Negative results of randomized clinical trials published in the surgical literature: Equivalency or error?

Research output: Contribution to journalArticle

Abstract

Hypothesis: We hypothesized that review of randomized controlled clinical trials (RCTs) with nonstatistically significant or "negative" results published in the surgical literature do not have appropriate statistical power to demonstrate equivalency between treatment arms. Data Sources and Study Selection: The MEDLINE database was searched to obtain reports of all RCTs with negative results published in 3 surgical journals from 1988 to 1998. Manual review of one year (1997) of publications for each journal was performed to validate our search strategy. Equivalency was evaluated using the Two One-Sided Tests Procedure and post hoc power calculations. Data Synthesis: Ninety reports of RCTs with negative results were identified in the surgical literature between 1988 and 1998. The manual review of 1997 showed a 100% retrieval rate for our search strategy. After applying the Two One-Sided Tests Procedure, 35 reports (39%) met the criteria for demonstrating equivalency. The other 55 reports (61%) contained at least a 10% absolute difference in the 90% confidence interval of Δ. Using the power calculation method, only 22 (24%) articles had a power greater than .80 to detect a 50% difference in therapeutic effect. Only 29% of the reports included a formal sample size calculation and these studies were more likely to demonstrate equivalency than those without a sample size estimate (P

Original languageEnglish (US)
Pages (from-to)796-800
Number of pages5
JournalArchives of Surgery
Volume136
Issue number7
StatePublished - 2001

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Randomized Controlled Trials
Sample Size
Information Storage and Retrieval
Therapeutic Uses
MEDLINE
Publications
Databases
Confidence Intervals

ASJC Scopus subject areas

  • Surgery

Cite this

Negative results of randomized clinical trials published in the surgical literature : Equivalency or error? / Dimick, Justin B.; Diener-West, Marie; Lipsett, Pamela A.

In: Archives of Surgery, Vol. 136, No. 7, 2001, p. 796-800.

Research output: Contribution to journalArticle

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AU - Diener-West, Marie

AU - Lipsett, Pamela A

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