Reporting of noninferiority and equivalence randomized trials for major prostaglandins: A systematic survey of the ophthalmology literatureReport as inadecuate




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Trials

, 9:69

First Online: 03 December 2008Received: 10 May 2008Accepted: 03 December 2008DOI: 10.1186-1745-6215-9-69

Cite this article as: Eyawo, O., Lee, CW., Rachlis, B. et al. Trials 2008 9: 69. doi:10.1186-1745-6215-9-69

Abstract

BackgroundStandards for reporting clinical trials have improved the transparency of patient-important research. The Consolidated Standards of Reporting Trials CONSORT published an extension to address noninferiority and equivalence trials. We aimed to determine the reporting quality of prostaglandin noninferiority and equivalence trials in the treatment of glaucoma.

MethodsWe searched, independently and in duplicate, 6 electronic databases for eligible trials evaluating prostaglandins. We abstracted data on reporting of methodological criteria, including reporting of per-protocol PP and intention-to-treat ITT analysis, sample size estimation with margins, type of statistical analysis conducted, efficacy summaries, and use of hyperemia measures.

ResultsTrials involving the four major prostaglandin groups latanoprost, travoprost, bimatoprost, unoprostone were analyzed. We included 36 noninferiority and 11 equivalence trials. Seventeen out of the included 47 trials 36%, 95% Confidence Intervals CI: 24–51 were crossover designs. Only 3 studies 6%, 95% CI: 2–17 reported a presented results of both ITT and PP populations. Twelve studies 26%, 95% CI: 15–39 presented only ITT results but mentioned that PP population had similar results. Thirteen trials 28%, 95% CI: 17–42 presented only PP results with no mention of ITT population results while 17 studies 36%, 95% CI: 24–51 presented only ITT results with no mention of PP population results. Thirty-four 72%, 95% CI: 58–83 of studies adequately described their margin of noninferiority-equivalence. Sequence generation was reported in 22-47 trials 47%, 95% CI: 33–61. Allocation concealment was reported in only 10-47 21%, 95% CI: 12–35 of the trials. Thirty-five studies 74%, 95% CI: 60–85 employed masking of at least two groups, 4-47 9%, 95% CI: 3–20 masked only patients and 8-47 17%, 95% CI: 9–30 were open label studies. Eight 17%, 95% CI: 9–30 of the 47 trials employed a combined test of noninferiority and superiority. We also found 6 differing methods of evaluating hyperemia.

ConclusionThe quality of reporting noninferiority-equivalency trials in the field of glaucoma is markedly heterogeneous. The adoption of the extended CONSORT statement by journals will potentially improve the transparency of this field.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-9-69 contains supplementary material, which is available to authorized users.

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Author: Oghenowede Eyawo - Chia-Wen Lee - Beth Rachlis - Edward J Mills

Source: https://link.springer.com/







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