دورية أكاديمية
أعرض في EDS

Statistical Power of Randomized Controlled Trials in Trauma Surgery.

التفاصيل البيبلوغرافية
العنوان: Statistical Power of Randomized Controlled Trials in Trauma Surgery.
المؤلفون: Berg A; From the Department of Trauma and Surgical Critical Care, Jackson Memorial Hospital, Miami, FL (Berg, Lyons, Badami, Reynolds, Pizano, Pust, Meizoso, Namias)., Lyons NB; From the Department of Trauma and Surgical Critical Care, Jackson Memorial Hospital, Miami, FL (Berg, Lyons, Badami, Reynolds, Pizano, Pust, Meizoso, Namias)., Badami A; From the Department of Trauma and Surgical Critical Care, Jackson Memorial Hospital, Miami, FL (Berg, Lyons, Badami, Reynolds, Pizano, Pust, Meizoso, Namias)., Reynolds J; From the Department of Trauma and Surgical Critical Care, Jackson Memorial Hospital, Miami, FL (Berg, Lyons, Badami, Reynolds, Pizano, Pust, Meizoso, Namias)., Pizano L; From the Department of Trauma and Surgical Critical Care, Jackson Memorial Hospital, Miami, FL (Berg, Lyons, Badami, Reynolds, Pizano, Pust, Meizoso, Namias)., Pust GD; From the Department of Trauma and Surgical Critical Care, Jackson Memorial Hospital, Miami, FL (Berg, Lyons, Badami, Reynolds, Pizano, Pust, Meizoso, Namias)., Meizoso J; From the Department of Trauma and Surgical Critical Care, Jackson Memorial Hospital, Miami, FL (Berg, Lyons, Badami, Reynolds, Pizano, Pust, Meizoso, Namias)., Namias N; From the Department of Trauma and Surgical Critical Care, Jackson Memorial Hospital, Miami, FL (Berg, Lyons, Badami, Reynolds, Pizano, Pust, Meizoso, Namias)., Yeh DD; and the Department of Trauma and Surgical Critical Care, Denver Health, Denver, CO (Yeh).
المصدر: Journal of the American College of Surgeons [J Am Coll Surg] 2023 Nov 01; Vol. 237 (5), pp. 731-736. Date of Electronic Publication: 2023 Jul 07.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Lippincott Williams & Wilkins, Inc Country of Publication: United States NLM ID: 9431305 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-1190 (Electronic) Linking ISSN: 10727515 NLM ISO Abbreviation: J Am Coll Surg Subsets: MEDLINE
أسماء مطبوعة: Publication: 2022- : [Baltimore, MD] : Lippincott Williams & Wilkins, Inc.
Original Publication: Chicago, Ill. : The College, c1994-
مواضيع طبية MeSH: Research Design* , Checklist*, Humans ; Randomized Controlled Trials as Topic ; Sample Size
مستخلص: Background: Our purpose was to conduct a bibliometric study investigating the prevalence of underpowered randomized controlled trials (RCTs) in trauma surgery.
Study Design: A medical librarian conducted a search of RCTs in trauma published from 2000 to 2021. Data extracted included study type, sample size calculation, and power analyses. Post hoc calculations were performed using a power of 80% and an alpha level of 0.05. A CONSORT checklist was then tabulated from each study as well as a fragility index for studies with statistical significance.
Results: In total 187 RCTs from multiple continents and 60 journals were examined. A total of 133 (71%) were found to have "positive" findings consistent with their hypothesis. When evaluating their methods, 51.3% of articles did not report how they calculated their intended sample size. Of those that did, 25 (27%) did not meet their target enrollment. When examining post hoc power, 46%, 57%, and 65% were adequately powered to detect small, medium, and large effect sizes, respectively. Only 11% of RCTs had complete adherence with CONSORT reporting guidelines and the average CONSORT score was 19 out of 25. For positive superiority trials with binary outcomes, the fragility index median (interquartile range) was 2 (2 to 8).
Conclusions: A concerningly large proportion of recently published RCTs in trauma surgery do not report a priori sample size calculations, do not meet enrollment targets, and are not adequately powered to detect even large effect sizes. There exists opportunity for improvement of trauma surgery study design, conduct, and reporting.
(Copyright © 2023 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.)
التعليقات: Comment in: J Am Coll Surg. 2023 Nov 1;237(5):737. (PMID: 37427848)
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تواريخ الأحداث: Date Created: 20230707 Date Completed: 20231023 Latest Revision: 20231024
رمز التحديث: 20240628
DOI: 10.1097/XCS.0000000000000800
PMID: 37417653
قاعدة البيانات: MEDLINE
الوصف
تدمد:1879-1190
DOI:10.1097/XCS.0000000000000800