex scenarios, and several variables may influence their effectiveness. Therefore, qualitative or mixed-methods study designs may shed light on barriers and facilitators, experiential education strategies and community involvement. Network- and community-level theories may help improving design and evaluation of interventions. Conclusions Eleven case reports and four RCTs provide evidence about stroke awareness interventions organized in the US. The studies provide only partial and inconclusive evidence about the effectiveness of the interventions. Hence, further research is needed on different countries and ethnic minorities. [ABSTRACT FROM AUTHOR]

Background The need to reduce smoking rates is a recognised public health policy issue in many countries. The workplace offers a potential context for offering smokers' programmes and interventions to assist smoking cessation or reduction. A qualitative evidence synthesis of employees' views about such programmes might explain why some interventions appear effective and others not, and can be used to develop evidence-based interventions for this population and setting. Methods A qualitative evidence synthesis of primary research exploring employees' views about workplace interventions to encourage smoking cessation, including both voluntary programmes and passive interventions, such as restrictions or bans. The method used was theory-based "best fit" framework synthesis. Results Five relevant theories on workplace smoking cessation were identified and used as the basis for an a priori framework. A comprehensive literature search, including interrogation of eight databases, retrieved 747 unique citations for the review. Fifteen primary research studies of qualitative evidence were found to satisfy the inclusion criteria. The synthesis produced an evidence-based conceptual model explaining employees' experiences of, and preferences regarding, workplace smoking interventions. Conclusion The synthesis suggests that workplace interventions should employ a range of different elements if they are to prove effective in reducing smoking among employees. This is because an employee who feels ready and able to change their behaviour has different needs and preferences from an employee who is not at that stage. Only a multi-faceted intervention can satisfy the requirements of all employees. [ABSTRACT FROM AUTHOR]

Background Adoption, adaptation, scale-up, spread, and sustainability are ill-defined, undertheorised, and little-researched implementation science concepts. An instrumental case study will track the adoption and adaptation, or not, of a locally developed innovation about dysphagia as a patient safety issue. The case study will examine a conceptual framework with a continuum of spread comprising hierarchical control or 'making it happen,' participatory adaptation or 'help it happen,' and facilitated evolution or 'let it happen.' Methods This case study is a prospective, longitudinal design using mixed methods. The fifteen-month (October 2012 to December 2013) instrumental case study is set in large, healthcare organisation in England. The innovation refers to introducing a nationally recognised, interdisciplinary dysphagia competency framework to guide workforce development about fundamental aspects of care. Adoption and adaptation will be examined at an organisational level and along two, contrasting care pathways: stroke and fractured neck of femur. A number of educational interventions will be deployed, including training a cadre of trainers to cascade the essentials of dysphagia management and developing a Dysphagia Toolkit as a learning resource. Mixed methods will be used to investigate scale-up, spread, and sustainability in acute and community settings. A purposive sample of senior managers and clinical leaders will be interviewed to identify path dependency or the context specific particularities of implementation. A pre- and post-evaluation, using mealtime observations and a survey, will investigate the learning effect on staff adherence to patient specific dysphagia recommendations and attitudes towards dysphagia, respectively. Official documents and an ethnographic field journal allow critical junctures, temporal aspects and confounding factors to be explored. Discussion Researching spread and sustainability presents methodological and practical challenges. These include fidelity, adaptation latitude, time, and organisational changes. An instrumental case study will allow these confounding factors to be tracked over time and in place. The case study is underpinned by, and will test a conceptual framework about spread, to explore theoretical generalizability. [ABSTRACT FROM AUTHOR]

Background: Systematic review methodologies can be harnessed to help researchers to understand and explain how complex interventions may work. Typically, when reviewing complex interventions, a review team will seek to understand the theories that underpin an intervention and the specific context for that intervention. A single published report from a research project does not typically contain this required level of detail. A review team may find it more useful to examine a “study cluster”; a group of related papers that explore and explain various features of a single project and thus supply necessary detail relating to theory and/or context. We sought to conduct a preliminary investigation, from a single case study review, of techniques required to identify a cluster of related research reports, to document the yield from such methods, and to outline a systematic methodology for cluster searching. Methods: In a systematic review of community engagement we identified a relevant project – the Gay Men’s Task Force. From a single “key pearl citation” we conducted a series of related searches to find contextually or theoretically proximate documents. We followed up Citations, traced Lead authors, identified Unpublished materials, searched Google Scholar, tracked Theories, undertook ancestry searching for Early examples and followed up Related projects (embodied in the CLUSTER mnemonic). Results: Our structured, formalised procedure for cluster searching identified useful reports that are not typically identified from topic-based searches on bibliographic databases. Items previously rejected by an initial sift were subsequently found to inform our understanding of underpinning theory (for example Diffusion of Innovations Theory), context or both. Relevant material included book chapters, a Web-based process evaluation, and peer reviewed reports of projects sharing a common ancestry. We used these reports to understand the context for the intervention and to explore explanations for its relative lack of success. Additional data helped us to challenge simplistic assumptions on the homogeneity of the target population. Conclusions: A single case study suggests the potential utility of cluster searching, particularly for reviews that depend on an understanding of context, e.g. realist synthesis. The methodology is transparent, explicit and reproducible. There is no reason to believe that cluster searching is not generalizable to other review topics. Further research should examine the contribution of the methodology beyond improved yield, to the final synthesis and interpretation, possibly by utilizing qualitative sensitivity analysis. [ABSTRACT FROM AUTHOR]

Background: Interdisciplinary team work is increasingly prevalent, supported by policies and practices that bring care closer to the patient and challenge traditional professional boundaries. To date, there has been a great deal of emphasis on the processes of team work, and in some cases, outcomes.Method: This study draws on two sources of knowledge to identify the attributes of a good interdisciplinary team; a published systematic review of the literature on interdisciplinary team work, and the perceptions of over 253 staff from 11 community rehabilitation and intermediate care teams in the UK. These data sources were merged using qualitative content analysis to arrive at a framework that identifies characteristics and proposes ten competencies that support effective interdisciplinary team work.Results: Ten characteristics underpinning effective interdisciplinary team work were identified: positive leadership and management attributes; communication strategies and structures; personal rewards, training and development; appropriate resources and procedures; appropriate skill mix; supportive team climate; individual characteristics that support interdisciplinary team work; clarity of vision; quality and outcomes of care; and respecting and understanding roles.Conclusions: We propose competency statements that an effective interdisciplinary team functioning at a high level should demonstrate. [ABSTRACT FROM AUTHOR]

Background: Following publication of the first worked example of the "best fit" method of evidence synthesis for the systematic review of qualitative evidence in this journal, the originators of the method identified a need to specify more fully some aspects of this particular derivative of framework synthesis. Methods and Results: We therefore present a second such worked example in which all techniques are defined and explained, and their appropriateness is assessed. Specified features of the method include the development of new techniques to identify theories in a systematic manner; the creation of an a priori framework for the synthesis; and the "testing" of the synthesis. An innovative combination of existing methods of quality assessment, analysis and synthesis is used to complete the process. This second worked example was a qualitative evidence synthesis of employees' views of workplace smoking cessation interventions, in which the "best fit"method was found to be practical and fit for purpose. Conclusions: The method is suited to producing context-specific conceptual models for describing or explaining the decision-making and health behaviours of patients and other groups. It offers a pragmatic means of conducting rapid qualitative evidence synthesis and generating programme theories relating to intervention effectiveness, which might be of relevance both to researchers and policy-makers. [ABSTRACT FROM AUTHOR]

Background: Recent terrorist attacks and natural disasters have led to an increased awareness of the importance of emergency planning. However, the extent to which emergency planners can access or use evidence remains unclear. The aim of this study was to identify, analyse and assess the location, source and quality of emergency planning publications in the academic and UK grey literature. Methods: We conducted a scoping review, using as data sources for academic literature Embase, Medline, Medline in Process, Psychinfo, Biosis, Science Citation Index, Cinahl, Cochrane library and Clinicaltrials.gov. For grey literature identification we used databases at the Health Protection Agency, NHS Evidence, British Association of Immediate Care Schemes, Emergency Planning College and the Health and Safety Executive, and the websites of UK Department of Health Emergency Planning Division and UK Resilience. Aggregative synthesis was used to analyse papers and documents against a framework based on a modified FEMA Emergency Planning cycle. Results: Of 2736 titles identified from the academic literature, 1603 were relevant. 45% were from North America, 27% were commentaries or editorials and 22% were event reports. Of 192 documents from the grey literature, 97 were relevant. 76% of these were event reports. The majority of documents addressed emergency planning and response. Very few documents related to hazard analysis, mitigation or capability assessment. Conclusions: Although a large body of literature exists, its validity and generalisability is unclear There is little evidence that this potential evidence base has been exploited through synthesis to inform policy and practice. The type and structure of evidence that would be of most value of emergency planners and policymakers has yet to be identified. [ABSTRACT FROM AUTHOR]

Background: A variety of different approaches to the synthesis of qualitative data are advocated in the literature. The aim of this paper is to describe the application of a pragmatic method of qualitative evidence synthesis and the lessons learned from adopting this "best fit" framework synthesis approach. Methods: An evaluation of framework synthesis as an approach to the qualitative systematic review of evidence exploring the views of adults to the taking of potential agents within the context of the primary prevention of colorectal cancer. Results: Twenty papers from North America, Australia, the UK and Europe met the criteria for inclusion. Fourteen themes were identified a priori from a related, existing conceptual model identified in the literature, which were then used to code the extracted data. Further analysis resulted in the generation of a more sophisticated model with additional themes. The synthesis required a combination of secondary framework and thematic analysis approaches and was conducted within a health technology assessment timeframe. Conclusion: The novel and pragmatic "best fit" approach to framework synthesis developed and described here was found to be fit for purpose. Future research should seek to test further this approach to qualitative data synthesis. [ABSTRACT FROM AUTHOR]

Background: The Quality of Reporting of Meta-analyses (QUOROM) statement provides guidance for improving the quality of reporting of systematic reviews and meta-analyses. To make the process of study selection transparent it recommends "a flow diagram providing information about the number of RCTs identified, included, and excluded and the reasons for excluding them". We undertook an empirical study to identify the extent of compliance in the UK Health Technology Assessment (HTA) programme. Methods: We searched Medline to retrieve all systematic reviews of therapeutic interventions in the HTA monograph series published from 2001 to 2005. Two researchers recorded whether each study contained a meta-analysis of controlled trials, whether a QUOROM flow diagram was presented and, if so, whether it expressed the relationship between the number of citations and the number of studies. We used Cohen's kappa to test inter-rater reliability. Results: 87 systematic reviews were retrieved. There was good and excellent inter-rater reliability for, respectively, whether a review contained a meta-analysis and whether each diagram contained a citation-to-study relationship. 49% of systematic reviews used a study selection flow diagram. When only systematic reviews containing a meta-analysis were analysed, compliance was only 32%. Only 20 studies (23% of all systematic reviews; 43% of those having a study selection diagram) had a diagram which expressed the relationship between citations and studies. Conclusion: Compliance with the recommendations of the QUOROM statement is not universal in systematic reviews or meta-analyses. Flow diagrams make the conduct of study selection transparent only if the relationship between citations and studies is clearly expressed. Reviewers should understand what they are counting: citations, papers, studies and trials are fundamentally different concepts which should not be confused in a diagram. [ABSTRACT FROM AUTHOR]

Background: Implementation fidelity refers to the degree to which an intervention or programme is delivered as intended. Only by understanding and measuring whether an intervention has been implemented with fidelity can researchers and practitioners gain a better understanding of how and why an intervention works, and the extent to which outcomes can be improved. Discussion: The authors undertook a critical review of existing conceptualisations of implementation fidelity and developed a new conceptual framework for understanding and measuring the process. The resulting theoretical framework requires testing by empirical research. Summary: Implementation fidelity is an important source of variation affecting the credibility and utility of research. The conceptual framework presented here offers a means for measuring this variable and understanding its place in the process of intervention implementation. [ABSTRACT FROM AUTHOR]

Background: Qualitative research makes an important contribution to our understanding of health and healthcare. However, qualitative evidence can be difficult to search for and identify, and the effectiveness of different types of search strategies is unknown. Methods: Three search strategies for qualitative research in the example area of support for breast-feeding were evaluated using six electronic bibliographic databases. The strategies were based on using thesaurus terms, free-text terms and broad-based terms. These strategies were combined with recognised search terms for support for breast-feeding previously used in a Cochrane review. For each strategy, we evaluated the recall (potentially relevant records found) and precision (actually relevant records found). Results: A total yield of 7420 potentially relevant records was retrieved by the three strategies combined. Of these, 262 were judged relevant. Using one strategy alone would miss relevant records. The broad-based strategy had the highest recall and the thesaurus strategy the highest precision. Precision was generally poor: 96% of records initially identified as potentially relevant were deemed irrelevant. Searching for qualitative research involves trade-offs between recall and precision. Conclusions: These findings confirm that strategies that attempt to maximise the number of potentially relevant records found are likely to result in a large number of false positives. The findings also suggest that a range of search terms is required to optimise searching for qualitative evidence. This underlines the problems of current methods for indexing qualitative research in bibliographic databases and indicates where improvements need to be made. [ABSTRACT FROM AUTHOR]

Background: Personalized healthcare relies on the identification of factors explaining why individuals respond differently to the same intervention. Analyses identifying such factors, so called predictors and moderators, have their own set of assumptions and limitations which, when violated, can result in misleading claims, and incorrect actions. The aim of this study was to develop a checklist for critically appraising the results of predictor and moderator analyses by combining recommendations from published guidelines and experts in the field., Methods: Candidate criteria for the checklist were retrieved through systematic searches of the literature. These criteria were evaluated for appropriateness using a Delphi procedure. Two Delphi rounds yielded a pilot checklist, which was tested on a set of papers included in a systematic review on reinforced home-based palliative care. The results of the pilot informed a third Delphi round, which served to finalize the checklist., Results: Forty-nine appraisal criteria were identified in the literature. Feedback was obtained from fourteen experts from (bio)statistics, epidemiology and other associated fields elicited via three Delphi rounds. Additional feedback from other researchers was collected in a pilot test. The final version of our checklist included seventeen criteria, covering the design (e.g. a priori plausibility), analysis (e.g. use of interaction tests) and results (e.g. complete reporting) of moderator and predictor analysis, together with the transferability of the results (e.g. clinical importance). There are criteria both for individual papers and for bodies of evidence., Conclusions: The proposed checklist can be used for critical appraisal of reported moderator and predictor effects, as assessed in randomized or non-randomized studies using individual participant or aggregate data. This checklist is accompanied by a user's guide to facilitate implementation. Its future use across a wide variety of research domains and study types will provide insights about its usability and feasibility.