{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,28]],"date-time":"2026-02-28T02:01:11Z","timestamp":1772244071746,"version":"3.50.1"},"update-to":[{"DOI":"10.3310\/nihropenres.13674.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,12,2]],"date-time":"2025-12-02T00:00:00Z","timestamp":1764633600000}}],"reference-count":10,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2025,12,2]],"date-time":"2025-12-02T00:00:00Z","timestamp":1764633600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100012357","name":"LifeArc","doi-asserted-by":"publisher","award":["RES\/0280\/0663"],"award-info":[{"award-number":["RES\/0280\/0663"]}],"id":[{"id":"10.13039\/100012357","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000272","name":"NIHR","doi-asserted-by":"crossref","award":["MIC-2016-014"],"award-info":[{"award-number":["MIC-2016-014"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["openresearch.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["NIHR Open Res"],"abstract":"<ns3:p>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 clinical decision making. To determine unmet diagnostic needs in pulmonary infection and exacerbation 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 used to inform a wider project to deliver a suite of target product profiles (TPPs) for CF lung microbiological infection and\/or exacerbation diagnostics. Thematic analysis was performed on the focus group data. Results Participants described their experience of current practice and existing diagnostics for detection, diagnosis, and management of infection and exacerbations in CF in the UK National Health Service (NHS). Unmet needs included: monitoring modalities and testing for treatment efficacy; acquiring samples with good clinical utility; more acceptable sampling methods; and faster microbiology and culture-based 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 \u2018accuracy\u2019, \u2018time to results\u2019, and \u2018patient acceptability\u2019. Both participants groups highlighted the need for suitable alternatives to sputum sampling and emphasised the need for novel biomarkers for the early detection and diagnosis of both infection and exacerbations. Amongst clinical representatives, test accuracy was generally valued over the time to results for a clinical test in a non-acute setting. Conclusions Focus groups offered rich and detailed insights into the opinions of clinical staff and pwCF alike which informed further stakeholder engagement and shaped the content, scope and characteristics of TPPs. Early and rapid detection would have a positive impact on clinical care and inform earlier clinical decision making.<\/ns3:p>","DOI":"10.3310\/nihropenres.13674.2","type":"journal-article","created":{"date-parts":[[2025,12,2]],"date-time":"2025-12-02T09:25:06Z","timestamp":1764667506000},"page":"81","update-policy":"https:\/\/doi.org\/10.3310\/nihropenres.crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Unmet diagnostic needs in cystic fibrosis infections and exacerbations: focus groups to inform target product profiles (TPPs)"],"prefix":"10.3310","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9446-8314","authenticated-orcid":false,"given":"Nicola","family":"Howe","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Constance","family":"Takawira","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1978-4370","authenticated-orcid":false,"given":"Raasti","family":"Naseem","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4777-5458","authenticated-orcid":false,"given":"Kile","family":"Green","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"6221","published-online":{"date-parts":[[2025,12,2]]},"reference":[{"key":"ref-1","doi-asserted-by":"publisher","first-page":"65-124","DOI":"10.1016\/s2213-2600(19)30337-6","article-title":"The future of cystic fibrosis care: a global perspective.","volume":"8","author":"S Bell","year":"2020","journal-title":"Lancet Respir Med."},{"key":"ref-2","doi-asserted-by":"publisher","first-page":"77-101","DOI":"10.1191\/1478088706qp063oa","article-title":"Using thematic analysis in psychology.","volume":"3","author":"V Braun","year":"2006","journal-title":"Qual Res Psychol."},{"key":"ref-3","doi-asserted-by":"publisher","first-page":"906-907","DOI":"10.1016\/j.jcf.2022.09.004","article-title":"Considerations for CF airway infection sampling and impact of CFTR modulators.","volume":"21","author":"L Caverly","year":"2022","journal-title":"J Cyst Fibros."},{"key":"ref-10","doi-asserted-by":"publisher","first-page":"112","DOI":"10.3310\/nihropenres.14054.1","article-title":"The development of patient-focused diagnostic target product profiles for detection of infection and exacerbation in people with Cystic Fibrosis [version 1; peer review: awaiting peer review].","volume":"5","author":"K Green","year":"2025","journal-title":"NIHR Open Res."},{"key":"ref-4","article-title":"Cystic Fibrosis Target Product Profile (TPP) focus group documents: topic guides and participant information sheets.","author":"N Howe","year":"2024a"},{"key":"ref-5","article-title":"Cystic Fibrosis Target Product Profiles: focus group data (clinical and people with CF)","author":"N Howe","year":"2024b"},{"key":"ref-6","doi-asserted-by":"publisher","DOI":"10.1016\/j.conctc.2024.101301","article-title":"Levelling the playing field through the London Network of the UK clinical trials accelerator platform.","volume":"39","author":"J Matthews","year":"2024","journal-title":"Contemp Clin Trials Commun."},{"key":"ref-7","doi-asserted-by":"publisher","first-page":"817-831","DOI":"10.1016\/j.resinv.2024.07.005","article-title":"What diagnostic tests are available for respiratory infections or pulmonary exacerbations in Cystic Fibrosis: a scoping literature review.","volume":"62","author":"R Naseem","year":"2024","journal-title":"Respir Investig."},{"key":"ref-8","doi-asserted-by":"publisher","first-page":"S23-42","DOI":"10.1016\/j.jcf.2014.03.010","article-title":"European Cystic Fibrosis society standards of care: best practice guidelines.","volume":"13(Suppl 1)","author":"A Smyth","year":"2014","journal-title":"J Cyst Fibros."},{"key":"ref-9","doi-asserted-by":"publisher","first-page":"93-102","DOI":"10.1016\/j.chest.2020.09.084","article-title":"Pulmonary exacerbations in adults with Cystic Fibrosis: a grown-up issue in a changing Cystic Fibrosis landscape.","volume":"159","author":"G Stanford","year":"2021","journal-title":"Chest."}],"container-title":["NIHR Open Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-81\/v2\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-81\/v2\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-81\/v2\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,2]],"date-time":"2025-12-02T09:25:08Z","timestamp":1764667508000},"score":1,"resource":{"primary":{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-81\/v2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,2]]},"references-count":10,"URL":"https:\/\/doi.org\/10.3310\/nihropenres.13674.2","relation":{"has-version":[{"id-type":"doi","id":"10.3310\/nihropenres.13674.1","asserted-by":"subject"}],"has-review":[{"id-type":"doi","id":"10.3310\/nihropenres.15418.r38622","asserted-by":"object"}]},"ISSN":["2633-4402"],"issn-type":[{"value":"2633-4402","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,2]]},"assertion":[{"value":"Indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-81\/v2#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.3310\/nihropenres.14847.r34834, Freddy Frost, Respiratory Department, University of Liverpool, Liverpool, England, 25 Mar 2025, version 1, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-81\/v1#referee-response-34834","order":0,"name":"referee-response-34834","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.3310\/nihropenres.14847.r37739, Elizabeth B. Burgener, Pediatric Pulmonology, Children's Hospital Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, California, 08 Nov 2025, version 1, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-81\/v1#referee-response-37739","order":1,"name":"referee-response-37739","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.3310\/nihropenres.14847.r37737, Morven Brown, Newcastle University, Newcastle upon Tyne, 10 Nov 2025, version 1, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-81\/v1#referee-response-37737","order":2,"name":"referee-response-37737","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This project is funded by the National Institute for Health and Care Research (NIHR) under the National Institute for Health and Care Research [(NIHR) In Vitro Diagnostics Co-operative (http:\/\/www.newcastle.mic.nihr.ac.uk\/) (Grant reference Number MIC-2016-014)] and LifeArc (Grant Number RES\/0280\/0663). The NIHR had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":3,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}