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 qualityimprovement 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 colos tomy 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).Interpretation: 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. (ClinicalTrials.gov trial register no. NCT00182130.) AbstractPreviously published at www.cmaj.ca

Self-reported practice patterns and knowledge of rectal cancer care among Canadian general surgeons

“…Most of the existing CPD literature related to rectal cancer care, including 2 Canadian studies, 22,23 has examined training surgeons in the technique of TME. Phang 22 de velop ed a province-wide strategy to improve rectal cancer care in British Columbia using didactic sessions, videos and hands-on cadaveric dissection.…”

Patterns of use and outcomes for radiation therapy in the Quality Initiative in Rectal Cancer (QIRC) trial

“…Despite excellent participation, the trial results were negative (i.e., results in the intervention and control arms were similar). 16 The interventions were designed to optimize surgeon intraoperative technique, not to optimize other surgical decisions, such as the use of RT.…”

“…16 Patients were eligible for trial inclusion if they underwent major surgery for rectal cancer. Rectal tumours were located within 15 cm of the anal verge by rigid sigmoidoscopy, or were at or below the level of the sacral promontory.…”

Uptake of an innovation in surgery: observations from the cluster-randomized Quality Initiative in Rectal Cancer trial

“…13,15 Briefly, we cluster-randomized 16 Ontario hospitals and their respective groups of surgeons to the QIRC strategy (i.e., 8 experimental arm sites with 56 surgeons) versus no intervention (i.e., 8 control arm sites with 49 surgeons). The primary study outcomes were rates of permanent colostomy and local tumour recurrence.…”

“…But the hospitals involved in the QIRC trial treat an estimated 25% of all patients with rectal cancer in Ontario (popu lation 13 million), and the 31 surgeons who completed study surveys performed 65% of the cases in the experimental arm. 15 Thus, survey responses likely represent perceptions and characteristics among a large percentage of surgeons treating rectal cancer patients in Ontario. As well, it is important to reiterate that there is an incredible paucity of quantitative data correlating the uptake of clinical innovations with the personal characteristics or perceptions of the involved clinicians.…”