TB PuRe : Pulmonary rehabilitation to reduce post-tuberculosis morbidity

摘要 肺康复降低结核病后发病率(TB PURE)项目的总体目标 是衡量肺康复(PR)计划的有效性、可行性和成本效益，以 在印度预防结核病(TB)后呼吸道疾病。结核病与肺损伤有关，肺损伤可能 尽管成功完成了结核病治疗，但结核病仍在继续。据估计，全球有1.55亿结核病幸存者， 然而，没有常规实施的干预措施来解决结核病后呼吸道发病率问题。公关是把钥匙 是慢性肺部疾病管理计划的组成部分，是改善患者健康状况的有效干预措施 以结果为中心。然而，在结核病治疗期间使用PR的临床益处是，在预防后 尚未对结核病呼吸道发病率进行调查。此外，尽管结核病有着悠久的自然历史 以及它在资源有限的情况下的不成比例的影响，以及以家庭为基础的结核病公关计划的可行性 患者的情况尚不清楚。因此，TB PURE的目标是：a)衡量两种药物的相对有效性 在结核病治疗期间实施的以家庭为基础的公关方案，用于预防结核病后呼吸道疾病；b) 描述诊所级服务组织、教练干预交付忠诚度和客户之间的交集 这两个公关计划的行为行动；c)比较以下项目的成本、成本效益和预算影响 这两种不同的公关策略作为常规方案实施。为了实现这些目标，690种成人药物- 在结核病治疗开始时有功能损害的敏感肺结核患者将在三个月内登记 印度的地理和流行病学多样化的研究地点。参与者将按1：1：1的比例随机进行 进入以下三个研究组之一：a)在结核病治疗期间进行2个月的家庭公关(短公关组)； B)在结核病治疗期间进行2个月的居家公关，然后再进行4个月的居家公关 尽管PR(延长PR臂)2个月，参与者仍有持续性功能障碍；c)标准结核病 无特定PR(标准护理臂)的治疗。主要结果将是6分钟的步行测试 比较短公关臂和延长公关臂与12个月后标准护理臂之间的距离 随机化。我们将评估公关干预措施的可接受性，以便在 使用可接受性理论框架的程序性设置。此外，我们将经验性地 在患者层面评估这两个公关计划的社会成本，将资源使用考虑在内 制定计划基础设施、实施、服务交付和患者成本。成本- 这两个项目的有效性将根据健康相关生活质量(HRQOL)结果进行评估 评估。我们的研究，如果意义重大，将产生迄今为止最有力的证据来支持常规 实施系统的公关计划，以减少结核病后呼吸道发病率。我们的多学科团队 拥有独特而互补的专业知识和在美国国立卫生研究院资助的结核病研究方面的良好记录 印度将确保结核病纯项目的成功实施。

ABSTRACT The overarching goal of the Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB PuRe) project is to measure the effectiveness, feasibility, and cost-effectiveness of a pulmonary rehabilitation (PR) program to prevent post-tuberculosis (TB) respiratory morbidity in India. TB is associated with lung impairment which can persist despite successful completion of TB treatment. There are an estimated 155 million TB survivors globally, yet there are no routinely implemented interventions for addressing post-TB respiratory morbidity. PR is a key component of the management plan for chronic lung diseases and is an effective intervention to improve patient- centered outcomes. However, the clinical benefit of PR, administered during TB treatment, in preventing post- TB respiratory morbidity has not been investigated. Furthermore, despite the long natural history of TB disease and its disproportionate impact in resource limited settings, the feasibility of a home-based PR program for TB patients is unclear. Therefore, the aims of TB PuRe are: a) to measure the comparative-effectiveness of two home-based PR programs, administered during TB treatment, for preventing post-TB respiratory morbidity; b) to describe the intersection between clinic-level service organization, coach intervention delivery fidelity, and client behavioral action for these two PR programs; c) to compare the costs, cost-effectiveness, and budget impact of the two different PR strategies implemented as a routine program. To achieve these aims, 690 adult drug- sensitive pulmonary TB patients with functional impairment at TB treatment initiation will be enrolled at three geographically and epidemiologically diverse study sites in India. Participants will be randomized in 1:1:1 ratio into one of the following three study arms: a) 2 months of home-based PR during TB treatment (short PR arm); b) 2 months of home-based PR during TB treatment followed by 4 additional months of home-based PR for participants with persistent functional impairment despite 2 months of PR (extended PR arm); c) standard TB treatment without specific PR (standard-of-care arm). The primary outcome will be the 6-minute walk test distance compared between short and extended PR arms, and the standard-of-care arm at 12 months after randomization. We will assess the PR interventions' acceptability to inform adoption of the PR strategies in a programmatic setting by using the Theoretical Framework for Acceptability. Furthermore, we will empirically assess societal costs of the two PR programs at the patient-level, factoring the resource-use in the process of development of programmatic infrastructure, implementation, service delivery, and patient costs. Cost- effectiveness of the two programs will be assessed based on Health-related Quality of Life (HrQOL) outcomes assessment. Our study, if significant, will generate the strongest evidence to date to support routine implementation of a systematic PR program to reduce post-TB respiratory morbidity. Our multidisciplinary team with distinct, yet complementary, expertise and a strong track record of conducting NIH funded TB research in India will ensure the successful execution of the TB PuRe project.