研究方案：一项评价乌干达社区卫生中心现场 GeneXpert 检测（XPEL-TB）有效性和实施情况的整群随机试验。
Study protocol: a cluster randomized trial to evaluate the effectiveness and implementation of onsite GeneXpert testing at community health centers in Uganda (XPEL-TB).
机构信息
Division of Pulmonary and Critical Care Medicine, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.
出版信息
Implement Sci. 2020 Apr 21;15(1):24. doi: 10.1186/s13012-020-00988-y.
BACKGROUND
Delays in diagnosis and treatment of tuberculosis (TB) remain common in high-burden countries. To improve case detection, substantial investments have been made to scale-up Xpert MTB/RIF (Xpert), a cartridge-based nucleic acid amplification test that can detect TB within 2 hours, as a replacement for sputum smear microscopy. However, the optimal strategy for implementation of Xpert testing remains unclear.
METHODS
The Xpert Performance Evaluation for Linkage to Tuberculosis Care (XPEL-TB) trial uses an ultra-pragmatic, hybrid type II effectiveness-implementation design to assess the effectiveness and implementation of a streamlined strategy for delivery of Xpert testing in real-world settings. Twenty health centers with TB microscopy units were selected to participate in the trial, with ten health centers randomized to the intervention strategy (onsite molecular testing using GeneXpert Edge, process redesign to facilitate same-day TB diagnosis and treatment, and performance feedback) or routine care (onsite sputum smear microscopy plus referral of sputum samples to Xpert testing sites). The primary outcome is the number of patients with microbiologically confirmed TB who were initiated on treatment within 14 days of presentation to the health center, which reflects successful completion of the TB diagnostic evaluation process. Secondary outcomes include health outcomes (6-month vital status), as well as measures of the reach, adoption, and implementation of the intervention strategy.
DISCUSSION
The design elements and implementation approach for the XPEL-TB trial were intentionally selected to minimize disruptions to routine care procedures, with the goal of limiting their influence on key primary and secondary outcomes. Trial findings may result in increased support and funding for rapid, onsite molecular testing as the standard-of-care for all patients being evaluated for TB.
TRIAL REGISTRATION
US National Institutes of Health's ClinicalTrials.gov, NCT03044158. Registered 06 February 2017. Pan African Clinical Trials Registry, PACTR201610001763265. Registered 03 September 2016.
背景
在高负担国家，结核病（TB）的诊断和治疗延误仍然很常见。为了提高病例检出率，已经投入大量资金来扩大 Xpert MTB/RIF（Xpert）的使用，Xpert 是一种基于检测盒的核酸扩增试验，可在 2 小时内检测出结核病，以替代痰涂片显微镜检查。然而，实施 Xpert 检测的最佳策略仍不清楚。
方法
Xpert 结核病诊断辅助检测的效果评价（XPEL-TB）试验采用超实用的混合 II 型有效性实施设计，以评估在实际环境中提供 Xpert 检测的简化策略的有效性和实施情况。选择了 20 个具有结核病显微镜检查单位的卫生中心参与试验，其中 10 个卫生中心随机分配到干预策略（使用 GeneXpert Edge 进行现场分子检测、重新设计流程以促进当日 TB 诊断和治疗、以及绩效反馈）或常规护理（现场痰涂片显微镜检查，以及将痰样本转诊至 Xpert 检测点）。主要结局是在向卫生中心就诊后 14 天内开始接受治疗的经微生物学证实的结核病患者人数，这反映了成功完成 TB 诊断评估过程。次要结局包括健康结局（6 个月的生存状态）以及干预策略的可达性、采用和实施的衡量指标。
讨论
XPEL-TB 试验的设计要素和实施方法旨在尽量减少对常规护理程序的干扰，其目的是限制这些程序对主要和次要结局的影响。试验结果可能会增加对快速现场分子检测的支持和资金投入，使其成为所有接受结核病评估患者的标准护理方法。
试验注册
美国国立卫生研究院的 ClinicalTrials.gov，NCT03044158。注册于 2017 年 2 月 6 日。泛非临床试验注册中心，PACTR201610001763265。注册于 2016 年 9 月 3 日。
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