title: Patient-reported outcomes and their predictors at 2- and 3-year follow-up after immediate latissimus dorsi breast reconstruction and adjuvant treatment.
abstract: BACKGROUND
  The aim of this study was to estimate the impact 2 and 3 years after surgery of implant-assisted latissimus dorsi (LDI) and autologous latissimus dorsi (ALD) flap breast reconstructions on patient-reported outcomes (PROs), and, secondarily, to determine whether baseline characteristics can predict PROs.
  
  
  METHODS
  This was a multicentre prospective cohort study. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) and breast cancer module (QLQ-BR23), Functional Assessment of Cancer Therapy - Breast (FACT-B), and Hospital Anxiety and Depression Scale (HADS) PROs were completed before surgery and at 2 and 3 years after breast reconstruction. The effects of LDI and ALD, adjusted for baseline clinicodemographic characteristics, were estimated with multiple linear regressions. Effect sizes above 0·5 were considered clinically important.
  
  
  RESULTS
  Some 206 patients (LDI 93, ALD 113) were recruited in 2007-2013; 66·5 per cent were node-negative and 34·6 per cent received radiotherapy. Women with adverse clinicopathological factors were more likely to have received radiotherapy and to undergo ALD. Patients in both surgical groups showed clinically important effects at 2 and 3 years, including improvements in emotional scales, but worse physical functioning, social well-being, body image and anxiety. Radiotherapy adversely affected social functioning at 2 years (P = 0·002). Women undergoing ALD reconstruction had significantly improved sexual functioning at 3 years (P = 0·003) relative to those who had LDI procedures, even after adjusting for case mix (P = 0·007). At 3 years, younger women experienced worse physical well-being than older women (P = 0·006), and chemotherapy was associated with worse arm symptoms (P = 0·005).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Breast Cancer Surgery Patient Reported and Clinical Outcomes Research Group, School of Clinical Sciences, University of Bristol, Southmead Hospital, Bristol, UK.
authors.forename: Z E
authors.initials: ZE
authors.lastname: Winters
authors.affiliation: Breast Cancer Surgery Patient Reported and Clinical Outcomes Research Group, School of Clinical Sciences, University of Bristol, Southmead Hospital, Bristol, UK.
authors.forename: M
authors.initials: M
authors.lastname: Afzal
authors.affiliation: Breast Cancer Surgery Patient Reported and Clinical Outcomes Research Group, School of Clinical Sciences, University of Bristol, Southmead Hospital, Bristol, UK.
authors.forename: V
authors.initials: V
authors.lastname: Balta
authors.affiliation: Breast Cancer Surgery Patient Reported and Clinical Outcomes Research Group, School of Clinical Sciences, University of Bristol, Southmead Hospital, Bristol, UK.
authors.forename: J
authors.initials: J
authors.lastname: Freeman
authors.affiliation: Breast Cancer Surgery Patient Reported and Clinical Outcomes Research Group, School of Clinical Sciences, University of Bristol, Southmead Hospital, Bristol, UK.
authors.forename: R
authors.initials: R
authors.lastname: Llewellyn-Bennett
authors.affiliation: Bristol Breast Care Centre, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
authors.forename: Z
authors.initials: Z
authors.lastname: Rayter
authors.affiliation: Bristol Breast Care Centre, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
authors.forename: J
authors.initials: J
authors.lastname: Cook
authors.affiliation: Research Design Service - South West, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: R
authors.initials: R
authors.lastname: Greenwood
authors.affiliation: Quality of Life Office, School of Psychology and Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: M T
authors.initials: MT
authors.lastname: King
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000601:surgery* / Q000628:therapy; D017024:Chemotherapy, Adjuvant; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016014:Linear Models; D016462:Mammaplasty / Q000379:methods*; D008875:Middle Aged; D063868:Patient Outcome Assessment; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant; D064171:Superficial Back Muscles / Q000601:surgery*; D013524:Surgical Flaps