A Disclosure Form for Work Submitted to Medical Journals: a Proposal from the International Committee of Medical Journal Editors.
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ABSTRACT:
SUBMITTER: Taichman DB
PROVIDER: S-EPMC6995812 | biostudies-literature | 2020 Feb
REPOSITORIES: biostudies-literature
Publications
A Disclosure Form for Work Submitted to Medical Journals: a Proposal from the International Committee of Medical Journal Editors.
Taichman Darren B DB Backus Joyce J Baethge Christopher C Bauchner Howard H Flanagin Annette A Florenzano Fernando F Frizelle Frank A FA Godlee Fiona F Gollogly Laragh L Haileamlak Abraham A Hong Sung Tae ST Horton Richard R James Astrid A Laine Christine C Miller Pamela W PW Pinborg Anja A Rubin Eric J EJ Sahni Peush P
Journal of Korean medical science 20200203 4
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| S-EPMC4732953 | biostudies-literature
Project description:ObjectiveTo assess the fulfilment of authors' and editors' individual disclosure of potential conflicts of interest in a group of highly influential medicine journals across a variety of specialties.DesignCross-sectional analysis.Setting and participantsTop-ranked five journals as per 2017 Journal Citation Report impact factor of 26 medical, surgery and imaging specialties.InterventionsObservational analysis.Primary and secondary outcome measuresPercentage of journals requiring disclosure of authors' and editors' individual potential conflicts of interest (CoI). Journals that were listed as followers of the International Committee of Medical Journal Editors (ICMJE) Recommendations, members of the Committee on Publication Ethics (COPE) and linked to a third party (ie, college, professional association/society, public institution).ResultsAlthough 99% (129/130) of journals required author's CoI disclosure, only 12% (16/130) reported individual editors' potential CoIs. Forty-five per cent (58/130) of journals were followers of the ICMJE Recommendations, and 73% (95/130) were COPE members. Most (69%; 90/130) were linked to a college, professional society/association or public institution. Only one journal did not have policies on individual authors' and editors' CoI disclosure.ConclusionVery few high-impact medical journals disclosed their editorial teams' individual potential CoIs-conversely, almost all required disclosure of authors' individual CoIs. Journal followers of the ICMJE Recommendations should regularly disclose the editors' individual CoIs, as this is the only legitimate way to ask the same transparency of authors.
| S-EPMC6661703 | biostudies-literature
Project description: Not available
| S-EPMC516198 | biostudies-literature
Project description: Not available
| S-EPMC1150264 | biostudies-literature
Project description:ObjectiveTo determine whether two specific criteria in Uniform Requirements for Manuscripts (URM) created by the International Committee of Medical Journal Editors (ICMJE)--namely, including the trial ID registration within manuscripts and timely registration of trials, are being followed.Materials and methodsObservational study using computerized analysis of publicly available Medline article data and clinical trial registry data. We analyzed a purposive set of five ICMJE founding journals looking at all trial articles published in those journals during 2010-2011, and data from the ClinicalTrials.gov (CTG) trial registry. We measured adherence to trial ID inclusion policy as the percentage of trial journal articles that contained a valid trial ID within the article (journal-based sample). Adherence to timely registration was measured as the percentage of trials that registered the trial before enrolling the first participant within a 60-day grace period. We also examined timely registration rates by year of all phase II and higher interventional trials in CTG (registry-based sample).ResultsTo determine trial ID inclusion, we analyzed 698 clinical trial articles in five journals. A total of 95.8% (661/690) of trial journal articles included the trial ID. In 88.3% the trial-article link is stored within a structured Medline field. To evaluate timely registration, we analyzed trials referenced by 451 articles from the selected five journals. A total of 60% (272/451) of articles were registered in a timely manner with an improving trend for trials initiated in later years (eg, 89% of trials that began in 2008 were registered in a timely manner). In the registry-based sample, the timely registration rates ranged from 56% for trials registered in 2006 to 72% for trials registered in 2011.DiscussionAdherence to URM requirements for registration and trial ID inclusion increases the utility of PubMed and links it in an important way to clinical trial repositories. This new integrated knowledge source can facilitate research prioritization, clinical guidelines creation, and precision medicine.ConclusionsThe five selected journals adhere well to the policy of mandatory trial registration and also outperform the registry in adherence to timely registration. ICMJE's URM policy represents a unique international mandate that may be providing a powerful incentive for sponsors and investigators to document clinical trials and trial result publications and thus fulfill important obligations to trial participants and society.
| S-EPMC3715364 | biostudies-literature
Project description:ImportanceThe benefits of responsible sharing of individual-participant data (IPD) from clinical studies are well recognized, but stakeholders often disagree on how to align those benefits with privacy risks, costs, and incentives for clinical trialists and sponsors. The International Committee of Medical Journal Editors (ICMJE) required a data sharing statement (DSS) from submissions reporting clinical trials effective July 1, 2018. The required DSSs provide a window into current data sharing rates, practices, and norms among trialists and sponsors.ObjectiveTo evaluate the implementation of the ICMJE DSS requirement in 3 leading medical journals: JAMA, Lancet, and New England Journal of Medicine (NEJM).Design, setting, and participantsThis is a cross-sectional study of clinical trial reports published as articles in JAMA, Lancet, and NEJM between July 1, 2018, and April 4, 2020. Articles not eligible for DSS, including observational studies and letters or correspondence, were excluded. A MEDLINE/PubMed search identified 487 eligible clinical trials in JAMA (112 trials), Lancet (147 trials), and NEJM (228 trials). Two reviewers evaluated each of the 487 articles independently.ExposurePublication of clinical trial reports in an ICMJE medical journal requiring a DSS.Main outcomes and measuresThe primary outcomes of the study were declared data availability and actual data availability in repositories. Other captured outcomes were data type, access, and conditions and reasons for data availability or unavailability. Associations with funding sources were examined.ResultsA total of 334 of 487 articles (68.6%; 95% CI, 64%-73%) declared data sharing, with nonindustry NIH-funded trials exhibiting the highest rates of declared data sharing (89%; 95% CI, 80%-98%) and industry-funded trials the lowest (61%; 95% CI, 54%-68%). However, only 2 IPD sets (0.6%; 95% CI, 0.0%-1.5%) were actually deidentified and publicly available as of April 10, 2020. The remaining were supposedly accessible via request to authors (143 of 334 articles [42.8%]), repository (89 of 334 articles [26.6%]), and company (78 of 334 articles [23.4%]). Among the 89 articles declaring that IPD would be stored in repositories, only 17 (19.1%) deposited data, mostly because of embargo and regulatory approval. Embargo was set in 47.3% of data-sharing articles (158 of 334), and in half of them the period exceeded 1 year or was unspecified.Conclusions and relevanceMost trials published in JAMA, Lancet, and NEJM after the implementation of the ICMJE policy declared their intent to make clinical data available. However, a wide gap between declared and actual data sharing exists. To improve transparency and data reuse, journals should promote the use of unique pointers to data set location and standardized choices for embargo periods and access requirements.
| S-EPMC7844597 | biostudies-literature
Project description:BACKGROUND:Registration of clinical trials is critical for promoting transparency and integrity in medical research; however, trials must be registered in a prospective fashion to deter unaccounted protocol modifications or selection of alternate outcomes that may enhance favorability of reported findings. We assessed adherence to the International Committee of Medical Journal Editors' (ICMJE) prospective registration policy and identified the frequency of registrations occurring after potential observation of primary outcome data among trials published in the highest-impact journals associated with US professional medical societies. Additionally, we examined whether trials that are unregistered or registered after potential observation of primary outcome data were more likely to report favorable findings. METHODS:We conducted a retrospective, cross-sectional analysis of the 50 most recently published clinical trials that reported primary results in each of the ten highest-impact US medical specialty society journals between 1 January 2010 and 31 December 2015. We used descriptive statistics to characterize the proportions of trials that were: registered; registered retrospectively; registered retrospectively potentially after initial ascertainment of primary outcomes; and reporting favorable findings, overall and stratified by journal and trial characteristics. Chi-squared analyses were performed to assess differences in registration by journal and trial characteristics. RESULTS:We reviewed 6869 original research reports published between 1 January 2010 and 31 December 2015 to identify a total of 486 trials across 472 publications. Of these 486 trials, 47 (10%) were unregistered. Among 439 registered trials, 340 (77%) were registered prospectively and 99 (23%) retrospectively. Sixty-seven (68%) of these 99 retrospectively registered trials, or 15% of all 439 registered trials, were registered after potential observation of primary outcome data ascertained among participants enrolled at inception. Industry-funded trials, those with enrollment sites in the US, as well as those assessing FDA-regulated interventions each had lower rates of retrospective registration. Unregistered trials were more likely to report favorable findings than were registered trials (89% vs. 64%; relative risk (RR) = 1.38, 95% confidence interval (CI) = 1.20-1.58; p = 0.004), irrespective of registration timing. CONCLUSIONS:Adherence to the ICMJE's prospective registration policy remains sub-standard, even in the highest-impact journals associated with US professional medical societies. These journals frequently published unregistered trials and trials registered after potential observation of primary outcome data.
| S-EPMC6106722 | biostudies-literature
Project description: Not available
| S-EPMC9635347 | biostudies-literature
Project description:BackgroundAlmost all medical journals now require authors to publicly disclose conflicts of interests (COI). The same standard and scrutiny is rarely employed for the editors of the journals although COI may affect editorial decisions.MethodsWe conducted a retrospective observational study to determine the prevalence and magnitude of financial relationships among editors of 60 influential US medical journals (10 each for internal medicine and five subspecialties: cardiology, gastroenterology, neurology, dermatology and allergy & immunology). Open Payments database was reviewed to determine the percentage of physician editors receiving payments and the nature and amount of these payments.Findings703 unique physician editors were included in our analysis. 320/703 (46%) received 8659 general payments totaling $8,120,562. The median number of payments per editor was 9 (IQR 3-26) and the median amount per payment was $91 (IQR $21-441). The median total payment received by each editor in one year was $4,364 (IQR $319-23,143). 152 (48%) editors received payments more than $5,000 in a year, a threshold considered significant by the National Institutes of Health. COI policies for editors were available for 34/60 (57%) journals but only 7/34 (21%) publicly reported the disclosures and only 2 (3.%) reported the dollar amount received.InterpretationA significant number of editors of internal medicine and subspecialty medical journals have financial COI and very few are publicly disclosed. Specialty journal editors have more COI compared to general medicine journal editors. Current policies for disclosing COI for editors are inconsistent and do not comply with the recommended standards.
| S-EPMC5959187 | biostudies-literature
Project description:ObjectiveTo generate an understanding of the communication practices that might influence the peer-review process in biomedical journals.MethodRecruitment was based on purposive maximum variation sampling. We conducted semistructured interviews. Data were analysed using thematic analysis method.Participants56 journal editors from general medicine (n=13) and specialty (n=43) biomedical journals. Most were editor-in-chiefs (n=39), men (n=40) and worked part time (n=50).ResultsOur analysis generated four themes (1) providing minimal guidance to peer reviewers-two subthemes described the way journal editors rationalised their behaviour: (a) peer reviewers should know without guidelines how to review and (b) detailed guidance and structure might have a negative effect; (2) communication strategies of engagement with peer reviewers-two opposing strategies that journal editors employed to handle peer reviewers: (a) use of direct and personal communication to motivate peer reviewers and (b) use of indirect communication to avoid conflict; (3) concerns about impact of review model on communication-maintenance of anonymity as a means of facilitating critical and unburdened communication and minimising biases and (4) different practices in the moderation of communication between authors and peer reviewers-some journal editors actively interjected themselves into the communication chain to guide authors through peer reviewers' comments, others remained at a distance, leaving it to the authors to work through peer reviewers' comments.ConclusionsThese journal editors' descriptions reveal several communication practices that might have a significant impact on the peer-review process. Editorial strategies to manage miscommunication are discussed. Further research on these proposed strategies and on communication practices from the point of view of authors and peer reviewers is warranted.
| S-EPMC7430556 | biostudies-literature