预测撒哈拉以南非洲地区早期抗逆转录病毒治疗死亡率的风险评分，以确定需要加强护理的人群：推导和外部验证队列研究。
Risk scores for predicting early antiretroviral therapy mortality in sub-Saharan Africa to inform who needs intensification of care: a derivation and external validation cohort study.
机构信息
Division of Global HIV & TB, United States Centers for Disease Control and Prevention (CDC), Nico House, City Centre, P.O. Box 30016, Lilongwe 3, Malawi.
TB Centre, London Sch. of Hygiene & Tropical Med, London, UK.
出版信息
BMC Med. 2020 Nov 9;18(1):311. doi: 10.1186/s12916-020-01775-8.
BACKGROUND
Clinical scores to determine early (6-month) antiretroviral therapy (ART) mortality risk have not been developed for sub-Saharan Africa (SSA), home to 70% of people living with HIV. In the absence of validated scores, WHO eligibility criteria (EC) for ART care intensification are CD4 < 200/μL or WHO stage III/IV.
METHODS
We used Botswana XPRES trial data for adult ART enrollees to develop CD4-independent and CD4-dependent multivariable prognostic models for 6-month mortality. Scores were derived by rescaling coefficients. Scores were developed using the first 50% of XPRES ART enrollees, and their accuracy validated internally and externally using South African TB Fast Track (TBFT) trial data. Predictive accuracy was compared between scores and WHO EC.
RESULTS
Among 5553 XPRES enrollees, 2838 were included in the derivation dataset; 68% were female and 83 (3%) died by 6 months. Among 1077 TBFT ART enrollees, 55% were female and 6% died by 6 months. Factors predictive of 6-month mortality in the derivation dataset at p < 0.01 and selected for the CD4-independent score included male gender (2 points), ≥ 1 WHO tuberculosis symptom (2 points), WHO stage III/IV (2 points), severe anemia (hemoglobin < 8 g/dL) (3 points), and temperature > 37.5 °C (2 points). The same variables plus CD4 < 200/μL (1 point) were included in the CD4-dependent score. Among XPRES enrollees, a CD4-independent score of ≥ 4 would provide 86% sensitivity and 66% specificity, whereas WHO EC would provide 83% sensitivity and 58% specificity. If WHO stage alone was used, sensitivity was 48% and specificity 89%. Among TBFT enrollees, the CD4-independent score of ≥ 4 would provide 95% sensitivity and 27% specificity, whereas WHO EC would provide 100% sensitivity but 0% specificity. Accuracy was similar between CD4-independent and CD4-dependent scores. Categorizing CD4-independent scores into low (< 4), moderate (4-6), and high risk (≥ 7) gave 6-month mortality of 1%, 4%, and 17% for XPRES and 1%, 5%, and 30% for TBFT enrollees.
CONCLUSIONS
Sensitivity of the CD4-independent score was nearly twice that of WHO stage in predicting 6-month mortality and could be used in settings lacking CD4 testing to inform ART care intensification. The CD4-dependent score improved specificity versus WHO EC. Both scores should be considered for scale-up in SSA.
背景
尚未为撒哈拉以南非洲（SSA）制定用于确定早期（6 个月）抗逆转录病毒治疗（ART）死亡率风险的临床评分，该地区居住着 70%的艾滋病毒感染者。在缺乏经过验证的评分的情况下，世界卫生组织（WHO）ART 护理强化的资格标准（EC）为 CD4<200/μL 或 WHO 分期 III/IV。
方法
我们使用博茨瓦纳 XPRES 试验数据为成年 ART 参与者开发了用于 6 个月死亡率的 CD4 独立和 CD4 依赖的多变量预后模型。通过重新缩放系数来获得分数。使用 XPRES ART 参与者的前 50%来开发分数，并使用南非结核病快速通道（TB Fast Track，TBFT）试验数据对其内部和外部进行验证。将评分与 WHO EC 进行预测准确性比较。
结果
在 5553 名 XPRES 参与者中，有 2838 名参与者被纳入推导数据集；68%为女性，83 人（3%）在 6 个月内死亡。在 1077 名 TBFT ART 参与者中，有 55%为女性，6%在 6 个月内死亡。在推导数据集中，在 p<0.01 时预测 6 个月死亡率的因素，并选择用于 CD4 独立评分的因素包括男性（2 分）、≥1 个 WHO 结核病症状（2 分）、WHO 分期 III/IV（2 分）、严重贫血（血红蛋白<8g/dL）（3 分）和体温>37.5°C（2 分）。相同的变量加上 CD4<200/μL（1 分）被纳入 CD4 依赖评分。在 XPRES 参与者中，CD4 独立评分≥4 分可提供 86%的敏感性和 66%的特异性，而 WHO EC 可提供 83%的敏感性和 58%的特异性。如果仅使用 WHO 分期，敏感性为 48%，特异性为 89%。在 TBFT 参与者中，CD4 独立评分≥4 分可提供 95%的敏感性和 27%的特异性，而 WHO EC 可提供 100%的敏感性，但无特异性。CD4 独立评分和 CD4 依赖评分的准确性相似。将 CD4 独立评分分为低（<4）、中（4-6）和高风险（≥7），在 XPRES 参与者中，6 个月的死亡率分别为 1%、4%和 17%，在 TBFT 参与者中，6 个月的死亡率分别为 1%、5%和 30%。
结论
CD4 独立评分预测 6 个月死亡率的敏感性几乎是 WHO 分期的两倍，可用于缺乏 CD4 检测的环境中，以告知 ART 护理强化。CD4 依赖评分与 WHO EC 相比提高了特异性。这两种评分都应考虑在 SSA 中推广。
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