Associations between nurse managers' leadership styles, team culture and competence planning in Norwegian municipal in-patient acute care services: A cross-sectional study.

BACKGROUND: Increased complexity in the primary healthcare services has followed in the wake of health reforms and reveals the need for competence enhancement in the nursing services. Effective and visionary leadership, sufficiently qualified staff and cooperation among professionals are considered as key measures to safeguard quality in the services. AIMS: To identify which leadership styles characterise first-line nurse managers in Norwegian municipal in-patient acute care (MipAC) units and to investigate how first-line nurse managers' leadership styles are associated with team culture and documented nursing competence planning. METHODS: A cross-sectional survey was distributed to all the first-line nurse managers in Norwegian MipAC units (n = 229). Data were collected between March and June 2019. The response rate was 80.5% (n = 182). First-line managers' background information and data about their focus on team culture and competence planning were recorded. Furthermore, we noted organisational structural characteristics, and managers' transformational (relational) leadership and transactional (task-oriented) leadership styles. RESULTS: The managers exhibited a high degree of transformational leadership behaviour, which was significantly associated with team culture. No significant associations between leadership behaviours and documented competence planning were found. Notably, we found a significant correlation between transformational and transactional leadership styles, indicating that the managers adapt their leadership behaviours to actual requirements and situations. Organisational structural factors: the share of registered nurses (RNs) on the staff and having a position for a professional development nurse were positively associated with competence planning. CONCLUSION: A relational leadership style promotes team culture and both factors may empower the professional nursing environment. However, first-line nurse managers need to acknowledge nursing competence planning as a central part of effective leadership. Having a professional development nurse position seems to complement leadership and ease the manager's responsibilities regarding team culture and competence planning.

Nursing competence in municipal in-patient acute care in Norway: a cross-sectional study.

BACKGROUND: The primary health care services are becoming increasingly complex, which presents challenges for the municipal nursing services. In Norway, municipal in-patient acute care (MipAC) has been introduced in all municipalities, and the competence at the services has been questioned. Few studies have examined the nursing services in the units. This study aims to get an overview of the nursing competence in those units across geographical regions, and different groups of organisation and localisation. METHODS: A cross-sectional study was conducted, and an ad hoc questionnaire was distributed to first-line leaders in all the MipAC units in Norway. Data were collected in the period between 6 March 2019 to 6 June 2019. Measures to get an overview of the nursing competence were ratio of registered nurses (RNs) in staff, count of shifts with only one RN on duty and count of RNs with master's degrees/specialisation. Descriptive comparative statistics were used. RESULTS: Of all 226 first-line leaders invited to participate, 207 (91.6%) responded to the questionnaire. Overall a considerable variance across the sample was revealed. The median ratio of RNs in staff was 56 (IQR = 40-70), the count of shifts with only one RN on duty median 28 (IQR = 5-49), and the count of RNs with a master's degree or specialisation median 3 (IQR = 0-5). The regions of Northern and Central Norway, MipACs located in nursing home and MipACs organised at long-term care units, showed significantly lower nursing competence in staff compared to the remaining institution and organisations. CONCLUSION: This study generates knowledge that can inform planning, priorities and interventions that may be initiated at all organisational and political levels concerning the MipAC services. An overall conclusion is that advanced nursing competence is lacking. The study also highlights the most urgent direction for improvements regarding nursing competence in the services. It seemed to be MipACs in Northern and Central Norway, and those located at nursing homes organised together with long-term care units, that needed improvements the most.

Exploring nursing competence to care for older patients in municipal in-patient acute care: A qualitative study.

AIM: To identify critical aspects of nursing competence to care for older patients in the context of municipal in-patient acute care. BACKGROUND: An increasingly complex and advanced primary healthcare system requires attention to the extent of nursing competence in municipal services. However, competence in complex and advanced care settings must be explored using perspectives which acknowledge the complexity of nurses' performance. DESIGN: A phenomenological hermeneutic, qualitative approach with individual in-depth interviews was used. COREQ reporting guidelines have been applied. METHODS: A sample of eight nurses and two physicians employed in municipal in-patient acute care units (MAUs) were purposively recruited to participate. Data were collected between May and June of 2017. Analysis and interpretation were conducted systematically in three steps: naïve reading, structural analysis and comprehensive understanding. FINDINGS: Two main themes were revealed. The first was the following: "The meaning of the individual nursing competence" including the themes "Having competence in clinical assessments, decision-making, and performing interventions"; "Having competence to collaborate, coordinate and facilitate"; and "Being committed." The second was the following: "The meaning of environmental and systemic factors for nursing competence," included the themes "Having professional leadership"; "Having a sufficiently qualified staff"; and "Working in an open, cooperative and professional work environment." CONCLUSION: Individual nursing competence in MAUs should include the capability to detect patient deterioration and to care for older patients in a holistic perspective. In addition, the professional environmental culture, supportive leadership and systemic factors seemed to be crucial to success. RELEVANCE TO CLINICAL PRACTICE: This study illustrates the nurses' responsibility for older patients' safety and quality of care in the MAUs. These findings can act as a foundation for the development and adaptation of educational programmes to accommodate requirements for nursing competence in MAUs. The broad perspective of nursing competence can give directions for quality improvements in MAUs.

Gender Identity Orientation and Sexual Activity-A Survey among Transgender and Gender-Diverse (TGD) Individuals in Norway.

BACKGROUND: The understanding and conceptualizing of gender and sexuality are continuously negotiated between individuals and cultures. Recently, new gender identity orientations have emerged, fighting pathologization and establishing new spaces and options for being sexually active gendered beings. OBJECTIVE: To investigate variations in sexual activities across different gender identity orientations. METHOD: A questionnaire used in France was adapted to the Norwegian context and implemented in this study. The participants were recruited through therapists, TGD organizations, and social media. RESULTS: A total of 538 individuals responded to the questionnaire, of which 336 provided a written description of their gender identity. Based on an analysis of the degree of male gender identity orientation, the degree of female gender identity orientation, and the degree of nonbinary gender identity orientation, three clusters appeared and were used in the analyses of sexual activities and preferences. CONCLUSIONS: Some findings could be attributed to lingering aspects of traditional gender roles, while others may be indicative of sexual expression stemming from societal acceptance of gender diversity and new identity orientations.

Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study.

BACKGROUND: Studies of lifestyle intervention programs in morbid obesity report large variations in weight loss outcomes. This is reported not only between but also within standardized programs. Such reports point to participants' characteristics as possible predictors of this outcome. The aim of this prospective cohort study was to identify predictors of weight loss after a 1-year partly residential intensive lifestyle intervention program (ILI). METHODS: Morbidly obese patients (n=199), all Caucasian, 71% women, mean (SD) age 45.2 (11.1) years, body mass index (BMI) 42.0 (6.2) kg/m(2), and excess body weight (>BMI=25 kg/m(2)) 49.4 (19.6) kg, were referred from public hospitals to a rehabilitation center and enrolled consecutively. The 1-year ILI comprised of four (n=104) or five (n=95) stays at the rehabilitation center. In both cases there was one main stay for 4 weeks and the remaining stays lasted 1 week each. In the home periods the patients were followed up by telephone and by their general practitioners (GP). The patients were also encouraged to use a predefined paper based diary. Health related quality of life (HRQL), diagnostic, anthropometric, socio-demographic, psychosocial and intervention characteristics were measured at baseline, 12 weeks and 1 year. Multiple linear regression analyses were performed to extract possible predictors of weight loss at 1-year. Direct and indirect effects of these predictors were tested through structural equation modeling. RESULTS: The mean (SD) 1-year weight loss was 10 (11) kg, corresponding to an 8 (8) % reduction of body weight from baseline. Mean excess weight loss (EWL) was 20 (22) % ranging from 104% to -77%. The adherence to a diary (r=.16), type 2 diabetes (r=-.14) and frequency of GP-visits (r=.23) were significantly associated with EWL at 12 weeks. Predictors of 1-year EWL were 12 week EWL (r=.66), occupational status (r=.11), age (r=.19), and mental HRQL (r=-.16), all p<.05. The path model explained 50% of the variation (r(2)=.50) of 1-year EWL. CONCLUSION: Larger 12 week weight loss, being employed, lower mental HRQL and being older predicts larger weight loss after 1 year in morbidly obese patients following ILI. Not having type 2 diabetes, using a diary combined with regular GP follow-up influence the 12-week weight loss. TRIAL REGISTRATION: Clinicaltrials.gov: NCT00477399.

Health related quality of life after gastric bypass or intensive lifestyle intervention: a controlled clinical study.

BACKGROUND: There is little robust evidence relating to changes in health related quality of life (HRQL) in morbidly obese patients following a multidisciplinary non-surgical weight loss program or laparoscopic Roux-en-Y Gastric Bypass (RYGB). The aim of the present study was to describe and compare changes in five dimensions of HRQL in morbidly obese subjects. In addition, we wanted to assess the clinical relevance of the changes in HRQL between and within these two groups after one year. We hypothesized that RYGB would be associated with larger improvements in HRQL than a part residential intensive lifestyle-intervention program (ILI) with morbidly obese subjects. METHODS: A total of 139 morbidly obese patients chose treatment with RYGB (n=76) or ILI (n=63). The ILI comprised four stays (seven weeks) at a specialized rehabilitation center over one year. The daily schedule was divided between physical activity, psychosocially-oriented interventions, and motivational approaches. No special diet or weight-loss drugs were prescribed. The participants completed three HRQL-questionnaires before treatment and 1 year thereafter. Both linear regression and ANCOVA were used to analyze differences between weight loss and treatment for five dimensions of HRQL (physical, mental, emotional, symptoms and symptom distress) controlling for baseline HRQL, age, age of onset of obesity, BMI, and physical activity. Clinical relevance was assessed by effect size (ES) where ES<.49 was considered small, between .50-.79 as moderate, and ES>.80 as large. RESULTS: The adjusted between group mean difference (95% CI) was 8.6 (4.6,12.6) points (ES=.83) for the physical dimension, 5.4 (1.5-9.3) points (ES=.50) for the mental dimension, 25.2 (15.0-35.4) points (ES=1.06) for the emotional dimension, 8.7 (1.8-15.4) points (ES=.37) for the measured symptom distress, and 2.5 for (.6,4.5) fewer symptoms (ES=.56), all in favor of RYGB. Within-group changes in HRQOL in the RYGB group were large for all dimensions of HRQL. Within the ILI group, changes in the emotional dimension, symptom reduction and symptom distress were moderate. Linear regression analyses of weight loss on HRQL change showed a standardized beta-coefficient of -.430 (p<.001) on the physical dimension, -.288 (p=.004) on the mental dimension, -.432 (p<.001) on the emotional dimension, .287 (p=.008) on number of symptoms, and .274 (p=.009) on reduction of symptom pressure. CONCLUSIONS: Morbidly obese participants undergoing RYGB and ILI had improved HRQL after 1 year. The weaker response of ILI on HRQL, compared to RYGB, may be explained by the difference in weight loss following the two treatments. TRIAL REGISTRATION: Clinical Trials.gov number NCT00273104.

Asymmetry in inter-municipal cooperation in health services - How does it affect service quality and autonomy?

Throughout Europe, local health services are increasingly being provided through various forms of inter-municipal cooperation (IMC). One of the most common forms of IMC is when small municipalities delegate the operational responsibility for providing health services to a larger host municipality. However, despite the size asymmetry usually inherent in this type of IMC, this aspect has largely been neglected in the existing literature, which mainly focuses on the size of individual municipalities. Based on data from 97 partner municipalities and 25 host municipalities in Norway, this study examines how varying degrees of size asymmetry between them affect the perceived service quality and loss of autonomy resulting from IMC in health services. From the perspective of the relatively smaller partner municipalities, the results suggest that these are likely to benefit greatly from size asymmetry in terms of improved service quality, although this would appear to be at the expense of losing decision-making autonomy to their host. However, from the perspective of the relatively larger hosts municipalities, this type of asymmetry is likely to affect service quality negatively while having no effect on decision-making autonomy.

Associations between structures, processes and outcomes in inter-municipal cooperation in out-of-hours services in Norway: A survey study.

Inter-municipal cooperation (IMC) has gained widespread recognition as a beneficial strategy for improving efficiency and quality in the provision of out-of-hours emergency care services (OOH services). Little attention, however, has been given to the additional costs of cooperation and the relational processes through which benefits and costs are likely to result. Based on survey data from 266 (77%) Norwegian municipalities involved in IMC in OOH services in 2015, this study aimed to investigate how the structure (governance form, complexity and stability) and quality (trust and consensus) of cooperation processes interact to influence the perceived outcomes (benefits and costs) of IMC in OOH services. Using Structural equation modeling, we found trust and consensus fully mediated the association between the structure and outcomes of IMC. More specifically, the results suggest that cooperation structures characterized by centralized governance, stability over time, and reduced complexity were likely to enhance the benefits and reduce the costs of IMC through trust and consensus.

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.

Obesity and other medical comorbidities among NT1 patients after the Norwegian H1N1 influenza epidemic and vaccination campaign.

STUDY OBJECTIVES: Narcolepsy type 1 (NT1) may be complicated by comorbidities. We aimed to study the extent of obesity and other medical comorbidities in a Norwegian population of NT1 patients with debut of symptoms after the 2009 H1N1 influenza epidemic and vaccination campaign. We also aimed to explore factors associated with obesity. METHODS: Ninety-one patients (48 children and 43 adults) were included in this cross-sectional study, 80 of whom were H1N1-vaccinated. All participants were hospitalized and underwent sleep investigation and physical examination, and completed a semi-structured clinical interview. RESULTS: In children, 16 females (70%) and 10 males (40%) were classified as overweight or obese. Twenty children (42%) had a co-existing medical disorder. Medical comorbidity was significantly positively associated with BMI in children (p = .032). In adults, 19 females (58%) and 7 males (70%) were classified as overweight or obese. Twenty-six adults (61%) had a co-existing medical disorder. We found no factors significantly associated with BMI in adults. On a fatigue scale from 0 to 100, lower scores indicating more fatigue, we found a mean (SD) total fatigue score of 50 (17) in children and 39 (16) in adults. CONCLUSION: In a cohort of predominantly H1N1-vaccinated NT1 patients, we found a high prevalence of overweight or obesity. Half of the cohort presented with one or more additional medical comorbidities, and patients reported a clinically relevant degree of fatigue. Our findings highlight the importance of carefully monitoring patients with NT1 with regard to the development of obesity, which is a significant risk factor for cardiovascular disorders.

Psychiatric symptoms in patients with post-H1N1 narcolepsy type 1 in Norway.

STUDY OBJECTIVES: Several studies have reported psychiatric comorbidity in patients with narcolepsy type 1 (NC1). The primary aim of this study was to explore the extent of psychiatric symptoms in a cohort of Norwegian NC1 patients, most of whom were H1N1-vaccinated. We also wanted to explore possible causes of the psychiatric symptoms seen in NC1. METHODS: Cross-sectional study. Psychiatric symptoms were assessed by the Achenbach System of Empirically Based Assessment (ASEBA) Child Behavior Check List (CBCL) in children and by Adult Self Report (ASR) in adults. RESULTS: The mean (SD) total T-scores were 58.6 (9.2) for children and 57.0 (9.8) for adults, these being mainly driven by internalizing problems. Internalizing symptom T-scores showed that 37.5% of the children and 33.3% of the adults were in the clinical range of concern. T-scores were lower when the questionnaire's sleep-related items were excluded. However, 27.5% of children and 22.2% of adults still remained within the total psychiatric symptoms clinical range. Psychiatric symptoms and excessive daytime sleepiness were not associated. However, in children fragmented sleep, measured by sleep-stage shift index was significantly negatively associated with all the psychiatric summary scores (all p ≤ 0.020), and awakening index was negatively associated with externalizing (p = 0.042) and total summary scores (p = 0.042). In adults, awakening index, but not sleep-stage shift index, was positively associated with internalizing score (p = 0.015). Hypocretin-1 levels showed no association with psychiatric symptoms. CONCLUSIONS: We found a high prevalence of psychiatric symptoms in NC1 patients. Fragmented sleep was significantly associated with psychiatric symptoms.

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.

Generic Health-Related Quality of Life May Not Be Associated with Weight Loss 4 Years After Bariatric Surgery: a Cross-Sectional Study.

BACKGROUND: There seems to exist a belief that weight loss is proportionally associated with improvement of health-related quality of life (HRQoL) after bariatric surgery. HRQoL is a complex multidimensional construct of one's perception of health and well-being and is measured through generic and disease specific questionnaires. OBJECTIVES: This study aimed to test the associations between weight loss after bariatric surgery and both generic and obesity-specific HRQoL, and mental distress, controlling for other patient characteristics. METHODS: The study was conducted at the Department of Surgery at Haugesund Hospital (Norway) based on a cohort of bariatric surgery patients operated between 2010 and 2013. Primary outcome measures included the SF-36 (generic HRQoL), IWQoL-Lite (obesity-specific HRQoL), and HADS (mental distress). Blocks of variables (time since surgery, personal characteristics, socioeconomics, comorbidities, surgical complications, experienced life crisis, and weight loss) were entered into hierarchical linear regression models with the four outcome measures as dependent variables. Cumulative explained variance (r2) and increase in r2 after the entry of each block of variables is reported. RESULTS: A total of 206 completed the outcome measures with a mean (SD) of 4.4 (1.1) years after surgery. The generic SF-36 physical and mental composite scores were significantly associated (p < .05) with socioeconomics, baseline comorbidities, and surgical complications. Obesity-specific IWQoL-Lite scores were significantly (p < .05) associated with weight loss. CONCLUSIONS: The study indicates that post-operative weight loss is associated with obesity-specific HRQoL but demonstrates no associations between weight loss and generic HRQoL, when controlling for other patient characteristics.

Changes in quality of life in individuals with narcolepsy type 1 after the H1N1-influenza epidemic and vaccination campaign in Norway: a two-year prospective cohort study.

OBJECTIVE: Cross-sectional studies show a lower health-related quality of life (HRQoL) in individuals with narcolepsy. We aimed to describe changes in HRQoL after two years of multidisciplinary follow-up in a cohort of mainly post-H1N1 vaccination narcolepsy type-1 (NT1) patients in Norway. METHODS: Prospective-cohort study. Narcolepsy diagnosis was based on the International Classification of Sleep Disorders (third edition). Psychiatric comorbidity was assessed using the Achenbach System of Empirically Based Assessment (ASEBA). HRQoL was evaluated with the Pediatric Quality of Life Inventory (PedsQL™ Generic Core Scales 4.0) at baseline and follow-up. Mean follow-up time was 20.7 (2.7) months. RESULTS: Thirty one patients (18 females) with NT1, mean age 14.6 (SD = 4.8) years answered questionnaires at baseline and follow-up. On a group level, the PedsQL Total Health Summary score significantly improved by a mean of 5.9 (95%CI = 0.4, 11.9), p = 0.038; this was mainly driven by improvements in the Physical Health Summary score by 9.8 (3.0, 16.5) points, p = 0.006 and the School Functioning Scale score by 7.5 (1.0, 13.9) points p = 0.025. The Total ASEBA score was correlated with PedsQL Total Health Summary score at baseline, but not with changes in HRQoL. Sodium oxybate (Xyrem®) treatment at follow up was positively associated with changes in PedsQL Total Health Summary score, after adjusting for age and gender, p = 0.027. CONCLUSION: HRQoL in NT1 patients improved after two years of follow-up. The use of sodium oxybate (Xyrem®) at follow-up was associated with increases in HRQoL. Psychiatric comorbidity was correlated with HRQoL at baseline but did not predict changes in HRQoL at follow-up.

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.

Impact of body weight, low energy diet and gastric bypass on drug bioavailability, cardiovascular risk factors and metabolic biomarkers: protocol for an open, non-randomised, three-armed single centre study (COCKTAIL).

INTRODUCTION: Roux-en-Y gastric bypass (GBP) is associated with changes in cardiometabolic risk factors and bioavailability of drugs, but whether these changes are induced by calorie restriction, the weight loss or surgery per se, remains uncertain. The COCKTAIL study was designed to disentangle the short-term (6 weeks) metabolic and pharmacokinetic effects of GBP and a very low energy diet (VLED) by inducing a similar weight loss in the two groups. METHODS AND ANALYSIS: This open, non-randomised, three-armed, single-centre study is performed at a tertiary care centre in Norway. It aims to compare the short-term (6 weeks) and long-term (2 years) effects of GBP and VLED on, first, bioavailability and pharmacokinetics (24 hours) of probe drugs and biomarkers and, second, their effects on metabolism, cardiometabolic risk factors and biomarkers. The primary outcomes will be measured as changes in: (1) all six probe drugs by absolute bioavailability area under the curve (AUCoral/AUCiv) of midazolam (CYP3A4 probe), systemic exposure (AUCoral) of digoxin and rosuvastatin and drug:metabolite ratios for omeprazole, losartan and caffeine, levels of endogenous CYP3A biomarkers and genotypic variation, changes in the expression and activity data of the drug-metabolising, drug transport and drug regulatory proteins in biopsies from various organs and (2) body composition, cardiometabolic risk factors and metabolic biomarkers. ETHICS AND DISSEMINATION: The COCKTAIL protocol was reviewed and approved by the Regional Committee for Medical and Health Research Ethics (Ref: 2013/2379/REK sørøst A). The results will be disseminated to academic and health professional audiences and the public via presentations at conferences, publications in peer-reviewed journals and press releases and provided to all participants. TRIAL REGISTRATION NUMBER: NCT02386917.

Standard vs Distal Roux-en-Y Gastric Bypass in Patients With Body Mass Index 50 to 60: A Double-blind, Randomized Clinical Trial.

Importance: Up to one-third of patients undergoing bariatric surgery have a body mass index (BMI) of more than 50. Following standard gastric bypass, many of these patients still have a BMI greater than 40 after peak weight loss. Objective: To assess the efficacy and safety of standard gastric bypass vs distal gastric bypass in patients with a BMI of 50 to 60. Design, Setting, and Participants: Double-blind, randomized clinical parallel-group trial at 2 tertiary care centers in Norway (Oslo University Hospital and Vestfold Hospital Trust) between May 2011 and April 2013. The study included 113 patients with a BMI of 50 to 60 aged 20 to 60 years. The 2-year follow-up was completed in May 2015. Interventions: Standard gastric bypass (alimentary limb, 150 cm) and distal gastric bypass (common channel, 150 cm), both with a biliopancreatic limb of 50 cm and a gastric pouch of about 25 mL. Main Outcomes and Measures: Primary outcome was the change in BMI from baseline until 2 years after surgery. Secondary outcomes were cardiometabolic risk factors, nutritional outcomes, adverse events, gastrointestinal symptoms, and health-related quality of life. Results: At baseline, the mean age of the patients was 40 years (95% CI, 38-41 years), 65% were women, mean BMI was 53.5 (95% CI, 52.9-54.0), and mean weight was 158.8 kg (95% CI, 155.3-162.3 kg). The mean reduction in BMI was 17.8 (95% CI, 16.9-18.6) after standard gastric bypass and 17.2 (95% CI, 16.3-18.0) after distal gastric bypass, and the mean between-group difference was 0.6 (95% CI, -0.6 to 1.8; P = .32). Reductions in mean levels of total and low-density lipoprotein cholesterol were greater after distal gastric bypass than standard gastric bypass, and between-group differences were 19 mg/dL (95% CI, 11-27 mg/dL ) and 28 mg/dL (95% CI, 21 to 34 mg/dL), respectively (P < .001 for both). Reductions in fasting glucose levels and hemoglobin A1c were greater after distal gastric bypass. Secondary hyperparathyroidism and loose stools were more frequent after distal gastric bypass. The number of adverse events and changes in health-related quality of life did not differ between the groups. Importantly, 1 patient developed liver failure and 2 patients developed protein-caloric malnutrition treated by elongation of the common channel following distal gastric bypass. Conclusions and Relevance: Distal gastric bypass was not associated with a greater BMI reduction than standard gastric bypass 2 years after surgery. However, we observed different changes in cardiometabolic risk factors and nutritional markers between the groups. Trial Registration: Clinicaltrials.gov Identifier: NCT00821197.

Health-related quality of life after bariatric surgery: a systematic review of prospective long-term studies.

Impaired health-related quality of life (HRQoL) is common in bariatric surgery candidates and is often one of the motivating factors for seeking bariatric surgery. Although many studies have reported changes in HRQoL after bariatric surgery, few are long-term prospective studies and no systematic review has been conducted. A systematic database search identified studies reporting HRQoL preoperatively and≥5 years after bariatric surgery. Change in HRQoL over time was the outcome variable, divided into primary and secondary outcomes. Seven prospective cohort studies met the inclusion criteria. Eight HRQoL measures and 6 surgical methods were identified. Long-term follow-up time ranged from 5-10 years, sample sizes from 44 to 655 patients, and follow-up rates from 61% to 92%. None of the 7 studies were randomized controlled trials, and only 2 studies used control groups. Six of 7 studies showed statistically significant improvements in all of the primary outcomes, and 1 study showed statistically significant improvements in 1 of 2 primary outcomes. Of the statistically significant HRQoL improvements, 92% were clinically meaningful. Peak improvements in primary HRQoL outcomes were typically observed during the first years of follow-up, followed by a gradual decline that seemed to stabilize 5 years postoperatively. Long-term HRQoL scores typically remained improved relative to preoperative scores but were somewhat below population norm scores. In conclusion, while bariatric surgery candidates reported impaired HRQoL presurgically, their HRQoL improved considerably after bariatric surgery and much of the initial HRQoL improvements were maintained over the long term.

Validity of the SF-36 in patients with morbid obesity.

BACKGROUND: The Medical Outcome Study 36-Item Short Form Health Survey (SF-36) is one of the most commonly applied generic quality of life instruments. The construct validity of the instrument in patients with morbid obesity is not established. PARTICIPANTS AND METHODS: A total of 475 morbidly obese patients (68% women) with a mean (standard deviation) age of 44.7 (11.8) years, weight of 123.5 (24.1) kg and BMI of 41.7 (6.3) kg/m(2), who had been referred to a rehabilitation center, completed the SF-36 form. Exploratory factor analyses were performed to examine the underlying component structure of the questionnaire. Confirmatory factor analyses were performed to assess model fit. RESULTS: The analysis suggested a 6-component structure rather than the 8-component structure used in the original SF-36. The first component consisted of items from the physical functioning subscale, the role physical subscale and the general health subscale, and explained 31% of the variance. The 6 components explained 61% of the total variance. The items loaded as expected in a physical and mental component. The assessment of model fit confirmed these findings. CONCLUSION: The 2 summary scales of the SF-36 have satisfactory validity in patients with morbid obesity. However, the validity of the 8 subscales is questionable, and the subscales should be interpreted with care.