Effect of semaglutide 2.4 mg on physical functioning and weight- and health-related quality of life in adults with overweight or obesity: Patient-reported outcomes from the STEP 1-4 trials.

AIMS: To summarize the effects of semaglutide 2.4 mg on weight-related quality of life (WRQOL) and health-related quality of life (HRQOL), focusing on the confirmatory secondary endpoint of physical functioning. MATERIALS AND METHODS: The STEP 1-4 Phase 3a, 68-week, double-blind, randomized controlled trials assessed the efficacy and safety of semaglutide 2.4 mg versus placebo in individuals with overweight/obesity. WRQOL and HRQOL were assessed by change from baseline to Week 68 in two different but complementary measures, the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT; STEP 1 and 2) and the SF-36v2 Health Survey Acute (SF-36v2; STEP 1-4). RESULTS: Superiority for semaglutide 2.4 mg over placebo based on IWQOL-Lite-CT and SF-36v2 physical functioning scores was confirmed in STEP 1 and 2 and in STEP 1, 2 and 4, respectively. At Week 68, a greater proportion of participants treated with semaglutide 2.4 mg than with placebo reached meaningful within-person change (MWPC) thresholds for IWQOL-Lite-CT Physical Function scores in STEP 1 (51.8% vs. 28.3%; p < 0.0001) and STEP 2 (39.6% vs. 29.5%; p = 0.0083) and the MWPC threshold for SF-36v2 Physical Functioning in STEP 1 (39.8% vs. 24.1%; p < 0.0001), STEP 2 (41.0% vs. 27.3%; p = 0.0001) and STEP 4 (18.0% vs. 6.6%; p < 0.0001). All other IWQOL-Lite-CT and SF-36v2 scale scores in STEP 1-4 were numerically improved with semaglutide 2.4 mg versus placebo, except for SF-36v2 Role Emotional in STEP 2. CONCLUSIONS: Semaglutide 2.4 mg significantly improved physical functioning, with greater proportions of participants achieving MWPC compared with placebo, and showed beneficial effects on WRQOL and HRQOL beyond physical functioning.

Sensitivity for Change Analyses of the Patient-Reported Outcomes in Obesity (PROS) Questionnaire: A Prospective Cohort Study.

Purpose: Many patients seeking bariatric surgery experience reduced health-related quality of life (HRQOL). A simple clinical tool, the Patient-Reported Outcomes in Obesity (PROS), was developed to address patients' HRQOL concerns during clinical consultations and facilitate meaningful dialogue. The present study aims to explore its sensitivity to change. Patients and Methods: A prospective study of patients undergoing bariatric surgery was conducted. The patients responded to items on the PROS and the Obesity-related Problems Scale (OP) before surgery and three, 12 and 24 months after surgery. Longitudinal mixed-effects models were applied to estimate the change in PROS and OP scores over time. Results: Thirty-eight patients were included. A significant change over time was detected for the PROS with the largest effect size at 24 months (effect size -1.34, p ˂ 0.001), while the corresponding effect size for the OP was -1.32 (p ˂ 0.001). In all items of the PROS, the majority of patients responded not bothered at 24 months. The items physical activity, pain, sleep and self-esteem showed the largest change in the percentage of patients reporting not bothered from baseline to 24 months after surgery. Conclusion: The PROS is sensitive to change over time and may be used as a brief, easy to administer tool to facilitate a conversation about obesity-specific quality of life in clinical consultations.

Patient-reported outcomes, weight loss, and remission of type 2 diabetes 3 years after gastric bypass and sleeve gastrectomy (Oseberg); a single-centre, randomised controlled trial.

BACKGROUND: Little is known about the comparative effects of various bariatric procedures on patient-reported outcomes. We aimed to compare 3-year effects of gastric bypass and sleeve gastrectomy on patient-reported outcome measures in patients with obesity and type 2 diabetes. METHODS: The Oseberg trial was a single-centre, parallel-group, randomised trial at Vestfold Hospital Trust, a public tertiary obesity centre in Tønsberg, Norway. Eligible patients were aged 18 years or older with previously verified BMI 35·0 kg/m2 or greater. Diabetes was diagnosed if glycated haemoglobin was at least 6·5% (48 mmol/mol) or by their use of anti-diabetic medications with glycated haemoglobin at least 6·1% (43 mmol/mol). Eligible patients were randomly assigned (1:1) to gastric bypass or sleeve gastrectomy. All patients received identical preoperative and postoperative treatment. Randomisation was done with a computerised random number generator and a block size of ten. Study personnel, patients, and the primary outcome assessor were blinded to allocations for 1 year. The prespecified secondary outcomes reported here were 3-year changes in several clinically important patient-reported outcomes, weight loss, and diabetes remission. Analyses were done in the intention to treat population. This trial is ongoing, closed to recruitment and is registered with ClinicalTrials.gov, NCT01778738. FINDINGS: Between Oct 15, 2012 and Sept 1, 2017, 319 consecutive patients with type 2 diabetes scheduled for bariatric surgery were assessed for eligibility. 101 patients were not eligible (29 did not have type 2 diabetes according to inclusion criteria and 72 other exclusion criteria) and 93 declined to participate. 109 patients were enrolled and randomly assigned to sleeve gastrectomy (n=55) or gastric bypass (n=54). 72 (66%) of 109 patients were female and 37 (34%) were male. 104 (95%) of patients were White. 16 patients were lost to follow up and 93 (85%) patients completed the 3-year follow-up. Three additional patients were contacted by phone for registration of comorbidities Compared with sleeve gastrectomy, gastric bypass was associated with a greater improvement in weight-related quality of life (between group difference 9·4, 95% CI 3·3 to 15·5), less reflux symptoms (0·54, 0·17 to -0·90), greater total bodyweight loss (8% difference, 25% vs 17%), and a higher probability of diabetes remission (67% vs 33%, risk ratio 2·00; 95% CI 1·27 to 3·14). Five patients reported postprandial hypoglycaemia in the third year after gastric bypass versus none after sleeve-gastrectomy (p=0·059). Symptoms of abdominal pain, indigestion, diarrhoea, dumping syndrome, depression, binge eating, and appetitive drive did not differ between groups. INTERPRETATION: At 3 years, gastric bypass was superior to sleeve gastrectomy in patients with type 2 diabetes and obesity regarding weight related quality of life, reflux symptoms, weight loss, and remission of diabetes, while symptoms of abdominal pain, indigestion, diarrhoea, dumping, depression and binge eating did not differ between groups. This new patient-reported knowledge can be used in the shared decision-making process to inform patients about similarities and differences between expected outcomes after the two surgical procedures. FUNDING: Morbid Obesity Centre, Vestfold Hospital Trust. TRANSLATION: For the Norwegian translation of the abstract see Supplementary Materials section.

Seven-year trajectories of body weight, quality of life and comorbidities following Roux-en-Y gastric bypass and sleeve gastrectomy.

BACKGROUND/OBJECTIVES: There is limited long-term data comparing the outcomes of sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) for severe obesity, both with respect to body weight, quality of life (QOL) and comorbidities. We aimed to determine 7-year trajectories of body mass index (BMI), QOL, obesity-related comorbidities, biomarkers of glucose and lipid metabolism, and early major complications after SG and RYGB. SUBJECTS/METHODS: Patients scheduled for bariatric surgery at two Norwegian hospitals, preferentially performing either SG or RYGB, were included consecutively from September 2011 to February 2015. Data was collected prospectively before and up to 7 years after surgery. Obesity-specific, generic and overall QOL were measured by the Impact of Weight on Quality of Life-Lite, Short-Form 36 and Cantril's ladder, respectively. Comorbidities were assessed by clinical examination, registration of medication and analysis of glucose and lipid biomarkers. Outcomes were examined with linear mixed effect models and relative risk estimates. RESULTS: Of 580 included patients, 543 (75% women, mean age 42.3 years, mean baseline BMI 43.0 kg/m2) were operated (376 SG and 167 RYGB). With 84.2% of participants evaluable after 5-7 years, model-based percent total weight-loss (%TWL) at 7 years was 23.4 after SG versus 27.3 after RYGB (difference 3.9%, p = 0.001). All levels of QOL improved similarly after the two surgical procedures but remained below reference data from the general population at all timepoints. Remission rates for type 2 diabetes, dyslipidemia, obstructive sleep-apnea and gastroesophageal reflux disease (GERD) as well as the rate of de novo GERD significantly favored RYGB. SG had fewer major early complications, but more minor and major late complications combined over follow-up. CONCLUSION: In routine health care, both SG and RYGB are safe procedures with significant long-term weight-loss, improvement of QOL and amelioration of comorbidities. Long-term weight-loss and remission rates of main obesity-related comorbidities were higher after RYGB.

The Norse Feedback in a population of patients undergoing bariatric surgery-Psychometric properties of a digital computer-adaptive questionnaire assessing mental health.

The Norse Feedback (NF) is a questionnaire developed for patient-reported outcome monitoring with a clinical feedback system (PRO/CFS). As mental health is a concern after bariatric surgery, the use of the NF as part of PRO/CFS may be beneficial. The aim of this study is to test the reliability and validity of the NF in patients who have been accepted for or have undergone bariatric surgery. We performed separate robust confirmatory factor analyses (CFAs) to test the unidimensionality on 19 of the NF scales. We also performed correlation analyses on 19 of the NF scales with the Obesity-related Problems scale (OP). We included 213 patients. In the CFA analyses, three out of 12 scales with four or more items showed satisfactory psychometric properties in all goodness of fit indices (Suicidality, Need for Control and Self-Criticism). Four scales showed satisfactory psychometric properties in all indices but RMSEA (Somatic Anxiety, Substance Use, Social Safety and Cognitive Problems). Several of the scales demonstrated floor effects. In the correlation analyses, 18 of the 19 scales showed small-to-moderate correlation coefficients with the OP. Our demonstration of satisfactory psychometric properties on several important scales of the NF suggests that this tool may prove valuable in the routine follow-up of mental health in this population. However, further work is needed to innovate the NF for patients undergoing bariatric surgery.

Mediators of suicidality 12 years after bariatric surgery relative to a nonsurgery comparison group.

BACKGROUND: Individuals undergoing bariatric surgery report higher levels of suicidality than the general population, but it is unknown what mediates this phenomenon or how this compares with individuals with severe obesity not receiving surgery. OBJECTIVES: We evaluated suicidality in 131 individuals 12 years post surgery compared with 205 individuals with severe obesity who did not undergo surgery. Changes in health-related quality of life (HRQOL) and metabolic health were assessed as mediators of suicidality. SETTING: University. METHODS: Suicidality was assessed with the Suicide Behaviors Questionnaire-Revised at 12 years. Metabolic health and HRQOL (Short Form-36 [SF-36] Mental Component Summary score, Physical Component Summary score, and Impact of Weight on Quality of Life-Lite) were assessed at baseline and 2 and 6 years. The effects of bariatric surgery on suicidality at 12 years were assessed through univariate and multivariate sequential moderated mediation models, with changes in metabolic health and HRQOL from 0-2 years and 2-6 years as mediators. RESULTS: Suicidality was higher in the surgery group versus the nonsurgery group (estimate [est.] = .708, SE = .292, P < .05). Only the indirect pathways at 2 years after surgery for SF-36 Mental Component Summary in the univariate models (est. = -.172, SE = .080, P < .05) and for SF-36 Physical Component Summary in the multivariate model (est. = .593, SE = .281, P < .05) were significant. CONCLUSION: Individuals undergoing bariatric surgery reported higher levels of suicidality at 12 years, which was mediated by less improvement in the mental and physical components of HRQOL in the first 2 years after surgery, suggesting the need for additional clinical monitoring.

A novel patient-reported outcome monitoring with clinical feedback system in bariatric surgery care: study protocol, design and plan for evaluation.

BACKGROUND: Consultations before and after bariatric surgery should include structured assessments of patients' health-related quality of life (HRQOL) and mental health. One way to conduct this assessment is to implement patient-reported outcome monitoring with a clinical feedback system (PRO/CFS). AIM: We will explore patients' and healthcare professionals' experiences when a PRO/CFS is an integrated part of bariatric surgery care. METHODS AND ANALYSES: This is a design paper in which a PRO/CFS will be implemented in two bariatric outpatient clinics. All patients who have an appointment with a healthcare professional prior to, and 3 and 12 months after surgery, will be asked to complete six digital questionnaires measuring HRQOL, mental health, bowel symptoms and eating self-efficacy prior to each consultation. A digital summary report generated from the patient's responses will form the basis for the clinical consultation. A team of patient representatives, healthcare professionals and researchers will be involved in all phases of designing the PRO/CFS to ensure its relevance for clinical consultations. The patients' experiences will be explored with a generic 12-item questionnaire, developed for use in outpatient clinics, prior to and 12 months after bariatric surgery. We will conduct focus-group interviews with patients and healthcare professionals to explore their experiences when PRO/CFS is integrated into the consultations. ETHICS AND DISSEMINATION: Written informed consent will be obtained for all participants in the study. The project is approved by the Norwegian Centre for Research Data, Department of Data Protection Services (ref. no. 282738). The project has also undergone Data Protection Impact Assessments, both at Førde Hospital Trust and at St. Olav Hospital (registration no. 2016/3912). Data from the qualitative and quantitative studies will be kept in de-identified form in a secured research database, and the findings will be published in international peer-reviewed journals and presented at scientific conferences.

Erosive Esophagitis and Symptoms of Gastroesophageal Reflux Disease in Patients with Morbid Obesity with and without Type 2 Diabetes: a Cross-sectional Study.

BACKGROUND: Type 2 diabetes (T2DM) is associated with gastroesophageal reflux disease (GERD) in the general population, but the relationship between these conditions in candidates for bariatric surgery is uncertain. We compared the prevalence of GERD and the association between GERD symptoms and esophagitis among bariatric candidates with and without T2DM. METHODS: Cross-sectional study of baseline data from the Oseberg study in Norway. Both groups underwent gastroduodenoscopy and completed validated questionnaires: Gastrointestinal Symptom Rating Scale and Gastroesophageal Reflux Disease Questionnaire. Participants with T2DM underwent 24-h pH-metry. RESULTS: A total of 124 patients with T2DM, 81 women, mean (SD) age 48.6 (9.4) years and BMI 42.3 (5.5) kg/m2, and 64 patients without T2DM, 46 women, age 43.0 (11.0) years and BMI 43.0 (5.0) kg/m2, were included. The proportions of patients reporting GERD-symptoms were low (< 29%) and did not differ significantly between groups, while the proportions of patients with esophagitis were high both in the T2DM and non-T2DM group, 58% versus 47%, p = 0.16. The majority of patients with esophagitis did not have GERD-symptoms (68-80%). Further, 55% of the patients with T2DM had pathologic acid reflux. Among these, 71% also had erosive esophagitis, whereof 67% were asymptomatic. CONCLUSIONS: The prevalence of GERD was similar in bariatric patients with or without T2DM, and the proportion of patients with asymptomatic GERD was high independent of the presence or absence of T2DM. Accordingly, GERD may be underdiagnosed in patients not undergoing a preoperative endoscopy or acid reflux assessment. TRIAL REGISTRATION: Clinical Trials.gov number NCT01778738.

Overall Treatment Satisfaction 5 Years After Bariatric Surgery.

INTRODUCTION: Up to 30 % of patients undergoing bariatric surgery are dissatisfied with treatment outcomes in the long term. The aim of this study was to examine overall satisfaction with treatment 5 years after bariatric surgery and its association with body mass index (BMI) and health-related quality of life (HRQOL). METHODS: Patients were surveyed 5 years after bariatric surgery; 108 patients had duodenal switch (DS) and 153 patients had laparoscopic sleeve gastrectomy (LSG). The main outcome was overall treatment satisfaction, assessed by a single question, and analyzed by multiple logistic regression. Estimates for continuous independent variables represent the odds ratios (OR) for a 2-standard deviation difference. RESULTS: Five years after surgery, 82.4 % of the patients were very satisfied or satisfied, whereas 17.6 % were unsure or dissatisfied. The following variables assessed at 5 years were associated with being dissatisfied/unsure: a higher BMI (OR = 6.1, 95 % CI = 2.7-14.0, p < 0.001), reduced obesity-specific HRQOL (OR = 3.0, 95 % CI = 1.1-7.8, p = 0.03), and reduced mental HRQOL (OR = 0.3, 95 % CI = 0.1-0.8, p = 0.02). We also found that a higher proportion of patients who underwent LSG, compared to DS, reported being dissatisfied/unsure (OR = 3.3, 95 % CI = 1.3-8.8, p = 0.01). CONCLUSION: Reduced mental HRQOL and obesity-related HRQOL, as well as higher BMI, were associated with less satisfaction with overall treatment outcomes 5 years after bariatric surgery. Differences in overall treatment satisfaction by type of operation warrant further investigation.

Changes in quality of life 5 years after sleeve gastrectomy: a prospective cohort study.

OBJECTIVES: Sleeve gastrectomy (SG) is the most frequently performed bariatric surgery procedure worldwide, but reports on long-term quality of life (QOL) outcomes are scarce. We investigated 5-year trajectories in QOL and their associations with weight loss after SG. DESIGN: A prospective cohort study. SETTING: The study was conducted in a single Norwegian bariatric surgery centre. PARTICIPANTS: Out of 150 operated patients, 127 were included. Mean age was 41 years, 68% were women and the follow-up rate at 1 year was 85% and 64% at 1 and 5 years, respectively. OUTCOME MEASURES: Data were collected preoperatively, and 1 and 5 years after surgery assessing three different levels of QOL. The main exposure was weight loss after SG, assessed as per cent excess body mass index (kg/m2) loss (%EBMIL). The Obesity-Related Problem (OP) scale was used to measure obesity-specific health-related QOL (HRQOL). Physical (PCS) and mental (MCS) composite summary scores of the Short Form 36 Health Survey were used to capture generic HRQOL and Cantril Ladder was used to assess overall QOL. RESULTS: All HRQOL/overall QOL measures significantly improved at 1 year, followed by modest decline from 1 to 5 years after surgery. Greater %EBMIL 5 years after surgery was significantly associated with improvements in OP and PCS scores, but not with MCS and Cantril Ladder scores. Although significant (p<0.001) and clinically relevant improvements in HRQOL/overall QOL outcomes were observed at 5 years, scores were still below the general population norms. CONCLUSION: Most patients undergoing SG experience substantial weight loss accompanied by statistically significant and clinically relevant long-term improvements in HRQOL/overall QOL. However, an important minority of patients still report low HRQOL/overall QOL 5 years after SG. Further research should aim to identify other factors that contribute to impaired QOL after bariatric surgery, even in the presence of successful weight control.

Single-centre, triple-blinded, randomised, 1-year, parallel-group, superiority study to compare the effects of Roux-en-Y gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and ß-cell function in subjects with morbid obesity: a protocol for the Obesity surgery in Tønsberg (Oseberg) study.

INTRODUCTION: Bariatric surgery is increasingly recognised as an effective treatment option for subjects with type 2 diabetes and obesity; however, there is no conclusive evidence on the superiority of Roux-en-Y gastric bypass or sleeve gastrectomy. The Oseberg study was designed to compare the effects of gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and ß-cell function. METHODS AND ANALYSIS: Single-centre, randomised, triple-blinded, two-armed superiority trial carried out at the Morbid Obesity Centre at Vestfold Hospital Trust in Norway. Eligible patients with type 2 diabetes and obesity were randomly allocated in a 1:1 ratio to either gastric bypass or sleeve gastrectomy. The primary outcome measures are (1) the proportion of participants with complete remission of type 2 diabetes (HbA1c≤6.0% in the absence of blood glucose-lowering pharmacologic therapy) and (2) ß-cell function expressed by the disposition index (calculated using the frequently sampled intravenous glucose tolerance test with minimal model analysis) 1 year after surgery. ETHICS AND DISSEMINATION: The protocol of the current study was reviewed and approved by the regional ethics committee on 12 September 2012 (ref: 2012/1427/REK sør-øst B). The results will be disseminated to academic and health professional audiences and the public via publications in international peer-reviewed journals and conferences. Participants will receive a summary of the main findings. TRIAL REGISTRATION NUMBER: NCT01778738;Pre-results.

Validation of a new measure of quality of life in obesity trials: Impact of Weight on Quality of Life-Lite Clinical Trials Version.

The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) is widely used in evaluations of weight-loss interventions, including pharmaceutical trials. Because this measure was developed using input from individuals undergoing intensive residential treatment, the IWQOL-Lite may include concepts not relevant to clinical trial populations and may be missing concepts that are relevant to these populations. An alternative version, the IWQOL-Lite Clinical Trials Version (IWQOL-Lite-CT), was developed and validated according to the US Food and Drug Administration's (FDA's) guidance on patient-reported outcomes. Psychometric analyses were conducted to validate the IWQOL-Lite-CT using data from two randomized trials (NCT02453711 and NCT02906930) that included individuals with overweight/obesity, with and without type 2 diabetes. Additional measures included the SF-36, global items, weight and body mass index. The IWQOL-Lite-CT is a 20-item measure with two primary domains (Physical [seven items] and Psychosocial [13 items]). A five-item Physical Function composite and Total score were also supported. Cronbach's alpha and intraclass correlation coefficients exceeded 0.77 at each time point; patterns of construct validity correlations were consistent with hypotheses; and scores demonstrated treatment benefit. The IWQOL-Lite-CT is appropriate for assessing weight-related physical and psychosocial functioning in populations commonly targeted for obesity clinical trials. Qualification from the FDA is being sought for use of the IWQOL-Lite-CT in clinical trials to support product approval and labelling claims.

Changes in Sexual Functioning in Women and Men in the 5 Years After Bariatric Surgery.

Importance: Short-term improvements in sexual functioning are reported after bariatric surgery, but to our knowledge, little is known about the durability of these improvements. Objective: To determine the percentage of adults with impairment in sexual functioning who experience durable improvements in sexual functioning after bariatric surgery and to identify factors associated with improvements. Design, Setting, and Participants: The Longitudinal Assessment of Bariatric Surgery-2 is an observational cohort study conducted at 10 hospitals in 6 US clinical centers. Adults undergoing their first bariatric procedure were recruited from 2005 through 2009, data were collected through August 2014. Data analysis was conducted from 2016 to April 2018. Interventions: Participants completed assessments before the procedure and annually thereafter for 5 years. Main Outcomes and Measures: A self-administered questionnaire was used to assess clinically meaningful differences before and after surgery in past-month sexual satisfaction, desire, and activity and physical health limitations to sexual activity among subgroups who reported sexual functioning at less than domain-specific thresholds before surgery. Results: Of 2215 participants eligible for sexual function follow-up, 2036 (91.9%) completed 1 or more follow-up assessment (1431 [64.6%] at year 5), of whom 1607 (78.9%) were women. At the presurgery assessment, median (interquartile range) age was 47 (37-55) years, and the median (interquartile range) body mass index was 45.8 (41.7-51.3). Among those who were not satisfied with their sexual life before surgery (1015 of 1456 women [69.7%]; 304 of 409 men [74.3%]), 56.0% of women (95% CI, 52.5%-59.5%) and 49.2% of men (95% CI, 42.4%-55.9%) experienced clinically meaningful improvements at year 1; these percentages did not significantly differ during further follow-up. Among those who reported physical limitations to sexual activity at baseline (892 of 1490 women [59.9%] and 267 of 406 men [65.8%]), the percentage experiencing improvement in this domain decreased during follow-up, but 73.6% (95% CI, 69.3%-78.0%) of women and 67.6% (95% CI, 59.6%-75.6%) of men continued to report improvements at year 5. Greater postsurgical reduction in depressive symptoms was independently associated with improvement in 4 domains of sexual life among women (frequency of sexual desire: adjusted relative risk [aRR] per 5-point decrease in Beck Depression Inventory score, 1.12 [95% CI, 1.07-1.18]; P < .001; frequency of sexual activity: aRR, 1.13 [95% CI, 1.08-1.18]; P < .001; the degree to which physical health limited sexual activity: aRR, 1.19 [95% CI, 1.14-1.23]; P < .001; and satisfaction with sexual life: aRR, 1.25 [95% CI, 1.19-1.31]; P < .001) and 2 domains among men (physical health limitations: aRR, 1.14 [95% CI, 1.04-1.26]; P = .008 and satisfaction with sexual life: aRR, 1.55 [95% CI, 1.33-1.81]; P < .001). Surgical procedure was not associated with improvement. Conclusions and Relevance: Per this study, approximately half of women and men who were not satisfied with their sexual life prior to bariatric surgery experienced improvements in satisfaction in 5 years of follow-up. Trial Registration: ClinicalTrials.gov Identifier: NCT00465829.

Eating self-efficacy as predictor of long-term weight loss and obesity-specific quality of life after sleeve gastrectomy: A prospective cohort study.

BACKGROUND: A person's confidence to control eating, eating self-efficacy (ESE), has been identified as a target for long-term weight management in nonsurgical weight loss interventions, but has to a limited extent been studied after bariatric surgery. OBJECTIVE: We investigated the association between ESE, weight loss, and obesity-specific quality of life (QOL) after sleeve gastrectomy (SG). SETTING: A single-center longitudinal study. METHODS: Data from adult patients were collected before SG, and at mean 16 months (±standard deviation 4 mo) and 55 (±4) months postoperatively. ESE was measured by the Weight Efficacy Lifestyle Questionnaire Short-Form. Multiple regression analyses were performed with excess body mass index loss (%EBMIL) and obesity-specific QOL as dependent variables. Age, sex, and other preoperative values were covariates in all models. RESULTS: Of 114 preoperative patients, 91 (80%) and 84 (74%) were available for follow-up 16 and 55 months after SG, respectively. Mean %EBMIL from baseline to 16 and 55 months was 76% (95% confidence interval: 71.9, 79.6) and 67% (95% confidence interval: 61.9, 72.2), respectively. Preoperative ESE scores improved significantly at both 16 and 55 months (P = .002) but did not predict postoperative %EBMIL or QOL at 55 months (ß = -.08, P = .485). Greater change in ESE from 0 to 16 months predicted higher %EBMIL (ß = .34, P = .013) at 55 months, and improvements in ESE from 0 to 55 months were significantly associated with higher %EBMIL (ß = .46, P = .001) and obesity-specific QOL (ß = .50, P < .001) 55 months after SG. CONCLUSION: Significant improvements in ESE were seen at 16 months, and remained high at 55 months after SG in this cohort. Patients who improved their ESE the most also experienced the highest weight loss and obesity-specific QOL 5 years postoperatively. Future research should address whether enhancement of ESE corresponds to sustained improvements in eating behavior after bariatric surgery.

12-year trajectory of health-related quality of life in gastric bypass patients versus comparison groups.

BACKGROUND: Few prospective studies compare long-term health-related quality of life (HRQOL) outcomes between bariatric surgery patients and individuals with severe obesity who do not undergo bariatric surgery. OBJECTIVES: This 12-year, prospective study evaluated the trajectory and durability of HRQOL changes in gastric bypass patients (surgery group; n = 418) and compared these changes to 2 nonsurgical groups. The nonsurgery group 1 (n = 417) sought but did not have surgery; nonsurgery group 2 (n = 321) had severe obesity but did not seek surgery. SETTING: Bariatric surgery center. METHODS: Weight-related (impact of weight on quality of life-lite [IWQOL-Lite]) and general (short-form health survey-36 [SF-36]) HRQOL questionnaires were administered at baseline and 2, 6, and 12 years postsurgery. RESULTS: At 12 years, the surgery group showed greatly improved weight-related HRQOL (IWQOL-Lite) and physical HRQOL (physical component summary of short-form health survey-36) from baseline, and differences between the surgery group and both nonsurgery groups were significant for IWQOL-Lite and physical component summary. IWQOL-Lite and physical component summary scores peaked at 2 years, followed by declines from 2 to 6 and 6 to 12 years. Small improvements in mental/psychosocial aspects of HRQOL (mental component summary of short-form health survey-36) seen in the surgery group at 2 years were not maintained at either 6 or 12 years. CONCLUSIONS: Gastric bypass patients demonstrated significantly higher weight-related and physical HRQOL at 12 years compared with their very low baseline scores, with the trajectory peaking at 2 years. Despite declining HRQOL between 2 and 12 years, the magnitude of improvement supports the clinical relevance of bariatric surgery for enhancing patients' quality of life.

Patient-Reported Outcome Measures 2 Years After Standard and Distal Gastric Bypass-a Double-Blind Randomized Controlled Trial.

BACKGROUND: The preferred surgical procedure for treating morbid obesity is debated. Patient-reported outcome measures (PROMs) are relevant for evaluation of the optimal bariatric procedure. METHODS: A total of 113 patients with BMI from 50 to 60 were randomly assigned to standard (n = 57) or distal (n = 56) Roux-en-Y gastric bypass (RYGB). Validated PROMS questionnaires were completed at baseline and 2 years after surgery. Data were analyzed using mixed models for repeated measures and the results are expressed as estimated means and mean changes. RESULTS: Obesity-related quality of life improved significantly after both procedures, without significant between-group differences (- 0.4 (95% CI = - 8.4, 7.2) points, p = 0.88, ES = 0.06). Both groups had significant reductions in the number of weight-related symptoms and symptom distress score, with a mean group difference (95% CI) of 1.4 (- 0.3, 3.3) symptoms and 5.0 (2.9. 12.8) symptom distress score points. There were no between-group differences for uncontrolled eating (22.0 (17.2-26.7) vs. 28.9 (23.3-34.5) points), cognitive restraint (57.4 (52.0-62.7) vs. 62.1 (57.9-66.2) points), and emotional eating (26.8 (20.5-33.1) vs. 32.6 (25.5-39.7) points). The prevalence of anxiety was 33% after standard and 25% after distal RYGB (p = 0.53), and for depression 12 and 9%, respectively (p = 0.76). CONCLUSIONS: There were no statistically significant differences between standard and distal RYGB 2 years post surgery regarding weight loss, obesity-related quality of life, weight-related symptoms, anxiety, depression, or eating behavior. TRIAL REGISTRATION: Clinical Trials.gov number NCT00821197.

Weight and Metabolic Outcomes 12 Years after Gastric Bypass.

BACKGROUND: Few long-term or controlled studies of bariatric surgery have been conducted to date. We report the 12-year follow-up results of an observational, prospective study of Roux-en-Y gastric bypass that was conducted in the United States. METHODS: A total of 1156 patients with severe obesity comprised three groups: 418 patients who sought and underwent Roux-en-Y gastric bypass (surgery group), 417 patients who sought but did not undergo surgery (primarily for insurance reasons) (nonsurgery group 1), and 321 patients who did not seek surgery (nonsurgery group 2). We performed clinical examinations at baseline and at 2 years, 6 years, and 12 years to ascertain the presence of type 2 diabetes, hypertension, and dyslipidemia. RESULTS: The follow-up rate exceeded 90% at 12 years. The adjusted mean change from baseline in body weight in the surgery group was -45.0 kg (95% confidence interval [CI], -47.2 to -42.9; mean percent change, -35.0) at 2 years, -36.3 kg (95% CI, -39.0 to -33.5; mean percent change, -28.0) at 6 years, and -35.0 kg (95% CI, -38.4 to -31.7; mean percent change, -26.9) at 12 years; the mean change at 12 years in nonsurgery group 1 was -2.9 kg (95% CI, -6.9 to 1.0; mean percent change, -2.0), and the mean change at 12 years in nonsurgery group 2 was 0 kg (95% CI, -3.5 to 3.5; mean percent change, -0.9). Among the patients in the surgery group who had type 2 diabetes at baseline, type 2 diabetes remitted in 66 of 88 patients (75%) at 2 years, in 54 of 87 patients (62%) at 6 years, and in 43 of 84 patients (51%) at 12 years. The odds ratio for the incidence of type 2 diabetes at 12 years was 0.08 (95% CI, 0.03 to 0.24) for the surgery group versus nonsurgery group 1 and 0.09 (95% CI, 0.03 to 0.29) for the surgery group versus nonsurgery group 2 (P<0.001 for both comparisons). The surgery group had higher remission rates and lower incidence rates of hypertension and dyslipidemia than did nonsurgery group 1 (P<0.05 for all comparisons). CONCLUSIONS: This study showed long-term durability of weight loss and effective remission and prevention of type 2 diabetes, hypertension, and dyslipidemia after Roux-en-Y gastric bypass. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others.).

Five-Year Outcomes After Vertical Sleeve Gastrectomy for Severe Obesity: A Prospective Cohort Study.

BACKGROUND: We present 5-year outcomes after vertical sleeve gastrectomy (VSG), including complications and revisions, weight change, obesity-related diseases and health-related quality of life (HRQOL). METHODS: Patients operated from December 2005 to November 2010 were included. All variables except HRQOL (obtained using Short Form-36) were assessed prospectively. HRQOL data was assessed cross-sectionally, comparing 5-year results to both a baseline cohort of severely obese patients prior to bariatric surgery and to Norwegian norms. RESULTS: Of 168 operated patients (mean age, 40.3 ± 10.5 years; 71% females), 92% completed 2-year and 82% 5-year follow-up. Re-intervention for complications occurred in four patients, whereas revision surgery was performed in six patients for weight regain and in one patient for gastroesophageal reflux disease (GERD). Mean body mass index (BMI) decreased from 46.2 ± 6.4 kg/m2 at baseline to 30.5 ± 5.8 kg/m2 at 2 years and 32.9 ± 6.1 kg/m2 at 5 years. Remission of type 2 diabetes mellitus (T2DM) and hypertension occurred in 79 and 62% at 2 years, and 63 and 60% at 5 years, respectively. The percentage of patients treated for GERD increased from 12% preoperatively to 29% at 2 years and 35% at 5 years. The physical and mental SF-36 summary scores showed significantly better HRQOL at 5 years compared with the baseline cohort, but did not reach population norms. CONCLUSION: The majority of VSG patients maintained successful weight loss and improvement of T2DM, hypertension and HRQOL at 5 years. Preventing weight regain and GERD are important considerations with this procedure.

Sexual functioning of men and women with severe obesity before bariatric surgery.

BACKGROUND: Obesity may impair sexual function through multiple mechanisms, but little is known about sexual dysfunction among adults with severe obesity seeking bariatric procedures. OBJECTIVES: To describe sexual function and associated factors before bariatric surgery. SETTING: Ten U.S. clinical facilities. METHODS: Before bariatric surgery, 2225 of 2458 Longitudinal Assessment of Bariatric Surgery-2 study participants (79% female, median age 45 years and median body mass index 46 kg/m2) completed a survey about sexual function over the past month. Mixed effects ordinal logistic regression models were used to identify factors independently related to 4 domains of sexual function. RESULTS: One third of women (34%) and one quarter of men (25%) were not sexually active, alone or with a partner, in the past month. Twenty-six percent of women and 12% of men reported no sexual desire. Physical health limited sexual activity at least moderately in 38% of women and 44% of men. About one half of the women (49%) and the men (54%) were moderately or very dissatisfied with their sexual life. Among women, older age, being Caucasian, urinary incontinence, depressive symptoms, and antidepressant medication use were associated with poorer sexual function in multiple domains. In men, older age, not being married, depressive symptoms, and antidepressant medication use were associated with poorer sexual function in multiple domains. CONCLUSION: Before bariatric surgery, approximately one half of women and men with severe obesity are dissatisfied with their sexual life. Older age, severity of depressive symptoms, and antidepressant medication use are associated with poorer sexual function in both sexes.

Psychosocial functioning before and after surgical treatment for morbid obesity: reliability and validation of the Norwegian version of obesity-related problem scale.

Background. The aims of this study were to translate the Obesity-Related Problem scale (OP scale) into the Norwegian language and test its reliability, validity and responsiveness in a Norwegian sample. Method. The questionnaire (OP scale) was translated from the original language (Swedish) into Norwegian. Patients completed the questionnaire prior to and one year after sleeve gastrectomy. Internal consistency was evaluated using Cronbach's α. Construct validity was tested by correlating the OP-scale with the SF-36 and the Cantril Ladder using the Pearson correlation coefficient. An exploratory and confirmatory factor analysis was used to test the unidimensionality of the OP scale. Responsiveness was tested by assessing changes in the OP scale from baseline to one year post-surgery using the paired sample t-test. Floor and ceiling effect were calculated as percentages. Results. A total of 181 patients (123 women) accepted for bariatric surgery was included in the study. The mean age was 43.1 ± 12.5 years, and mean body mass index (BMI) before surgery was 45 ± 6.9. The mean value of the OP scale at baseline was 63.30 ± 24.43 (severe impairment) and 21.01 ± 20.98 at one year follow-up (mild impairment). Internal consistency was high at baseline (Cronbach's α 0.91). The floor effect was small at baseline and high at one year. The ceiling effect was small at baseline and at one year. Exploratory and conformatory factor analysis showed one factor with a high percent of explained variance. Correlations between OP scale at baseline, SF-36, Cantril Ladder and BMI were statistically significant and in the predicted direction to support validity of the Norwegian OP scale. After one year correlations between the change in OP scale and the change in SF-36 scores, Cantril Ladder and BMI were also statistically significant, except for the change in the Role Physical-scale. The OP scale showed greater responsiveness than either the SF-36 or Cantril Ladder. Conclusion. These results confirm that the Norwegian version of the OP scale is a valid and reliable instrument for measuring psychosocial functioning in patients with clinically severe obesity.