Evidence map›Paper›PMID 37812323›Full record

ArticleJournal of patient-reported outcomes2023

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.

Christel McMullan, Ameeta Retzer, Sarah E Hughes, Olalekan Lee Aiyegbusi, Camilla Bathurst, Alan Boyd, Jamie Coleman, Elin Haf Davies, Alastair K Denniston, Helen Dunster and 15 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of patient-reported outcomes, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.4field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 6 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 9 institutions in 2 countries.

Christel McMullanCentre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK. c.mcmullan@bham.ac.uk.ORCID http://orcid.org/0000-0002-0878-1513
Ameeta RetzerCentre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Sarah E HughesCentre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Olalekan Lee AiyegbusiCentre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Camilla BathurstNational Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham, Birmingham, UK.
Alan BoydAlan Boyd Consultancy, Crewe, UK.
Jamie ColemanInstitute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
Elin Haf DaviesAparito Ltd, Wrexham, Wales.
Alastair K DennistonCentre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Helen DunsterUniveristy of Birmingham Enterprise, Birmingham, UK.
Chris FrostAparito Ltd, Wrexham, Wales.
Rosie HardingBirmingham Law School, University of Birmingham, Birmingham, UK.
Amanda HunnIndependent Adviser, Manchester, UK.
Derek KyteSchool of Allied Health & Community, University of Worcester, Worcester, UK.
Rebecca MalpassNational Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham, Birmingham, UK.
Gary McNamaraCognitant, London, UK.
Sandra MitchellNational Cancer Institute, Bethesda, USA.
Saloni MittalUniversity Hospital Birmingham, Birmingham, UK.
Philip N NewsomeCentre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Gary PriceCentre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Anna RoweNational Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham, Birmingham, UK.
Wilma van ReilResearch Governance, University Hospital Birmingham, Birmingham, UK.
Anita WalkerCentre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Roger WilsonCentre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Melanie CalvertCentre for Patient Reported Outcome Research (CPROR), Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
University Hospitals Birmingham NHS Foundation Trust · GBNIHR Surgical Reconstruction and Microbiology Research Centre · GBUniversity of Birmingham · GBBoyds (United Kingdom) · GBCognizant (United Kingdom) · GBNational Cancer Institute · USNational Institute for Health Research · GBUK Health Forum · GBUniversity of Worcester · GB

Funding

Department of HealthMedical Research Council MC_PC_17183
6 · The paper itself

Abstract

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 (PROmics

trial registrationISRCTN, ISRCTN80103507. Registered 01 April 2022, https://www.isrctn.com/ISRCTN80103507.

Indexed as

Quality of LifeUser-Centered DesignCyclic AMPElectronicsHumansPatient Reported Outcome MeasuresUser-Computer Interfacecyclic adenosine-5'-trimetaphosphateCyclic AMPCognitive interviewsEarly phase advanced therapy trialElectronic patient reported outcomesInflammatory conditionsUsability testing

Identifiers

PMID37812323
PMCPMC10562321
OpenAlexW4387439360

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.