Article:Ghislain, I, Zikos, E, Coens, C et al. (11 more authors) (2016) Health-related quality of life in locally advanced and metastatic breast cancer: methodological and clinical issues in randomised controlled trials. The Lancet Oncology, 17 (7). e294-e304.

Background: Clinical evidence on patient-reported outcome measures (PROMS) in breast reconstruction is lacking. The aim of this study was to evaluate PROMs in implant-assisted latissimus dorsi (LDI) or tissue-only autologous latissimus dorsi (ALD) flap reconstruction in relation to complications and adjuvant treatments. Early complications up to 3 months after surgery were reported in 66 and 51·0 per cent of patients in the LDI and ALD groups respectively (P = 0·062) and long-term complications (4-12 months) in 48 and 45·0 per cent (P = 0·845). Role functioning and pain (P = 0·002 for both) were adversely affected in the ALD group compared with results in the LDI group, with no significant effects of radiotherapy on any health-related quality of life (HRQL). Chemotherapy and early complications adversely affected HRQL, which improved between 3 and 12 months after surgery (P < 0·010 for all).Conclusion: There is evidence of similar HRQL between types of latissimus dorsi breast reconstruction for up to a year after surgery. There appear to be no overarching effects for radiotherapy after mastectomy on the specific HRQL domains studied in the short term. The identification of variables that affect HRQL is important, including their integration into the analysis of PROMs.

Clinically important changes occurred in physical functioning, breast symptoms, body image and psychological distress. These results will guide selections of key PRO domains and sample-size calculation of future studies.