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Background: In May 2020, England implemented "deemed consent" legislation, to make it easier for individuals to donate their organs and convey their decision when alive. Families are supposed to support the decision but can still override it if they disagree. We aimed to learn more about this changed role when families were approached about organ donation., Methods: A qualitative study using semi-structured interviews with families, feedback from nurses, comparisons with audit data, and public involvement. We used framework analysis with a health systems perspective and utilitarian theory to explore if the law worked., Findings: 103 participants were interviewed representing 83 potential donation cases. In 31/83 (37%) cases donation was fully supported, in 41/83 (49%) cases families supported retrieval of some organs, tissues and procedures, and in 11/83 (13%) cases families declined completely. Themes explaining why the law was not (yet) working included: Understanding and agreeing the family's role, confusion about deemed consent, not supporting the deceased expressed decisions, organ donation as too much of a harm, the different experiences of donation pathways, transition from end-of-life to organ donation discussions, experiences of 'consent', paperwork and processes. Families frequently questioned if their relative wanted to have a surgery rather than supporting the person who died to save lives., Conclusion: Families use the unique experience of their relative dying in intensive care to create alternate narratives whereby the outcome satisfies their own utility and not necessarily those of the potential donor. New public ongoing media campaigns crafted to be more supportive of organ donation as a benefit to transplant recipients could help families overcome the many difficulties they encounter at the bedside., Implications for Clinical Practice: The soft opt-out policy has not empowered nurses to help families at their most vulnerable to increase their support for and consent to deceased organ donation., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Objectives: To investigate the experiences of women with kidney disease, residing in the United Kingdom (UK), living through the first 18 months of the COVID-19 pandemic with specific focus on preconception decision-making, family planning, and parenting., Methods: We conducted a mixed-methods study, comprising an online survey and follow-up interviews, with UK-resident women aged 18-50., Results: We received 431 surveys and conducted 30 interviews. Half (n = 221, 51%) of the survey respondents considered that COVID-19 influenced the quality of communication with healthcare professionals and 68% (n = 295) felt that the pandemic disrupted their support networks. Interview participants indicated that delayed and canceled appointments caused anxiety, grief, and loss of pregnancy options. Women's perception of themselves as (good) mothers as well as their capacity to have and raise a child, meet partners, and sustain healthy relationships was negatively affected by the "clinically extremely vulnerable" label. Women's trust in their healthcare was dismantled by miscommunication and variation in lockdown rules that caused confusion and increased worry. Women reported that COVID-19 contributed to postnatal depression, excessive concern over infant mortality, preoccupation over others following rules, and catastrophising., Conclusion: Some women in the UK with chronic kidney disease lost or missed their opportunity to have children during the pandemic. Future pandemic planners need to look more holistically and longer term at what is and is not classed as an emergency, both in how services are reconfigured and how people with chronic conditions are identified, communicated with, and treated., (© 2024 The Authors. Perspectives on Sexual and Reproductive Health published by Wiley Periodicals LLC on behalf of University of Ottawa.)

Aims: To identify the needs, experiences and preferences of women with kidney disease in relation to their reproductive health to inform development of shared decision-making interventions., Design: UK-wide mixed-methods convergent design (Sep 20-Aug 21)., Methods: Online questionnaire (n = 431) with validated components. Purposively sampled semi-structured interviews (n = 30). Patient and public input throughout., Findings: Kidney disease was associated with defeminization, negatively affecting current (sexual) relationships and perceptions of future life goals. There was little evidence that shared decision making was taking place. Unplanned pregnancies were common, sometimes influenced by poor care and support and complicated systems. Reasons for (not) wanting children varied. Complicated pregnancies and miscarriages were common. Women often felt that it was more important to be a "good mother" than to address their health needs, which were often unmet and unrecognized. Impacts of pregnancy on disease and options for alternates to pregnancy were not well understood., Conclusion: The needs and reproductive priorities of women are frequently overshadowed by their kidney disease. High-quality shared decision-making interventions need to be embedded as routine in a feminized care pathway that includes reproductive health. Research is needed in parallel to examine the effectiveness of interventions and address inequalities., Impact: We do not fully understand the expectations, needs, experiences and preferences of women with kidney disease for planning and starting a family or deciding not to have children. Women lack the knowledge, resources and opportunities to have high-quality conversations with their healthcare professionals. Decisions are highly personal and related to a number of health, social and cultural factors; individualized approaches to care are essential. Healthcare services need to be redesigned to ensure that women are able to make informed choices about pregnancy and alternative routes to becoming a parent., Patient or Public Contribution: The original proposal for this research came from listening to the experiences of women in clinic who reported unmet needs and detailed experiences of their pregnancies (positive and negative). A patient group was involved in developing the funding application and helped to refine the objectives by sharing their experiences. Two women who are mothers living with kidney disease were co-opted as core members of the research team. We hosted an interim findings event and invited patients and wider support services (adoption, fertility, surrogacy, education and maternal chronic kidney disease clinics) from across the UK to attend. We followed the UK national standards for patient and public involvement throughout., (© 2023 The Authors. Journal of Advanced Nursing published by John Wiley & Sons Ltd.)

Aim: To explain the differences in organ donation consent outcomes of a new nursing role (Specialist Requesters) derived from the United States (US) compared with the existing nursing role (Specialist Nurses in Organ Donation)., Design: Thirty-month observational qualitative process evaluation: Implementation theory-informed analysis., Methods: Qualitative content analysis of free text describing challenges, processes and practice from 996 bespoke routinely collected potential organ donor 'approach forms' from two regions: one where there was no difference, and one with an observed difference in consent outcomes., Results: Region A consent rate: Specialist Requester 75.8%, Specialist Nurse in Organ Donation71.8%. Region B consent rate: Specialist Requester 71.4%, Specialist Nurse in Organ Donation 82%. Region A Specialist Requesters turned the family position from no or uncertain to support organ donation in 73% of cases, compared with 27.4% in Region B. Two Specialist Requesters in Region A were highly effective. Region B experienced problems with intervention fidelity and implementation., Conclusions: The benefits of the Specialist Requester role remain unclear. Positive differences in consent rates achieved by Specialist Requesters in the originator region reduced over time and have yet to be successfully replicated in other regions., Impact: The impact of Specialist Requesters on consent outcomes varied across regions and it was not known why. Specialist Requesters in Region A were better at getting family member(s) to support organ donation. In Region B, Specialist Nurse in Organ Donation consent rates were higher and problems with intervention fidelity were identified (recruitment, staffing, less experience). Policy makers need to understand it is not just a matter of waiting for the Specialist Requester intervention to work. Ongoing training and recruiting the right people with the right skills need to be addressed and consistently reviewed., (© 2020 John Wiley & Sons Ltd.)

Background: Randomised trials (also referred to as 'randomised controlled trials' or 'trials') are the optimal way to minimise bias in evaluating the effects of competing treatments, therapies and innovations in health care. It is important to achieve the required sample size for a trial, otherwise trialists may not be able to draw conclusive results leading to research waste and raising ethical questions about trial participation. The reasons why potential participants may accept or decline participation are multifaceted. Yet, the evidence of effectiveness of interventions to improve recruitment to trials is not substantial and fails to recognise these individual decision-making processes. It is important to synthesise the experiences and perceptions of those invited to participate in randomised trials to better inform recruitment strategies., Objectives: To explore potential trial participants' views and experiences of the recruitment process for participation. The specific objectives are to describe potential participants' perceptions and experiences of accepting or declining to participate in trials, to explore barriers and facilitators to trial participation, and to explore to what extent barriers and facilitators identified are addressed by strategies to improve recruitment evaluated in previous reviews of the effects of interventions including a Cochrane Methodology Review., Search Methods: We searched the Cochrane Library, Medline, Embase, CINAHL, Epistemonikos, LILACS, PsycINFO, ORRCA, and grey literature sources. We ran the most recent set of searches for which the results were incorporated into the review in July 2017., Selection Criteria: We included qualitative and mixed-methods studies (with an identifiable qualitative component) that explored potential trial participants' experiences and perceptions of being invited to participate in a trial. We excluded studies that focused only on recruiters' perspectives, and trials solely involving children under 18 years, or adults who were assessed as having impaired mental capacity., Data Collection and Analysis: Five review authors independently assessed the titles, abstracts and full texts identified by the search. We used the CART (completeness, accuracy, relevance, timeliness) criteria to exclude studies that had limited focus on the phenomenon of interest. We used QSR NVivo to extract and manage the data. We assessed methodological limitations using the Critical Skills Appraisal Programme (CASP) tool. We used thematic synthesis to analyse and synthesise the evidence. This provided analytical themes and a conceptual model. We used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in each finding. Our findings were integrated with two previous intervention effectiveness reviews by juxtaposing the quantitative and qualitative findings in a matrix., Main Results: We included 29 studies (published in 30 papers) in our synthesis. Twenty-two key findings were produced under three broad themes (with six subthemes) to capture the experience of being invited to participate in a trial and making the decision whether to participate. Most of these findings had moderate to high confidence. We identified factors from the trial itself that influenced participation. These included how trial information was communicated, and elements of the trial such as the time commitment that might be considered burdensome. The second theme related to personal factors such as how other people can influence the individual's decision; and how a personal understanding of potential harms and benefits could impact on the decision. Finally, the potential benefits of participation were found to be key to the decision to participate, namely personal benefits such as access to new treatments, but also the chance to make a difference and help others. The conceptual model we developed presents the decision-making process as a gauge and the factors that influence whether the person will, or will not, take part., Authors' Conclusions: This qualitative evidence synthesis has provided comprehensive insight into the complexity of factors that influence a person's decision whether to participate in a trial. We developed key questions that trialists can ask when developing their recruitment strategy. In addition, our conceptual model emphasises the need for participant-centred approaches to recruitment. We demonstrated moderate to high level confidence in our findings, which in some way can be attributed to the large volume of highly relevant studies in this field. We recommend that these insights be used to direct or influence or underpin future recruitment strategies that are developed in a participant-driven way that ultimately improves trial conduct and reduces research waste., (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

In an attempt to improve organ donation rates, some countries are considering moving from "opt-in" systems where citizens must express their willingness to be an organ donor, to "opt-out" systems where consent is presumed unless individuals have expressed their wishes otherwise, by, for example, joining an "opt-out" register. In Wales-a part of the United Kingdom-the devolved government recently legislated for an "opt-out" system. For the change to be effective, a public awareness campaign was critical to the policy's success. Using quantitative and qualitative content analysis, we explored media coverage of the change to better understand the relationship between the state, policy actors, media and the public when such policy changes take place. Our findings illustrate how a state communication campaign can effectively set the media agenda within which we saw a degree of interdependency created with the state using the media to promote policy, and the media relying on the state for credible information. Yet we also found that the media is not uncritical and observed how it uses its autonomy to influence policy setting. Over the period of study, we found that a change in tone and view towards deemed consent organ donation has taken place in the media. However, while this may influence or reflect public attitudes, it is yet to be seen whether the media campaign translates into behavioural change that will result in increases in organ donations., (© 2019 The Authors Health Expectations published by John Wiley & Sons Ltd.)

Simon Lewin and colleagues present a methodology for increasing transparency and confidence in qualitative research synthesis.

Background: Children with cancer, parents, and clinicians, face difficult decisions when cure is no longer possible. Little is known about decision-making processes, how agreement is reached, or perspectives of different actors. Professionals voice concerns about managing parental expectations and beliefs, which can be contrary to their own and may change over time. We conducted the first systematic review to determine what constitutes best medico-legal practice for children under 19 years as context to exploring the perspectives of actors who make judgements and decisions when cancer treatment is no longer curative., Methods: Theory-informed mixed-method thematic systematic review with theory development., Results: Eight legal/ethical guidelines and 18 studies were included. Whilst there were no unresolved dilemmas, actors had different perspectives and motives. In line with guidelines, the best interests of the individual child informed decisions, although how different actors conceptualized 'best interests' when treatment was no longer curative varied. Respect for autonomy was understood as following child/parent preferences, which varied from case to case. Doctors generally shared information so that parents alone could make an informed decision. When parents received reliable information, and personalized interest in their child, they were more likely to achieve shared trust and clearer transition to palliation. Although under-represented in research studies, young people's perspectives showed some differences to those of parents and professionals. For example, young people preferred to be informed even when prognosis was poor, and they had an altruistic desire to help others by participating in research., Conclusion: There needs to be fresh impetus to more effectively and universally implement the ethics of professionalism into daily clinical practice in order to reinforce humanitarian attitudes. Ethical guidelines and regulations attempt to bring professionals together by articulating shared values. While important, ethics training must be supported by institutions/organizations to assist doctors to maintain good professional standards. Findings will hopefully stimulate further normative and descriptive lines of research in this complex under-researched field. Future research needs to be undertaken through a more deliberative cultural lens that includes children's and multi-disciplinary team members' perspectives to more fully characterize and understand the dynamics of the decision-making process in this specific end-of life context.

Aim: This protocol outlines a study to address knowledge gaps about the types and formats of children's information which could support decision-making in respect of health, medicines and self-care., Background: Partnership between the public and health services is seen as the key to a healthier society and cost-effective care. A requirement of participative models is the provision of high quality information. Little information is available specifically for children, young people and their families, and little evidence concerning types and formats which could support decision-making., Methods: A mixed-method study will be conducted through three inter-related phases. Tracer-conditions will be used to focus the research, with a specific, although not exclusive, emphasis on medicines. Phase 1:, Context: systematic literature review and critical discourse analysis of currently available children's information. Phase 2: In-depth study: we will conduct focus groups, semi-structured interviews and non-participant observation to address a range of questions about what children think about currently available information sources (focus groups), what information children and their families need and how and when they and healthcare professionals use information sources to support decision-making concerning choice (interviews and observation). Phase 3: data synthesis and comparative analysis., Discussion: Outcomes include the types, formats and characteristics of information likely to support children's decision-making and choices predominantly around medicines and clinical options.

A considerable proportion of quantitative research remains unpublished once completed. Little research has documented non-dissemination and dissemination bias in qualitative research. This study aimed to generate evidence on the extent of non-dissemination in qualitative research. We followed a cohort of qualitative studies presented as conference abstracts to ascertain their subsequent publication status. We searched for subsequent full publication in MEDLINE, in the Cumulative Index to Nursing & Allied Health Literature and in Google Scholar. We matched abstracts to subsequent publications according to authors, method of data collection and phenomenon of interest. Fisher's exact test was calculated to examine associations between study characteristics and publication. Factors potentially associated with time to publication were evaluated with Cox regression analysis. For 91 of 270 included abstracts (33.70%; 95% CI 28.09%-39.68%), no full publication was identified. Factors that were found to be associated with subsequent full publication were oral presentation (OR 4.62; 95% CI 2.43-8.94) and university affiliation (OR 1.96; 95% CI 1.05-3.66). Compared to oral presentations, studies presented as posters took longer time to reach full publication (hazard ratio 0.35, 95% CI 0.21-0.58). This study shows that it was not possible to retrieve a full publication for over one-third of abstracts. Our findings suggest that where this non-dissemination is systematic, it may lead to distortions of the qualitative evidence-base for decision-making through dissemination bias. Our findings are congruent with those of other studies. Further research might investigate non-dissemination of qualitative studies in other disciplines to consolidate our findings.

Objectives: We aimed to identify migraine treatment features preferred by patients and treatment outcomes most valued by patients. Background: The values and preferences of people living with migraine are critical for both the choice of acute therapy and management approach of migraine. Methods: We conducted a qualitative evidence synthesis. Two reviewers independently selected studies, appraised methodological quality, and undertook a framework synthesis. We developed summary of findings tables following the approach of Grading of Recommendations, Assessment, Development and Evaluations Confidence in the Evidence from Reviews of Qualitative Research to assess confidence in the findings. Results: Of 1691 candidate references, we included 19 studies (21 publications) involving 459 patients. The studies mostly recruited White women from North America (11 studies) and Europe (8 studies). We identified eight themes encompassing features preferred by patients in a migraine treatment process. Themes described a treatment process that included shared decision‐making, a tailored approach, trust in health‐care professionals, sharing of knowledge and diversity of treatment options, a holistic approach that does not just address the headache, ease of communication especially for complex treatments, a non‐undermining approach, and reciprocity with mutual respect between patient and provider. In terms of the treatment itself, seven themes emerged including patients' preferences for nonpharmacologic treatment, high effectiveness, rapidity of action, long‐lasting effect, lower cost and more accessibility, self‐management/self‐delivery option that increases autonomy, and a mixed preference for abortive versus prophylactic treatments. The treatment outcomes that have high value to patients included maintaining or improving function; avoiding side effects, potential for addiction to medications, and pain reoccurrence; and avoiding non‐headache symptoms such as nausea, vomiting, and sensitivity to light or sounds. Conclusion: Patient values and preferences were individually constructed, varied widely, and could be at odds with conventional medical perspectives and evidence of treatment effects. Considering the availability of numerous treatments for acute migraine, it is necessary that decision‐making incorporates patient values and preferences identified in qualitative research. The findings of this qualitative synthesis can be used to facilitate an individually tailored approach, strengthen the patient–health‐care system relationship, and guide choices and decisions in the context of a clinical encounter or a clinical practice guideline. [ABSTRACT FROM AUTHOR]

Aim: To report a protocol for a qualitative study to better understand the key factors that influence decision making about pregnancy from women's perspectives and to use these data to develop a theoretical model for shared decision‐making tools for the multiple stakeholders. Design: Mixed‐method design using online surveys (with validated components) and purposively sampled follow‐up semi structured interviews. Methods: Funded from September 2020 for 12 months. Online surveys of adult women (aged 18–50) identified via all Wales kidney database (n ≥ 500), additional recruitment through multidisciplinary healthcare professionals, relevant third sector organizations and social media. Follow‐up in‐depth qualitative interviews with n = 30 women. Linear regression models to identify associations between shared decision‐making preferences and clinical and psychosocial variables. Qualitative interviews will use a visual timeline task to empower women in taking control over their narratives. Qualitative data will be fully transcribed and analysed thematically, based around a chronological and theoretical (theoretical domains framework) structure that maps out key challenges and opportunities for improved decision support in the care pathway. Visual timelines will be used during stakeholder consultation activities, to enable us to co‐create a map of current support, gaps in provision, and opportunities for interventions. Quantitative data will be analysed descriptively to characterize our cohort. We will assemble a multidisciplinary shared decision‐making intervention development group and provide ongoing stakeholder consultation activities with patient and public representatives. Discussion: Outcomes will support new learning into; the ways women's knowledge of kidney disease may affect family planning and pregnancy, their needs in terms of psychological and social support, and how they weigh up the pros and cons of starting a family. Impact: Evidence will inform the design of new shared decision‐making tools to better support women with the complex and often emotional decisions about having children while living with kidney disease. [ABSTRACT FROM AUTHOR]

An editorial is presented that address the persistent issue of authors submitting trial reports that fail to meet journal eligibility criteria and the standards set by the AllTrials initiative. It discusses the establishment of a Quantitative Intervention Evaluation (QIE) Editor role and a group of statistical reviewers to address issues with submitted papers.

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]

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 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 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 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]

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: Qualitative research findings are increasingly used to inform decision-making. Research has indicated that not all quantitative research on the effects of interventions is disseminated or published. The extent to which qualitative researchers also systematically underreport or fail to publish certain types of research findings, and the impact this may have, has received little attention. Methods: A survey was delivered online to gather data regarding non-dissemination and dissemination bias in qualitative research. We invited relevant stakeholders through our professional networks, authors of qualitative research identified through a systematic literature search, and further via snowball sampling. Results: 1032 people took part in the survey of whom 859 participants identified as researchers, 133 as editors and 682 as peer reviewers. 68.1% of the researchers said that they had conducted at least one qualitative study that they had not published in a peer-reviewed journal. The main reasons for non-dissemination were that a publication was still intended (35.7%), resource constraints (35.4%), and that the authors gave up after the paper was rejected by one or more journals (32.5%). A majority of the editors and peer reviewers “(strongly) agreed” that the main reasons for rejecting a manuscript of a qualitative study were inadequate study quality (59.5%; 68.5%) and inadequate reporting quality (59.1%; 57.5%). Of 800 respondents, 83.1% “(strongly) agreed” that non-dissemination and possible resulting dissemination bias might undermine the willingness of funders to support qualitative research. 72.6% and 71.2%, respectively, “(strongly) agreed” that non-dissemination might lead to inappropriate health policy and health care. Conclusions: The proportion of non-dissemination in qualitative research is substantial. Researchers, editors and peer reviewers play an important role in this. Non-dissemination and resulting dissemination bias may impact on health care research, practice and policy. More detailed investigations on patterns and causes of the non-dissemination of qualitative research are needed. [ABSTRACT FROM AUTHOR]

Aim To report the first large-scale realistic nurse-led implementation, optimization and evaluation of a complex children's continuing-care policy. Background Health policies are increasingly complex, involve multiple Government departments and frequently fail to translate into better patient outcomes. Realist methods have not yet been adapted for policy implementation. Design Research methodology - Evaluation using theory-based realist methods for policy implementation. Methods An expert group developed the policy and supporting tools. Implementation and evaluation design integrated diffusion of innovation theory with multiple case study and adapted realist principles. Practitioners in 12 English sites worked with Consultant Nurse implementers to manipulate the programme theory and logic of new decision-support tools and care pathway to optimize local implementation. Methods included key-stakeholder interviews, developing practical diffusion of innovation processes using key-opinion leaders and active facilitation strategies and a mini-community of practice. New and existing processes and outcomes were compared for 137 children during 2007-2008. Results Realist principles were successfully adapted to a shorter policy implementation and evaluation time frame. Important new implementation success factors included facilitated implementation that enabled 'real-time' manipulation of programme logic and local context to best-fit evolving theories of what worked; using local experiential opinion to change supporting tools to more realistically align with local context and what worked; and having sufficient existing local infrastructure to support implementation. Ten mechanisms explained implementation success and differences in outcomes between new and existing processes. Conclusions Realistic policy implementation methods have advantages over top-down approaches, especially where clinical expertise is low and unlikely to diffuse innovations 'naturally' without facilitated implementation and local optimization. [ABSTRACT FROM AUTHOR]

Background: The United Kingdom has led the world in the development of children's palliative care. Over the past two decades, the illness trajectories of children with life-limiting conditions have extended with new treatments and better home-based care. Future planning is a critically under-researched aspect of children's palliative care globally. This paper describes the development, implementation and evaluation of innovative child and parent-held palliative care planning resources. The resources were designed to facilitate parent and child thinking and engagement in future planning, and to determine care preferences and preferred locations of care for children with life-limiting conditions from diagnosis onwards. These resources fill a significant gap in palliative care planning before the end-of-life phase. Methods: Drawing on contemporaneous research on producing evidence-based children's health information, we collaborated with leading children's not-for-profit organisations, parents, children, and professionals. A set of resources (My Choices booklets) were developed for parents and children and evaluated using interviews (parents, children, professionals) and questionnaires (professionals) and an open web-based consultation. Results: Parents and children responded in three ways: Some used the booklets to produce detailed written plans with clear outcomes and ideas about how best to achieve desired outcomes. Others preferred to use the booklet to help them think about potential options. Remaining parents found it difficult to think about the future and felt there was no point because they perceived there to be no suitable local services. Professionals varied in confidence in their ability to engage with families to plan ahead and identified many challenges that prevented them from doing so. Few families shared their plans with professionals. Parents and children have far stronger preferences for home-care than professionals. Conclusion: The My Choices booklets were revised in light of findings, have been endorsed by Together for Short Lives, and are free to download in English and Welsh for use by parents and young people globally. More work needs to be done to support families who are not yet receptive to planning ahead. Professionals would benefit from more training in person-centred approaches to future planning and additional communications skills to increase confidence and ability to engage with families to deliver sensitive palliative care planning. [ABSTRACT FROM AUTHOR]

Background: Decision making in health and social care requires robust syntheses of both quantitative and qualitative evidence. Meta-ethnography is a seven-phase methodology for synthesising qualitative studies. Developed in 1988 by sociologists in education Noblit and Hare, meta-ethnography has evolved since its inception; it is now widely used in healthcare research and is gaining popularity in education research. The aim of this article is to provide up-to-date, in-depth guidance on conducting the complex analytic synthesis phases 4 to 6 of meta-ethnography through analysis of the latest methodological evidence.Methods: We report findings from a methodological systematic review conducted from 2015 to 2016. Fourteen databases and five other online resources were searched. Expansive searches were also conducted resulting in inclusion of 57 publications on meta-ethnography conduct and reporting from a range of academic disciplines published from 1988 to 2016.Results: Current guidance on applying meta-ethnography originates from a small group of researchers using the methodology in a health context. We identified that researchers have operationalised the analysis and synthesis methods of meta-ethnography - determining how studies are related (phase 4), translating studies into one another (phase 5), synthesising translations (phase 6) and line of argument synthesis - to suit their own syntheses resulting in variation in methods and their application. Empirical research is required to compare the impact of different methods of translation and synthesis. Some methods are potentially better at preserving links with the context and meaning of primary studies, a key principle of meta-ethnography. A meta-ethnography can and should include reciprocal and refutational translation and line of argument synthesis, rather than only one of these, to maximise the impact of its outputs.Conclusion: The current work is the first to articulate and differentiate the methodological variations and their application for different purposes and represents a significant advance in the understanding of the methodological application of meta-ethnography. [ABSTRACT FROM AUTHOR]