Thiam Sylla, LeFevre Andrea M, Hane Fatoumata, Ndiaye Alimatou, Ba Fatoumata, Fielding Katherine L, Ndir Moustapha, Lienhardt Christian
Institut de Recherche pour le Développement, Programme Tuberculose, Dakar, Senegal.
JAMA. 2007 Jan 24;297(4):380-6. doi: 10.1001/jama.297.4.380.
Poor adherence to treatment remains a major obstacle to efficient tuberculosis (TB) control in developing countries. Innovative strategies to improve access and adherence to treatment are needed.
To assess the effectiveness of a contextualized intervention strategy aimed at improving patients' adherence to treatment and to evaluate its impact on TB control in a resource-poor country in Africa with prevalent TB infection.
DESIGN, SETTING, AND PATIENTS: A cluster randomized controlled trial, conducted between June 2003 and January 2005, at 16 government district health centers in Senegal. Patients older than 15 years with newly diagnosed sputum smear-positive pulmonary TB were randomly assigned to the intervention or control group.
The intervention strategy included reinforced counseling through improved communication between health personnel and patients, decentralization of treatment, choice of directly observed therapy (DOT) supporter by the patient, and reinforcement of supervision activities. In the control group, the usual TB control program procedures remained unchanged.
Proportion of patients successfully completing the 8-month course of treatment and the proportion of patients defaulting from treatment.
A total of 1522 patients were recruited into the study. Treatment was successful for 682 (88%) of 778 patients recruited in the intervention group, and for 563 (76%) of 744 patients recruited in the control group (adjusted risk ratio [RR], 1.18; 95% confidence interval [CI], 1.03-1.34). The proportion of patients defaulting was reduced in the intervention group to 5.5% (n = 43) compared with 16.8% (n = 125) in the control group (adjusted RR, 0.43; 95% CI, 0.21-0.89).
The intervention package based on improved patients counseling and communication, decentralization of treatment, patient choice of DOT supporter, and reinforcement of supervision activities led to improvement in patient outcomes compared with the usual TB control procedures. This approach may be generalized in the context of TB control programs in resource-poor countries.
clinicaltrials.gov Identifier: NCT00412009.
在发展中国家，治疗依从性差仍然是有效控制结核病的主要障碍。需要创新策略来改善治疗的可及性和依从性。
评估一种情境化干预策略在提高患者治疗依从性方面的有效性，并评估其对非洲一个结核病感染流行的资源匮乏国家结核病控制的影响。
设计、地点和患者：2003年6月至2005年1月在塞内加尔的16个政府区级卫生中心进行了一项整群随机对照试验。年龄超过15岁的新诊断为痰涂片阳性肺结核的患者被随机分配到干预组或对照组。
干预策略包括通过改善卫生人员与患者之间的沟通加强咨询、治疗去中心化、患者选择直接观察治疗（DOT）支持者以及加强监督活动。在对照组中，常规结核病控制项目程序保持不变。
成功完成8个月疗程的患者比例和治疗中断的患者比例。
共有1522名患者纳入研究。干预组招募的778名患者中有682名（88%）治疗成功，对照组招募的744名患者中有563名（76%）治疗成功（调整风险比[RR]，1.18；95%置信区间[CI]，1.03 - 1.34）。干预组患者中断治疗的比例降至5.5%（n = 43），而对照组为16.8%（n = 125）（调整RR，0.43；95%CI，0.21 - 0.89）。
与常规结核病控制程序相比，基于改善患者咨询与沟通、治疗去中心化、患者选择DOT支持者以及加强监督活动的干预方案使患者治疗结果得到改善。这种方法可能在资源匮乏国家的结核病控制项目中推广。
clinicaltrials.gov标识符：NCT00412009。
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