Multicomponent Strategy with Decentralized Molecular Testing for Tuberculosis.

Multicomponent Strategy with Decentralized Molecular Testing for Tuberculosis.
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结核病分散分子检测的多组分策略。

DOI:
10.1056/nejmoa2105470
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发表时间:
2021-12-23
期刊:
The New England journal of medicine
影响因子:
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其他
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需要制定有效的战略,以促进结核病高负担国家及时诊断和治疗结核病。我们进行了一项分组随机试验,乌干达社区卫生中心被分配到多组分诊断策略(现场结核病分子检测,指导诊所工作流程的重组,以及每月质量指标的反馈)或常规护理(现场结核病涂片显微镜检查和基于组织的分子检测)。主要结果是在16个月的干预期间,在前往卫生中心进行评估后14天内接受确诊肺结核治疗的成人人数。次要结果包括完成结核病检测、当天诊断和当天治疗。还根据比例对结果进行了评估。共有20个健康中心接受随机分组,每组10个。在对10,644名符合条件的成年人(中位年龄40岁)的数据进行评估时,60.1%是女性,43.8%患有人类免疫缺陷病毒感染。干预策略导致更多患者在就诊后14天内接受确诊肺结核治疗(10个干预卫生中心的342名患者与10个对照卫生中心的220名患者;校正率比为1.56; 95%置信区间[CI]为1.21至2.01)。干预中心完成结核病检测的患者多于控制中心(校正率比,1.85; 95% CI,1.21 - 2.82),当天诊断(校正率比,1.89; 95%CI,1.39 - 2.56),并接受确诊结核病的当天治疗(校正率比,2.38; 95% CI,1.57 - 3.61)。在706例确诊的结核病患者中,干预组在就诊当天(校正率比,2.29; 95%CI,1.23 - 4.25)或就诊后14天内(校正率比,1.22; 95%CI,1.06 - 1.40)接受治疗的比例高于对照组。一项包括现场分子检测和实施支助的多组分诊断战略消除了提供高质量结核病评价服务的障碍,使更多的患者接受检测、诊断和治疗确诊的结核病。(由国家心肺血液研究所资助; XPEL-TB ClinicalTrials.gov编号,NCT 03044158。
Effective strategies are needed to facilitate the prompt diagnosis and treatment of tuberculosis in countries with a high burden of the disease. We conducted a cluster-randomized trial in which Ugandan community health centers were assigned to a multicomponent diagnostic strategy (on-site molecular testing for tuberculosis, guided restructuring of clinic workflows, and monthly feedback of quality metrics) or routine care (on-site sputum-smear microscopy and referral-based molecular testing). The primary outcome was the number of adults treated for confirmed tuberculosis within 14 days after presenting to the health center for evaluation during the 16-month intervention period. Secondary outcomes included completion of tuberculosis testing, same-day diagnosis, and same-day treatment. Outcomes were also assessed on the basis of proportions. A total of 20 health centers underwent randomization, with 10 assigned to each group. Of 10,644 eligible adults (median age, 40 years) whose data were evaluated, 60.1% were women and 43.8% had human immunodeficiency virus infection. The intervention strategy led to a greater number of patients being treated for confirmed tuberculosis within 14 days after presentation (342 patients across 10 intervention health centers vs. 220 across 10 control health centers; adjusted rate ratio, 1.56; 95% confidence interval [CI], 1.21 to 2.01). More patients at intervention centers than at control centers completed tuberculosis testing (adjusted rate ratio, 1.85; 95% CI, 1.21 to 2.82), received a same-day diagnosis (adjusted rate ratio, 1.89; 95% CI, 1.39 to 2.56), and received same-day treatment for confirmed tuberculosis (adjusted rate ratio, 2.38; 95% CI, 1.57 to 3.61). Among 706 patients with confirmed tuberculosis, a higher proportion in the intervention group than in the control group were treated on the same day (adjusted rate ratio, 2.29; 95% CI, 1.23 to 4.25) or within 14 days after presentation (adjusted rate ratio, 1.22; 95% CI, 1.06 to 1.40). A multicomponent diagnostic strategy that included on-site molecular testing plus implementation supports to address barriers to delivery of high-quality tuberculosis evaluation services led to greater numbers of patients being tested, receiving a diagnosis, and being treated for confirmed tuberculosis. (Funded by the National Heart, Lung, and Blood Institute; XPEL-TB ClinicalTrials.gov number, NCT03044158.)
DOI: 10.1016/j.conctc.2021.100707
发表时间: 2021-06
影响因子: 1.5
作者:
Reza TF;Nalugwa T;Nantale M;Adams K;Fielding K;Nakaweesa A;Oyuku D;Nabwire S;Musinguzi J;Ojok C;Babirye D;Ackerman SL;Handley MA;Kityamuwesi A;Dowdy DW;Moore DAJ;Davis JL;Turyahabwe S;Katamba A;Cattamanchi A
通讯作者: Cattamanchi A