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Reporting of noninferiority and equivalence randomized trials for major prostaglandins: a systematic survey of the ophthalmology literature.

ABSTRACT: BACKGROUND: Standards 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. METHODS: We 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. RESULTS: Trials 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. CONCLUSION: The 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.

SUBMITTER: Eyawo O

PROVIDER: S-EPMC2621118 | biostudies-literature | 2008

REPOSITORIES: biostudies-literature

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Reporting of noninferiority and equivalence randomized trials for major prostaglandins: a systematic survey of the ophthalmology literature.

Eyawo Oghenowede O Lee Chia-Wen CW Rachlis Beth B Mills Edward J EJ

Trials 20081203

<h4>Background</h4>Standards 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.<h4>Methods</h4>We searched, independently and in duplicate, 6 electronic databases for eligible trials evaluating prosta ...[more]

PMID: 19055743

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Project description:ImportanceSpin, the inaccurate reporting of randomized clinical trials (RCTs) with results that are not statistically significant for the primary end point, distorts interpretation of results and leads to misinterpretation. However, the prevalence of spin and related factors in noninferiority cancer RCTs remains unclear.ObjectiveTo examine misleading reporting, or spin, and the associated factors in noninferiority cancer RCTs through a systematic review.Data sourcesA systematic search of the PubMed database was performed for articles published between January 1, 2010, and December 31, 2019, using the Cochrane Highly Sensitive Search Strategy.Study selectionTwo investigators independently selected studies using the inclusion criteria of noninferiority parallel-group RCTs aiming to confirm effects to cancer treatments published between January 1, 2010, and December 31, 2019, reporting results that were not statistically significant for the primary end points.Data extraction and synthesisStandardized data abstraction was used to extract information concerning the trial characteristics and spin based on a prespecified definition. The main investigator extracted the trial characteristics while both readers independently evaluated the spin. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline was followed.Main outcomes and measuresThe main outcome was spin prevalence in any section of the report. Spin was defined as use of specific reporting strategies, from whatever motive, to highlight that the experimental treatment is beneficial, despite no statistically significant difference for the primary outcome, or to distract the reader from results that are not statistically significant. The associations (prevalence difference and odds ratios [ORs]) between spin and trial characteristics were also evaluated.ResultsThe analysis included 52 of 2752 reports identified in the PubMed search. Spin was identified in 39 reports (75.0%; 95% CI, 61.6%-84.9%), including the abstract (34 reports [65.4%; 95% CI, 51.1%-76.9%]) and the main text (38 reports [73.1%; 95% CI, 59.7%-83.3%]). Univariate analysis found that the spin prevalence was higher in reports with data managers (prevalence difference, 27%; 95% CI, 1.1%-50.3%), reports without funding from for-profit sources (prevalence difference, 31.2%; 95% CI, 4.8%-53.8%), and reports of novel experimental treatments (prevalence difference, 37.5%; 95% CI, 5.8%-64.7%). Multivariable analysis found that novel experimental treatment (OR, 4.64; 95% CI, 0.98-22.02) and funding only from nonprofit sources only (OR, 5.20; 95% CI, 1.21-22.29) were associated with spin.Conclusions and relevanceIn this systematic review, most noninferiority RCTs reporting results that were not statistically significant for the primary end points showed distorted interpretation and inaccurate reporting. The novelty of an experimental treatment and funding only from nonprofit sources were associated with spin.

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Reporting of noninferiority and equivalence randomized trials for major prostaglandins: a systematic survey of the ophthalmology literature.

Publications

Reporting of noninferiority and equivalence randomized trials for major prostaglandins: a systematic survey of the ophthalmology literature.

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