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Association of prior metabolic and bariatric surgery with severity of coronavirus disease 2019 (COVID-19) in patients with obesity.
Aminian, A, Fathalizadeh, A, Tu, C, Butsch, WS, Pantalone, KM, Griebeler, ML, Kashyap, SR, Rosenthal, RJ, Burguera, B, Nissen, SE
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2021;17(1):208-214
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A growing body of evidence indicates that patients with obesity are disproportionately affected with a severe form of SARS-CoV-2 infection and may experience resultant higher mortality. The aim of this study was to determine the association of prior metabolic surgery with severity of SARSCoV-2 infection in patients with severe obesity. This study is a retrospective, matched-cohort analysis of a prospective, observational, institutional review board–approved clinical registry of all patients tested for SARS-CoV-2 infection. The study population included a total of 363 patients, including 33 individuals who had metabolic surgery and 330 matched patients who tested positive. Results indicate that a history of metabolic surgery is associated with lower severity of SARSCoV-2 infection in patients with severe obesity, as manifested by lower risks of hospital and ICU admission. Authors conclude that prior metabolic surgery with subsequent weight loss and improvement of metabolic abnormalities could potentially reduce morbidity from SARS-CoV-2 infection.
Abstract
BACKGROUND Obesity is a risk factor for poor clinical outcomes in patients with coronavirus disease 2019 (COVID-19). OBJECTIVES To investigate the relationship between prior metabolic surgery and the severity of COVID-19 in patients with severe obesity. SETTING Cleveland Clinic Health System in the United States. METHODS Among 4365 patients who tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) between March 8, 2020 and July 22, 2020 in the Cleveland Clinic Health System, 33 patients were identified who had a prior history of metabolic surgery. The surgical patients were propensity matched 1:10 to nonsurgical patients to assemble a cohort of control patients (n = 330) with a body mass index (BMI) ≥ 40 kg/m2 at the time of SARS-CoV-2 testing. The primary endpoint was the rate of hospital admission. The exploratory endpoints included admission to the intensive care unit (ICU), need for mechanical ventilation and dialysis during index hospitalization, and mortality. After propensity score matching, outcomes were compared in univariate and multivariate regression models. RESULTS The average BMI of the surgical group was 49.1 ± 8.8 kg/m2 before metabolic surgery and was down to 37.2 ± 7.1 at the time of SARS-CoV-2 testing, compared with the control group's BMI of 46.7 ± 6.4 kg/m2. In the univariate analysis, 6 (18.2%) patients in the metabolic surgery group and 139 (42.1%) patients in the control group were admitted to the hospital (P = .013). In the multivariate analysis, a prior history of metabolic surgery was associated with a lower hospital admission rate compared with control patients with obesity (odds ratio, 0.31; 95% confidence interval, 0.11-0.88; P = .028). While none of the 4 exploratory outcomes occurred in the metabolic surgery group, 43 (13.0%) patients in the control group required ICU admission (P = .021), 22 (6.7%) required mechanical ventilation, 5 (1.5%) required dialysis, and 8 (2.4%) patients died. CONCLUSION Prior metabolic surgery with subsequent weight loss and improvement of metabolic abnormalities was associated with lower rates of hospital and ICU admission in patients with obesity who became infected with SARS-CoV-2. Confirmation of these findings will require larger studies.
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Effectiveness of Combining Antiobesity Medication With an Employer-Based Weight Management Program for Treatment of Obesity: A Randomized Clinical Trial.
Pantalone, KM, Smolarz, BG, Ramasamy, A, Baz Hecht, M, Harty, BJ, Rogen, B, Griebeler, ML, Borukh, E, Young, JB, Burguera, B
JAMA network open. 2021;(7):e2116595
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Abstract
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.
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Systematic reviews supporting practice guideline recommendations lack protection against bias.
Brito, JP, Tsapas, A, Griebeler, ML, Wang, Z, Prutsky, GJ, Domecq, JP, Murad, MH, Montori, VM
Journal of clinical epidemiology. 2013;(6):633-8
Abstract
OBJECTIVE To evaluate the quality of systematic reviews (SRs) affecting clinical practice in endocrinology. STUDY DESIGN AND SETTING We identified all SRs cited in The Endocrine Society's Clinical Practice Guidelines published between 2006 and January 2012. We evaluated the methodological and reporting quality of the SRs in duplicate using the Assessment of Multiple Systematic Reviews (AMSTAR) tool. We also noted if the guidelines recommendations that are clearly supported by SRs acknowledged their quality. RESULTS During the 5-year period of study, endocrine guidelines cited 69 SRs. These SRs had a mean AMSTAR score of 6.4 (standard deviation, 2.5) of a maximum score of 11, with scores improving over time. SRs of randomized trials had higher AMSTAR scores than those of observational studies. Low-quality SRs (methodological AMSTAR score 1 or 2 of 5, n = 24, 35%) were cited in 24 different recommendations and were the main evidentiary support for five recommendations, of which only one acknowledged the quality of SRs. CONCLUSION Few recommendations in endocrinology are supported by SRs. The quality of SRs is suboptimal and is not acknowledged by guideline developers.
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Pharmacologic interventions for painful diabetic neuropathy: an umbrella systematic review and comparative effectiveness network meta-analysis (Protocol).
Griebeler, ML, Tsapas, A, Brito, JP, Wang, Z, Phung, OJ, Montori, VM, Murad, MH
Systematic reviews. 2012;:61
Abstract
BACKGROUND Neuropathic pain can reduce the quality of life and independence of 30% to 50% of patients with diabetes. The comparative effectiveness of analgesics for patients with diabetic neuropathy remains unclear. The aim of the current work, therefore, was to summarize the evidence about the analgesic effectiveness of the most common oral and topical agents used for the treatment of peripheral diabetic neuropathy. METHODS We will use an umbrella approach (systematic review of systematic reviews) to identify eligible randomized controlled trials (RCTs) for the most common oral or topical analgesics for painful diabetic neuropathy. Two reviewers will independently determine RCT eligibility. Disagreement will be solved by consensus and arbitrated by a third reviewer. We will extract descriptive, methodological and efficacy data in duplicate. Results will be pooled and analyzed using classic random-effects meta-analyses and network meta-analyses to compute the absolute and relative efficacy of therapeutic options. We will use the I2 statistic and Cochran's Q test to assess heterogeneity. Risk of bias and publication bias, if appropriate, will be evaluated, as well as overall strength of the evidence. DISCUSSION This network meta-analysis aims to synthesize available direct and indirect evidence of effectiveness of analgesics in the treatment of painful diabetic neuropathy. The network approach will offer the opportunity to generate a ranking based on efficacy and along with known side effects, costs, and administration burdens will enable patients and clinicians to make choices that best reflect their preferences for treatment of painful diabetic neuropathy.