Peer Review Report For: Eliciting required and desired diagnostic test characteristics to develop patient-focused target product profiles (TPPs) for diagnosing infection and exacerbations in cystic fibrosis [version 1; peer review: 2 approved, 1 approved with reservations]

Résumé fourni par la source

Background In addition to new antimicrobials for people with Cystic Fibrosis (pwCF), new diagnostics are needed to detect and diagnose infections, guide clinical care, and inform decision making. To determine the unmet needs in pulmonary infection diagnostics in Cystic Fibrosis (CF), the required diagnostic test characteristics and priorities of different stakeholders involved in the care of pwCF were collected and analysed. Methods Three focus groups (two clinical and one pwCF) were conducted and contributed to a wider project to deliver a suite of target product profiles (TPPs) for CF lung microbiological diagnostics. Thematic analysis was performed on the recordings, transcripts, and notes taken during the interviews. Results Participants described their experience of the current practices and existing diagnostics for detection, diagnosis and management of infection and exacerbations in CF in the UK NHS. Unmet needs included: monitoring modalities and testing for treatment efficacy; the lack of samples with good clinical utility; more acceptable methods for sampling; faster microbiology and culture testing. Greater communication between the laboratory and clinical teams, and equity of care across UK CF centres was also highlighted. TPP characteristics of importance to pwCF and clinical representatives included ‘accuracy’, ‘time to results’, and ‘patient acceptability’. Participants across all groups highlighted the need for suitable alternatives to sputum and emphasised the need for novel biomarkers for the early detection and diagnosis of infection and exacerbation. Amongst clinical representatives, test accuracy was largely valued over the time to results for a clinical test in a non-acute setting. Conclusions These focus groups offered rich and detailed insights into the opinions of clinical staff and pwCF alike on the current landscape of diagnosis and management of pulmonary infection and exacerbations in CF. Early and rapid detection would likely have a positive impact on clinical care and inform earlier clinical decision making.

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