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

Autor: Palmer M; Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa., van der Zalm MM; Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa., Schaaf HS; Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa., Goussard P; Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa., Morrison J; Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa., Seddon JA; Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa;, Department of Infectious Disease, Imperial College London, London, United Kingdom., Hissar S; National Institute for Research in Tuberculosis, Chennai, India., Baskaran D; National Institute for Research in Tuberculosis, Chennai, India., Kinikar A; B.J. Government Medical College, Pune, India., Raichur P; B.J. Government Medical College, Pune, India., Wobudeya E; Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda., Chabala C; University Teaching Hospital, Lusaka, Zambia., Lebeau K; Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom., Crook AM; Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom., Turkova A; Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom., Gibb D; Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom., Hesseling AC; Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa.
Jazyk: angličtina
Zdroj: The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease [Int J Tuberc Lung Dis] 2024 Nov 01; Vol. 28 (11), pp. 547-553.
DOI: 10.5588/ijtld.24.0076
Abstrakt:

INTRODUCTION

SHINE (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.

METHODS

Children 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.

RESULTS

A 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.

DISCUSSION

Using 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..
Databáze: MEDLINE
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