Development of a core outcome set for cutaneous squamous cell carcinoma trials: identification of core domains and outcomes.

BACKGROUND: The lack of uniformity in the outcomes reported in clinical studies of the treatment of cutaneous squamous cell carcinoma (cSCC) complicates efforts to compare treatment effectiveness across trials. OBJECTIVES: To develop a core outcome set (COS), a minimum set of agreed-upon outcomes to be measured in all clinical trials of a given disease or outcome, for the treatment of cSCC. METHODS: One hundred and nine outcomes were identified via a systematic literature review and interviews with 28 stakeholders. After consolidation of this long list, 55 candidate outcomes were rated by 19 physician and 10 patient stakeholders, in two rounds of Delphi exercises. Outcomes scored 'critically important' (score of 7, 8 or 9) by ≥ 70% of patients and ≥ 70% of physicians were provisionally included. At the consensus meeting, after discussion and voting of 44 international experts and patients, the provisional list was reduced to a final core set, for which consensus was achieved among all meeting participants. RESULTS: A core set of seven outcomes was finalized at the consensus meeting: (i) serious or persistent adverse events, (ii) patient-reported quality of life, (iii) complete response, (iv) partial response, (v) recurrence-free survival, (vi) progression-free survival and (vii) disease-specific survival. CONCLUSIONS: In order to increase the comparability of results across trials and to reduce selective reporting bias, cSCC researchers should consider reporting these core outcomes. Further work needs to be performed to identify the measures that should be reported for each of these outcomes.

A multi-institutional, propensity-score-matched comparison of post-operative outcomes between general anesthesia and monitored anesthesia care with intravenous sedation in umbilical hernia repair.

PURPOSE: Monitored anesthesia care with intravenous sedation (MAC/IV), recently proposed as a good choice for hernia repair, has faster recovery and better patient satisfaction than general anesthesia; however the possibility of oversedation and respiratory distress is a widespread concern. There is a paucity of the literature examining umbilical hernia repairs (UHR) and optimal anesthesia choice, despite its importance in determining clinical outcomes. METHODS: A retrospective analysis of anesthesia type in UHR was performed in the National Surgical Quality Improvement Program 2005-2013 database. General anesthesia and MAC/IV groups were propensity-score-matched (PSM) to reduce treatment selection bias. Surgical complications, medical complications, and post-operative hospital stays exceeding 1 day were the primary outcomes of interest. Pre-operative characteristics and post-operative outcomes were compared between the two anesthesia groups using univariate and multivariate statistics. RESULTS: PSM removed all observed differences between the two groups (p > 0.05 for all tracked pre-operative characteristics). MAC/IV cases required fewer post-operative hospital stays exceeding 1 day (3.5 vs 6.3 %, p < 0.001). Univariate analysis showed that overall complication rate did not differ (1.7 vs 1.8 %, p = 0.569), however MAC/IV cases resulted in fewer incidences of septic shock (<0.1 vs 0.1 %, p = 0.016). After multivariate logistic regression, MAC/IV was revealed to yield significantly lower chances of overall medical complications (OR = 0.654, p = 0.046). CONCLUSION AND RELEVANCE: UHR under MAC/IV causes fewer medical complications and reduces post-operative hospital stays compared to general anesthesia. The implications for surgeons and patients are broad, including improved surgical safety, cost-effective care, and patient satisfaction.

Assessing the safety of outpatient ventral hernia repair: a NSQIP analysis of 7666 patients.

PURPOSE: Given the paucity of literature on outpatient ventral hernia repair (VHR), and that assessment of the safety of outpatient surgical procedures is becoming an active area of investigation, we have performed a multi-institutional retrospective analysis benchmarking rates of 30-day complications and readmissions and identifying predictive factors for these outcomes. METHODS: National surgical quality improvement project data files from 2011 to 2012 were reviewed to collect data on all patients undergoing outpatient VHR during that period. The incidence of 30-day peri-operative complication and unplanned readmission was surveyed. We created a multivariate regression model to identify predictive factors for overall, surgical, and medical complications and unplanned readmissions with proper risk adjustment. RESULTS: 30-day complication and readmission rates in outpatient VHR were acceptably low. 3% of the queried outpatients experienced an overall complication, 2.1% a surgical complication, and 1.1% a medical complication. 3.3% of all patients were readmitted within 30 days. Upon multivariate analysis, predictors of overall complications included age, BMI, history of Chronic Obstructive Pulmonary Disease (COPD), and total operation time, predictors of surgical complications included age, BMI, total operation time, predictors of medical complications included total operation time, and predictors of unplanned readmissions included history of COPD, bleeding disorder, American Society of Anesthesiologists Class 3, 4, or 5, total operation time, and use of the laparoscopic technique. CONCLUSION: We have demonstrated that the risk of peri-operative morbidity in VHR as granularly defined in our study is low in the outpatient setting. Identification of predictive factors will be important to patient risk stratification.