dc.contributor.author | Bhattacharya, IS | |
dc.contributor.author | Haviland, JS | |
dc.contributor.author | Hopwood, P | |
dc.contributor.author | Coles, CE | |
dc.contributor.author | Yarnold, JR | |
dc.contributor.author | Bliss, JM | |
dc.contributor.author | Kirby, AM | |
dc.contributor.author | IMPORT Trialists, | |
dc.date.accessioned | 2019-03-04T13:00:49Z | |
dc.date.issued | 2019-05 | |
dc.identifier.citation | Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 2019, 134 pp. 220 - 230 | |
dc.identifier.issn | 0167-8140 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/3110 | |
dc.identifier.eissn | 1879-0887 | |
dc.identifier.doi | 10.1016/j.radonc.2019.01.036 | |
dc.description.abstract | BACKGROUND: In an era of low local relapse rates after adjuvant breast radiotherapy, risks of late normal-tissue effects (NTE) need to be balanced against risk of relapse. NTE are assessed using patient-reported outcome measures (PROMs), clinician-reported outcomes (CRO) and photographs. This analysis investigates whether PROMs can be used as primary NTE endpoints in breast radiotherapy trials. METHODS: Analyses were conducted within IMPORT LOW (ISRCTN12852634) at 2 and 5 years. NTE were recorded by CRO, photographs and PROMs. Measures of agreement tested concordance, risk ratios for radiotherapy groups were compared, and influence of baseline characteristics on concordance investigated. RESULTS: In 1095 patients who consented to PROMS and photographs, PROMs were available at 2 and/or 5 years for 976 patients, of whom 909 had CRO and 844 had photographs. Few patients had moderate/marked NTE, irrespective of method used (eg. 19% patients and 9% clinicians reported breast shrinkage at year-5). Patients reported more NTE than assessed from CRO or photographs (p < 0.001 for most NTE). Concordance between assessments was poor on an individual patient level; eg. for year-5 breast shrinkage, % agreement = 48% and weighted kappa = 0.17. Risk ratios comparing radiotherapy schedules were consistent between PROMs and CRO or photographs. CONCLUSIONS: Few patients had moderate/marked NTE irrespective of method used. Patients reported more NTE than CRO and photographs, therefore NTE may be underestimated if PROMs are not used. Despite poor concordance between methods, effect sizes from PROMs were consistent with CRO and photographs, suggesting PROMs can be used as primary NTE endpoints in breast radiotherapy trials. | |
dc.format | Print-Electronic | |
dc.format.extent | 220 - 230 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER IRELAND LTD | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | IMPORT Trialists | |
dc.subject | Humans | |
dc.subject | Breast Neoplasms | |
dc.subject | Neoplasm Recurrence, Local | |
dc.subject | Disease Progression | |
dc.subject | Photography | |
dc.subject | Combined Modality Therapy | |
dc.subject | Radiotherapy, Adjuvant | |
dc.subject | Radiotherapy | |
dc.subject | Endpoint Determination | |
dc.subject | Adult | |
dc.subject | Middle Aged | |
dc.subject | Female | |
dc.subject | Randomized Controlled Trials as Topic | |
dc.subject | Clinical Trials, Phase III as Topic | |
dc.subject | Patient Reported Outcome Measures | |
dc.title | Can patient-reported outcomes be used instead of clinician-reported outcomes and photographs as primary endpoints of late normal tissue effects in breast radiotherapy trials? Results from the IMPORT LOW trial. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2019-01-30 | |
rioxxterms.versionofrecord | 10.1016/j.radonc.2019.01.036 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2019-05 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology | |
pubs.notes | Not known | |
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/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Breast Cancer Radiotherapy | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Breast Cancer Radiotherapy/Breast Cancer Radiotherapy (hon.) | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
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/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Breast Cancer Radiotherapy | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Breast Cancer Radiotherapy/Breast Cancer Radiotherapy (hon.) | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.publication-status | Published | |
pubs.volume | 134 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Clinical Trials & Statistics Unit | |
icr.researchteam | Breast Cancer Radiotherapy | |
dc.contributor.icrauthor | Bhattacharya, Indrani | |
dc.contributor.icrauthor | Haviland, Joanne | |
dc.contributor.icrauthor | Yarnold, John | |
dc.contributor.icrauthor | Bliss, Judith | |