ArticleBMC medical research methodology2014
The thresholds for statistical and clinical significance - a five-step procedure for evaluation of intervention effects in randomised clinical trials.
Article in BMC medical research methodology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 101 papers, 25 of them syntheses that pooled it.
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Who cites it
101 citing papers in PubMed, 25 syntheses or guidelines pooled it.
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- Social skills training for attention deficit hyperactivity disorder (ADHD) in children aged 5 to 18 years.The Cochrane database of systematic reviews · 2019Pooled it
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- Trastuzumab combined with doublet or single-agent chemotherapy as first-line therapy for HER2-positive metastatic breast cancer.Breast cancer research and treatment · 2018Pooled it
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- Direct-acting antivirals for chronic hepatitis C.The Cochrane database of systematic reviews · 2017Pooled it
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- Selective serotonin reuptake inhibitors versus placebo in patients with major depressive disorder. A systematic review with meta-analysis and Trial Sequential Analysis.BMC psychiatry · 2017Pooled it
41 more citing papers are in PubMed but not listed here.
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThresholds for statistical significance are insufficiently demonstrated by 95% confidence intervals or P-values when assessing results from randomised clinical trials. First, a P-value only shows the probability of getting a result assuming that the null hypothesis is true and does not reflect the probability of getting a result assuming an alternative hypothesis to the null hypothesis is true. Second, a confidence interval or a P-value showing significance may be caused by multiplicity. Third, statistical significance does not necessarily result in clinical significance. Therefore, assessment of intervention effects in randomised clinical trials deserves more rigour in order to become more valid.
methodsSeveral methodologies for assessing the statistical and clinical significance of intervention effects in randomised clinical trials were considered. Balancing simplicity and comprehensiveness, a simple five-step procedure was developed.
resultsFor a more valid assessment of results from a randomised clinical trial we propose the following five-steps: (1) report the confidence intervals and the exact P-values; (2) report Bayes factor for the primary outcome, being the ratio of the probability that a given trial result is compatible with a 'null' effect (corresponding to the P-value) divided by the probability that the trial result is compatible with the intervention effect hypothesised in the sample size calculation; (3) adjust the confidence intervals and the statistical significance threshold if the trial is stopped early or if interim analyses have been conducted; (4) adjust the confidence intervals and the P-values for multiplicity due to number of outcome comparisons; and (5) assess clinical significance of the trial results.
conclusionsIf the proposed five-step procedure is followed, this may increase the validity of assessments of intervention effects in randomised clinical trials.
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