Cited by 894Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsStatistical Methods and Bayesian Inference

The DOI matches its Crossref record; 76 of the 76 references it cites were found in a registry or an index.

A tutorial on sensitivity analyses in clinical trials: the what, why, when and how

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Abstract

BACKGROUND: Sensitivity analyses play a crucial role in assessing the robustness of the findings or conclusions based on primary analyses of data in clinical trials. They are a critical way to assess the impact, effect or influence of key assumptions or variations--such as different methods of analysis, definitions of outcomes, protocol deviations, missing data, and outliers--on the overall conclusions of a study.The current paper is the second in a series of tutorial-type manuscripts intended to discuss and clarify aspects related to key methodological issues in the design and analysis of clinical trials. DISCUSSION: In this paper we will provide a detailed exploration of the key aspects of sensitivity analyses including: 1) what sensitivity analyses are, why they are needed, and how often they are used in practice; 2) the different types of sensitivity analyses that one can do, with examples from the literature; 3) some frequently asked questions about sensitivity analyses; and 4) some suggestions on how to report the results of sensitivity analyses in clinical trials. SUMMARY: When reporting on a clinical trial, we recommend including planned or posthoc sensitivity analyses, the corresponding rationale and results along with the discussion of the consequences of these analyses on the overall findings of the study.

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Crossref · 10.1186/1471-2288-13-92

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Research works printed but not linked: 2

  1. Goldsmith CH, Gafni A, Drummond MF, Torrance GW, Stoddart GL: Sensitivity Analysis and Experimental Design: The Case of Economic Evaluation of Health Care Programmes. Proceedings of the Third Canadian Conference on Health Economics 1986. 1987, Winnipeg MB: The University of Manitoba Press
  2. Spiegelhalter DJ, Best NG, Lunn D, Thomas A: Bayesian Analysis using BUGS: A Practical Introduction. 2009, New York, NY: Chapman and Hall

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Metadata

Authors
Thabane, L., Mbuagbaw, L., Zhang, S., Samaan, Z., Marcucci, M., Ye, C., Thabane, M., Giangregorio, L., Dennis, B., Kosa, D., Debono, V. B., Dillenburg, R., Fruci, V., Bawor, M., Lee, J., Wells, G., & Goldsmith, C. H.
Affiliations
  • Population Health Research Institute (CA)
  • St. Joseph’s Healthcare Hamilton (CA)
  • McMaster University (CA)
  • GlaxoSmithKline (Canada) (CA)
  • University of Waterloo (CA)
  • Korea University (KR)
  • University of Ottawa (CA)
  • Simon Fraser University (CA)
Corresponding author
Thabane, Lehana
Venue
BMC Medical Research Methodology
Published
2013-07-16
Volume
13
Issue
1
Pages
92-92
ISSN
1471-2288 (ISSN-L)
OpenAlex
W2095437242
Cited by
893
References
76
Citations by year
2026: 76 · 2025: 113 · 2024: 107 · 2023: 109 · 2022: 90 · 2021: 84 · 2020: 90 · 2019: 52 · 2018: 57 · 2017: 43 · 2016: 31 · 2015: 28 · 2014: 11 · 2013: 1
FWCI
20.82
Type
journal article
Language
en
Open access
Locations
  • BMC Medical Research Methodology (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • uO Research (University of Ottawa) (submittedVersion, public-domain)
  • Archivio Istituzionale della Ricerca (Universita Degli Studi Di Milano) (submittedVersion, other-oa)
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods and Bayesian Inference
Keywords
sensitivity analysis, clinical trials, missing data, outliers, protocol deviations, outcome definitions
MeSH terms
Clinical Trials as Topic, Humans, Outcome and Process Assessment, Health Care, Research Design, Sensitivity and Specificity

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