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Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy.

ABSTRACT: OBJECTIVE:We assessed the adequacy of randomized controlled trial (RCT) registration, changes to registration data and reporting completeness for articles in ICMJE journals during 2.5 years after registration requirement policy. METHODS:For a set of 149 reports of 152 RCTs with ClinicalTrials.gov registration number, published from September 2005 to April 2008, we evaluated the completeness of 9 items from WHO 20-item Minimum Data Set relevant for assessing trial quality. We also assessed changes to the registration elements at the Archive site of ClinicalTrials.gov and compared published and registry data. RESULTS:RCTs were mostly registered before 13 September 2005 deadline (n?=?101, 66.4%); 118 (77.6%) started recruitment before and 31 (20.4%) after registration. At the time of registration, 152 RCTs had a total of 224 missing registry fields, most commonly 'Key secondary outcomes' (44.1% RCTs) and 'Primary outcome' (38.8%). More RCTs with post-registration recruitment had missing Minimum Data Set items than RCTs with pre-registration recruitment: 57/118 (48.3%) vs. 24/31 (77.4%) (?(2) (1)?=?7.255, P?=?0.007). Major changes in the data entries were found for 31 (25.2%) RCTs. The number of RCTs with differences between registered and published data ranged from 21 (13.8%) for Study type to 118 (77.6%) for Target sample size. CONCLUSIONS:ICMJE journals published RCTs with proper registration but the registration data were often not adequate, underwent substantial changes in the registry over time and differed in registered and published data. Editors need to establish quality control procedures in the journals so that they continue to contribute to the increased transparency of clinical trials.

SUBMITTER: Huic M

PROVIDER: S-EPMC3177887 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy.

Huić Mirjana M Marušić Matko M Marušić Ana A

PloS one 20110921 9

<h4>Objective</h4>We assessed the adequacy of randomized controlled trial (RCT) registration, changes to registration data and reporting completeness for articles in ICMJE journals during 2.5 years after registration requirement policy.<h4>Methods</h4>For a set of 149 reports of 152 RCTs with ClinicalTrials.gov registration number, published from September 2005 to April 2008, we evaluated the completeness of 9 items from WHO 20-item Minimum Data Set relevant for assessing trial quality. We also ...[more]

PMID: 21957485

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Project description:Background:Since the early 2000s, a number of publications in the medical literature have highlighted inadequacies in the design, conduct and reporting of pilot trials. This work led to two notable publications in 2016: a conceptual framework for defining feasibility studies and an extension to the CONSORT 2010 statement to include pilot trials. It was hoped that these publications would educate researchers, leading to better use of pilot trials and thus more rigorously planned and informed randomised controlled trials. The aim of the present work is to evaluate the impact of these publications in the field of physical activity by reviewing the literature pre- and post-2016. This first article presents the pre-2016 review of the reporting and the current editorial policy applied to pilot trials published in physical activity journals. Methods:Fourteen physical activity journals were screened for pilot and feasibility studies published between 2012 and 2015. The CONSORT 2010 extension to pilot and feasibility studies was used as a framework to assess the reporting quality of the studies. Editors of the eligible physical activity journals were canvassed regarding their editorial policy for pilot and feasibility studies. Results:Thirty-one articles across five journals met the eligibility criteria. These articles fell into three distinct categories: trials that were carried out in preparation for a future definitive trial (23%), trials that evaluated the feasibility of a novel intervention but did not explicitly address a future definitive trial (23%) and trials that did not have any clear objectives to address feasibility (55%). Editors from all five journals stated that they generally do not accept pilot trials, and none gave reference to the CONSORT 2010 extension as a guideline for submissions. Conclusion:The result that over half of the studies did not have feasibility objectives is in line with previous research findings, demonstrating that these findings are not being disseminated effectively to researchers in the field of physical activity. The low standard of reporting across most reviewed articles and the neglect of the extended CONSORT 2010 statement by the journal editors highlight the need to actively disseminate these guidelines to ensure their impact.

Project description:BACKGROUND AND OBJECTIVE:Trial registration is widely endorsed as it is considered not only to enhance transparency and quality of reporting but also to help safeguard against outcome reporting bias and probably spin, known as specific reporting that could distort the interpretation of results thus mislead readers. We planned to investigate the current registration status of recently published randomized controlled trials (RCTs) of acupuncture, outcome reporting bias in the prospectively registered trials, and the association between trial registration and presence of spin and methodological factors in acupuncture RCTs. METHODS:Acupuncture RCTs published in English in recent 5 years (January 2013 to December 2017) were searched in PubMed, Cochrane Central Register of Controlled Trials, and EMBASE. Trial registration records identified in the publications and trial registries were classified into prospectively registered, retrospectively registered, or unregistered. Primary outcomes were identified and the direction of the results was judged as statistically significant (positive) or statistically nonsignificant (negative). We compared registered and published primary outcomes to assess outcome reporting bias and assessed whether discrepancies favored statistically significant outcomes. Frequency and strategies of spin in published reports with statistically nonsignificant results for primary outcomes were then identified. We also analyzed whether the trial registration status was associated with spin and quality of methodological factors. RESULTS:Of the 322 included RCTs, 41.9% (n = 135) were prospectively registered. Among 64 studies that were prospectively registered and specified primary outcomes, 25 trials had the discrepancies between the registered and published primary outcomes and 60% of them (15 trials) favored the statistically significant findings. Among 169 studies that specified primary outcomes, trial registration status was not associated with the direction of results, i.e., statistically significant or not. Spin was identified in 56.4% out of 78 studies with statistically nonsignificant primary outcomes and claiming efficacy with no consideration of statistically nonsignificant primary outcomes was the most common strategy for spin. Trial registration status was not statistically different between studies with and without spin. CONCLUSION:While trial registration seemed to have improved over time, primary outcomes in registered records and publications were often inconsistent, tending to favor statistically significant findings and spin was common in studies with statistically nonsignificant primary outcomes. Journal editors and researchers in this field should be alerted to still prevalent reporting bias and spin.

Project description:ObjectiveTo assess whether the completeness of reporting of health research is related to journals' endorsement of reporting guidelines.DesignSystematic review.Data sourcesReporting guidelines from a published systematic review and the EQUATOR Network (October 2011). Studies assessing the completeness of reporting by using an included reporting guideline (termed "evaluations") (1990 to October 2011; addendum searches in January 2012) from searches of either Medline, Embase, and the Cochrane Methodology Register or Scopus, depending on reporting guideline name.Study selectionEnglish language reporting guidelines that provided explicit guidance for reporting, described the guidance development process, and indicated use of a consensus development process were included. The CONSORT statement was excluded, as evaluations of adherence to CONSORT had previously been reviewed. English or French language evaluations of included reporting guidelines were eligible if they assessed the completeness of reporting of studies as a primary intent and those included studies enabled the comparisons of interest (that is, after versus before journal endorsement and/or endorsing versus non-endorsing journals).Data extractionPotentially eligible evaluations of included guidelines were screened initially by title and abstract and then as full text reports. If eligibility was unclear, authors of evaluations were contacted; journals' websites were consulted for endorsement information where needed. The completeness of reporting of reporting guidelines was analyzed in relation to endorsement by item and, where consistent with the authors' analysis, a mean summed score.Results101 reporting guidelines were included. Of 15,249 records retrieved from the search for evaluations, 26 evaluations that assessed completeness of reporting in relation to endorsement for nine reporting guidelines were identified. Of those, 13 evaluations assessing seven reporting guidelines (BMJ economic checklist, CONSORT for harms, PRISMA, QUOROM, STARD, STRICTA, and STROBE) could be analyzed. Reporting guideline items were assessed by few evaluations.ConclusionsThe completeness of reporting of only nine of 101 health research reporting guidelines (excluding CONSORT) has been evaluated in relation to journals' endorsement. Items from seven reporting guidelines were quantitatively analyzed, by few evaluations each. Insufficient evidence exists to determine the relation between journals' endorsement of reporting guidelines and the completeness of reporting of published health research reports. Journal editors and researchers should consider collaborative prospectively designed, controlled studies to provide more robust evidence.Systematic review registrationNot registered; no known register currently accepts protocols for methodology systematic reviews.

Project description:Background & aimsIn 2005, the registration of all randomised controlled trials (RCTs) before enrolment of participants became a condition for publication by the International Committee of Medical Journal Editors to increase transparency in trial reporting. Among RCTs on transarterial chemoembolisation (TACE) for the treatment of hepatocellular carcinoma (HCC) published after 2007, we assess the proportion that were registered and compare registered primary outcomes (PO) with those reported in publications to determine whether primary outcome reporting bias favoured significant outcomes.MethodsWe searched MEDLINE and EMBASE for reports of RCTs evaluating TACE for HCC treatment between 1 September 2007 and 31 March 2018. Registration and publication information for each included RCT was compared using a standardised data extraction form.ResultsThirteen out of 53 (25%) included RCTs were correctly registered (i.e. before the starting date of the RCT), 14 (26%) were registered after the RCT starting date, and 26 (49%) were not registered. Six out of 14 of the retrospectively registered RCTs (43%) were registered after their completion date. The PO was clearly reported in the published article of all registered RCTs, whereas the report was not clear in 8/26 (31%) of the non-registered RCTs (p = 0.01). Among registered RCTs, 8/27 (30%) had major discrepancies between registered and published PO. The influence of these discrepancies could be assessed in 6 of them and was shown to statistically favour significant results in 2.ConclusionsRegistration and outcome reporting in RCTs on TACE for HCC are often inadequate. Registration should be reinforced because it is a key to transparency.Lay summaryTrial registration is fundamental to our understanding and interpretation of results, as it provides information on all relevant clinical trials (to place the results in a broader context), and on the details of their associated protocols (to ensure that the scientific plan is followed). Once a randomised controlled trial (RCT) is completed, the trial results are usually publicly shared via scientific articles that are expected to thoroughly and objectively report them. This study shows that half of the RCTs evaluating transarterial chemoembolisation for hepatocellular carcinoma were not registered, and identified major discrepancies between registered and published primary outcome favouring significant results.

Project description:BackgroundClinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications.ObjectiveTo describe the characteristics of TCM trials, estimate bias risk and outcome-reporting bias in clinical trials.Data sources and study selectionFifteen trial registries were searched from their inception to July 2012 to identify randomised trials on TCM including Chinese herbs, acupuncture and/or moxibustion, cupping, tuina, qigong, etc.Data extractionWe extracted data including TCM specialty and treated disease/conditions from the registries and searched for subsequent publications in PubMed and Chinese databases. We compared information in the registries of completed trials with any publications focusing on study design, sample size, randomisation, bias risk including reporting bias from the register protocol.Results1096 registered randomised trials were identified evaluating TCM, of which 505 were completed studies (46.1%). The most frequent conditions were pain (13.3%), musculoskeletal (11.7%), nervous (8.7%), digestive (7.1%), circulatory (6.5%), respiratory (6.3%), mental and behavioural disorders (6.2%) and cancer (6.0%). The trial register data identified parallel, phase II/III randomised trials with sample size estimations and blinding, but limited information about randomisation (sequence generation and allocation concealment). Comparing trial registration data of 115 completed trials (22.8%) with their subsequent 136 publications, inconsistencies were identified in one or more of the following: sample size (11%), outcome assessor blinding (37.5%), primary outcomes (29%) and safety (28%) reporting.ConclusionsIncreasing numbers of clinical trials investigating a variety of TCM interventions have been registered in international trial registries. The study design of registered TCM trials has improved in estimating sample size, use of blinding and placebos. However, selective outcome reporting is widespread and similar to conventional medicine and therefore study conclusions should be interpreted with caution.

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Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy.

Publications

Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy.

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