To Örebro University

Objectives: Irritable bowel syndrome (IBS) is a common functional gastrointestinal condition. A respectful patient-doctor relationship with good communication is crucial for optimal treatment. Q-methodology is a combination of qualitative and quantitative methods used to study subjectivity. The aim of this study was to compare viewpoints on IBS between patients with IBS and general practitioners (GPs).

Methods: We conducted a Q-methodology study by including 30 patients and 30 GPs. All participants were asked to complete Q- sorting of 66 statements on IBS using an online software program. Data were processed using factor analysis. In addition, 3 patients and 3 GPs were interviewed.

Results: Three factors were extracted from both groups: Patient Factor 1 'Question the diagnosis of IBS', Patient Factor 2 'Lifestyle changes for a physical disorder', Patient Factor 3 'Importance of a diagnosis', GP Factor 1 'Unknown causes of great suffering', GP Factor 2 'Lifestyle changes are important, stress makes IBS worse', GP Factor 3 'Recognized the way IBS affects patients'. There was a strong and statistically significant correlation between patient Factor 1 and GP Factor 1, with a Pearson's r of 0.81 (p < 0.001). Correlations between other factors varied.

Conclusions: There was consensus between patients and GPs that IBS is a physical and not a psychiatric disorder of unknown etiology. They also seemed to agree that IBS has a great negative impact on patients' lives and that lifestyle changes are beneficial. There were conflicting opinions regarding gender, cultural factors and the use of antidepressants.

Aims: The objective was to compare anxiety, depression, and quality of life (QoL) in individuals living with type 1 (T1D) and type 2 (T2D) diabetes with matched controls during the second wave of the COVID-19 pandemic.

Methods: Via randomization, individuals living with diabetes T1D (n = 203) and T2D (n = 413), were identified during February-July 2021 through health-care registers. Population controls (n = 282) were matched for age, gender, and residential area. Questionnaires included self-assessment of anxiety, depression, QoL, and demographics in relation to SARS-CoV-2 exposure. Blood was collected through home-capillary sampling, and SARS-CoV-2 Nucleocapsid (NCP) and Spike antibodies (SC2_S1) were determined by multiplex Antibody Detection by Agglutination-PCR (ADAP) assays.

Results: Younger age and health issues were related to anxiety, depression, and QoL, with no differences between the study groups. Female gender was associated with anxiety, while obesity was associated with lower QoL. The SARS-CoV-2 NCP seroprevalence was higher in T1D (8.9 %) compared to T2D (3.9 %) and controls (4.0 %), while the SARS-CoV-2 SC2_S1 seroprevalence was higher for controls (25.5 %) compared to T1D (16.8 %) and T2D (14.0 %).

Conclusions: A higher SARS-CoV-2 infection rate in T1D may be explained by younger age and higher employment rate, and the associated increased risk for viral exposure.

BACKGROUND: The World Health Organisation (WHO) 2013 diagnostic criteria for gestational diabetes mellitus (GDM) has been criticised due to the limited evidence of benefits on pregnancy outcomes in different populations when switching from previously higher glycemic thresholds to the lower WHO-2013 diagnostic criteria. The aim of this study was to determine whether the switch from previous Swedish (SWE-GDM) to the WHO-2013 GDM criteria in Sweden following risk factor-based screening improves pregnancy outcomes.

METHODS AND FINDINGS: A stepped wedge cluster randomised trial was performed between January 1 and December 31, 2018 in 11 clusters (17 delivery units) across Sweden, including all pregnancies under care and excluding preexisting diabetes, gastric bypass surgery, or multifetal pregnancies from the analysis. After implementation of uniform clinical and laboratory guidelines, a number of clusters were randomised to intervention (switch to WHO-2013 GDM criteria) each month from February to November 2018. The primary outcome was large for gestational age (LGA, defined as birth weight >90th percentile). Other secondary and prespecified outcomes included maternal and neonatal birth complications. Primary analysis was by modified intention to treat (mITT), excluding 3 clusters that were randomised before study start but were unable to implement the intervention. Prespecified subgroup analysis was undertaken among those discordant for the definition of GDM. Multilevel mixed regression models were used to compare outcome LGA between WHO-2013 and SWE-GDM groups adjusted for clusters, time periods, and potential confounders. Multiple imputation was used for missing potential confounding variables. In the mITT analysis, 47 080 pregnancies were included with 6 882 (14.6%) oral glucose tolerance tests (OGTTs) performed. The GDM prevalence increased from 595/22 797 (2.6%) to 1 591/24 283 (6.6%) after the intervention. In the mITT population, the switch was associated with no change in primary outcome LGA (2 790/24 209 (11.5%) versus 2 584/22 707 (11.4%)) producing an adjusted risk ratio (aRR) of 0.97 (95% confidence interval 0.91 to 1.02, p = 0.26). In the subgroup, the prevalence of LGA was 273/956 (28.8%) before and 278/1 239 (22.5%) after the switch, aRR 0.87 (95% CI 0.75 to 1.01, p = 0.076). No serious events were reported. Potential limitations of this trial are mainly due to the trial design, including failure to adhere to guidelines within and between the clusters and influences of unidentified temporal variations.

CONCLUSIONS: In this study, implementing the WHO-2013 criteria in Sweden with risk factor-based screening did not significantly reduce LGA prevalence defined as birth weight >90th percentile, in the total population, or in the subgroup discordant for the definition of GDM. Future studies are needed to evaluate the effects of treating different glucose thresholds during pregnancy in different populations, with different screening strategies and clinical management guidelines, to optimise women's and children's health in the short and long term.

TRIAL REGISTRATION: The trial is registered with ISRCTN (41918550).

AIMS: Risk factors for lower limb amputation (LLA) in individuals with diabetes have been under-studied. We examined how 1/demographic and socioeconomic, 2/medical, and 3/lifestyle risk factors may be associated with LLA in people with newly diagnosed diabetes.

METHODS: Using the Swedish national diabetes register from 2007 to 2016, we identified all individuals ≥18 years with an incident diabetes diagnosis and no previous amputation. These individuals were followed from the date of diabetes diagnosis to amputation, emigration, death, or the end of the study in 2017 using data from the In-Patient Register and the Total Population Register. The cohort consisted of 66,569 individuals. Information about demographic, socioeconomic, medical, and lifestyle risk factors was ascertained around the time of the first recorded diabetes diagnosis, derived from the above-mentioned registers. Cox proportional hazard models were used to obtain hazard ratios (HR) with 95% confidence intervals (CI).

RESULTS: During the median follow-up time of 4 years, there were 133 individuals with LLA. The model adjusting for all variables showed a higher risk for LLA with higher age, HR 1.08 (95% CI 1.05-1.10), male sex, HR 1.57 (1.06-2.34), being divorced, HR 1.67 (1.07-2.60), smokers HR 1.99 (1.28-3.09), insulin treated persons HR 2.03 (1.10-3.74), people with low physical activity (PA) HR 2.05 (1.10-3.74), and people with an increased foot risk at baseline HR > 4.12. People with obesity had lower risk, HR 0.46 (0.29-0.75).

CONCLUSIONS: This study found a higher risk for LLA among people with higher age, male sex, who were divorced, had a higher foot risk group, were on insulin treatment, had lower PA levels, and were smokers. No significant association was found between risk for LLA and education level, country of origin, type of diabetes, blood glucose level, hypertension, hyperlipidemia, creatinine level, or glomerular filtration rate. Obesity was associated with lower risk for LLA. Identified variables may have important roles in LLA risk among people with diabetes.

Introduction: The study was designed to assess outcomes with once-daily oral semaglutide in adults with type 2 diabetes (T2D) na & iuml;ve to injectable glucose-lowering agents, in Swedish clinical practice.

Methods: In this non-interventional, multicentre study, participants initiated oral semaglutide and were followed for 34-44 weeks. The primary endpoint was glycated haemoglobin (HbA(1c)) change from baseline to end of study (EOS). Secondary endpoints included body weight (BW) change from baseline to EOS, proportion of participants achieving HbA(1c) < 7%, and proportion achieving both a HbA(1c) reduction >= 1% and BW reduction of >= 3% or >= 5%, at EOS. Participants completed Diabetes Treatment Satisfaction Questionnaires (DTSQ status/change) and a dosing conditions questionnaire.

Results: A total of 187 participants (mean age 62.5 years) initiated oral semaglutide. Baseline mean HbA(1c) and BW were 7.8% (n = 177) and 96.9 kg (n = 165), respectively. Estimated mean changes in HbA(1c) and BW were - 0.88%-points (95% confidence interval [CI] - 1.01 to - 0.75; P < 0.0001) and - 4.72% (95% CI - 5.58 to - 3.86; P < 0.0001), respectively. At EOS, 64.6% of participants had HbA(1c) < 7%, and 22.9% achieved HbA(1c) reduction of >= 1% and BW reduction of >= 5%. DTSQ status and change scores improved by 1.44 (P = 0.0260) and 12.3 points (P < 0.0001), respectively. Oral semaglutide was easy or very easy to consume for 86.4% of participants. Most common adverse events (AEs) were gastrointestinal disorders; nine participants (4.8%) had serious AEs; one (0.5%) experienced severe hypoglycaemia.

Conclusion: In this real-world study population, we observed significant reductions in HbA(1c) and BW in people living with T2D when prescribed semaglutide tablets as part of routine clinical practice in Sweden, with improved treatment satisfaction among participants and no new safety concerns.

AIM: To describe experiences of living with obesity before the start of a group-based lifestyle intervention.

BACKGROUND: Obesity is a chronic disease that affects a person's physical and psychological health. Increased knowledge of experiences of living with obesity is required.

DESIGN: A qualitative study with a descriptive design.

METHODS: Semi-structured individual interviews with 17 participants living with obesity (Body Mass Index 32-49) were conducted between October and November 2019. The interviews were analysed using qualitative content analysis. The COREQ checklist was followed.

RESULTS: The analysis resulted in one main theme: Struggling for a lighter tomorrow and three subthemes: Suffering, Resilience and Need for support in making changes. For the majority of the participants, living with obesity was a lifelong struggle involving suffering on different levels. Yet despite this, the participants had not given up and hoped for a better life. They showed a degree of resilience and motivation, and a perceived ability to achieve lifestyle changes. However, there was a pronounced need for support to help them achieve this.

CONCLUSION: Living with obesity is complex and carries a risk of medical complications as well as psychosocial suffering. Healthy lifestyle habits to achieve better health and to lose weight should be encouraged, taking patient resources into account. Patients also need help in handling weight stigmatisation, and both healthcare professionals and society must engage with this.

RELEVANCE TO CLINICAL PRACTICE: Obesity is a chronic disease, and patients need ongoing support. Therefore, care for patients with obesity in primary health care must be further developed. Patient resources and strengths have to be acknowledged and encouraged in the process of helping them adopt healthy lifestyle habits. The findings of this study can contribute to ending weight stigmatisation by increasing the knowledge of living with obesity.

AIMS: To evaluate whether dog ownership from the time of type 2 diabetes diagnosis improved glycaemic control, increased achievement of major guideline treatment goals or reduced the risk of all-cause death.

METHODS: Patients diagnosed with type 2 diabetes were followed by linkage of four Swedish national registers covering diabetes, dog ownership, socioeconomics, and mortality. Linear regression was used to estimate the mean yearly change in glycated haemoglobin (HbA1c). Cox survival analysis and logistic regression were used to analyse associations between dog ownership and all-cause death and achievement of treatment goals, respectively.

RESULTS: Of 218,345 individuals included, 8,352 (3.8%) were dog-owners. Median follow-up was 5.2 years. Dog-owners had worse yearly change in HbA1c, and were less likely to reach HbA1c, low-density lipoprotein (LDL), and systolic blood pressure (SBP) treatment goals than non-dog-owners (adjusted odds ratios [95% CI] of 0.93 [0.88-0.97], 0.91 [0.86-0.95], and 0.95 [0.90-1.00], respectively). There was no difference in the risk of all-cause death (adjusted hazard ratio [95% CI] 0.92 [0.81-1.04], dog owners versus not).

CONCLUSION: Owning a dog when diagnosed with diabetes did not lead to better achievement of treatment goals or reduced mortality, but was in fact associated with a smaller reduction in HbA1c and reduced likelihood of achieving treatment goals.

Background and aims: Risk factors for lower limb amputation (LLA) in individuals with diabetes have been under-studied. We examined how demographic and socioeconomic, medical and life-style risk factors may be associated with LLA in people with newly diagnosed diabetes.

Materials and methods: We conducted a cohort study using Swedish national register-linked data. We identified, through the Swedish national diabetes register, all individuals 18 years or older with an incident diabetes diagnosis and no previous amputation from 2007 to 2016. These individuals were followed from the date of the diagnosis to amputation, emigration, death, or the end of the study in 2017, whichever occurred first. Several national Swedish registers were used to obtain data on incident LLA and potential risk factors, including demographic and socioeconomic, medical and lifestyle variables. Variables with more than 40% missing data were excluded from the analysis. The cohort consisted of 66,569 individuals, where of 133 hadan amputation. Cox proportional hazards models were used to obtain hazard ratio (HR) with 95% confidence interval (CI) for associations between demographic and socioeconomic, medical and lifestyle vari-ables and amputation risk. Both unadjusted and mutually adjusted models were fitted.

Results: During the median follow-up time of 4 years there were in total 133 LLA. Based on the model mutually adjusting for all variables, higher age, HR 1.08 (95% CI, 1.05 - 1.10) per year, and being divorced compared with being married, HR 1.67 (1.07 - 2.60) showed positive association. Male sex indicated higher risk, HR 1.57 (1.06 - 2.34). Individuals with an increased foot risk at baseline had increased risk for LLA compared to individuals with healthy feet (neuropathy/angiopathy, HR 4.12 (2.84 - 5.98), previous wounds, HR 8.26 (3.29 - 20.74), ongoing severe foot disease, HR 11.24 (4.82 - 26.23). Insulin treatment compared with diet-only treatment showed HR 2.03 (1.10 - 3.74). Hypertension and HbA1c were not statistically significantly associated with LLA risk. People with obesity had a statistically significant lower risk, HR 0.46 (0.29 - 0.75), compared with individuals with normal weight. Smoking was associated with an increased risk compared with no smoking, HR 1.99 (1.28 - 3.09). Finally, low physical activity (<1 time/week) was associated with an increased risk with a HR of 2.05 (1.30 - 3.23) compared with daily physical activity.

Conclusion: This study found a higher risk for LLA among people with higher age, male sex, who were divorced, who had a higher foot risk group, who were on insulin treatment, lower physical activity levels, and who were smoking. Obesity was associated with lower risk for LLA. Thus, these variables may have important roles in LLA risk among individuals with diabetes.

AIMS: SMARTEST is a register-based randomized clinical trial (RRCT) that compares dapagliflozin to metformin in early-stage type 2 diabetes. The primary outcome includes progression of microvascular complications based on data from the Swedish National Diabetes Register (NDR). In this sub-study, the aim was to validate microvascular complication variables in the NDR against electronic health records (EHRs).

METHODS: Data were extracted from EHRs of 276 SMARTEST participants with a median observation period of 3 years in the Uppsala, Örebro and Sörmland counties and compared with NDR data. Agreement was determined for all corresponding data entries as well as for progression of microvascular complications after randomization.

RESULTS: The agreement for all corresponding data entries was 98.9% (Intraclass Correlation Coefficient 0.999) for creatinine and eGFR, 95.1% for albuminuria, 91.6% for foot-at-risk and 98.2% for retinopathy status (Kappa 0.67-0.91). The agreement for progression of microvascular complications was 98.0% for CKD stage, 98.9% for albuminuria grade, 96.3% for foot-at-risk grade and 99.6% for retinopathy grade progression (Gwet's AC1 0.96-1.00). CONCLUSION: Microvascular complication variables in the NDR show good agreement with EHR data. The use of a well-established national health care registry, exemplified by the NDR, for endpoint collection in RRCTs such as SMARTEST is supported by this study.