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      Cardio-psycho-metabolic outcomes of bariatric surgery: design and baseline of the WAS trial

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          Abstract

          Obesity is a rapidly emerging health problem and an established risk factor for cardiovascular diseases. Bariatric surgery profoundly reduces body weight and mitigates sequelae of obesity. The open, randomized controlled Würzburg Adipositas Studie (WAS) trial compares the effects of Roux-en-Y gastric bypass (RYGB) vs psychotherapy-supported lifestyle modification in morbidly obese patients. The co-primary endpoint addresses 1-year changes in cardiovascular function (peak VO 2 during cardiopulmonary exercise testing) and the quality of life (QoL) (Short-Form-36 physical functioning scale). Prior to randomization, all included patients underwent a multimodal anti-obesity treatment for 6–12 months. Thereafter, the patients were randomized and followed through month 12 to collect the primary endpoints. Afterwards, patients in the lifestyle group could opt for surgery, and final visit was scheduled for all patients 24 months after randomization. Sample size calculation suggested to enroll 90 patients in order to arrive at minimally 22 patients per group evaluable for the primary endpoint. Secondary objectives were to quantify changes in body weight, left ventricular hypertrophy, systolic and diastolic function (by echocardiography and cardiac MRI), functional brain MRI, psychometric scales, and endothelial and metabolic function. WAS enrolled 93 patients (72 women, median age 38 years, BMI 47.5 kg/m 2) exhibiting a relevantly compromised exercise capacity (median peakVO 2 18.3 mL/min/kg) and the QoL (median physical functioning scale 50). WAS is the first randomized controlled trial focusing on the effects of RYGB on cardiovascular function beyond hypertension. In addition, it will provide a wealth of high-quality data on the cerebral, psychiatric, hepatic, and metabolic function in obese patients after RYGB.

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          Most cited references73

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          The PHQ-9: validity of a brief depression severity measure.

          While considerable attention has focused on improving the detection of depression, assessment of severity is also important in guiding treatment decisions. Therefore, we examined the validity of a brief, new measure of depression severity. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ-9 was completed by 6,000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-9 depression severity increased, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and health care utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-9 score > or =10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Results were similar in the primary care and obstetrics-gynecology samples. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.
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            The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection.

            A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. The history of the development of the SF-36, the origin of specific items, and the logic underlying their selection are summarized. The content and features of the SF-36 are compared with the 20-item Medical Outcomes Study short-form.
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              Health Effects of Overweight and Obesity in 195 Countries over 25 Years.

              Background While the rising pandemic of obesity has received significant attention in many countries, the effect of this attention on trends and the disease burden of obesity remains uncertain. Methods We analyzed data from 67.8 million individuals to assess the trends in obesity and overweight prevalence among children and adults between 1980 and 2015. Using the Global Burden of Disease study data and methods, we also quantified the burden of disease related to high body mass index (BMI), by age, sex, cause, and BMI level in 195 countries between 1990 and 2015. Results In 2015, obesity affected 107.7 million (98.7-118.4) children and 603.7 million (588.2- 619.8) adults worldwide. Obesity prevalence has doubled since 1980 in more than 70 countries and continuously increased in most other countries. Although the prevalence of obesity among children has been lower than adults, the rate of increase in childhood obesity in many countries was greater than the rate of increase in adult obesity. High BMI accounted for 4.0 million (2.7- 5.3) deaths globally, nearly 40% of which occurred among non-obese. More than two-thirds of deaths related to high BMI were due to cardiovascular disease. The disease burden of high BMI has increased since 1990; however, the rate of this increase has been attenuated due to decreases in underlying cardiovascular disease death rates. Conclusions The rapid increase in prevalence and disease burden of elevated BMI highlights the need for continued focus on surveillance of BMI and identification, implementation, and evaluation of evidence-based interventions to address this problem.

                Author and article information

                Journal
                Endocr Connect
                Endocr Connect
                EC
                Endocrine Connections
                Bioscientifica Ltd (Bristol )
                2049-3614
                11 January 2022
                01 February 2022
                : 11
                : 2
                : e210338
                Affiliations
                [1 ]Division of Endocrinology and Diabetology, Department of Internal Medicine I , University Hospital, University of Würzburg, Würzburg, Germany
                [2 ]Comprehensive Heart Failure Center , University & University Hospital Würzburg, Würzburg, Germany
                [3 ]Department of Psychiatry , Psychosomatics and Psychotherapy, University Hospital, University of Würzburg, Würzburg, Germany
                [4 ]Division of Cardiology , Department of Internal Medicine I, University Hospital, University of Würzburg, Würzburg, Germany
                [5 ]Department of General , Visceral, Transplant, Vascular, and Pediatric Surgery, University Hospital, University of Würzburg, Würzburg, Germany
                [6 ]Department of Radiology , University Hospital, University of Würzburg, Würzburg, Germany
                [7 ]Division of Pneumology , Department of Internal Medicine I, University Hospital, University of Würzburg, Würzburg, Germany
                [8 ]Division of Hepatology , Department of Internal Medicine II, University Hospital, University of Würzburg, Würzburg, Germany
                [9 ]Department of General Practice , University Hospital, University of Würzburg, Würzburg, Germany
                [10 ]Center for Clinical Trials , University Hospital, University of Würzburg, Würzburg, Germany
                Author notes
                Correspondence should be addressed to M Fassnacht: fassnacht_m@ 123456ukw.de
                Author information
                http://orcid.org/0000-0002-7085-8657
                Article
                EC-21-0338
                10.1530/EC-21-0338
                8859939
                35015697
                32589fbe-1a8a-40ef-a2a2-ab162807d148
                © The authors

                This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

                History
                : 17 December 2021
                : 11 January 2022
                Categories
                Research

                randomized controlled trial,morbid obesity,roux-en-y gastric bypass,lifestyle intervention,heart failure,cardiovascular and brain function,quality of life

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