Shirin Heidari.

Dr. Shirin Heidari is the lead author of the Sex and Gender Equity in Research (SAGER) guidelines. In this interview with Dr. Isabel Goldman at Cell, she discusses her research, GENDRO, the SAGER guidelines and importance of considering sex- and gender-related variables in research, and her work on sexual and reproductive health in forced displacement.

Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs).

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.

Addressing Privacy Concerns Surrounding Oocyte Donation in the United States: Gone With Anonymity.

Oocyte donation has greatly expanded in the past several decades since the first procedure was performed in 1983. According to the Centers for Disease Control, the number of cycles using donor oocytes increased from 18,011 cycles in 2010 to 27,131 cycles in 2019. Oocyte donation has become an important reproductive option for women with diminished ovarian reserve, recurrent failed in vitro fertilization, or heritable genetic conditions. It is also particularly important for single men, same-sex male couples, and men with a transgender woman partner. More recently, societal changes accompanying the expansion of social media and broader access to direct-to-consumer DNA testing have raised concerns about privacy and anonymity. In this article, we review two specific aspects of donor privacy: privacy related to personal identifiers provided by clinics or donor egg bank websites and privacy related to direct-to-consumer genetic testing. We also provide clinical recommendations specific to the United States for working with oocyte donors and donor oocyte recipients.

"How to article:" guidelines for serving on an expert panel.

Academics in medicine are frequently asked to serve on panels to discuss their clinical, research, education, administrative or personal expertise. While panel discussions are often the highlight of a conference or event, in the medical literature, there is very little published on how an individual can effectively prepare and present as an expert panelist. This paper offers guidelines that will enable academics to prepare, deliver, and engage in active dialogue during a panel discussion. Specific tactics include how to accept invitations to serve on a panel, conducting pre-panel conference meetings and background research, preparing concise opening statements and new insights, connecting with the audience, answering questions in a collaborative spirit, and debriefing after the panel. These guidelines will be valuable to any individual invited to serve on a panel discussion and will promote future panelists in engaging in constructive and fulfilling dialogue, with the ultimate goal of leaving the audience with a greater understanding of the topic of discourse.

Endorsements of five reporting guidelines for biomedical research by journals of prominent publishers.

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.

Biofield Therapies: Guidelines for Reporting Clinical Trials.

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.

Informing the development of the SUCCEED reporting guideline for studies on the scaling of health interventions: A systematic review.

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.

The use of systematic reviews for conducting new studies in physiotherapy research: a meta-research study comparing author guidelines of physiotherapy-related journals.

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.

Call to digital health leaders: test and leverage this guideline to support health information technology implementation in practice.

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.

Introducing SoNHR-Reporting guidelines for Social Networks In Health Research.

OBJECTIVE: The overall goal of this work is to produce a set of recommendations (SoNHR-Social Networks in Health Research) that will improve the reporting and dissemination of social network concepts, methods, data, and analytic results within health sciences research. METHODS: This study used a modified-Delphi approach for recommendation development consistent with best practices suggested by the EQUATOR health sciences reporting guidelines network. An initial set of 28 reporting recommendations was developed by the author team. A group of 67 (of 147 surveyed) experienced network and health scientists participated in an online feedback survey. They rated the clarity and importance of the individual recommendations, and provided qualitative feedback on the coverage, usability, and dissemination opportunities of the full set of recommendations. After examining the feedback, a final set of 18 recommendations was produced. RESULTS: The final SoNHR reporting guidelines are comprised of 18 recommendations organized within five domains: conceptualization (how study research questions are linked to network conceptions or theories), operationalization (how network science portions of the study are defined and operationalized), data collection & management (how network data are collected and managed), analyses & results (how network results are analyzed, visualized, and reported), and ethics & equity (how network-specific human subjects, equity, and social justice concerns are reported). We also present a set of exemplar published network studies which can be helpful for seeing how to apply the SoNHR recommendations in research papers. Finally, we discuss how different audiences can use these reporting guidelines. CONCLUSIONS: These are the first set of formal reporting recommendations of network methods in the health sciences. Consistent with EQUATOR goals, these network reporting recommendations may in time improve the quality, consistency, and replicability of network science across a wide variety of important health research areas.

Preliminary guideline for reporting bibliometric reviews of the biomedical literature (BIBLIO): a minimum requirements.

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.

Overview of Early Childhood Caries in Nigeria and Global Recommended Treatment Guidelines.

BACKGROUND: Early childhood caries (ECC) is characterized by "the presence of one or more decayed (non-cavitated or cavitated lesions), missing (due to caries), or filled surfaces, in any primary tooth in a child 71 months of age or younger". There have been reports of increased incidence of caries in developing countries.A systematic analysis of the global burden of diseases, injuries and risk factors for 195 countries from 1990 to 2015 reported that almost 8% of children globally were affected by untreated ECC. As such, ECC was classified as one of the diseases of public health concern because it affects millions of infants and preschool children worldwide. This study aimed to review the prevalence and associated factors of early childhood caries in Nigeria and also provides current overview alongside globally recommended treatment guidelines. DATA SOURCE: PubMed database, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews (to February 2022) was used for articles search on the guidelines and recommendations for the treatment of ECC. Guidelines and recommendations published by the American Academy of Paediatric Dentistry, International Association of Paediatric Dentistry and European Academy of Paediatric Dentistry from 2017-2020 were retrieved. The following keys used in the MeSH were 'early childhood caries among Nigerian children, 'caries in preschool Nigerian children' 'treatment guidelines', 'treatment policies'and 'treatment recommendations. STUDY SELECTION: A total of 105 (24 plus 81) articles were retrieved but 21(15 plus 6 articles) were selected after the removal of non-specific and duplicated articles. RESULTS: The prevalence of early childhood caries ranged from 4.3-23.5% in Nigeria while the treatment guidelines and recommendations were case-specific. CONCLUSION: The prevalence of early childhood caries varies within the country's geo-political zones.

CONTEXTE: Les caries de la petite enfance (CPE) se caractérisent par "la présence d'une ou de plusieurs surfaces cariées (lésions non cavités ou cavités), manquantes (en raison de caries) ou obturées, sur une ou plusieurs dents primaires chez un enfant de 71 mois ou moins". Des rapports ont fait état d'une incidence accrue de caries dans les pays en développement. Une analyse systématique de la charge mondiale des maladies, des blessures et des facteurs de risque pour 195 pays de 1990 à 2015 a indiqué qu'environ 8 % des enfants dans le monde étaient touchés par des CPE non traitées. En tant que tel, les CPE ont été classées comme l'une des maladies préoccupantes pour la santé publique car elles touchent des millions de nourrissons et de jeunes enfants dans le monde. Cette étude visait à examiner la prévalence et les facteurs associés des caries de la petite enfance au Nigeria et à fournir une vue d'ensemble actuelle ainsi que des lignes directrices de traitement recommandées au niveau mondial. SOURCE DES DONNÉES: La base de données PubMed, le Registre Cochrane central des essais contrôlés et la base de données Cochrane des revues systématiques (jusqu'à février 2022) ont été utilisés pour la recherche d'articles sur les lignes directrices et recommandations pour le traitement des CPE. Les lignes directrices et recommandations publiées par l'American Academy of Paediatric Dentistry, l'International Association of Paediatric Dentistry et l'European Academy of Paediatric Dentistry de 2017 à 2020 ont été récupérées. Les termes suivants ont été utilisés dans le MeSH : 'caries de la petite enfance chez les enfants nigérians', 'caries chez les enfants préscolaires nigérians', 'lignes directrices de traitement', 'politiques de traitement' et 'recommandations de traitement'. SÉLECTION DES ÉTUDES: Un total de 105 (24 plus 81) articles ont été récupérés, mais 21 (15 plus 6 articles) ont été sélectionnés après la suppression des articles non spécifiques et en double. RÉSULTATS: La prévalence des caries de la petite enfance variait de 4,3 % à 23,5 % au Nigeria, tandis que les lignes directrices et recommandations de traitement étaient spécifiques à chaque cas. CONCLUSION: La prévalence des caries de la petite enfance variait au sein des zones géopolitiques du pays. Mots-clés: Caries de la petite enfance, CPE, Lignes directrices de traitement.

Development, Evaluation, and impLemenTation for guideline adaptation: a quality improvement protocol for the DELTA study in global health practice.

BACKGROUND: Guideline adaptation is an emerging field to provide more appropriate recommendations for local clinical practice quality and to promote global health equity. However, its utilization status, adaptation procedures, and related materials remain to be studied. METHODS: This study developed a quality improvement protocol for a study as the Development, Evaluation, and impLemenTation for guideline Adaptation (DELTA) study. Current adapted clinical practice guidelines (CPGs) will be systematically searched. Their characteristics, utilization status, and adaptation procedures will be extracted, compared, and analyzed. Whether these adapted CPGs rigorously followed the instruments and steps of adaptation frameworks will also be appraised. In addition, the advantages and limitations of current adaptation methods and their suitable application situations will be analyzed. In addition, future perspectives as DELTA series and DELTA system, aiming for comprehensively evaluating current needs for guideline adaptation and developing a unified framework and related materials were proposed to improve the acceptability, applicability, and implementation of guideline adaptation in clinical practice. The DELTA series are divided into four phases: phase I in analyzing status, characteristics, and procedures and completeness of adapted CPGs; phase II in analyzing differences, heterogeneity, and implementation between adapted and original CPGs; and phase III in collecting, analyzing, and comparing all available adaptation materials. With these research bases, an international working group will be established in phase IV and will develop unified guideline adaptation materials after Delphi consensus, including adaptation frameworks, appraisal tools and checklists, registries, and databases. DISCUSSION: Guideline adaptation has been advanced as an efficient way to guide local clinical practice. However, it still faces several major challenges. The proposed DELTA study, series, and system will further contribute to this emerging topic. TRIAL REGISTRATION:  This study has been registered by the PROSPERO international database. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=400170 .

Review of Validated Methods to Evaluate Diet History in Diet Therapy and Counselling: An Overview and Analysis of Screeners Based on Food-Based Dietary Guidelines.

Evidence-based dietetic practice calls for systematically developed assessment methods for nutritional assessment in dietetic counselling and therapy (DCT). Screeners can provide a quick and easy way to determine a client's diet quality and contribute to quality assurance in DCT. The aim of this systematic review was to give a comparative overview of screeners based on national food-based dietary guidelines (FBDGs) and to derive recommendations for developing an FBDG-based screener for DCT. The literature search in PubMed (MEDLINE), embase and Web of Science was conducted between May and July 2022, and updated in March 2023, in accordance with the consensus-based standards for the selection of health measurement instruments (COSMIN). The analysis focused on characteristics of screener design and measurement properties for screener testing. In total, 13 studies on 11 screeners based on FBDGs were included; 7 screeners were targeted to DCT. The content and scoring of screeners were based on the corresponding national FBDGs. The validity and/or reliability of screeners were investigated in 11 studies; responsiveness was not tested for any screener and practicality was considered in all studies. Based on the screeners reviewed, a systematic rationale to develop, enhance and test screeners based on national FBDGs was established.

Guidelines, Consensus Statements, and Standards for the Use of Artificial Intelligence in Medicine: Systematic Review.

BACKGROUND: The application of artificial intelligence (AI) in the delivery of health care is a promising area, and guidelines, consensus statements, and standards on AI regarding various topics have been developed. OBJECTIVE: We performed this study to assess the quality of guidelines, consensus statements, and standards in the field of AI for medicine and to provide a foundation for recommendations about the future development of AI guidelines. METHODS: We searched 7 electronic databases from database establishment to April 6, 2022, and screened articles involving AI guidelines, consensus statements, and standards for eligibility. The AGREE II (Appraisal of Guidelines for Research & Evaluation II) and RIGHT (Reporting Items for Practice Guidelines in Healthcare) tools were used to assess the methodological and reporting quality of the included articles. RESULTS: This systematic review included 19 guideline articles, 14 consensus statement articles, and 3 standard articles published between 2019 and 2022. Their content involved disease screening, diagnosis, and treatment; AI intervention trial reporting; AI imaging development and collaboration; AI data application; and AI ethics governance and applications. Our quality assessment revealed that the average overall AGREE II score was 4.0 (range 2.2-5.5; 7-point Likert scale) and the mean overall reporting rate of the RIGHT tool was 49.4% (range 25.7%-77.1%). CONCLUSIONS: The results indicated important differences in the quality of different AI guidelines, consensus statements, and standards. We made recommendations for improving their methodological and reporting quality. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews (CRD42022321360); https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=321360.

Screening and Management of Congenital Hypothyroidism - Guidelines by American Academy of Pediatrics, 2023.

Guidelines for screening and management of congenital hypothyroidism in neonates have been recently updated by the American Academy of Pediatrics (AAP). This article compares new AAP guideline with the Indian Society for Pediatric and Adolescent Endocrinology (ISPAE) Guidelines, 2018 and lists the changes in screening, diagnosis, and management of congenital hypothyroidism suggested in the new guidelines, along with clinical utilization in the Indian scenario.

Guía de práctica clínica basada en la evidencia sobre intervenciones de prevención, promoción, cuidado de las complicaciones y apoyo a las familias de los recién nacidos prematuros o con bajo peso al nacer. Versión resumida. Octubre de 2023 / Evidence-based clinical practice guide on prevention interventions, advocacy, care of complications and support for families of preterm or low birth weight newborns. Summary version. October 2023

El Instituto Nacional de Salud (INS) coordinó la elaboración de la presente guía de práctica clínica, con apoyo de un equipo multidisciplinario del Sistema Nacional Integrado de Salud (SNIS), y asesoría metodológica de OPS/OMS. El objetivo del documento es contar con recomendaciones informadas en la evidencia para la prevención, promoción, cuidado de las complicaciones y apoyo a las familias de los recién nacidos prematuros o con bajo peso al nacer; y ponerlas a la disponibilidad de los profesionales de la salud, para la atención de la población descrita en esta guía, siendo además una herramienta para los tomadores de decisiones, facilitando su implantación y reduciendo brechas en salud

The National Institute of Health (INS) coordinated the preparation of this clinical practice guide, with the support of a multidisciplinary team from the National Integrated Health System (NHIS), and methodological advice from PAHO/WHO. The aim of the document is to provide informed evidence-based recommendations for prevention, promotion, care of complications and support for the families of premature or low birth weight newborns; and make them available to health professionals, for the care of the population described in this guide, being also a tool for decision makers, facilitating their implementation and reducing health gaps

Guía de práctica clínica basada en la evidencia sobre intervenciones de prevención, promoción, cuidado de las complicaciones y apoyo a las familias de los recién nacidos prematuros o con bajo peso al nacer. Versión completa. Octubre de 2023 / Evidence-based clinical practice guide on prevention interventions, advocacy, care of complications and support for families of preterm or low birth weight newborns. Full version. October 2023

El Instituto Nacional de Salud (INS) coordinó la elaboración de la presente guía de práctica clínica, con apoyo de un equipo multidisciplinario del Sistema Nacional Integrado de Salud (SNIS), y asesoría metodológica de OPS/OMS. El objetivo del documento es contar con recomendaciones informadas en la evidencia para la prevención, promoción, cuidado de las complicaciones y apoyo a las familias de los recién nacidos prematuros o con bajo peso al nacer; y ponerlas a la disponibilidad de los profesionales de la salud, para la atención de la población descrita en esta guía, siendo además una herramienta para los tomadores de decisiones, facilitando su implantación y reduciendo brechas en salud

The National Institute of Health (INS) coordinated the preparation of this clinical practice guide, with the support of a multidisciplinary team from the National Integrated Health System (NHIS), and methodological advice from PAHO/WHO. The aim of the document is to provide informed evidence-based recommendations for prevention, promotion, care of complications and support for the families of premature or low birth weight newborns; and make them available to health professionals, for the care of the population described in this guide, being also a tool for decision makers, facilitating their implementation and reducing health gaps