SynthesisTranslational psychiatry2017
Outcome reporting bias in randomized-controlled trials investigating antipsychotic drugs.
Synthesis in Translational psychiatry, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 5 syntheses or guidelines pooled it, 52 citations in OpenAlex.
- Pooled it
- Identifying spin bias of nonsignificant findings in biomedical studies.BMC research notes · 2023Pooled it
- Pooled it
- Selective Reporting of Outcomes in Tinnitus Trials: Comparison of Trial Registries With Corresponding Publications.Frontiers in neurology · 2021Pooled it
- Interventions to Improve Antimicrobial Stewardship for Older People in Care Homes: A Systematic Review.Drugs & aging · 2019Pooled it
- Article
- Article
- Safety reporting in trials on glaucoma interventions registered in ClinicalTrials.gov and corresponding publications.Scientific reports · 2024Article
- Dissemination and outcome reporting bias in clinical malaria intervention trials: a cross-sectional analysis.Malaria journal · 2024Article
- Correcting for outcome reporting bias in a meta-analysis: A meta-regression approach.Behavior research methods · 2024Article
- Casting New Light on Statistical Power: An Illuminating Analogy and Strategies to Avoid Underpowered Trials.American journal of epidemiology · 2022Article
- Selective outcome reporting across psychopharmacotherapy randomized controlled trials.International journal of methods in psychiatric research · 2022Article
- Ensuring the quality and specificity of preregistrations.PLoS biology · 2020Article
- The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.BMJ (Clinical research ed.) · 2020Article
- Article
- Compromising Outcomes.Journal of the American Society of Nephrology : JASN · 2019Article
- Assessing the Quality of Abstracts in Randomized Controlled Trials Published in High Impact Cardiovascular Journals.Circulation. Cardiovascular quality and outcomes · 2019Article
- Side effect profile and comparative tolerability of 21 antidepressants in the acute treatment of major depression in adults: protocol for a network meta-analysis.Evidence-based mental health · 2019Article
- The Weak Spots in Contemporary Science (and How to Fix Them).Animals : an open access journal from MDPI · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Recent literature hints that outcomes of clinical trials in medicine are selectively reported. If applicable to psychotic disorders, such bias would jeopardize the reliability of randomized clinical trials (RCTs) investigating antipsychotics and thus their extrapolation to clinical practice. We therefore comprehensively examined outcome reporting bias in RCTs of antipsychotic drugs by a systematic review of prespecified outcomes on ClinicalTrials.gov records of RCTs investigating antipsychotic drugs in schizophrenia and schizoaffective disorder between 1 January 2006 and 31 December 2013. These outcomes were compared with outcomes published in scientific journals. Our primary outcome measure was concordance between prespecified and published outcomes; secondary outcome measures included outcome modifications on ClinicalTrials.gov after trial inception and the effects of funding source and directionality of results on record adherence. Of the 48 RCTs, 85% did not fully adhere to the prespecified outcomes. Discrepancies between prespecified and published outcomes were found in 23% of RCTs for primary outcomes, whereas 81% of RCTs had at least one secondary outcome non-reported, newly introduced, or changed to a primary outcome in the respective publication. In total, 14% of primary and 44% of secondary prespecified outcomes were modified after trial initiation. Neither funding source (P=0.60) nor directionality of the RCT results (P=0.10) impacted ClinicalTrials.gov record adherence. Finally, the number of published safety endpoints (N=335) exceeded the number of prespecified safety outcomes by 5.5 fold. We conclude that RCTs investigating antipsychotic drugs suffer from substantial outcome reporting bias and offer suggestions to both monitor and limit such bias in the future.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.