Assessment of the Impact of an Endpoint Committee in the Ocular Hypertension Treatment Study. Am J Ophthalmol 2019 Mar;199:193-199
Date
11/25/2018Pubmed ID
30471242Pubmed Central ID
PMC6382552DOI
10.1016/j.ajo.2018.11.006Scopus ID
2-s2.0-85059523607 (requires institutional sign-in at Scopus site) 17 CitationsAbstract
PURPOSE: To assess the impact of a masked Endpoint Committee on estimates of the incidence of primary open-angle glaucoma (POAG) treatment efficacy and statistical power of the Ocular Hypertension Treatment Study-Phase 1, 1994-2002 (OHTS-1).
DESIGN: Retrospective interrater reliability analysis of endpoint attribution by the Endpoint Committee.
METHODS: After study closeout, we recalculated estimates of endpoint incidence, treatment efficacy, and statistical power using all-cause endpoints and POAG endpoints. To avoid bias, only the first endpoint per participant is included in this report.
RESULTS: The Endpoint Committee reviewed 267 first endpoints from 1636 participants. The Endpoint Committee attributed 58% (155 of 267) of the endpoints to POAG. The incidence of all-cause endpoints vs POAG endpoints was 19.5% and 13.2%, respectively, in the observation group and 13.1% and 5.8%, respectively, in the medication group. Treatment effect for all-cause endpoints was a 33% reduction in risk (relative risk = 0.67, 95% confidence interval [CI] of 0.54-0.84) and a 56% reduction in risk for POAG endpoints (relative risk = 0.44, 95% CI of 0.31-0.61). Post hoc statistical power for detecting treatment effect was 0.94 for all-cause endpoints and 0.99 for POAG endpoints.
CONCLUSION: Endpoint Committee adjudication of endpoints improved POAG incidence estimates, increased statistical power, and increased calculated treatment effect by 23%. An Endpoint Committee should be considered in therapeutic trials when common ocular and systemic comorbidities, other than the target condition, could compromise study results.
Author List
Gordon MO, Higginbotham EJ, Heuer DK, Parrish RK 2nd, Robin AL, Morris PA, Dunn DA, Wilson BS, Kass MA, Ocular Hypertension Treatment StudyAuthor
Dale Heuer MD Emeritus Professor in the Ophthalmology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdultAntihypertensive Agents
Endpoint Determination
Female
Glaucoma, Open-Angle
Humans
Intraocular Pressure
Male
Middle Aged
Ocular Hypertension
Optic Disk
Optic Nerve Diseases
Reproducibility of Results
Retrospective Studies
Risk Factors
Tonometry, Ocular
Treatment Outcome
Vision Disorders
Visual Field Tests
Visual Fields
