Team Approach: Nutritional Assessment and Interventions in Elective Hip and Knee Arthroplasty.

¼: Nutritional assessment is a critical element of routine preoperative assessment and should be approached by an interdisciplinary team that involves the primary care physician, dietitian, and orthopaedist. ¼: Patients should be stratified on the basis of their nutritional risk, which influences downstream optimization and deficiency reversal. ¼: The scientific literature indicates that nutritional supplementation affords protection against adverse outcomes and helps functional recovery, even among patients who are not at nutritional risk. ¼: Published investigations recommend a sufficient preoperative interval (at least 4 weeks) to ensure an adequate nutritional intervention in malnourished patients as opposed to regarding them as nonsurgical candidates.

Effectiveness of Combining Antiobesity Medication With an Employer-Based Weight Management Program for Treatment of Obesity: A Randomized Clinical Trial.

Importance: The clinical efficacy of antiobesity medications (AOMs) as adjuncts to lifestyle intervention is well characterized, but data regarding their use in conjunction with workplace wellness plans are lacking, and coverage of AOMs by US private employers is limited. Objective: To determine the effect of combining AOMs with a comprehensive, interdisciplinary, employer-based weight management program (WMP) compared with the WMP alone on weight loss, treatment adherence, and work productivity and limitations. Design, Setting, and Participants: This 1-year, single-center, open-label, parallel-group, real-world, randomized clinical trial was conducted at the Cleveland Clinic's Endocrinology and Metabolism Institute in Cleveland, Ohio, from January 7, 2019, to May 22, 2020. Participants were adults with obesity (body mass index [BMI; calculated as weight in kilograms divided by height in meters squared] ≥30) enrolled in the Cleveland Clinic Employee Health Plan. Interventions: In total, 200 participants were randomized 1:1, 100 participants to WMP combined with an AOM (WMP+Rx), and 100 participants to WMP alone. The WMP was the Cleveland Clinic Endocrinology and Metabolism Institute's employer-based integrated medical WMP implemented through monthly multidisciplinary shared medical appointments. Participants in the WMP+Rx group initiated treatment with 1 of 5 US Food and Drug Administration-approved medications for chronic weight management (orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion, and liraglutide, 3.0 mg) according to standard clinical practice. Main Outcomes and Measures: The primary end point was the percentage change in body weight from baseline to month 12. Results: The 200 participants were predominately (177 of 200 [88.5%]) women, had a mean (SD) age of 50.0 (10.3) years, and a mean (SD) baseline weight of 105.0 (19.0) kg. For the primary intention-to-treat estimand, the estimated mean (SE) weight loss was -7.7% (0.7%) for the WMP+Rx group vs -4.2% (0.7%) for the WMP group, with an estimated treatment difference of -3.5% (95% CI, -5.5% to -1.5%) (P < .001). The estimated percentage of participants achieving at least 5% weight loss was 62.5% for WMP+Rx vs 44.8% for WMP (P = .02). The rate of attendance at shared medical appointments was higher for the WMP+Rx group than for the WMP group. No meaningful differences in patient-reported work productivity or limitation measures were observed. Conclusions and Relevance: Clinically meaningful superior mean weight loss was achieved when access to AOMs was provided in the real-world setting of an employer-based WMP, compared with the WMP alone. Such results may inform employer decisions regarding AOM coverage and guide best practices for comprehensive, interdisciplinary employer-based WMPs. Trial Registration: ClinicalTrials.gov Identifier: NCT03799198.

Who Should Get Extended Thromboprophylaxis After Bariatric Surgery?: A Risk Assessment Tool to Guide Indications for Post-discharge Pharmacoprophylaxis.

OBJECTIVE: To determine the risk factors for 30-day postdischarge venous thromboembolism (VTE) after bariatric surgery and to identify potential indications for extended pharmacoprophylaxis. BACKGROUND: VTE is among most common causes of death after bariatric surgery. Most VTEs occur after hospital stay; still a few patients receive extended pharmacoprophylaxis postdischarge. METHODS: From American College of Surgeons-National Surgical Quality Improvement Program, we identified 91,963 patients, who underwent elective primary and revisional bariatric surgery between 2007 and 2012. Regression-based techniques were used to create a risk assessment tool to predict risk of postdischarge VTE. The model was validated using the 2013 American College of Surgeons-National Surgical Quality Improvement Program dataset (N = 20,575). Significant risk factors were used to create a user-friendly online risk calculator. RESULTS: The overall 30-day incidence of postdischarge VTE was 0.29% (N = 269). In those experiencing a postdischarge VTE, mortality increased about 28-fold (2.60% vs 0.09%; P < 0.001). Among 45 examined variables, the final risk-assessment model contained 10 categorical variables including congestive heart failure, paraplegia, reoperation, dyspnea at rest, nongastric band surgery, age ≥60 years, male sex, BMI ≥50 kg/m, postoperative hospital stay ≥3 days, and operative time ≥3 hours. The model demonstrated good calibration (Hosmer-Lemeshow goodness-of-fit test, P = 0.71) and discrimination (c-statistic = 0.74). Nearly 2.5% of patients had a predicted postdischarge VTE risk >1%. CONCLUSIONS: More than 80% of post-bariatric surgery VTE events occurred post-discharge. Congestive heart failure, paraplegia, dyspnea at rest, and reoperation are associated with the highest risk of post-discharge VTE. Routine post-discharge pharmacoprophylaxis can be considered for high-risk patients (ie, VTE risk >0.4%).

[TRAMOMTANA (Multidisciplinary treatment of morbid obesity: medication, behavioral therapy, nutritional support, and physical activity). From question to reality in an investigator-initiated clinical trial (II)]. / TRAMOMTANA (Tratamiento Multidisciplinar de la Obesidad Mórbida: Medicamentos, Terapia de comportamiento, Apoyo Nutricional y Actividad física). De la pregunta a la realidad de un ensayo clínico investigador iniciado (II).

Implementation of an intensive, multidisciplinary weight loss program in patients with morbid obesity is reported. This program is based on behavioral changes, lifestyle intervention, medication, and group therapy sessions. Our objective is to show that the results achieved with this two-year weight loss program will be at least similar to those achieved with bariatric surgery in patients with morbid obesity. We also intend to show that this multidisciplinary treatment induces an improvement in the comorbidity rate associated to smaller costs for our national health system.

[Key points in the start and conduct of a clinical trial. From question to reality in an investigator-initiated clinical trial (I)]. / Puntos clave en la puesta en marcha y desarrollo de un Ensayo Clínico. De la pregunta a la realidad de un Ensayo Clínico investigador iniciado (I).

Evidence-based clinical practice requires integration of individual professional experience with the best objective data to make the best therapeutic decision. The best degree of scientific evidence derives from controlled, randomized clinical trials and post-marketing drug surveillance studies and meta-analyses. During our clinical activities, we often search unsuccessfully for a clinical trial which answers our scientific questions. It is at those times that we may sometimes consider the conduct of a clinical trial. If you, as a clinical investigator, have a (relevant) scientific question that could potentially require the conduct of a clinical trial to achieve a response and have no support from a pharmaceutical company to perform it, you may find it useful to read this article, in which an attempt has been made to briefly and clearly explain the applicable regulations for planning a clinical trial. Our humble intention is that this publication becomes a useful tool for any independent researcher.