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      Mapping the universe of registered reports

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      Nature Human Behaviour
      Springer Nature America, Inc

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          An Agenda for Purely Confirmatory Research.

          The veracity of substantive research claims hinges on the way experimental data are collected and analyzed. In this article, we discuss an uncomfortable fact that threatens the core of psychology's academic enterprise: almost without exception, psychologists do not commit themselves to a method of data analysis before they see the actual data. It then becomes tempting to fine tune the analysis to the data in order to obtain a desired result-a procedure that invalidates the interpretation of the common statistical tests. The extent of the fine tuning varies widely across experiments and experimenters but is almost impossible for reviewers and readers to gauge. To remedy the situation, we propose that researchers preregister their studies and indicate in advance the analyses they intend to conduct. Only these analyses deserve the label "confirmatory," and only for these analyses are the common statistical tests valid. Other analyses can be carried out but these should be labeled "exploratory." We illustrate our proposal with a confirmatory replication attempt of a study on extrasensory perception.
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            Comparison of registered and published primary outcomes in randomized controlled trials.

            As of 2005, the International Committee of Medical Journal Editors required investigators to register their trials prior to participant enrollment as a precondition for publishing the trial's findings in member journals. To assess the proportion of registered trials with results recently published in journals with high impact factors; to compare the primary outcomes specified in trial registries with those reported in the published articles; and to determine whether primary outcome reporting bias favored significant outcomes. MEDLINE via PubMed was searched for reports of randomized controlled trials (RCTs) in 3 medical areas (cardiology, rheumatology, and gastroenterology) indexed in 2008 in the 10 general medical journals and specialty journals with the highest impact factors. For each included article, we obtained the trial registration information using a standardized data extraction form. Of the 323 included trials, 147 (45.5%) were adequately registered (ie, registered before the end of the trial, with the primary outcome clearly specified). Trial registration was lacking for 89 published reports (27.6%), 45 trials (13.9%) were registered after the completion of the study, 39 (12%) were registered with no or an unclear description of the primary outcome, and 3 (0.9%) were registered after the completion of the study and had an unclear description of the primary outcome. Among articles with trials adequately registered, 31% (46 of 147) showed some evidence of discrepancies between the outcomes registered and the outcomes published. The influence of these discrepancies could be assessed in only half of them and in these statistically significant results were favored in 82.6% (19 of 23). Comparison of the primary outcomes of RCTs registered with their subsequent publication indicated that selective outcome reporting is prevalent.
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              Likelihood of Null Effects of Large NHLBI Clinical Trials Has Increased over Time

              Background We explore whether the number of null results in large National Heart Lung, and Blood Institute (NHLBI) funded trials has increased over time. Methods We identified all large NHLBI supported RCTs between 1970 and 2012 evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease. Trials were included if direct costs >$500,000/year, participants were adult humans, and the primary outcome was cardiovascular risk, disease or death. The 55 trials meeting these criteria were coded for whether they were published prior to or after the year 2000, whether they registered in clinicaltrials.gov prior to publication, used active or placebo comparator, and whether or not the trial had industry co-sponsorship. We tabulated whether the study reported a positive, negative, or null result on the primary outcome variable and for total mortality. Results 17 of 30 studies (57%) published prior to 2000 showed a significant benefit of intervention on the primary outcome in comparison to only 2 among the 25 (8%) trials published after 2000 (χ2=12.2,df= 1, p=0.0005). There has been no change in the proportion of trials that compared treatment to placebo versus active comparator. Industry co-sponsorship was unrelated to the probability of reporting a significant benefit. Pre-registration in clinical trials.gov was strongly associated with the trend toward null findings. Conclusions The number NHLBI trials reporting positive results declined after the year 2000. Prospective declaration of outcomes in RCTs, and the adoption of transparent reporting standards, as required by clinicaltrials.gov, may have contributed to the trend toward null findings.
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                Author and article information

                Journal
                Nature Human Behaviour
                Nat Hum Behav
                Springer Nature America, Inc
                2397-3374
                November 2018
                October 1 2018
                November 2018
                : 2
                : 11
                : 793-796
                Article
                10.1038/s41562-018-0444-y
                31558810
                55651188-9e52-4d8d-8397-7ab414064efb
                © 2018

                http://www.springer.com/tdm

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