title: Lung clearance index: evidence for use in clinical trials in cystic fibrosis.
abstract: The ECFS-CTN Standardisation Committee has undertaken this review of lung clearance index as part of the group's work on evaluation of clinical endpoints with regard to their use in multicentre clinical trials in CF. The aims were 1) to review the literature on reliability, validity and responsiveness of LCI in patients with CF, 2) to gain consensus of the group on feasibility of LCI and 3) to gain consensus on answers to key questions regarding the promotion of LCI to surrogate endpoint status. It was concluded that LCI has an attractive feasibility and clinimetric properties profile and is particularly indicated for multicentre trials in young children with CF and patients with early or mild CF lung disease. This is the first article to collate the literature in this manner and support the use of LCI in clinical trials in CF.
authors: Centre for Health and Rehabilitation Technologies (CHaRT), Institute for Nursing and Health Research, University of Ulster, Newtownabbey, UK; Regional Cystic Fibrosis Centre, Belfast Health and Social Care Trust, Belfast, UK.
authors: L
authors: L
authors: Kent
authors: Centre de Référence de la Mucoviscidose, Hospices Civils de Lyon, Lyon, France.
authors: P
authors: P
authors: Reix
authors: Scottish Adult Cystic Fibrosis Service, Western General Hospital, Edinburgh, UK; Molecular and Clinical Medicine, University of Edinburgh, UK.
authors: J A
authors: JA
authors: Innes
authors: Department of Paediatrics, J.W. Goethe-Universität Frankfurt, Germany.
authors: S
authors: S
authors: Zielen
authors: Centre de Référence de la Mucoviscidose, Hôpital Necker-Enfants Malades, Paris, France.
authors: M
authors: M
authors: Le Bourgeois
authors: Cystic Fibrosis Center, Pediatric Department, Meyer Children's Hospital, Florence, Italy.
authors: C
authors: C
authors: Braggion
authors: Erasmus MC, Rotterdam, The Netherlands.
authors: S
authors: S
authors: Lever
authors: Department of Pediatric Pulmonology, Wilhelmina Children's Hospital, University Medical Center Utrecht, The Netherlands.
authors: H G M
authors: HG
authors: Arets
authors: Children's Cystic Fibrosis Centre, Leeds Teaching Hospitals, Leeds, UK.
authors: K
authors: K
authors: Brownlee
authors: Centre for Health and Rehabilitation Technologies (CHaRT), Institute for Nursing and Health Research, University of Ulster, Newtownabbey, UK; Regional Cystic Fibrosis Centre, Belfast Health and Social Care Trust, Belfast, UK.
authors: J M
authors: JM
authors: Bradley
authors: Department of Gene Therapy, Imperial College London, UK.
authors: K
authors: K
authors: Bayfield
authors: Centre for Infection and Immunity, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, UK.
authors: K
authors: K
authors: O'Neill
authors: Department of Pediatrics and Pediatric Neurology, Cystic Fibrosis Center, Sapienza University of Rome, Italy.
authors: D
authors: D
authors: Savi
authors: Royal Brompton & Harefield NHS Foundation Trust, London, UK.
authors: D
authors: D
authors: Bilton
authors: Gothenburg CF Centre, Queen Silvia Children's Hospital, Göteborg, Sweden.
authors: A
authors: A
authors: Lindblad
authors: Department of Gene Therapy, Imperial College London, UK; Royal Brompton & Harefield NHS Foundation Trust, London, UK.
authors: J C
authors: JC
authors: Davies
authors: Centre de Référence de la Mucoviscidose, Hôpital Necker-Enfants Malades, Paris, France; Université Paris Descartes, Paris, France.
authors: I
authors: I
authors: Sermet
authors: Pediatric Pulmonology, University Hospitals Leuven and KU Leuven, Leuven, Belgium. Electronic address: christiane.deboeck@uzleuven.be.
authors: K
authors: K
authors: De Boeck
mesh_terms: D015415:Biomarkers; D001944:Breath Tests / Q000379:methods*; D003550:Cystic Fibrosis / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D005240:Feasibility Studies; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D015203:Reproducibility of Results; D012129:Respiratory Function Tests / Q000379:methods / Q000592:standards; D012720:Severity of Illness Index
chemical_list: D015415:Biomarkers
keywords: Clinimetric properties; Lung clearance index; Multiple breath washout; Outcome measures; Surrogate endpoints