Do Patient-reported Outcome Measures Agree with Clinical and Photographic Assessments of Normal Tissue Effects after Breast Radiotherapy? The Experience of the Standardisation of Breast Radiotherapy (START) Trials in Early Breast Cancer.
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Date
2016-06-01Author
Haviland, JS
Hopwood, P
Mills, J
Sydenham, M
Bliss, JM
Yarnold, JR
START Trialists' Group,
Type
Journal Article
Metadata
Show full item recordAbstract
AIMS: In radiotherapy trials, normal tissue effects (NTE) are important end points and it is pertinent to ask whether patient-reported outcome measures (PROMs) could replace clinical and/or photographic assessments. Data from the Standardisation of Breast Radiotherapy (START) trials are examined. MATERIALS AND METHODS: NTEs in the treated breast were recorded by (i) annual clinical assessments, (ii) photographs at 2 and 5 years, (iii) PROMs at 6 months, 1, 2 and 5 years after radiotherapy. Hazard ratios for the radiotherapy schedules were compared. Measures of agreement of assessments at 2 and 5 years tested concordance. RESULTS: PROMs were available at 2 and/or 5 years for 1939 women, of whom 1870 had clinical and 1444 had photographic assessments. All methods were sensitive to the dose difference between schedules. Patients reported a higher prevalence for all NTE end points than clinicians or photographs (P < 0.001 for most NTEs). Concordance was generally poor; weighted kappa at 2 years ranged from 0.05 (telangiectasia) to 0.21 (shrinkage and oedema). The percentage agreement was lowest between PROMs and photographic assessments of change in breast appearance (38%). CONCLUSIONS: All three methods produced similar conclusions for the comparison of trial schedules, despite low concordance between the methods on an individual patient basis. Careful consideration should be given to the different contributions of the measures of NTE in future radiotherapy trials.
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Subject
START Trialists' Group
Breast
Humans
Breast Neoplasms
Early Diagnosis
Prognosis
Proportional Hazards Models
Adult
Aged
Aged, 80 and over
Middle Aged
Female
Patient Reported Outcome Measures
Dose Fractionation, Radiation
Research team
Clinical Trials & Statistics Unit
Language
eng
Date accepted
2015-12-15
License start date
2016-06
Citation
Clinical oncology (Royal College of Radiologists (Great Britain)), 2016, 28 (6), pp. 345 - 353
Publisher
ELSEVIER SCIENCE LONDON
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