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.

Humans User-Centered Design Quality of Life User-Computer Interface Electronics Patient Reported Outcome Measures
Cognitive interviews Early phase advanced therapy trial Electronic patient reported outcomes Inflammatory conditions Usability testing

Journal

Journal of patient-reported outcomes
ISSN: 2509-8020
Titre abrégé: J Patient Rep Outcomes
Pays: Germany
ID NLM: 101722688

Informations de publication

Date de publication:
09 10 2023
Historique:
received: 09 08 2022
accepted: 10 09 2023
medline: 10 10 2023
pubmed: 9 10 2023
entrez: 9 10 2023
Statut: epublish

Résumé

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. 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. 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. By testing the effectiveness, efficiency, and satisfaction of our novel ePRO system (PROmics ISRCTN, ISRCTN80103507. Registered 01 April 2022, https://www.isrctn.com/ISRCTN80103507. More and more patients tell clinicians how they feel by completing questionnaires electronically. Therefore, it is important to assess how easy it is for patients to do this. In this study, we describe how we developed an electronic platform for patients to report their symptoms and how we tested the usability of this platform with patient partners and research nurses. Once the electronic platform was developed, quality of life and symptoms questionnaires were programmed onto it. Alerts were sent to the clinical team if specific scores were obtained on the symptoms questionnaires. Although two patient partners were not able to finish the testing session because of technical issues, the ones who completed the session liked its simplicity and responsiveness. The research nurses also liked the system and only suggested minor modifications. Following this testing, we refined the electronic platform to test it further in a larger study which investigates the safety and use of a drug. We hope that thanks to this electronic platform, we will obtain useful information on the safety and efficacy of treatment.

Sections du résumé

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 (PROmics
TRIAL REGISTRATION
ISRCTN, ISRCTN80103507. Registered 01 April 2022, https://www.isrctn.com/ISRCTN80103507.
More and more patients tell clinicians how they feel by completing questionnaires electronically. Therefore, it is important to assess how easy it is for patients to do this. In this study, we describe how we developed an electronic platform for patients to report their symptoms and how we tested the usability of this platform with patient partners and research nurses. Once the electronic platform was developed, quality of life and symptoms questionnaires were programmed onto it. Alerts were sent to the clinical team if specific scores were obtained on the symptoms questionnaires. Although two patient partners were not able to finish the testing session because of technical issues, the ones who completed the session liked its simplicity and responsiveness. The research nurses also liked the system and only suggested minor modifications. Following this testing, we refined the electronic platform to test it further in a larger study which investigates the safety and use of a drug. We hope that thanks to this electronic platform, we will obtain useful information on the safety and efficacy of treatment.

Autres résumés

Type: plain-language-summary (eng)
More and more patients tell clinicians how they feel by completing questionnaires electronically. Therefore, it is important to assess how easy it is for patients to do this. In this study, we describe how we developed an electronic platform for patients to report their symptoms and how we tested the usability of this platform with patient partners and research nurses. Once the electronic platform was developed, quality of life and symptoms questionnaires were programmed onto it. Alerts were sent to the clinical team if specific scores were obtained on the symptoms questionnaires. Although two patient partners were not able to finish the testing session because of technical issues, the ones who completed the session liked its simplicity and responsiveness. The research nurses also liked the system and only suggested minor modifications. Following this testing, we refined the electronic platform to test it further in a larger study which investigates the safety and use of a drug. We hope that thanks to this electronic platform, we will obtain useful information on the safety and efficacy of treatment.

Identifiants

DOI: 10.1186/s41687-023-00634-3 PMID: 37812323 PMC: PMC10562321
pubmed: 37812323
doi: 10.1186/s41687-023-00634-3
pii: 10.1186/s41687-023-00634-3
pmc: PMC10562321
doi:

Substances chimiques

cyclic adenosine-5'-trimetaphosphate 53355-60-5

Banques de données

ISRCTN
['ISRCTN80103507']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

98

Subventions

Organisme : Department of Health
Pays : United Kingdom

Informations de copyright

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

Références

J Natl Cancer Inst. 2019 Nov 1;111(11):1170-1178
pubmed: 30959516
BMJ Open. 2022 Sep 6;12(9):e063199
pubmed: 36691123
Value Health. 2009 Jun;12(4):419-29
pubmed: 19900250
J Clin Oncol. 2016 Feb 20;34(6):557-65
pubmed: 26644527
Hepatology. 2018 Jul;68(1):155-165
pubmed: 29152767
Health Qual Life Outcomes. 2018 Jul 05;16(1):133
pubmed: 29976215
Clin Trials. 2021 Apr;18(2):168-179
pubmed: 33231103
Cancer. 2018 Jan 1;124(1):153-160
pubmed: 28885707
Clin Trials. 2018 Dec;15(6):616-623
pubmed: 30230365
Nat Med. 2022 Jan;28(1):18-20
pubmed: 35039659
Hemoglobin. 2015;39(3):162-8
pubmed: 25831427
J Clin Oncol. 1999 Mar;17(3):998-1007
pubmed: 10071295
J Natl Cancer Inst. 2009 Dec 2;101(23):1624-32
pubmed: 19920223
BMC Cancer. 2019 May 17;19(1):463
pubmed: 31101017
Health Qual Life Outcomes. 2015 Oct 07;13:167
pubmed: 26446159
Health Qual Life Outcomes. 2015 Jan 22;13:2
pubmed: 25608560
BMJ Open. 2016 Jun 15;6(6):e010938
pubmed: 27311907
Hum Cell. 2021 Sep;34(5):1289-1300
pubmed: 34057700
Trials. 2022 Jan 15;23(1):42
pubmed: 35033186
Semin Radiat Oncol. 2002 Jan;12(1 Suppl 1):1-3
pubmed: 11917276
Drug Saf. 2013 Dec;36(12):1129-49
pubmed: 24092596
Immunology. 2012 Jun;136(2):115-22
pubmed: 22348589
Comput Biol Med. 2018 Oct 1;101:120-127
pubmed: 30130638
Best Pract Res Clin Rheumatol. 2007 Aug;21(4):637-47
pubmed: 17678825
Perm J. 2014 Summer;18(3):22-6
pubmed: 25102515
JAMA Oncol. 2015 Nov;1(8):1051-9
pubmed: 26270597
Value Health. 2018 Jun;21(6):742-747
pubmed: 29909880
Control Clin Trials. 2003 Apr;24(2):182-99
pubmed: 12689739
PLoS One. 2016 Jan 19;11(1):e0144658
pubmed: 26785084
Value Health. 2013 Jun;16(4):480-9
pubmed: 23796281
BMJ Open. 2016 Oct 3;6(10):e012281
pubmed: 27697875
Qual Life Res. 2020 Feb;29(2):325-333
pubmed: 31691202
Lancet Oncol. 2006 Nov;7(11):903-9
pubmed: 17081915
Cancer. 2018 Mar 1;124(5):991-997
pubmed: 29131323
J Clin Oncol. 1993 Mar;11(3):570-9
pubmed: 8445433
Evid Rep Technol Assess (Full Rep). 2008 Nov;(175):1-1422
pubmed: 19408968
Curr Pharm Teach Learn. 2021 Feb;13(2):181-188
pubmed: 33454077
JMIR Perioper Med. 2020 Apr 3;3(1):e15588
pubmed: 33393920
Semin Radiat Oncol. 2003 Jul;13(3):176-81
pubmed: 12903007
Semin Hematol. 1997 Jul;34(3 Suppl 2):13-9
pubmed: 9253779
Can J Urol. 2011 Dec;18(6):5998-6006
pubmed: 22166326
Oncologist. 2013;18(1):64-72
pubmed: 23287880
BMJ. 2002 May 18;324(7347):1193-4
pubmed: 12016186
Nat Med. 2022 Jun;28(6):1120-1124
pubmed: 35513530
Qual Life Res. 2003 Jun;12(4):395-404
pubmed: 12797712

Auteurs

Christel McMullan (C)

Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK. c.mcmullan@bham.ac.uk.
NIHR Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham, UK. c.mcmullan@bham.ac.uk.
Centre for Trauma Science Research, University of Birmingham, Birmingham, UK. c.mcmullan@bham.ac.uk.
ORCID: 0000-0002-0878-1513

Ameeta Retzer (A)

Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, 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.

Sarah E Hughes (SE)

Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, 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.

Olalekan Lee Aiyegbusi (OL)

Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, 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.

Camilla Bathurst (C)

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.

Alan Boyd (A)

Alan Boyd Consultancy, Crewe, UK.

Jamie Coleman (J)

Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.

Elin Haf Davies (EH)

Aparito Ltd, Wrexham, Wales.

Alastair K Denniston (AK)

Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, 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.

Helen Dunster (H)

Univeristy of Birmingham Enterprise, Birmingham, UK.

Chris Frost (C)

Aparito Ltd, Wrexham, Wales.

Rosie Harding (R)

Birmingham Law School, University of Birmingham, Birmingham, UK.

Amanda Hunn (A)

Independent Adviser, Manchester, UK.

Derek Kyte (D)

School of Allied Health & Community, University of Worcester, Worcester, UK.

Rebecca Malpass (R)

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.

Gary McNamara (G)

Cognitant, London, UK.

Sandra Mitchell (S)

National Cancer Institute, Bethesda, USA.

Saloni Mittal (S)

University Hospital Birmingham, Birmingham, UK.

Philip N Newsome (PN)

Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, 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.

Gary Price (G)

Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.

Anna Rowe (A)

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.

Wilma van Reil (W)

Research Governance, University Hospital Birmingham, Birmingham, UK.

Anita Walker (A)

Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
NIHR Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham, UK.

Roger Wilson (R)

Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
National Cancer Research Institute (NCRI) Consumer Forum, London, UK.

Melanie Calvert (M)

Centre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, 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.

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