Patient reported outcome assessment must be inclusive and equitable

Calvert, Melanie; Rivera, Samantha Cruz; Retzer, Ameeta; Hughes, Sarah; Campbell, Lisa; Molony-Oates, Barbara; Aiyegbusi, Olalekan Lee; Stover, Angela M.; Wilson, Roger; McMullan, Christel; Anderson, Nicola; Turner, Grace; Davies, Elin Haf; Verdi, Rav; Velikova, Galina; Kamudoni, Paul; Muslim, Syed; Gheorghe, Adrian; O’Connor, Daniel; Liu, Xiaoxuan; Wu, Albert W.; Denniston, Alastair K

doi:10.1038/s41591-022-01781-8

Cited by 88 publications

(66 citation statements)

References 18 publications

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“…44 Therefore, when feasible, more than one mode should be offered to ensure that vulnerable populations are able to have access to a survey platform. 45 Some key functionalities of electronic PROM systems that add value include: the generation of reports or visualisations for clinicians to review the longitudinal trajectory of PROs; the generation of automated patient self-care advice on actions they can take for the management of mild symptoms; and the ability to alert clinicians when patients report symptoms or physical function impairments of a magnitude or level of worsening that warrants clinical attention. When implementing any PROM system, workflow and staff capacity must be considered to ensure that clinicians have ample time allocated for reviewing alerts and reports.…”

Section: Modes Of Administrationmentioning

confidence: 99%

The role of patient-reported outcome measures in the continuum of cancer clinical care: ESMO Clinical Practice Guideline

et al. 2022

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Section: Modes Of Administrationmentioning

confidence: 99%

The role of patient-reported outcome measures in the continuum of cancer clinical care: ESMO Clinical Practice Guideline

et al. 2022

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“…Digital exclusion, particularly for underserved populations that may have limited access to digital devices, contributes a further source of bias to the proposed study. 38 Sampling bias will be addressed by recruiting purposively for maximum variation and through the inclusion of participants who declined to use the PROmics system or who reverted to the use of paper-based PROs Open access at some point in the trial. Questionnaires programmed onto the PROmics system are currently in UK English; however, if the solution proves feasible, translated and culturally validated measures will be included in future work.…”

Section: Discussionmentioning

confidence: 99%

Feasibility of a new electronic patient-reported outcome (ePRO) system for an advanced therapy clinical trial in immune-mediated inflammatory disease (PROmics): protocol for a qualitative feasibility study

et al. 2022

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IntroductionThe use of electronic patient-reported outcome (ePRO) systems to capture PRO data in clinical trials is increasing; however, their feasibility, acceptability and utility in clinical trials of advanced therapy medicinal products (ATMPs) are not yet well understood. This protocol describes a qualitative study that aims to evaluate the feasibility and acceptability of ePRO data capture using a trial-specific ePRO system (the PROmics system) within an advanced therapy trial involving patients with immune-mediated inflammatory disease (rheumatoid arthritis, lupus, primary sclerosing cholangitis (PSC) and Crohn’s disease).Methods and analysisThis protocol for a remote, qualitative, interview-based feasibility study is embedded within the POLARISE trial, a single-arm, phase II, multisite ATMP basket trial in the UK. 10–15 patients enrolled in the POLARISE trial and 10–15 research team members at the trial sites will be recruited. Participants will take part in semistructured interviews which will be transcribed verbatim and analysed thematically according to the framework method. Data collection and analysis will occur concurrently and iteratively. Researcher triangulation will be used to achieve a consensus-based analysis, enhancing rigour and trustworthiness.Ethics and disseminationThis study was approved by the London—West London and GTAC Research Ethics Committee (Ref: 21/LO/0475). Informed consent will be obtained from all participants prior to data collection. The study findings will be published in peer-review journals and disseminated via conference presentations and other media. Our patient and public involvement and engagement group and ATMP stakeholder networks will be consulted to maximise dissemination and impact.Trial registration numberISRCTN80103507.

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“…Collecting information about the effects of various treatment modalities on HRQL is thus important in order to inform patients and their next of kin. PROMs are indispensable in modern health care, because, if developed and validated in an appropriate way, they not only include the patients, but genuinely put them at the center, and measure what is important to them [ 4 , 23 , 24 , 25 , 28 , 29 ]. PROMs capture more important aspects than mere radiological or other objectively measured outcomes, e.g., joint range of motion, muscle strength, etc.…”

Section: Discussionmentioning

confidence: 99%

LIMB-Q Kids—German Translation and Cultural Adaptation

et al. 2022

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(1) Purpose: Lower limb deformities can have a severe impact on health-related quality of life (HRQL). LIMB-Q Kids is a new patient-reported outcome measure (PROM) aiming to elucidate the experience of 8–18-year-old patients before, during and after treatment, and to measure the different aspects of HRQL. The aim of this study was to translate and culturally adapt LIMB-Q Kids to German. (2) Methods: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines were followed. Three forward translations, a backward translation, an expert panel meeting with eight participants, and twenty cognitive debriefing interviews led to the final German version of LIMB-Q Kids. (3) Results: In the forward translations, 4/159 items were difficult to translate, and 2/159 items in the backward translation differed from the original English version. Cognitive debriefing interviews with 20 patients identified 7/159 items that were difficult to comprehend/answer, and 2 of these items were changed. (4) Conclusions: Lower limb deformities can have a great impact on children, and it is important to measure and consider the impact on HRQL. In order to be able to use PROMs in different countries, conceptually equivalent translations and cultural adaptations should be performed in order to ensure comprehensibility. The final German version of LIMB-Q Kids is ready for use in an international field test.

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Patient reported outcome assessment must be inclusive and equitable

Cited by 88 publications

References 18 publications

The role of patient-reported outcome measures in the continuum of cancer clinical care: ESMO Clinical Practice Guideline

The role of patient-reported outcome measures in the continuum of cancer clinical care: ESMO Clinical Practice Guideline

Feasibility of a new electronic patient-reported outcome (ePRO) system for an advanced therapy clinical trial in immune-mediated inflammatory disease (PROmics): protocol for a qualitative feasibility study

LIMB-Q Kids—German Translation and Cultural Adaptation

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