Moro R N, Sterling T R, Saukkonen J, Vernon A, Horsburgh C R, Chaisson R E, Hamilton C D, Villarino M E, Goldberg S
Centers for Disease Control and Prevention (CDC), Atlanta, CDC Foundation Research Collaboration, Atlanta, Georgia.
Vanderbilt University School of Medicine, Nashville, Tennessee.
Int J Tuberc Lung Dis. 2017 Mar 1;21(3):286-296. doi: 10.5588/ijtld.16.0469. Epub 2017 Jan 13.
A post-hoc exploratory analysis of a randomized, open-label clinical trial that enrolled 8053 participants from the United States, Canada, Brazil, and Spain.
To assess factors associated with non-completion of study follow-up (NCF) in a 33-month latent tuberculous infection treatment trial, PREVENT TB.
Participants were randomized to receive 3 months of weekly directly observed therapy vs. 9 months of daily self-administered therapy. NCF was defined as failing to be followed for at least 993 days (33 months) from enrollment. Possible factors associated with NCF were analyzed using univariate and multivariate regression via Cox proportional hazard model.
Of 7061 adults selected for analysis, 841 (11.9%) did not complete study follow-up. Homelessness, young age, low education, history of incarceration, smoking, missing an early clinic visit, receiving isoniazid only, and male sex were significantly associated with NCF. Similar results were found in the North American region (United States and Canada) only. In Brazil and Spain, the only significant factor was missing an early clinic visit.
Study subjects at higher risk for NCF were identified by characteristics known at enrollment or in early follow-up. Evaluation of follow-up in other trials might help determine whether the identified factors consistently correlate with retention.
对一项随机、开放标签的临床试验进行事后探索性分析，该试验纳入了来自美国、加拿大、巴西和西班牙的8053名参与者。
在一项为期33个月的潜伏性结核感染治疗试验PREVENT TB中，评估与未完成研究随访（NCF）相关的因素。
参与者被随机分配接受3个月的每周直接观察治疗或9个月的每日自我给药治疗。NCF被定义为自入组后未能随访至少993天（33个月）。使用Cox比例风险模型通过单变量和多变量回归分析与NCF相关的可能因素。
在选定进行分析的7061名成年人中，841人（11.9%）未完成研究随访。无家可归、年轻、教育程度低、有监禁史、吸烟、错过早期门诊就诊、仅接受异烟肼治疗以及男性与NCF显著相关。仅在北美地区（美国和加拿大）发现了类似结果。在巴西和西班牙，唯一的显著因素是错过早期门诊就诊。
通过入组时或早期随访时已知的特征识别出了NCF风险较高的研究对象。对其他试验中的随访情况进行评估可能有助于确定所识别的因素是否始终与留存率相关。
