Distinguishing Clinical From Statistical Significances in Contemporary Comparative Effectiveness Research.
Ann Surg
; 279(6): 907-912, 2024 Jun 01.
Article
en En
| MEDLINE
| ID: mdl-38390761
ABSTRACT
OBJECTIVE:
To determine the prevalence of clinical significance reporting in contemporary comparative effectiveness research (CER).BACKGROUND:
In CER, a statistically significant difference between study groups may or may not be clinically significant. Misinterpreting statistically significant results could lead to inappropriate recommendations that increase health care costs and treatment toxicity.METHODS:
CER studies from 2022 issues of the Annals of Surgery , Journal of the American Medical Association , Journal of Clinical Oncology , Journal of Surgical Research , and Journal of the American College of Surgeons were systematically reviewed by 2 different investigators. The primary outcome of interest was whether the authors specified what they considered to be a clinically significant difference in the "Methods."RESULTS:
Of 307 reviewed studies, 162 were clinical trials and 145 were observational studies. Authors specified what they considered to be a clinically significant difference in 26 studies (8.5%). Clinical significance was defined using clinically validated standards in 25 studies and subjectively in 1 study. Seven studies (2.3%) recommended a change in clinical decision-making, all with primary outcomes achieving statistical significance. Five (71.4%) of these studies did not have clinical significance defined in their methods. In randomized controlled trials with statistically significant results, sample size was inversely correlated with effect size ( r = -0.30, P = 0.038).CONCLUSIONS:
In contemporary CER, most authors do not specify what they consider to be a clinically significant difference in study outcome. Most studies recommending a change in clinical decision-making did so based on statistical significance alone, and clinical significance was usually defined with clinically validated standards.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Investigación sobre la Eficacia Comparativa
Límite:
Humans
Idioma:
En
Año:
2024
Tipo del documento:
Article