Evidence of publication bias in reporting acute stroke clinical trials

David S. Liebeskind, Chelsea S. Kidwell, James W. Sayre, Jeffrey L. Saver

Research output: Contribution to journalArticlepeer-review

43 Scopus citations

Abstract

OBJECTIVE: To ascertain the extent of publication bias in the reporting of acute stroke clinical trials. METHODS: We identified controlled acute ischemic stroke clinical trials reported in English over a 45-year period from 1955 to 1999 through systematic search of MEDLINE, the Cochrane Controlled Stroke Trials Register, and additional databases. We analyzed trial methodology, quality, outcome, study sponsorship, and timing of publication to identify various forms of publication bias, including nonpublication bias, abbreviated publication bias, and time-lag bias. RESULTS: One hundred seventy-eight acute ischemic stroke trials, enrolling 73,949 subjects, evaluated 75 agents or nonpharmacologic interventions. A greater proportion of harmful outcomes in unpublished studies (n = 4) compared with published trials (0.75 vs 0.06, p < 0.0001) and underreporting of smaller, nonbeneficial studies in acute stroke suggest nonpublication bias. Although a definite time-lag bias was not evident, nonbeneficial studies were slower to proceed from enrollment completion to publication (2.3 vs 2.0 years, p = 0.207), with an even longer delay for nonbeneficial corporate pharmaceutical sponsored trials (2.8 vs 2.1 years, p = 0.086), despite superior trial report quality scores for corporate-sponsored studies when compared with nonprofit/governmental studies (mean 69.2 ± 95% CI 3.9 vs 53.4 ± 95% CI 9.2, p < 0.005). CONCLUSION: Publication bias is evident in the acute stroke research literature, supporting the need for prospective trial registration.

Original languageEnglish (US)
Pages (from-to)973-979
Number of pages7
JournalNeurology
Volume67
Issue number6
DOIs
StatePublished - Sep 2006
Externally publishedYes

ASJC Scopus subject areas

  • Clinical Neurology

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