TY - JOUR
T1 - A tutorial on sensitivity analyses in clinical trials
T2 - The what, why, when and how
AU - Thabane, Lehana
AU - Mbuagbaw, Lawrence
AU - Zhang, Shiyuan
AU - Samaan, Zainab
AU - Marcucci, Maura
AU - Ye, Chenglin
AU - Thabane, Marroon
AU - Giangregorio, Lora
AU - Dennis, Brittany
AU - Kosa, Daisy
AU - Debono, Victoria Borg
AU - Dillenburg, Rejane
AU - Fruci, Vincent
AU - Bawor, Monica
AU - Lee, Juneyoung
AU - Wells, George
AU - Goldsmith, Charles H.
N1 - Funding Information:
This work was supported in part by funds from the CANNeCTIN programme.
PY - 2013
Y1 - 2013
N2 - 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.
AB - 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.
KW - Clinical trials
KW - Robustness
KW - Sensitivity analysis
UR - http://www.scopus.com/inward/record.url?scp=84880099876&partnerID=8YFLogxK
U2 - 10.1186/1471-2288-13-92
DO - 10.1186/1471-2288-13-92
M3 - Review article
C2 - 23855337
AN - SCOPUS:84880099876
SN - 1471-2288
VL - 13
JO - BMC Medical Research Methodology
JF - BMC Medical Research Methodology
IS - 1
M1 - 92
ER -