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Reporting characteristics of non-primary publications of results of randomized trials: a cross-sectional review.

ABSTRACT: For a randomized trial, the primary publication is usually the one which reports the results of the primary outcome and provides consolidated data from all study centers. Other aspects of a randomized trial's findings (that is, non-primary results) are often reported in subsequent publications.We carried out a cross-sectional review of the characteristics and type of information reported in non-primary reports (n = 69) of randomized trials (indexed in PubMed core clinical journals in 2009) and whether they report pre-specified or exploratory analyses. We also compared consistency of information in non-primary publications with that reported in the primary publication.The majority (n = 56; 81%) of non-primary publications were large, multicenter trials, published in specialty journals. Most reported subgroup analyses (n = 27; 39%), analyzing a specific subgroup of patients from the randomized trial, or reported on secondary outcomes (n = 29; 42%); 19% (n = 13) reported extended follow-up. Less than half reported details of trial registration (n = 30; 43%) or the trial protocol (n = 27; 39%) and in 41% (n = 28) it was unclear from reading the abstract that the report was not the primary publication for the trial. Non-primary publications often analyzed and reported multiple different outcomes (16% reported >20 outcomes) and in 10% (n = 7) it was unclear how many outcomes had actually been assessed; in 42% (n = 29) it was unclear whether the analyses reported were pre-specified or exploratory. Only 39% (n = 27) of non-primary publications described the primary outcome of the randomized trial, 6% (n = 4) reported its numerical results and 9% (n = 6) details of how participants were randomized.Non-primary publications often lack important information about the randomized trial and the type of analyses conducted and whether these were pre-specified or exploratory to enable readers to accurately identify and assess the validity and reliably of the study findings. We provide recommendations for what information authors should include in non-primary reports of randomized trials.

SUBMITTER: Hopewell S

PROVIDER: S-EPMC3733891 | biostudies-other | 2013 Jul

REPOSITORIES: biostudies-other

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Reporting characteristics of non-primary publications of results of randomized trials: a cross-sectional review.

Hopewell Sally S Collins Gary S GS Hirst Allison A Kirtley Shona S Tajar Abdelouahid A Gerry Stephen S Altman Douglas G DG

Trials 20130731

<h4>Background</h4>For a randomized trial, the primary publication is usually the one which reports the results of the primary outcome and provides consolidated data from all study centers. Other aspects of a randomized trial's findings (that is, non-primary results) are often reported in subsequent publications.<h4>Methods</h4>We carried out a cross-sectional review of the characteristics and type of information reported in non-primary reports (n = 69) of randomized trials (indexed in PubMed co ...[more]

PMID: 23902608

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Project description:BackgroundReporting the scoring details of continuous outcome measures in randomized trials allows readers to interpret the size of any effect of the intervention. This study aimed to determine, in a sample of randomized trials: 1) the completeness of reporting of scoring details for continuous outcome measures, and 2) whether trial authors comment on the clinical significance of statistically significant trial results.MethodsA descriptive analysis of randomized trials of non-pharmacological interventions published during 2009 in the six leading general medical journals (n = 138), and which used at least one continuous outcome measure (n = 85). From each trial report, two authors independently extracted the following information about each continuous outcome measure: the reporting of its scoring details, presentation of its results, and the reporting and justification of the clinical significance of the results.ResultsAcross the 84 trials, we identified 336 continuous outcome measures. A total of 146 (44%) were published measures, 12 (4%) were adapted from published measures, 5 (1%) were developed for the trial, and 173 (51%) were 'conventional measures' for which scoring details are not necessary (such as weight). For 57 (35%) of the 163 non-conventional outcome measures no scoring details or reference to the outcome measure were provided in the trial report. Of the 159 outcome measures with a statistically significant result, clinical significance was not mentioned for 81 (51%) and was reported without any elaboration or justification for 39 (25%) of them.ConclusionsScoring details of continuous outcome measures used in this sample of randomized trials of non-pharmacological interventions were incompletely reported, which hampers interpretation of a trial's results. Complete reporting of scoring details is important when considering the clinical significance of the results. When deciding about an intervention, having this information may help clinicians in their conversations with patients about the possible benefits and harms, and their size, of the intervention.

Project description:Spin in the reporting of randomized controlled trials, where authors report research in a way that potentially misrepresents results and mislead readers, has been demonstrated in the broader medical literature. We investigated spin in wound care trials with (a) no statistically significant result for the primary outcome and (b) no clearly specified primary outcome.We searched the Cochrane Wounds Group Specialised Register of Trials for randomized controlled trials (RCTs). Eligible studies were: Parallel-group RCTs of interventions for foot, leg or pressure ulcers published in 2004 to 2009 (inclusive) with either a clearly identified primary outcome for which there was a statistically non-significant result (Cohort A) or studies that had no clear primary outcome (Cohort B).We extracted general study details. For both Cohorts A and B we then assessed for the presence of spin. For Cohort A we used a pre-defined process to assess reports for spin. For Cohort B we aimed to assess spin by recording the number of positive treatment effect claims made. We also compared the number of statistically significant and non-significant results reported in the main text and the abstract looking specifically for spin in the form of selective outcome reporting.Of the 71 eligible studies, 28 were eligible for Cohort A; of these, 71% (20/28) contained spin. Cohort B contained 43 studies; of these, 86% (37/43) had abstracts that claimed a favorable treatment claim. Whilst 74% (32/43) of main text results in Cohort B included at least one statistically non-significant result, this was not reflected in the abstract where only 28% contained (12/43) at least one statistically non-significant result.Spin is a frequent phenomenon in reports of RCTs of wound treatments. Studies without statistically significant results for the primary outcome used spin in 71% of cases. Furthermore, 33% (43/132) of reports of wound RCTs did not specify a primary outcome and there was evidence of spin and selective outcome reporting in the abstracts of these. Readers should be wary of only reading the abstracts of reports of RCTs of wound treatments since they are frequently misleading regarding treatment effects.

Project description:ObjectiveTo compare results reporting and the presence of spin in COVID-19 study preprints with their finalised journal publications.DesignCross-sectional study.SettingInternational medical literature.ParticipantsPreprints and final journal publications of 67 interventional and observational studies of COVID-19 treatment or prevention from the Cochrane COVID-19 Study Register published between 1 March 2020 and 30 October 2020.Main outcome measuresStudy characteristics and discrepancies in (1) results reporting (number of outcomes, outcome descriptor, measure, metric, assessment time point, data reported, reported statistical significance of result, type of statistical analysis, subgroup analyses (if any), whether outcome was identified as primary or secondary) and (2) spin (reporting practices that distort the interpretation of results so they are viewed more favourably).ResultsOf 67 included studies, 23 (34%) had no discrepancies in results reporting between preprints and journal publications. Fifteen (22%) studies had at least one outcome that was included in the journal publication, but not the preprint; eight (12%) had at least one outcome that was reported in the preprint only. For outcomes that were reported in both preprints and journals, common discrepancies were differences in numerical values and statistical significance, additional statistical tests and subgroup analyses and longer follow-up times for outcome assessment in journal publications.At least one instance of spin occurred in both preprints and journals in 23/67 (34%) studies, the preprint only in 5 (7%), and the journal publications only in 2 (3%). Spin was removed between the preprint and journal publication in 5/67 (7%) studies; but added in 1/67 (1%) study.ConclusionsThe COVID-19 preprints and their subsequent journal publications were largely similar in reporting of study characteristics, outcomes and spin. All COVID-19 studies published as preprints and journal publications should be critically evaluated for discrepancies and spin.

Project description:Background:Accurate reporting on sex and gender in health research is integral to ensuring that health interventions are safe and effective. In Canada and internationally, governments, research organizations, journal editors, and health agencies have called for more inclusive research, provision of sex-disaggregated data, and the integration of sex and gender analysis throughout the research process. Sex and gender analysis is generally defined as an approach for considering how and why different subpopulations (e.g., of diverse genders, ages, and social locations) may experience health conditions and interventions in different or similar ways.The objective of this study was to assess the extent and nature of reporting about sex and/or gender, including whether sex and gender analysis (SGA) was carried out in a sample of Canadian randomized controlled trials (RCTs) with human participants. Methods:We searched MEDLINE from 01 January 2013 to 23 July 2014 using a validated filter for identification of RCTs, combined with terms related to Canada. Two reviewers screened the search results to identify the first 100 RCTs that were either identified in the trial publication as funded by a Canadian organization or which had a first or last author based in Canada. Data were independently extracted by two people from 10% of the RCTs during an initial training period; once agreement was reached on this sample, the remainder of the data extraction was completed by one person and verified by a second. Results:The search yielded 1433 records. We screened 256 records to identify 100 RCTs which met our eligibility criteria. The median sample size of the RCTs was 107 participants (range 12-6085). While 98% of studies described the demographic composition of their participants by sex, only 6% conducted a subgroup analysis across sex and 4% reported sex-disaggregated data. No article defined "sex" and/or "gender." No publication carried out a comprehensive sex and gender analysis. Conclusions:Findings highlight poor uptake of sex and gender considerations in the Canadian RCT context and underscore the need for better articulated guidance on sex and gender analysis to improve reporting of evidence, inform policy development, and guide future research.

Project description:To assess the reporting quality of acupuncture trials for knee osteoarthritis (KOA), and explore the factors associated with the reporting.Three English and four Chinese databases were searched from inception to December 2016 for randomized control trials testing effects of acupuncture for knee osteoarthritis. We used the standard CONSORT (2010 version), CONSORT Extension for Non-Pharmacological Treatments, and STRICTA for measuring the quality of reporting. Using pre-specified study characteristics, we undertook regression analyses to examine factors associated with the reporting quality.A total of 318 RCT reports were included. For the standard CONSORT, ten items were substantially under-reported (reported in less than 5% of RCTs), including specification of important changes to methods after trial commencement (0.6%), description of any changes to trial outcomes (0.0%), implementation of interim analyses and stopping guidelines (0.6%), statement about why the trial ended or was stopped (1.6%), statement about the registration status (4.4%), accessibility of full trial protocol (4.7%), implementation of randomization (4.7%), description of the similarity of interventions (3.5%), conduct of ancillary analyses (3.8%) and presentation of methods for additional analyses (4.4%). Four of the STRICTA items were under-reported (reported in less than 10% of RCTs), including description of acupuncture style (8.5%), presentation of extent to which treatment varied (1.3%), statement of practitioner background (7.2%) and rationale for the control (9.1%). For CONSORT Extension, the reporting was poor across all items (reported in less than 10% of trials). Trials including authors with expertise in epidemiology or statistics, published in English, or enrolling patients from multiple centers were more likely to have better reporting.The reporting in RCTs of acupuncture for KOA was generally poor. To improve the reporting quality, journals should encourage strict adherence to the reporting guidelines.

Dataset Information

Reporting characteristics of non-primary publications of results of randomized trials: a cross-sectional review.

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Reporting characteristics of non-primary publications of results of randomized trials: a cross-sectional review.

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