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dc.contributor.authorBhattacharya, ISen_US
dc.contributor.authorHaviland, JSen_US
dc.contributor.authorHopwood, Pen_US
dc.contributor.authorColes, CEen_US
dc.contributor.authorYarnold, JRen_US
dc.contributor.authorBliss, JMen_US
dc.contributor.authorKirby, AMen_US
dc.contributor.authorIMPORT Trialistsen_US
dc.coverage.spatialIrelanden_US
dc.date.accessioned2019-03-04T13:00:49Z
dc.date.issued2019-05en_US
dc.identifierhttps://www.ncbi.nlm.nih.gov/pubmed/31005219en_US
dc.identifierS0167-8140(19)30066-0en_US
dc.identifier.citationRadiother Oncol, 2019, 134 pp. 220 - 230en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/3110
dc.identifier.eissn1879-0887en_US
dc.identifier.doi10.1016/j.radonc.2019.01.036en_US
dc.description.abstractBACKGROUND: 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.en_US
dc.format.extent220 - 230en_US
dc.languageengen_US
dc.language.isoengen_US
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.subjectBreasten_US
dc.subjectNormal tissue effectsen_US
dc.subjectPROMsen_US
dc.subjectPatient-reporteden_US
dc.subjectRadiotherapyen_US
dc.subjectTrialsen_US
dc.titleCan 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.en_US
dc.typeJournal Article
dcterms.dateAccepted2019-01-30en_US
rioxxterms.versionofrecord10.1016/j.radonc.2019.01.036en_US
rioxxterms.licenseref.startdate2019-05en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfRadiother Oncolen_US
pubs.notesNot knownen_US
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-statusPublisheden_US
pubs.volume134en_US
pubs.embargo.termsNot knownen_US
icr.researchteamClinical Trials & Statistics Uniten_US
icr.researchteamBreast Cancer Radiotherapyen_US
dc.contributor.icrauthorBliss, Judithen_US
dc.contributor.icrauthorBhattacharya, Indranien_US
dc.contributor.icrauthorYarnold, Johnen_US
dc.contributor.icrauthorKirby, Annaen_US
dc.contributor.icrauthorHaviland, Joanneen_US


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Except where otherwise noted, this item's license is described as http://creativecommons.org/licenses/by/4.0/