Clinical significance in pediatric oncology randomized controlled treatment trials: a systematic review

Background: Clinical significance in a randomized controlled trial (RCT) can be determined using the minimal clinically important difference (MCID), which should inform the delta value used to determine sample size. The primary objective was to assess clinical significance in the pediatric oncology randomized controlled trial (RCT) treatment literature by evaluating: (1) the relationship between the treatment effect and the delta value as reported in the sample size calculation, and (2) the concordance between statistical and clinical significance. The secondary objective was to evaluate the reporting of methodological attributes related to clinical significance. Methods: RCTs of pediatric cancer treatments, where a sample size calculation with a delta value was reported or could be calculated, were systematically reviewed. MEDLINE, EMBASE, and the Cochrane Childhood Cancer Group Specialized Register through CENTRAL were searched from inception to July 2016. Results: RCTs (77 overall; 11 and 66), representing 95 (13 and 82) randomized questions were included for non-inferiority and superiority RCTs (herein, respectively). The minority (22.1% overall; 76.9 and 13.4%) of randomized questions reported conclusions based on clinical significance, and only 4.2% (15.4 and 2.4%) explicitly based the delta value on the MCID. Over half (67.4% overall; 92.3 and 63.4%) reported a confidence interval or standard error for the primary outcome experimental and control values and 12.6% (46.2 and 7.3%) reported the treatment effect, respectively. Of the 47 randomized questions in superiority trials that reported statistically non-significant findings, 25.5% were possibly clinically significant. Of the 24 randomized questions in superiority trials that were statistically significant, only 8.3% were definitely clinically significant. Conclusions: A minority of RCTs in the pediatric oncology literature reported methodological attributes related to clinical significance and a notable portion of statistically insignificant studies were possibly clinically significance.Applied Science, Faculty ofOther UBCNon UBCNursing, School ofReviewedFacult

The Shame–Blame Game: Is It Still Necessary? A National Survey of Shame-based Teaching Practice in Canadian Plastic Surgery Programs

Background:. As understanding of poor physician mental health and burnout strengthens, it is becoming important to identify factors that detract from wellbeing. Shame-based learning (SBL) is detrimental to psychological health and can contribute to burnout, substance abuse and suicide. This study endeavoured to quantify the unknown prevalence and effects of SBL in Canadian plastic surgery programs. Methods:. An electronic survey was sent to all attending surgeons and trainee (residents and fellows) members of the Canadian Society of Plastic Surgeons. SBL was assessed using a validated questionnaire. Data was analyzed using descriptive statistics and thematic analysis. Results:. 98 responses (14.7%) comprising of 63 attending surgeons and 36 trainees were received. The majority of attending surgeons (78 percent) and trainees (67%) have been shamed. Fourteen percent of trainees and 9% of attending surgeons felt that SBL is necessary. The most common event provoking shaming for trainees was wrong answers (56%) and for attending surgeons was disagreement in clinical care (21%). For both groups, shamers were in positions of authority. The most common effect of SBL in trainees was a loss of self-confidence (53%), compared to no negative effect in attending surgeons (49 percent). Thirty-nine percent of trainees dealt with shaming events with support from fellow trainees (39 percent), while attending surgeons kept it to themselves (40 percent). Conclusion:. SBL is present in Canadian plastic surgery residency programs and has numerous detrimental effects. To foster better mental health, residency programs should identify ongoing SBL and make efforts to transition to healthier feedback strategies