Item generation for a patient reported outcome measure (PRoM) in idiopathic pulmonary fibrosis (IPF): Application of consensus methods

Introduction: Selecting a PRoM for IPF populations has inherent challenges. There is a paucity of longitudinal data to determine reliability of candidate instruments and little standardisation in development and application to research and clinical practice. Incorporating what is already known, we are using an innovative methodology for item generation to inform the development of an FDA (2009) compliant IPF-PRoM. Methodology: 26 published instruments used in IPF were identified; a validation list was applied and 13 were retained and deconstructed. 410 items generated were rated, discussed and ranked by a multidisciplinary panel. 28 patients with IPF took part in focus groups in 3 UK centres. Transcripts underwent thematic analysis and data coding. A Nominal Group of 10 Interstitial Lung Disease physicians rated, discussed and ranked domains from the literature or generated by focus groups. Quantitative data from rating/ranking and qualitative data from transcriptions were incorporated into a Delphi survey. Interim Results: Delphi Round 1 (R1): 223 statements rated according to perceived level of importance on a Likert scale 1-7 (9very9 to 9not at all9 important). 3 parallel surveys: patient (n=74); healthcare professional (n=29) and carer (n=18). Response rate u003e93%. Consensus was determined using a combination of level of agreement, median score ≥5 and ratio of proportionate responses. 84 items were retained for R2 (February 2015) and 16 added from analysis of comments. Discussion: A patient-led Delphi is an appropriate and reliable method to achieve consensus on what is important to patients; this approach will optimise content validity of the IPF PRoM.