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.

Effect of once-weekly subcutaneous semaglutide 2.4 mg on weight- and health-related quality of life in an East Asian population: Patient-reported outcomes from the STEP 6 trial.

We assessed the effect of semaglutide 2.4 and 1.7 mg versus placebo on weight-related quality of life (WRQOL) and health-related quality of life (HRQOL) in the STEP 6 trial. Adults from East Asia (body mass index [BMI] ≥27.0 kg/m2 with ≥2 weight-related comorbidities, or ≥35.0 kg/m2 with ≥1 weight-related comorbidity) were randomized 4:1:2:1 to once-weekly subcutaneous semaglutide 2.4 mg or placebo, or semaglutide 1.7 mg or placebo, plus lifestyle intervention for 68 weeks. WRQOL and HRQOL were assessed from baseline to Week 68 using the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) and the 36-Item-Short-Form-Survey-version-2.0 acute (SF-36v2), with changes in scores by categories of baseline BMI (

Development of an Assessment Tool for Completion by Patients with Overweight or Obesity.

INTRODUCTION: Discussions of weight-management strategies between patients and healthcare providers can yield positive outcomes for people with overweight or obesity. Nonetheless, people with overweight or obesity encounter communication challenges and other barriers to pursuing effective weight-management strategies with their healthcare providers. The aim of this study was to develop a new self-completed assessment tool to initiate and facilitate conversations related to weight management between patients and healthcare providers. METHODS: Developing the assessment tool involved a series of steps and draft versions of the tool, based on feedback from key opinion leaders in the field of obesity (N = 4) and input from people with overweight or obesity (N = 18). Three iterative rounds of qualitative interviews were conducted in the USA. A targeted review of prior qualitative research was conducted to identify common and important impacts of obesity on patients' functioning. Standard qualitative analytical methods were used to identify concepts of importance in a concept elicitation exercise during the interviews and were evaluated for potential inclusion in the tool. Potential problems with the tool were flagged during cognitive debriefing of the draft tool. RESULTS: During 18 individual interviews, participants referenced the impact of their weight on their lives, including health and comorbidities, physical function, emotional/mental functioning, social life, and physical appearance. Over the course of the tool's development, 24 common and important impacts of obesity on patients' functioning were reduced to a final set of eight concepts in the final tool that were deemed important and relevant to both patients and key opinion leaders. CONCLUSIONS: The assessment tool is a five-item, self-completed measure expected to foster patient self-advocacy for individuals with overweight or obesity by giving them an opportunity to define their weight-management goals and discuss these, along with various medical interventions, with a healthcare provider.

Effect of aerobic exercise intensity on health-related quality of life in severe obesity: a randomized controlled trial.

BACKGROUND: Aerobic exercise is an important part of obesity treatment and may improve health-related quality of life (HRQOL). The objective of this study was to compare the effect of two different exercise programs on health-related quality of life in patients with severe obesity. METHODS: This was a single-center, open-label, randomized, parallel-group study comparing the effects of a 24-week moderate-intensity continuous training (MICT) program and a combined high-intensity interval training program with MICT (HIIT/MICT). The primary objective (specified secondary outcome) was to assess HRQOL by using the general health dimension of the Short Form Health Survey (SF-36). The secondary objectives were to assess other dimensional SF-36 scores, the impact of weight on the physical and psychosocial aspects of quality of life (IWQOL-Lite), and the burden of obesity-specific weight symptoms (WRSM). RESULTS: 73 patients were enrolled and reported patient reported outcome measures, with 71 patients (55% females) allocated to either MICT (n = 34) or HIIT/MICT (n = 37). In the intention-to-treat analysis, general health scores increased between baseline and 24-week follow-up in both the HIIT/MICT group and the MICT group, with a mean change of 13 (95% CI 6-21) points and 11 (95% CI 5-17) points, respectively, with no difference between the groups. The effect sizes of these changes were moderate. The vitality and social functioning scores of SF-36, and the physical function and self-esteem scores of IWQOL-Lite increased moderately in both groups, with no difference between groups. The tiredness, back pain, and physical stamina scores based on WRSM showed moderate to strong changes in both the groups. CONCLUSIONS: Patients who had completed a combined HIIT/MICT program did not experience larger improvements in general health compared with those completing a clean 24-week MICT program. Exercise may confer general health benefits independent of intensity. TRIALS REGISTRATION: Regional Committees for Medical and Health Research Ethics south east, Norway, October 23, 2013 (identifier: 2013/1849) and ClinicalTrials.gov December 8, 2014 (identifier: NCT02311738).

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.

Confirmatory psychometric evaluations of the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT).

The Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) was developed to assess weight-related physical and psychosocial functioning in the context of clinical trials. Data from two pivotal trials of once-weekly subcutaneous semaglutide for the purpose of weight management (NCT03548935 and NCT03552757) were analysed to confirm the structure, reliability, validity, and responsiveness of the IWQOL-Lite-CT and evaluate the magnitude of meaningful within-patient change in patients with overweight or obesity, with and without type 2 diabetes. Factor analyses and inter-item correlations confirmed the IWQOL-Lite-CT structure and scoring algorithm. Each composite score (physical, physical function, psychosocial, and total) demonstrated excellent internal consistency (Cronbach's alphas ≥ 0.82) and test-retest reliability (intraclass correlation coefficients ≥ 0.85) in both trials. Patterns of cross-sectional and longitudinal construct validity correlations were generally consistent with hypotheses. Each of the IWQOL-Lite-CT composites was able to discriminate between known groups. Effect sizes and paired t tests comparing IWQOL-Lite-CT scores at baseline and Week 68 were statistically significant for all composites in both trials (P < 0.0001), providing strong support for the ability to detect change. Results of anchor-based analyses supported responder thresholds ranging from 13.5 to 16.6 across composite scores. The IWQOL-Lite-CT, a comprehensive assessment of weight-related functioning from the patient perspective, is appropriate for use in clinical trials evaluating the efficacy of new treatments for weight management.

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.

Patient-reported quality of life with obesity - development of a new measurement scale. / Pasientrapportert livskvalitet ved fedme ­ utvikling av nytt måleinstrument.

BACKGROUND: Many questionnaires for measuring the quality of life for patients with obesity require comprehensive calculation before they are used. There is a need for questionnaires that permit simple assessment of the responses during a patient consultation. We have developed the questionnaire Patient-Reported Outcomes in Obesity (PROS). The objective of the study was to test the reliability and validity of the questionnaire. MATERIAL AND METHOD: The questionnaire was used to ask patients about the extent to which they perceived their weight or body shape as bothersome. A group of patients with an average body mass index (BMI) of 42 (n = 109) completed the PROS questionnaire and The Impact of Weight Quality of Life questionnaire (IWQOL-Lite) before undergoing obesity surgery. Another group with an average body mass index of 29 (n = 95) completed the PROS questionnaire 1-5 years after having undergone obesity surgery. 67,7 % of the patients were > 40 years and 79 % were women. For the statistical analysis we used Cronbach's alpha, factor analysis, Spearman's rank test and independent t-test. RESULTS: Cronbach's alpha for the total PROS score was 0.90, and the factor analysis showed a significant factor (eigenvalue = 4.7) that explained 58.4 % of the variance. The test-retest correlation was 0.93 (p < 0.001). The correlation coefficients between the PROS score, the total IWQOL-Lite score (rs = -0.91) and body mass index (rs = 0.60) were all significant (p < 0.001). The t-test showed an effect size (difference in standard deviation) between the non-surgery and the surgery groups of 1.9 (95 % CI 1.6-2.5) for the PROS questionnaire and 2.1 (95 % CI 1.7-2.5 for the total IWQOL-Lite score. INTERPRETATION: The PROS questionnaire is a reliable and valid questionnaire for measurement of obesity-specific quality of life.

Health-related quality of life after camp-based family obesity treatment: an RCT.

OBJECTIVE: To compare the effects of a 2-year camp-based immersion family treatment for obesity with an outpatient family-based treatment for obesity on health-related quality of life (HRQoL) in two generations. DESIGN: Randomised controlled trial. SETTING: Rehabilitation clinic, tertiary care hospital and primary care. PATIENTS: Families with at least one child (7-12 years) and one parent, both with obesity. INTERVENTIONS: Summer camp for 2 weeks, with four repetition weekends, or lifestyle school, including four outpatient days over 4 weeks. Behavioural techniques to promote a healthier lifestyle. MAIN OUTCOME MEASURES: Children's and parents' HRQoL were assessed using generic and obesity-specific measures. Outcomes were analysed using linear mixed models according to intention to treat, and multiple imputations were used for missing data. RESULTS: Ninety children (50% girls) with a mean (SD) age of 9.7 (1.2) years and body mass index 28.7 (3.9) kg/m2 were included in the analyses. Summer camp children had an estimated mean (95% CI) of 5.3 (0.4 to 10.1) points greater improvement in adiposity-specific HRQoL score at 2 years compared with the lifestyle school children, and this improvement was even larger in the parent proxy-report, where mean difference was 7.3 (95% CI 2.3 to 12.2). Corresponding effect sizes were 0.33 and 0.44. Generic HRQoL questionnaires revealed no significant differences between treatment groups in either children or parents from baseline to 2 years. CONCLUSIONS: A 2-year family camp-based immersion obesity treatment programme had significantly larger effects on obesity-specific HRQoL in children's self-report and parent proxy-reports in children with obesity compared with an outpatient family-based treatment programme. TRIAL REGISTRATION NUMBER: NCT01110096.

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.

Implications of differing attitudes and experiences between providers and persons with obesity: results of the national ACTION study.

Objective: Our aim was to explore how differing attitudes, expectations, and experiences among people with obesity (PwO) and healthcare providers (HCPs) might have an impact on effectively implementing current obesity treatment guidelines. Methods: Online surveys were conducted among 3,008 adult PwO (BMI≥30 by self-reported height and weight) and 606 HCPs. Results: PwO with weight loss ≥ 10% during the previous three years were more likely to have been diagnosed with obesity and to have discussed a weight loss plan with an HCP. However, only 21% believe HCPs have a responsibility to actively contribute to their obesity treatment. Further, HCPs tend not to effectively communicate the diagnosis of obesity, its nature as a serious and chronic disease, the full range of treatment options, and obesity's implications for health and quality of life. Regarding treatment goals, HCPs more often focus on BMI reduction, while PwO's goals focus on improved functioning, energy, and appearance. HCPs also tend to underestimate their patients' motivation to address their obesity. Twenty-eight percent of HCPs 'completely agreed' that losing weight was a high priority for PwO, whereas more than half of PwO 'completely agreed' that losing weight was a high priority for them. When asked how their HCP could better support them, PwO most often expressed a desire for helpful resources, as well as assistance with specific and realistic goal-setting to improve health. Conclusions: HCPs can more effectively implement obesity treatment guidelines by more clearly and proactively communicating with PwO about their diagnosis, health implications of obesity, desired treatment goals, and the full range of treatment options. HCPs should understand that most PwO believe that managing their disease is solely their own responsibility. HCPs can also encourage more effective conversations by better appreciating their patients' motivation and treatment goals.

A call to action to inform patient-centred approaches to obesity management: Development of a disease-illness model.

Patient-centred care is an essential component of high-quality health care, shown to improve clinical outcomes and patient satisfaction, and reduce costs. While there are several authoritative models of obesity pathophysiology and treatment algorithms, a truly patient-centred model is lacking. We describe the development of a patient-centric obesity model. A disease-illness framework was selected because it emphasizes each patient's unique experience while capturing biomedical aspects of the disease. Model input was obtained from an accumulation of research including contributions from experts in obesity and patient-reported outcomes, qualitative research with adults living in the United States, and two targeted literature searches. The model places the patient with obesity at its core and links pathologic imbalances of energy intake and expenditure to environmental, sociodemographic, psychological, behavioural, physiological and medical health determinants. It highlights relationships between obesity signs and symptoms, comorbid conditions, impacts on health-related quality of life, and some barriers to obesity management that must be considered to attain better outcomes. Providers need to evaluate patients holistically, understand what changes each patient is motivated to make, and recognize what challenges might impede weight reduction, improvements in comorbid conditions, signs and symptoms, and health-related quality of life before pursuing individualized treatment goals. Patients living with obesity who do lose weight perceive benefits beyond weight loss. Ideally, this model will increase awareness of the complex, heterogeneous impacts of obesity on patients' well-being and recognition of obesity as a chronic disease, and prompt a call to action among stakeholders to improve quality of care.

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.