title: The need for patient-centred clinical research in idiopathic pulmonary fibrosis.
abstract: Patient-centredness is an accepted term and is perceived by healthcare professionals to be morally and ethically desirable. We are motivated by the belief that this approach will improve the patient-professional experience of the decision-making process and improve health outcomes. We acknowledge that patients, either as participants or as co-investigators, have positive contributions to make to research. As the idiopathic pulmonary fibrosis (IPF) community enters a new era of clinical research activity we consider that there is greater capacity for patient involvement and partnership.Patient involvement in research can be optimised through collaborations in the research design, study conduct, and dissemination. There is increasing interest in using patient- reported outcomes (PROs), such as health-related quality of life, and symptoms measures to inform decision-making and ensure patient perspectives are taken into account. PROs are an essential component of specialist IPF services, to monitor and improve care delivery and to measure and benchmark performance. In clinical trials, PROs can additionally be used to define entry criteria, evaluate efficacy of an intervention, and evaluate adverse events. We suggest that there is a much wider scope for including patient-centred PROs in clinical research and for creative thought in developing patient co-investigator roles.Participation in research activity requires highly refined decision-making processes, particularly in a condition such as IPF, which has an often unpredictable trajectory. The IPF research landscape has changed and the design and conduct of clinical trials in IPF requires some radical rethinking. It is accepted that involving patients in the role of co-investigators will impact the research questions we ask and result in study designs that are patient-centred. IPF clinical trials have been hindered by the lack of availability of validated, disease-specific questionnaires. A conservative approach appears to have been taken to the inclusion of generic symptom or quality of life measures as PRO endpoints. Thus, the impact of new drugs on the quality of life of research participants demonstrates only minimal benefit. It is time to refocus on a patient-centred approach with regards to the co-investigator role, PRO development, and research participants.
authors.affiliation: NIHR Clinical Research Fellow Imperial College National Heart & Lung Institute and Royal Brompton Hospital, Emmanuel Kaye Building, Manresa Road, London, SW3 6LR, UK. a.russell@imperial.ac.uk.
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Russell
authors.affiliation: Department of Medical Psychology, Academic Medical Centre, University of Amsterdam, Meibergdreef 15, 1105 AZ, Amsterdam, The Netherlands. m.a.sprangers@amc.uva.nl.
authors.forename: Mirjam A G
authors.initials: MA
authors.lastname: Sprangers
authors.affiliation: British Lung Foundation, 73-75 Goswell Road, London, EC1V 7ER, UK. steven.wibberley@blf.org.uk.
authors.forename: Steven
authors.initials: S
authors.lastname: Wibberley
authors.affiliation: British Lung Foundation, 73-75 Goswell Road, London, EC1V 7ER, UK. noel.snell@blf.org.uk.
authors.forename: Noel
authors.initials: N
authors.lastname: Snell
authors.affiliation: Pulmonary Fibrosis Foundation, 230 East Ohio Street, Suite 304, Chicago, IL, 60611, USA. dmrose@pulmonaryfibrosis.org.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Rose
authors.affiliation: Interstitial Lung Disease Program, National Jewish Health, Southside Building, Office G011 1400 Jackson Street, Denver, CO, 80206, USA. swigrisj@njhealth.org.
authors.forename: Jeff J
authors.initials: JJ
authors.lastname: Swigris
mesh_terms: D005260:Female; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000628:therapy*; D008297:Male; D017063:Outcome Assessment, Health Care; D010358:Patient Participation / Q000639:trends*; D011788:Quality of Life; D012107:Research Design / Q000639:trends*; D011795:Surveys and Questionnaires