Are surgical trials with negative results being interpreted correctly?

Research output: Contribution to journalArticle

Baruch A. Brody, Carol M. Ashton, Dandan Liu, Youxin Xiong, Xuan Yao, Nelda P. Wray

Background: Many published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings. Study Design: We examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power (β ≥ 0.9) were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We examined the remaining 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies. Results: Three of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power < 0.90. However, we examined only a modest number of trial reports from 1 year. Conclusions: Negative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated.

Original languageEnglish (US)
Pages (from-to)158-166
Number of pages9
JournalJournal of the American College of Surgeons
Volume216
Issue number1
DOIs
StatePublished - Jan 1 2013

PMID: 23177270

PMCID: PMC4165332

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Are surgical trials with negative results being interpreted correctly? / Brody, Baruch A.; Ashton, Carol M.; Liu, Dandan; Xiong, Youxin; Yao, Xuan; Wray, Nelda P.

In: Journal of the American College of Surgeons, Vol. 216, No. 1, 01.01.2013, p. 158-166.

Research output: Contribution to journalArticle

Harvard

Brody, BA, Ashton, CM, Liu, D, Xiong, Y, Yao, X & Wray, NP 2013, 'Are surgical trials with negative results being interpreted correctly?' Journal of the American College of Surgeons, vol. 216, no. 1, pp. 158-166. https://doi.org/10.1016/j.jamcollsurg.2012.09.015

APA

Brody, B. A., Ashton, C. M., Liu, D., Xiong, Y., Yao, X., & Wray, N. P. (2013). Are surgical trials with negative results being interpreted correctly? Journal of the American College of Surgeons, 216(1), 158-166. https://doi.org/10.1016/j.jamcollsurg.2012.09.015

Vancouver

Brody BA, Ashton CM, Liu D, Xiong Y, Yao X, Wray NP. Are surgical trials with negative results being interpreted correctly? Journal of the American College of Surgeons. 2013 Jan 1;216(1):158-166. https://doi.org/10.1016/j.jamcollsurg.2012.09.015

Author

Brody, Baruch A. ; Ashton, Carol M. ; Liu, Dandan ; Xiong, Youxin ; Yao, Xuan ; Wray, Nelda P. / Are surgical trials with negative results being interpreted correctly?. In: Journal of the American College of Surgeons. 2013 ; Vol. 216, No. 1. pp. 158-166.

BibTeX

@article{6ad447a6fddf4680b0befc83c57143c8,
title = "Are surgical trials with negative results being interpreted correctly?",
abstract = "Background: Many published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings. Study Design: We examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power (β ≥ 0.9) were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We examined the remaining 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies. Results: Three of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power < 0.90. However, we examined only a modest number of trial reports from 1 year. Conclusions: Negative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated.",
author = "Brody, {Baruch A.} and Ashton, {Carol M.} and Dandan Liu and Youxin Xiong and Xuan Yao and Wray, {Nelda P.}",
year = "2013",
month = "1",
day = "1",
doi = "10.1016/j.jamcollsurg.2012.09.015",
language = "English (US)",
volume = "216",
pages = "158--166",
journal = "Journal of the American College of Surgeons",
issn = "1072-7515",
publisher = "Elsevier",
number = "1",

}

RIS

TY - JOUR

T1 - Are surgical trials with negative results being interpreted correctly?

AU - Brody, Baruch A.

AU - Ashton, Carol M.

AU - Liu, Dandan

AU - Xiong, Youxin

AU - Yao, Xuan

AU - Wray, Nelda P.

PY - 2013/1/1

Y1 - 2013/1/1

N2 - Background: Many published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings. Study Design: We examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power (β ≥ 0.9) were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We examined the remaining 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies. Results: Three of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power < 0.90. However, we examined only a modest number of trial reports from 1 year. Conclusions: Negative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated.

AB - Background: Many published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings. Study Design: We examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power (β ≥ 0.9) were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We examined the remaining 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies. Results: Three of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power < 0.90. However, we examined only a modest number of trial reports from 1 year. Conclusions: Negative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated.

UR - http://www.scopus.com/inward/record.url?scp=84871186922&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84871186922&partnerID=8YFLogxK

U2 - 10.1016/j.jamcollsurg.2012.09.015

DO - 10.1016/j.jamcollsurg.2012.09.015

M3 - Article

VL - 216

SP - 158

EP - 166

JO - Journal of the American College of Surgeons

T2 - Journal of the American College of Surgeons

JF - Journal of the American College of Surgeons

SN - 1072-7515

IS - 1

ER -

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