Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (eagle): a randomised controlled trial
Participants with observations from at least one of these
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Participants with observations from at least one of these timepoints were included in the analyses. Baseline EQ-5D scores and intraocular pressure values were used as explanatory variables. The model included fi xed eff ects for sex, ethnic origin, diagnosis, whether glaucoma was present in one or both eyes, and intervention. Dummy variables for the timepoint were included to enable investigation of the eff ects of the interventions at each timepoint. Random eff ects were included for centre and individual. The model was extended for subgroup analyses by fi tting a dummy variable for each respective subgroup. These dummy variables were used to create further interaction terms to represent the eff ect of clear- lens extraction in the subgroups at each of the timepoints, expressed as odds ratios and 95% CIs. The secondary continuous and binary outcomes were analysed with appropriate generalised linear models. The unit of analysis for the clinical outcomes was the treated eye (the worse eye if both were suitable for treatment). For quality of life measures, the unit of analysis was the participant, with bilateral disease included as a fi xed eff ect covariate. To account for missing answers in questionnaires we followed the authors’ recommendations. These allow a score to be generated if there are missing questions in the NEI-VFQ-25, whereas for EQ-5D and the glaucoma- specifi c disability questionnaire, no score is assigned. Planned subgroup analyses used the minimisation variables ethnic origin (Chinese or non-Chinese), diagnosis (primary angle closure or primary angle-closure glaucoma), and unilateral or bilateral disease. We added an unplanned subgroup analysis after baseline visual acuity data were assessed to explore the possible diff erence in the primary outcome between patients with excellent and slightly decreased visual acuity (≥85 ETDRS letters vs <85 ETDRS letters). The in-trial cost-eff ectiveness data were obtained with seemingly unrelated regression adjustment for baseline cost and EQ-5D score. We compared mean costs and eff ects to estimate the incremental cost-eff ectiveness ratio (ICER) for clear-lens extraction versus standard care. tải về 315.39 Kb. Chia sẻ với bạn bè của bạn:
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