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The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) adopted Guideline M10 entitled "Bioanalytical Method Validation and Study Sample Analysis" in May 2022. In October 2023, approximately one year after the adoption of the ICH M10 guideline, a "Hot Topic" session was held during the AAPS PharmSci 360 meeting to discuss the implementation of the guideline. The session focused on items the bioanalytical community felt were challenging to implement or ambiguous within the guideline. These topics included cross-validation, parallelism, comparative bioavailability studies, combination drug stability, endogenous analyte bioanalysis, and dilution QCs. In addition, the regulatory perspective on the guideline was presented. This report provides a summary of the Hot Topic session., (© 2024. The Author(s).)

Background: The focus on health maximisation in a healthcare economic evaluation (HEE) - that is health gains are of equal value regardless of the recipient- has significant implications as health systems attempt to address persistent and growing health inequities. This study aimed to systematically compare and contrast the equity principles of different health technology assessment (HTA) agencies and how equity is addressed in HEE guidelines., Methods: HTA agencies were identified through the ISPOR, GEAR, iDSI, HTAi, INAHTA, HTAsiaLink, and RedETSA websites in June 2021 and updated in August 2023. Agencies websites were then searched to retrieve HEE guidelines. The guidelines were grouped into two categories: well-established and newly-developed agency guidelines, based on whether or not they published their first guidelines before 2009. Data extracted summarised the methodological details in the reference cases, including specifics on how equity featured and in what role. In those agencies where equity did not feature explicitly in the HEE guidelines, an additional search of the agency website was undertaken to understand if equity featured in those agencies' decision-making frameworks., Results: The study included 46 guidelines from 51 countries. Only 30% of the guidelines were explicit about the equity assumptions. Health equity (using a broad definition) was mentioned in 29 guidelines and 14 included a specific definition while only seven recommended specific methods to incorporate inequalities. Addressing equity concerns was usually suggested as an additional analyses rather than a key part of the assessment. It was unclear how equity was incorporated into decision-making processes. In addition, equity was mentioned in other guidance - such as decision-making frameworks - provided by five agencies that did not mention it in the HEE guidelines, and 7 of 14 topic selection criteria that were identified., Conclusion: Equity is given less attention than efficiency in HEE guidelines. This indicates that HTA agencies while subscribing to an extra-welfarist approach have a narrow evaluative space - focusing on maximising health and not considering the opportunity cost of the equity constraint. The omission of equity and the lack of systematic approaches in guidelines poses a threat to the international endeavours to reduce inequities. It is timely for HTA agencies to reconsider their positions on equity explicitly., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The process of preparing a scientific manuscript is intricate, encompassing several critical stages, including pre-writing, research development, drafting, peer review, editing, publication, dissemination, and access. Among these, the peer review process (PRP) stands out as a pivotal component requiring seamless collaboration among editors, reviewers, and authors. Reviewers play a crucial role in assessing the manuscript's quality and providing constructive feedback, which authors must adeptly navigate to enhance their work and meet journal standards. This process can often appear daunting and time-consuming, as authors are required to address numerous comments and requested changes. Authors are encouraged to perceive reviewers as consultants rather than adversaries, viewing their critiques as opportunities for improvement rather than personal attacks., Methods: Opinion article., Aim: To equip authors with practical strategies for engaging effectively in the PRP and improving their publication acceptance rates., Results: Key guidelines include thoroughly understanding and prioritizing feedback, maintaining professionalism, and systematically addressing each comment. In cases of significant disagreement or misunderstanding, authors have the option to refer the issue to the editor. Crafting a well-organized and scientific "response to reviews" along with the revised manuscript can substantially increase the likelihood of acceptance. Best practices for writing an effective response to reviews include expressing gratitude, addressing major revisions first, seeking opinions from co-authors and colleagues, and adhering strictly to journal guidelines. Emphasizing the importance of planning responses, highlighting changes in the revised manuscript, and conducting a final review ensures all corrections are properly documented., Conclusion: By following these guidelines, authors can enhance their manuscripts' quality, foster positive relationships with reviewers, and ultimately contribute to scholarly advancement., Competing Interests: No competing interests were disclosed., (Copyright: © 2024 Hidouri S et al.)

Background : When properly utilized, artificial intelligence generated content (AIGC) may improve virtually every aspect of research, from data gathering to synthesis. Nevertheless, when used inappropriately, the use of AIGC may lead to the dissemination of inaccurate information and introduce potential ethical concerns. Research Design : Cross-sectional. Study Sample: 65 top surgical journals. Data Collection: Each journals submission guidelines and portal was queried for guidelines regarding AIGC use. Results : We found that, in July 2023, 60% of the top 65 surgical journals had introduced guidelines for use, with more surgical journals (68%) introducing guidelines than surgical subspecialty journals (52.5%), including otolaryngology (40%). Furthermore, of the 39 with guidelines, only 69.2% gave specific use guidelines. No included journal, at the time of analysis, explicitly disallowed AIGC use. Conclusions : Altogether, this data suggests that while many journals have quickly reacted to AIGC usage, the quality of such guidelines is still variable. This should be pre-emptively addressed within academia., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

A guideline is proposed that comprises the minimum items to be reported in research studies involving an eye tracker and human or non-human primate participant(s). This guideline was developed over a 3-year period using a consensus-based process via an open invitation to the international eye tracking community. This guideline will be reviewed at maximum intervals of 4 years., (© 2023. The Author(s).)

Globally, the demand for qualitative research has risen, driven by the health sector's need for in-depth investigation of complex issues behind any phenomenon that may be inadequately comprehended and that other research methods cannot explore, uncover, or describe. The authors aimed to improve the accessibility and comprehensiveness of reporting guidelines for qualitative research. A comprehensive review of scientific articles was conducted on PubMed, Medline, CINAHL, and Embase, and it retrieved 1989 articles plus 13 more articles through the snowball method. After screening, 17 key articles were identified, which led to the development of Comprehensive Criteria for Reporting Qualitative Research that comprises 14 categories, offering key elements in an organized table. This novel guideline complements the two widely used guidelines, Consolidated Criteria for Reporting Qualitative Research and Standards for Reporting Qualitative Research , by including additional aspects like objectives, existing knowledge, rationale behind methodologies, conclusions, recommendations, and reference citations. The study responds to the rising need for improved qualitative research reporting guidelines in global health.

This study presented a narrative review of the six latest sets of guidelines on physical activity for children and adolescents from Australia, Canada, China, the United Kingdom, the United States and WHO, and analysed the history of the development of the guidelines; the policy context in which the guidelines were developed; and the main subjects of the guidelines. The core elements of the latest guidelines were identified and compared, including frequency, intensity, duration (time), and type of physical activity, assessment intensity of physical activity, and risk prevention for physical activity participation. There is an urgent need for obtaining the latest scientific evidence to support and update the contents of the Chinese guidelines. We therefore make the following recommendations for future revisions of the Chinese guidelines based on the findings of this study: (1) to update the recommended frequency, intensity, duration, and type of physical activities that meet the needs for Chinese children and adolescents; (2) to update the methods for assessing physical activity intensity, and identifying and managing the risk factors in participating in physical activity; and (3) to incorporate analyses and reviews of school physical education curriculum for effectively achieving the adequate levels of physical activity., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Hu, Zhou, Crowley-McHattan and Liu.)

The biomedical research community addresses reproducibility challenges in animal studies through standardized nomenclature, improved experimental design, transparent reporting, data sharing, and centralized repositories. The ARRIVE guidelines outline documentation standards for laboratory animals in experiments, but genetic information is often incomplete. To remedy this, we propose the Laboratory Animal Genetic Reporting (LAG-R) framework. LAG-R aims to document animals' genetic makeup in scientific publications, providing essential details for replication and appropriate model use. While verifying complete genetic compositions may be impractical, better reporting and validation efforts enhance reliability of research. LAG-R standardization will bolster reproducibility, peer review, and overall scientific rigor., (© 2024. The Author(s).)

Background: The importance of building ventilation to protect health has been more widely recognized since the COVID-19 pandemic. Outdoor air ventilation in buildings dilutes indoor-generated air pollutants (including bioaerosols) and reduces resulting occupant exposures. Many countries and organizations have advisory guidelines or mandatory standards for minimum ventilation rates (VRs) to maintain indoor air quality (IAQ). Because directly measuring VRs is often difficult, many IAQ guidelines instead specify indoor concentration limits for carbon dioxide (CO 2 ), using CO 2 exhaled by building occupants as an indicator of VR. Although indoor CO 2 guidelines are common, the evidence basis for the various CO 2 limits has not been clear., Objective: To review current indoor CO 2 guidelines worldwide and the supportive evidence provided., Methods: We identified worldwide CO 2 -based guidelines for IAQ or ventilation, along with any supportive evidence provided. We excluded occupational guidelines for CO 2 levels ≥5000 ppm., Results: Among 43 guidelines identified, 35 set single CO 2 concentration limits and eight set multi-tiered limits; 16 mentioned no specific human effect to be controlled, 19 specified only odor dissatisfaction, five specified non-infectious health effects, and three specified airborne infectious disease transmission. The most common indoor CO 2 limit was 1000 ppm. Thirteen guidelines specified maximum CO 2 limits as extended time-weighted averages, none with evidence linking averaged limits to occupant effects. Of only 18 guidelines citing evidence to support limits set, we found this evidence persuasive for eight. Among these eight guidelines, seven set limits to control odor perception. One provided 17 scientifically-based CO 2 limits, for specific example space uses and occupancies, to control long-range COVID-19 transmission indoors., Impact: Many current indoor carbon dioxide (CO 2 ) guidelines for indoor air quality specified no adverse effects intended for control. Odor dissatisfaction was the effect mentioned most frequently, few mentioned health, and three mentioned control of infectious disease. Only one CO 2 guideline was developed from scientific models to control airborne transmission of COVID-19. Most guidelines provided no supportive evidence for specified limits; few provided persuasive evidence. No scientific basis is apparent for setting one CO 2 limit for IAQ across all buildings, setting a CO 2 limit for IAQ as an extended time-weighted average, or using any arbitrary one-time CO 2 measurement to verify a desired VR., (© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.)

Human stem cell-based modeling systems are valuable tools that can greatly improve the clinical translation of basic research. Importantly, the successful application of human stem cell-based models to biomedical research depends on the widespread adoption of ethical principles and practical standards. To achieve this outcome, the International Society for Stem Cell Research (ISSCR) provides a comprehensive set of recommendations that aim to promote the ethical usage of human stem cells and to ensure rigor and reproducibility within the field. Understanding and implementing these recommendations should be a top priority for investigators around the world., Competing Interests: Competing interests J.C.W. is co-founder and scientific advisor board member of Greenstone Biosciences. However, the work here was performed independently., (© 2024. Published by The Company of Biologists Ltd.)

Introduction: Observational studies are fraught with several biases including reverse causation and residual confounding. Overview of reviews of observational studies (ie, umbrella reviews) synthesise systematic reviews with or without meta-analyses of cross-sectional, case-control and cohort studies, and may also aid in the grading of the credibility of reported associations. The number of published umbrella reviews has been increasing. Recently, a reporting guideline for overviews of reviews of healthcare interventions (Preferred Reporting Items for Overviews of Reviews (PRIOR)) was published, but the field lacks reporting guidelines for umbrella reviews of observational studies. Our aim is to develop a reporting guideline for umbrella reviews on cross-sectional, case-control and cohort studies assessing epidemiological associations., Methods and Analysis: We will adhere to established guidance and prepare a PRIOR extension for systematic reviews of cross-sectional, case-control and cohort studies testing epidemiological associations between an exposure and an outcome, namely Preferred Reporting Items for Umbrella Reviews of Cross-sectional, Case-control and Cohort studies (PRIUR-CCC). Step 1 will be the project launch to identify stakeholders. Step 2 will be a literature review of available guidance to conduct umbrella reviews. Step 3 will be an online Delphi study sampling 100 participants among authors and editors of umbrella reviews. Step 4 will encompass the finalisation of PRIUR-CCC statement, including a checklist, a flow diagram, explanation and elaboration document. Deliverables will be (i) identifying stakeholders to involve according to relevant expertise and end-user groups, with an equity, diversity and inclusion lens; (ii) completing a narrative review of methodological guidance on how to conduct umbrella reviews, a narrative review of methodology and reporting in published umbrella reviews and preparing an initial PRIUR-CCC checklist for Delphi study round 1; (iii) preparing a PRIUR-CCC checklist with guidance after Delphi study; (iv) publishing and disseminating PRIUR-CCC statement., Ethics and Dissemination: PRIUR-CCC has been approved by The Ottawa Health Science Network Research Ethics Board and has obtained consent (20220639-01H). Participants to step 3 will give informed consent. PRIUR-CCC steps will be published in a peer-reviewed journal and will guide reporting of umbrella reviews on epidemiological associations., Competing Interests: Competing interests: MS received honoraria/has been a consultant for Angelini, Lundbeck, Otsuka., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

While the technologies that enable Artificial Intelligence (AI) continue to advance rapidly, there are increasing promises regarding AI's beneficial outputs and concerns about the challenges of human-computer interaction in healthcare. To address these concerns, institutions have increasingly resorted to publishing AI guidelines for healthcare, aiming to align AI with ethical practices. However, guidelines as a form of written language can be analyzed to recognize the reciprocal links between its textual communication and underlying societal ideas. From this perspective, we conducted a discourse analysis to understand how these guidelines construct, articulate, and frame ethics for AI in healthcare. We included eight guidelines and identified three prevalent and interwoven discourses: (1) AI is unavoidable and desirable; (2) AI needs to be guided with (some forms of) principles (3) trust in AI is instrumental and primary. These discourses signal an over-spillage of technical ideals to AI ethics, such as over-optimism and resulting hyper-criticism. This research provides insights into the underlying ideas present in AI guidelines and how guidelines influence the practice and alignment of AI with ethical, legal, and societal values expected to shape AI in healthcare., (© 2024. The Author(s).)

Background: Meaningful involvement of adolescents in health research is their fundamental human right and has many benefits. A lack of awareness among researchers on how to meaningfully involve adolescents in health research has been linked to adolescent under involvement in health research. To address this barrier, studies have reported the need for more guidance. To inform the development of better guidelines on adolescent involvement, there is a need to first consolidate the currently available guidance on adolescent involvement in health research and to identify the gaps in these guidelines. This review aims to systematically identify all the currently available guidelines on adolescent involvement in health research and evaluate their scope, content, context, and quality., Methods: This rapid review was pre-registered with PROSPERO #CRD42021293586. It included documents that incorporated tangible recommendations on the involvement of adolescents in health research. We searched six databases for peer-reviewed literature: MEDLINE, CINAHL, Embase, Scopus, Web of Science, and ERIC. We conducted a grey literature search in Google Scholar, Google, websites of 472 relevant organisations and sought expert input. The quality of the guidelines was assessed using the Appraisal of Guidelines for REsearch & Evaluation (AGREE-II) Instrument. Data was analysed using descriptive analyses and narrative synthesis., Results: We found that the current guidelines on adolescent involvement in health research are often narrow in scope, targeting specific users and populations while focusing on limited research areas. The guidelines individually fail to provide comprehensive coverage of recommendations across all topics related to adolescent research involvement, that are collectively addressed across all included guidelines. Furthermore, these guidelines tend to be context-specific and are generally of low quality, often due to inadequate stakeholder involvement and a lack of rigorous development methods., Conclusion: This review provides a consolidated list of guidelines on adolescent involvement in health research along with their quality scores as a resource for researchers to select the guidelines suitable for their research topic, context, and scope for adolescent involvement. There is a need to develop a set of guidelines on adolescent involvement in research, which are comprehensive in scope, cover all key aspects of adolescent involvement in health research, can be adapted for different contexts, and which are based on rigorous and systematic methods., Patient and Public Involvement: Adolescent co-researchers D. B. and C. W. were involved at different stages of the review process. D. B. screened 25% of the peer-reviewed articles at the title and abstract screening stage and 10% at full-text screening stage. C. W. extracted data from 10% of the included guidelines. Both co-researchers reviewed and shared their feedback on the article and are co-authors on this paper. They will also be invited to contribute to further dissemination of the findings from this review., (© 2024 The Authors. Health Expectations published by John Wiley & Sons Ltd.)

Refugees and asylum seekers may experience challenges related to pre-arrival experiences, structural disadvantage after migration and during resettlement requiring the need for special protection when participating in research. The aim was to review if and how people with refugee and asylum seeker backgrounds have had their need for special protection addressed in national and international research ethics guidelines. A systematic search of grey literature was undertaken. The search yielded 2187 documents of which fourteen met the inclusion criteria. Few guidelines addressed specific ethical considerations for vulnerable groups much less people with refugee and asylum seeker backgrounds. One guideline explicitly addressed vulnerability for refugees and asylums seekers. To ensure members of ethics committees and researchers consider the potential challenges of conducting research with these groups, guidelines may need to be supplemented with a refugee and asylum seeker specific research ethics framework. Such a framework may be necessary to optimally protect people with refugee and asylum seeker backgrounds in research., (© 2023. Crown.)

This paper extends the FAIR (Findable, Accessible, Interoperable, Reusable) guidelines to provide criteria for assessing if software conforms to best practices in open source. By adding "USE" (User-Centered, Sustainable, Equitable), software development can adhere to open source best practice by incorporating user-input early on, ensuring front-end designs are accessible to all possible stakeholders, and planning long-term sustainability alongside software design. The FAIR-USE4OS guidelines will allow funders and researchers to more effectively evaluate and plan open-source software projects. There is good evidence of funders increasingly mandating that all funded research software is open source; however, even under the FAIR guidelines, this could simply mean software released on public repositories with a Zenodo DOI. By creating FAIR-USE software, best practice can be demonstrated from the very beginning of the design process and the software has the greatest chance of success by being impactful., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Sonabend et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

In recent years, the high temperature and heatwaves have seriously affected the health of Chinese residents, and there is an important need for public health protection guidelines for high temperature and heatwaves in China. The National Bureau of Disease Control and Prevention has organized experts to fully investigate the evidence from epidemiological research on the health of populations in high temperature and heatwaves globally and in China, analyze the health hazards and protection needs of different populations, and put forward practical and effective individual protection measures and health recommendations. For this reason, the "Guideline for Public Health Protection against High Temperature and Heatwaves" (referred to as the "Guideline") was officially issued in June 2023. This article interprets the background and significance of the Guideline, the principles of compilation, the main considerations, the main contents, the implementations and promotions and other aspects, to improve the understanding of the content of the Guideline and strengthen the publicity and implementations.

Great advances have been made in the knowledge of development and regulatory approval of medicinal product containing genetically modified cells. Although a guideline has been available in the EU since 2012, the current updated version provides a useful guide to developers and professionals involved in the regulatory process of these medicines. This article presents the main issues communicated in that guidance, the regulators' insights and a commentary from the academic developers' point of view., (© 2024 British Pharmacological Society.)

Objectives: To describe, and explain the rationale for, the methods used and decisions made during development of the updated SPIRIT 2024 and CONSORT 2024 reporting guidelines., Methods: We developed SPIRIT 2024 and CONSORT 2024 together to facilitate harmonization of the two guidelines, and incorporated content from key extensions. We conducted a scoping review of comments suggesting changes to SPIRIT 2013 and CONSORT 2010, and compiled a list of other possible revisions based on existing SPIRIT and CONSORT extensions, other reporting guidelines, and personal communications. From this, we generated a list of potential modifications or additions to SPIRIT and CONSORT, which we presented to stakeholders for feedback in an international online Delphi survey. The Delphi survey results were discussed at an online expert consensus meeting attended by 30 invited international participants. We then drafted the updated SPIRIT and CONSORT checklists and revised them based on further feedback from meeting attendees., Results: We compiled 83 suggestions for revisions or additions to SPIRIT and/or CONSORT from the scoping review and 85 from other sources, from which we generated 33 potential changes to SPIRIT (n = 5) or CONSORT (n = 28). Of 463 participants invited to take part in the Delphi survey, 317 (68%) responded to Round 1, 303 (65%) to Round 2 and 290 (63%) to Round 3. Two additional potential checklist changes were added to the Delphi survey based on Round 1 comments. Overall, 14/35 (SPIRIT n = 0; CONSORT n = 14) proposed changes reached the predefined consensus threshold (≥80% agreement), and participants provided 3580 free-text comments. The consensus meeting participants agreed with implementing 11/14 of the proposed changes that reached consensus in the Delphi and supported implementing a further 4/21 changes (SPIRIT n = 2; CONSORT n = 2) that had not reached the Delphi threshold. They also recommended further changes to refine key concepts and for clarity., Conclusion: The forthcoming SPIRIT 2024 and CONSORT 2024 Statements will provide updated, harmonized guidance for reporting randomized controlled trial protocols and results, respectively. The simultaneous development of the SPIRIT and CONSORT checklists has been informed by current empirical evidence and extensive input from stakeholders. We hope that this report of the methods used will be helpful for developers of future reporting guidelines., Competing Interests: Declaration of competing interest R. T. received support from the Medical Research Council–National Institute of Health and Care Research (MRC-NIHR). S. H. received support from MRC-NIHR. G. S. C. received support from MRC-NIHR. J. A. d. B. received support from MRC-NIHR. S. H., I. B., A.-W. C., A. H., K. F. S., and D. M. are members of the SPIRIT–CONSORT Executive Group. G. S. C. is director of the UK EQUATOR Centre. D. M. is director of the Canadian EQUATOR Centre. I. B. is deputy director of the French EQUATOR Centre. J. A. d. B. is a member of the UK EQUATOR Centre. D. M., A. H., and I. B. are members of the editorial board of the Journal of Clinical Epidemiology. Other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

The appropriate plot effectively conveys the author's conclusions to the readers. Journal of Korean Medical Science is providing a series of guidelines to show you how to make consistent and excellent plots more easily. In this article, we introduce scatter plots and more., Competing Interests: The authors have no potential conflicts of interest to disclose., (© 2024 The Korean Academy of Medical Sciences.)

The reproducibility crisis across animal studies jeopardizes the credibility of the main findings derived from animal research, even though these findings are critical for informing human studies. To clarify and improve transparency among animal studies, the ARRIVE reporting guidelines were first announced in 2010 and upgraded to version 2.0 in 2020. However, compliance with and awareness of those reporting guidelines has remained suboptimal. Journal editors should encourage the authors to adhere to those guidelines. Authors, editors, referees, and reviewers should be aware of the ARRIVE guideline 2.0 when assessing and evaluating the methodology and findings of animal studies. However, we should also question whether reporting guidelines alone can change a research culture and improve the reproducibility of animal investigations. Reported research may not reflect actual research. Large segments of animal research efforts are wasted because of poor design choices and because of non-publication rather than suboptimal reporting. Better training of the scientific workforce, interventions at improving animal research at the design stage, registration practices, and alignment of the reward system with the publication of rigorous animal research may achieve more than reporting guidelines alone., Competing Interests: Declaration of conflicting interestsThe authors have no conflicts of interest to declare.

Background: Evidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evidence relies on replication to ensure sufficient power and broad applicability of findings. Prompt reporting is therefore essential; however, SWAT publications are often the first to be abandoned in the face of other time pressures. Reporting guidance for embedded methodology trials does exist but is not widely used. We sought therefore to build on these guidelines to develop a straightforward, concise reporting standard, which remains adherent to the CONSORT guideline., Methods: An iterative process was used to develop the guideline. This included initial meetings with key stakeholders, development of an initial guideline, pilot testing of draft guidelines, further iteration and pilot testing, and finalisation of the guideline., Results: We developed a reporting guideline applicable to randomised SWATs, including replications of previous evaluations. The guideline follows the Consolidated Standards for Reporting Trials (CONSORT) statement and provides example text to ensure ease and clarity of reporting across all domains., Conclusions: The SWAT reporting guideline will aid authors, reviewers, and journal editors to produce and review clear, structured reports of randomised SWATs, whilst also adhering to the CONSORT guideline., Trial Registration: EQUATOR Network - Guidelines Under Development ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#SWAT ). Registered on 25 March 2021., (© 2024. The Author(s).)

Biomedical research reporting guidelines provide a framework by which journal editors and the researchers who conduct studies can ensure that the reported research is both complete and transparent. With more than 16 different guidelines for the 11 major study types of medical and health research, authors need to be familiar with journal reporting standards. To assess the current endorsements of reporting guidelines for biomedical and health research, this study examined the instructions for authors (IFAs) of 559 biomedical journals by 11 prominent publishers that publish original research or systematic reviews/meta-analyses. Data from the above original sources were cleaned and restructured, and analyzed in a database and text miner. Each journal's instructions or information for authors were examined to code if any of five prominent reporting guidelines were mentioned and what form the guideline adherence demonstration took. Seventeen journals published the reporting guidelines. Four of the five reporting guidelines listed journals as endorsers. For journals with open peer review reports, a sample of journals and peer reviews was analyzed for mention of adherence to reporting guidelines. The endorsement of research guidelines by publishers and their associated journals is inconsistent for some publishers, with only a small number of journals endorsing relevant guidelines. Based on the analysis of open peer reviews, there is evidence that some reviewers check the adherence to the endorsed reporting guidelines. Currently, there is no universal endorsement of reporting guidelines by publishers nor ways of demonstrating adherence to guidelines. Journals may not directly inform authors of their guideline endorsements, making it more difficult for authors to adhere to endorsed guidelines. Suggestions derived from the findings are provided for authors, journals, and reporting guidelines to ensure increased adequate use of endorsed reporting guidelines., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Wang et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Quality reporting contributes to effective translation of health research in practice and policy. As an initial step in the development of a reporting guideline for scaling, the Standards for reporting stUdies of sCaling evidenCEd-informED interventions (SUCCEED), we performed a systematic review to identify relevant guidelines and compile a list of potential items., Methods: We conducted a systematic review according to Cochrane method guidelines. We searched the following databases: MEDLINE, Embase, PsycINFO, Cochrane Library, CINAHL, Web of Science, from their respective inceptions. We also searched websites of relevant organizations and Google. We included any document that provided instructions or recommendations, e.g., reporting guideline, checklist, guidance, framework, standard; could inform the design or reporting of scaling interventions; and related to the health sector. We extracted characteristics of the included guidelines and assessed their methodological quality using a 3-item internal validity assessment tool. We extracted all items from the guidelines and classified them according to the main sections of reporting guidelines (title, abstract, introduction, methods, results, discussion and other information). We performed a narrative synthesis based on descriptive statistics., Results: Of 7704 records screened (published between 1999 and 2019), we included 39 guidelines, from which data were extracted from 57 reports. Of the 39 guidelines, 17 were for designing scaling interventions and 22 for reporting implementation interventions. At least one female author was listed in 31 guidelines, and 21 first authors were female. None of the authors belonged to the patient stakeholder group. Only one guideline clearly identified a patient as having participated in the consensus process. More than half the guidelines (56%) had been developed using an evidence-based process. In total, 750 items were extracted from the 39 guidelines and distributed into the 7 main sections., Conclusion: Relevant items identified could inform the development of a reporting guideline for scaling studies of evidence-based health interventions. This and our assessment of guidelines could contribute to better reporting in the science and practice of scaling., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.)

Highlights Guidelines have been created to improve the reporting of clinical trials of biofield therapies, e.g. External Qigong, Healing Touch, Reiki, and Therapeutic Touch. Appropriate use of these guidelines is likely to strengthen the evidence base for biofield therapies as well as increase their usage as stand-alone practices and as complementary therapies within mainstream healthcare.

Background: Requiring authors to base their research on a systematic review of the existing literature prevents the generation of redundant scientific studies, thereby avoiding the deprivation of effective therapies for trial participants and the waste of research funds. Scientific medical journals could require this in their author guidelines. While this applies to all areas of research, it is also relevant to physiotherapy and rehabilitation research, which predominantly involve interventional trials in patients., Objective: The aim of this study was to determine the extent to which the use of systematic reviews to justify a new trial is already being requested by physiotherapy-related scientific medical journals (PTJs). In addition, a comparison was made between PTJs and scientific medical journals with the highest impact factor in the Science Citation Index Extended (SCIE)., Methods: This meta-research study is based on a systematic examination of the author guidelines of 149 PTJs. The journals were identified and included based on the number of publications with physiotherapy as a keyword in the databases PEDro, and Medline (Pubmed). The included author guidelines were analysed for the extent to which they specified that a new trial should be justified by a systematic review of the literature. Additionally, they were compared with 14 scientific medical journals with the highest impact factor in the SCIE (LJs)., Results: In their author guidelines, none of the included PTJs required or recommended the use of a systematic review to justify a new trial. Among LJs, four journals (28.57%), all associated with the Lancet group, required the study justification through a systematic review of the literature., Conclusion: Neither PTJs nor LJs require or recommend the use of a systematic review to justify a new trial in their author guidelines. This potentially leaves room for unethical scientific practices and should be critically considered in future research., (© 2024. The Author(s).)

Background: The 2009 Institute of Medicine (IOM) gestational weight gain (GWG) guidelines were initially developed for pregnant women in the United States., Objective: This study aimed to investigate whether the IOM guidelines were suitable for pregnant Chinese women., Methods: A retrospective cohort study comprising 20,593 singleton pregnant women was conducted at the Beijing Obstetrics and Gynaecology Hospital (1 January 2018 to 31 December 2019). Applicability was evaluated by comparing the GWG corresponding to the lowest point of the predicted composite risk curve with the 2009 IOM GWG Guidelines. The IOM Guidelines serve as the standard for the GWG categories and the pre-pregnancy body mass index. An exponential function model was used to fit the weight gain during pregnancy and the probability of caesarean section, preterm birth, small for gestational age, and large for gestational age. A quadratic function model was used to fit the combined probability of the above-mentioned adverse pregnancy outcomes. The applicability of the IOM guidelines was evaluated by comparing the weights corresponding to the lowest predicted probability with the GWG range recommended by the IOM guidelines., Results: According to the 2009 IOM GWG Guidelines, 43% of the women achieved adequate weight, almost 32% gained excessive weight, and 25% gained inadequate weight. The GWG range proposed by the IOM included the lowest predicted probability value for underweight women and exceeded the lowest predicted probability for normal weight, overweight, and obese women., Conclusions: The 2009 IOM guidelines were suitable for Chinese women whose pre-pregnancy body mass index was classified as underweight. The guidelines were not suitable for normal, overweight, or obese pre-pregnancy body mass index classifications. Therefore, based on the above evidence, the 2009 IOM guidelines are not suitable for all Chinese women.

Background: A bibliometric review of the biomedical literature could be essential in synthesizing evidence if thoroughly conducted and documented. Although very similar to review papers in nature, it slightly differs in synthesizing the data when it comes to providing a pile of evidence from different studies into a single document. This paper provides a preliminary guideline for reporting bibliometric reviews of the biomedical literature (BIBLIO)., Methods: The BIBLIO was developed through two major processes: literature review and the consensus process. The BIBLIO started with a comprehensive review of publications on the conduct and reporting of bibliometric studies. The databases searched included PubMed, Scopus, Web of Sciences, and Cochrane Library. The process followed the general recommendations of the EQUATOR Network on how to develop a reporting guideline, of which one fundamental part is a consensus process. A panel of experts was invited to identify additional items and was asked to choose preferred options or suggest another item that should be included in the checklist. Finally, the checklist was completed based on the comments and responses of the panel members in four rounds., Results: The BIBLIO includes 20 items as follows: title (2 items), abstract (1 item), introduction/background (2 items), methods (7 items), results (4 items), discussion (4 items). These should be described as a minimum requirements in reporting a bibliometric review., Conclusions: The BIBLIO for the first time provides a preliminary guideline of its own kind. It is hoped that it could contribute to the transparent reporting of bibliometric reviews. The quality and utility of BIBILO remain to be investigated further., (© 2023. The Author(s).)

Background: Health information technology (HIT) is increasingly used to enable health service/system transformation. Most HIT implementations fail to some degree; very few demonstrate sustainable success. No guidelines exist for health service leaders to leverage factors associated with success. The purpose of this paper is to present an evidence-based guideline for leaders to test and leverage in practice., Methods: This guideline was developed from a literature review and refined by a set of eight interviews with people in senior HIT roles, which were thematically analysed. It was refined in the consultancy work of the first author and confirmed after minor refinements., Results: Five key actions were identified: relationships, vision, HIT system attributes, constant evaluation and learning culture., Conclusions: This guideline presents a significant opportunity for health system leaders to systematically check relevant success factors during the implementation process of single projects and regional/national programmes., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Although air quality has gradually improved in recent years, as shown by the decrease in PM 2.5 concentration, the problem of rising ambient ozone has become increasingly serious. To reduce hazards to human health and environmental welfare exposure to ozone, scientists and government regulators have developed ozone guidelines and standards. These answer the questions of which levels of exposure are hazardous to human health and the environment, and how can ambient ozone exposure be guaranteed, respectively. So what are the basis for the ozone guidelines and standards? This paper reviews in detail the process of revising ozone guidelines and standards by the World Health Organization (WHO) and the United States Environmental Protection Agency (EPA). The present study attempts to explore and analyze the scientific basis and empirical methods for updating guidelines and standards, in a view to guide the future revision process and provide directions for further scientific research. We found many epidemiological and toxicological studies and exposure-response relationships provided strong support for developing and revising the ozone guidelines. When setting standards, ozone exposure has been effectively considered, and the economic costs, health, and indirect economic benefits of standard compliance were reasonably estimated. Accordingly, epidemiological and toxicological studies and the establishment of exposure-response relationships, as well as exposure and risk assessment and benefit-cost estimates of standards compliance should be strengthened for the further update of guidelines and standards. In addition, with the increasing prominence of combined air pollution led by ozone and PM 2.5 , more joint exposure scientific research related to ozone guidelines and standards should be undertaken., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Xue and Zhang.)

Oxygen is one of the most commonly used emergency therapies. Like other therapies, oxygen can cause harm if used inappropriately. During the COVID-19 pandemic, guidelines were released to optimize oxygen and medication use. In the current study, we examine whether oxygen and medication use during the first wave of the COVID-19 pandemic was in concordance with new guidelines. A retrospective cross-sectional study was conducted using routinely collected data from University of Birmingham NHS Foundation Trust in England. Patients were admitted between April 2020 and September 2020, were over the age of 18 years, and had a confirmed diagnosis of COVID-19. To assess adherence to the oxygen guidelines (i.e. SpO2 adherence), the percentage of times oxygen therapy was administered within, over, and under guideline specifications were calculated for patients overall, and then for patients with and without chronic obstructive pulmonary disease (COPD)/pulmonary disease separately. Next, two multinomial regression analyses were conducted to assess whether clinical processes, pre-admission diagnoses, and other demographic factors were related to oxygen use. Analysis 1 included patients not diagnosed with COPD/pulmonary disease. Analysis 2 included patients diagnosed with COPD/pulmonary disease. Results are reported as tallies, percentages, and odds ratios with 95% confidence intervals. To assess adherence to a new medication guideline, the percentage of patients administered oxygen and dexamethasone was calculated for those admitted after 25 June 2020. The overall number of patients included in our SpO2 adherence analyses was 8751 (female = 4168). Oxygen was used within guideline specifications less than half the time, i.e. 41.6% (n = 3638/8751); non-adherence involving under-administering (3.5%, n = 304/8751) was markedly lower than over-administering (55.0%, n = 4809/8751). Adherence was higher for patients without COPD (43.7%, n = 3383/7741) than with COPD (25.2%, n = 255/1010). Under-administering was low across groups (non-COPD 3.5%, n = 274/7741 and COPD 2.9%, n = 30/1010). Over-administering was markedly lower for non-COPD (52.3%, n = 4084/7741) than COPD (71.8%, n = 725/1010) patients. Diagnoses associated with over-administering varied across the groups. Regarding the dexamethasone guidelines, of the 6397 patients admitted after the 24th of June, only 12.6% (n = 805) received dexamethasone. Suboptimal use of oxygen and medication were common during the first wave of the COVID-19 pandemic. As found in previous studies, over-administering was more common than under-administering. The new guidelines issued during the COVID-19 pandemic were not by themselves sufficient to optimize oxygen use. Behavioural strategies are explored which may help policymakers optimize oxygen use., (© The Author(s) 2023. Published by Oxford University Press on behalf of International Society for Quality in Health Care.)

Background: It has been widely recognized that ethics is central to the practice of medicine. Since physicians' identities are heavily influenced by their basic medical training, education in ethics during this period would facilitate their professional development. To enable this, some global and national organizations have published guidelines detailing the aspects of ethics that need to be taught to medical student. However, it is not known how many such guidelines exist and to what extent they concur or differ., Aim: This study aims to identify and examine the content of existing national or international guidelines on the inclusion of ethics in basic medical education, in the English language. By doing so, it hopes to explore and highlight the similarities and differences regarding their pedagogical goals and their prescribed content, thereby contributing to a more holistic understanding on the state of medical ethics education., Methods: Data collection was performed through systematic searches on Google and on scientific databases. The guidelines that fulfilled the inclusion criteria were thematically analyzed using the method proposed by Braun and Clarke (2006). The resulting themes and sub-themes were grouped and characterized., Results: Thirteen guidelines (ten national and three international) fulfilled the inclusion criteria. Among these, two major approaches can be discerned: value-based and norm-based. Value-based guidelines tend to be more globally applicable, because they endorse more abstract and universal principles. Norm-based guidelines, on the other hand, are more context-specific and have a practical focus. Understanding this distinction could facilitate discussions on different perspectives in ethics education., (© 2022. The Author(s), under exclusive licence to Springer Nature B.V.)

Introduction: Young people use social media to communicate about self-harm and suicide and this is associated with both potential risks and protective effects. The #chatsafe guidelines were originally developed in 2018 to equip young people to communicate safely online about suicide. They were shown to be safe, acceptable, and beneficial; however, they do not provide guidance on self-harm, and social media is constantly evolving. This study aimed to update the #chatsafe guidelines to reflect new evidence and current social media affordances, and to include guidance on self-harm., Methods: A Delphi expert consensus study was conducted, comprising six stages: 1) A systematic search of peer-reviewed and grey literature; 2) A series of roundtables with key stakeholders including social media companies, policymakers, and young people; 3) Questionnaire development; 4) Expert panel formation; 5) Data collection and analysis; and 6) Guideline development., Results: A total of 191 items were included in the new #chatsafe guidelines. These were organised into eight themes, which became the overarching sections of the guidelines: 1) General tips; 2) Creating self-harm and suicide content; 3) Consuming self-harm and suicide content; 4) Livestreams of self-harm and suicide acts; 4) Self-harm and suicide games, pacts, and hoaxes; 6) Self-harm and suicide communities; 7) Bereavement and communicating about someone who has died by suicide; and 8) Guidance for influencers., Discussion: The new guidelines include updated and new information on online communication about self-harm, livestreams, games, pacts, and hoaxes, as well as guidance for influencers. They will be disseminated via a national social media campaign and supported by a series of adult-facing resources. Given the acceptability of the original guidelines and the ubiquitous use of social media by young people, it is hoped that the new guidelines will be a useful resource for young people and adults alike, both in Australia and worldwide., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Robinson et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

To foster research integrity (RI), research institutions should develop a continuous RI education approach, addressing various target groups. To support institutions to achieve this, we developed RI education guidelines together with RI experts and research administrators, exploring similarities and differences in recommendations across target groups, as well as recommendations about RI education using approaches other than formal RI training. We used an iterative co-creative process. We conducted four half-day online co-creation workshops with 16 participants in total, which were informed by the RI education evidence-base. In the first two workshops, participants generated ideas for guidelines' content, focusing on different target groups and various approaches to RI education. Based on this content we developed first drafts of the guidelines. Participants in the third and fourth workshop refined those drafts. We next organized a working group which further prioritized, reorganized, and optimized the content of the guidelines. We developed four guidelines on RI education focusing on (a) bachelor, master and PhD students; (b) post-doctorate and senior researchers; (c) other RI stakeholders; as well as (d) continuous RI education. Across guidelines, we recommend mandatory RI training; follow-up refresher training; informal discussions about RI; appropriate rewards and incentives for active participation in RI education; and evaluation of RI educational events. Our work provides experience-based co-created guidance to research institutions on what to consider when developing a successful RI education strategy. Each guideline is offered as a distinct, publicly available tool in our toolbox ( www.sops4ri.eu/toolbox ) which institutions can access, adapt and implement to meet their institution-specific RI education needs.Trial registration https://osf.io/zej5b ., (© 2023. The Author(s).)

Aim: To examine trends in public awareness and knowledge of drinking guidelines in the UK since their revision in 2016, which had moved from a daily to a weekly guideline, made the guideline the same for men and women, and reduced the guideline for men by around one-third., Method: Data were from a representative, repeat cross-sectional survey. We analysed changes in awareness and knowledge of drinking guidelines among 8168 adult drinkers between 2016 and 2022 and associations with sociodemographic characteristics, smoking status and level of alcohol consumption., Results: The proportion of drinkers aware of guidelines declined from 86.0% (95%CI 84.0-88.0%) in 2016 to 81.7% (79.5-84.0%) in 2019, then increased during the COVID-19 pandemic, peaking at 91.6% (90.1-93.1%) in 2020. The proportion who correctly identified the guideline as a maximum of exactly 14 units/week remained at around a quarter from 2016 (25.0%, 22.4-27.5%) to 2018 (25.8%, 23.2-28.3%), whereas the proportion who gave a figure of 14 units or fewer rose from 52.1 (49.2-55.0%) to 57.4% (54.6-60.3%). However, by 2022, guideline knowledge had worsened significantly, with these figures falling to 19.7 (17.4-21.9%) and 46.5% (43.6-49.4%), respectively. Changes over time were similar across subgroups. Odds of guideline awareness and knowledge were higher among drinkers who were aged ≥35, female, more educated and from more advantaged social grades., Conclusions: The majority of adult drinkers in the UK are aware of low-risk drinking guidelines. However, 6 years since their announcement, knowledge of the revised drinking guidelines remains poor. Less than a quarter know the recommended weekly limit and only around half think it is 14 units or less. Inequalities have persisted over time, such that disadvantaged groups remain less likely to know the guidelines., (© The Author(s) 2023. Medical Council on Alcohol and Oxford University Press.)

Background: Hand hygiene is an important measure to prevent disease transmission., Objective: To summarise current international guideline recommendations for hand hygiene in community settings and to assess to what extent they are consistent and evidence based., Eligibility Criteria: We included international guidelines with one or more recommendations on hand hygiene in community settings-categorised as domestic, public or institutional-published by international organisations, in English or French, between 1 January 1990 and 15 November 2021., Data Sources: To identify relevant guidelines, we searched the WHO Institutional Repository for Information Sharing Database, Google, websites of international organisations, and contacted expert organisations and individuals., Charting Methods: Recommendations were mapped to four areas related to hand hygiene: (1) effective hand hygiene; (2) minimum requirements; (3) behaviour change and (4) government measures. Recommendations were assessed for consistency, concordance and whether supported by evidence., Results: We identified 51 guidelines containing 923 recommendations published between 1999 and 2021 by multilateral agencies and international non-governmental organisations. Handwashing with soap is consistently recommended as the preferred method for hand hygiene across all community settings. Most guidelines specifically recommend handwashing with plain soap and running water for at least 20 s; single-use paper towels for hand drying; and alcohol-based hand rub (ABHR) as a complement or alternative to handwashing. There are inconsistent and discordant recommendations for water quality for handwashing, affordable and effective alternatives to soap and ABHR, and the design of handwashing stations. There are gaps in recommendations on soap and water quantity, behaviour change approaches and government measures required for effective hand hygiene. Less than 10% of recommendations are supported by any cited evidence., Conclusion: While current international guidelines consistently recommend handwashing with soap across community settings, there remain gaps in recommendations where clear evidence-based guidance might support more effective policy and investment., Competing Interests: Competing interests: None declared., (© World Health Organization 2023. Licensee BMJ.)

Competing Interests: Competing interests: None declared.

Background Context: Spinal cord injury brings devastating consequences and huge economic burden. Different authoritative organizations have developed different guidelines for pharmacological treatments of spinal cord injury, but there is a lack of a critical appraisal of them., Purpose: To systematically review and appraise guidelines regarding their recommendations for pharmacological treatments for spinal cord injury., Study Design: Systematic review., Methods: We searched Medline, Embase, Cochrane, and Web of Science from January 2000 to January 2022 as well as guideline-specific databases (eg, Congress of Neurological Surgeons) and Google Scholar. We included the most updated guideline containing evidence-based recommendations or consensus-based recommendations developed by specific authoritative organizations if multiple versions were available. We appraised guidelines through the Appraisal of Guidelines for Research and Evaluation, 2nd edition instrument consisting of six domains (eg, applicability). With supporting evidence, recommendations were classified as: for, against, neither for nor against. We utilized an evidence assessment system to categorize the quality of supporting evidence as poor, fair, or good., Results: Eight guidelines developed from 2008 to 2020 were included, but all of them scored lowest in the domain of applicability among all six domains. Twelve pharmacological agents (eg, methylprednisolone) were studied. For methylprednisolone, three guidelines (3/8=37.5%) recommended for (one evidence-based and two consensus-based), three (3/8=37.5%) recommended against (all evidence-based), and two (2/8=25%) recommended neither for nor against. For monosialotetrahexosylganglioside (GM-1), one guideline (1/4=25%) recommended for (consensus-based), one (1/4=25%) recommended against (evidence-based), and two (2/4=50%) recommended neither for nor against. For other agents (eg, minocycline), most guidelines (3/5=60%) recommended neither for nor against, one (1/5=20%) recommended against naloxone (evidence-based) and nimodipine (evidence-based), and one (1/5=20%) recommended for neural growth factor (consensus-based). The quality of most of the supporting evidence was poor, and the rest was fair., Conclusions: There were inconsistencies among recommendations for methylprednisolone and GM-1. Evidence-based recommendations tended to recommend against, whereas consensus-based recommendations tended to recommend for., Competing Interests: Declarations of Competing Interests The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: To investigate how quickly evidence was incorporated into the Australian living guidelines for COVID-19 during the first 12 months of the pandemic., Study Design and Setting: For each study concerning drug therapies included in the guideline from April 3, 2020 to April 1, 2021, we extracted the publication date of the study, and the guideline version the study was included in. We analyzed two subgroups of studies as follows: those published in high impact factor journals and those with 100 or more participants., Results: In the first year, we published 37 major versions of the guidelines, incorporating 129 studies that investigated 48 drug therapies informing 115 recommendations. The median time from first publication of a study to incorporation in the guideline was 27 days (interquartile range [IQR], 16 to 44), ranging from 9 to 234 days. For the 53 studies in the highest impact factor journals, the median was 20 days (IQR 15 to 30), and for the 71 studies with 100 or more participants the median was 22 days (IQR 15 to 36)., Conclusion: Developing and sustaining living guidelines where evidence is rapidly incorporated is a resource- and time-intensive undertaking; however, this study demonstrates that it is feasible, even over a long period., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Introduction: The EVALUA GPS project aims to evaluate the impact of the implementation of the National Institute for Health Care and Excellence (NICE) guideline 'Community engagement: improving health and well-being and reducing health inequalities' adapted to the Spanish context., Methods and Analysis: Phase I: A tool will be designed to evaluate the impact of implementing the recommendations of the adapted NICE guideline. The tool will be developed through a review of the literature on implementation of public health guidelines between 2000 and 2021 and an expert's panel consensus., Phase Ii: The developed tool will be implemented in 16 community-based programmes, acting as intervention sites, and 4 controls through a quasi-experimental pre-post study. Phase III: A final online web tool, based on all previously collected information, will be developed to support the implementation of the adapted NICE guidelines recommendations in other contexts and programmes., Data Collection and Analysis: Data will be collected through surveys and semistructured interviews. Quantitative and qualitative data will be analysed to identify implementation scenarios, changes in community engagement approaches, and barriers and facilitators to the implementation of the recommendations. All this information will be further synthesised to develop the online tool., Ethics and Dissemination: The proposed research has been approved by the Clinical Research Ethics Committee of Aragon. Results will be presented at national and international conferences and published in peer-reviewed open access journals. The interactive online tool (phase III) will include examples of its application from the fieldwork., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Clinical research on neonatal resuscitation has accelerated over recent decades. However, an important methodologic limitation is that there are no standardized definitions or reporting guidelines for neonatal resuscitation clinical studies. To address this, the International Liaison Committee on Resuscitation Neonatal Life Support Task Force established a working group to develop the first Utstein-style reporting guideline for neonatal resuscitation. The working group modeled this approach on previous Utstein-style guidelines for other populations. This reporting guideline focuses on resuscitation of newborns immediately after birth for respiratory failure, bradycardia, severe bradycardia, or cardiac arrest. We identified 7 relevant domains: setting, patient, antepartum, birth/preresuscitation, resuscitation process, postresuscitation process, and outcomes. Within each domain, relevant data elements were identified as core versus supplemental. Core data elements should be collected and reported for all neonatal resuscitation studies, while supplemental data elements may be collected and reported using standard definitions when possible. The Neonatal Utstein template includes both core and supplemental elements across the 7 domains, and the associated Data Table provides detailed information and reporting standards for each data element. The Neonatal Utstein reporting guideline is anticipated to assist investigators engaged in neonatal resuscitation research by standardizing data definitions. The guideline will facilitate data pooling in meta-analyses, enhancing the strength of neonatal resuscitation treatment recommendations and subsequent guidelines., (Copyright © 2023 by the American Academy of Pediatrics.)

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and declare that GG is co-founder and co-chair of the GRADE working group. Provenance and peer review: Not commissioned; externally peer reviewed.

Importance: Clinicians, patients, and policy makers rely on published results from clinical trials to help make evidence-informed decisions. To critically evaluate and use trial results, readers require complete and transparent information regarding what was planned, done, and found. Specific and harmonized guidance as to what outcome-specific information should be reported in publications of clinical trials is needed to reduce deficient reporting practices that obscure issues with outcome selection, assessment, and analysis., Objective: To develop harmonized, evidence- and consensus-based standards for reporting outcomes in clinical trial reports through integration with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement., Evidence Review: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for the reporting of outcomes in clinical trial reports., Findings: The scoping review and consultation with experts identified 128 recommendations relevant to reporting outcomes in trial reports, the majority (83%) of which were not included in the CONSORT 2010 statement. All recommendations were consolidated into 64 items for Delphi voting; after the Delphi survey process, 30 items met criteria for further evaluation at the consensus meeting and possible inclusion in the CONSORT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 17 items that elaborate on the CONSORT 2010 statement checklist items and are related to completely defining and justifying the trial outcomes, including how and when they were assessed (CONSORT 2010 statement checklist item 6a), defining and justifying the target difference between treatment groups during sample size calculations (CONSORT 2010 statement checklist item 7a), describing the statistical methods used to compare groups for the primary and secondary outcomes (CONSORT 2010 statement checklist item 12a), and describing the prespecified analyses and any outcome analyses not prespecified (CONSORT 2010 statement checklist item 18)., Conclusions and Relevance: This CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement provides 17 outcome-specific items that should be addressed in all published clinical trial reports and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results.