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Editorials5 April 2016Sharing Clinical Trial Data: A Proposal From the International Committee of Medical Journal EditorsFREEDarren B. Taichman, MD, PhD, Joyce Backus, MSLS, Christopher Baethge, MD, Howard Bauchner, MD, Peter W. de Leeuw, MD, Jeffrey M. Drazen, MD, John Fletcher, MB, BChir, MPH, Frank A. Frizelle, MBChB, FRACS, Trish Groves, MBBS, MRCPsych, Abraham Haileamlak, MD, Astrid James, MBBS, Christine Laine, MD, MPH, Larry Peiperl, MD, Anja Pinborg, MD, Peush Sahni, MBBS, MS, PhD, and Sinan Wu, MDDarren B. Taichman, MD, PhDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Associate Director for Library Operations, National Library of Medicine; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal); Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Editor-in-Chief, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, Canadian Medical Association Journal; Editor-in-Chief, New Zealand Medical Journal; Head of Research, British Medical Journal; Editor-in-Chief, Ethiopian Journal of Health Sciences; Deputy Editor, The Lancet; Editor-in-Chief, Annals of Internal Medicine; Chief Editor, PLOS Medicine; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Representative and Past President, World Association of Medical Editors; Representative, Chinese Medical Journal , Joyce Backus, MSLSSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Associate Director for Library Operations, National Library of Medicine; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal); Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Editor-in-Chief, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, Canadian Medical Association Journal; Editor-in-Chief, New Zealand Medical Journal; Head of Research, British Medical Journal; Editor-in-Chief, Ethiopian Journal of Health Sciences; Deputy Editor, The Lancet; Editor-in-Chief, Annals of Internal Medicine; Chief Editor, PLOS Medicine; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Representative and Past President, World Association of Medical Editors; Representative, Chinese Medical Journal , Christopher Baethge, MDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Associate Director for Library Operations, National Library of Medicine; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal); Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Editor-in-Chief, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, Canadian Medical Association Journal; Editor-in-Chief, New Zealand Medical Journal; Head of Research, British Medical Journal; Editor-in-Chief, Ethiopian Journal of Health Sciences; Deputy Editor, The Lancet; Editor-in-Chief, Annals of Internal Medicine; Chief Editor, PLOS Medicine; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Representative and Past President, World Association of Medical Editors; Representative, Chinese Medical Journal , Howard Bauchner, MDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Associate Director for Library Operations, National Library of Medicine; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal); Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Editor-in-Chief, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, Canadian Medical Association Journal; Editor-in-Chief, New Zealand Medical Journal; Head of Research, British Medical Journal; Editor-in-Chief, Ethiopian Journal of Health Sciences; Deputy Editor, The Lancet; Editor-in-Chief, Annals of Internal Medicine; Chief Editor, PLOS Medicine; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Representative and Past President, World Association of Medical Editors; Representative, Chinese Medical Journal , Peter W. de Leeuw, MDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Associate Director for Library Operations, National Library of Medicine; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal); Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Editor-in-Chief, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, Canadian Medical Association Journal; Editor-in-Chief, New Zealand Medical Journal; Head of Research, British Medical Journal; Editor-in-Chief, Ethiopian Journal of Health Sciences; Deputy Editor, The Lancet; Editor-in-Chief, Annals of Internal Medicine; Chief Editor, PLOS Medicine; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Representative and Past President, World Association of Medical Editors; Representative, Chinese Medical Journal , Jeffrey M. Drazen, MDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Associate Director for Library Operations, National Library of Medicine; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal); Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Editor-in-Chief, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, Canadian Medical Association Journal; Editor-in-Chief, New Zealand Medical Journal; Head of Research, British Medical Journal; Editor-in-Chief, Ethiopian Journal of Health Sciences; Deputy Editor, The Lancet; Editor-in-Chief, Annals of Internal Medicine; Chief Editor, PLOS Medicine; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Representative and Past President, World Association of Medical Editors; Representative, Chinese Medical Journal , John Fletcher, MB, BChir, MPHSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Associate Director for Library Operations, National Library of Medicine; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal); Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Editor-in-Chief, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, Canadian Medical Association Journal; Editor-in-Chief, New Zealand Medical Journal; Head of Research, British Medical Journal; Editor-in-Chief, Ethiopian Journal of Health Sciences; Deputy Editor, The Lancet; Editor-in-Chief, Annals of Internal Medicine; Chief Editor, PLOS Medicine; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Representative and Past President, World Association of Medical Editors; Representative, Chinese Medical Journal , Frank A. Frizelle, MBChB, FRACSSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Associate Director for Library Operations, National Library of Medicine; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal); Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Editor-in-Chief, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, Canadian Medical Association Journal; Editor-in-Chief, New Zealand Medical Journal; Head of Research, British Medical Journal; Editor-in-Chief, Ethiopian Journal of Health Sciences; Deputy Editor, The Lancet; Editor-in-Chief, Annals of Internal Medicine; Chief Editor, PLOS Medicine; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Representative and Past President, World Association of Medical Editors; Representative, Chinese Medical Journal , Trish Groves, MBBS, MRCPsychSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Associate Director for Library Operations, National Library of Medicine; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal); Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Editor-in-Chief, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, Canadian Medical Association Journal; Editor-in-Chief, New Zealand Medical Journal; Head of Research, British Medical Journal; Editor-in-Chief, Ethiopian Journal of Health Sciences; Deputy Editor, The Lancet; Editor-in-Chief, Annals of Internal Medicine; Chief Editor, PLOS Medicine; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Representative and Past President, World Association of Medical Editors; Representative, Chinese Medical Journal , Abraham Haileamlak, MDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Associate Director for Library Operations, National Library of Medicine; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal); Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Editor-in-Chief, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, Canadian Medical Association Journal; Editor-in-Chief, New Zealand Medical Journal; Head of Research, British Medical Journal; Editor-in-Chief, Ethiopian Journal of Health Sciences; Deputy Editor, The Lancet; Editor-in-Chief, Annals of Internal Medicine; Chief Editor, PLOS Medicine; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Representative and Past President, World Association of Medical Editors; Representative, Chinese Medical Journal , Astrid James, MBBSSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Associate Director for Library Operations, National Library of Medicine; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal); Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Editor-in-Chief, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, Canadian Medical Association Journal; Editor-in-Chief, New Zealand Medical Journal; Head of Research, British Medical Journal; Editor-in-Chief, Ethiopian Journal of Health Sciences; Deputy Editor, The Lancet; Editor-in-Chief, Annals of Internal Medicine; Chief Editor, PLOS Medicine; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Representative and Past President, World Association of Medical Editors; Representative, Chinese Medical Journal , Christine Laine, MD, MPHSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Associate Director for Library Operations, National Library of Medicine; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal); Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Editor-in-Chief, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, Canadian Medical Association Journal; Editor-in-Chief, New Zealand Medical Journal; Head of Research, British Medical Journal; Editor-in-Chief, Ethiopian Journal of Health Sciences; Deputy Editor, The Lancet; Editor-in-Chief, Annals of Internal Medicine; Chief Editor, PLOS Medicine; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Representative and Past President, World Association of Medical Editors; Representative, Chinese Medical Journal , Larry Peiperl, MDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Associate Director for Library Operations, National Library of Medicine; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal); Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Editor-in-Chief, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, Canadian Medical Association Journal; Editor-in-Chief, New Zealand Medical Journal; Head of Research, British Medical Journal; Editor-in-Chief, Ethiopian Journal of Health Sciences; Deputy Editor, The Lancet; Editor-in-Chief, Annals of Internal Medicine; Chief Editor, PLOS Medicine; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Representative and Past President, World Association of Medical Editors; Representative, Chinese Medical Journal , Anja Pinborg, MDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Associate Director for Library Operations, National Library of Medicine; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal); Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Editor-in-Chief, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, Canadian Medical Association Journal; Editor-in-Chief, New Zealand Medical Journal; Head of Research, British Medical Journal; Editor-in-Chief, Ethiopian Journal of Health Sciences; Deputy Editor, The Lancet; Editor-in-Chief, Annals of Internal Medicine; Chief Editor, PLOS Medicine; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Representative and Past President, World Association of Medical Editors; Representative, Chinese Medical Journal , Peush Sahni, MBBS, MS, PhDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Associate Director for Library Operations, National Library of Medicine; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal); Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Editor-in-Chief, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, Canadian Medical Association Journal; Editor-in-Chief, New Zealand Medical Journal; Head of Research, British Medical Journal; Editor-in-Chief, Ethiopian Journal of Health Sciences; Deputy Editor, The Lancet; Editor-in-Chief, Annals of Internal Medicine; Chief Editor, PLOS Medicine; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Representative and Past President, World Association of Medical Editors; Representative, Chinese Medical Journal , and Sinan Wu, MDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Associate Director for Library Operations, National Library of Medicine; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal); Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Editor-in-Chief, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, Canadian Medical Association Journal; Editor-in-Chief, New Zealand Medical Journal; Head of Research, British Medical Journal; Editor-in-Chief, Ethiopian Journal of Health Sciences; Deputy Editor, The Lancet; Editor-in-Chief, Annals of Internal Medicine; Chief Editor, PLOS Medicine; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Representative and Past President, World Association of Medical Editors; Representative, Chinese Medical Journal Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M15-2928 SectionsAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk. In a growing consensus, many funders around the world—foundations, government agencies, and industry—now mandate data sharing. Here we outline ICMJE's proposed requirements to help meet this obligation. We encourage feedback on the proposed requirements. Anyone can provide feedback at www.icmje.org by 18 April 2016.The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Further details may be found in the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals at www.icmje.org.As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the deidentified individual-patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication. The data underlying the results are defined as the IPD required to reproduce the article's findings, including necessary metadata. This requirement will go into effect for clinical trials that begin to enroll participants beginning 1 year after the ICMJE adopts its data-sharing requirements.*Enabling responsible data sharing is a major endeavor that will affect the fabric of how clinical trials are planned and conducted and how their data are used. By changing the requirements of the manuscripts we will consider for publication in our journals, editors can help foster this endeavor. As editors, our direct influence is logically, and practically, limited to those data underpinning the results and analyses we publish in our journals.The ICMJE also proposes to require that authors include a plan for data sharing as a component of clinical trial registration. This plan must include where the researchers will house the data and, if not in a public repository, the mechanism by which they will provide others access to the data, as well as other data-sharing plan elements outlined in the 2015 Institute of Medicine Report (e.g., whether data will be freely available to anyone upon request or only after application to and approval by a learned intermediary, whether a data use agreement will be required) (1). ClinicalTrials.gov has added an element to its registration platform to collect data-sharing plans. We encourage other trial registries to similarly incorporate mechanisms for the registration of data-sharing plans. Trialists who want to publish in ICMJE member journals (or nonmember journals that choose to follow these recommendations) should choose a registry that includes a data-sharing plan element as a specified registry item or allows for its entry as a free-text statement in a miscellaneous registry field. As a condition of consideration for publication in our member journals, authors will be required to include a description of the data-sharing plan in the submitted manuscript. Authors may choose to share the deidentified IPD underlying the results presented in the article under less restrictive, but not more restrictive, conditions than were indicated in the registered data-sharing plan.ICMJE already requires the prospective registration of all clinical trials prior to enrollment of the first participant. This requirement aims, in part, to prevent selective publication and selective reporting of research outcomes, and to prevent unnecessary duplication of research effort. Including a commitment to a data-sharing plan is a logical addition to trial registration that will further each of these goals. Prospective trial registration currently includes documenting the planned primary and major secondary end points to be assessed, which enables identification of incomplete reporting as well as post hoc analyses. Declaring the plan for sharing data prior to their collection will further enhance transparency in the conduct and reporting of clinical trials by exposing when data availability following trial completion differs from prior commitments.Sharing clinical trial data, including deidentified IPD, requires planning to ensure appropriate ethics committee or institutional review board approval and the informed consent of study participants. Accordingly, we will defer these requirements for 1 year to allow investigators, trial sponsors, and regulatory bodies time to plan for their implementation.Just as the confidentiality of trial participants must be protected (through the deidentification of IPD), and the needs of those reasonably requesting data met (through the provision of useable data), the reasonable rights of investigators and trial sponsors must also be protected. ICMJE proposes the following to safeguard these rights. First, ICMJE editors will not consider the deposition of data in a registry to constitute prior publication. Second, authors of secondary analyses using these shared data must attest that their use was in accordance with the terms (if any) agreed to upon their receipt. Third, they must reference the source of the data using a unique identifier of a clinical trial's data set to provide appropriate credit to those who generated it and allow searching for the studies it has supported. Fourth, authors of secondary analyses must explain completely how theirs differ from previous analyses. In addition, those who generate and then share clinical trial data sets deserve substantial credit for their efforts. Those using data collected by others should seek collaboration with those who collected the data. However, because collaboration will not always be possible, practical, or desired, an alternative means of providing appropriate credit needs to be developed and recognized in the academic community. We welcome ideas about how to provide such credit.Data sharing is a shared responsibility. Editors of individual journals can help foster data sharing by changing the requirements of the manuscripts they will consider for publication in their journals. Funders and sponsors of clinical trials are in a position to support and ensure adherence to IPD sharing obligations. If journal editors become aware that IPD sharing obligations are not being met, they may choose to request additional information; to publish an expression of concern; to notify the sponsors, funders, or institutions; or in certain cases, to retract the publication.In the rare situation in which compliance with these requirements is impossible, editors may consider authors' requests for exceptions. If an exception is made, the reason(s) must be explained in the publication.Sharing data will increase confidence and trust in the conclusions drawn from clinical trials. It will enable the independent confirmation of results, an essential tenet of the scientific process. It will foster the development and testing of new hypotheses. Done well, sharing clinical trial data should also make progress more efficient by making the most of what may be learned from each trial and by avoiding unwarranted repetition. It will help to fulfill our moral obligation to study participants, and we believe it will benefit patients, investigators, sponsors, and society.Reference1. Institute of Medicine. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: National Academies Pr; 2015. Google Scholar Comments0 CommentsSign In to Submit A Comment Alain Braillon, MDUniversity Hospital, Amiens France22 April 2016 Sharing data from clinical trials … whether published or not The Journal must be commended for supporting the International Committee of Medical Journal Editors (ICMJE) proposal: "authors of manuscripts considered for publication in ICMJE members' journals must agree to share de-identified individual patient data no later than six months after publication".(1)Nevertheless, the problem of unpublished trials cannot be ignored as highlighted by a French experience. Initial results from controlled randomized trials suggesting a benefit of baclofen in alcohol use disorders (AUD) only included a small number of patients and were not confirmed in further trials. This, as the lack of pre-clinical pre-requisite did not preclude a skyrocking off label use. Presently in France, more than 100,000 patients with AUD are prescribed baclofen off label. Worst, only 6% are registered in the "Temporary Recommendations for Use" (RTUs) specifically enforced by the French Medicine Agency which requires data collection for patient monitoring.(2) Indeed, off-label drug use is usually not supported by sound scientific evidence, hinders the development of evidence-based medicine and therapeutic innovation, is costly to healthcare system, and exposes patients to unnecessary harm, including mortality, for uncertain benefit.(3-5) The French off label use of baclofen is even more alarming: extremely high doses (145 ± 75 mg/day, two or three fold higher than in other countries) while the marketing authorization for spasticity forbids the use of more than 40 mg/day and warns against associated alcohol use.(6) However, French prescribers bypass the specific framework aimed to protect the patients. A well-designed French trial with more than 300 patients (NCT01738282) was finalized in December 2014 (final data collection date for primary outcome measure). The sponsor, Ethypharm, the company marketing baclofen, has not released results yet. In June 2015 Ethypharm claimed it had bought the results of a trial funded by the Paris Public Hospitals Authority (NCT01604330) with 323 patients (Final data collection date for primary outcome: September 2014. Study completion date:October 2015).(http://www.ethypharm.fr/wp-content/uploads/2015/07/Communiqu%C3%A9_accord_APHP-Ethypharm_20150611.pdf) Again no results released yet, even in French meetings. Only claims stating the results will be presented in September 2016 during a meeting in Berlin with a marketing authorization planned for 2017.(http://www.addictaide.fr/actualite/congres-isbra-esbra-berlin-2-5-septembre-2016/) Meanwhile, in October 2015 the French private-equity firm Astorg Partners explored the sale of its company Ethypharm.( http://www.bloomberg.com/news/articles/2015-10-07/france-s-astorg-said-to-weigh-sale-of-pharma-business-ethypharm). Weird isn't it?Competing interests: I was a late co-investigator for NCT01738282 and did not include patients1 Taichman DB, Backus J, Baethge C et al. Sharing clinical trial data: A proposal from the International Committee of Medical Journal Editors. Ann Intern Med 2016;164:505-6.2 Degrassat-Théas A, Bocquet F, Sinègre M, Peigné J, Paubel P. The "Temporary Recommendations for Use": A dual-purpose regulatory framework for off-label drug use in France. Health Policy. 2015;119:1399-405.3 Chiu Y, Bero L, Hessol NA, Lexchin J, Harrington C. A literature review of clinical outcomes associated with antipsychotic medication use in North American nursing home residents. Health Policy. 2015;119:802-134 Good CB, Gellad WF. Off-Label drug use and adverse drug events: Turning up the heat on off-label prescribing. JAMA Intern Med. 2015. Online Nov 2. doi: 10.1001/jamainternmed.2015.6068. 5 Eguale T, Buckeridge DL, Verma A, Winslade NE, Benedetti A, Hanley JA, Tamblyn R. Association of off-label drug use and adverse drug events in an adult population. JAMA Intern Med. 2015. Online Nov 2 doi:10.1001/jamainternmed.2015.60586 Braillon A. Baclofen and protecting the patients during research. Alcohol Alcohol 2012;47:631. Richard J Hayes, on behalf of colleaguesLondon School of Hygiene & Tropical Medicine20 April 2016 Response to Editorial "Sharing Clinical Trial Data – a Proposal from the International Committee of Medical Journal Editors" We welcome the move towards greater sharing of data from trials but have concerns about unintended consequences of the proposal, particularly in community-based trials in low and middle income countries (LMIC). Our main concern is the short 6-month period proposed before data should be shared. Our studies often take many years of intensive fieldwork before the primary results are available. Published output during the trial is often limited to maintain blinding, and the careers of the researchers are critically dependent on post-trial outputs. The team focuses its effort on analysing and presenting the primary findings at the earliest possible date, especially when they are of major policy relevance. Following this, there will usually be a series of pre-planned further analyses. These studies – which often involve tens of thousands of research participants – will generally be conducted by teams which may include scientists from institutions where research capacity

Editorials4 July 2017Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal EditorsFREEDarren B. Taichman, MD, PhD, Peush Sahni, MBBS, MS, PhD, Anja Pinborg, MD, Larry Peiperl, MD, Christine Laine, MD, MPH, Astrid James, MBBS, Sung-Tae Hong, MD, PhD, Abraham Haileamlak, MD, Laragh Gollogly, MD, MPH, Fiona Godlee, FRCP, Frank A. Frizelle, MBChB, FRACS, Fernando Florenzano, MD, Jeffrey M. Drazen, MD, Howard Bauchner, MD, Christopher Baethge, MD, and Joyce Backus, MSLSDarren B. Taichman, MD, PhDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineSearch for more papers by this author, Peush Sahni, MBBS, MS, PhDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineSearch for more papers by this author, Anja Pinborg, MDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineSearch for more papers by this author, Larry Peiperl, MDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineSearch for more papers by this author, Christine Laine, MD, MPHSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineSearch for more papers by this author, Astrid James, MBBSSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineSearch for more papers by this author, Sung-Tae Hong, MD, PhDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineSearch for more papers by this author, Abraham Haileamlak, MDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineSearch for more papers by this author, Laragh Gollogly, MD, MPHSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineSearch for more papers by this author, Fiona Godlee, FRCPSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineSearch for more papers by this author, Frank A. Frizelle, MBChB, FRACSSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineSearch for more papers by this author, Fernando Florenzano, MDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineSearch for more papers by this author, Jeffrey M. Drazen, MDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineSearch for more papers by this author, Howard Bauchner, MDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineSearch for more papers by this author, Christopher Baethge, MDSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineSearch for more papers by this author, and Joyce Backus, MSLSSecretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineSearch for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M17-1028 SectionsAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk. In January 2016 we published a proposal aimed at helping to create an environment in which the sharing of deidentified individual participant data becomes the norm. In response to our request for feedback we received many comments from individuals and groups (1). Some applauded the proposals while others expressed disappointment they did not more quickly create a commitment to data sharing. Many raised valid concerns regarding the feasibility of the proposed requirements, the necessary resources, the real or perceived risks to trial participants, and the need to protect the interests of patients and researchers.It is encouraging that data sharing is already occurring in some settings. Over the past year, however, we have learned that the challenges are substantial and the requisite mechanisms are not in place to mandate universal data sharing at this time. Although many issues must be addressed for data sharing to become the norm, we remain committed to this goal.Therefore, ICMJE will require the following as conditions of consideration for publication of a clinical trial report in our member journals:1. As of 1 July 2018 manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement as described below.2. Clinical trials that begin enrolling participants on or after 1 January 2019 must include a data sharing plan in the trial's registration. The ICMJE's policy regarding trial registration is explained at www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html. If the data sharing plan changes after registration this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.Data sharing statements must indicate the following: whether individual deidentified participant data (including data dictionaries) will be shared; what data in particular will be shared; whether additional, related documents will be available (e.g., study protocol, statistical analysis plan, etc.); when the data will become available and for how long; by what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism). Illustrative examples of data sharing statements that would meet these requirements are in the Table.Table. Examples of Data Sharing Statements That Fulfill These ICMJE Requirements*These initial requirements do not yet mandate data sharing, but investigators should be aware that editors may take into consideration data sharing statements when making editorial decisions. These minimum requirements are intended to move the research enterprise closer to fulfilling our ethical obligation to participants. Some ICMJE member journals already maintain, or may choose to adopt, more stringent requirements for data sharing.Sharing clinical trial data is one step in the process articulated by the World Health Organization (WHO) and other professional organizations as best practice for clinical trials: universal prospective registration; public disclosure of results from all clinical trials (including through journal publication); and data sharing. Although universal compliance with the requirement to prospectively register clinical trials has not yet been achieved and requires continued emphasis, we must work toward fulfilling the other steps of best practice as well—including data sharing.As we move forward into this new norm where data are shared, greater understanding and collaboration among funders, ethics committees, journals, trialists, data analysts, participants, and others will be required. We are currently working with members of the research community to facilitate practical solutions to enable data sharing. The United States Office for Human Research Protections has indicated that provided the appropriate conditions are met by those receiving them, the sharing of deidentified individual participant data from clinical trials does not require separate consent from trial participants (2). Specific elements to enable data sharing statements that meet these requirements have been adopted at ClinicalTrials.gov (https://prsinfo.clinicaltrials.gov/definitions.html#shareData). The WHO also supports the addition of such elements at the primary registries of the International Clinical Trials Registry Platform. Unresolved issues remain, including appropriate scholarly credit to those who share data, and the resources needed for data access, the transparent processing of data requests, and data archiving. We welcome creative solutions to these problems at www.icmje.org.We envision a global research community in which sharing deidentified data becomes the norm. Working toward this vision will help maximize the knowledge gained from the efforts and sacrifices of clinical trial participants.References1. Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, et al. Sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors [Editorial]. Ann Intern Med. 2016;164:505-6. [PMID: 26792258]. doi:10.7326/M15-2928 LinkGoogle Scholar2. Menikoff J. Letter from Jerry Menikoff, MD, JD, Director, Office for Human Research Protections, to ICMJE Secretariat. 7 March 2017. Accessed at http://icmje.org/news-and-editorials/menikoff_icmje_questions_20170307.pdf Google Scholar Comments0 CommentsSign In to Submit A Comment Author, Article, and Disclosure InformationAffiliations: Secretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine; Representative and Past President, World Association of Medical Editors; Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal); Chief Editor, PLOS Medicine; Editor-in-Chief, Annals of Internal Medicine; Deputy Editor, The Lancet; Editor-in-Chief, Journal of Korean Medical Science; Editor-in-Chief, Ethiopian Journal of Health Sciences; Editor, Bulletin of the World Health Organization, Coordinator, WHO Press; Editor-in-Chief, The BMJ (British Medical Journal); Editor-in-Chief, New Zealand Medical Journal; Editor, Revista Médica de Chile (Medical Journal of Chile); Editor-in-Chief, New England Journal of Medicine; Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network; Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International; Representative and Associate Director for Library Operations, National Library of MedicineNote: This article is being published simultaneously in Annals of Internal Medicine, BMJ (British Medical Journal), Bulletin of the World Health Organization, Deutsches Ärzteblatt (German Medical Journal), Ethiopian Journal of Health Sciences, JAMA (Journal of the American Medical Association), Journal of Korean Medical Science, New England Journal of Medicine, New Zealand Medical Journal, PLOS Medicine, The Lancet, Revista Médica de Chile (Medical Journal of Chile), and Ugeskrift for Laeger (Danish Medical Journal).Disclaimer: Dr. Sahni's affiliation as representative and past president of the World Association of Medical Editors (WAME) does not imply endorsement by WAME member journals that are not part of the ICMJE.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-1028.Corresponding Author: Darren B. Taichman, MD, PhD, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106; e-mail, [email protected]org.This article was published at Annals.org on 6 June 2017. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byData Sharing Enters a New EraHoward Bauchner, MD, Mary M. McDermott, MD, and Atul J. Butte, MD, PhDSharing study materials in health and medical researchMeta-research studies should improve and evaluate their own data sharing practicesClearinghouse Standards of Evidence on the Transparency, Openness, and Reproducibility of Intervention EvaluationsCOVID-19 interventional trials: Analysis of data sharing intentions during a time of pandemicRegulatory Frameworks for Clinical Trial Data Sharing: Scoping ReviewLimited engagement with transparent and open science standards in the policies of pain journals: a cross-sectional evaluationCollaborative maternity and newborn dashboard (CoMaND) for the COVID-19 pandemic: a protocol for timely, adaptive monitoring of perinatal outcomes in Melbourne, AustraliaInstructions for Authors—July 2021Issues and Challenges Associated with Data-Sharing in LMICs: Perspectives of Researchers in ThailandFAIR data sharing: The roles of common data elements and harmonizationCriteria for academic promotion in medicineData-sharing recommendations in biomedical journals and randomised controlled trials: an audit of journals following the ICMJE recommendationsBig Data – How to Realize the PromiseDevelopment of ICH-GCP-compliant Data Management System in ARO ― Utilization of the ECRIN Data Centre Certification Programme ―Did awarding badges increase data sharing in BMJ Open ? A randomized controlled trialInstructions for Authors—January 2020A guidance was developed to identify participants with missing outcome data in randomized controlled trialsA cross-sectional audit showed that most Cochrane intervention reviews searched trial registersInstructions for AuthorsThe U.S. Environmental Protection Agency's Proposed Transparency Rule Threatens HealthRenee N. Salas, MD, MPH, MS, Francine Laden, ScD, Wendy B. Jacobs, JD, and Ashish K. Jha, MD, MPHPotentially missing data are considerably more frequent than definitely missing data: a methodological survey of 638 randomized controlled trialsAmerican College of Physicians Ethics Manual Seventh EditionLois Snyder Sulmasy, JD and Thomas A. Bledsoe, MD, for the ACP Ethics, Professionalism and Human Rights Committee*Instructions for AuthorsData Sharing Statements for Clinical Trials: One Step Down the RoadDarren B. Taichman, MD, PhD and Christine Laine, MD, MPHInstructions for AuthorsIncreasing Transparency Around Peer Review and ResearchGlobal Standards to Expedite Learning From Medical Research DataInstructions for AuthorsHappy 65th Anniversary to Obstetrics & GynecologyImproving research in women′s health in Nordic countries: challenges and opportunities aheadYours, Mine, Ours……data sharing in clinical research 4 July 2017Volume 167, Issue 1Page: 63-65KeywordsClinical trial reportingClinical trialsDecision makingDisclosureGlobal healthResearch facilitiesStatistical dataVision ePublished: 6 June 2017 Issue Published: 4 July 2017 PDF downloadLoading ...

D uring the 20th century the united states witnessed sweeping social, political, and economic transformations as well as far‐reaching advancements in medical diagnosis and care. Despite the dramatic changes in demography, the meaning of citizenship, and the ability to treat and cure acute and chronic diseases, foreigners were consistently associated with germs and contagion. In this article we explore why, at critical junctures in American history, immigrants have been stigmatized as the etiology of a wide variety of physical and societal ills. Anti‐immigrant rhetoric and policy have often been framed by an explicitly medical language, one in which the line between perceived and actual threat is slippery and prone to hysteria and hyperbole. Our examination focuses on three periods of immigration history: (1) the late 19th century to the passage of the National Origins Act in 1924 when millions of newcomers arrived in the United States and increasingly stringent quotas were enacted; (2) an era of retrenchment and exclusion from 1924 to 1965 when far fewer immigrants entered yet their identification with disease and contamination remained intact; (3) and the period from 1965 to the present, when family reunification laws became the centerpiece of immigration policy and spawned the migration of millions of Asians and Latin Americans to this country. During the 20th century the United States witnessed social, political, and economic transformations as well as advancements in medical diagnosis and care. Despite changes in demography, the meaning of citizenship, and the ability to treat and cure acute and chronic diseases, foreigners were consistently associated with germs and contagion. This article explores why, at critical junctures in American history, immigrants have been stigmatized as the etiology of a variety of physical and societal ills. The article analyzes three periods from 1880 to the present and suggests that now, as germs progressively and, often, indiscriminately cross national, social, and economic boundaries through multiple vectors, the mistakes of the past must not be repeated. Protecting the public health in the current era of globalization requires an ecumenical, pragmatic, and historically informed approach to understanding the links between immigration and disease.

The Coronavirus Disease 2019 (COVID-19) pandemic has caused an unprecedented disruption in medical education and healthcare systems worldwide. The disease can cause life-threatening conditions and it presents challenges for medical education, as instructors must deliver lectures safely, while ensuring the integrity and continuity of the medical education process. It is therefore important to assess the usability of online learning methods, and to determine their feasibility and adequacy for medical students. We aimed to provide an overview of the situation experienced by medical students during the COVID-19 pandemic, and to determine the knowledge, attitudes, and practices of medical students regarding electronic medical education. A cross-sectional survey was conducted with medical students from more than 13 medical schools in Libya. A paper-based and online survey was conducted using email and social media. The survey requested demographic and socioeconomic information, as well as information related to medical online learning and electronic devices; medical education status during the COVID-19 pandemic; mental health assessments; and e-learning knowledge, attitudes, and practices. A total of 3,348 valid questionnaires were retrieved. Most respondents (64.7%) disagreed that e-learning could be implemented easily in Libya. While 54.1% of the respondents agreed that interactive discussion is achievable by means of e-learning. However, only 21.1% agreed that e-learning could be used for clinical aspects, as compared with 54.8% who disagreed with this statement and 24% who were neutral. Only 27.7% of the respondents had participated in online medical educational programs during the COVID-19 pandemic, while 65% reported using the internet for participating in study groups and discussions. There is no vaccine for COVID-19 yet. As such, the pandemic will undeniably continue to disrupt medical education and training. As we face the prospect of a second wave of virus transmission, we must take certain measures and make changes to minimize the effects of the COVID-19 outbreak on medical education and on the progression of training. The time for change is now, and there should be support and enthusiasm for providing valid solutions to reduce this disruption, such as online training and virtual clinical experience. These measures could then be followed by hands-on experience that is provided in a safe environment.

Background: Thyroid disease in pregnancy is a common clinical problem. Since the guidelines for the management of these disorders by the American Thyroid Association (ATA) were first published in 2011, significant clinical and scientific advances have occurred in the field. The aim of these guidelines is to inform clinicians, patients, researchers, and health policy makers on published evidence relating to the diagnosis and management of thyroid disease in women during pregnancy, preconception, and the postpartum period. Methods: The specific clinical questions addressed in these guidelines were based on prior versions of the guidelines, stakeholder input, and input of task force members. Task force panel members were educated on knowledge synthesis methods, including electronic database searching, review and selection of relevant citations, and critical appraisal of selected studies. Published English language articles were eligible for inclusion. The American College of Physicians Guideline Grading System was used for critical appraisal of evidence and grading strength of recommendations. The guideline task force had complete editorial independence from the ATA. Competing interests of guideline task force members were regularly updated, managed, and communicated to the ATA and task force members. Results: The revised guidelines for the management of thyroid disease in pregnancy include recommendations regarding the interpretation of thyroid function tests in pregnancy, iodine nutrition, thyroid autoantibodies and pregnancy complications, thyroid considerations in infertile women, hypothyroidism in pregnancy, thyrotoxicosis in pregnancy, thyroid nodules and cancer in pregnant women, fetal and neonatal considerations, thyroid disease and lactation, screening for thyroid dysfunction in pregnancy, and directions for future research. Conclusions: We have developed evidence-based recommendations to inform clinical decision-making in the management of thyroid disease in pregnant and postpartum women. While all care must be individualized, such recommendations provide, in our opinion, optimal care paradigms for patients with these disorders.

OBJECTIVE: To update the American College of Rheumatology (ACR) 2000 recommendations for hip and knee osteoarthritis (OA) and develop new recommendations for hand OA. METHODS: A list of pharmacologic and nonpharmacologic modalities commonly used to manage knee, hip, and hand OA as well as clinical scenarios representing patients with symptomatic hand, hip, and knee OA were generated. Systematic evidence-based literature reviews were conducted by a working group at the Institute of Population Health, University of Ottawa, and updated by ACR staff to include additions to bibliographic databases through December 31, 2010. The Grading of Recommendations Assessment, Development and Evaluation approach, a formal process to rate scientific evidence and to develop recommendations that are as evidence based as possible, was used by a Technical Expert Panel comprised of various stakeholders to formulate the recommendations for the use of nonpharmacologic and pharmacologic modalities for OA of the hand, hip, and knee. RESULTS: Both “strong” and “conditional” recommendations were made for OA management. Modalities conditionally recommended for the management of hand OA include instruction in joint protection techniques, provision of assistive devices, use of thermal modalities and trapeziometacarpal joint splints, and use of oral and topical nonsteroidal antiinflammatory drugs (NSAIDs), tramadol, and topical capsaicin. Nonpharmacologic modalities strongly recommended for the management of knee OA were aerobic, aquatic, and/or resistance exercises as well as weight loss for overweight patients. Nonpharmacologic modalities conditionally recommended for knee OA included medial wedge insoles for valgus knee OA, subtalar strapped lateral insoles for varus knee OA, medially directed patellar taping, manual therapy, walking aids, thermal agents, tai chi, self management programs, and psychosocial interventions. Pharmacologic modalities conditionally recommended for the initial management of patients with knee OA included acetaminophen, oral and topical NSAIDs, tramadol, and intraarticular corticosteroid injections; intraarticular hyaluronate injections, duloxetine, and opioids were conditionally recommended in patients who had an inadequate response to initial therapy. Opioid analgesics were strongly recommended in patients who were either not willing to undergo or had contraindications for total joint arthroplasty after having failed medical therapy. Recommendations for hip OA were similar to those for the management of knee OA. CONCLUSION: These recommendations are based on the consensus judgment of clinical experts from a wide range of disciplines, informed by available evidence, balancing the benefits and harms of both nonpharmacologic and pharmacologic modalities, and incorporating their preferences and values. It is hoped that these recommendations will be utilized by health care providers involved in the management of patients with OA.

AIM: The International Position Statement provides the opportunity to summarise all existing clinical trial and best practice evidence for older people with frailty and diabetes. It is the first document of its kind and is intended to support clinical decisions that will enhance safety in management and promote high quality care. METHODS: The Review Group sought evidence from a wide range of studies that provide sufficient confidence (in the absence of grading) for the basis of each recommendation. This was supported by a given rationale and key references for our recommendations in each section, all of which have been reviewed by leading international experts. Searches for any relevant clinical evidence were generally limited to English language citations over the previous 15 years. The following databases were examined: Embase, Medline/PubMed, Cochrane Trials Register, Cinahl, and Science Citation. Hand searching of 16 key major peer-reviewed journals was undertaken by two reviewers (AJS and AA) and these included Lancet, Diabetes, Diabetologia, Diabetes Care, British Medical Journal, New England Journal of Medicine, Journal of the American Medical Association, Journal of Frailty and Aging, Journal of the American Medical Directors Association, and Journals of Gerontology - Series A Biological Sciences and Medical Sciences. RESULTS: Two scientific supporting statements have been provided that relate to the area of frailty and diabetes; this is accompanied by evidence-based decisions in 9 clinical domains. The Summary has been supported by diagrammatic figures and a table relating to the inter-relations between frailty and diabetes, a frailty assessment pathway, an exercise-based programme of intervention, a glucose-lowering algorithm with a description of available therapies. CONCLUSIONS: We have provided an up to date evidence-based approach to practical decision-making for older adults with frailty and diabetes. This Summary document includes a user-friendly set of recommendations that should be considered for implementation in primary, community-based and secondary care settings.

The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) convened a writing group to develop a consensus statement on the management of type 1 diabetes in adults. The writing group has considered the rapid development of new treatments and technologies and addressed the following topics: diagnosis, aims of management, schedule of care, diabetes self-management education and support, glucose monitoring, insulin therapy, hypoglycemia, behavioral considerations, psychosocial care, diabetic ketoacidosis, pancreas and islet transplantation, adjunctive therapies, special populations, inpatient management, and future perspectives. Although we discuss the schedule for follow-up examinations and testing, we have not included the evaluation and treatment of the chronic microvascular and macrovascular complications of diabetes as these are well-reviewed and discussed elsewhere. The writing group was aware of both national and international guidance on type 1 diabetes and did not seek to replicate this but rather aimed to highlight the major areas that health care professionals should consider when managing adults with type 1 diabetes. Though evidence-based where possible, the recommendations in the report represent the consensus opinion of the authors.

This is a joint statement from the American College of Surgeons Committee on Trauma, the American College of Emergency Physicians, the National Association of Emergency Medical Services Physicians and the National Association of Emergency Medical Technicians regarding the clinical use of resuscitative endovascular balloon occlusion of the aorta (REBOA) in civilian trauma systems in the USA. This statement addresses the system of care needed to manage trauma patients requiring the use of REBOA, in light of the current evidence available in this patient population. This statement was developed by an expert panel following a comprehensive review of the literature with representation from all sponsoring organizations and the US Military. This is an update to the previous statement published in 2018. It has been formally endorsed by the four sponsoring organizations.

Summary Objective: The International Medical Informatics Association (IMIA) agreed on revising the existing international recommendations in health informatics /medical informatics education. These should help to establish courses, course tracks or even complete programs in this field, to further develop existing educational activities in the various nations and to support international initiatives concerning education in biomedical and health informatics (BMHI), particularly international activities in educating BMHI specialists and the sharing of courseware. Method: An IMIA task force, nominated in 2006, worked on updating the recommendations’ first version. These updates have been broadly discussed and refined by members of IMIA’s National Member Societies, IMIA’s Academic Institutional Members and by members of IMIA’s Working Group on Health and Medical Informatics Education. Results and Conclusions: The IMIA recommendations center on educational needs for health care professionals to acquire knowledge and skills in information processing and information and communication technology. The educational needs are described as a three-dimensional framework. The dimensions are: 1) professionals in health care (e.g. physicians, nurses, BMHI professionals), 2) type of specialization in BMHI (IT users, BMHI specialists), and 3) stage of career progression (bachelor, master, doctorate). Learning outcomes are defined in terms of knowledge and practical skills for health care professionals in their role a) as IT user and b) as BMHI specialist. Recommendations are given for courses /course tracks in BMHI as part of educational programs in medicine, nursing, health care management, dentistry, pharmacy, public health, health record administration, and informatics /computer science as well as for dedicated programs in BMHI (with bachelor, master or doctor degree). To support education in BMHI, IMIA offers to award a certificate for high-quality BMHI education. It supports information exchange on programs and courses in BMHI through its Working Group on Health and Medical Informatics Education.

Probiotics are widely regarded as live microorganisms that, when administered in sufficient amounts, confer a health benefit, but guidance is needed on the most appropriate use of the term. This Consensus Statement outlines recommendations for the scope and definition of the term 'probiotic' as determined by an expert panel convened by the International Scientific Association for Probiotics and Prebiotics in October 2013. An expert panel was convened in October 2013 by the International Scientific Association for Probiotics and Prebiotics (ISAPP) to discuss the field of probiotics. It is now 13 years since the definition of probiotics and 12 years after guidelines were published for regulators, scientists and industry by the Food and Agriculture Organization of the United Nations and the WHO (FAO/WHO). The FAO/WHO definition of a probiotic—“live microorganisms which when administered in adequate amounts confer a health benefit on the host”—was reinforced as relevant and sufficiently accommodating for current and anticipated applications. However, inconsistencies between the FAO/WHO Expert Consultation Report and the FAO/WHO Guidelines were clarified to take into account advances in science and applications. A more precise use of the term 'probiotic' will be useful to guide clinicians and consumers in differentiating the diverse products on the market. This document represents the conclusions of the ISAPP consensus meeting on the appropriate use and scope of the term probiotic.

PURPOSE: To address whether all medically fit patients with curatively resected stage II colon cancer should be offered adjuvant chemotherapy as part of routine clinical practice, to identify patients with poor prognosis characteristics, and to describe strategies for oncologists to use to discuss adjuvant chemotherapy in practice. METHODS: An American Society of Clinical Oncology Panel, in collaboration with the Cancer Care Ontario Practice Guideline Initiative, reviewed pertinent information from the literature through May 2003. RESULTS: A literature-based meta-analysis found no evidence of a statistically significant survival benefit of adjuvant chemotherapy for stage II patients. Recommendations The routine use of adjuvant chemotherapy for medically fit patients with stage II colon cancer is not recommended. However, there are populations of patients with stage II disease that could be considered for adjuvant therapy, including patients with inadequately sampled nodes, T4 lesions, perforation, or poorly differentiated histology. CONCLUSION: Direct evidence from randomized controlled trials does not support the routine use of adjuvant chemotherapy for patients with stage II colon cancer. Patients and oncologists who accept the relative benefit in stage III disease as adequate indirect evidence of benefit for stage II disease are justified in considering the use of adjuvant chemotherapy, particularly for those patients with high-risk stage II disease. The ultimate clinical decision should be based on discussions with the patient about the nature of the evidence supporting treatment, the anticipated morbidity of treatment, the presence of high-risk prognostic features on individual prognosis, and patient preferences. Patients with stage II disease should be encouraged to participate in randomized trials.

The terminology for human papillomavirus(HPV)–associated squamous lesions of the lower anogenital tract has a long history marked by disparate diagnostic terms derived from multiple specialties. It often does not reflect current knowledge of HPV biology and pathogenesis. A consensus process was convened to recommend terminology unified across lower anogenital sites. The goal was to create a histopathologic nomenclature system that reflects current knowledge of HPV biology, optimally uses available biomarkers, and facilitates clear communication across different medical specialties. The Lower Anogenital Squamous Terminology (LAST) Project was co-sponsored by the College of American Pathologists and the American Society for Colposcopy and Cervical Pathology and included 5 working groups; 3 work groups performed comprehensive literature reviews and developed draft recommendations. Another work group provided the historical background and the fifth will continue to foster implementation of the LAST recommendations. After an open comment period, the draft recommendations were presented at a consensus conference attended by LAST work group members, advisors, and representatives from 35 stakeholder organizations including professional societies and government agencies. Recommendations were finalized and voted on at the consensus meeting. The final, approved recommendations standardize biologically relevant histopathologic terminology for HPV-associated squamous intraepithelial lesions and superficially invasive squamous carcinomas across all lower anogenital tract sites and detail the appropriate use of specific biomarkers to clarify histologic interpretations and enhance diagnostic accuracy. A plan for disseminating and monitoring recommendation implementation in the practicing community was also developed. The implemented recommendations will facilitate communication between pathologists and their clinical colleagues and improve accuracy of histologic diagnosis with the ultimate goal of providing optimal patient care.

AIM: The "2023 Guideline for the Management of Patients With Aneurysmal Subarachnoid Hemorrhage" replaces the 2012 "Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage." The 2023 guideline is intended to provide patient-centric recommendations for clinicians to prevent, diagnose, and manage patients with aneurysmal subarachnoid hemorrhage. METHODS: A comprehensive search for literature published since the 2012 guideline, derived from research principally involving human subjects, published in English, and indexed in MEDLINE, PubMed, Cochrane Library, and other selected databases relevant to this guideline, was conducted between March 2022 and June 2022. In addition, the guideline writing group reviewed documents on related subject matter previously published by the American Heart Association. Newer studies published between July 2022 and November 2022 that affected recommendation content, Class of Recommendation, or Level of Evidence were included if appropriate. Structure: Aneurysmal subarachnoid hemorrhage is a significant global public health threat and a severely morbid and often deadly condition. The 2023 aneurysmal subarachnoid hemorrhage guideline provides recommendations based on current evidence for the treatment of these patients. The recommendations present an evidence-based approach to preventing, diagnosing, and managing patients with aneurysmal subarachnoid hemorrhage, with the intent to improve quality of care and align with patients' and their families' and caregivers' interests. Many recommendations from the previous aneurysmal subarachnoid hemorrhage guidelines have been updated with new evidence, and new recommendations have been created when supported by published data.

Editorial| Online November 01 2002 The Occupational Therapy Practice Framework: The Evolution of Our Professional Language Mary Jane Youngstrom Mary Jane Youngstrom Mary Jane Youngstrom, MS, OTR, FAOTA, served as chair of the Commission on Practice from 1998-2002. She is Clinical Instructor in the Occupational Therapy Education Program at the University of Kansas Medical Center and Director of the Entry Level Master Curriculum in that program Search for other works by this author on: This Site PubMed Google Scholar Author & Article Information Online Issn: 1943-7676 Print Issn: 0272-9490 Copyright © 2002 by the American Occupational Therapy Association, Inc.2002 The American Journal of Occupational Therapy, 2002, Vol. 56(6), 607–608. https://doi.org/10.5014/ajot.56.6.607 Views Icon Views Article contents Figures & tables Video Audio Supplementary Data Peer Review Share Icon Share Facebook Twitter LinkedIn MailTo Tools Icon Tools Get Permissions Cite Icon Cite Search Site Citation Mary Jane Youngstrom; The Occupational Therapy Practice Framework: The Evolution of Our Professional Language. Am J Occup Ther November/December 2002, Vol. 56(6), 607–608. doi: https://doi.org/10.5014/ajot.56.6.607 Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search Search Dropdown Menu toolbar search search input Search input auto suggest filter your search All ContentThe American Journal of Occupational Therapy Search Advanced Search Keywords: languages, occupational therapy practice framework This content is only available via PDF. Copyright © 2002 by the American Occupational Therapy Association, Inc.2002 Article PDF first page preview Close Modal You do not currently have access to this content.

AIM: The "2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation" provides recommendations to guide clinicians in the treatment of patients with atrial fibrillation. METHODS: A comprehensive literature search was conducted from May 12, 2022, to November 3, 2022, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Library, the Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline. Additional relevant studies, published through November 2022, during the guideline writing process, were also considered by the writing committee and added to the evidence tables, where appropriate. STRUCTURE: Atrial fibrillation is the most sustained common arrhythmia, and its incidence and prevalence are increasing in the United States and globally. Recommendations from the "2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation" and the "2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing atrial fibrillation and thromboembolic risk assessment, anticoagulation, left atrial appendage occlusion, atrial fibrillation catheter or surgical ablation, and risk factor modification and atrial fibrillation prevention have been developed.

OBJECTIVE: To develop a new evidence-based, pharmacologic treatment guideline for rheumatoid arthritis (RA). METHODS: We conducted systematic reviews to synthesize the evidence for the benefits and harms of various treatment options. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to rate the quality of evidence. We employed a group consensus process to grade the strength of recommendations (either strong or conditional). A strong recommendation indicates that clinicians are certain that the benefits of an intervention far outweigh the harms (or vice versa). A conditional recommendation denotes uncertainty over the balance of benefits and harms and/or more significant variability in patient values and preferences. RESULTS: The guideline covers the use of traditional disease-modifying antirheumatic drugs (DMARDs), biologic agents, tofacitinib, and glucocorticoids in early (<6 months) and established (≥6 months) RA. In addition, it provides recommendations on using a treat-to-target approach, tapering and discontinuing medications, and the use of biologic agents and DMARDs in patients with hepatitis, congestive heart failure, malignancy, and serious infections. The guideline addresses the use of vaccines in patients starting/receiving DMARDs or biologic agents, screening for tuberculosis in patients starting/receiving biologic agents or tofacitinib, and laboratory monitoring for traditional DMARDs. The guideline includes 74 recommendations: 23% are strong and 77% are conditional. CONCLUSION: This RA guideline should serve as a tool for clinicians and patients (our two target audiences) for pharmacologic treatment decisions in commonly encountered clinical situations. These recommendations are not prescriptive, and the treatment decisions should be made by physicians and patients through a shared decision-making process taking into account patients' values, preferences, and comorbidities. These recommendations should not be used to limit or deny access to therapies.

PURPOSE: To update the American Society of Clinical Oncology (ASCO) guideline for antiemetics in oncology. METHODS: A systematic review of the medical literature was completed to inform this update. MEDLINE, the Cochrane Collaboration Library, and meeting materials from ASCO and the Multinational Association for Supportive Care in Cancer were all searched. Primary outcomes of interest were complete response and rates of any vomiting or nausea. RESULTS: Thirty-seven trials met prespecified inclusion and exclusion criteria for this systematic review. Two systematic reviews from the Cochrane Collaboration were identified; one surveyed the pediatric literature. The other compared the relative efficacy of the 5-hydroxytryptamine-3 (5-HT(3)) receptor antagonists. RECOMMENDATIONS: Combined anthracycline and cyclophosphamide regimens were reclassified as highly emetic. Patients who receive this combination or any highly emetic agents should receive a 5-HT(3) receptor antagonist, dexamethasone, and a neurokinin 1 (NK(1)) receptor antagonist. A large trial validated the equivalency of fosaprepitant, a single-day intravenous formulation, with aprepitant; either therapy is appropriate. Preferential use of palonosetron is recommended for moderate emetic risk regimens, combined with dexamethasone. For low-risk agents, patients can be offered dexamethasone before the first dose of chemotherapy. Patients undergoing high emetic risk radiation therapy should receive a 5-HT(3) receptor antagonist before each fraction and for 24 hours after treatment and may receive a 5-day course of dexamethasone during fractions 1 to 5. The Update Committee noted the importance of continued symptom monitoring throughout therapy. Clinicians underestimate the incidence of nausea, which is not as well controlled as emesis.

Each decade, the American Heart Association (AHA) develops an Impact Goal to guide its overall strategic direction and investments in its research, quality improvement, advocacy, and public health programs. Guided by the AHA's new Mission Statement, to be a relentless force for a world of longer, healthier lives, the 2030 Impact Goal is anchored in an understanding that to achieve cardiovascular health for all, the AHA must include a broader vision of health and well-being and emphasize health equity. In the next decade, by 2030, the AHA will strive to equitably increase healthy life expectancy beyond current projections, with global and local collaborators, from 66 years of age to at least 68 years of age across the United States and from 64 years of age to at least 67 years of age worldwide. The AHA commits to developing additional targets for equity and well-being to accompany this overarching Impact Goal. To attain the 2030 Impact Goal, we recommend a thoughtful evaluation of interventions available to the public, patients, providers, healthcare delivery systems, communities, policy makers, and legislators. This presidential advisory summarizes the task force's main considerations in determining the 2030 Impact Goal and the metrics to monitor progress. It describes the aspiration that these goals will be achieved by working with a diverse community of volunteers, patients, scientists, healthcare professionals, and partner organizations needed to ensure success.