ÌÇÐÄvlog

Object moved to here.

Practical Guide to Statistical Considerations in Clinical Trials in Surgery | Research, Methods, Statistics | JAMA Surgery | ÌÇÐÄvlog

ÌÇÐÄvlog

[Skip to Navigation]
Sign In
1.
Ioannidis  JP.  Why most published research findings are false.   PLoS Med. 2005;2(8):e124. doi:
2.
Gamble  C, Krishan  A, Stocken  D,  et al.  Guidelines for the content of statistical analysis plans in clinical trials.  Ìý´³´¡²Ñ´¡. 2017;318(23):2337-2343. doi:
3.
Chan  AW, Tetzlaff  JM, Gøtzsche  PC,  et al.  SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.  Ìýµþ²Ñ´³. 2013;346:e7586. doi:
4.
Brookes  ST, Whitley  E, Peters  TJ, Mulheran  PA, Egger  M, Davey Smith  G.  Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives.   Health Technol Assess. 2001;5(33):1-56. doi:
5.
Hernán  MA, Robins  JM.  Per-protocol analyses of pragmatic trials.   N Engl J Med. 2017;377(14):1391-1398. doi:
6.
Committee for Medicinal Products for Human Use. Guideline on adjustment for baseline covariates in clinical trials. Accessed September 25, 2022.
7.
Little  RJ, D’Agostino  R, Cohen  ML,  et al.  The prevention and treatment of missing data in clinical trials.   N Engl J Med. 2012;367(14):1355-1360. doi:
Views 2,607
Guide to Statistics and Methods
Randomized Clinical Trials in Surgery
October 26, 2022

Practical Guide to Statistical Considerations in Clinical Trials in Surgery

Author Affiliations
  • 1Department of Surgery, Amsterdam UMC, location AMC, Amsterdam Gastroenterology Endocrinology and Metabolism, University of Amsterdam, Amsterdam, the Netherlands
  • 2Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California
  • 3Statistical Editor, JAMA Surgery
  • 4Veterans Affairs Boston Health Care System, Boston University, Boston, Massachusetts
  • 5Harvard Medical School, Boston, Massachusetts
JAMA Surg. 2023;158(1):89-90. doi:10.1001/jamasurg.2022.4892

Statistics is the discipline that helps in making meaningful inferences about the real world from data. Statistics is founded on a construct of hypothesis testing, relying on a range of conditions and assumptions to estimate unbiased treatment effects and differentiate these from chance. Careful consideration of the hypothesis and the corresponding conditions and assumptions are required when formulating the research question and designing and executing a trial up to the interpretation of the results. Like surgery, statistics is a discipline to which one can devote a life of learning and practice that cannot be casually applied. It is therefore important to include a biostatistician from the start and through all phases of the project. We hereby briefly summarize some of the key statistical considerations in clinical trials in surgery (Box).

×