Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands.
Center of Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands.
Trials. 2020 May 14;21(1):407. doi: 10.1186/s13063-020-04343-w.
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.
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.
Netherlands National Trial Register: NTR6163. Registered on 6 December 2016.
胸部 X 光检查是疑似非创伤性肺部疾病患者诊断工作中的标准成像程序。与胸部 X 光检查相比，超低剂量（ULD）胸部计算机断层扫描（CT）提供了有关肺部状况的更详细信息。但目前尚不清楚这在多大程度上能改善患者的预后和医疗保健效率。在急诊科疑似非创伤性肺部疾病患者中采用最佳成像策略：胸部 X 光检查或超低剂量胸部 CT（OPTIMACT）研究是一项多中心、实用、非劣效性随机对照试验，旨在评估在这类患者的诊断工作中，用 ULD 胸部 CT 替代常规胸部 X 光检查的效果，从患者相关的健康结果和成本两方面进行评估。在随机分配的 1 个日历月期间，分别采用常规胸部 X 光检查或 ULD 胸部 CT 扫描作为成像策略。本文详细介绍了 OPTIMACT 试验的统计分析计划，该计划在数据分析之前制定。
方法/结果：28 天的功能健康是主要的临床结局。28 天的功能健康通过 SF-12 问卷版本 1 的物理成分综合量表来衡量。次要结局包括心理健康（SF-12 的心理成分综合量表）、住院时间、28 天内死亡率、前 28 天内的质量调整生命年等效值（根据欧洲五维健康量表五级量表计算）、急诊科出院时的正确诊断与 28 天后最终回溯诊断的比较、因胸部 X 光或 ULD 胸部 CT 偶然发现而进行随访的患者数量，以及医疗保健成本。
经过这项实用试验，我们将对用 ULD 胸部 CT 替代胸部 X 光检查在患者相关健康结果和成本方面的有效性有更精确的估计。
荷兰国家试验注册中心：NTR6163。于 2016 年 12 月 6 日注册。
