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The Cochrane Qualitative and Implementation Methods Group develops and publishes guidance on the synthesis of qualitative and mixed-method evidence from process evaluations. Despite a proliferation of methods for the synthesis of qualitative research, less attention has focused on how to integrate these syntheses within intervention effectiveness reviews. In this article, we report updated guidance from the group on approaches, methods, and tools, which can be used to integrate the findings from quantitative studies evaluating intervention effectiveness with those from qualitative studies and process evaluations. We draw on conceptual analyses of mixed methods systematic review designs and the range of methods and tools that have been used in published reviews that have successfully integrated different types of evidence. We outline five key methods and tools as devices for integration which vary in terms of the levels at which integration takes place; the specialist skills and expertise required within the review team; and their appropriateness in the context of limited evidence. In situations where the requirement is the integration of qualitative and process evidence within intervention effectiveness reviews, we recommend the use of a sequential approach. Here, evidence from each tradition is synthesized separately using methods consistent with each tradition before integration takes place using a common framework. Reviews which integrate qualitative and process evaluation evidence alongside quantitative evidence on intervention effectiveness in a systematic way are rare. This guidance aims to support review teams to achieve integration and we encourage further development through reflection and formal testing. Refereed/Peer-reviewed

Objectives: This article provides reviewers with guidance on methods for identifying and processing evidence to understand intervention implementation. Study Design and Setting: Strategies, tools, and methods are applied to the systematic review process to illustrate how process and implementation can be addressed using quantitative, qualitative, and other sources of evidence (i.e., descriptive textual and nonempirical). Results: Reviewers can take steps to navigate the heterogeneity and level of uncertainty present in the concepts, measures, and methods used to assess implementation. Activities can be undertaken in advance of a Cochrane quantitative review to develop program theory and logic models that situate implementation in the causal chain. Four search strategies are offered to retrieve process and implementation evidence. Recommendations are made for addressing rigor or risk of bias in process evaluation or implementation evidence. Strategies are recommended for locating and extracting data from primary studies. The basic logic is presented to assist reviewers to make initial review-level judgments about implementation failure and theory failure. Conclusion: Although strategies, tools, and methods can assist reviewers to address process and implementation using quantitative, qualitative, and other forms of evidence, few exemplar reviews exist. There is a need for further methodological development and trialing of proposed approaches. Refereed/Peer-reviewed

Objective: The mixed methods appraisal tool (MMAT) was developed for critically appraising different study designs. This study aimed to improve the content validity of three of the five categories of studies in the MMAT by identifying relevant methodological criteria for appraising the quality of qualitative, survey, and mixed methods studies. Study Design and Setting: First, we performed a literature review to identify critical appraisal tools and extract methodological criteria. Second, we conducted a two-round modified e-Delphi technique. We asked three method-specific panels of experts to rate the relevance of each criterion on a five-point Likert scale. Results: A total of 383 criteria were extracted from 18 critical appraisal tools and a literature review on the quality of mixed methods studies, and 60 were retained. In the first and second rounds of the e-Delphi, 73 and 56 experts participated, respectively. Consensus was reached for six qualitative criteria, eight survey criteria, and seven mixed methods criteria. These results led to modifications of eight of the 11 MMAT (version 2011) criteria. Specifically, we reformulated two criteria, replaced four, and removed two. Moreover, we added six new criteria. Conclusion: Results of this study led to improve the content validity of this tool, revise it, and propose a new version (MMAT version 2018).

The Cochrane Qualitative and Implementation Methods Group develops and publishes guidance on the synthesis of qualitative and mixed-method implementation evidence. Choice of appropriate methodologies, methods, and tools is essential when developing a rigorous protocol and conducting the synthesis. Cochrane authors who conduct qualitative evidence syntheses have thus far used a small number of relatively simple methods to address similarly written questions. Cochrane has invested in methodological work to develop new tools and to encourage the production of exemplar reviews to show the value of more innovative methods that address a wider range of questions. In this paper, in the series, we report updated guidance on the selection of tools to assess methodological limitations in qualitative studies and methods to extract and synthesize qualitative evidence. We recommend application of Grades of Recommendation, Assessment, Development, and Evaluation-Confidence in the Evidence from Qualitative Reviews to assess confidence in qualitative synthesized findings. This guidance aims to support review authors to undertake a qualitative evidence synthesis that is intended to be integrated subsequently with the findings of one or more Cochrane reviews of the effects of similar interventions. The review of intervention effects may be undertaken concurrently with or separate to the qualitative evidence synthesis. We encourage further development through reflection and formal testing. Refereed/Peer-reviewed

A Theory of Change (ToC) is an approach to map programmes aimed at inducing change in a specific context, with the goal of increasing their impact. We applied this approach to the specific case of handwashing and sanitation practices in low- and middle-income countries and developed a ToC as part of a systematic review exercise. Different existing sources of information were used to inform the initial draft of the ToC. In addition, stakeholder involvement occurred and peer review took place. Our stakeholders included methodological (ToC/quantitative and qualitative research) and content experts (WASH (Water, Sanitation, Hygiene)/behaviour change), as well as end-users/practitioners, policy-makers and donors. In conclusion, the development of a ToC, and the involvement of stakeholders in its development, was critical in terms of understanding the context in which the promotional programmes are being implemented. We recommend ToC developers to work with stakeholders to create a ToC relevant for practice. ispartof: International Journal of Environmental Health Research vol:28 issue:1 pages:8-22 ispartof: location:England status: published

In Australia, Aboriginal and Torres Strait Islander People carry a greater burden of cancerrelated mortality than non-Aboriginal Australians. The Cancer Data and Aboriginal Disparities Project aims to develop and test an integrated, comprehensive cancer monitoring and surveillance system capable of incorporating epidemiological and narrative data to address disparities and advocate for clinical system change. Methods and analysis: The Advanced Cancer Data System will integrate routinely collected unit record data from the South Australian Population Cancer Registry and a range of other data sources for a retrospective cohort of indigenous people with cancers diagnosed from 1990 to 2010. A randomly drawn non-Aboriginal cohort will be matched by primary cancer site, sex, age and year at diagnosis. Cross-Tabulations and regression analyses will examine the extent to which demographic attributes, cancer stage and survival vary between the cohorts. Narratives from Aboriginal people with cancer, their families, carers and service providers will be collected and analysed using patient pathway mapping and thematic analysis. Statements from the narratives will structure both a concept mapping process of rating, sorting and prioritising issues, focusing on issues of importance and feasibility, and the development of a real-Time Aboriginal Cancer Measure of Experience for ongoing linkage with epidemiological data in the Advanced Cancer Data System. Aboriginal Community engagement underpins this Project. Ethics and dissemination: The research has been approved by relevant local and national ethics committees. Findings will be disseminated in local andinternational peer-reviewed journals and conference presentations. In addition, the research will provide data for knowledge translation activities across thepartner organisations and feed directly into the Statewide Cancer Control Plan. It will provide a mechanism for monitoring and evaluating theimplementation of the recommendations in these documents. Refereed/Peer-reviewed

International audience; Objective : The mixed methods appraisal tool (MMAT) was developed for critically appraising different study designs. This study aimed to improve the content validity of three of the five categories of studies in the MMAT by identifying relevant methodological criteria for appraising the quality of qualitative, survey, and mixed methods studies.Study Design and Setting : First, we performed a literature review to identify critical appraisal tools and extract methodological criteria. Second, we conducted a two-round modified e-Delphi technique. We asked three method-specific panels of experts to rate the relevance of each criterion on a five-point Likert scale.Results : A total of 383 criteria were extracted from 18 critical appraisal tools and a literature review on the quality of mixed methods studies, and 60 were retained. In the first and second rounds of the e-Delphi, 73 and 56 experts participated, respectively. Consensus was reached for six qualitative criteria, eight survey criteria, and seven mixed methods criteria. These results led to modifications of eight of the 11 MMAT (version 2011) criteria. Specifically, we reformulated two criteria, replaced four, and removed two. Moreover, we added six new criteria.Conclusion : Results of this study led to improve the content validity of this tool, revise it, and propose a new version (MMAT version 2018).

Cochrane Reviews are systematic reviews of primary research in human health care and health policy, and are internationally recognized health care resources for use in a decision-making process.1 Cochrane works collaboratively with contributors around the world to produce authoritative, relevant, and reliable reviews. Cochrane reviews are commonly used in a guideline development process to determine recommendations for practice. The Cochrane Qualitative and Implementation Methods Group provide methodological advice and guidance to Cochrane as well as leading methodological development to benefit the wider qualitative evidence synthesis community. In this introductory paper 1 we briefly outline the evolution of qualitative and mixed-method synthesis methods, the role of qualitative and mixedmethod syntheses in a decision-making process, and the contribution of qualitative and mixed-method syntheses to understanding complexity in complex intervention reviews. We then introduce a series of papers that provide Cochrane guidance on conducting qualitative and mixed-method evidence syntheses for a decision-making context. ispartof: Journal of Clinical Epidemiology vol:97 issue:97 pages:35-38 ispartof: location:United States status: published

Objectives: To outline contemporary and novel developments for the presentation and reporting of syntheses of qualitative, implementation, and process evaluation evidence and provide recommendations for the use of reporting guidelines. Study Design and Setting: An overview of reporting guidelines for qualitative, implementation, and process evaluation evidence syntheses drawing on current international literature and the collective expert knowledge of the Cochrane Qualitative and Implementation Methods Group.Results: Several reporting guidelines exist that can be used or adapted to report syntheses of qualitative, implementation, and process evaluation evidence. Methods to develop individual guidance varied. The use of a relevant reporting guideline can enhance the transparency, consistency, and quality of reporting. Guidelines that exist are generic, method specific, and for particular aspects of the reviewing process, searching.Conclusion: Caution is expressed over the potential for reporting guidelines to produce a mechanistic approach moving the focus away from the content and toward the procedural aspects of the review. The use of a reporting guideline is recommended and a five-step decision flowchart to guide the choice of reporting guideline is provided. Gaps remain in method-specific reporting guidelines such as mixed-study, implementation, and process evaluation evidence syntheses. Refereed/Peer-reviewed

Introduction The inequity of randomising participants to control groups in randomised controlled trials (RCTs) is often considered inappropriate, especially for research trials that include vulnerable populations such as Indigenous peoples. The Aboriginal and Torres Strait Islander Women’s Fitness Program conducted a trial that randomly assigned participants to ‘active’ and ‘waitlisted’ groups. This paper reports on participant views of the randomisation protocol. Methods A pragmatic RCT was conducted in an urban setting to assess the effectiveness of the 12-week Aboriginal and Torres Strait Islander Women’s Fitness Program on metabolic health outcomes and waist circumference. Qualitative interviews were conducted at follow-up, one of the objectives was to explore participant perspectives on the research protocol, including participant randomisation to ‘Active’ and ‘Waitlisted’ groups. Results A total of 49 interviews were conducted (26 Active and 23 Waitlisted participants). Two key factors influenced participant views on the protocol: 1) group assignment; and 2) how well they understood the research design, including the justification for randomisation. ‘Active’ participants were concerned about the inequity of the randomisation process but overall supported the study protocol. Although most Waitlisted participants were disappointed about having to wait 12-months for the program, some participants derived motivation from being waitlisted, whilst others lost motivation. Well-informed participants were more likely to express both support for the randomisation process and an understanding of the research benefits than participants not attending an information session prior to registration. Conclusions Participants were more accepting of the research protocol if it was clearly explained to them, if they understood the randomisation process and felt the randomisation was justified in terms of the potential for the results to benefit other Aboriginal and Torres Strait Islander women. Our study suggests that the time and resources required to adequately explain the research protocol in research trials should not be undervalued. Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12610000224022).

Aboriginal Australians, including Aboriginal Health Workers (AHWs), smoke at rates double the non-Aboriginal population. This study utilized concept mapping methodology to identify and prioritize culturally relevant strategies to promote smoking cessation in AHWs. Stakeholder participants included AHWs, other health service employees and tobacco control personnel. Smoking cessation strategies (n = 74) were brainstormed using 34 interviews, 3 focus groups and a stakeholder workshop. Stakeholders sorted strategies into meaningful groups and rated them on perceived importance and feasibility. A concept map was developed using multi-dimensional scaling and hierarchical cluster analyses. Ten unique clusters of smoking cessation strategies were depicted that targeted individuals, family and peers, community, workplace and public policy. Smoking cessation resources and services were represented in addition to broader strategies addressing social and environmental stressors that perpetuate smoking and make quitting difficult. The perceived importance and feasibility of clusters were rated differently by participants working in health services that were government-coordinated compared with community-controlled. For health service workers within vulnerable populations, these findings clearly implicate a need for contextualized strategies that mitigate social and environmental stressors in addition to conventional strategies for tobacco control. The concept map is being applied in knowledge translation to guide development of smoking cessation programs for AHWs. Refereed/Peer-reviewed

A systematic review of qualitative studies was undertaken to understand the barriers to physical activity experienced by adolescents who were overweight or obese. From a search of electronic databases and ‘grey’ literature, published between 1950 and 2009, 15 studies met the inclusion criteria. Bronfenbrenner’s model of human development provided an ecological lens for identifying and synthesising barriers to physical activity. Two reviewers appraised study quality. Miles and Huberman’s cross-case analysis was integrated with thematic networking to synthesize the individual, interpersonal and environmental level barriers for boys and girls of different ethnicities and socioeconomic status, across school settings and generalised context. Thirty-five barriers were identified, 13 of which occurred in physical activity situations in the school setting, 18 were not linked to a specific setting, and the remainder were common across both contexts. The fact that these barriers emerged from studies that focused on topics such as victimisation and mental health is particularly poignant and reflects the potentially pervasive influence of adolescent’s excessive weight not only in relation to physical activity situations but other aspects of their lives. Furthermore, socioeconomic status and ethnicity was poorly considered, with only one study linking these participant characteristics to quotations and discussing the potential implications. At present, there are few qualitative studies with sufficiently thick description or interpretive validity that provide insight into this vulnerable group of adolescents, and give them a voice to influence policy and practice.

Background Aboriginal Australians suffer from poorer overall health compared to the general Australian population, particularly in terms of cardiovascular disease and prognosis following a cardiac event. Despite such disparities, Aboriginal Australians utilise health care services at much lower rates than the general population. Improving health care utilisation (HCU) among Aboriginal cardiac patients requires a better understanding of the factors that constrain or facilitate use. The study aimed to identify ecological factors influencing health care utilisation (HCU) for Aboriginal cardiac patients, from the time of their cardiac event to 6–12 months post-event, in central Australia. Methods This qualitative descriptive study was guided by an ecological framework. A culturally-sensitive illness narrative focusing on Aboriginal cardiac patients’ “typical” journey guided focus groups and semi-structured interviews with Aboriginal cardiac patients, non-cardiac community members, health care providers and community researchers. Analysis utilised a thematic conceptual matrix and mixed coding method. Themes were categorised into Predisposing, Enabling, Need and Reinforcing factors and identified at Individual, Interpersonal, Primary Care and Hospital System levels. Results Compelling barriers to HCU identified at the Primary Care and Hospital System levels included communication, organisation and racism. Individual level factors related to HCU included language, knowledge of illness, perceived need and past experiences. Given these individual and health system barriers patients were reliant on utilising alternate family-level supports at the Interpersonal level to enable their journey. Conclusion Aboriginal cardiac patients face significant barriers to HCU, resulting in sub-optimal quality of care, placing them at risk for subsequent cardiovascular events and negative health outcomes. To facilitate HCU amongst Aboriginal people, strategies must be implemented to improve communication on all levels and reduce systemic barriers operating within the health system.

Introduction Long-term measures to reduce tobacco consumption in Australia have had differential effects in the population. The prevalence of smoking in Aboriginal peoples is currently more than double that of the non-Aboriginal population. Aboriginal Health Workers are responsible for providing primary health care to Aboriginal clients including smoking cessation programs. However, Aboriginal Health Workers are frequently smokers themselves, and their smoking undermines the smoking cessation services they deliver to Aboriginal clients. An understanding of the barriers to quitting smoking experienced by Aboriginal Health Workers is needed to design culturally relevant smoking cessation programs. Once smoking is reduced in Aboriginal Health Workers, they may then be able to support Aboriginal clients to quit smoking. Methods We undertook a fundamental qualitative description study underpinned by social ecological theory. The research was participatory, and academic researchers worked in partnership with personnel from the local Aboriginal health council. The barriers Aboriginal Health Workers experience in relation to quitting smoking were explored in 34 semi-structured interviews (with 23 Aboriginal Health Workers and 11 other health staff) and 3 focus groups (n = 17 participants) with key informants. Content analysis was performed on transcribed text and interview notes. Results Aboriginal Health Workers spoke of burdensome stress and grief which made them unable to prioritise quitting smoking. They lacked knowledge about quitting and access to culturally relevant quitting resources. Interpersonal obstacles included a social pressure to smoke, social exclusion when quitting, and few role models. In many workplaces, smoking was part of organisational culture and there were challenges to implementation of Smokefree policy. Respondents identified inadequate funding of tobacco programs and a lack of Smokefree public spaces as policy level barriers. The normalisation of smoking in Aboriginal society was an overarching challenge to quitting. Conclusions Aboriginal Health Workers experience multilevel barriers to quitting smoking that include personal, social, cultural and environmental factors. Multidimensional smoking cessation programs are needed that reduce the stress and burden for Aboriginal Health Workers; provide access to culturally relevant quitting resources; and address the prevailing normalisation of smoking in the family, workplace and community.

Background Aboriginal Health Workers (AHWs) have a mandate to deliver smoking cessation support to Aboriginal people. However, a high proportion of AHWs are smokers and this undermines their delivery of smoking cessation programs. Smoking tobacco is the leading contributor to the burden of disease in Aboriginal Australians and must be prevented. Little is known about how to enable AHWs to quit smoking. An understanding of the factors that perpetuate smoking in AHWs is needed to inform the development of culturally relevant programs that enable AHWs to quit smoking. A reduction of smoking in AHWs is important to promote their health and also optimise the delivery of smoking cessation support to Aboriginal clients. Methods We conducted a fundamental qualitative description study that was nested within a larger mixed method participatory research project. The individual and contextual factors that directly or indirectly promote (i.e. perpetuate) smoking behaviours in AHWs were explored in 34 interviews and 3 focus groups. AHWs, other health service staff and tobacco control personnel shared their perspectives. Data analysis was performed using a qualitative content analysis approach with collective member checking by AHW representatives. Results AHWs were highly stressed, burdened by their responsibilities, felt powerless and undervalued, and used smoking to cope with and support a sense of social connectedness in their lives. Factors directly and indirectly associated with smoking were reported at six levels of behavioural influence: personal factors (e.g. stress, nicotine addiction), family (e.g. breakdown of family dynamics, grief and loss), interpersonal processes (e.g. socialisation and connection, domestic disputes), the health service (e.g. job insecurity and financial insecurity, demanding work), the community (e.g. racism, social disadvantage) and policy (e.g. short term and insecure funding). Conclusions An extensive array of factors perpetuated smoking in AHWs. The multitude of personal, social and environmental stressors faced by AHWs and the accepted use of communal smoking to facilitate socialisation and connection were primary drivers of smoking in AHWs in addition to nicotine dependence. Culturally sensitive multidimensional smoking cessation programs that address these factors and can be tailored to local needs are indicated.

PurposeAlthough implementation fidelity is an important component in the evaluation of school health promotion programs, it assumes that teaching is the most relevant teacher role. To understand the social context of program implementation, a qualitative study was undertaken with the aim of identifying the schoolteacher's role in implementing the objectives of the Kahnawake Schools Diabetes Prevention Project (KSDPP), a locally governed Kanienke:háka (Mohawk) community‐based diabetes prevention program.Design/methodology/approachProspective semi‐structured interviews were conducted cross‐sectionally with 30 teachers, two administrators and one physical education teacher across four intervention years. Interviews were analysed retrospectively using qualitative thematic analysis.FindingsIn implementing KSDPP objectives teachers adopted, to varying degrees, the roles of teaching the health education curriculum, enforcing the school nutrition policy, role modelling healthy lifestyles, and encouraging healthy lifestyles. Taken together, these roles point to a high‐order role of teachers taking responsibility for enabling healthy lifestyles in their children, which is congruent with a wholistic approach to health. Study findings suggest that children in different classrooms were exposed to a different intervention dose based on the extent to which teachers applied each role.Research limitations/implicationsThe findings suggest that the current conceptualisation of implementation fidelity should be expanded to account for the influence of the social context (i.e. teachers' roles) on the implementation of health promotion program objectives.Originality/valueConsistent with an ecological approach to intervention, teachers would benefit from interventions that predispose, enable, and reinforce their capacity to adopt and apply health promotion roles.

Objective: The mixed methods appraisal tool (MMAT) was developed for critically appraising different study designs. This study aimed to improve the content validity of three of the five categories of studies in the MMAT by identifying relevant methodological criteria for appraising the quality of qualitative, survey, and mixed methods studies. Study Design and Setting: First, we performed a literature review to identify critical appraisal tools and extract methodological criteria. Second, we conducted a two-round modified e-Delphi technique. We asked three method-specific panels of experts to rate the relevance of each criterion on a five-point Likert scale. Results: A total of 383 criteria were extracted from 18 critical appraisal tools and a literature review on the quality of mixed methods studies, and 60 were retained. In the first and second rounds of the e-Delphi, 73 and 56 experts participated, respectively. Consensus was reached for six qualitative criteria, eight survey criteria, and seven mixed methods criteria. These results led to modifications of eight of the 11 MMAT (version 2011) criteria. Specifically, we reformulated two criteria, replaced four, and removed two. Moreover, we added six new criteria. Conclusion: Results of this study led to improve the content validity of this tool, revise it, and propose a new version (MMAT version 2018).