Background Laparoscopic gastrectomy could reduce pain and opioid consumption, compared to open gastrectomy. However, it is difficult to judge the clinical relevance of this reduction, since these... Show moreBackground Laparoscopic gastrectomy could reduce pain and opioid consumption, compared to open gastrectomy. However, it is difficult to judge the clinical relevance of this reduction, since these outcomes are reported in few randomized trials and in limited detail.Methods This secondary analysis of a multicenter randomized trial compared laparoscopic versus open gastrectomy for resectable gastric adenocarcinoma (cT1-4aN0-3bM0). Postoperative pain was analyzed by opioid consumption in oral morphine equivalents (OME, mg/day) at postoperative day (POD) 1-5, WHO analgesic steps, and Numeric Rating Scales (NRS, 0-10) at POD 1-10 and discharge. Regression and mixed model analyses were performed, with and without correction for epidural analgesia.Results Between 2015 and 2018, 115 patients in the laparoscopic group and 110 in the open group underwent surgery. Some 16 patients (14%) in the laparoscopic group and 73 patients (66%) in the open group received epidural analgesia. At POD 1-3, mean opioid consumption was 131, 118, and 53 mg OME lower in the laparoscopic group, compared to the open group, respectively (all p < 0.001). After correcting for epidural analgesia, these differences remained significant at POD 1-2 (47 mg OME, p = 0.002 and 69 mg OME, p < 0.001, respectively). At discharge, 27% of patients in the laparoscopic group and 43% patients in the open group used oral opioids (p = 0.006). Mean highest daily pain scores were between 2 and 4 at all PODs, < 2 at discharge, and did not relevantly differ between treatment arms.Conclusion In this multicenter randomized trial, postoperative pain was comparable between laparoscopic and open gastrectomy. After laparoscopic gastrectomy, this was generally achieved without epidural analgesia and with fewer opioids. Show less
Heer, F. de; Kluin, J.; Elkhoury, G.; Jondeau, G.; Enriquez-Sarano, M.; Schafers, H.J.; ... ; Aortic Valve Repair Res Network In 2019
Objectives: Current national registries are lacking detailed pathology-driven analysis and long-term patients outcomes. The Heart Valve Society (HVS) aortic valve (AV) repair research network... Show moreObjectives: Current national registries are lacking detailed pathology-driven analysis and long-term patients outcomes. The Heart Valve Society (HVS) aortic valve (AV) repair research network started the Aortic Valve Insufficiency and ascending aorta Aneurysm InternATiOnal Registry (AVIATOR) to evaluate long-term patient outcomes of AV repair and replacement. The purpose of the current report is to describe the AVIATOR initiative and report in a descriptive manner the patients included.Methods: The AV repair research network includes surgeons, cardiologists, and scientists and established an online database compliant with the guidelines for reporting valve-related events. Prospective inclusion started from January 2013. Adult patients (18 years or older) who were operated on between 1995 and 2017 with complete procedural specification of the type of repair/replacement were selected for descriptive analysis.Results: Currently 58 centers from 17 countries include 4896 patients with 89% AV repair (n = 4379) versus 11% AV replacement (n = 517). AV repair was either isolated (28%), or associated with tubular/partial root replacement (22%) or valve-sparing root replacement (49%) with an in-hospital mortality of 0.5%, 1.7%, and 1.2%, respectively. AV replacement was either isolated (24%), associated with tubular/partial root replacement (17%) or root replacement (59%) with an in-hospital mortality of 1%, 2.6%, and 2.0%, respectively.Conclusions: The multicenter surgical AVIATOR registry, by applying uniform definitions, should provide a solid evidence base to evaluate the place of repair versus replacement on the basis of long-term patient outcomes. Obtaining data completeness and adequate representation of all surgery types remain challenging. Toward the near future AVIATOR-medical will start to study natural history, as will AVIATOR-kids, with a focus on pediatric disease. Show less
Steinley, Hoffman, Brusco, and Sher (2017) proposed a new method for evaluating the performance of psychological network models: fixed-margin sampling. The authors investigated LASSO regularized... Show moreSteinley, Hoffman, Brusco, and Sher (2017) proposed a new method for evaluating the performance of psychological network models: fixed-margin sampling. The authors investigated LASSO regularized Ising models (eLasso) by generating random datasets with the same margins as the original binary dataset, and concluded that many estimated eLasso parameters are not distinguishable from those that would be expected if the data were generated by chance. We argue that fixed-margin sampling cannot be used for this purpose, as it generates data under a particular null-hypothesis: a unidimensional factor model with interchangeable indicators (i.e., the Rasch model). We show this by discussing relevant psychometric literature and by performing simulation studies. Results indicate that while eLasso correctly estimated network models and estimated almost no edges due to chance, fixed-margin sampling performed poorly in classifying true effects as “interesting” (Steinley et al. 2017, p. 1004). Further simulation studies indicate that fixed-margin sampling offers a powerful method for highlighting local misfit from the Rasch model, but performs only moderately in identifying global departures from the Rasch model. We conclude that fixed-margin sampling is not up to the task of assessing if results from estimated Ising models or other multivariate psychometric models are due to chance. Show less
