English version of Japanese Clinical Practice Guidelines 2022 for gastrointestinal stromal tumor (GIST) issued by the Japan Society of Clinical Oncology.

The Japan Society of Clinical Oncology Clinical Practice Guidelines 2022 for gastrointestinal stromal tumor (GIST) have been published in accordance with the Minds Manual for Guideline Development 2014 and 2017. A specialized team independent of the working group for the revision performed a systematic review. Since GIST is a rare type of tumor, clinical evidence is not sufficient to answer several clinical and background questions. Thus, in these guidelines, we considered that consensus among the experts who manage GIST, the balance between benefits and harms, patients' wishes, medical economic perspective, etc. are important considerations in addition to the evidence. Although guidelines for the treatment of GIST have also been published by the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO), there are some differences between the treatments proposed in those guidelines and the treatments in the present guidelines because of the differences in health insurance systems among countries.

Barriers and facilitators in developing patient versions of clinical practice guidelines - qualitative interviews on experiences of international guideline producers.

BACKGROUND: Several guideline organizations produce patient versions of clinical practice guidelines (PVGs) which translate recommendations into simple language. A former study of our working group revealed that few guideline organizations publish their methods used to develop PVGs. Clear definitions of PVGs do not prevail and their purposes often remain unclear. We aimed to explore experts' perspectives on developing, disseminating and implementing PVGs to discuss and incorporate these experiences when consenting on methodological guidance and further improving PVGs. METHODS: We conducted 17 semi-structured telephone interviews with international experts working with PVGs from September 2021 through January 2022. We conducted the interviews in English or German, they were recorded and transcribed verbatim. We utilized Mayring's qualitative content analysis with MAXQDA software to analyze the data. RESULTS: In two interviews two participants were interviewed at the same time. This resulted in a total of 19 participants from 16 different organizations and eight different countries participated. Most were female (16/19) and their experience in working with PVGs ranged from 1 to 20 years. All follow methodological standards when developing PVGs, but the extent of these standards and their public accessibility differs. Aims and target groups of PVGs vary between organizations. Facilitators for developing PVGs are working with a multidisciplinary team, financial resources, consultation processes and a high-quality underlying CPG. Facilitators for disseminating and implementing PVGs are using various strategies. Barriers, on the other hand, are the lack of these factors. All participants mentioned patient involvement as a key aspect in PVG development. CONCLUSION: The steps in the PVG development process are largely similar across the countries. Focus is placed on the involvement of patients in the development process, although the extent of participation varies. The experts collectively attribute great importance to PVGs overall, but in order to constantly adapt to medical progress and changing conditions, the focus in the future may be more on formats like living guidelines. Although there are different views on the mandatory development of PVGs, there is a consistent call for more transparency regarding the methodology used for PVGs.

Use of qualitative research in World Health Organisation guidelines: a document analysis.

BACKGROUND: Guidelines depend on effect estimates, usually derived from randomised controlled trials, to inform their decisions. Qualitative research evidence may improve decisions made but where in the process and the methods to do this have not been so clearly established. We sought to describe and appraise how qualitative research has been used to inform World Heath Organization guidance since 2020. METHODS: We conducted a document analysis of WHO guidelines from 2020 to 2022. We purposely sampled guidelines on the topics of maternal and newborn health (MANH) and infectious diseases, as most of the qualitative synthesis to date has been conducted on these topics, likely representing the 'best case' scenario. We searched the in-built repository feature of the WHO website and used standardised search terms to identify qualitative reporting. Using deductive frameworks, we described how qualitative evidence was used to inform guidelines and appraised the standards of this use. RESULTS: Of the 29 guidelines, over half used qualitative research to help guide decisions (18/29). A total of 8 of these used qualitative research to inform the guideline scope, all 18 to inform recommendations, and 1 to inform implementation considerations. All guidelines drew on qualitative evidence syntheses (QES), and five further supplemented this with primary qualitative research. Qualitative findings reported in guidelines were typically descriptive, identifying people's perception of the benefits and harms of interventions or logistical barriers and facilitators to programme success. No guideline provided transparent reporting of how qualitative research was interpreted and weighed used alongside other evidence when informing decisions, and only one guideline reported the inclusion of qualitative methods experts on the panel. Only a few guidelines contextualised their recommendations by indicating which populations and settings qualitative findings could be applied. CONCLUSIONS: Qualitative research frequently informed WHO guideline decisions particularly in the field of MANH. However, the process often lacked transparency. We identified unmet potential in informing implementation considerations and contextualisation of the recommendations. Use in these areas needs further methods development.

Applying the WHO-INTEGRATE evidence-to-decision framework in the development of WHO guidelines on parenting interventions: step-by-step process and lessons learnt.

BACKGROUND: Development of guidelines for public health, health system, and health policy interventions demands complex systems thinking to understand direct and indirect effects of interventions within dynamic systems. The WHO-INTEGRATE framework, an evidence-to-decision framework rooted in the norms and values of the World Health Organization (WHO), provides a structured method to assess complexities in guidelines systematically, such as the balance of an intervention's health benefits and harms and their human rights and socio-cultural acceptability. This paper provides a worked example of the application of the WHO-INTEGRATE framework in developing the WHO guidelines on parenting interventions to prevent child maltreatment, and shares reflective insights regarding the value added, challenges encountered, and lessons learnt. METHODS: The methodological approach comprised describing the intended step-by-step application of the WHO-INTEGRATE framework and gaining reflective insights from introspective sessions within the core team guiding the development of the WHO guidelines on parenting interventions and a methodological workshop. RESULTS: The WHO-INTEGRATE framework was used throughout the guideline development process. It facilitated reflective deliberation across a broad range of decision criteria and system-level aspects in the following steps: (1) scoping the guideline and defining stakeholder engagement, (2) prioritising WHO-INTEGRATE sub-criteria and guideline outcomes, (3) using research evidence to inform WHO-INTEGRATE criteria, and (4) developing and presenting recommendations informed by WHO-INTEGRATE criteria. Despite the value added, challenges, such as substantial time investment required, broad scope of prioritised sub-criteria, integration across diverse criteria, and sources of evidence and translation of insights into concise formats, were encountered. CONCLUSIONS: Application of the WHO-INTEGRATE framework was crucial in the integration of effectiveness evidence with insights into implementation and broader implications of parenting interventions, extending beyond health benefits and harms considerations and fostering a whole-of-society-perspective. The evidence reviews for prioritised WHO-INTEGRATE sub-criteria were instrumental in guiding guideline development group discussions, informing recommendations and clarifying uncertainties. This experience offers important lessons for future guideline panels and guideline methodologists using the WHO-INTEGRATE framework.

Adherence of Clinical Practice Guidelines for Oropharyngeal Dysphagia in Parkinson Disease to Trustworthy Standards: A Systematic Survey.

Despite the high prevalence and burden of dysphagia in Parkinson disease (PD), the availability and trustworthiness of clinical practice guidelines (CPGs) regarding its assessment and management remains uncertain. The objective of this study is to appraise the quality of CPGs for dysphagia in PD. We searched OVID Medline, Embase, CINAHL and SpeechBite from January 2011 to July 2023 for guidance documents addressing screening, referral, monitoring, assessment, or management of dysphagia in PD. We additionally conducted an informal search of web pages of relevant professional societies and government organizations. Paired reviewers independently screened studies, and for relevant guidance documents, abstracted data and assessed their quality using the National Guideline Clearinghouse Extent of Adherence to Trustworthy Standards instrument. Thirteen CPGs proved eligible. Of these, eight (62%) were developed by professional societies. Overall, CPGs were deemed low quality. Eleven (85%) CPGs reported funding sources, and nine (69%) reported conflicts of interest. Five (35%) guidance documents included a methodologist, four (30%) included patient partners, four (30%) described study selection processes, and two (15%) clearly described relevant benefits and harms. Regarding dysphagia-specific recommendations, less than half of guidance documents met standards for trustworthiness; six (46%) provided a synthesis of available evidence, eight (54%) specified strength of recommendations, and two (15%) articulated unambiguous recommendations. Limited guidance exists regarding screening, monitoring and referral for dysphagia in PD. Existing guidance frequently fails to meet standards for trustworthiness. International, multidisciplinary, evidence-based practice guidelines with adequate methodological and patient partner involvement are needed.

Skin-to-skin contact after birth: Developing a research and practice guideline.

AIM: Skin-to-skin contact immediately after birth is recognised as an evidence-based best practice and an acknowledged contributor to improved short- and long-term health outcomes including decreased infant mortality. However, the implementation and definition of skin-to-skin contact is inconsistent in both practice and research studies. This project utilised the World Health Organization guideline process to clarify best practice and improve the consistency of application. METHODS: The rigorous guideline development process combines a systematic review with acumen and judgement of experts with a wide range of credentials and experience. RESULTS: The developed guideline received a strong recommendation from the Expert Panel. The result concluded that there was a high level of confidence in the evidence and that the practice is not resource intensive. Research gaps were identified and areas for continued work were delineated. CONCLUSION: The World Health Organization guideline development process reached the conclusion immediate, continuous, uninterrupted skin-to-skin contact should be the standard of care for all mothers and all babies (from 1000 g with experienced staff if assistance is needed), after all modes of birth. Delaying non-essential routine care in favour of uninterrupted skin-to-skin contact after birth has been shown to be safe and allows for the progression of newborns through their instinctive behaviours.

Adults born prematurely prefer a periviability guideline that considers multiple prognostic factors beyond gestational age.

AIM: The aim of the study was to explore the perspectives of adults born prematurely on guidelines for management at extreme premature birth and personalisation at the limit of viability. METHODS: We conducted four 2-h online focus group interviews in the Netherlands. RESULTS: Twenty-three participants born prematurely were included in this study, ranging in age from 19 to 56 years and representing a variety of health outcomes. Participants shared their perspectives on different types of guidelines for managing extremely premature birth. They agreed that a guideline was necessary to prevent arbitrary treatment decisions and to avoid physician bias. All participants favoured a guideline that is based upon multiple prognostic factors beyond gestational age. They emphasised the importance of discretion, regardless of the type of guideline used. Discussions centred mainly on the heterogeneity of value judgements about outcomes after extreme premature birth. Participants defined personalisation as 'not just looking at numbers and statistics'. They associated personalisation mainly with information provision and decision-making. Participants stressed the importance of involving families in decision-making and taking their care needs seriously. CONCLUSION: Adults born prematurely prefer a periviability guideline that considers multiple prognostic factors and allows for discretion.

Approaches to clinical guideline development in healthcare: a scoping review and document analysis.

BACKGROUND: Over the past decade, an industry has emerged around Clinical Practice Guideline (CPG) development in healthcare, which has increased pressure on guideline-producing organisations to develop CPGs at an accelerated rate. These are intended to improve the quality of care provided to patients while containing healthcare costs and reducing variability in clinical practice. However, this has inadvertently led to discrepancies in CPG recommendations between health organisations, also challenging healthcare providers who rely on these for decision-making and to inform clinical care. From a global perspective, although some countries have initiated national protocols regarding developing, appraising and implementing high-quality CPGs, there remains no standardised approach to any aspect of CPG production. METHODS: A scoping review of the literature and document analysis were conducted according to Joanna Brigg's Institute methodology for scoping reviews. This comprised two qualitative methods: a comprehensive review of the literature (using CINAHL, Scopus and PubMeD) and a document analysis of all national and international guideline development processes (manual search of health-related websites, national/international organisational health policies and documents). RESULTS: A set of clear principles and processes were identified as crucial to CPG development, informing the planning, implementation and dissemination of recommendations. Fundamentally, two common goals were reported: to improve the quality and consistency of clinical practice (patient care) and to reduce the duplication or ratification of low-grade CPGs. CONCLUSIONS: Consultation and communication between CPG working parties, including a wide range of representatives (including professional organisations, regional and local offices, and relevant national bodies) is essential. Further research is required to establish the feasibility of standardising the approach and disseminating the recommendations.

The perceptions and experience of developing patient (version of) guidelines: a descriptive qualitative study with Chinese guideline developers.

OBJECTIVE: To understand developers' perception of patient (versions of) guidelines (PVGs), and identify challenges during the PVG development, with the aim to inform methodological guidance for future PVG development. METHODS: We used a descriptive qualitative design. Semi-structured interviews were conducted virtually from December 2021 to April 2022, with a purposive sampling of 12 PVG developers from nine teams in China. Conventional and directed content analysis was used for data analysis. RESULTS: The interviews identified PVG developers' understanding of PVGs, their current practice experience, and the challenges of developing PVGs. Participants believed PVGs were a type of health education material for patients; therefore, it should be based on patient needs and be understandable and accessible. Participants suggested that PVGs could be translated/adapted from one or several clinical practice guidelines (CPG), or developed de novo (i.e., the creation of an entirely new PVG with its own set of research questions that are independent of existing CPGs). Participants perceived those existing methodological guidelines for PVG development might not provide clear instructions for PVGs developed from multiple CPGs and from de novo development. Challenges to PVG development include (1) a lack of standardized and native guidance on developing PVGs; (2) a lack of standardized guidance on patient engagement; (3) other challenges: no publicly known and trusted platform that could disseminate PVGs; concerns about the conflicting interests with health professionals. CONCLUSIONS AND PRACTICE IMPLICATIONS: Our study suggests clarifying the concept of PVG is the primary task to develop PVGs and carry out related research. There is a need to make PVG developers realize the roles of PVGs, especially in helping decision-making, to maximize the effect of PVG. It is necessary to develop native consensus-based guidance considering developers' perspectives regarding PVGs.

Transparency of clinical practice guideline funding: a cross-sectional analysis of the German AWMF registry.

BACKGROUND: While reporting of individual conflicts of interest is formalised, it is unclear to what extent the funding of clinical practice guidelines (CPGs) is formally reported. The aim of this study is to explore the accuracy and comprehensiveness of reporting on funding in German CPGs. METHODS: We searched for CPGs in the registry of the Association of the Scientific Medical Societies in Germany in July 2020. Information on guideline funding was categorised by two reviewers independently and discrepancies were clarified by discussion with a third reviewer. Accuracy and comprehensiveness of reporting on funding was assessed using the German Instrument for Methodological Guideline Appraisal (DELBI). RESULTS: We included 507 CPGs published between 2015 and 2020 in the main analysis. 23/507 (4.5%) of the CPGs achieved the highest DELBI score by including information on funding sources, expenses and the amount of funding provided, as well as a statement on the independence of the guideline authors from the funding institution(s). CPGs with more rigorous methodological requirements (systematic review of the literature and/or structured consensus-building) received higher DELBI scores. CONCLUSION: German CPGs do not communicate their funding transparently. Transparency of CPG funding could be achieved by making it mandatory to publish information for all guidelines. For that purpose, a standardised form and guidance should be developed.

TransitionED: A protocol for Co-designing and implementing Canadian practice guidelines for transitions for youth with eating disorders.

OBJECTIVE: Limited guidelines inform the transition from paediatric to adult healthcare for youth and young adults (YYA) with eating disorders (EDs). This study will develop, implement, and evaluate Canadian Clinical Practice Guidelines for ED transition, including identifying the relevant measurement and evaluation tools for transition readiness and continuity of care. METHODS: This study consists of three phases. Phase 1 involves conducting a scoping review of the evidence on transition interventions, outcomes, and measurement tools for YYA with EDs, along with guideline development using the modified Delphi method. Phase 2 identifies the contextual/cultural factors relevant to guideline implementation and co-designing an implementation protocol with governance committees and research partners. Phase 3 involves the application and evaluation of the proposed guide lines using the implementation protocol, and assessing the acceptability and feasibility of a prototype transition intervention in two Canadian paediatric ED programs. CONCLUSIONS: Results will provide the knowledge needed to enhance the lives of YYA, improve the effectiveness of the ED care system, and support the scale of the transition guidelines across Canada. These guidelines will have international relevance by potentially informing the field on how to support young people with EDs transitioning in similar funding structures and systems of care.

Evidence surveillance for a living clinical guideline: Case study of the Australian stroke guidelines.

BACKGROUND: Continual evidence surveillance is an integral feature of living guidelines. The Australian Stroke Guidelines include recommendations on 100 clinical topics and have been 'living' since 2018. OBJECTIVES: To describe the approach for establishing and evaluating an evidence surveillance system for the living Australian Stroke Guidelines. METHODS: We developed a pragmatic surveillance system based on an analysis of the searches for the 2017 Stroke Guidelines and evaluated its reliability by assessing the potential impact on guideline recommendations. Search retrieval and screening workload are monitored monthly, together with the frequency of changes to the guideline recommendations. RESULTS: Evidence surveillance was guided by practical considerations of efficiency and sustainability. A single PubMed search covering all guideline topics, limited to systematic reviews and randomised trials, is run monthly. The search retrieves about 400 records a month of which a sixth are triaged to the guideline panels for further consideration. Evaluations with Epistemonikos and the Cochrane Stroke Trials Register demonstrated the robustness of adopting this more restrictive approach. Collaborating with the guideline team in designing, implementing and evaluating the surveillance is essential for optimising the approach. CONCLUSION: Monthly evidence surveillance for a large living guideline is feasible and sustainable when applying a pragmatic approach.

What is a clinical practice guideline? A roadmap to their development. Special report from the Guidelines Task Force of the International League Against Epilepsy.

Clinical practice guidelines (CPGs) are statements that provide evidence-based recommendations aimed at optimizing patient care. However, many other documents are often published as "guidelines" when they are not; these documents, although also important in clinical practice, are usually not systematically produced following rigorous processes linking the evidence to the recommendations. Specifically, the International League Against Epilepsy (ILAE) guideline development toolkit aims to ensure that high-quality CPGs are developed to fill knowledge gaps and optimize the management of epilepsy. In addition to adhering to key methodological processes, guideline developers need to consider that effective CPGs should lead to improvements in clinical processes of care and health care outcomes. This requires monitoring the effectiveness of epilepsy-related CPGs and interventions to remove the barriers to epilepsy CPG implementation. This article provides an overview of what distinguishes quality CPGs from other documents and discusses their benefits and limitations. We summarize the recently revised ILAE CPG development process and elaborate on the barriers and facilitators to guideline dissemination, implementation, and adaptation.

A collaborative approach to adopting/adapting guidelines. The Australian 24-hour movement guidelines for children (5-12 years) and young people (13-17 years): An integration of physical activity, sedentary behaviour, and sleep.

BACKGROUND: In 2018, the Australian Government updated the Australian Physical Activity and Sedentary Behaviour Guidelines for Children and Young People. A requirement of this update was the incorporation of a 24-hour approach to movement, recognising the importance of adequate sleep. The purpose of this paper was to describe how the updated Australian 24-Hour Movement Guidelines for Children and Young People (5 to 17 years): an integration of physical activity, sedentary behaviour and sleep were developed and the outcomes from this process. METHODS: The GRADE-ADOLOPMENT approach was used to develop the guidelines. A Leadership Group was formed, who identified existing credible guidelines. The Canadian 24-Hour Movement Guidelines for Children and Youth best met the criteria established by the Leadership Group. These guidelines were evaluated based on the evidence in the GRADE tables, summaries of findings tables and recommendations from the Canadian Guidelines. We conducted updates to each of the Canadian systematic reviews. A Guideline Development Group reviewed, separately and in combination, the evidence for each behaviour. A choice was then made to adopt or adapt the Canadian recommendations for each behaviour or create de novo recommendations. We then conducted an online survey (n=237) along with three focus groups (n=11 in total) and 13 key informant interviews. Stakeholders used these to provide feedback on the draft guidelines. RESULTS: Based on the evidence from the Canadian systematic reviews and the updated systematic reviews in Australia, the Guideline Development Group agreed to adopt the Canadian recommendations and, apart from some minor changes to the wording of good practice statements, maintain the wording of the guidelines, preamble, and title of the Canadian Guidelines. The Australian Guidelines provide evidence-informed recommendations for a healthy day (24-hours), integrating physical activity, sedentary behaviour (including limits to screen time), and sleep for children (5-12 years) and young people (13-17 years). CONCLUSIONS: To our knowledge, this is only the second time the GRADE-ADOLOPMENT approach has been used to develop movement behaviour guidelines. The judgments of the Australian Guideline Development Group did not differ sufficiently to change the directions and strength of the recommendations and as such, the Canadian Guidelines were adopted with only very minor alterations. This allowed the Australian Guidelines to be developed in a shorter time frame and at a lower cost. We recommend the GRADE-ADOLOPMENT approach, especially if a credible set of guidelines that was developed using the GRADE approach is available with all supporting materials. Other countries may consider this approach when developing and/or revising national movement guidelines.

The conduct and reporting of qualitative evidence syntheses in health and social care guidelines: a content analysis.

BACKGROUND: This paper is part of a broader investigation into the ways in which health and social care guideline producers are using qualitative evidence syntheses (QESs) alongside more established methods of guideline development such as systematic reviews and meta-analyses of quantitative data. This study is a content analysis of QESs produced over a 5-year period by a leading provider of guidelines for the National Health Service in the UK (the National Institute for Health and Care Excellence) to explore how closely they match a reporting framework for QES. METHODS: Guidelines published or updated between Jan 2015 and Dec 2019 were identified via searches of the National Institute for Health and Care excellence (NICE) website. These guidelines were searched to identify any QES conducted during the development of the guideline. Data relating to the compliance of these syntheses against a reporting framework for QES (ENTREQ) were extracted and compiled, and descriptive statistics used to provide an analysis of the of QES conduct, reporting and use by this major international guideline producer. RESULTS: QES contributed, in part, to 54 out of a total of 192 guidelines over the five-year period. Although methods for producing and reporting QES have changed substantially over the past decade, this study found that there has been little change in the number or quality of NICE QESs over time. The largest predictor of quality was the centre or team which undertook the synthesis. Analysis indicated that elements of review methods which were similar to those used in quantitative systematic reviews tended to be carried out well and mostly matched the criteria in the reporting framework, but review methods which were more specific to a QES tended to be carried out less well, with fewer examples of criteria in the reporting framework being achieved. CONCLUSION: The study suggests that use, conduct and reporting of optimal QES methods requires development, as over time the quality of reporting of QES both overall, and by specific centres, has not improved in spite of clearer reporting frameworks and important methodological developments. Further staff training in QES methods may be helpful for reviewers who are more familiar with conventional forms of systematic review if the highest standards of QES are to be achieved. There seems potential for greater use of evidence from qualitative research during guideline development.

Clinical practice guideline for end-of-life care in patients with cancer: a modified ADAPTE process.

PURPOSE: This study seeks to adapt a guideline for end-of-life care in patients with cancer to be used by healthcare teams. METHODS: This methodological study was conducted by modifying the ADAPTE process and adding to it a qualitative study and consensus ratings by a multidisciplinary panel of experts. A qualitative study was thus performed to identify the end-of-life needs of patients with cancer. Then, the source guidelines and the results of the qualitative study were used to draft the initial version of the guideline, with 85 adaptation recommendations. A multidisciplinary panel of healthcare experts performed the external review of the recommendations based on the four criteria of relatedness, comprehensibility, usefulness, and feasibility and scored them on a scale of 1-9. The mean score of each recommendation was calculated, and the recommendations were classified into three categories: appropriate (mean score of 7-9), uncertain (mean score of 4-6.99), and inappropriate (mean score of 1-3.99). RESULTS: All the recommendations were approved, as they all had a mean score of 7 or higher, and were then categorized into 11 dimensions: communication management; participatory and evidence-based decision-making management; pain management; dyspnea management; nausea and vomiting management; anorexia and cachexia management; constipation management; death rattle management; management of delirium, anxiety, and restlessness; hydration management; and pharmacological considerations. CONCLUSION: The adaptation of the guideline for end-of-life care in patients with cancer in Iran was performed by modifying the ADAPTE process with the participation of multidisciplinary stakeholders and based on the local needs.

Trends in the development process of clinical practice guidelines: a questionnaire survey for the guideline development groups in Japan.

BACKGROUND: Clinical practice guidelines (CPGs) are representative methods for promoting healthcare standardization and improving its quality. Previous studies on the CPG (published by 2006) development process in Japan reported that the involvement of experts and patients, efficient evidence collection and appraisal, and paucity of evidence on Japanese patients should be improved for the efficient CPG development. This study aimed to clarify the trends of CPG development process in Japan, focusing on the involvement of experts and patients, efficient evidence collection and appraisal, and paucity of Japanese evidence. METHODS: A cross-sectional questionnaire survey was conducted for CPG development groups to collect information on the development activities of the CPGs published from 2012 to 2019. These CPGs were identified from the Japanese guideline clearinghouse. The questionnaire included the questions on composing the group, securing funding sources, collecting and appraising the research evidence, and the difficulties in the CPG development process. The questionnaires were distributed to the chairpersons of the CPG development groups through postal mail from November 2020 to January 2021. Combining the data from the current survey with those of previous studies reporting the development process of CPGs published by 2011, we analyzed the trend in the CPG development process. RESULTS: Of the total 265 CPGs included in the analysis, 164 (response rate: 41.4%) were from the current survey and 101 (response rate: 44.5%) were from previous studies. Among these, 40 (15.1%) were published by 2005, 47 (17.7%) in 2006-2010, 77 (29.1%) in 2011-2015, and 101 (38.1%) in 2016-2019. The proportion of CPGs involving methodologists did not increase through the publication periods. The proportion of CPGs involving patients almost doubled from the first period (15.9%) to the fourth period (32.4%). The yield rates of the articles did not change through the publication periods. The difficulty in "Coping with the paucity of Japanese evidence" has been improving consistently (69.2% in the first period to 37.4% in the fourth period). CONCLUSIONS: Our results suggest the need for methodological improvement in the efficient collection and appraisal of evidence and in the system assigning experts to the CPG development groups.

Enhancing patient and public contribution in health outcome selection during clinical guideline development: an ethnographic study.

BACKGROUND: Patient and public involvement (PPI) is a cornerstone in enhancing healthcare research and delivery, including clinical guideline development. Health outcomes concern changes in the health status of an individual or population that are attributable to an intervention. Discussion of relevant health outcomes impacts the resulting clinical guidelines for practice. This study explores how the input of PPI contributors at the National Institute of Health and Care Excellence (NICE) is integrated into guideline development, particularly in relation to health outcome selection. METHODS: The study used an ethnographic methodological approach. Data comprised: observations of committee meetings, scoping workshops and training sessions, and in-depth interviews with PPI contributors, health professionals and chairs from clinical guideline development committees. Data were analysed thematically. RESULTS: PPI contributors' input in the guideline development process was often of limited scope, particularly in selecting health outcomes. Key constraints on their input included: the technical content and language of guidelines, assumed differences in the health-related priorities between PPI contributors and health professionals, and the linear timeline of the guideline development process. However, PPI contributors can influence clinical guideline development including the selection of relevant health outcomes. This was achieved through several factors and highlights the important role of the committee chair, the importance of training and support for all committee members, the use of plain language and the opportunity for all committee members to engage. CONCLUSIONS: Lay member input during the outcome selection phase of clinical guideline development is achievable, but there are challenges to overcome. Study findings identify ways that future guideline developers can support meaningful lay involvement in guideline development and health outcome selection.

Using the WHO-INTEGRATE evidence-to-decision framework to develop recommendations for induction of labour.

BACKGROUND: In 2019, WHO prioritized updating recommendations relating to three labour induction topics: labour induction at or beyond term, mechanical methods for labour induction, and outpatient labour induction. As part of this process, we aimed to review the evidence addressing factors beyond clinical effectiveness (values, human rights and sociocultural acceptability, health equity, and economic and feasibility considerations) to inform WHO Guideline Development Group decision-making using the WHO-INTEGRATE evidence-to-decision framework, and to reflect on how methods for identifying, synthesizing and integrating this evidence could be improved. METHODS: We adapted the framework to consider the key criteria and sub-criteria relevant to our intervention. We searched for qualitative and other evidence across a variety of sources and mapped the eligible evidence to country income setting and perspective. Eligibility assessment and quality appraisal of qualitative evidence syntheses was undertaken using a two-step process informed by the ENTREQ statement. We adopted an iterative approach to interpret the evidence and provided both summary and detailed findings to the decision-makers. We also undertook a review to reflect on opportunities to improve the process of applying the framework and identifying the evidence. RESULTS: Using the WHO-INTEGRATE framework allowed us to explore health rights and equity in a systematic and transparent way. We identified a lack of qualitative and other evidence from low- and middle-income settings and in populations that are most impacted by structural inequities or traditionally excluded from research. Our process review highlighted opportunities for future improvement, including adopting more systematic evidence mapping methods and working with social science researchers to strengthen theoretical understanding, methods and interpretation of the evidence. CONCLUSIONS: Using the WHO-INTEGRATE evidence-to-decision framework to inform decision-making in a global guideline for induction of labour, we identified both challenges and opportunities relating to the lack of evidence in populations and settings of need and interest; the theoretical approach informing the development and application of WHO-INTEGRATE; and interpretation of the evidence. We hope these insights will be useful for primary researchers as well as the evidence synthesis and health decision-making communities, and ultimately contribute to a reduction in health inequities.

The National Institute for Health and Care Excellence information specialist development pathway: Developing the skills, knowledge and confidence to quality assure search strategies.

Quality assurance (QA) is an important process in ensuring that systematic reviews and other evidence syntheses are supported by a high-quality search. This paper describes how the National Institute for Health and Care Excellence (NICE) in the UK established a development pathway to ensure its information specialists had the skills, knowledge and confidence to undertake search QA. The key component of the pathway is that it blends technical knowledge with interpersonal skills. The pathway develops technical skills in the early steps before using peer support activities to build confidence while undertaking a range of searches. QA is effective when the search lead communicates the contextual information that has influenced search development. QA is treated as a collaboration to get the right search for the review. The key requirements for search QA, alongside technical knowledge, are communication, collaboration and negotiation skills.