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

McMullan, C.; Retzer, A.; Hughes, S.E.; Lee Aiyegbusi, O.; Bathurst, C.; Boyd, A.; Coleman, J.; Haf Davies, E.; Denniston, A.K.; Dunster, H.; Frost, C.; Harding, R.; Hunn, A.; Kyte, Derek; Malpass, R.; McNamara, G.; Mitchell, S.A.; Mittal, S.; Newsome, P.; Price, G.; Rowe, A.; van Reil, W.; Walker, A.; Wilson, R.; Calvert, M.J.

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McMullan, C. ORCID: https://orcid.org/0000-0002-0878-1513, Retzer, A. ORCID: https://orcid.org/0000-0002-4156-8386, Hughes, S.E. ORCID: https://orcid.org/0000-0001-5656-1198, Lee Aiyegbusi, O. ORCID: https://orcid.org/0000-0001-9122-8251, Bathurst, C., Boyd, A., Coleman, J. ORCID: https://orcid.org/0000-0002-7512-5153, Haf Davies, E., Denniston, A.K. ORCID: https://orcid.org/0000-0001-7849-0087, Dunster, H., Frost, C., Harding, R. ORCID: https://orcid.org/0000-0002-3063-3525, Hunn, A., Kyte, Derek ORCID: https://orcid.org/0000-0002-7679-6741, Malpass, R., McNamara, G., Mitchell, S.A., Mittal, S., Newsome, P. ORCID: https://orcid.org/0000-0001-6085-3652, Price, G., Rowe, A., van Reil, W., Walker, A., Wilson, R. and Calvert, M.J. ORCID: https://orcid.org/0000-0002-1856-837X (2023) 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, 7 (1). ISSN Electronic: 2509-8020

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Abstract:

Background: Electronic 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. Methods: An 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. Results: Nine 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. Conclusion: By 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

Additional Information:

© Crown 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/

Uncontrolled Discrete Keywords:

Electronic patient reported outcomes, Early phase advanced therapy trial, Cognitive interviews, Inflammatory conditions, Usability testing

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College of Health, Life and Environmental Sciences > School of Allied Health and Community

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School of Health and Wellbeing

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