dc.contributor.author | Philipps, L | |
dc.contributor.author | Foster, S | |
dc.contributor.author | Gardiner, D | |
dc.contributor.author | Gath, J | |
dc.contributor.author | Gillman, A | |
dc.contributor.author | Haviland, J | |
dc.contributor.author | Hill, E | |
dc.contributor.author | King, D | |
dc.contributor.author | Manning, G | |
dc.contributor.author | Stiles, M | |
dc.contributor.author | Hall, E | |
dc.contributor.author | Lewis, R | |
dc.coverage.spatial | England | |
dc.date.accessioned | 2023-10-11T10:20:18Z | |
dc.date.available | 2023-10-11T10:20:18Z | |
dc.date.issued | 2023-09-21 | |
dc.identifier | bmjopen-2023-073817 | |
dc.identifier.citation | BMJ Open, 2023, 13 (9), pp. e073817 - | |
dc.identifier.issn | 2044-6055 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/6012 | |
dc.identifier.eissn | 2044-6055 | |
dc.identifier.eissn | 2044-6055 | |
dc.identifier.doi | 10.1136/bmjopen-2023-073817 | |
dc.description.abstract | INTRODUCTION: Patient-reported outcomes (PRO) are currently collected from trial participants using paper questionnaires by the Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU). Streamlining PRO collection using electronic questionnaires (ePRO) may improve data collection and patient experience. Here, we outline our protocol for a Study within a trial of electronic versus paper-based Patient-Reported oUtcomes CollEction (SPRUCE), which investigates the acceptability of ePRO in oncology clinical trials. METHODS AND ANALYSIS: SPRUCE was developed alongside patient and public contributors. SPRUCE runs in multiple host trials with a partially randomised patient preference design, allowing participants to be randomised or choose their preference of electronic or paper questionnaires. Questionnaires are scheduled in accordance with host trial follow-up. The primary objective will assess differences in return rates (compliance) between ePRO and paper PROs at the first timepoint post-host trial intervention in the randomised group. Paper PRO compliance is expected to be 90%. 244 randomised participants are required to exclude ≤80% compliance rates with ePRO (10% non-inferiority margin, with 80% power and one-sided alpha=0.05). SPRUCE aims to assess acceptability of ePRO in oncology clinical trials, establish whether ePRO is acceptable to ICR-CTSU trial participants and can capture complete PRO data, consistent with paper PROs. ETHICS AND DISSEMINATION: The SPRUCE protocol (ICR-CTSU/2021/10074) was approved by the Coventry and Warwick Central Research Ethics Committee (21/WM/0223) on 21 October 2021. Results will be disseminated via presentations, publications and lay summaries. No participant identifiable data will be included. TRIAL REGISTRATION: SWAT169. | |
dc.format | Electronic | |
dc.format.extent | e073817 - | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | BMJ PUBLISHING GROUP | |
dc.relation.ispartof | BMJ Open | |
dc.subject | adult oncology | |
dc.subject | patient reported outcome measures | |
dc.subject | quality of life | |
dc.subject | Humans | |
dc.subject | Patient Preference | |
dc.subject | Academies and Institutes | |
dc.subject | Data Collection | |
dc.subject | Electronics | |
dc.subject | Patient Reported Outcome Measures | |
dc.title | Study within a trial of electronic versus paper-based Patient-Reported oUtcomes CollEction (SPRUCE): study protocol for a partially randomised patient preference study. | |
dc.type | Journal Article | |
dc.date.updated | 2023-10-11T09:59:32Z | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1136/bmjopen-2023-073817 | |
rioxxterms.licenseref.uri | http://creativecommons.org/licenses/by/4.0/ | |
rioxxterms.licenseref.startdate | 2023-09-21 | |
rioxxterms.type | Journal Article/Review | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/37734892 | |
pubs.issue | 9 | |
pubs.organisational-group | ICR | |
pubs.organisational-group | ICR/Primary Group | |
pubs.organisational-group | ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit | |
pubs.organisational-group | ICR/Students | |
pubs.organisational-group | ICR/Students/PhD and MPhil | |
pubs.organisational-group | ICR/Students/PhD and MPhil/19/20 Starting Cohort | |
pubs.publication-status | Published online | |
pubs.publisher-url | http://dx.doi.org/10.1136/bmjopen-2023-073817 | |
pubs.volume | 13 | |
icr.researchteam | Clin Trials & Stats Unit | |
dc.contributor.icrauthor | Philipps, Lara | |
dc.contributor.icrauthor | Hall, Emma | |
dc.contributor.icrauthor | Lewis, Rebecca | |
icr.provenance | Deposited by Mrs Jessica Perry (impersonating Prof Emma Hall) on 2023-10-11. Deposit type is initial. No. of files: 2. Files: SPRUCE protocol paper- revisions clean.docx; Study within a trial of electronic versus paper-based Patient-Reported oUtcomes CollEction (SPRUCE) study protocol for a par.pdf | |