Bias estimation in study design: a meta-epidemiological analysis of transcatheter versus surgical aortic valve replacement.

BACKGROUND: Paucity of RCTs of non-drug technologies lead to widespread dependence on non-randomized studies. Relationship between nonrandomized study design attributes and biased estimates of treatment effects are poorly understood. Our purpose was to estimate the bias associated with specific nonrandomized study attributes among studies comparing transcatheter aortic valve implantation with surgical aortic valve replacement for the treatment of severe aortic stenosis. RESULTS: We included 6 RCTs and 87 nonrandomized studies. Surgical risk scores were similar for comparison groups in RCTs, but were higher for patients having transcatheter aortic valve implantation in nonrandomized studies. Nonrandomized studies underestimated the benefit of transcatheter aortic valve implantation compared with RCTs. For example, nonrandomized studies without adjustment estimated a higher risk of postoperative mortality for transcatheter aortic valve implantation compared with surgical aortic valve replacement (OR 1.43 [95% CI 1.26 to 1.62]) than high quality RCTs (OR 0.78 [95% CI 0.54 to 1.11). Nonrandomized studies using propensity score matching (OR 1.13 [95% CI 0.85 to 1.52]) and regression modelling (OR 0.68 [95% CI 0.57 to 0.81]) to adjust results estimated treatment effects closer to high quality RCTs. Nonrandomized studies describing losses to follow-up estimated treatment effects that were significantly closer to high quality RCT than nonrandomized studies that did not. CONCLUSION: Studies with different attributes produce different estimates of treatment effects. Study design attributes related to the completeness of follow-up may explain biased treatment estimates in nonrandomized studies, as in the case of aortic valve replacement where high-risk patients were preferentially selected for the newer (transcatheter) procedure.

The Art of Surgery: Balancing Compassionate With Virtual Care.

The recent drive to include virtual care in surgical practice has been accelerated due to the COVID-19 pandemic. Many physicians feel that communicating via telehealth is unlike traditional methods of providing health care, and thus guidance on maintaining excellence in communication is necessary, especially as academic literature on virtual care in surgery is nonexistent. Challenges faced in transitioning to virtual care include the inability to utilize body language, barriers to traditional physical examination, exacerbation of existing vulnerabilities and inequities in patient groups, the declining quality of medical education, and the fragmentation of the multidisciplinary health care team. This paper seeks to resolve these challenges by focusing on the pillars of good communication, including preparation, professionalism, empathy, respect, and the virtual physical examination.

High-Intensity vs Low-Intensity Knowledge Translation Interventions for Surgeons and Their Association With Process and Outcome Measures Among Patients Undergoing Rectal Cancer Surgery.

Importance: Surgeon-directed knowledge translation (KT) interventions for rectal cancer surgery are designed to improve patient measures, such as rates of permanent colostomy and in-hospital mortality, and to improve survival. Objective: To evaluate the association of sustained, iterative, integrated KT rectal cancer surgery interventions directed at all surgeons with process and outcome measures among patients undergoing rectal cancer surgery in a geographic region. Design, Setting, and Participants: This quality improvement study used administrative data from patients who underwent rectal cancer surgery from April 1, 2004, to March 31, 2015, in 14 health regions in Ontario, Canada. Follow-up was completed on March 31, 2020. Exposures: Surgeons in 2 regions were offered intensive KT interventions, including annual workshops, audit and feedback sessions, and, in 1 of the 2 regions, operative demonstrations, from 2006 to 2012 (high-intensity KT group). Surgeons in the remaining 12 regions did not receive these interventions (low-intensity KT group). Main Outcomes and Measures: Among patients undergoing rectal cancer surgery, proportions of preoperative pelvic magnetic resonance imaging (MRI), preoperative radiotherapy, and type of surgery were evaluated, as were in-hospital mortality and overall survival. Logistic regression models with an interaction term between group and year were used to assess whether process measures and in-hospital mortality differed between groups over time. Results: A total of 15 683 patients were included in the analysis (10 052 [64.1%] male; mean [SD] age, 65.9 [12.1] years), of whom 3762 (24.0%) were in the high-intensity group (2459 [65.4%] male; mean [SD] age, 66.4 [12.0] years) and 11 921 (76.0%) were in the low-intensity KT group (7593 [63.7%] male; mean [SD] age, 65.7 [12.1] years). A total of 1624 patients (43.2%) in the high-intensity group and 4774 (40.0%) in the low-intensity KT group underwent preoperative MRI (P < .001); 1321 (35.1%) and 4424 (37.1%), respectively, received preoperative radiotherapy (P = .03); and 967 (25.7%) and 2365 (19.8%), respectively, received permanent stoma (P < .001). In-hospital mortality was 1.6% (59 deaths) in the high-intensity KT group and 2.2% (258 deaths) in the low-intensity KT group (P = .02). Differences remained significant in multivariable models only for permanent stoma (odds ratio [OR], 1.67; 95% CI, 1.24-2.24; P < .001) and in-hospital mortality (OR, 0.67; 95% CI, 0.51-0.87; P = .003). In both groups over time, significant increases in the proportion of patients undergoing preoperative MRI (from 6.3% to 67.1%) and preoperative radiotherapy (from 16.5% to 44.7%) occurred, but there were no significant changes for permanent stoma (25.4% to 25.3% in the high-intensity group and 20.0% to 18.3% in the low-intensity group) and in-hospital mortality (0.8% to 0.8% in the high-intensity group and 2.2% to 1.8% in the low-intensity group). Time trends were similar between groups for measures that did or did not change over time. Patient overall survival was similar between groups (hazard ratio, 1.00; 95% CI, 0.90-1.11; P = .99). Conclusions and Relevance: In this quality improvement study, between-group differences were found in only 2 measures (permanent stoma and in-hospital mortality), but these differences were stable over time. High-intensity KT group interventions were not associated with improved patient measures and outcomes. Proper evaluation of KT or quality improvement interventions may help avoid opportunity costs associated with ineffective strategies.