title: Sentinel lymph node biopsy in vulvar cancer: a health technology assessment for the canadian health care context.
abstract: OBJECTIVE
  Inguinofemoral lymphadenectomy for vulvar cancer is associated with a high incidence of groin wound complications and lymphedema. Sentinel lymph node biopsy (SLNB) is a morbidity-reducing alternative to lymphadenectomy. The objective of this health technology assessment was to determine the clinical effectiveness, cost-effectiveness, and organizational feasibility of SLNB in the Canadian health care system.
  
  
  METHODS
  A review of the English-language literature published from January 1992 to October 2011 was performed across five databases and six grey-literature sources. Predetermined eligibility criteria were used to select studies, and results in the clinical, economic, and organizational domains were summarized. Included studies were evaluated for methodologic quality using the Newcastle-Ottawa Scale.
  
  
  RESULTS
  Of 825 reports identified, 88 observational studies met the eligibility criteria. Overall study quality was poor, with a median Newcastle-Ottawa Scale score of 2 out of 9 stars. Across all studies, the detection rate of the sentinel lymph node was 82.2% per groin and the false-negative rate was 6.3%. The groin recurrence rate after negative SLNB was 3.6% compared with 4.3% after negative lymphadenectomy, and complications were reduced after SLNB. No economic evaluations were identified comparing SLNB to lymphadenectomy. Safe implementation of SLNB requires appropriate patient selection, detection technique, and attention to the learning curve.
  
  
  CONCLUSIONS
  Although study quality is poor, the available data suggest implementation of SLNB may be safe and feasible in Canadian centres with adequate procedural volumes, assuming that implementation includes careful patient selection, careful technique, and ongoing quality assessment. Cost-effectiveness has yet to be determined.
authors.affiliation: Division of Gynecologic Oncology, University of Toronto, Toronto ON; Health Research Methodology Program, McMaster University, Hamilton ON.
authors.forename: Clare J
authors.initials: CJ
authors.lastname: Reade
authors.affiliation: Division of Gynecologic Oncology, Juravinski Cancer Centre, McMaster University, Hamilton ON.
authors.forename: Waldo
authors.initials: W
authors.lastname: Jimenez
authors.affiliation: Department of Clinical Epidemiology & Biostatistics, PATH Research Institute, McMaster University, Hamilton ON.
authors.forename: Daria
authors.initials: D
authors.lastname: O'Reilly
authors.affiliation: Division of Gynecologic Oncology, Odette Cancer Centre, University of Toronto, Toronto ON.
authors.forename: Al
authors.initials: A
authors.lastname: Covens
mesh_terms: D020811:Biomedical Technology; D002170:Canada; D003362:Cost-Benefit Analysis; D005188:False Negative Reactions; D005260:Female; D006119:Groin; D006801:Humans; D008197:Lymph Node Excision / Q000009:adverse effects; D009364:Neoplasm Recurrence, Local / Q000473:pathology; D021701:Sentinel Lymph Node Biopsy / Q000191:economics; D013673:Technology Assessment, Biomedical; D014846:Vulvar Neoplasms / Q000473:pathology* / Q000601:surgery