Wolfson Institute of Population Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Homerton Healthcare NHS Foundation Trust, London, UK.
Eur Respir J. 2024 Nov 7;64(5). doi: 10.1183/13993003.01733-2023. Print 2024 Nov.
Control of latent tuberculosis infection (LTBI) is a priority in the World Health Organization strategy to eliminate TB. Many high-income, low TB incidence countries have prioritised LTBI screening and treatment in recent migrants. We tested whether a novel model of care, based entirely within primary care, was effective and safe compared to secondary care.
This was a pragmatic cluster-randomised, parallel group, superiority trial (ClinicalTrials.gov: NCT03069807) conducted in 34 general practices in London, UK, comparing LTBI treatment in recent migrants in primary care to secondary care. The primary outcome was treatment completion, defined as taking ≥90% of antibiotic doses. Secondary outcomes included treatment acceptance, adherence, adverse effects, patient satisfaction, TB incidence and a cost-effectiveness analysis. Analyses were performed on an intention-to-treat basis.
Between September 2016 and May 2019, 362 recent migrants with LTBI were offered treatment and 276 accepted. Treatment completion was similar in primary and secondary care (82.6% 86.0%; adjusted OR (aOR) 0.64, 95% CI 0.31-1.29). There was no difference in drug-induced liver injury between primary and secondary care (0.7% 2.3%; aOR 0.29, 95% CI 0.03-2.84). Treatment acceptance was lower in primary care (65.2% (146/224) 94.2% (130/138); aOR 0.10, 95% CI 0.03-0.30). The estimated cost per patient completing treatment was lower in primary care, with an incremental saving of GBP 315.27 (95% CI 313.47-317.07).
The treatment of LTBI in recent migrants within primary care does not result in higher rates of treatment completion but is safe and costs less when compared to secondary care.
控制潜伏性结核感染(LTBI)是世界卫生组织消除结核病战略的重点。许多高收入、低结核病发病率的国家最近都优先考虑对新移民进行 LTBI 筛查和治疗。我们测试了一种完全基于初级保健的新型护理模式是否比二级保健更有效和安全。
这是一项在英国伦敦的 34 家普通诊所进行的实用聚类随机、平行组、优效性试验(ClinicalTrials.gov:NCT03069807),比较了初级保健中对新移民的 LTBI 治疗与二级保健。主要结局是治疗完成率,定义为服用≥90%的抗生素剂量。次要结局包括治疗接受率、依从性、不良反应、患者满意度、结核病发病率和成本效益分析。分析基于意向治疗进行。
在 2016 年 9 月至 2019 年 5 月期间,362 名患有 LTBI 的新移民接受了治疗,其中 276 人接受了治疗。初级保健和二级保健中的治疗完成率相似(82.6%(224/273) 86.0%(130/151);调整后的比值比(aOR)为 0.64,95%CI 为 0.31-1.29)。初级保健和二级保健之间的药物性肝损伤没有差异(0.7%(224/3128) 2.3%(130/5649);aOR 为 0.29,95%CI 为 0.03-2.84)。初级保健中的治疗接受率较低(65.2%(146/224) 94.2%(130/138);aOR 为 0.10,95%CI 为 0.03-0.30)。完成治疗的每位患者的估计成本在初级保健中较低,增量节省为 315.27 英镑(95%CI 313.47-317.07)。
与二级保健相比,将新移民的 LTBI 治疗纳入初级保健并不会导致更高的治疗完成率,但更安全且成本更低。