title: A systematic review of the clinical evidence to guide treatment recommendations in breast reconstruction based on patient- reported outcome measures and health-related quality of life.
abstract: BACKGROUND
  Advances in breast cancer diagnosis and management have produced significant improvements in disease-free and breast cancer related survival. Consequently, there is increasing focus on the quality of long-term cancer survivorship. Of the 44,000 women diagnosed annually in the United Kingdom, 30% to 40% are required to undergo mastectomy. During the past 30 years, significant technical advances in breast reconstruction have increased performance of this surgical practice as a means to potentially improve health-related quality of life (HRQoL) for breast cancer survivors. Breast reconstruction studies increasingly aim to assess more discriminating outcomes based on the patients' own perception of the surgical result and its effect on HRQoL. This incremental output in HRQoL evaluation is being fuelled by both healthcare providers and official bodies such as the Food and Drug Administration, together with demands for more comprehensive comparative effectiveness data to permit fully informed consent by patients.
  
  
  METHODS
  In this systematic review, the authors apply inclusion and exclusion criteria to effectively screen 1012 abstracts identified in the field of HRQoL in breast reconstruction between 1978 and 2009. Each study was evaluated with respect to its design and statistical methodology. Each was reviewed with a recommended standard checklist of methodological requirements as described by Efficace et al (J Clin Oncol. 2003;21:3502-3511).
  
  
  RESULTS
  A total of 34 papers that included HRQL outcomes in breast reconstruction were identified and reviewed in detail. The majority of studies were retrospective in nature with significant inherent limitations. Specifically, they were compromised by potentially biased patient recall. Most of these studies lacked both an a priori outcome of interest and statistical rigor jeopardizing estimations of potential effect size. In addition, more than 90% of the studies failed to report or describe missing data. Thirteen studies provided level I (n = 2) and II (n = 11) evidence. While these studies benefited from more robust design, the majority used generic instruments such as 36-item short form (SF-36), which may not be sufficiently sensitive to measure changes consequent to breast reconstruction (ie, effect on body image or psychosocial well-being). Furthermore, these studies were generally underpowered to detect meaningful clinical difference or to permit subgroup analyses. Further limitations included reliance on single center design that may negatively impact generalizability and deficiencies in reporting the number and types of surgical complications, which potentially has an effect on HRQoL outcomes.
  
  
  CONCLUSIONS
  This systematic review reveals tendency for sound scientific methodology in HRQoL to be undermined by poorly designed and underpowered studies. In the current healthcare environment, patients and providers increasingly seek meaningful data to guide clinical decisions; policy makers are similarly in need of a rigorous patient-centered, comparative effectiveness data to inform national level decision-making. In light of this and the limitations of the existing published data, there is a pressing need for further Level I and II evidence in the form of randomized controlled trials as well as well-designed, multicenter prospective longitudinal studies in breast reconstruction. Such studies should incorporate sensitive and condition-specific patient-report outcome measures, provide adequate sample sizes, and respect established guidelines for rigorous HRQoL methodology.
authors: Clinical Sciences at South Bristol, Breast Reconstruction Quality of Life Group, University Hospitals Bristol NHS Foundation Trust, University of Bristol, Bristol, UK. zoe.winters@bristol.ac.uk
authors: Zoë Ellen
authors: ZE
authors: Winters
authors: John R
authors: JR
authors: Benson
authors: Andrea L
authors: AL
authors: Pusic
mesh_terms: D001943:Breast Neoplasms / Q000601:surgery*; D005260:Female; D006801:Humans; D016462:Mammaplasty; D017063:Outcome Assessment, Health Care; D011788:Quality of Life