Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, MA, USA; Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
TB Centre, London School of Hygiene & Tropical Medicine, London, UK; Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi.
Lancet Glob Health. 2019 Feb;7(2):e200-e208. doi: 10.1016/S2214-109X(18)30436-4.
Testing urine improves the number of tuberculosis diagnoses made among patients in hospital with HIV. In conjunction with the two-country randomised Rapid Urine-based Screening for Tuberculosis to Reduce AIDS-related Mortality in Hospitalised Patients in Africa (STAMP) trial, we used a microsimulation model to estimate the effects on clinical outcomes and the cost-effectiveness of adding urine-based tuberculosis screening to sputum screening for hospitalised patients with HIV.
We compared two tuberculosis screening strategies used irrespective of symptoms among hospitalised patients with HIV in Malawi and South Africa: a GeneXpert assay (Cepheid, Sunnyvale, CA, USA) for Mycobacterium tuberculosis and rifampicin resistance (Xpert) in sputum samples (standard of care) versus sputum Xpert combined with a lateral flow assay for M tuberculosis lipoarabinomannan in urine (Determine TB-LAM Ag test, Abbott, Waltham, MA, USA [formerly Alere]; TB-LAM) and concentrated urine Xpert (intervention). A cohort of simulated patients was modelled using selected characteristics of participants, tuberculosis diagnostic yields, and use of hospital resources in the STAMP trial. We calibrated 2-month model outputs to the STAMP trial results and projected clinical and economic outcomes at 2 years, 5 years, and over a lifetime. We judged the intervention to be cost-effective if the incremental cost-effectiveness ratio (ICER) was less than US$750/year of life saved (YLS) in Malawi and $940/YLS in South Africa. A modified intervention of adding only TB-LAM to the standard of care was also evaluated. We did a budget impact analysis of countrywide implementation of the intervention.
The intervention increased life expectancy by 0·5-1·2 years and was cost-effective, with an ICER of $450/YLS in Malawi and $840/YLS in South Africa. The ICERs decreased over time. At lifetime horizon, the intervention remained cost-effective under nearly all modelled assumptions. The modified intervention was at least as cost-effective as the intervention (ICERs $420/YLS in Malawi and $810/YLS in South Africa). Over 5 years, the intervention would save around 51 000 years of life in Malawi and around 171 000 years of life in South Africa. Health-care expenditure for screened individuals was estimated to increase by $37 million (10·8%) and $261 million (2·8%), respectively.
Urine-based tuberculosis screening of all hospitalised patients with HIV could increase life expectancy and be cost-effective in resource-limited settings. Urine TB-LAM is especially attractive because of high incremental diagnostic yield and low additional cost compared with sputum Xpert, making a compelling case for expanding its use to all hospitalised patients with HIV in areas with high HIV burden and endemic tuberculosis.
UK Medical Research Council, UK Department for International Development, Wellcome Trust, US National Institutes of Health, Royal College of Physicians, Massachusetts General Hospital.
检测尿液可提高在感染 HIV 的住院患者中诊断结核病的数量。在结合了两国的随机快速尿液基础结核病筛查以减少非洲住院患者与艾滋病相关的死亡率（STAMP）试验的情况下，我们使用了一个微观模拟模型来评估对临床结果的影响和添加尿液基础结核病筛查对住院 HIV 患者的痰液筛查的成本效益。
我们比较了在马拉维和南非住院的 HIV 患者中使用的两种不论症状的结核病筛查策略：用于检测结核分枝杆菌和利福平耐药性的 GeneXpert 检测（Cepheid，加利福尼亚州森尼韦尔）在痰样本（标准护理）中（Xpert）与痰 Xpert 结合用于尿液中的结核分枝杆菌脂阿拉伯甘露聚糖的侧向流动检测（Abbott，马萨诸塞州沃尔瑟姆的 Determine TB-LAM Ag 测试，简称 TB-LAM）和浓缩尿液 Xpert（干预）。使用 STAMP 试验中参与者的选定特征、结核病诊断率和医院资源的使用情况，对模拟患者队列进行建模。我们将 2 个月的模型输出校准到 STAMP 试验结果，并预测 2 年、5 年和终生的临床和经济结果。如果增量成本效益比（ICER）低于马拉维每年每挽救 1 生命（YLS）750 美元和南非每年每挽救 1 生命 940 美元，则认为干预措施具有成本效益。还评估了仅将 TB-LAM 添加到标准护理中的改良干预措施。我们对该干预措施在全国范围内实施进行了预算影响分析。
该干预措施使预期寿命延长了 0.5-1.2 年，并且具有成本效益，在马拉维和南非的 ICER 分别为 450 美元/YLS 和 840 美元/YLS。ICER 随时间下降。在终生范围内，在几乎所有模型假设下，该干预措施仍然具有成本效益。改良干预措施至少与干预措施一样具有成本效益（ICER 分别为马拉维和南非的 420 美元/YLS 和 810 美元/YLS）。在 5 年内，该干预措施将分别节省马拉维约 51000 年的生命和南非约 171000 年的生命。预计筛查个体的医疗保健支出将分别增加 3700 万美元（10.8%）和 2.61 亿美元（2.8%）。
对所有住院的 HIV 患者进行尿液基础结核病筛查可以提高预期寿命并在资源有限的环境中具有成本效益。与痰 Xpert 相比，尿液 TB-LAM 具有较高的增量诊断率和较低的附加成本，因此尤其具有吸引力，这为扩大其在高 HIV 负担和地方性结核病地区所有住院的 HIV 患者中的使用提供了有力的理由。
英国医学研究理事会、英国国际发展部、惠康信托基金、美国国立卫生研究院、皇家内科医师学院、马萨诸塞州总医院。
