Poor registration and publication practices in clinical trials of targeted therapeutics for endocrine and metabolic diseases: an observational study.

OBJECTIVE: To assess the completeness and concordance of reporting in registries and corresponding publications of interventional trials on targeted therapeutics for endocrine and metabolic disorders. STUDY DESIGN AND SETTING: We searched clinical trial registries in September 2022 for completed interventional trials of target therapeutics for endocrine and metabolic disorders registered from 2005 onwards. We used ClinicalTrials.gov and the World Health Organization International Clinical Trial Registration Platform (WHO ICTRP) registration requirements to extract data and assess the completeness of initial entry and final updates to trial registration and concordance with their published journal articles. RESULTS: Among 149 clinical trials included, 121 (81%) had corresponding publications. Missing mandatory registration data items were identified in 88 (67%) trials at the initial registration, 17 (13%) at the last registration, and in 85 (77%) corresponding publications. All trials showed changes between initial registration and final registration update, and 98% showed changes from the initial registration to publication. Changes between initial registration and final update were most common in the categories 'Completion date' (92%), 'Key secondary outcomes' (82%), and 'Date of first enrolment' (70%). Changes between initial registration and publication were most common in categories 'Sample size' (91%), 'Key inclusion and exclusion criteria' (81%), 'Key secondary outcomes' (84%), and 'Completion date' (83%). CONCLUSION: Despite the legal and journal registration requirements, the completeness and consistency of reporting mandatory data items in registries and corresponding publications regarding targeted therapeutics for endocrine and metabolic disorders are inadequate. Our findings raise questions about the integrity and reliability of clinical trials focusing on targeted therapeutics.

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

BACKGROUND AND OBJECTIVE: The Grading of Recommendations, Assessment, Development and Evaluations (GRADE)-ADOLOPMENT methodology has been widely used to adopt, adapt, or de novo develop recommendations from existing or new guideline and evidence synthesis efforts. The objective of this guidance is to refine 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 doing the following: (1) showcasing alternative pathways for starting an adolopment effort; (2) elaborating on the different essential steps of this approach, such as building on existing evidence-to-decision (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 6 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.

Promoting research integrity in funding: Co-creating guidelines for research funding organizations.

Research Funding Organizations (RFOs) play an important role in promoting research integrity (RI). Not only do they allocate resources to research institutions and researchers, but they also set and monitor research standards in their funded projects. In spite of their crucial role, there is a paucity of guidance on how RFOs can promote research integrity. As part of the EU-Funded SOPs4RI project, we aimed to address this gap by co-creating guidelines to help RFOs promote RI, engaging a diverse group of stakeholders. Based on a Delphi survey, reviews of evidence and stakeholder interviews, three guideline topics were identified: 1) the selection and evaluation of proposals; 2) monitoring of funded projects; and 3) prevention of unjustified interference. Four sets of co-creation workshops were conducted for each guideline topic, and the input revised and finalized. Understanding these debates could help RFOs from diverse cultural and organizational backgrounds who are developing their own RI guidelines. Therefore, in this paper, we summarize the key results and emphasize the final recommendations. Further, we provide the main points of discussion that occurred during the workshops and explain how they were addressed or resolved in the final guidelines and how they can help in future endeavors to improve funders' practices to foster RI.

Panel stacking is a threat to consensus statement validity.

Consensus statements can be very influential in medicine and public health. Some of these statements use systematic evidence synthesis but others fail on this front. Many consensus statements use panels of experts to deduce perceived consensus through Delphi processes. We argue that stacking of panel members toward one particular position or narrative is a major threat, especially in absence of systematic evidence review. Stacking may involve financial conflicts of interest, but nonfinancial conflicts of strong advocacy can also cause major bias. Given their emerging importance, we describe here how such consensus statements may be misleading, by analyzing in depth a recent high-impact Delphi consensus statement on COVID-19 recommendations as a case example. We demonstrate that many of the selected panel members and at least 35% of the core panel members had advocated toward COVID-19 elimination (Zero-COVID) during the pandemic and were leading members of aggressive advocacy groups. These advocacy conflicts were not declared in the Delphi consensus publication, with rare exceptions. Therefore, we propose that consensus statements should always require rigorous evidence synthesis and maximal transparency on potential biases toward advocacy or lobbyist groups to be valid. While advocacy can have many important functions, its biased impact on consensus panels should be carefully avoided.

Conclusiveness, readability and textual characteristics of plain language summaries from medical and non-medical organizations: a cross-sectional study.

This cross-sectional study compared plain language summaries (PLSs) from medical and non-medical organizations regarding conclusiveness, readability and textual characteristics. All Cochrane (medical PLSs, n = 8638) and Campbell Collaboration and International Initiative for Impact Evaluation (non-medical PLSs, n = 163) PLSs of latest versions of systematic reviews published until 10 November 2022 were analysed. PLSs were classified into three conclusiveness categories (conclusive, inconclusive and unclear) using a machine learning tool for medical PLSs and by two experts for non-medical PLSs. A higher proportion of non-medical PLSs were conclusive (17.79% vs 8.40%, P < 0.0001), they had higher readability (median number of years of education needed to read the text with ease 15.23 (interquartile range (IQR) 14.35 to 15.96) vs 15.51 (IQR 14.31 to 16.77), P = 0.010), used more words (median 603 (IQR 539.50 to 658.50) vs 345 (IQR 202 to 476), P < 0.001). Language analysis showed that medical PLSs scored higher for disgust and fear, and non-medical PLSs scored higher for positive emotions. The reason for the observed differences between medical and non-medical fields may be attributed to the differences in publication methodologies or disciplinary differences. This approach to analysing PLSs is crucial for enhancing the overall quality of PLSs and knowledge translation to the general public.

The definition of research misconduct should be stated in the abstract when reporting research on research misconduct.

Research integrity is the cornerstone for a reliable and trustworthy science. Research misconduct is classically defined as fabrication, falsification, or plagiarism. To be considered as such, the action must have been committed with the intent to mislead or deceive. There are many other research misbehaviors such as duplication, fake-peer review or lack of disclosure of conflicts of interest, that are often included in the definition of research misconduct in codes, policies, and professional documents. The definition of research misconduct varies among countries and institutions, the seriousness and intentionality of the action. This variability is also present in research articles on the prevalence of research misconduct because it is common for each author to use a different definition, creating confusion for readers. We argue that the definition of research misconduct used in a study should be stated already in the abstract, particularly because not all publications are in open access, so that readers can fully understand what the study found concerning research misconduct without needing to have access to the full article.

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.

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.

Evaluating health claim assessment skills of parents with preschool children: A cross-sectional study using Informed Health Choices Claim Evaluation Tool.

Background: Health literacy is a global problem and is particularly relevant when making health care decisions about small children. We analysed how parents of preschool children assess health claims and explored the predictors of their assessment skill. Methods: We conducted a survey with questions from the Claim Evaluation Tools (CET) database, part of the Informed Health Choices (IHC) project, in ten paediatric primary care practices of the Split-Dalmatia County Health Center, Split, Croatia, from 1 February to 31 March 2023. Eligible participants were parents accompanying preschool-aged children for check-ups. We also collected data on parents' and children's demographic and health characteristics (including the presence of any chronic illness in the child), visits to paediatric emergency service, hospitalisations, vaccination status, the presence of chronic illness of parents or relatives, and whether parents had to made treatment decisions for themselves and/or their family member. Results: Overall, 402 parents of preschool children (median age 35 years (interquartile range (IQR) = 31.0-38.3)) had a median IHC CET test score of 10.0 (IQR = 8.0-11.0) out of 12 questions. The multiple regression analysis showed that female gender, higher level of education, being employed, and having a history of a visit to paediatric emergency service were significant predictors of the test score, explaining 21.9% of the variance. Conclusions: Parents of preschool children have a very good ability for critical assessment of health-related statements in a complex health care system and an environment of generally unsatisfactory health literacy. Further studies should explore how parents understand health claims in different geographical, socio-economic and cultural setting, and explore educational interventions to increase critical thinking abilities and informed decision-making, especially among fathers, unemployed parents and those with lower levels of education.

Completeness of intervention description in invasive cardiology trials: an observational study of ClinicalTrials.gov registry and corresponding publications.

Introduction: Non-pharmacological invasive interventions in cardiology are complex and often inadequately reported. Template for Intervention Description and Replication (TIDieR) checklist and guide were developed to aid reporting and assessment of non-pharmacological interventions. The aim of our study was to assess the completeness of describing invasive cardiology interventions in clinical trials at the level of trial registration and corresponding journal article publication. Methodology: We searched for clinical trials in invasive cardiology registered in Clinicaltrials.gov and corresponding journal publications. We used the 10-item TIDieR checklist for registries and 12-item checklist for journal publications. Results: Out of 7,017 registry items retrieved by our search, 301 items were included in the analysis. The search for corresponding published articles yielded 192 journal publications. The majority of trials were funded by the industry and were medical device trials. The median number of reported TIDieR items was 4.5 (95% CI 4.49-4.51) out of 10, and while the corresponding journal articles reported 6.5 (95% CI 6.0-6.5) out of 12 TIDieR items. Conclusion: Registration and reporting of invasive cardiology trials is often incomplete and adequate detailed description of the interventions is not provided. TIDieR checklist is an important tool which should be used to ensure rigorous reporting of non-pharmacological interventions in cardiology.

Assessing the quality and completeness of reporting in health systems guidance for pandemics using the AGREE-HS tool.

Background: During health emergencies, leading healthcare organisations, such as the World Health Organization (WHO), the European Centre for Disease Control and Prevention (ECDC), and the United States Centers for Disease Control and Prevention (CDC), provide guidance for public health response. Previous studies have evaluated clinical practice guidelines (CPGs) produced in response to epidemics or pandemics, yet few have focused on public health guidelines and recommendations. To address this gap, we assessed health systems guidance (HSG) produced by the WHO, the ECDC, and the CDC for the 2009 H1N1 and COVID-19 pandemics. Methods: We extracted HSG for the H1N1 and COVID-19 pandemics from the organisations' dedicated repositories and websites. After screening the retrieved documents for eligibility, five assessors evaluated them using the Appraisal of Guidelines Research & Evaluation - Health Systems (AGREE-HS) tool to assess the completeness and transparency of reporting according to the five AGREE-HS domains: "Topic", "Participants", "Methods", "Recommendations", and "Implementability". Results: Following the screening process, we included 108 HSG in the analysis. We observed statistically significant differences between the H1N1 and COVID-19 pandemics, with HSG issued during COVID-19 receiving higher AGREE-HS scores. The HSG produced by the CDC had significantly lower overall scores and single-domain scores compared to the WHO and ECDC. However, all HSG scored relatively low, under the median of 40 total points (range = 10-70), indicating incomplete reporting. The HSG produced by all three organisations received a median score <4 (range = 1-7) for the "Participants", "Methods", and "Implementability" domains. Conclusions: There is still significant progress to be made in the quality and completeness of reporting in HSG issued during pandemics, especially regarding methodological approaches and the composition of the guidance development team. Due to their significant impact and importance for healthcare systems globally, HSG issued during future healthcare crises should adhere to best reporting practices to increase uptake by stakeholders and ensure public trust in healthcare organisations.

Tool to assess recognition and understanding of elements in Summary of Findings Table for health evidence synthesis: a cross-sectional study.

of Findings (SoF) tables concisely present the main findings of evidence synthesis of health evidence, but how users navigate it to understand and interpret the presented information is not clear. We quantified the interaction of medical students with an SoF table while answering a knowledge quiz. Read&Learn tool was used to measure the number of target and non-target table cells visited for each question and the time spent on these cells. Students positively identified target elements for quiz questions and answered simpler questions, but struggled with critical thinking and understanding study outcomes. The question on outcomes with the largest improvement post-intervention had the fewest correct answers, the longest interaction with table cells and the most opened cells before answering. Students spent a median of 72% of the time reading target table cells. A heatmap of the interactions showed that they were mostly answer-oriented. Further development of the tool and metrics is needed to use the tool and the metrics to study the cognitive processes during the assessment of health evidence.

Research misconduct as a challenge for academic institutions and scientific journals.

Research misconduct refers to a set of unethical practices in research and publication and is the main reason for retraction of articles published in the academic literature. Research misconduct has negative consequences and has generated public scepticism about research, which has led to increasing distrust in science. In this context, a joint effort by the scientific community, academic institutions, scientific journals and research funders is needed to identify and prevent research misconduct. In this paper, we will evaluate what has already been done and what is needed to do to better address research misconduct. The focus of this paper will be on the actions taken by academic institutions, as the first line of defence, and scientific journals, as the gatekeepers of science. However, scientific journals and academic institutions are only a part of a much larger and multistakeholder effort needed to address the challenges scientific research is facing.

Reporting characteristics of nonsurgical periodontal therapy trials registered in ClinicalTrials.gov: an observational study.

Aim: To evaluate the completeness of the description of nonsurgical periodontal therapy interventions in clinical trials registered in ClinicalTrials.gov and correspondence of registered information for trial participants and outcome measures with published articles. Materials & methods: We retrieved data from ClinicalTrials.gov and corresponding publications. The completeness of intervention reporting was assessed using the Template for Intervention Description and Replication (TIDieR) checklist for oral hygiene instructions (OHI), professional mechanical plaque removal (PMPR), and subgingival instrumentation, antiseptics and antibiotics. The completeness of registration of trial protocol information was assessed according to the WHO Trial Registration DataSet for participant information (enrollment, sample size calculation, age, gender, condition) and primary/secondary outcome measures. Results: 79 included trials involved OHI (n = 38 trials, 48.1%), PMPR (n = 19, 24.1%), antiseptics (n = 11, 12.7%), or antibiotics (n = 11, 12.7%). There was a great variety in the terms used to describe these interventions. Most of the analyzed trials (93.7%) were completed and did not provide any data on study phase (74.7%). The description of intervention in the registry in ClinicalTrials.gov was inadequate for all analyzed interventions, with description inconsistencies in matching publications. There were also discrepancies in registered and published outcomes: for 39 trials with published results, 18 had different registered and reported primary outcomes, and 29 different registered and reported secondary outcomes. Conclusion: The completeness of the description of nonsurgical therapy of periodontitis in clinical trials is unsatisfactory, reducing the quality of translation of the new evidence and procedures into clinical practice. Significant discrepancy in registered and reported trial outcomes calls into question the validity of reported results and relevance for practice.

Researchers on research integrity: a survey of European and American researchers.

BACKGROUND: Reports of questionable or detrimental research practices (QRPs) call into question the reliability of scientific evidence and the trustworthiness of research. A critical component of the research ecosystem is the organization within which research takes place. We conducted a survey to explore the attitudes and beliefs of European and American researchers about the organisations in which they work, their own research practices and their attitudes towards research integrity and research integrity policies. METHODS: We administered an online survey (International Research Integrity Survey (IRIS)) to 2,300 active researchers based in the US and 45,000 in Europe (including UK, Norway, Iceland and Switzerland).  We employed a stratified probability sample of the authors of research articles published between 2016 and 2020 included in Clarivate's Web of Science citation database. Coverage includes researchers in the humanities, social sciences, natural sciences and medical sciences, who hold at least a master's level degree. RESULTS: In comparison to researchers in the US, European researchers admit to more QRPs and are less confident in maintaining high research integrity (RI) standards. In the US and Europe, many researchers judge their organization to fall short of best RI practice. All researchers recognize the benefits of RI, reliable knowledge and the trust of colleagues and the public, and there is support for RI training particularly among Europeans. CONCLUSION: To create and maintain a culture of integrity in scientific research, a collective commitment from researchers, their institutions and funders is needed. Researchers rely on many channels of communication about research integrity and thus the involvement of many different participants in the research system is required to make improvements. Policies must be developed to reinforce best practice rather than being seen as an irrelevance to the real business of research.

Similar Outcomes of Web-Based and Face-to-Face Training of the GRADE Approach for the Certainty of Evidence: Randomized Controlled Trial.

BACKGROUND: The GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach is a system for transparent evaluation of the certainty of evidence used in clinical practice guidelines and systematic reviews. GRADE is a key part of evidence-based medicine (EBM) training of health care professionals. OBJECTIVE: This study aimed to compare web-based and face-to-face methods of teaching the GRADE approach for evidence assessment. METHODS: A randomized controlled trial was conducted on 2 delivery modes of GRADE education integrated into a course on research methodology and EBM with third-year medical students. Education was based on the Cochrane Interactive Learning "Interpreting the findings" module, which had a duration of 90 minutes. The web-based group received the web-based asynchronous training, whereas the face-to-face group had an in-person seminar with a lecturer. The main outcome measure was the score on a 5-question test that assessed confidence interval interpretation and overall certainty of evidence, among others. Secondary outcomes included writing a recommendation for practice and course satisfaction. RESULTS: In all, 50 participants received the web-based intervention, and 47 participants received the face-to-face intervention. The groups did not differ in the overall scores for the Cochrane Interactive Learning test, with a median of 2 (95% CI 1.0-2.0) correct answers for the web-based group and 2 (95% CI 1.3-3.0) correct answers for the face-to-face group. Both groups gave the most correct answers to the question about rating a body of evidence (35/50, 70% and 24/47, 51% for the web-based and face-to-face group, respectively). The face-to-face group better answered the question about the overall certainty of evidence question. The understanding of the Summary of Findings table did not differ significantly between the groups, with a median of 3 correct answers to 4 questions for both groups (P=.352). The writing style for the recommendations for practice also did not differ between the 2 groups. Students' recommendations mostly reflected the strengths of the recommendations and focused on the target population, but they used passive words and rarely mentioned the setting for the recommendation. The language of the recommendations was mostly patient centered. Course satisfaction was high in both groups. CONCLUSIONS: Training in the GRADE approach could be equally effective when delivered asynchronously on the web or face-to-face. TRIAL REGISTRATION: Open Science Framework akpq7; https://osf.io/akpq7/.

Changes in Registration Parameters for Ongoing Clinical Trials in Ukraine After 2022 Russian Invasion.

Importance: Clinical trial activity in Ukraine was seriously affected by the Russian invasion. However, data are lacking on how this conflict affects clinical trials. Objective: To evaluate whether registered changes to trial information reflect war-related disturbances to trials in Ukraine. Design, Setting, and Participants: This cross-sectional study included noncompleted trials conducted in Ukraine from February 24, 2022, to February 24, 2023. Trials conducted in Estonia and Slovakia were also analyzed for comparison. Study records within the ClinicalTrials.gov archive were accessed by using the change history feature in the tabular view for each record. Exposure: Russian invasion of Ukraine. Main Outcomes and Measures: The frequency of changes to the protocol and results registration parameters before and after the start of the war, February 24, 2022. Results: A total of 888 ongoing trials conducted only in Ukraine (5.2%) or in multiple countries (94.8%), and enrolling a median of 348 participants were analyzed. Almost all sponsors for 775 industry-funded trials were non-Ukrainian (99.6%). On February 24, 2023, 267 trials (30.1%) were without any recorded update in the registry after the war. In 15 (1.7%) multisite trials, Ukraine was removed as a location country after mean (SD) of 9.4 (3.0) postwar months. The rates of changes in 20 parameters 1 year before and after the war started had a mean (SD) absolute difference of 3.0% (2.5%). Besides study status changes in each study record version, the contacts and locations field was the most frequently modified (56.1%), with a higher rate for multisite (58.2%) than in only Ukrainian (17.4%) trials. This finding was consistent for all analyzed registration parameters. In trials conducted solely in Ukraine, the median number of record versions was the year before (95% CI, 0-0) and after February 2022 (95% CI, 0-1), similar to registered trials from Estonia and Slovakia. Conclusions and Relevance: Results of this study suggest that war-related changes in trial conduct in Ukraine may not be completely visible in the largest public trial registry, which is expected to present accurate and timely information on clinical trials. These findings raise questions regarding the updating practices for registration information, which should be mandatory, especially in times of crises, to ensure the safety and the rights of trial participants in a war zone.

Diplomatic response to global health challenges in recognizing patient needs: A qualitative interview study.

Background: Global health diplomacy is the applied practice of foreign affairs to further national goals that focus on health issues requiring international cooperation and collective action. We aimed to determine how international diplomats and health policy-related professionals in the EU understand the concept of health diplomacy, which impacts both diplomatic relations as well as patients' rights. Methods: In a qualitative interview study, we used a heterogeneous stratified purposeful sampling to reach participants from different countries and different practitioners from the Pyramid of Health Diplomacy: core, multi-stakeholder, and informal. Reflexive thematic analysis was used to identify the main themes. Findings: We contacted 131 practitioners of GHD, of which 37 responded, and nine agreed to be interviewed. From 11 interview questions, four main themes emerged from the analysis of the individual interview. The participants reported limited knowledge about the definition of GHD but also that they engaged in daily activities and decisions of inter-governmental bodies. They were not aware of existing special education and training for health attachés and made suggestions for improving the field and practice of GHD. They were not fully familiar with the European Charter of Patients' Rights. There was a consensus from all participants that patient rights need to improve as a fundamental right. They stressed the fact that the hospital lockdown and the right access to healthcare were impaired during the COVID pandemic. Interpretation: The role of health diplomacy in linking public health and foreign affairs is key to respecting patients' rights. Health over other interests is becoming an increasingly critical element in foreign policy. Establishing a clear career path for health attachés is necessary to foster effective global health agreements and coordination across countries.

Key issues for stakeholder engagement in the development of health and healthcare guidelines.

Established in 2015, the Multi-Stakeholder Engagement (MuSE) Consortium is an international network of over 120 individuals interested in stakeholder engagement in research and guidelines. The MuSE group is developing guidance for stakeholder engagement in the development of health and healthcare guideline development. The development of this guidance has included multiple meetings with stakeholders, including patients, payers/purchasers of health services, peer review editors, policymakers, program managers, providers, principal investigators, product makers, the public, and purchasers of health services and has identified a number of key issues. These include: (1) Definitions, roles, and settings (2) Stakeholder identification and selection (3) Levels of engagement, (4) Evaluation of engagement, (5) Documentation and transparency, and (6) Conflict of interest management. In this paper, we discuss these issues and our plan to develop guidance to facilitate stakeholder engagement in all stages of the development of health and healthcare guideline development.

A group of international researchers, patient partners, and other stakeholders are working together to create a checklist for when and how to involve stakeholders in health guideline development. Health guidelines include clinical practice guidelines, which your healthcare provider uses to determine treatments for health conditions. While working on this checklist, the team identified key issues to work on, including: (1) Definitions, roles, and settings (2) Stakeholder identification and selection (3) Levels of engagement, (4) Evaluation of engagement, (5) Documentation and transparency, and (6) Conflict of interest management. This paper describes each issue and how the team plans to produce guidance papers to address them.