PURPOSE To evaluate the relationship between medication adherence and visual field progression in participants randomized to the medication arm of the Collaborative Initial Glaucoma Treatment Study (CIGTS). DESIGN The CIGTS was a randomized, multicenter clinical trial comparing initial treatment with topical medications to trabeculectomy for 607 participants with newly diagnosed glaucoma. PARTICIPANTS Three hundred seven participants randomized to the medication arm of the CIGTS. METHODS Participants were followed up at 6-month intervals for up to 10 years. Self-reported medication adherence and visual fields were measured. Medication adherence was assessed by telephone from responses to the question, "Did you happen to miss any dose of your medication yesterday?" The impact of medication adherence on mean deviation (MD) over time was assessed with a linear mixed regression model adjusting for the effects of baseline MD and age, cataract extraction, interactions, and time (through year 8, excluding time after crossover to surgery). Medication adherence was modeled as a cumulative sum of the number of prior visits where a missed dose of medication was reported. MAIN OUTCOME MEASURE Mean deviation over time. RESULTS Three hundred seven subjects (306 with adherence data) were randomized to treatment with topical medications and followed up for an average of 7.3 years (standard deviation, 2.3 years). One hundred forty-two subjects (46%) reported never missing a dose of medication over all available follow-up, 112 patients (37%) reported missing medication at up to one third of visits, 31 patients (10%) reported missing medication at one third to two thirds of visits, and 21 patients (7%) reported missing medication at more than two thirds of visits. Worse medication adherence was associated with loss of MD over time (P = 0.005). For subjects who reported never missing a dose of medication, the average predicted MD loss over 8 years was 0.62 dB, consistent with age-related loss (95% confidence interval [CI], 0.17-1.06; P = 0.007); subjects who reported missing medication doses at one third of visits had a loss of 1.42 dB (95% CI, 0.86-1.98; P < 0.0001); and subjects who reported missing medication doses at two thirds of visits showed a loss of 2.23 dB (95% CI, 1.19-3.26; P < 0.0001). CONCLUSIONS This longitudinal assessment demonstrated a statistically and clinically significant association between medication nonadherence and glaucomatous vision loss.

中文翻译：

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合作性青光眼初始治疗研究中药物依从性与视野进展之间的关联。


目的 评估随机分入合作初始青光眼治疗研究 (CIGTS) 药物组的参与者的药物依从性和视野进展之间的关系。设计 CIGTS 是一项随机、多中心临床试验，对 607 名新诊断青光眼的参与者进行了局部药物初始治疗与小梁切除术的比较。参与者 307 名参与者被随机分配到 CIGTS 的药物组。方法 参与者每 6 个月接受一次随访，随访时间长达 10 年。测量了自我报告的药物依从性和视野。药物依从性是通过电话根据对“您昨天是否漏服任何剂量的药物？”这一问题的回答来评估的。使用线性混合回归模型评估药物依从性对平均偏差 (MD) 随时间的影响，调整基线 MD 和年龄、白内障摘除术、相互作用和时间（截至 8 年，不包括交叉手术后的时间）的影响。药物依从性被建模为报告漏服药物的先前就诊次数的累积总和。主要结果测量随时间变化的平均偏差。结果 307 名受试者（306 名有依从性数据）被随机分配接受局部药物治疗，并平均随访 7.3 年（标准差为 2.3 年）。 142 名受试者 (46%) 报告在所有可用的随访中从未漏服一剂药物，112 名患者 (37%) 报告在多达三分之一的就诊中漏服药物，31 名患者 (10%) 报告漏服药物三分之一至三分之二的就诊中，有 21 名患者 (7%) 报告在超过三分之二的就诊中缺少药物。 随着时间的推移，较差的药物依从性与 MD 的丧失相关（P = 0.005）。对于从未漏服一剂药物的受试者，8 年内平均预测 MD 损失为 0.62 dB，与年龄相关损失一致（95% 置信区间 [CI]，0.17-1.06；P = 0.007）；三分之一就诊时报告缺少药物剂量的受试者损失了 1.42 dB（95% CI，0.86-1.98；P < 0.0001）；在三分之二的访视中报告遗漏药物剂量的受试者显示出 2.23 dB 的损失（95% CI，1.19-3.26；P < 0.0001）。结论 这项纵向评估表明，药物不依从性与青光眼视力丧失之间存在统计和临床显着关联。