To Örebro University

The lack of standardization in patient-reported outcome measures (PROMs) has made measurement and comparison of quality of life (QoL) outcomes in research focused on obesity treatment challenging. This study reports on the results of the second and third global multidisciplinary Standardizing Quality of life measures in Obesity Treatment (S.Q.O.T.) consensus meetings, where a core set of PROMs to measure nine previously selected patient-reported outcomes (PROs) in obesity treatment research was established. The S.Q.O.T. II online and S.Q.O.T. III face-to-face hybrid consensus meetings were held in October 2021 and May 2022. The meetings were led by an independent moderator specializing in PRO measurement. Nominal group techniques, Delphi exercises, and anonymous voting were used to select the most suitable PROMs by consensus. The meetings were attended by 28 and 27 participants, respectively, including a geographically diverse selection of people living with obesity (PLWO) and experts from various disciplines. Out of 24 PROs and 16 PROMs identified in the first S.Q.O.T. consensus meeting, the following nine PROs and three PROMs were selected via consensus: BODY-Q (physical function, physical symptoms, psychological function, social function, eating behavior, and body image), IWQOL-Lite (self-esteem), and QOLOS (excess skin). No PROM was selected to measure stigma as existing PROMs deemed to be inadequate. A core set of PROMs to measure QoL in research focused on obesity treatment has been selected incorporating patients' and experts' opinions. This core set should serve as a minimum to use in obesity research studies and can be combined with clinical parameters.

BACKGROUND: More than 10% of the global population has a BMI above 35. Bariatric surgery is an efficient way to treat this condition. Unfortunately, there is a risk of nutritional deficiencies. The number of studies after a longer time span is scarce. The aim of this study was to determine the occurrence of anaemia five and ten years after bariatric surgery and how it was related to substitution therapy.

PATIENTS AND METHODS: Registry data from individuals having primary bariatric surgery in the Scandinavian Obesity Surgery Registry (SOReg) from 2007 to 2022 and with a follow-up at five or ten years was retrieved. Demographic data including weight, as well as method of surgery, Hb levels, supplementation, PPI use and stomal ulcerations were recorded.

RESULTS: In total, 39,992 individuals (mean age 41 years, range 18-74, 77% women) could be included. The majority, 78%, had undergone laparoscopic Roux-en-Y gastric bypass. After five years, 2838/13,944 women (20.3%) and 456/4049 men (11.2%) had anaemia. After ten years, 644/3400 women (18.9%) and 178/947 men (18.8%) had anaemia. The use of oral iron increased from 40 to 45%, and the need for parenteral iron intake increased from 5 to 11%.

CONCLUSIONS: Anaemia is a significant but manageable condition five and ten years after bariatric surgery. Despite the prescription of oral iron supplements to 45% ten years after surgery, the Hb levels could still not be fully restored. Consequently, the importance of follow-up visits and continuous supplementation is emphasised.

BACKGROUND: This study is part of an initiative to improve the FAIRness (Findability, Accessibility, Interoperability, Reusability) of metabolic bariatric surgery (MBS) registries globally. It explores the extent to which European registry data can be manually integrated without first making them FAIR and assesses these registries' current level of FAIRness. The findings establish a baseline for evaluation and provide recommendations to enhance MBS data management practices.

METHODS: Data dictionaries from five national MBS registries in Germany, France, the Netherlands, the UK, and a combined registry for Scandinavia (Norway and Sweden) were evaluated regarding their ability to manually integrate registry datasets with one another. The FAIR Data Maturity Model from the Research Data Alliance (RDA) FAIR Data Maturity Model Working Group was used to assess the FAIRness of both metadata and data of the registries.

RESULTS: The registries showed significant variability in variables and coding structures, with inconsistent numerical formats and without linkage to international standards such as SNOMED CT, LOINC, or NCIt, making data integration labor-intensive and assumption-heavy. Despite the presence of data dictionaries, all registries failed the FAIR assessment because machine-readable data was unavailable, and only human-readable metadata was available in the form of data dictionaries in a spreadsheet.

CONCLUSION: Our study reveals significant inconsistencies in data structuring and a failure to comply with the FAIR Principles, which limit effective data analysis and comparison. This emphasizes the critical need for standardized data management practices. We recommend four next steps to improve the FAIRness of MBS registries: (1) annotate data elements using standardized terminology systems, (2) deposit registry-level metadata in a repository, (3) request globally unique and persistent identifiers for datasets, and (4) define access restrictions.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) has gained increasing popularity worldwide, yet concerns persist regarding the development of gastroesophageal reflux disease (GERD) postoperatively.

OBJECTIVES: This study aimed to evaluate the influence of technical aspects of LSG, specifically bougie size and distance from the pylorus to resection line edge, on the risk of developing symptomatic GERD within 2years following surgery.

SETTING: Data from the Scandinavian Obesity Surgery Registry (SOReg) and the National Prescribed Drug Register were utilized for this analysis.

METHODS: A retrospective observational study was conducted encompassing all LSG patients in Sweden between 2012 and 2020 who did not receive preoperative proton pump inhibitor (PPI) prescriptions. Patients were categorized based on bougie size and pyloric distance. Regular PPI use, defined as a dispensed prescription of more than 300 tablets per year, was employed as a proxy measure of symptomatic GERD and was compared between the groups.

RESULTS: The study included 7,435 patients with complete data on dispensed PPI prescription both preoperatively and throughout the 2-year follow-up period. Information on bougie size and pyloric distance was available for 97.4% and 84.9%, respectively. Narrower bougie size and greater pyloric distance were associated with increased risk of regular PPI use postsurgery. Advanced age and female sex were independent risk factors for post-LSG regular PPI use, while initial body mass index (BMI), total weight loss (%TWL), and comorbidities showed no significant associations.

CONCLUSIONS: Using a narrow bougie and initiating resection at a greater distance from the pylorus were associated with higher risk of symptomatic de novo GERD following LSG.

Dumping and post-bariatric hypoglycaemia (PBH) are side effects that occur after bariatric surgery. The aim of this study was to estimate the prevalence of dumping and PBH symptoms before Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) at 6 months, 1 year, 2 years and 5 years after surgery in a Swedish population. A cross-sectional single-centre study was performed at Lindesberg Hospital, Region Örebro County, Sweden, between 2020 and 2023. The Swedish version of the Dumping Severity Scale (DSS-Swe) questionnaire, which includes eight items regarding dumping symptoms and six items regarding hypoglycaemia symptoms, was used. A total of 742 DSS-Swe questionnaires were included. The average age at surgery was 42.0 years (standard deviation [SD] = 11.9), and the average body mass index was 41.8 kg/m2 (SD = 5.9). The surgical methods consisted of RYGB (66.3%) and SG (33.7%). The proportion of RYGB patients with highly suspected dumping increased from 4.9% before surgery to 26.3% (adjusted odds ratio [OR] = 7.35, 95% confidence interval [CI] = 3.08-17.52) at the 5-year follow-up. PBH symptoms increased from 1.4% before surgery to 19.3% at the 5-year follow-up (adjusted OR = 17.88, 95% CI = 4.07-78.54). For SG patients, no significant increase in dumping or PBH symptoms was observed. In patients with persistent type 2 diabetes (T2D), there were no cases of highly suspected hypoglycaemia following RYGB or SG. Symptoms of dumping and PBH were common after RYGB, while no clear increase was observed after SG. Persistent T2D seems to be a protective factor against PBH symptoms.

OBJECTIVE: To determine the 10-year outcomes regarding weight loss and remission of obesity-related diseases after primary Roux-en-Y gastric bypass (RYGB), when performed in routine clinical care.

SUMMARY OF BACKGROUND DATA: Long-term results of metabolic bariatric surgery (MBS) are important, as the number of patients needing help with this chronic condition is increasing globally. However, results from larger nation-wide studies are lacking.

METHODS: Cohort study of RYGB-patients from the Scandinavian Obesity Surgery Registry (SOReg), a national Swedish quality registry of MBS. Supplementary data was obtained from the Prescribed Drug Register (pharmacological therapy) and the National Diabetes Register (clinical data). Weight loss, complete remission of comorbidities (defined as no pharmacological therapy and normal laboratory values), and associations for new-onset disease were studied.

RESULTS: 29,578 individuals (mean age 41.0±11.0 y, 75.6% females) had a RYGB in Sweden 2007-2012. At ten years, mean body weight was reduced from 112.7 kg to 91.4 kg, corresponding to a total body weight loss of 24.6%. A significant complete remission rate persisted in type 2 diabetes (29.7%), hypertension (15.1%) and dyslipidemia (8.8%), while the use of antidepressants increased by 38.6%, P<0.001 for all. The use of continuous positive airway pressure for sleep apnea decreased from 9.8% to 4.1%. New-onset disease was in general associated to age, low weight loss and presence of other comorbidities.

CONCLUSIONS: At ten years, patients undergoing primary RYGB in Sweden demonstrate lasting weight loss and substantial remission of obesity-related diseases. RYGB is a valuable treatment option in the long-term for patients with severe obesity.

Background: The Swiss-Finnish Bariatric Metabolic Outcome Score (SF-BARI Score), based on merged data of two RCTs, is a composite endpoint designed to evaluate and categorize outcomes after metabolic bariatric surgery (MBS). The aim of this study was to externally validate the score using registry data.

Methods: Individual patient data were included from the Dutch Audit for Treatment of Obesity, the Scandinavian Obesity Surgery Registries (SOReg-Sweden and SOReg-Norway), and the merged RCT data used for establishing the SF-BARI Score. All patients undergoing primary MBS from January 2010 to June 2018, with complete baseline characteristics, as well as complete 1- and 5-year follow-up data, were included. The mean total score and distribution were compared between the combined registry and merged RCT data.

Results: There was no statistically significant difference in the mean SF-BARI Score between the registries (21 603 patients) and merged RCTs (457 patients) at 5 years (90.9 versus 89.1 points; difference = 1.8 (95% c.i. -1.0 to 4.7); P = 0.212), and the score distribution was similar. Statistically significant differences in baseline characteristics existed regarding sex (male 20.9% versus 29.3%), type 2 diabetes (16.7% versus 33.9%), hypertension (30.4% versus 66.1%), dyslipidaemia (13.7% versus 46.5%), obstructive sleep apnoea syndrome (12.0% versus 17.4%), and sleeve gastrectomy (SG) rate (21.0% versus 49.9%) (P < 0.001). The mean score estimate at 5 years in Roux-en-Y gastric bypass was 11.2 (95% c.i. 10.2 to 12.2) points higher compared with SG (P < 0.001).

Conclusion: This study verified the feasibility of the SF-BARI Score, enabling standardized reporting and allowing for comparison of different treatment modalities.

BACKGROUND: With the increasing prevalence of obesity and type 2 diabetes, the availability of different treatment options remains essential. Studies comparing the outcomes of glucagon-like peptide 1 receptor agonists with those of metabolic bariatric surgery in patients with type 2 diabetes and obesity are lacking.

METHODS: Using propensity score matching, based on data from several nationwide clinical registries, patients who underwent primary metabolic bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) were matched with patients who received glucagon-like peptide 1 receptor agonists. Outcome measures included the occurrence of major cardiovascular events, microvascular complications, and potential side effects (alcohol/substance abuse, self-harm, and fractures).

RESULTS: Over a mean follow-up of 7 years, major cardiovascular events occurred in 191 of 2039 patients (cumulative incidence 14.5%) in the surgery group compared with 247 of 2039 patients (19.6%) in the glucagon-like peptide 1 receptor agonist group (HR 0.75 (95% c.i. 0.62 to 0.91), P = 0.003). Patients in the surgery group had lower haemoglobin A1c values 5 years after treatment (mean difference 9.82 (95% c.i. 8.51 to 11.14) mmol/mol, P < 0.001) and fewer microvascular complications (retinopathy HR 0.88 (95% c.i. 0.79 to 0.99), P = 0.039; nephropathy HR 0.72 (95% c.i. 0.66 to 0.80), P < 0.001; and neuropathy or leg ulcers HR 0.82 (95% c.i. 0.74 to 0.92), P < 0.001), but a higher risk of alcohol/substance abuse (HR 2.56 (95% c.i. 1.87 to 3.50), P < 0.001), self-harm (HR 1.41 (95% c.i. 1.17 to 1.71), P < 0.001), and fractures (HR 1.86 (95% c.i. 1.11 to 3.12), P = 0.019).

CONCLUSION: Compared with glucagon-like peptide 1 receptor agonist treatment, metabolic bariatric surgery is associated with superior metabolic outcomes and a lower risk of major cardiovascular events in patients with type 2 diabetes and obesity, but a higher risk of alcohol/substance abuse, self-harm, and fractures.

Purpose: The focus of measuring success in obesity treatment is shifting from weight loss to patients' health and quality of life. The objective of this study was to select a core set of patient-reported outcomes and patient-reported outcome measures to be used in clinical obesity care.

Materials and Methods: The Standardizing Quality of Life in Obesity Treatment III, face-to-face hybrid consensus meeting, including people living with obesity as well as healthcare providers, was held in Maastricht, the Netherlands, in 2022. It was preceded by two prior multinational consensus meetings and a systematic review.

Results: The meeting was attended by 27 participants, representing twelve countries from five continents. The participants included healthcare providers, such as surgeons, endocrinologists, dietitians, psychologists, researchers, and people living with obesity, most of whom were involved in patient representative networks. Three patient-reported outcome measures (patient-reported outcomes) were selected: the Impact of Weight on Quality of Life-Lite (self-esteem) measure, the BODY-Q (physical function, physical symptoms, psychological function, social function, eating behavior, and body image), and the Quality of Life for Obesity Surgery questionnaire (excess skin). No patient-reported outcome measure was selected for stigma.

Conclusion: A core set of patient-reported outcomes and patient-reported outcome measures for measuring quality of life in clinical obesity care is established incorporating patients' and experts' opinions. This set should be used as a minimum for measuring quality of life in routine clinical practice. It is essential that individual patient-reported outcome measure scores are shared with people living with obesity in order to enhance patient engagement and shared decision-making.

Background and aims: Bariatric surgery (BS) is an effective treatment for long-term weight loss in people with type 2 diabetes (T2D) and obesity. However, long-term prospective data on the efficacy and safety of BS with roux-en-y gastric bypass or sleeve gastrectomy in T2D populations are limited. AIMS: Evaluate the long-term effects of BS in people with T2D up to 14 years after surgery.

Materials and methods: A nationwide, matched, longitudinal, retrospective study based on data from the Swedish National Diabetes Registry (NDR) and the Swedish Obesity Surgery Registry (SOReg). Both registries cover more than 95% of all individuals with T2D and bariatric surgeries, respectively. A cohort of 8399 individuals with T2D (SOReg) who had undergone BS between 2007 and 2020 was matched by sex, age and BMI, with a control group from NDR who had not had surgery (n=8399). This study assessed the 28-day mortality rate after a CVD event, the long-term incidence of heart and kidney failure, psychiatric disorders and nutritional deficiencies. Data on outcomes were collected as ICD codes from the Swedish National Patient Registry and the Cause of Death Registry. Risks were quantified using unadjusted Cox regression models, yielding HR with 95% CI.

Results: In total, 16798 individuals with overweight or obesity were included and followed for up to 14 years. The mean BMI at the start of follow-up was 41±6 kg/m 2 , with a mean age of 49±10 years for both groups. The mean duration of T2D at baseline was 6.1 years for the control group and 6.5 years for the surgery group. The surgical group had slightly higher HbA1 c levels and education, but were less often single and had lower nicotine use (standardised mean difference, SMD >0.1). No significant differences were observed in cholesterol, eGFR, the prevalence of CVD, heart and kidney failure, psychiatric disorders, or nutritional deficiencies at baseline (SMD<0.1). During follow-up, the risk of heart failure, kidney failure, and death within 28 days of a CVD event was up to 45% lower in the surgically treated group compared to the controls (p <0.0001). However, the risk of hospitalisation for psychiatric disorders was increased after surgery (HR 1.21; 95% CI 1.13-1.29; p<0.0001). The surgically treated individuals also had a twofold increased risk of developing nutritional deficiencies compared to controls (HR 2.06; CI 1.84-2.31; p<0.0001) during the follow-up period.

Conclusion: This nationwide study shows that the benefits of bariatric surgery on CVD death, and heart and kidney failure for people with T2D are maintained in the long term. However, surgery increases the risk of suffering from psychiatric disorders or nutritional deficiencies for these individuals.