Long-term impact of gastropexy on use of acid-reducing medication, second operations for gastroesophageal reflux and subjective reflux symptoms after sleeve gastrectomy.

We investigated whether adding gastropexy to sleeve gastrectomy (SG) reduced gastroesophageal reflux disease (GERD) in patients operated for severe obesity, assessed mainly by use of anti-reflux medication (ARM) and second operations due to GERD worsening. In a prospective non-randomized study, patients undergoing SG at two Norwegian hospitals were included from 2011 to 2015 and followed for 7 years. GERD was defined by regular use of ARM, and epigastric pain and heartburn were measured by the Rome II questionnaire. Gastropexy was done by suturing the gastrocolic ligament to the staple line. Patients undergoing SG only, mainly before gastropexia was introduced in 2013, were compared to those with additional gastropexy from 2013 onwards. Of 376 included patients (75% females, mean age 42.6 years and BMI 42.9 kg/m2 ), 350 (93%) and 232 (62%) were available for evaluation after 1 and 7 years, respectively. Baseline characteristics in the no-gastropexy (n = 235) and gastropexy groups (n = 141) were similar. In patients without ARM use before surgery, the use increased and in those that used ARM at baseline, the proportion decreased, with no difference in the no-gastropexy and gastropexy groups. With a combined endpoint of ARM use and/or second operation for GERD, there was no difference during follow-up between the two groups. With time, adding gastropexy did not reduce symptoms of GERD significantly. In this population, adding gastropexy to SG did not reduce use of ARM and/or second operation for uncontrolled GERD, epigastric pain or heartburn during the first 7 postoperative years.

Intensified follow-up of patients with type 1 diabetes and poor glycaemic control: a multicentre quality improvement collaborative based on data from the Norwegian Diabetes Register for Adults.

BACKGROUND: Patients with type 1 diabetes mellitus (T1DM) and poor glycaemic control are at high risk of developing microvascular and macrovascular complications. The aim of this study was to determine if a quality improvement collaborative (QIC) initiated by the Norwegian Diabetes Register for adults (NDR-A) could reduce the proportion of patients with T1DM with poor glycaemic control (defined as glycated haemoglobin (HbA1c)≥75 mmol/mol) and reduce mean HbA1c at participating clinics compared with 14 control clinics. METHOD: Multicentre study with controlled before and after design. Representatives of 13 diabetes outpatient clinics (n=5145 patients with T1DM) in the intervention group attended four project meetings during an 18-month QIC. They were required to identify areas requiring improvement at their clinic and make action plans. Continuous feedback on HbA1c outcomes was provided by NDR-A during the project. In total 4084 patients with type 1 diabetes attended the control clinics. RESULTS: Between 2016 and 2019, the overall proportion of patients with T1DM and HbA1c≥75 mmol/mol in the intervention group were reduced from 19.3% to 14.1% (p<0.001). Corresponding proportions in the control group were reduced from 17.3% (2016) to 14.4% (2019) (p<0.001). Between 2016 and 2019, overall mean HbA1c decreased by 2.8 mmol/mol (p<0.001) at intervention clinics compared with 2.3 mmol/mol (p<0.001) at control clinics. After adjusting for the baseline differences in glycaemic control, there were no significant differences in the overall improvement in glycaemic control between intervention and control clinics. CONCLUSIONS: The registry linked QIC did not result in a significantly greater improvement in glycaemic control at intervention clinics compared with control clinics. However, there has been a sustained improvement in glycaemic control and importantly a significant reduction in the proportion of patients with poor glycaemic control at both intervention and control clinics during and after the QIC time frame. It is possible that some of this improvement may be due to a spillover effect from the QIC.

Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: the DiaPROM randomised controlled pilot trial.

OBJECTIVE: To pilot test the proposed DiaPROM trial components and address uncertainties associated with conducting a full-scale randomised controlled trial (RCT) to evaluate whether such a trial is feasible. DESIGN: Two-arm pilot RCT. PARTICIPANTS: Adults aged ≥18-39 years, with minimum 1 year type 1 diabetes duration, attending outpatient follow-up. Exclusion criteria were pregnancy, severe cognitive, somatic or psychiatric conditions and impaired vision. RANDOMISATION AND INTERVENTION: All participants completed electronic Patient-Reported Outcome Measures (PROMs) prior to the annual diabetes consultation. Using computer-generated block-randomisation without blinding, we assigned participants in a 1:1 ratio stratified by sex to receive standard care or an intervention. Physicians reviewed diabetes distress scores (Problem Areas In Diabetes scale) and referred individuals with scores ≥30 or single item(s) ≥3 to minimum two diabetes nurse consultations where reported problems were reviewed and discussed. OUTCOMES: Recruitment and retention rates; participants perceptions about intervention components. Variance and estimated between-group differences in follow-up scores (Diabetes Distress Scale (DDS), WHO 5-Well-being Index, Perceived Competence for Diabetes Scale and glycaemic control) and DDS correlation with baseline scores, to assist sample size calculations. RESULTS: We randomised 80 participants to the control or intervention arm (one participant was later excluded). 23/39 intervention arm participants qualified for additional consultations and 17 attended. 67/79 attended the 12-month follow-up (15.2% attrition); 5/17 referred to additional consultations were lost to follow-up (29.4% attrition). Participants reported PROMs as relevant (84.6%) and acceptable (97.4%) but rated the usefulness of consultations as moderate to low. Baseline mean±SD DDS score was 2.1±0.69; DDS SD was 0.71 (95% CI: 0.60 to 0.86) at follow-up; correlation between baseline and follow-up DDS scores was 0.8 (95% CI: 0.7 to 0.9). CONCLUSIONS: The pilot trial revealed need for intervention modifications ahead of a full-scale trial to evaluate use of PROMs in diabetes consultations. Specifically, participant acceptability and intervention implementation need further investigation.

No association between subnormal serum vitamin B12 and anemia in older nursing home patients.

PURPOSE: Since evidence of an association between vitamin B12 (B12) deficiency and anemia in older people is limited and inconclusive, we wanted to investigate this association in old, frail nursing home patients. METHODS: The study includes patients admitted to short-term, post-acute care (n = 765) and residents in long-term care (LTC) (n = 1665), in the municipality of Bergen. Anemia was defined according to the WHO criteria: Hb < 13 g/dL in men and < 12 g/dL in women, and as Hb < 11 g/dL, in both sex (moderate/severe anemia). The presence of anemia was analyzed in patients with subnormal (< 250 pmol/L), normal (250-650 pmol/L) and high (> 650 pmol/L) B12, and the association between anemia and clinical parameters, and including B12, was analyzed using logistic regression models. The use of B12 supplementation was investigated in the LTC patients. RESULTS: Mean age of the 2430 patients was 86 ± 7 years. WHO-defined anemia was seen in 1023 (42%), and moderate/severe anemia in 384 (16%) of the patients. In multiple logistic regression analyses, we found no statistically significant associations of subnormal B12 with WHO-defined anemia or moderate/severe anemia. Renal insufficiency, iron deficiency and CRP > 10 mg/L were significantly associated with both types of anemia, (p < 0.001). Among the LTC residents, 405 (24%) received B12 supplements, 112 (7%) of them had elevated B12 > 650 pmol/L. CONCLUSION: In older nursing home patients, no association was observed between subnormal B12 and anemia. Older patients in Western societies with mild/moderate anemia should not be treated with B12 supplements without further investigation.

Which population groups should be targeted for cardiovascular prevention? A modelling study based on the Norwegian Hordaland Health Study (HUSK).

OBJECTIVE: To assess level of cardiovascular risk factors in a non-selected, middle-aged population. To estimate the proportion target for risk intervention according to present guidelines and according to different cut-off levels for two risk algorithms. DESIGN: Population survey, modelling study. SETTING: The Norwegian Hordaland Health Study (HUSK) 1997-99. SUBJECTS: A total of 22 289 persons born in 1950-57. MAIN OUTCOME MEASURES: Own and relatives' cardiovascular morbidity, antihypertensive and lipid-lowering treatment, smoking, blood pressure, cholesterol. Framingham and Systematic Coronary Risk Evaluation (SCORE) algorithms. The European guidelines on CVD prevention in clinical practice were applied to estimate size of risk groups. RESULTS: Some 9.7% of men and 7.6% of women had CVD, diabetes mellitus, a high level of one specific risk factor, or received lipid-lowering or antihypertensive treatment. Applying a SCORE (60 years) cut-off level at 5% to the rest of the population selected 52.4% of men and 0.8% of women into a primary prevention group, while a cut-off level at 8% included 22.0% and 0.06% respectively. A cut-off level for the Framingham score (60 years) of 20% selected 43.6% of men and 4.7% of women, while a cut-off level of 25% selected 25.6% of men and 1.8% of women. CONCLUSION: The findings illustrate how choices regarding risk estimation highly affect the size of the target population. Modelling studies are important when preparing guidelines, to address implications for resource allocation and risk of medicalization. The population share to be targeted for primary prevention ought to be estimated, including the impact of various cut-off points for risk algorithms on the size of the risk population.