title: Systematic review and critical appraisal of the impact of acellular dermal matrix use on the outcomes of implant-based breast reconstruction.
abstract: BACKGROUND
  Acellular dermal matrix (ADM) may improve outcomes in implant-based breast reconstruction (IBBR). The aim of this study was critically to appraise and evaluate the current evidence for ADM-assisted IBBR.
  
  
  METHODS
  Comprehensive electronic searches identified complete papers published in English between January 2000 and August 2013, reporting any outcome of ADM-assisted IBBR. All systematic reviews, randomized clinical trials (RCTs) and non-randomized studies (NRSs) with more than 20 ADM recipients were included. Studies were critically appraised using AMSTAR for systematic reviews, the Cochrane risk-of-bias tool for RCTs and its adaptation for NRSs. Characteristics and results of identified studies were summarized.
  
  
  RESULTS
  A total of 69 papers (8 systematic reviews, 1 RCT, 40 comparative studies and 20 case series) were identified, all of which were considered at high risk of bias, mostly due to patient selection and selective outcome reporting. The median ADM group sample size was 51.0 (i.q.r. 33.0-127.0). Most studies were single-centre (54), and they were often single-surgeon (16). ADM was most commonly used for immediate (40) two-stage IBBR (36) using human ADM (47), with few studies evaluating ADM-assisted single-stage procedures (10). All reported clinical outcomes (for example implant loss) and more than half of the papers (33) assessed process outcomes, but few evaluated cosmesis (16) or patient-reported outcomes (10). Heterogeneity between study design and, especially, outcome measurement precluded meaningful data synthesis.
  
  
  CONCLUSIONS
  Current evidence for the value of ADMs in IBBR is limited. Use in practice should therefore be considered experimental, and evaluation within registries or well designed and conducted studies, ideally RCTs, is recommended to prevent widespread adoption of a potentially inferior intervention.
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: S
authors.initials: S
authors.lastname: Potter
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.|Department of Surgery, Royal United Hospital, Bath, UK.
authors.forename: D
authors.initials: D
authors.lastname: Browning
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: J
authors.initials: J
authors.lastname: Savović
authors.affiliation: Breast Unit, Linda McCartney Centre, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK.
authors.forename: C
authors.initials: C
authors.lastname: Holcombe
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.|Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: J M
authors.initials: JM
authors.lastname: Blazeby
mesh_terms: D062088:Acellular Dermis; D019928:Breast Implantation / Q000379:methods*; D005260:Female; D006801:Humans; D017063:Outcome Assessment, Health Care