title: The Cambridge Breast Intensity-modulated Radiotherapy Trial: Comparison of Clinician- versus Patient-reported Outcomes.
abstract: OBJECTIVE
  Breast radiotherapy-associated toxicity is often reported using clinical and photographic assessments. The addition of patient-reported outcome measures (PROMs) is becoming more common. This study investigated the concordance between clinician- and patient-reported outcomes.
  
  
  METHODS
  The Cambridge Breast Intensity-modulated Radiotherapy (IMRT) trial prospectively collected data on clinician assessment and PROMs at 2 and 5 years after breast radiotherapy. Clinician assessment included physical examination and photographic assessment. PROMs included European Organization for Research and Treatment of Cancer (EORTC) BR23 questionnaire and four breast radiotherapy-specific questions. The correlation between patient and clinician scores were analysed on an independent patient basis using percentage agreement, Cohen's kappa coefficient (k) and Bowker's test of symmetry. The analysis was repeated after stratifying patients based on age, baseline Hospital Anxiety and Depression Score (HADS) and baseline body image score.
  
  
  RESULTS
  At 2 and 5 years, a weak level of concordance was seen between the clinician-based assessment and PROMS for all the five toxicity end points (k = 0.05-0.21), with individual patient-based agreement of 32.9-78.3% and a highly discordant Bowker's test of symmetry (P < 0.001). The most frequently reported moderate-severe toxicity by patients was change in breast appearance (14% at both 2 and 5 years), whereas it was breast induration (36% and 25% at 2 and 5 years, respectively) by the clinicians. The lack of concordance was not affected by patient's age, baseline HADS and baseline body image score.
  
  
  CONCLUSIONS
  This study found that moderate-severe toxicity reported by patients is low and the overall concordance between clinicians and patients is low. This could be due to methodological limitations or alternatively reflects the subjective nature of PROMs. Incorporation of a patient's perception on treatment-related toxicity will have important implications for treatment decisions and follow-up care.
authors.affiliation: Oncology Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK; Department of Oncology, Colchester Hospital University NHS Foundation Trust, Essex, UK. Electronic address: drmukesh12@doctors.net.uk.
authors.forename: M B
authors.initials: MB
authors.lastname: Mukesh
authors.affiliation: Cambridge Cancer Trials Centre, Cambridge Clinical Trials Unit - Cancer Theme, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
authors.forename: W
authors.initials: W
authors.lastname: Qian
authors.affiliation: School of Clinical Medicine, University of Cambridge, Cambridge, UK.
authors.forename: C C
authors.initials: CC
authors.lastname: Wah Hak
authors.affiliation: Oncology Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
authors.forename: J S
authors.initials: JS
authors.lastname: Wilkinson
authors.affiliation: Oncology Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK; Cancer Research UK Centre for Genetic Epidemiology and Department of Oncology, University of Cambridge, Strangeways Research Laboratory, Cambridge, UK.
authors.forename: G C
authors.initials: GC
authors.lastname: Barnett
authors.affiliation: Oncology Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
authors.forename: A M
authors.initials: AM
authors.lastname: Moody
authors.affiliation: Oncology Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
authors.forename: C
authors.initials: C
authors.lastname: Wilson
authors.affiliation: Oncology Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
authors.forename: C E
authors.initials: CE
authors.lastname: Coles
mesh_terms: D001007:Anxiety / Q000175:diagnosis / Q000209:etiology; D001291:Attitude of Health Personnel; D001943:Breast Neoplasms / Q000532:radiotherapy*; D018270:Carcinoma, Ductal, Breast / Q000532:radiotherapy; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000532:radiotherapy; D003863:Depression / Q000175:diagnosis / Q000209:etiology; D005260:Female; D006801:Humans; D063868:Patient Outcome Assessment; D000071066:Patient Reported Outcome Measures; D058996:Quality Improvement; D011832:Radiation Injuries / Q000175:diagnosis* / Q000209:etiology; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects* / Q000379:methods; D011795:Surveys and Questionnaires
keywords: Breast cancer; concordance; late treatment toxicity; radiotherapy