Surgical Quality Assurance in COLOR III: Standardization and Competency Assessment in a Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to develop an objective and reliable surgical quality assurance system (SQA) for COLOR III, an international multicenter randomized controlled trial (RCT) comparing transanal total mesorectal excision (TaTME) with laparoscopic approach for rectal cancer. BACKGROUND OF SUMMARY DATA: SQA influences outcome measures in RCTs such as lymph nodes harvest, in-hospital mortality, and locoregional cancer recurrence. However, levels of SQA are variable. METHOD: Hierarchical task analysis of TaTME was performed. A 4-round Delphi methodology was applied for standardization of TaTME steps. Semistructured interviews were conducted in round 1 to identify key steps and tasks, which were rated as mandatory, optional, or prohibited in rounds 2 to 4 using questionnaires. Competency assessment tool (CAT) was developed and its content validity was examined by expert surgeons. Twenty unedited videos were assessed to test reliability using generalizability theory. RESULTS: Eighty-three of 101 surgical tasks identified reached 70% agreement (26 mandatory, 56 optional, and 1 prohibited). An operative guide of standardized TaTME was created. CAT is matrix of 9 steps and 4 performance qualities: exposure, execution, adverse event, and end-product. The overall G-coefficient was 0.883. Inter-rater and interitem reliability were 0.883 and 0.986. To enter COLOR III, 2 unedited TaTME and 1 laparoscopic TME videos were submitted and assessed by 2 independent assessors using CAT. CONCLUSION: We described an iterative approach to develop an objective SQA within multicenter RCT. This approach provided standardization, the development of reliable and valid CAT, and the criteria for trial entry and monitoring surgical performance during the trial.

Uptake of Transanal Total Mesorectal Excision in North America: Initial Assessment of a Structured Training Program and the Experience of Delegate Surgeons.

BACKGROUND: Transanal total mesorectal excision is a new approach to curative-intent rectal cancer surgery. Training and surgeon experience with this approach has not been assessed previously in America. OBJECTIVE: The purpose of this study was to characterize a structured training program and to determine the experience of delegate surgeons. DESIGN: Data were assimilated from an anonymous, online survey delivered to attendees on course completion. Data on surgeon performance during hands-on cadaveric dissection were collected prospectively. SETTINGS: This study was conducted at a single tertiary colorectal surgery referral center, and cadaveric hands-on training was conducted at a specialized surgeon education center. MAIN OUTCOME MEASURES: The main outcome measurement was the use of the course and surgeon experience posttraining. RESULTS: During a 12-month period, eight 2-day transanal total mesorectal excision courses were conducted. Eighty-one colorectal surgeons successfully completed the course. During cadaveric dissection, 71% achieved a complete (Quirke 3) specimen; 26% were near complete (Quirke 2), and 3% were incomplete (Quirke 1). A total of 9.1% demonstrated dissection in the incorrect plane, whereas 4.5% created major injury to the rectum or surrounding structures, excluding the prostate. Thirty eight (46.9%) of 81 surgeon delegates responded to an online survey. Of survey respondents, 94.6% believed training should be required before performing transanal total mesorectal excision. Posttraining, 94.3% of surgeon delegates planned to use transanal total mesorectal excision for distal-third rectal cancers, 74.3% for middle-third cancers, and 8.6% for proximal-third cancers. The most significant complication reported was urethral injury; 5 were reported by the subset of survey respondents who had performed this operation postcourse. LIMITATIONS: The study was limited by inherent reporting bias, including observer and recall biases. CONCLUSIONS: Although this structured training program for transanal total mesorectal excision was found to be useful by the majority of respondents, the risk of iatrogenic injury after training remains high, suggesting that this training pedagogy alone is insufficient. See Video Abstract at http://links.lww.com/DCR/A335.

Low-density lipoprotein cholesterol goal attainment among high-risk patients: Does a combined intervention targeting patients and providers work?

BACKGROUND: Physicians are aware of the National Cholesterol Education Program guidelines; however, most patients fail to attain cholesterol goals. OBJECTIVE: To determine whether a combined program of patient education and provider awareness could improve the National Cholesterol Education Program goal attainment among patients at high risk for cardiovascular events. METHODS: One hundred seven high-risk patients with cardiovascular disease were educated in a single 15-minute session regarding their cholesterol levels, risk factors, and medication adherence. Those with scores of 2 or lower on the Morisky questionnaire were classified as low-adherence patients, and those with scores of 3 or higher were classified as high-adherence patients. Seven physicians were provided this information and were requested to evaluate the dyslipidemia management of these patients. Lipid levels were reevaluated 8 to 12 weeks after the intervention. RESULTS: At the start of the study, 38 (35.5%) of the 107 patients were at target low-density lipoprotein cholesterol (LDL-C) levels, and 64 of the 107 patients (59.8%) were at target levels after the intervention. High-adherence patients decreased their LDL-C levels from a mean of 118.6 mg/dL (3.07 mmol/L) to 98.6 mg/dL (2.55 mmol/L); low-adherence patients increased their LDL-C levels after the intervention from 134.5 mg/dL (3.48 mmol/L) to 142.1 mg/dL (3.68 mmol/L). A comparison between the LDL-C goal achievers vs nonachievers revealed a significant difference in adherence (P = .001). Among the goal achievers, significant decreases in preintervention vs postintervention total cholesterol levels (P = .001) and LDL-C levels (P = .001) were also noted. CONCLUSION: This study demonstrates that an intervention simultaneously targeting patients and providers is successful in improving goal attainment among high-risk patients.