A FeAsibility items Checklist for assessing implementation characTeristics of patient-reported Outcome measures in Research, Regulation and Routine clinical care (FACTOR3): Development and evaluation
Clinical Medicine, vol. 26, pp. 100592
Abstract
STUDY OBJECTIVE: Patient-reported outcome measures (PROMs) provide valuable data to inform regulatory decision making, health technology assessment and routine clinical care. We aimed to develop a feasibility item checklist for PROMs and their selection, beyond their psychometric properties (FACTOR3). METHODS: We followed a five-stage method to select parameters for PROM evaluation. 1) A scoping literature review identified candidate items for consideration; 2) round 1 modified Delphi was used to select items for inclusion or exclusion, conducted by the design group (n = 14); 3) feedback on the checklist was provided by representatives from the European Medicines Agency and National Institute for Health and Care Excellence; 4) round 2 modified Delphi was used to finalise item selection, conducted by the clinical domains group (n = 21) and 5) evaluation of the feasibility item checklist using a selection of PROMS (EQ5D-5L, HeartQOL, the Oxford Hip Score, The EORTC Core Questionnaire QLQ-C30, Re-QOL-10 and NEI-VFQ-25) (Fig. 1). RESULTS: The scoping review identified 13 items relating to the intrinsic feasibility of using PROMs which were considered in the modified Delphi. The final FACTOR3 checklist included eight unique candidate items: price; licensing, comprehensibility, duration, coverage, translations, electronic device compatibility; and minimal important difference. Of the six PROMS evaluated, the intraclass correlation coefficient was 0.81, suggesting good reliability. CONCLUSIONS: FACTOR3 is a feasibility item checklist to assess the implementation characteristics of PROMs in research, regulation and routine clinical care. It may be used in conjunction with existing psychometric evaluation and user guides for PROMS to facilitate their use in health care.
Authors 18
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Asad Bhatty corresponding
University of Leeds · Leeds Teaching Hospitals NHS Trust
Affiliation as printed
Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK; Leeds Institute for Data Analytics, University of Leeds, Leeds, UK; Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK. Electronic address: A.N.Bhatty@leeds.ac.uk
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James Cook University Hospital · South Tees Hospitals NHS Foundation Trust · University of York · Hull York Medical School
Affiliation as printed
Hull York Medical School, University of York, York, UK; Academic Cardiovascular Unit, South Tees NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UK
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James Cook University Hospital · South Tees Hospitals NHS Foundation Trust
Affiliation as printed
Academic Cardiovascular Unit, South Tees NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UK
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University of Leeds · Leeds Teaching Hospitals NHS Trust
Affiliation as printed
Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK; Leeds Institute for Data Analytics, University of Leeds, Leeds, UK; Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK
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European Society of Cardiology
Affiliation as printed
European Society of Cardiology Patient Forum, UK
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European Society of Cardiology
Affiliation as printed
European Society of Cardiology Patient Forum, UK
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Affiliation as printed
Department of Clinical Psychology, Leiden University, Netherlands and Arkin Mental Health Institute, Amsterdam, the Netherlands
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Affiliation as printed
Centre for Patient-Reported Outcome Research (CPROR), Department of Applied Health Sciences, University of Birmingham, Birmingham, UK; National Institute of Health and Care Research (NIHR) Blood and Transplant Research Unit (BTRU) in Precision Cellular Therapeutics at the University of Birmingham, UK; NIHR Applied Research Collaboration (ARC) West Midlands, Birmingham, UK; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK
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University of York · Hull York Medical School
Affiliation as printed
Hull York Medical School, University of York, York, UK; York and Scarborough Teaching Hospitals NHS Foundation Trust, York, UK
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Affiliation as printed
Psychometric Laboratory for Health Sciences, University of Leeds, Leeds, UK
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Affiliation as printed
Centre for Health Economics, University of York, Heslington, York, UK
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Affiliation as printed
School of Medicine, Trinity College, University of Dublin, Dublin, Ireland
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A. O. Ordine Mauriziano di Torino · University of Turin
Affiliation as printed
Department of Oncology, University of Turin, Division of Medical Oncology, Ordine Mauriziano Hospital, Turin, Italy
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James Cook University Hospital
Affiliation as printed
Academic Centre for Surgery, The James Cook University Hospital, Middlesbrough, UK
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Affiliation as printed
Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, UK
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Affiliation as printed
Global Allergy and Airways Patient Platform, Vienna, Austria
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Affiliation as printed
Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK; Leeds Institute for Data Analytics, University of Leeds, Leeds, UK
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University of Leeds · Leeds Teaching Hospitals NHS Trust
Affiliation as printed
Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK; Leeds Institute for Data Analytics, University of Leeds, Leeds, UK; Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK
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