title: The cluster-randomized Quality Initiative in Rectal Cancer trial: evaluating a quality-improvement strategy in surgery.
abstract: BACKGROUND
  Following surgery for rectal cancer, two unfortunate outcomes for patients are permanent colostomy and local recurrence of cancer. We tested whether a quality-improvement strategy to change surgical practice would improve these outcomes.
  
  
  METHODS
  Sixteen hospitals were cluster-randomized to the intervention (Quality Initiative in Rectal Cancer strategy) or control (normal practice) arm. Consecutive patients with primary rectal cancer were accrued from May 2002 to December 2004. Surgeons at hospitals in the intervention arm could voluntarily participate by attending workshops, using opinion leaders, inviting a study team surgeon to demonstrate optimal techniques of total mesorectal excision, completing postoperative questionnaires, and receiving audits and feedback. Main outcome measures were hospital rates of permanent colostomy and local recurrence of cancer.
  
  
  RESULTS
  A total of 56 surgeons (n = 558 patients) participated in the intervention arm and 49 surgeons (n = 457 patients) in the control arm. The median follow-up of patients was 3.6 years. In the intervention arm, 70% of surgeons participated in workshops, 70% in intraoperative demonstrations and 71% in postoperative questionnaires. Surgeons who had an intraoperative demonstration provided care to 86% of the patients in the intervention arm. The rates of permanent colostomy were 39% in the intervention arm and 41% in the control arm (odds ratio [OR] 0.97, 95% confidence interval [CI] 0.63-1.48). The rates of local recurrence were 7% in the intervention arm and 6% in the control arm (OR 1.06, 95% CI 0.68-1.64).
  
  
  CONCLUSIONS
  Despite good participation by surgeons, the resource-intense quality-improvement strategy did not reduce hospital rates of permanent colostomy or local recurrence compared with usual practice.
authors.affiliation: Department of Surgery, McMaster University, St. Joseph's Healthcare, Hamilton, Ontario, Canada. marko.simunovic@jcc.hhsc.ca
authors.forename: Marko
authors.initials: M
authors.lastname: Simunovic
authors.forename: Angela
authors.initials: A
authors.lastname: Coates
authors.forename: Charles H
authors.initials: CH
authors.lastname: Goldsmith
authors.forename: Lehana
authors.initials: L
authors.lastname: Thabane
authors.forename: Dana
authors.initials: D
authors.lastname: Reeson
authors.forename: Andrew
authors.initials: A
authors.lastname: Smith
authors.forename: Robin S
authors.initials: RS
authors.lastname: McLeod
authors.forename: Franco
authors.initials: F
authors.lastname: DeNardi
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Whelan
authors.forename: Mark N
authors.initials: MN
authors.lastname: Levine
mesh_terms: D000368:Aged; D003107:Colorectal Surgery / Q000193:education / Q000379:methods; D003125:Colostomy / Q000193:education / Q000379:methods / Q000706:statistics & numerical data; D016001:Confidence Intervals; D004493:Education; D005260:Female; D006761:Hospitals; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D009864:Ontario; D017063:Outcome Assessment, Health Care; D011787:Quality of Health Care / Q000706:statistics & numerical data; D012004:Rectal Neoplasms / Q000601:surgery*; D012007:Rectum / Q000601:surgery; D055502:Secondary Prevention