Consistency of published primary outcomes with prospectively registered outcomes for manuscripts describing clinical trial results Not Applicable Consistency of published primary outcomes with prospectively registered outcomes for manuscripts describing clinical trial results
Conditions
Interventions
As this trial uses a stepped wedge design, participating journals will all begin the study in the control arm. Beginning in month 3, the participating journals will be crossed over into the interventi
Sponsors
Cooper University Health System
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Manuscripts: 1. Sent for peer review during the one year study period by any of the participating journals 2. Include human subjects or groups of humans (e.g. cluster randomised trials) 3. Report results from an interventional study which prospectively assigns participants to one or more arms consisting of health-related interventions in order to evaluate an effect on health outcomes
Exclusion criteria
Exclusion criteria: Manuscripts: 1. Describe a planned trial without reporting trial results 2. Clearly state that the manuscript is not intended to report on the trial's primary outcome (i.e. manuscript describes only secondary or subgroup analyses) 3. Resubmitted manuscripts which have already completed the first round of peer review. Manuscripts sent for peer review from multiple participating journals during the study will be analysed in the first journal’s cluster, and will not be included a second time if resubmitted to a different participating journal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of a clearly defined, prospectively registered primary trial outcome that is consistent with the primary outcome in the published manuscript, as determined by two independent outcome assessors. This measure is recorded as a dichotomous variable: the registered and published primary outcomes are either consistent or not. This will be determined after all of the included manuscripts that are accepted for publication by participating journals have been published. We use the following definitions to make this determination: We define prospective registration as registration of a primary outcome with ClinicalTrials.gov or any of the Primary Registries in the WHO Registry Network prior to enrollment of the trial's first participant. A clearly defined outcome provides sufficient information to reasonably allow its identification on review of the study results and to allow an independent investigator to design a study measuring the same parameter. Outcomes will be considered to be consistent if every primary outcome described in the registry is reported as a primary outcome in the manuscript, and every primary outcome reported in the manuscript is described as a primary outcome in the registry. Two investigators will independently assess all registered and published outcomes for consistency. Both investigators will be blinded to whether the manuscript was in the control or intervention phase and to the content of the manuscript draft sent for initial peer review. Any discrepancies will be resolved by consensus after having both authors review the full text of the manuscript and registry; persistent disagreements will be adjudicated by a third investigator. Trials not prospectively registered will be considered to have inconsistent outcomes, as these publications will introduce new outcomes by definition. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be assessed after all the included manuscripts that are accepted for publication by participating journals have been published: 1. Acceptance rate, assessed by recording the final editorial decision for clinical trial manuscripts sent for peer review during the study period 2. Number of manuscripts that disclose an outcome change within the published manuscript. Among trial manuscripts with primary outcome discrepancies present, we will determine whether the manuscript disclosed the outcome change 3. Number of trials with changes to the primary outcome between the initial submitted manuscript and the published manuscript. For manuscripts which are published we will assess the consistency between primary trial outcomes described in the initial manuscript submitted for peer review and the primary trial outcomes described in the published version of the manuscript. 4. Number of manuscripts with consistent outcomes between the registered and published primary outcome when the registered primary outcome is not clearly defined. Among trials with registered primary outcomes that were registered prospectively but unclearly, we will determine whether the registered outcomes are consistent with the published outcomes. 5. Statistical significance of outcome changes. Manuscripts with inconsistencies between the prospectively registered and published primary outcomes will be assessed to determine whether the change in outcomes affected the statistical significance (as defined in each included manuscript) of published outcomes. 6. Discrepancies in secondary outcomes. We will assess included manuscripts to determine whether discrepancies are present between prospectively registered secondary outcomes and published secondary outcomes and will describe the nature of identified discrepancies. 7. Time elapsed between initial submission and publication. We | — |
Countries
United States of America
Outcome results
None listed