Development and usability testing of an electronic patient-reported outcome (ePRO) solution for patients with inflammatory diseases in an Advanced Therapy Medicinal Product (ATMP) basket trial

Journal of Patient-Reported Outcomes

Research

Alan Boyd¹  Elin Haf Davies²  Chris Frost²  Rosie Harding³  Gary Price⁴  Alastair K. Denniston⁵  Sarah E. Hughes⁶  Olalekan Lee Aiyegbusi⁷  Anita Walker⁸  Ameeta Retzer⁹  Melanie Calvert^1,10  Christel McMullan^1,11  Roger Wilson^1,12  Philip N. Newsome^1,13  Gary McNamara^1,14  Amanda Hunn^1,15  Jamie Coleman^1,16  Sandra Mitchell^1,17  Anna Rowe^1,18  Camilla Bathurst^1,18  Rebecca Malpass^1,18  Wilma van Reil^1,19  Derek Kyte^2,20  Helen Dunster^2,21  Saloni Mittal^2,22 

[1] Alan Boyd Consultancy, Crewe, UK;Aparito Ltd, Wrexham, Wales;Birmingham Law School, University of Birmingham, Birmingham, UK;Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, B15 2TT, Edgbaston, Birmingham, UK;Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, B15 2TT, Edgbaston, Birmingham, UK;Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK;DEMAND Hub, University of Birmingham, Birmingham, UK;Health Data Research UK, London, UK;Academic Unit of Ophthalmology, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK;University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK;National Institute of Health Research Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust and University College London, Institute of Ophthalmology, London, UK;Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, B15 2TT, Edgbaston, Birmingham, UK;Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK;National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) West Midlands, Birmingham, UK;Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, B15 2TT, Edgbaston, Birmingham, UK;Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK;National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) West Midlands, Birmingham, UK;National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham, Birmingham, UK;Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, B15 2TT, Edgbaston, Birmingham, UK;NIHR Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham, UK;Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, B15 2TT, Edgbaston, Birmingham, UK;NIHR Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham, UK;Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK;Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, B15 2TT, Edgbaston, Birmingham, UK;NIHR Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham, UK;Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK;National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) West Midlands, Birmingham, UK;National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham, Birmingham, UK;DEMAND Hub, University of Birmingham, Birmingham, UK;Health Data Research UK, London, UK;Midlands Health Data Research UK, Birmingham, UK;Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, B15 2TT, Edgbaston, Birmingham, UK;NIHR Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham, UK;Centre for Trauma Science Research, University of Birmingham, Birmingham, UK;Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, B15 2TT, Edgbaston, Birmingham, UK;National Cancer Research Institute (NCRI) Consumer Forum, London, UK;Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, B15 2TT, Edgbaston, Birmingham, UK;National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham, Birmingham, UK;Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK;Cognitant, London, UK;Independent Adviser, Manchester, UK;Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK;National Cancer Institute, Bethesda, USA;National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham, Birmingham, UK;Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK;Research Governance, University Hospital Birmingham, Birmingham, UK;School of Allied Health & Community, University of Worcester, Worcester, UK;Univeristy of Birmingham Enterprise, Birmingham, UK;University Hospital Birmingham, Birmingham, UK;

关键词: Electronic patient reported outcomes;    Usability testing;    Inflammatory conditions;    Cognitive interviews;    Early phase advanced therapy trial;   

DOI  :  10.1186/s41687-023-00634-3

 received in 2022-08-09, accepted in 2023-09-10,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundElectronic patient-reported outcome (ePRO) systems are increasingly used in clinical trials to provide evidence of efficacy and tolerability of treatment from the patient perspective. The aim of this study is twofold: (1) to describe how we developed an electronic platform for patients to report their symptoms, and (2) to develop and undertake usability testing of an ePRO solution for use in a study of cell therapy seeking to provide early evidence of efficacy and tolerability of treatment and test the feasibility of the system for use in later phase studies.MethodsAn ePRO system was designed to be used in a single arm, multi-centre, phase II basket trial investigating the safety and activity of the use of ORBCEL-C™ in the treatment of patients with inflammatory conditions. ORBCEL-C™ is an enriched Mesenchymal Stromal Cells product isolated from human umbilical cord tissue using CD362+ cell selection. Usability testing sessions were conducted using cognitive interviews and the ‘Think Aloud’ method with patient advisory group members and Research Nurses to assess the usability of the system.ResultsNine patient partners and seven research nurses took part in one usability testing session. Measures of fatigue and health-related quality of life, the PRO-CTCAE™ and FACT-GP5 global tolerability question were included in the ePRO system. Alert notifications to the clinical team were triggered by PRO-CTCAE™ and FACT-GP5 scores. Patient participants liked the simplicity and responsiveness of the patient-facing app. Two patients were unable to complete the testing session, due to technical issues. Research Nurses suggested minor modifications to improve functionality and the layout of the clinician dashboard and the training materials.ConclusionBy testing the effectiveness, efficiency, and satisfaction of our novel ePRO system (PROmicsR), we learnt that most people with an inflammatory condition found it easy to report their symptoms using an app on their own device. Their experiences using the PROmicsR ePRO system within a trial environment will be further explored in our upcoming feasibility testing. Research nurses were also positive and found the clinical dashboard easy-to-use. Using ePROs in early phase trials is important in order to provide evidence of therapeutic responses and tolerability, increase the evidence based, and inform methodology development.Trial registration: ISRCTN, ISRCTN80103507. Registered 01 April 2022, https://www.isrctn.com/ISRCTN80103507

【 授权许可】

CC BY   
© International Society for Quality of Life Research (ISOQOL) 2023

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