Avedisian Onanian Centre for Health Services Research & Development, Gerald and Patricia Turpanjian School of Public Health, American University of Armenia, Yerevan, Armenia.
Department of Epidemiology, Fielding School of Public Health, University of California, Los Angeles, Los Angeles, USA.
BMC Pulm Med. 2020 Apr 25;20(1):105. doi: 10.1186/s12890-020-1141-y.
WHO's directly observed therapy (DOT) strategy for tuberculosis (TB) treatment depends upon a well-organized healthcare system. This study sought to evaluate the effectiveness of self-administered drug intake supported by a family member versus in-clinic DOT.
This open-label, nationally-representative stratified cluster randomized controlled non-inferiority trial with two parallel equal arms involved drug-susceptible pulmonary TB patients in the continuation treatment phase. We randomly assigned outpatient-TB-centres (52 clusters) to intervention and control arms. The intervention included an educational/counseling session to enhance treatment adherence; weekly visits to outpatient-TB-centres to receive medication, and daily SMS medication reminders and phone calls to track adherence and record side effects. Controls followed clinical DOT at Outpatient-TB-centres. Both groups participated in baseline and 4-5 months follow-up surveys. The trial's non-inferiority comparisons include: treatment success as the clinical (primary) outcome and medication adherence (self-reported), knowledge, depressive symptoms, stigma, quality of life, and social support as non-clinical (secondary) outcomes.
Per-protocol analysis showed that the intervention (n = 187) and control (n = 198) arms achieved successful treatment outcome of 92.0 and 92.9%, respectively, indicating that the treatment success in the intervention group was non-inferior to DOT. Knowledge, depression, stigma, quality of life, and social support also showed non-inferiority, demonstrating substantial improvement over time for knowledge (change in the intervention = 1.05: 95%CL (0.49, 1.60); change in the control = 1.09: 95%CL (0.56, 1.64)), depression score (change in the intervention = - 3.56: 95%CL (- 4.99, - 2.13); change in the control = - 1.88: 95% CL (- 3.26, - 0.49)) and quality of life (change in the intervention = 5.01: 95%CL (- 0.64, 10.66); change in the control = 7.29: 95%CL (1.77, 12.81)). The intervention resulted in improved treatment adherence.
This socially empowering alternative strategy might be a preferable alternative to DOT available to patients in Armenia and in other countries. Further research evaluating cost effectiveness of the intervention and generalizability of the results is warranted.
Clinicaltrials.gov: NCT02082340, March 10, 2014.
世界卫生组织（WHO）的直接观察治疗（DOT）结核病（TB）治疗策略依赖于组织完善的医疗体系。本研究旨在评估由家庭成员支持的自我药物摄入与门诊 DOT 治疗的效果。
这是一项开放标签、全国代表性分层聚类随机对照非劣效性试验，具有两个平行的相等手臂，涉及继续治疗阶段的药物敏感型肺结核患者。我们将门诊结核病中心（52 个集群）随机分配到干预组和对照组。干预措施包括开展教育/咨询会议以提高治疗依从性；每周到门诊结核病中心就诊以接受药物治疗，并每天发送短信药物提醒和电话，以跟踪依从性并记录副作用。对照组在门诊结核病中心接受临床 DOT 治疗。两组均参加基线和 4-5 个月的随访调查。试验的非劣效性比较包括：治疗成功作为临床（主要）结局和药物依从性（自我报告）、知识、抑郁症状、耻辱感、生活质量和社会支持作为非临床（次要）结局。
按方案分析显示，干预组（n=187）和对照组（n=198）分别达到 92.0%和 92.9%的治疗成功，表明干预组的治疗成功率不劣于 DOT。知识、抑郁、耻辱感、生活质量和社会支持也显示出非劣效性，表明知识（干预组变化=1.05：95%CL（0.49, 1.60）；对照组变化=1.09：95%CL（0.56, 1.64））、抑郁评分（干预组变化=-3.56：95%CL（-4.99, -2.13）；对照组变化=-1.88：95%CL（-3.26, -0.49））和生活质量（干预组变化=5.01：95%CL（-0.64, 10.66）；对照组变化=7.29：95%CL（1.77, 12.81））有显著改善。干预措施导致治疗依从性提高。
这种具有社会赋权作用的替代策略可能是亚美尼亚和其他国家患者可替代 DOT 的首选方案。需要进一步研究评估干预的成本效益和结果的普遍性。
Clinicaltrials.gov：NCT02082340，2014 年 3 月 10 日。
