ArticleEvidence-based mental health2016
Designing and analysing clinical trials in mental health: an evidence synthesis approach.
Article in Evidence-based mental health, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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
3 citing papers in PubMed.
- Valproate for acute mania.The Cochrane database of systematic reviews · 2019Review
- Enhancing pediatric clinical trial feasibility through the use of Bayesian statistics.Pediatric research · 2017Article
- Relative to SSRI users, SSRI-statin users have fewer psychiatric hospital contacts and no increase in suicidal behaviour or all-cause mortality.Evidence-based mental health · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveWhen planning a clinical study, evidence on the treatment effect is often available from previous studies. However, this evidence is mostly ignored for the analysis of the new study. This is unfortunate, since using it could lead to a smaller study without compromising power. We describe a design that addresses this issue.
methodsWe use a Bayesian meta-analytic model to incorporate the available evidence in the analysis of the new study. The shrinkage estimate for the new study integrates the evidence from the other studies. At the planning phase of the study, it allows a statistically justified reduction of the sample size.
resultsThe design is illustrated using data from an Food and Drug Administration (FDA) review of lurasidone for the treatment of schizophrenia. Three studies inform the meta-analysis before the new study is conducted. Results from an additional phase III study, which were not available at the time of the FDA review, are then used for the actual analysis.
conclusionsIn the presence of reliable and relevant evidence, the design offers a way to conduct a smaller study without compromising power. It therefore fills a gap between the assessment of evidence and its actual use in the design and analysis of studies.
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What OpenQuestion 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 OpenQuestion graph.