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

Abstract

Highlights Few patients reported moderate/marked normal tissue effects (NTE) irrespective of assessment method used. Patients reported more NTE than clinician-reported outcomes or photographs. Concordance was poor on an individual patient level. Treatment comparisons were consistent between assessment methods.

Is breast seroma after tumour resection associated with patient-reported breast appearance change following radiotherapy? Results from the IMPORT HIGH (CRUK/06/003) trial

“…The choice of endpoint used in our case–control study may also explain our results being different to those of other published studies. PROMs provide the patient-perspective of side-effects and it has been shown that patients report a higher prevalence of NTE compared with clinicians or photographs [6], [7]. Therefore, PROMs may be a more sensitive endpoint.…”

“…The majority of these trials used clinician assessments of NTE and/or serial photographs. Patient-reported outcome measures (PROMs) provide an opportunity to understand the patients’ own perception of NTE and studies have found that patients report more NTE compared with clinicians and those detected on photographs [6], [7]. However, the association between the presence of seroma and patient-reported NTE following breast radiotherapy has not been investigated to date.…”

Chinese multicentre prospective registry of breast cancer patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC): a study protocol

“…Studies showed that outcomes were scored differently by patients and professionals, and CRO and photographs might underestimate complications as compared with PROs 33 37. Sparano et al 3 systematically investigated the concordance between clinician-reported symptomatic adverse events (AEs) and information obtained via PROMs in 207 cancer RCTs, and found that 64.2% RCTs showed a discordance in AEs between PRO and CRO.…”

“…Change in photographic breast appearance was assessed at 3, 12 and 24 months postoperatively and compared with the baseline photograph, before and after radiotherapy. Breast size and surgical deficit were scored from the baseline photographs on a 3-point scale (small, medium, large) 33 34. After radiotherapy, change in breast appearance (none/mild/marked) was scored on a pair of photographs with standard positions in comparison with the baseline photograph 33 34.…”

“…Breast size and surgical deficit were scored from the baseline photographs on a 3-point scale (small, medium, large) 33 34. After radiotherapy, change in breast appearance (none/mild/marked) was scored on a pair of photographs with standard positions in comparison with the baseline photograph 33 34. A panel of at least three independent observers blinded to patient identity, treatment allocation and radiotherapy centre scored the photographs 33 34…”