PredicTB: Validating a clinical risk score for early management of tuberculosis in Ugandan primary health clinics

PredicTB：验证乌干达初级卫生诊所结核病早期管理的临床风险评分

• 批准号: 10371151
• 负责人: David Wesley Dowdy
• 金额: $ 16.28万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-16 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10371151
• 关键词: Adopted; Adoption; Adult; Age; Asia; Bacteriology; Caring; Cessation of life; Clinic; Clinical; Clinical Data; Clinical Management; Cluster randomized trial; Communicable Diseases; Communication; Communities; Country; Data; Diagnosis; Diagnostic tests; Disease; Disincentive; Effectiveness; Epidemic; Evaluation; Guidelines; HIV; HIV therapy; Hand; Health; Health care facility; Individual; Location; Maintenance; Medical; Microbiology; Modeling; Morbidity - disease rate; Outcome; Patient Self-Report; Patient-Focused Outcomes; Patients; Persons; Physicians; Pragmatic clinical trial; Prevalence; Provider; Public Health; Pulmonary Tuberculosis; Reach Effectiveness Adoption Implementation and Maintenance; Reporting; Research Design; Resource-limited setting; Resources; Risk; Sexually Transmitted Diseases; Site Visit; Surveys; Symptoms; Test Result; Testing; Time; Training; Travel; Tuberculosis; Tuberculosis diagnosis; Uganda; Viral; antiretroviral therapy; base; care seeking; clinical decision-making; clinical practice; clinical risk; community transmission; comparison group; cost effective; cost effectiveness; curative treatments; design; disability-adjusted life years; disease transmission; effectiveness evaluation; effectiveness implementation study; follow-up; high risk; implementation evaluation; improved; mortality; novel; peri-urban; post implementation; primary outcome; research clinical testing; rural South Africa; rural area; sex; standard of care; systematic review; tool; transmission process; treatment duration; tuberculosis treatment

PROJECT SUMMARY An estimated 1.5 million people die of tuberculosis (TB) every year. Many of these are people who seek care in under-resourced clinics (for example, in rural areas or informal settlements) where same-day TB diagnosis is not available. These patients are often unable to return promptly to receive their results and start treatment, resulting in ongoing disease transmission and often death. If TB treatment could be started on the same day as these patients initially seek care, substantial mortality and transmission could be averted. Our team has developed and validated a clinical risk score (“PredicTB”) for adult pulmonary TB that could aid in clinical decision-making. This risk score ranges from 1-10, can be calculated by hand in under a minute using readily available clinical data (e.g., age, sex, self-reported HIV status), and has sufficiently high accuracy to inform decisions about same-day empiric treatment initiation while confirmatory test results are pending. Same-day treatment initiation improves patient outcomes for other infectious diseases (for example, sexually transmitted diseases including HIV), and this novel clinical risk score holds similar promise for TB, the leading cause of infectious mortality worldwide. However, before conducting a large-scale cluster randomized trial to evaluate whether this score could improve patient-important outcomes, it is critical to first generate evidence that this score could be effective and be implemented in the most-resource-limited settings for which it is intended. We propose a type 2 hybrid effectiveness-implementation evaluation of the PredicTB clinical risk score in four peri-urban clinics in Uganda, with an additional four clinics serving as a comparison group. Our Specific Aims are to evaluate the effectiveness of PredicTB on clinical outcomes including rapid treatment initiation, TB mortality, and loss to care (Aim 1); to evaluate the implementation of PredicTB in terms of reach, adoption, implementation, and maintenance (Aim 2); and the project the long-term impact and cost-effectiveness of PredicTB implementation (Aim 3). Our primary outcome is the increase in the proportion of patients with microbiologically confirmed TB who start treatment within seven days of initial presentation. To accomplish our aims, we will adopt a highly pragmatic study design in which we train clinicians in the use of the PredicTB score and perform quarterly site visits but otherwise minimize contact between study staff and treating clinicians. This will enable us to evaluate whether implementation of PredicTB is likely to impact clinical decision-making and patient outcomes under actual field settings. If successful, this evaluation will provide critical data to justify (or halt) the conduct of a large-scale pragmatic clinical trial – not only will it generate preliminary evidence of effectiveness, but it will also inform appropriate implementation. Patients in highly resource-constrained settings are at greatest risk of suffering the ill effects of TB disease, including long-term morbidity and death. This study represents an important first step toward improving clinical management for these marginalized patients and thus toward reaching global targets for ending the TB epidemic.

项目摘要 每年估计有150万人死于结核病（TB）。 资源不足的诊所（例如，在农村地区或信息中）妓女当天的结核病诊断是 这些患者通常无法恢复结果并开始治疗 导致持续的疾病跨性别，经常在结核病治疗中死亡。 这些患者最初寻求护理，可以避免使用大量的死亡率和传播 开发并验证了成年肺结核的临床风险评分（“预测”），可以帮助临床 决策。该风险分数范围为1-10 可用的临床数据（例如年龄，性别，自我报告的艾滋病毒状况），并且具有足够高的精度来告知 关于当天经验治疗启动的决定，同时尚待确认测试结果。 治疗启动可改善其他抗疾病的其他疾病 包括艾滋病毒在内的疾病），这种NOIS新颖的临床风险评分对结核病也有类似的承诺。 然而，在进行大规模群集随机试验之前，全球感染性死亡率 该分数是否可以改善患者至关重要的结果，至关重要的是首先产生证据表明这一点 得分可能是有效的，并在预期的最有限的设置中实现。 我们提出了预测b临床风险评分的2型混合有效性 - 四个 我们在乌干达的郊区诊所的具体目标，其中有四个诊所作为比较组。 正在评估评估对临床结果的预测评估，包括快速治疗启动，结核病 死亡率和护理损失（目标1）； 实施和维护（AIM 2）和项目的长期影响和成本效益 预测实施（目标3）。 微生物学证实了在七天内开始治疗的结核病 目的，我们将采用一种高度务实的研究设计 得分并进行季度访问，但在学习人员和治疗之间接触 临床医生。 在实际现场设置下的决策和患者结果。 关键数据证明（或停止）大规模务实临床试验的进行合理性 有效性的初步证据，但也将为适当的实施提供信息。 资源构成的环境最大的风险遭受结核病疾病的不良影响，长期倾斜 这项研究是提高临床管理的重要第一步 这些边缘化的患者，因此达到了结束结核病流行的全球目标。