Approaches and processes for paediatric chest X-ray classification used in the SHINE TB treatment-shortening trial.

IF 3.4 3区 医学 Q2 INFECTIOUS DISEASES
M Palmer, M M van der Zalm, H S Schaaf, P Goussard, J Morrison, J A Seddon, S Hissar, D Baskaran, A Kinikar, P Raichur, E Wobudeya, C Chabala, K Lebeau, A M Crook, A Turkova, D Gibb, A C Hesseling
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引用次数: 0

Abstract

INTRODUCTIONSHINE (Shorter Treatment for Minimal Tuberculosis in Children) was the first Phase 3 paediatric TB treatment-shortening trial. Robust chest X-ray (CXR) classification methods were integral to excluding severe disease for trial eligibility and to retrospectively adjudicating TB status at baseline. We describe and critically evaluate the CXR classification approaches and processes used in the SHINE trial.METHODSChildren with non-severe TB were randomised to 4- vs 6-months anti-TB treatment. Radiologically non-severe TB was defined on CXR. CXRs were systematically interpreted by on-site clinicians prospectively for eligibility determination and retrospectively by experts to inform adjudication of baseline TB status and disease severity.RESULTSA screening CXR was successfully obtained from all 1,204 enrolled children; 1,134 CXRs from children with intra-thoracic TB were reviewed by expert readers. Compared with the expert panel, enrolling clinicians classified more CXRs as abnormal and 'typical TB' and all as radiologically non-severe. The expert panel retrospectively classified 71/1,134 (6%) CXRs as severe. Of these, 4 (5.6%) had unfavourable outcomes compared with 34 (3.0%) in the trial overall.DISCUSSIONUsing CXRs to classify radiological disease severity and inform eligibility decisions in real-time by local enrolling clinicians was feasible and safe in this large paediatric TB trial. Retrospective central expert CXR review was successful. Refinement of the CXR methods for the classification of both disease severity and TB status could support standardised implementation in routine care and research..

SHINE 结核病缩短治疗试验中使用的儿科胸部 X 光片分类方法和流程。
简介HINE(儿童结核病轻症缩短治疗)是首个儿童结核病缩短治疗 3 期试验。强大的胸部 X 光(CXR)分类方法是排除严重疾病以获得试验资格和回顾性判定基线结核病状态不可或缺的一部分。我们描述并严格评估了 SHINE 试验中使用的 CXR 分级方法和流程。放射学上的非重症肺结核是根据 CXR 定义的。由现场临床医生对 CXR 进行系统判读,以确定入选资格,并由专家对 CXR 进行回顾性判读,为判定结核病基线状态和疾病严重程度提供依据。与专家组相比,入组的临床医生将更多的 CXR 分为异常和 "典型肺结核",且所有 CXR 在放射学上均为非重症。专家组回顾性地将 71/1,134 张(6%)CXR 分为重度。讨论在这项大型儿科结核病试验中,由当地入组临床医生实时使用 CXRs 对放射学疾病严重程度进行分类并为资格决定提供信息是可行且安全的。中央专家对 CXR 的回顾性审查是成功的。改进用于疾病严重程度和结核病状态分类的 CXR 方法有助于在常规护理和研究中标准化实施。
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来源期刊
CiteScore
4.90
自引率
20.00%
发文量
266
审稿时长
2 months
期刊介绍: The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.
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