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Background Bardet–Biedl syndrome is a rare genetic disease associated with hyperphagia and early-onset, severe obesity. There is limited evidence on how hyperphagia and obesity affect health-related quality of life in patients with Bardet–Biedl syndrome, and on how management of these symptoms may influence disease burden. This analysis evaluated changes in health-related quality of life in adults and children with Bardet–Biedl syndrome in a Phase 3 trial following 1 year of setmelanotide treatment (ClinicalTrials.gov identifier: NCT03746522). Methods Patients with Bardet–Biedl syndrome and obesity received 52 weeks of treatment with setmelanotide and completed various self-reported health-related quality of life measures. Patients aged < 18 years or their caregiver completed the Pediatric Quality of Life Inventory (PedsQL; meaningful improvement, 4.4-point change); adults aged ≥ 18 years completed the Impact of Weight on Quality of Life Questionnaire-Lite (IWQOL-Lite; meaningful improvement range, 7.7–12-point change). Descriptive outcomes were reported in patients with data both at active treatment baseline and after 52 weeks of treatment. Results Twenty patients (< 18 years, n = 9; ≥ 18 years, n = 11) reported health-related quality of life at baseline and 52 weeks. For children and adolescents, PedsQL score mean change from baseline after 52 weeks was + 11.2; all patients with PedsQL impairment at baseline (n = 4) experienced clinically meaningful improvement. In adults, IWQOL-Lite score mean change from baseline was + 12.0. Of adults with IWQOL-Lite impairment at baseline (n = 8), 62.5% experienced clinically meaningful improvement. In adults, IWQOL-Lite score was significantly correlated with changes in percent body weight ( P  = 0.0037) and body mass index ( P  = 0.0098). Conclusions After 1 year of setmelanotide, patients reported clinically meaningful improvements across multiple health-related quality of life measures. This study highlights the need to address the impaired health-related quality of life in Bardet–Biedl syndrome, and supports utility of setmelanotide for reducing this burden. Trial Registration NCT03746522. Registered November 19, 2018, https://clinicaltrials.gov/ct2/show/NCT03746522 .

PurposeTo develop the mapping functions from the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) scores onto the EQ-5D-5L and SF-6Dv2 utility values among the overweight and obese population in China.MethodsA representative sample of the overweight and obese population in China stratified by age, sex, body mass index (BMI), and area of residence was collected by online survey and the sample was randomly divided into development (80%) and validation (20%) datasets. The conceptual overlap between the IWQOL-Lite and the EQ-5D-5L or SF-6Dv2 was evaluated by Spearman’s correlation coefficients. Five models, including OLS, Tobit, CLAD, GLM, and PTM were explored to derive mapping functions using the development dataset. The model performance was assessed using MAE, RMSE, and the percentage of AE > 0.05 and AE > 0.1 in the validation dataset.ResultsA total of 1000 respondents (48% female; mean [SD] age: 51.7 [15.3]; mean [SD] BMI: 27.4 [2.8]) were included in this study. The mean IWQOL-Lite scores and the utility values of EQ-5D-5L and SF-6Dv2 were 78.5, 0.851, and 0.734, respectively. The best-performing models predicting EQ-5D-5L and SF-6Dv2 utilities both used IWQOL-Lite total score as a predictor in the CLAD model (MAE: 0.083 and 0.076 for the EQ-5D-5L and SF-6Dv2; RMSE: 0.125 and 0.103 for the EQ-5D-5L and SF-6Dv2; AE > 0.05: 20.5% and 27.5% for the EQ-5D-5L and SF-6Dv2; AE > 0.10: 9.5% and 15.0% for the EQ-5D-5L and SF-6Dv2).ConclusionCLAD models with the IWQOL-Lite total score can be used to predict both the EQ-5D-5L and SF-6Dv2 utility values among overweight and obese population in China.

Introduction Individuals with proopiomelanocortin (POMC) or leptin receptor (LEPR) deficiency are young and experience severe obesity, hyperphagia, and comorbidities, which can impair quality of life (QOL). Methods Two pivotal Phase 3 trials explored the effect of setmelanotide on body weight and hunger in individuals with obesity due to POMC (NCT02896192) or LEPR (NCT03287960) deficiency. QOL and depression were investigated in parallel using the disease-specific, age-appropriate Impact of Weight on Quality of Life-Lite (IWQOL-Lite), Pediatric Quality of Life Inventory (PedsQL), and Patient Health Questionnaire-9 (PHQ-9). Results In total, the POMC and LEPR trials enrolled 21 patients. Adults (≥ 18 years old; n = 7) had moderate-to-severe impairment in QOL at baseline, with mean (standard deviation [SD]) IWQOL-Lite total score 60.3 (13.2; maximum IWQOL-Lite total score = 100). The effect of setmelanotide on IWQOL-Lite total score was observed as soon as Week 5. Among those with scores at Week 52, 5 of 6 adults experienced a clinically meaningful improvement, with mean (SD) total scores increased from baseline by 24.2 (12.1) points. Children (6–12 years old; n = 2) and adolescents (13–17 years old; n = 4) had impaired QOL at baseline, with mean (SD) self-reported PedsQL total scores 53.3 (6.2) and 63.3 (29.1), respectively (maximum PedsQL total score = 100). Three of 5 patients experienced clinically meaningful improvement in PedsQL, with 2 children whose PedsQL total score increased by 28.3 and 3.3 points and 3 adolescents whose mean (SD) total score increased from baseline by 5.8 (18.3) points. Baseline mean (SD) PHQ-9 score (in those ≥ 12 years old) was 5.3 (3.8) and was generally maintained through Week 52. Conclusions Patients with POMC or LEPR deficiency had impaired, and in some cases severely impaired, QOL before setmelanotide treatment. Setmelanotide improved QOL in patients as early as Week 5, with some patients no longer experiencing impaired QOL at Week 52. Improvements in QOL may be related to a reduction in hunger and body weight associated with setmelanotide. Because of the highly complex psychological consequences of rare genetic diseases of obesity, some patients may require a long period of treatment to improve QOL and benefit from interdisciplinary care.

Purpose To evaluate measurement properties of the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) instrument among Chinese overweight and obese populations. Methods A representative sample of Chinese overweight and obese populations was recruited stratified by age, sex, residence and body mass index (BMI). Social-demographic characteristics, self-reported EQ-5D-5 L and IWQOL-Lite responses were collected through the online survey. Test-retest reliability was assessed using intraclass correlation coefficient (ICC) among a subgroup of the total sample. Structural validity was evaluated by confirmatory factor analysis (CFA). Convergent validity and known-group validity were examined using Spearman’s rank correlation and effect sizes, respectively. Results A total of 1000 respondents (48% female; mean age: 51.7 years; mean BMI: 27.4) were included in this study. Ceiling and floor effects of the IWQOL-Lite were 5.4% and 0.67%, respectively. The ICC between the two tests was 0.992 for IWQOL-Lite among the subgroup ( N  = 150). The results of the CFA suggested that the five-factor model had an acceptable structural validity (GFI = 0.894, CFI = 0.960, TLI = 0.957, RMSEA = 0.054 and SRMR = 0.033). The Spearman’s rank correlation (range: 0.413–0.611) indicated a satisfactory convergent validity. The effect sizes values of IWQOL-Lite total score and different dimensions were moderate. Conclusions The IWQOL-Lite has been demonstrated to have satisfactory validity and reliability in measuring the HRQoL of Chinese overweight and obese populations. Further research is needed to confirm the sensitivity and responsiveness. Highlights Overweight and obesity are one of the major public health problems worldwide, with serious negative impacts on health-related quality of life (HRQoL). The impact of weight on quality of life-lite (IWQOL-Lite) is a widely used measure to evaluate HRQoL for overweight and obese populations. However, no study has validated the measurement properties of the IWQOL-Lite among Chinese population. Our study aimed to evaluate the measurement properties of the IWQOL-Lite in China. We evaluated several measurement properties, including ceiling and floor effects, test-retest reliability, structural validity, convergent validity and known-group validity, of the IWQOL-Lite in a representative sample of Chinese overweight and obese individuals. We found that the IWQOL-Lite is a valid and reliable tool for measuring the HRQoL of overweight and obese populations in China. This supports the use of the IWQOL-Lite in overweight and obese populations in the future.

Summary Objective This multicenter, randomized, controlled, open‐label trial examined weight‐related quality of life, control over eating behaviour and sexual function after 26 weeks of treatment with either 32 mg naltrexone sustained release (SR)/360 mg bupropion SR plus a comprehensive lifestyle intervention program (NB + CLI, N = 153) or usual care (UC, N = 89), which included minimal lifestyle intervention. Methods Impact of Weight on Quality of Life‐Lite, Binge Eating Scale and Arizona Sexual Experiences Scale were assessed at baseline (BL) and weeks 16 and 26. Results NB + CLI and UC participants lost 9.46 and 0.94% respectively of initial body weight at week 26 (P < 0.0001). NB + CLI participants had greater improvements in Impact of Weight on Quality of Life‐Lite total score than UC participants (P < 0.0001). In participants with moderate/severe Binge Eating Scale scores at BL, 91% of NB + CLI and 18% of UC participants experienced categorical improvements. In participants with Arizona Sexual Experiences Scale‐defined sexual dysfunction at BL, 58% of NB + CLI and 19% of UC participants no longer met dysfunction criteria at week 26. The most frequent adverse events leading to discontinuation before week 26 in NB + CLI included nausea (10.5%); anxiety (3.3%); and headache, hypertension, insomnia and palpitations (1.3% each). Conclusion Compared with UC, participants treated with NB + CLI experienced greater improvements in weight‐related quality of life, control over eating behaviour, and sexual function.

BackgroundMajor impairment of health-related quality of life (HRQoL) is one of the main reasons why obese patients request surgical treatment.ObjectiveTo prospectively analyze the impact of HRQoL between obese patients who underwent surgery and those who were wait-listed.MethodsBetween April 2017 and March 2018, 70 surgical and 69 wait-listed patients were interviewed twice, at baseline and at the 12-month follow-up. Quality of life was measured by the SF-12v2 and the Impact of Weight on Quality of Life-Lite (IWQoL-Lite) questionnaires. Sociodemographic-, clinical-, and surgical-related variables were collected.ResultsOne hundred thirty-nine patients were analyzed, showing similar baseline characteristics but differences in HRQoL. Performing more qualified work improved scores on some aspects of the SF-12 survey. In contrast, women scored worse on the self-esteem domain, and men scored worse on the mental health domain. By group, at the 12-month follow-up, statistically significant differences were found among all aspects of the questionnaires between both groups (P < 0.001) and between baseline and postoperative 12-month follow-up in the surgical group (P < 0.001). Furthermore, scores were lower in all domains in the evolution of wait-listed patients, with statistically significant differences among the Bodily Pain, Emotional Role, Mental Health, and Mental Component Summary Domains (P < 0.05).ConclusionHRQoL is a multimodal concept that allows the identification of factors impacting obese patients’ quality of life. It promotes the benefit of surgery against waiting list delays, which can take up to 4 years in our hospital. Therefore, HRQoL is an important pillar to justify more resources for reducing unacceptable surgical delays.

Obesity is highly prevalent and associated with several adverse outcomes including health-related quality-of-life (HRQoL), work productivity, and activity impairment. The objective of this study is to examine group differences in HRQoL and labor-related health outcomes among participants in the OPTIWIN program, which compared the effectiveness of two intensive behavioral weight loss interventions. Participants (n = 273) were randomized to OPTIFAST®(OP) or food-based (FB) dietary interventions for 52 weeks. HRQoL and labor-related health outcomes were measured at baseline, week 26, and week 52, using two questionnaires. At baseline, there were no differences between groups on the Impact of Weight on Quality-of-Life Questionnaire (IWQOL-Lite). At week 26, the OP group had statistically significant differences towards better HRQoL for Physical Function, Self-Esteem, and the total score compared with the FB group. At week 52, the OP group showed better HRQoL in the total score (p = 0.0012) and in all but one domain. Moreover, the adjusted change-from-baseline normalized total score at week 52 was −5.9 points (p = 0.0001). Finally, the mean IWQOL-Lite normalized score showed that HRQoL improves by 0.4442 units (p < 0.0001) per kg lost, and that greater weight reduction was positively associated with better HRQoL. No statistically significant group differences were found with the Work Productivity and Activity Impairment (General Health) (WPAI-GH) Questionnaire. HRQoL improves with highly intensive, well-structured weight loss interventions. Greater weight loss lead to larger improvements. The lack of negative effect on productivity and activity suggests that these interventions may be compatible with an active work lifestyle.

Few studies have investigated changes in health-related quality of life (HRQOL) in surgical patients who have undergone a laparoscopic sleeve gastrectomy. Prospective data were obtained from 78 consecutive patients undergoing laparoscopic sleeve gastrectomy (LSG; mean age, 42.4 years; mean body weight, 131 kg; mean body mass index (BMI), 47 kg/m 2 (24.4% of superobese patients)). Two HRQOL questionnaires were administered preoperatively and 12 months postsurgery: the generic Medical Outcomes Study Short Form-36 and the weight-specific IWQOL-Lite questionnaire. Excess weight loss at 12 months was 57.18%. No mortality was recorded. HRQOL scores revealed a significant improvement in all areas of both questionnaires. However, changes in HRQOL were not associated consistently with amount of weight loss. Laparoscopic sleeve gastrectomy is an effective and safe procedure, with positive changes in health-related quality of life as well as weight reduction. A fruitful area for future research is the investigation of long-term changes in HRQOL after LSG.

Purpose Phentermine/topiramate combination therapy resulted in significant weight loss and improvements in cardiometabolic risk factors in patients with obesity/overweight in two published 56-week randomized, placebocontrolled trials (EQUIP and CONQUER). The purpose of the current study was to examine whether phentermine/topiramate is also associated with greater improvements in health-related quality of life (HRQOL) and whether HRQOL improvements are solely attributable to weight reduction. Methods Patients in EQUIP (n = 751) had a body mass index (BMI) ≥ 35 with no obesity-related comorbidity. Patients in CONQUER (n = 1623) had a BMI ≥ 27 and ≤ 45 and at least two obesity-related comorbid conditions. HRQOL was assessed with Impact of Weight on Quality of Life-Lite (IWQOL-Lite) and Medical Outcomes Study Short Form (SF-36) (CONQUER only). Results Significant improvements in both obesity-specific and physical HRQOL were observed at 56 weeks in both trials (p < .0001). In EQUIP, BMI reduction fully mediated improvements in IWQOL-Lite total score (p < .0001). In CONQUER, both BMI reduction (all p values <.0001) and change in depressive symptoms (all p values <.025) were significant mediators of improved IWQOL-Lite total score and SF-36 Physical Component Summary score. Gender, psychiatric history, and baseline triglycerides moderated these relationships. Conclusions Both trials demonstrated that treatment with phentermine/topiramate improved HRQOL compared with placebo. Although reduction in BMI accounted for the majority of improvements in obesity-specific and physical HRQOL, decrease in depressive symptoms was also a significant mediator. Results highlight the predominance of weight reduction as a key factor in improving HRQOL in obesity.

We describe an integrated method for determining meaningful change in health-related quality of life (HRQOL) that combines information from anchor-based and distribution-based methods and illustrate this method using data aggregated from weight loss studies. A total of 1476 participants in weight loss studies were evaluated at baseline and at 6 months using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite). Severity of baseline impairment was determined by comparing scores with those obtained from a normative sample of 534 normal/overweight individuals. The precision of the IWQOL-Lite was evaluated using standard error of measurement corrected for regression to the mean. Weight loss was used as an anchor for evaluating changes in IWQOL-Lite scores. Change in HRQOL varied as a function of weight loss and baseline severity of HRQOL. Using this integrated method, an improvement of 7.7 to 12 points (depending on baseline severity) on IWQOL-Lite total score is considered meaningful. Meaningful change in HRQOL can be determined using an integrated method that (1) combines information from anchor-based and distribution-based methods, (2) reconciles discrepancies between these two methods, and (3) adjusts for baseline severity and regression to the mean. This method may be applied to other types of HRQOL measures and conditions.