OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose chest CT (OPTIMACT) trial-statistical analysis plan
OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose chest CT (OPTIMACT) trial-statistical analysis plan
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DOI：
10.1186/s13063-020-04343-w
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发表时间：
2020-05-14
期刊：
影响因子：
2.5
通讯作者：
Bossuyt, Patrick M. M.
中科院分区：
文献类型：
--
作者：
Kanglie, Maadrika M. N. P.;Bipat, Shandra;Bossuyt, Patrick M. M.
背景胸部X线检查是对怀疑患有非创伤性肺部疾病的患者进行诊断性检查的标准成像程序。与胸部X射线相比，超低剂量（ULD）胸部计算机断层扫描（CT）扫描提供了有关肺部疾病的更详细信息。这在多大程度上转化为改善患者的治疗效果和医疗保健效率尚不清楚。在急诊科疑似非创伤性肺部疾病患者中的OPTimal IMAging策略：胸部X线或超低剂量胸部CT（OPTIMACT）研究是一项多中心、实用、非劣效性随机对照试验，旨在评价ULD胸部CT在此类患者诊断检查中替代胸部X线的患者相关健康结局和成本。在随机分配的1个日历月期间，使用传统胸部X光或ULD胸部CT扫描作为成像策略。本文详细介绍了在数据分析之前制定的OPTIMACT试验的统计分析计划。方法/结果28天的功能健康是主要的临床结局。第28天的功能健康通过简明量表（SF）-12问卷第1版的身体成分汇总量表进行测量。次要结果是心理健康（SF-12的心理健康量表）、住院时间、28天内死亡率、前28天内的质量调整生命年当量（源自EuroQol五维五级量表），与第28天的最终事后诊断相比，急诊科出院时的正确诊断，由于胸部X线或ULD胸部CT的偶然发现而进行随访的患者数量以及医疗保健费用。结论：在这项务实的试验后，我们将有准确的估计的有效性，取代胸部X线与ULD胸部CT方面的患者相关的健康结果和成本。
Background A chest X-ray is a standard imaging procedure in the diagnostic work-up of patients suspected of having non-traumatic pulmonary disease. Compared to a chest X-ray, an ultra-low-dose (ULD) chest computed tomography (CT) scan provides substantially more detailed information on pulmonary conditions. To what extent this translates into an improvement in patient outcomes and health care efficiency is yet unknown. The OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose chest CT (OPTIMACT) study is a multicenter, pragmatic, non-inferiority randomized controlled trial designed to evaluate replacement of chest X-ray by ULD chest CT in the diagnostic work-up of such patients, in terms of patient-related health outcomes and costs. During randomly assigned periods of 1 calendar month, either conventional chest X-ray or ULD chest CT scan was used as the imaging strategy. This paper presents in detail the statistical analysis plan of the OPTIMACT trial, developed prior to data analysis. Methods/results Functional health at 28 days is the primary clinical outcome. Functional health at 28 days is measured by the physical component summary scale of the Short Form (SF)-12 questionnaire version 1. Secondary outcomes are mental health (mental component summary scale of the SF-12), length of hospital stay, mortality within 28 days, quality-adjusted life year equivalent during the first 28 days (derived from the EuroQol five-dimension, five-level instrument), correct diagnoses at emergency department discharge as compared to the final post hoc diagnosis at day 28, number of patients in follow-up because of incidental findings on chest X-ray or ULD chest CT, and health care costs. Conclusions After this pragmatic trial we will have precise estimates of the effectiveness of replacing chest X-ray with ULD chest CT in terms of patient-related health outcomes and costs.