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.
Highlights
Standards for reporting clinical trials have improved the transparency of patientimportant research
There is emerging debate about the adherence to standards or recommendations made by regulatory bodies in the design, statistical analysis, description, and reporting of randomised clinical trials (RCT) intended to show noninferiority or equivalence [1]
In the extension of the Consolidated Standards of Reporting Trials (CONSORT) statement, conducting and reporting PP analyses alongside ITT has been suggested as a means of increasing confidence in the study finding when both methods produce similar results
Summary
Standards for reporting clinical trials have improved the transparency of patientimportant research. The Consolidated Standards of Reporting Trials (CONSORT) published an extension to address noninferiority and equivalence trials. There is emerging debate about the adherence to standards or recommendations made by regulatory bodies in the design, statistical analysis, description, and reporting of randomised clinical trials (RCT) intended to show noninferiority or equivalence [1]. The recent extension of the Consolidated Standards of Reporting Trials (CONSORT) statement to noninferiority and equivalence trials [1], the U. In designs intending to show noninferiority (i.e. that a new treatment is at least as good as or no worse than an existing treatment) or equivalence (i.e. show that a new treatment has equal or comparable efficacy effects), one area of debate has been the application of the intent-to-treat (ITT) principle versus the per-protocol (PP) analysis [5]. In the extension of the CONSORT statement, conducting and reporting PP analyses alongside ITT has been suggested as a means of increasing confidence in the study finding when both methods produce similar results
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