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Do urology journals enforce trial registration? A cross-sectional study of published trials.

ABSTRACT: Objectives (1) To assess endorsement of trial registration in author instructions of urology-related journals and (2) to assess whether randomised controlled trials (RCTs) in the field of urology were effectively registered. Design Cross-sectional study of author instructions and published trials. Setting Journals publishing in the field of urology. Participants First, the authors analysed author instructions of 55 urology-related journals indexed in 'Journal Citation Reports 2009' (12/2010). The authors divided these journals in two groups: those requiring and those not mentioning trial registration as a precondition for publication. Second, the authors chose the five journals with the highest impact factor (IF) from each group. Intervention MEDLINE search to identify RCTs published in these 10 journals in 2009 (01/2011); search of the clinical trials meta-search interface of WHO (International Clinical Trials Registry Platform) for RCTs that lacked information about registration (01-03/2011). Two authors independently assessed the information. Outcome measures Proportion of journals providing advice about trial registration and proportion of trials registered. Results Of 55 journals analysed, 26 (47.3%) provided some editorial advice about trial registration. Journals with higher IFs were more likely to mention trial registration explicitly (p=0.015). Of 106 RCTs published in 2009, 63 were registered (59.4%) with a tendency to an increase after 2005 (83.3%, p=0.035). 71.4% (30/42) of the RCTs that were published in journals mentioning and requiring registration, and 51.6% (33/64) of the RCTs that were published in journals that did not mention trial registration explicitly were registered. This difference was statistically significant (p=0.04). Conclusions The existence of a statement about trial registration in author instructions resulted in a higher proportion of registered RCTs in those journals. Journals with higher IFs were more likely to mention trial registration.

SUBMITTER: Kunath F

PROVIDER: S-EPMC3236819 | biostudies-other | 2011

REPOSITORIES: biostudies-other

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Do urology journals enforce trial registration? A cross-sectional study of published trials.

Kunath Frank F Grobe Henrik R HR Keck Bastian B Rücker Gerta G Wullich Bernd B Antes Gerd G Meerpohl Joerg J JJ

BMJ open 20111206 2

Objectives (1) To assess endorsement of trial registration in author instructions of urology-related journals and (2) to assess whether randomised controlled trials (RCTs) in the field of urology were effectively registered. Design Cross-sectional study of author instructions and published trials. Setting Journals publishing in the field of urology. Participants First, the authors analysed author instructions of 55 urology-related journals indexed in 'Journal Citation Reports 2009' (12/2010). ...[more]

PMID: 22146890

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Project description:ObjectiveProspective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective registration is still commonly found. We assessed to what extent retrospective registration is reported transparently in journal publications and investigated factors associated with transparent reporting.DesignWe used a dataset of trials registered in ClinicalTrials.gov or Deutsches Register Klinischer Studien, with a German University Medical Center as the lead centre, completed in 2009-2017, and with a corresponding peer-reviewed results publication. We extracted all registration statements from results publications of retrospectively registered trials and assessed whether they mention or justify the retrospective registration. We analysed associations of retrospective registration and reporting thereof with registration number reporting, International Committee of Medical Journal Editors (ICMJE) membership/-following and industry sponsorship using χ2 or Fisher exact test.ResultsIn the dataset of 1927 trials with a corresponding results publication, 956 (53.7%) were retrospectively registered. Of those, 2.2% (21) explicitly report the retrospective registration in the abstract and 3.5% (33) in the full text. In 2.1% (20) of publications, authors provide an explanation for the retrospective registration in the full text. Registration numbers were significantly underreported in abstracts of retrospectively registered trials compared with prospectively registered trials. Publications in ICMJE member journals did not have statistically significantly higher rates of both prospective registration and disclosure of retrospective registration, and publications in journals claiming to follow ICMJE recommendations showed statistically significantly lower rates compared with non-ICMJE-following journals. Industry sponsorship of trials was significantly associated with higher rates of prospective registration, but not with transparent registration reporting.ConclusionsContrary to ICMJE guidance, retrospective registration is disclosed and explained only in a small number of retrospectively registered studies. Disclosure of the retrospective nature of the registration would require a brief statement in the manuscript and could be easily implemented by journals.

Project description:BACKGROUND:Randomised controlled trials (RCTs) provide the most reliable information to inform clinical practice and patient care. We aimed to map global clinical research publication activity through RCT-related articles in high-impact-factor medical journals over the past five decades. METHODS:We conducted a cross-sectional analysis of articles published in the highest ranked medical journals with an impact factor > 10 (according to Journal Citation Reports published in 2017). We searched PubMed/MEDLINE (from inception to December 31, 2017) for all RCT-related articles (e.g. primary RCTs, secondary analyses and methodology papers) published in high-impact-factor medical journals. For each included article, raw metadata were abstracted from the Web of Science. A process of standardization was conducted to unify the different terms and grammatical variants and to remove typographical, transcription and/or indexing errors. Descriptive analyses were conducted (including the number of articles, citations, most prolific authors, countries, journals, funding sources and keywords). Network analyses of collaborations between countries and co-words are presented. RESULTS:We included 39,305 articles (for the period 1965-2017) published in forty journals. The Lancet (n = 3593; 9.1%), the Journal of Clinical Oncology (n = 3343; 8.5%) and The New England Journal of Medicine (n = 3275 articles; 8.3%) published the largest number of RCTs. A total of 154 countries were involved in the production of articles. The global productivity ranking was led by the United States (n = 18,393 articles), followed by the United Kingdom (n = 8028 articles), Canada (n = 4548 articles) and Germany (n = 4415 articles). Seventeen authors who had published 100 or more articles were identified; the most prolific authors were affiliated with Duke University (United States), Harvard University (United States) and McMaster University (Canada). The main funding institutions were the National Institutes of Health (United States), Hoffmann-La Roche (Switzerland), Pfizer (United States), Merck Sharp & Dohme (United States) and Novartis (Switzerland). The 100 most cited RCTs were published in nine journals, led by The New England Journal of Medicine (n = 78 articles), The Lancet (n = 9 articles) and JAMA (n = 7 articles). These landmark contributions focused on novel methodological approaches (e.g. the "Bland-Altman method") and trials on the management of chronic conditions (e.g. diabetes control, hormone replacement therapy in postmenopausal women, multiple therapies for diverse cancers, cardiovascular therapies such as lipid-lowering statins, antihypertensive medications, and antiplatelet and antithrombotic therapy). CONCLUSIONS:Our analysis identified authors, countries, funding institutions, landmark contributions and high-impact-factor medical journals publishing RCTs. Over the last 50 years, publication production in leading medical journals has increased, with Western countries leading in research but with low- and middle-income countries showing very limited representation.

Project description: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.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.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.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.

Project description:An up-to-date systematic review is important for researchers to decide whether to embark on new research or continue supporting ongoing studies. The aim of this study is to examine the time taken between the last search, submission, acceptance and publication dates of systematic reviews published in nursing journals.Nursing journals indexed in Journal Citation Reports were first identified. Thereafter, systematic reviews published in these journals in 2014 were extracted from three databases. The quality of the systematic reviews were evaluated by the AMSTAR. The last search, submission, acceptance, online publication, full publication dates and other characteristics of the systematic reviews were recorded. The time taken between the five dates was then computed. Descriptive statistics were used to summarize the time differences; non-parametric statistics were used to examine the association between the time taken from the last search and full publication alongside other potential factors, including the funding support, submission during holiday periods, number of records retrieved from database, inclusion of meta-analysis, and quality of the review.A total of 107 nursing journals were included in this study, from which 1070 articles were identified through the database search. After screening for eligibility, 202 systematic reviews were included in the analysis. The quality of these reviews was low with the median score of 3 out of 11. A total of 172 (85.1%), 72 (35.6%), 153 (75.7%) and 149 (73.8%) systematic reviews provided their last search, submission, acceptance and online published dates respectively. The median numbers of days taken from the last search to acceptance and to full publication were, respectively, 393 (IQR: 212-609) and 669 (427-915) whereas that from submission to full publication was 365 (243-486). Moreover, the median number of days from the last search to submission and from submission to online publication were 167.5 (53.5-427) and 153 (92-212), respectively. No significant association were revealed between the time lag and those potential factors.The median time from the last search to acceptance for systematic reviews published in nursing journals was 393 days. Readers for systematic reviews are advised to check the time taken from the last search date of the reviews in order to ensure that up-to-date evidence is consulted for effective clinical decision-making.

Project description:BackgroundWhile conducting systemic reviews, searching for ongoing or unpublished trials is critical to address publication bias. As of April 2019, records of ongoing or unpublished randomized and/or quasi-randomized controlled trials registered in the International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov are available in the Cochrane Central Register of Controlled Trials (CENTRAL). These records registered in CENTRAL include studies published since the inception of ICTRP and ClinicalTrials.gov . Whether systematic reviewers can search CENTRAL to identify ongoing or unpublished trials instead of ICTRP and ClinicalTrials.gov is unknown.MethodsThis was a cross-sectional study. A consecutive sample of ongoing or unpublished studies published from June 1, 2019 to December 27, 2019 was selected from the Cochrane Reviews. The sensitivity and the number needed to read (NNR) were assessed from among the studies selected from CENTRAL instead of ICTRP and ClinicalTrials.gov and also assessed the characteristics of studies not identified by searching CENTRAL.ResultsIn total, 247 records from 50 Cochrane reviews were included; of these, 200 were identified by searching CENTRAL, whereas the remaining 47 records were not. The sensitivity of searching CENTRAL was 0.81 (95% confidence interval [CI]: 0.76, 0.85). The NNR was 115 (95% CI: 101, 133). The 47 unidentified studies were registered through ClinicalTrials.gov or ICTRP. Sixteen unidentified studies were not indexed in CENTRAL.ConclusionsFor systematic reviewers, searching CENTRAL could not substitute for searching ClinicalTrials.gov and/or ICTRP. Systematic reviewers should not only search CENTRAL but also ICTRP and ClinicalTrials.gov to identify unpublished trials.Trial registrationA pre-specified protocol was applied to conduct this study. The study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR).Trial registration numberUMIN000038981 .

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Do urology journals enforce trial registration? A cross-sectional study of published trials.

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Do urology journals enforce trial registration? A cross-sectional study of published trials.

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