GRADE Guidance 39: Using GRADE-ADOLOPMENT to adopt, adapt or create contextualized recommendations from source guidelines and evidence syntheses.

INTRODUCTION: The GRADE-ADOLOPMENT methodology has been widely used to adopt, adapt or de novo develop recommendations from existing or new guideline and evidence synthesis efforts. This guidance refines the operationalization for applying GRADE-ADOLOPMENT. METHODS: Through iterative discussions, online meetings and email communications, the GRADE-ADOLOPMENT Project Group drafted the updated guidance. We then conducted a review of handbooks of guideline-producing organizations, and a scoping review of published and planned Adolopment guideline projects. The lead authors refined the existing approach based on the scoping review findings and feedback from members of the GRADE Working Group. We presented the revised approach to the group in November 2022 (approximately 115 people), in May 2023 (approximately 100 people) and twice in September 2023 (approximately 60 and 90 people) for approval. RESULTS: This GRADE guidance shows how to effectively and efficiently contextualize recommendations using the GRADE-ADOLOPMENT approach by: (1) showcasing alternative pathways for starting an adolopment effort; (2) elaborating on the different essential steps of this approach, such as building on existing EtDs when available or developing new EtDs if necessary; and (3) providing examples from adolopment case studies to facilitate the application of the approach. We demonstrate how to use contextual evidence to make judgments about EtD criteria, and highlight the importance of making the resulting EtDs available to facilitate adolopment efforts by others. CONCLUSION: This updated GRADE guidance further operationalizes the application of GRADE-ADOLOPMENT based on over six years of experience. It serves to support uptake and application by end users interested in contextualizing recommendations to a local setting or specific reality in a short period of time or with limited resources.

Exploring decision-makers' challenges and strategies when selecting multiple systematic reviews: insights for AI decision support tools in healthcare.

BACKGROUND: Systematic reviews (SRs) are being published at an accelerated rate. Decision-makers may struggle with comparing and choosing between multiple SRs on the same topic. We aimed to understand how healthcare decision-makers (eg, practitioners, policymakers, researchers) use SRs to inform decision-making and to explore the potential role of a proposed artificial intelligence (AI) tool to assist in critical appraisal and choosing among SRs. METHODS: We developed a survey with 21 open and closed questions. We followed a knowledge translation plan to disseminate the survey through social media and professional networks. RESULTS: Our survey response rate was lower than expected (7.9% of distributed emails). Of the 684 respondents, 58.2% identified as researchers, 37.1% as practitioners, 19.2% as students and 13.5% as policymakers. Respondents frequently sought out SRs (97.1%) as a source of evidence to inform decision-making. They frequently (97.9%) found more than one SR on a given topic of interest to them. Just over half (50.8%) struggled to choose the most trustworthy SR among multiple. These difficulties related to lack of time (55.2%), or difficulties comparing due to varying methodological quality of SRs (54.2%), differences in results and conclusions (49.7%) or variation in the included studies (44.6%). Respondents compared SRs based on the relevance to their question of interest, methodological quality, and recency of the SR search. Most respondents (87.0%) were interested in an AI tool to help appraise and compare SRs. CONCLUSIONS: Given the identified barriers of using SR evidence, an AI tool to facilitate comparison of the relevance of SRs, the search and methodological quality, could help users efficiently choose among SRs and make healthcare decisions.

Guidance on how to efficiently find, choose, and use available systematic reviews was developed.

OBJECTIVES: The aim of this paper is to provide clinicians and authors of clinical guidelines or patient information with practical guidance on searching and choosing systematic reviews(s) (SR[s]) and, where adequate, on making use of SR(s). STUDY DESIGN AND SETTING: At the German conference of the Evidence-Based Medicine Network (EbM Network) a workshop on the topic was held to identify the most important areas where guidance for practice appears necessary. After the workshop, we established working groups. These included SR users with different backgrounds (eg, information specialists, epidemiologists) and working areas. Each working group developed and consented a draft guidance based on their expert knowledge and experiences. The results were presented to the entire group and finalized in an iterative process. RESULTS: We developed a practical guidance that answers questions that usually arise when choosing and using SR(s). (1) How to efficiently find high-quality SRs? (2) How to choose the most appropriate SR? (3) What to do if no SR of sufficient quality could be identified? In addition, we developed an algorithm that links these steps and accounts for their interaction. The resulting guidance is primarily directed at clinicians and developers of clinical practice guidelines or patient information resources. CONCLUSION: We suggest practical guidance for making the best use of SRs when answering a specific research question. The guidance may contribute to the efficient use of existing SRs. Potential benefits when using existing SRs should be always weighted against potential limitations.

Systems for electronic documentation and sharing of advance care planning preferences: a scoping review.

Digital approaches to support advance care planning (ACP) documentation and sharing are increasingly being used, with a lack of research to characterise their design, content, and use. This study aimed to characterise how digital approaches are being used to support ACP documentation and sharing internationally. A scoping review was performed in accordance with the JBI (formerly Joanna Briggs Institute) guidelines and the PRISMA 2020 checklist, prospectively registered on Open Science Framework (https://osf.io/xnrg3). MEDLINE, EMBASE, PsycINFO, ACM Digital, IEEE Xplore and CINAHL were searched in February 2023. Only publications in English, published from 2008 onwards were considered. Eligibility criteria included a focus on ACP and electronic systems. Out of 2,393 records, 34 reports were included, predominantly from the USA (76.5%). ACP documentation is typically stored in electronic health records (EHRs) (67.6%), with a third (32.4%) enabling limited patient access. Non-standard approaches (n = 15;44.1%) were the commonest study design of included reports, with outcome measures focusing on the influence of systems on the documentation (i.e. creation, quantity, quality, frequency or timing) of ACP information (n = 23;67.6%). Digital approaches to support ACP are being implemented and researched internationally with an evidence base dominated by non-standard study designs. Future research is needed to extend outcome measurement to consider aspects of care quality and explore whether the content of existing systems aligns with aspects of care that are valued by patients.

Automation tools to support undertaking scoping reviews.

OBJECTIVE: This paper describes several automation tools and software that can be considered during evidence synthesis projects and provides guidance for their integration in the conduct of scoping reviews. STUDY DESIGN AND SETTING: The guidance presented in this work is adapted from the results of a scoping review and consultations with the JBI Scoping Review Methodology group. RESULTS: This paper describes several reliable, validated automation tools and software that can be used to enhance the conduct of scoping reviews. Developments in the automation of systematic reviews, and more recently scoping reviews, are continuously evolving. We detail several helpful tools in order of the key steps recommended by the JBI's methodological guidance for undertaking scoping reviews including team establishment, protocol development, searching, de-duplication, screening titles and abstracts, data extraction, data charting, and report writing. While we include several reliable tools and software that can be used for the automation of scoping reviews, there are some limitations to the tools mentioned. For example, some are available in English only and their lack of integration with other tools results in limited interoperability. CONCLUSION: This paper highlighted several useful automation tools and software programs to use in undertaking each step of a scoping review. This guidance has the potential to inform collaborative efforts aiming at the development of evidence informed, integrated automation tools and software packages for enhancing the conduct of high-quality scoping reviews.

Large scoping reviews: managing volume and potential chaos in a pool of evidence sources.

Scoping reviews can identify a large number of evidence sources. This commentary describes and provides guidance on planning, conducting, and reporting large scoping reviews. This guidance is informed by experts in scoping review methodology, including JBI (formerly Joanna Briggs Institute) Scoping Review Methodology group members, who have also conducted and reported large scoping reviews. We propose a working definition for large scoping reviews that includes approximately 100 sources of evidence but must also consider the volume of data to be extracted, the complexity of the analyses, and purpose. We pose 6 core questions for scoping review authors to consider when planning, developing, conducting, and reporting large scoping reviews. By considering and addressing these questions, scoping review authors might better streamline and manage the conduct and reporting of large scoping reviews from the planning to publishing stage.

Use, applicability, and dissemination of patient versions of clinical practice guidelines in oncology in Germany: a qualitative interview study with healthcare providers.

BACKGROUND: People with cancer have high information needs; however, they are often inadequately met. Patient versions of clinical practice guidelines (PVGs), a special form of evidence-based information, translate patient-relevant recommendations from clinical practice guidelines into lay language. To date, little is known about the experience of PVGs from healthcare providers' perspective in healthcare. This study aims to investigate the use, applicability, and dissemination of PVGs in oncology from the healthcare providers' perspective in Germany. METHODS: Twenty semi-structured telephone interviews were conducted with oncological healthcare providers in Germany between October and December 2021. Interviews were recorded and transcribed verbatim. Mayring's qualitative content analysis with MAXQDA software was utilised to analyse the data. RESULTS: A total of 20 healthcare providers (14 female, 6 male), mainly working as psychotherapists/psycho-oncologists and physicians, participated. Most participants (75%) were aware of the existence of PVGs. The content was predominantly perceived as comprehensible and relevant, whereas opinions on the design and format were mixed. The perceived lack of up-to-date information limited participants' trust in the content. Most felt that PVGs positively impact healthcare owing to the fact that they improve patients' knowledge about their disease. Additionally, PVGs served as a guide and helped healthcare providers structure physician-patient talks. Healthcare provider's unawareness of the existence of PVGs was cited as an obstructive factor to its dissemination to patients. CONCLUSION: Limited knowledge of the existence of PVGs among healthcare providers, coupled with alternative patient information, hinders the use and dissemination of PVGs in healthcare. However, the applicability of PVGs seemed to be acceptable owing to their content and good comprehensibility, especially with respect to physician-patient communication.

Only half of the authors of overviews of exercise-related interventions use some strategy to manage overlapping primary studies-a metaresearch study.

OBJECTIVES: The conduct of systematic reviews (SRs) and overviews share several similarities. However, because the unit of analysis for overviews is the SRs, there are some unique challenges. One of the most critical issues to manage when conducting an overview is the overlap of data across the primary studies included in the SRs. This metaresearch study aimed to describe the frequency of strategies to manage the overlap in overviews of exercise-related interventions. STUDY DESIGN AND SETTING: A systematic search in MEDLINE (Ovid), Embase (Ovid), Cochrane Library, Epistemonikos, and other sources was conducted from inception to June 2022. We included overviews of SRs that considered primary studies and evaluated the effectiveness of exercise-related interventions for any health condition. The overviews were screened by two authors independently, and the extraction was performed by one author and checked by a second. We found 353 overviews published between 2005 and 2022 that met the inclusion criteria. RESULTS: One hundred and sixty-four overviews (46%) used at least one strategy to visualize, quantify, or resolve overlap, with a matrix (32/164; 20%), absolute frequency (34/164; 21%), and authors' algorithms (24/164; 15%) being the most used methods, respectively. From 2016 onwards, there has been a trend toward increasing the use of some strategies to manage overlap. Of the 108 overviews that used some strategy to resolve the overlap, ie, avoiding double or multiple counting of primary study data, 79 (73%) succeeded. In overviews where no strategies to manage overlap were reported (n = 189/353; 54%), 16 overview authors (8%) recognized this as a study limitation. CONCLUSION: Although there is a trend toward increasing its use, only half of the authors of the overviews of exercise-related interventions used a strategy to visualize, quantify, or resolve overlap in the primary studies' data. In the future, authors should report such strategies to communicate more valid results.

Validated geographic search filters for bibliographic databases: a scoping review protocol.

OBJECTIVE: The purpose of this scoping review is to identify validated geographic search filters and report their methodology and performance measures. INTRODUCTION: Data on specific geographic areas can be required for evidence syntheses topics, such as the investigation of regional inequalities in health care or to answer context-specific epidemiological questions. Search filters are useful tools for reviewers aiming to identify publications with common characteristics in bibliographic databases. Geographic search filters limit the literature search results to a specific geographic feature (eg, a country or region). INCLUSION CRITERIA: We will include reports on validated geographic search filters that aim to identify research evidence about a defined geographic area (eg, a country/region or a group of countries/regions). METHODS: This review will be conducted in accordance with JBI methodology for scoping reviews. The literature search will be conducted in PubMed and Embase. The InterTASC Information Specialists' Sub-Group Search Filter resource and Google Scholar will also be searched. Reports published in any language, from database inception to the present, will be considered for inclusion. Two researchers will independently screen the title, abstract, and full text of the search results. A third reviewer will be consulted in the event of any disagreements. The data extraction will include study characteristics, basic characteristics of the geographical search filter (eg, country/region), and the methods used to develop and validate the search filter. The extracted data will be summarized narratively and presented in a table. REVIEW REGISTRATION: Open Science Framework https://osf.io/5czhs.

Application of the PANELVIEW instrument to evaluate the guideline development process of the German polytrauma guideline.

BACKGROUND: PANELVIEW is an instrument for evaluating the appropriateness of the process, methods, and outcome of guideline development and the satisfaction of the guideline group with these steps. OBJECTIVE: To evaluate the guideline development process of the German guideline on the treatment of patients with severe/multiple injuries ('German polytrauma guideline') from the perspective of the guideline group, and to identify areas where this process may be improved in the future. METHODS: We administered PANELVIEW to the participants of the 2022 update of the German polytrauma guideline. All guideline group members, including delegates of participating medical societies, steering group members, authors of guideline chapters, the chair, and methodological lead, were invited to participate. Responses were analysed using descriptive statistics. Comments received were categorised by domains/items of the tool. RESULTS: After the first, second, and last consensus conference, the guideline group was invited via email to participate in a web-based survey. Response rates were 36% (n/N = 13/36), 40% (12/30), and 37% (20/54), respectively. The mean scores for items ranged between 5.1 and 6.9 on a scale from 1 (fully disagree) to 7 (fully agree). Items with mean scores below 6.0 were related to (1) administration, (2) consideration of patients' views, perspectives, values, and preferences, and (3) the discussion of research gaps and needs for future research. CONCLUSION: The PANELVIEW tool showed that the guideline group was satisfied with most aspects of the guideline development process. Areas for improvement of the process were identified. Strategies to improve response rates should be explored.

Methods proposed for monitoring the implementation of evidence-based research: a cross-sectional study.

OBJECTIVES: Evidence-based research (EBR) is the systematic and transparent use of prior research to inform a new study so that it answers questions that matter in a valid, efficient, and accessible manner. This study surveyed experts about existing (e.g., citation analysis) and new methods for monitoring EBR and collected ideas about implementing these methods. STUDY DESIGN AND SETTING: We conducted a cross-sectional study via an online survey between November 2022 and March 2023. Participants were experts from the fields of evidence synthesis and research methodology in health research. Open-ended questions were coded by recurring themes; descriptive statistics were used for quantitative questions. RESULTS: Twenty-eight expert participants suggested that citation analysis should be supplemented with content evaluation (not just what is cited but also in which context), content expert involvement, and assessment of the quality of cited systematic reviews. They also suggested that citation analysis could be facilitated with automation tools. They emphasized that EBR monitoring should be conducted by ethics committees and funding bodies before the research starts. Challenges identified for EBR implementation monitoring were resource constraints and clarity on responsibility for EBR monitoring. CONCLUSION: Ideas proposed in this study for monitoring the implementation of EBR can be used to refine methods and define responsibility but should be further explored in terms of feasibility and acceptability. Different methods may be needed to determine if the use of EBR is improving over time.

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.

[Quality of life of ostomates in Germany]. / Lebensqualität von Menschen mit einem künstlichen Darmausgang in Deutschland.

BACKGROUND: The presence of an ostomy may have a serious impact on the quality of life (QoL). The aim of this study was to evaluate the QoL of ostomates in Germany. METHOD: An online survey was performed using the validated Gastrointestinal Quality of Life Index (GIQLI) by Eypasch et al. Ostomates ≥ 18 yrs. with an ostomy duration ≥ 3 months were eligible to participate. RESULTS: Completed questionnaires from 519 participants (79.3 % female) with a median age of 50 yrs. (range 19-83 yrs.) and a median ostomy duration of 3 yrs. (range 3 months-58 yrs.) were analyzed. The most common indications for an ostomy were Crohn's disease (36.5 %), colorectal cancer (19.8 %) and ulcerative colitis (18.2 %). The mean GIQLI-Score in the study population was 94.8 ± 24.6, with higher scores corresponding with better QoL and healthy individuals reach 125.8. Limitations were recorded with regard to sleep, tiredness, energy level, endurance, fitness and sexuality. Individuals with a stoma due to Colitis (103,0 ± 24,5), colorectal cancer (99,2 ± 21,7) and Crohn's (95,0 ± 22,8) had the highest mean GIQLI-scores amongst all ostomates. DISCUSSION: The findings of this study confirm that ostomates have a reduced QoL compared to the healthy population. Amongst all ostomates, those with colitis, colorectal cancer and Crohn's have a better QoL compared to ostomy carriers with other diagnoses.

Author instructions in biomedical journals infrequently address systematic review reporting and methodology: a cross-sectional study.

OBJECTIVES: We aimed to analyze how instructions for authors in journals indexed in MEDLINE address systematic review (SR) reporting and methodology. STUDY DESIGN AND SETTING: We analyzed instructions for authors in 20% of MEDLINE-indexed journals listed in the online catalog of the National Library of Medicine on July 27, 2021. We extracted data only from the instructions published in English. We extracted data on the existence of instructions for reporting and methodology of SRs. RESULTS: Instructions from 1,237 journals mentioned SRs in 45% (n = 560) of the cases. Systematic review (SR) registration was mentioned in 104/1,237 (8%) of instructions. Guidelines for reporting SR protocols were found in 155/1,237 (13%) of instructions. Guidelines for reporting SRs were explicitly mentioned in 461/1,237 (37%), whereas the EQUATOR (Enhancing the Quality and Transparency of Health Research) network was referred to in 474/1,237 (38%) of instructions. Less than 2% (n = 20) of instructions mentioned risk of bias and meta-analyses; less than 1% mentioned certainty of evidence assessment, methodological expectations, updating of SRs, overviews of SRs, or scoping reviews. CONCLUSION: Journals indexed in MEDLINE rarely provide instructions for authors regarding SR reporting and methodology. Such instructions could potentially raise authors' awareness and improve how SRs are prepared and reported.

Safety outcomes of direct oral anticoagulants in older adults with atrial fibrillation: a systematic review and meta-analysis of (subgroup analyses from) randomized controlled trials.

Balancing stroke prevention and risk of bleeding in patients with atrial fibrillation (AF) is challenging. Direct oral anticoagulants (DOACs) are by now considered standard of care for treating patients with AF in international guidelines. Our objective was to assess the safety of long-term intake of DOACs in older adults with AF. We included RCTs in elderly (≥ 65 years) patients with AF. A systematic search in MEDLINE and EMBASE was performed on 19 April 2022. For determination of risk of bias, the RoB 2 tool was applied. We pooled outcomes using random-effects meta-analyses. The quality of evidence was assessed using GRADE. Eleven RCTs with a total of 63,374 patients were identified. Two RCTs compared apixaban with either warfarin or aspirin, four edoxaban with either placebo, aspirin, or vitamin K antagonists (VKAs), two dabigatran with warfarin and three rivaroxaban with warfarin. DOACs probably reduce mortality in elderly patients with AF (HR 0.89 95%CI 0.77 to 1.02). Low-dose DOACs likely reduce bleeding compared to VKAs (HR ranged from 0.47 to 1.01). For high-dose DOACS the risk of bleeding varied widely (HR ranged from 0.80 to 1.40). We found that low-dose DOACs probably decrease mortality in AF patients. Moreover, apixaban and probably edoxaban are associated with fewer major or clinically relevant bleeding (MCRB) events compared to VKAs. For dabigatran and rivaroxaban, the risk of MCRB varies depending on dose. Moreover, subgroup analyses indicate that in the very old (≥ 85) the risk for MCRB events might be increased when using DOACs.Registration: PROSPERO: CRD42020187876.

Does the second opinion directive in Germany reach the patient? A parallel-convergent mixed-methods study.

BACKGROUND: A Second Opinion Directive (SOD) was introduced in Germany in December 2018 for elective surgeries such as hysterectomy, tonsillotomy, tonsillectomy, and shoulder arthroscopy. The aim of the SOD is to avoid surgeries which are not medically induced and to support patients in their decision-making process. A physician who indicates an SOD-relevant procedure must inform the patient about the SOD and its specifications. At this time, it is not clear whether physicians provide information about the SOD to patients and whether and how the SOD is implemented in daily practice. Furthermore, nothing is known about how patients react when they are told that they have the right to seek a second opinion according to the SOD. METHODS: To assess this, we undertook a parallel-convergent mixed-methods study with a qualitative and quantitative phase. Qualitative data were analysed by structured qualitative content analysis and survey data were analysed descriptively. RESULTS: 26 interviews were conducted with patients for whom one of the above-mentioned surgeries was indicated. In parallel, a questionnaire survey with 102 patients was conducted. The results show that the SOD is not implemented in Germany for the selected indications because patients were not informed as intended. At the same time, when the right to obtain a second opinion was explained, it seemed to have a positive effect on the physician-patient relationship from patients` perspective. CONCLUSIONS: It is possible that there is a lack of information for physicians, which in turn leads to an information deficit for patients. Better information for physicians might be part of the solution, but a negative attitude towards the SOD might also result in the low education rate. Therefore, in addition, potential patients or even the general population should be better informed about the possibility of obtaining a second opinion.

Timing of complementary feeding for early childhood allergy prevention: An overview of systematic reviews.

OBJECTIVE: To summarise and critically appraise systematic review (SR) evidence on the effects of timing of complementary feeding (CF) on the occurrence of allergic sensitisation and disease. DESIGN: Overview of SRs. AMSTAR-2 and ROBIS were used to assess methodological quality and risk of bias (RoB) of SRs. RoB 2 Tool was used to assess RoB of primary randomised controlled trials (RCTs) (or extracted). The certainty of evidence (CoE) was assessed using GRADE. Findings were synthesised narratively. DATA SOURCES: MEDLINE (via PubMed and Ovid), the Cochrane Library and Web of Science Core Collection (2010 to 27 February 2023). ELIGIBILITY CRITERIA: SRs investigating the effects of timing of CF in infants or young children (0-3 years) on risk of developing food allergy (FA), allergic sensitisation, asthma, allergic rhinitis, atopic eczema and adverse events based on RCT evidence. RESULTS: Eleven SRs were included. Only two SRs had low RoB; common issues were failure to report on funding of primary studies and failure to provide a list of excluded trials. Common limitations of included trials were lack of blinding of outcome assessment or detailed trial preregistration, and inadequate handling of high loss to follow up. Primary study overlap was very high for specific FA and slight to moderate for FA in general and other primary outcomes. Introducing specific foods (peanut, cooked egg) early probably reduces the risk of specific FA. Evidence for other allergic outcomes was mostly very uncertain and based on few primary studies. Trials varied regarding timing of CF, nature of complementary foods and population risk, which limited comparability between SRs. CONCLUSIONS: For developing guidelines to support decision-making on the timing of CF as a preventive strategy, early introduction of specific foods (i.e. egg and peanut) seems promising and safe, whereas more extensive research is required regarding other allergic outcomes and potential adverse events.