Effects of exercise on symptoms of anxiety in primary care patients: A randomized controlled trial.

BACKGROUND: There is a need for high-quality research regarding exercise interventions for persons with anxiety disorders. We investigate whether a 12-week exercise intervention, with different intensities, could reduce anxiety symptoms in patients with anxiety disorders. METHODS: 286 patients were recruited from primary care in Sweden. Severity of symptoms was self-assessed using the Beck Anxiety Inventory (BAI) and the Montgomery Åsberg Depression Rating Scale (MADRS-S). Participants were randomly assigned to one of two group exercise programs with cardiorespiratory and resistance training and one control/standard treatment non-exercise group, with 1:1:1 allocation. RESULTS: Patients in both exercise groups showed larger improvements in both anxiety and depressive symptoms compared to the control group. No differences in effect sizes were found between the two groups. To study a clinically relevant improvement, BAI and MADRS-S were dichotomized with the mean change in the control group as reference. In adjusted models the odds ratio for improved symptoms of anxiety after low-intensity training was 3.62 (CI 1.34-9.76) and after moderate/high intensity 4.88 (CI 1.66-14.39), for depressive symptoms 4.96 (CI 1.81-13.6) and 4.36 (CI 1.57-12.08) respectively. There was a significant intensity trend for improvement in anxiety symptoms. LIMITATIONS: The use of self-rating measures which bears the risk of an under- or overestimation of symptoms. CONCLUSIONS: A 12-week group exercise program proved effective for patients with anxiety syndromes in primary care. These findings strengthen the view of physical exercise as an effective treatment and could be more frequently made available in clinical practice for persons with anxiety issues.

Anxiety severity and cognitive function in primary care patients with anxiety disorder: a cross-sectional study.

BACKGROUND: Deficits in cognitive performance are reported in patients with anxiety disorders, but research is limited and inconsistent. We aimed to investigate cross-sectional associations between cognitive function, with focus on executive function, and anxiety severity in primary care patients diagnosed with anxiety disorders. METHODS: 189 Swedish patients aged 18-65 years (31% men) with anxiety disorders diagnosed according to Mini International Neuropsychiatric Interview were included. Severity of anxiety was assessed using Beck Anxiety Inventory self-assessment scale. Digit span, block design and matrix reasoning tests from the Wechsler Adult Intelligence Scale IV, and the design fluency test from the Delis-Kaplan Executive Function System were used. Multivariable linear regression models were applied to investigate the relationship of anxiety severity and cognitive functioning. Comparisons were also performed to a normed non-clinical population, using the Wilcoxon signed rank test. RESULTS: More severe anxiety was associated with lower digit span test scores (R2 = 0.109, B = -0.040, p = 0.018), but not with block design, matrix reasoning or design fluency tests scores, after adjustment for comorbid major depression in a multivariable model. When compared to a normed population, patients with anxiety performed significantly lower on the block design, digit span forward, digit span sequencing and matrix reasoning tests. CONCLUSIONS: Severity of anxiety among patients with anxiety disorder was associated with executive functions related to working memory, independently of comorbid major depression, but not with lower fluid intelligence. A further understanding of the executive behavioral control in patients with anxiety could allow for more tailored treatment strategies including medication, therapy and interventions targeted to improve specific cognitive domains.

A randomized, double-blind study of iodine supplementation during pregnancy in Sweden: pilot evaluation of maternal iodine status and thyroid function.

PURPOSE: Pregnant women in Sweden are mildly iodine deficient. We investigated the effect of daily iodine supplementation on the iodine and thyroid status of pregnant women. METHODS: In this pilot, randomized, double-blind trial, 200 thyroid-healthy pregnant women were recruited at mean (standard deviation) pregnancy week 8.85 (1.62) and assigned (1:1) to daily intake of a multivitamin tablet with or without 150 µg of iodine. Urine and serum samples were collected at baseline and once during the second and third trimesters. Urinary iodine concentration (UIC), serum thyroglobulin (Tg), thyroid-stimulating hormone (TSH), free thyroxine (FT4), and thyroid peroxidase antibodies (TPOabs) were analyzed. Neonatal TSH data were collected. UIC and Tg were also analyzed in a group of 89 thyroid-healthy non-pregnant women of reproductive age (WRA). RESULTS: At baseline, the intervention and the control groups had similar median UIC (interquartile range (IQR)): 110 µg/L (74-119) and 111 µg/L (66-168), respectively. The intervention group reached iodine sufficiency with median UIC (IQR) 139 µg/L (89-234) and 136 µg/L (91-211) in the second and third trimester, respectively, without significant difference from the lower limit of the recommended range, i.e. 150-250 µg/L (p = 0.42 and p = 0.87, respectively). The intervention group had higher median UIC and lower median Tg compared to the control group during the second (p < 0.001 and p = 0.019, respectively) and third trimester (p < 0.001 and p = 0.003, respectively), whereas thyroid hormones, serum TPOabs, and neonatal TSH were similar. The WRA group presented median UIC (IQR) 65 µg/L (30-98) and median Tg (IQR) 18 µg/L (13-27). CONCLUSION: A daily supplement containing 150 µg of iodine to a group of pregnant women with mild iodine deficiency improved the iodine status from mild ID to iodine sufficiency. This improvement seems to have had a positive impact on maternal thyroglobulin. This study is now under extension to investigate the children's neuropsychological development. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02378246, May 3, 2015, retrospectively registered.

Inadequate iodine intake in lactating women in Sweden: A pilot 1-year, prospective, observational study.

INTRODUCTION: Breastfed infants depend on breast-milk iodine for growth and brain development, as iodine is a trace element important for thyroid hormone production. Iodine need is higher during lactation; hence, mothers and children are at risk of iodine deficiency. We aimed to explore maternal iodine and thyroidal status during lactation. MATERIAL AND METHODS: Pregnant women were recruited in Gothenburg, southwest Sweden. Maternal urine and serum were collected at pregnancy week 35-37 (n = 84) and 0.5, 4, and 12 months postpartum. Seventy mothers provided breast milk at 0.5 months. RESULTS: Median (interquartile range) breast-milk iodine concentration was 90 (66-116) µg/L. About 58% had breast-milk iodine concentration <100 µg/L. Iodine supplement users (n = 13) had higher breast-milk iodine concentration than non-users (n = 49) (140 µg/L vs 71 µg/L, P = .001). Exclusively breastfeeding women at 4 months postpartum (n = 57) had lower median urinary iodine concentration (85 µg/L vs 133 µg/L, P = .004) and higher thyroglobulin serum concentration (22.3 µg/L vs 11.8 µg/L, P = .032) than non-exclusively breastfeeding women (n = 25). Concentrations of thyroid hormones were unaffected. CONCLUSIONS: This pilot study suggests that lactating women in southwest Sweden present mildly inadequate iodine intake, mainly among non-iodine supplement users and exclusively breastfeeding mothers. Studies on the coverage of the iodine fortification program in breastfeeding women are warranted.

Is C-reactive protein associated with influenza A or B in primary care patients with influenza-like illness? A cross-sectional study.

OBJECTIVE: Identifying influenza A or B as cause of influenza-like illness (ILI) is a challenge due to non-specific symptoms. An accurate, cheap and easy to use biomarker might enhance targeting influenza-specific management in primary care. The aim of this study was to investigate if C-reactive protein (CRP) is associated with influenza A or B, confirmed with PCR testing, in patients presenting with ILI. DESIGN: Cross-sectional study. SETTING: Primary care in Lithuania, Norway and Sweden. SUBJECTS: A total of 277 patients at least 1 year of age consulting primary care with ILI during seasonal influenza epidemics. MAIN OUTCOME MEASURES: Capillary blood CRP analysed as a point-of-care test and detection of influenza A or B on nasopharyngeal swabs in adults, and nasal and pharyngeal swabs in children using PCR. RESULTS: The prevalence of positive tests for influenza A among patients was 44% (121/277) and the prevalence of influenza B was 21% (58/277). Patients with influenza A infection could not be identified based on CRP concentration. However, increasing CRP concentration in steps of 10 mg/L was associated with a significantly lower risk for influenza B with an adjusted odds ratio of 0.42 (0.25-0.70; p<.001). Signs of more severe symptoms like shortness of breath, sweats or chills and dizziness were associated with higher CRP. CONCLUSIONS: There was no association between CRP and influenza A. Increased concentration of CRP was associated with a lower risk for having influenza B, a finding that lacks clinical usefulness. Hence, CRP testing should be avoided in ILI, unless bacterial pneumonia is suspected. Key points Identifying influenza A or B as cause of influenza-like illness (ILI) is a challenge due to non-specific symptoms. There was no association between concentration of CRP and influenza A. Increased concentration of CRP was associated with a lower risk for having influenza B, a finding that lacks clinical usefulness. A consequence is that CRP testing should be avoided in ILI, unless bacterial pneumonia or similar is suspected.

Iodine deficiency in pregnant women in Sweden: a national cross-sectional study.

PURPOSE: Voluntary salt iodization at 50 mg/kg salt ensures adequate iodine nutrition in Swedish school-aged children, but iodine status in pregnant women is uncertain. METHODS: We conducted a cross-sectional national study of 743 pregnant women, at median gestational age of 23 weeks (IQR 9, 38), recruited from maternal health care centers. We measured: urinary iodine concentration (UIC) and urinary creatinine concentration in spot urine samples; thyroglobulin (Tg), thyroid-stimulating hormone (TSH), and total thyroxine (tT4) on dried blood spots (DBS); and thyreoperoxidase antibodies in serum samples. Data on dietary supplement use were obtained, and women were classified as supplement users (consuming multivitamins containing ≥ 150 µg iodine/day) and non-supplement users (no supplements or < 150 µg iodine/day from supplements). RESULTS: Overall median UIC [bootstrapped 95% confidence interval (CI)] was 101 µg/L (95, 108; n = 737): 149 µg/L (132, 164) in supplement users (n = 253) and 85 µg/L (79, 92) in non-supplement users (n = 440) (p < 0.001). Overall geometric mean DBS-Tg (95% CI) was 22.1 µg/L (20.8, 23.5; n = 675) and the prevalence of elevated DBS-Tg was 19%. DBS-Tg was lower in supplement users (n = 229) than in non-supplement users (n = 405) (19.1 vs 24.4 µg/L, p < 0.001). DBS-TSH, DBS-tT4, and S-TPOab positivity did not differ between the two groups. CONCLUSIONS: Pregnant women in Sweden have inadequate iodine nutrition. Women not taking iodine supplements containing ≥ 150 µg iodine/day are affected by mild iodine deficiency and are at higher risk for increased thyroid activity, while maintaining euthyroidism. Iodine intake should be improved in women both before and after conception by promotion of iodized salt instead of non-iodized salt. We urge regular monitoring of iodine status in the general Swedish population, as well as in risk groups.

Correlations of water iodine concentration to earlier goitre frequency in Sweden-an iodine sufficient country with long-term iodination of table salt.

BACKGROUND: Before iodination of Swedish table salt in 1936, iodine deficiency resulting in goitre and hypothyroidism was common. Sweden has become iodine sufficient, as shown in a national survey in 2007, proving its iodination fortification programme effective for the general population. The objective of this study was to collect drinking water from water treatment plants nationally and test if water iodine concentration (WIC) correlated to urinary iodine concentration (UIC) of school-aged children in a national survey 2007 to former goitre frequency in 1929 and to thyroid volume data in 2007. METHODS: In 2012, 166 treatment plants, located in 57% (166 of 290) of all Swedish municipalities, were asked to collect drinking water samples of approximately 10 ml. In 2007, tap water samples of the same volume were collected from 30 randomly selected schools for the national survey. Analysis of WIC was done in both treatment plants in 2012 (n = 166) and tap water in 2007 (n = 30). The correlation of WIC to the children's UIC and thyroid volume after iodination was tested based on data from the national survey in 2007. The association of WIC to former goitre frequency was tested based on pre-iodination data, derived from a map of goitre frequency drawn in 1929. RESULTS: The median WIC from water treatment plants was 4.0 µg/L (range 0-27 µg/L). WIC was similar in coastal and inland areas, for both ground and surface water. WIC correlated with historical goitre areas and was lower in the goitre areas than in non-goitre areas (p < 0.001). WIC in the same municipalities as the schools correlated with the UIC of children (p < 0.01), but not with their thyroid volume. CONCLUSIONS: WIC still contributes to iodine nutrition in Sweden, but iodination overrides the goitre effect.

Effects of exercise on symptoms of anxiety, cognitive ability and sick leave in patients with anxiety disorders in primary care: study protocol for PHYSBI, a randomized controlled trial.

BACKGROUND: Anxiety disorders are common and associated with reduced quality of life, impaired physical and mental health and an increased economic burden for society. While evidence exists for the effectiveness of exercise treatment for depression, there is a need for high-quality randomized clinical trials (RCT) with a focus on anxiety disorders. Further research is also warranted regarding outcomes of cognitive function, other health-related variables, dose-response effects, work ability and potential mechanisms. METHOD/DESIGN: Using a parallel, RCT design with three assessment points (baseline, post-intervention and one-year follow-up), we aim to assess the effect of a 12-week exercise intervention in primary care patients with anxiety disorders (n = 180), diagnosed using the Mini International Neuropsychiatric Interview (M.I.N.I; Swedish version 6.0.0d DSM-IV). Participants are randomly assigned to three physical exercise groups: one low-intensity training group, one moderate- to high intensity training group and one control non-exercise group. Assessments include measures of anxiety symptoms, cognitive function, physical health variables such as cardiovascular fitness, sick-leave and levels of hormones/cytokines in blood samples. DISCUSSION: Findings from this study will provide novel insights regarding the effects of exercise treatment on not only anxiety symptoms but also other outcomes including mental and physical health, cognitive function, dose-response effects, work ability/sick leave and on biomarkers that may help explain underlying mechanisms. TRIAL REGISTRATION: The trial was registered at ClinicalTrial.gov NCT03247270 August 8, 2017.

More cost-effective management of patients with musculoskeletal disorders in primary care after direct triaging to physiotherapists for initial assessment compared to initial general practitioner assessment.

BACKGROUND: A model for triaging patients in primary care to provide immediate contact with the most appropriate profession to treat the condition in question has been developed and implemented in parts of Sweden. Direct triaging of patients with musculoskeletal disorders (MSD) to physiotherapists at primary healthcare centres has been proposed as an alternative to initial assessment by general practitioners (GPs) and has been shown to have many positive effects. The aim of this study was to evaluate the cost-effectiveness from the societal perspective of this new care-pathway through primary care regarding triaging patients with MSD to initial assessment by physiotherapists compared to standard practice with initial GP assessment. METHODS: Nurse-assessed patients with MSD (N = 55) were randomised to initial assessment and treatment with either physiotherapists or GPs and were followed for 1 year regarding health-related quality of life, utilization of healthcare resources and absence from work for MSD. Quality-adjusted life-years (QALYs) were calculated based on EQ5D measured at 5 time-points. Costs for healthcare resources and production loss were compiled. Incremental cost-effectiveness ratios (ICERS) were calculated. Multiple imputation was used to compensate for missing values and bootstrapping to handle uncertainty. A cost-effectiveness plane and a cost-effectiveness acceptability curve were construed to describe the results. RESULTS: The group who were allocated to initial assessment by physiotherapists had slightly larger gains in QALYs at lower total costs. At a willingness-to-pay threshold of 20,000 €, the likelihood that the intervention was cost-effective from a societal perspective including production loss due to MSD was 85% increasing to 93% at higher thresholds. When only healthcare costs were considered, triaging to physiotherapists was still less costly in relation to health improvements than standard praxis. CONCLUSION: From the societal perspective, this small study indicated that triaging directly to physiotherapists in primary care has a high likelihood of being cost-effective. However, further larger randomised trials will be necessary to corroborate these findings. TRIAL REGISTRATION: ClinicalTrials.gov NCT02218749 . Registered August 18, 2014.

Health effects of direct triaging to physiotherapists in primary care for patients with musculoskeletal disorders: a pragmatic randomized controlled trial.

BACKGROUND: Physiotherapists and general practitioners (GPs) both act as primary assessors for patients with musculoskeletal disorders in primary care. Previous studies have shown that initial triaging to physiotherapists at primary healthcare centres has advantages regarding efficiency in the work environment and utilization of healthcare. In this study, we aimed primarily to determine whether triaging to physiotherapists affects the progression of health aspects over time differently than traditional management with initial GP assessment. The secondary aim was to determine whether triaging to physiotherapists affects patients' attitudes of responsibility for musculoskeletal disorders. METHODS: This was a pragmatic trial where both recruitment and treatment strategies were determined by clinical, not study-related parameters, and was initiated at three primary care centres in Sweden. Working-age patients of both sexes seeking primary care for musculoskeletal disorders and nurse assessed as suitable for triaging to physiotherapists were randomized to initial consultations with either physiotherapists or GPs. They received self-assessment questionnaires before the initial consultation and were followed up at 2, 12, 26 and 52 weeks with the same questionnaires. Outcome measures were current and mean (3 months) pain intensities, functional disability, risk for developing chronic musculoskeletal pain, health-related quality of life and attitudes of responsibility for musculoskeletal conditions. Trends over time were analysed with a regression model for repeated measurements. RESULTS: The physiotherapist-triaged group showed significant improvement for health-related quality of life at 26 weeks and showed consistent but nonsignificant tendencies to greater reductions of current pain, mean pain in the latest 3 months, functional disability and risk for developing chronic pain compared with traditional management. The triage model did not consistently affect patients' attitudes of responsibility for musculoskeletal disorders. CONCLUSIONS: Triaging to physiotherapists for primary assessment in primary care leads to at least as positive health effects as primary assessment by GPs and can be recommended as an alternative management pathway for patients with musculoskeletal disorders. CLINICALTRIALSGOV IDENTIFIER: NCT148611.

Bone mineral density in primary care patients related to serum calcium concentrations: a longitudinal cohort study from Sweden.

OBJECTIVE: Elevated calcium concentration is a commonly used measure in screening analyses for primary hyperparathyroidism (pHPT) and cancer. Low bone mineral density (BMD) and osteoporosis are common features of pHPT and strengthen the indication for parathyroidectomy. It is not known whether an elevated calcium concentration could be a marker of low BMD in suspected pHPT patients with a normal parathyroid hormone concentration. PURPOSE: To study if low BMD and osteoporosis are more common after ten years in patients with elevated compared with normal calcium concentrations at baseline. DESIGN: Prospective case control study. SETTING: Primary care, southern Sweden. SUBJECTS: One hundred twenty-seven patients (28 men) with baseline elevated, and 254 patients (56 men) with baseline normal calcium concentrations, mean age 61 years, were recruited. After ten years, 77% of those still alive (74 with elevated and 154 with normal calcium concentrations at baseline) participated in a dual energy x-ray absorptiometry measurement for BMD assessment and analysis of calcium and parathyroid hormone concentrations. MAIN OUTCOME MEASURES: Association between elevated and normal calcium concentration at base-line and BMD at follow-up. Correlation between calcium and parathyroid hormone concentrations and BMD at follow-up. RESULTS: A larger proportion of the patients with elevated baseline calcium concentrations who participated in the follow-up had osteoporosis (p value = 0.036), compared with the patients with normal concentrations. In contrast, no correlation was found between calcium or parathyroid hormone concentrations and BMD at follow-up. CONCLUSIONS: In this study, patients with elevated calcium concentrations at baseline had osteoporosis ten years later more often than controls (45% vs. 29%), which highlights the importance of examining these patients further using absorptiometry, even when their parathyroid hormone level is normal. Key Points Osteoporosis is common, difficult to detect and usually untreated. It is not known whether elevated calcium concentrations, irrespective of the PTH level, could be a marker of low bone mineral density. No correlation was found between calcium or parathyroid hormone concentrations and bone mineral density at follow-up. In this study, patients with elevated calcium concentrations at baseline had osteoporosis ten years later more often than controls (45% vs. 29%).

Role of iodine-containing multivitamins during pregnancy for children's brain function: protocol of an ongoing randomised controlled trial: the SWIDDICH study.

INTRODUCTION: Iodine is essential for normal brain development. Moderate and severe fetal iodine deficiency results in substantial to serious developmental delay in children. Mild iodine deficiency in pregnancy is associated with neurodevelopmental deficits in the offspring, but evidence from randomised trials is lacking. The aim of the Swedish Iodine in Pregnancy and Development in Children study is to determine the effect of daily supplementation with 150 µg iodine during pregnancy on the offspring's neuropsychological development up to 14 years of age. METHODS AND ANALYSIS: Thyroid healthy pregnant women (n=1275: age range 18-40 years) at ≤12 weeks gestation will be randomly assigned to receive multivitamin supplements containing 150 µg iodine or non-iodine-containing multivitamin daily throughout pregnancy. As a primary outcome, IQ will be measured in the offspring at 7 years (Wechsler Intelligence Scale for Children-V). As secondary outcomes, IQ will be measured at 3.5 and 14 years, psychomotor development at 18 months and 7 years, and behaviour at 3.5, 7 and 14 years. Iodine status (urinary iodine concentration) will be measured during pregnancy and in the offspring at 3.5, 7 and 14 years. Thyroid function (thyroid hormones, thyroglobulin), and deiodinase type 2 polymorphisms will be measured during pregnancy and in the offspring at 7 and 14 years. Structural MRI or other relevant structural or functional brain imaging procedures will be performed in a subgroup of children at 7 and 14 years. Background and socioeconomic information will be collected at all follow-up times. ETHICS AND DISSEMINATION: This study is approved by the Ethics Committee in Göteborg, Sweden (Diary numbers: 431-12 approved 18 June 2012 (pregnancy part) and 1089-16 approved 8 February 2017 (children follow-up)). According to Swedish regulations, dietary supplements are governed by the National Food Agency and not by the Medical Product Agency. Therefore, there is no requirement for a monitoring committee and the National Food Agency does not perform any audits of trial conduct. The trial will be conducted in accordance with the Declaration of Helsinki. The participating sites will be contacted regarding important protocol changes, both orally and in writing, and the trial registry database will be updated accordingly. Study results will be presented at relevant conferences, and submitted to peer-reviewed journals with open access in the fields of endocrinology, paediatrics and nutrition. After the appropriate embargo period, the results will be communicated to participants, healthcare professionals at the maternal healthcare centres, the public and other relevant groups, such as the national guideline group for thyroid and pregnancy and the National Food Agency. TRIAL REGISTRATION NUMBER: NCT02378246; Pre-results.

Iodine Status After Bariatric Surgery-a Prospective 10-Year Report from the Swedish Obese Subjects (SOS) Study.

CONTEXT: Bariatric surgery can lead to nutrient deficiencies. Gastric by-pass (GBP) entails restriction and malabsorption, whereas, vertical banded gastroplasty (VBG) is only restrictive. OBJECTIVE: The objective of this study is to study whether GBP-patients develop iodine deficiency from malabsorption, and if GBP- and VBG-patients develop lower 24-h urinary iodine excretion (24-UIE) than obese non-operated controls (OB-controls) due to lower iodine intake. DESIGN: The Swedish Obese Subjects (SOS) study is a prospective, non-randomized study of 4047 obese patients included 1987-2001, who chose bariatric surgery or non-surgical treatment. SOS-groups were compared at baseline, after 2 and 10 years and with population-based subsamples (MONICA-controls). PATIENTS: One hundred eighty-eight GBP-patients were matched with 188 VBG-patients and 188 OB-controls and with three subgroups from 412 MONICA-controls. MAIN OUTCOME MEASUREMENTS: Primary outcome was 24-UIE. Secondary outcomes were iodine intake, iodine supplementation, TSH, FT4, and thyroid morbidity. RESULTS: At baseline, median 24-UIE was higher in GBP-patients, VBG-patients and OB-controls than in MONICA-controls (214, 201, 203 and 137 µg/day, p < 0.001). At 10 years, 24-UIE in GBP-patients (161 µg/day) and VBG-patients (149 µg/day) was lower compared with baseline (p < 0.01) and OB-controls (189 µg/day, p < 0.01), but similar to 24-UIE in MONICA-controls (137 µg/day). The 10-year-dietary iodine intake was similar in GPB-patients and OB-controls, but higher in VBG-patients. Iodine supplementation was taken by 0-9% in SOS-groups. CONCLUSION: After surgery, GBP- and VBG-patients did not suffer from iodine deficiency, but both groups had lower iodine status than OB-controls. Dietary supplements recommended after bariatric surgery do not need to include iodine, in iodine sufficient countries. TRIAL REGISTRATION: clinicaltrials.gov : NCT01479452.

Prevalence of primary aldosteronism among patients with type 2 diabetes.

CONTEXT: Diabetes and hypertension coexist in 40%-60% of individuals with type 2 diabetes. The coexistence of these two conditions is associated with increased risk of retinopathy, nephropathy and cardiovascular disease. OBJECTIVE: To investigate the prevalence of primary aldosteronism (PA) in a general cohort of persons with type 2 diabetes. DESIGN: Cross-sectional study involving six diabetes outpatient clinics in Sweden. PATIENTS: were enrolled individuals with type 2 diabetes between February 2008 and December 2013. MEASUREMENTS: Plasma aldosterone concentrations (PAC pmol/L) and direct renin concentrations (DRC mIU/L) were measured. Patients with increased aldosterone renin ratios (ARR) >65 were further evaluated for PA. RESULTS: Of 578 consecutively screened patients with type 2 diabetes, 27 were treated with mineralocorticoid receptor antagonists (MRA) and potassium-sparing diuretics not further evaluated. Among the remaining 551 patients, 38 had increased ARR, including 22 who were clinically indicated for PA tests and 16 who were not further evaluated due to severe comorbidities and old age. There were five (0.93%) patients with confirmed PA after computerized tomography and adrenal venous sampling. Patients with PA had higher systolic blood pressure (P=.032) and lower potassium levels (P=.027) than those without PA. No significant association was found between plasma aldosterone and diabetic complications. CONCLUSIONS: The prevalence of PA in an unselected cohort of patients with type 2 diabetes is relatively low, and measures of plasma aldosterone are not strong risk factors for micro- and macrovascular diabetic complications.

Comparison Between the Montgomery-Asberg Depression Rating Scale-Self and the Beck Depression Inventory II in Primary Care.

OBJECTIVE: The Montgomery-Asberg Depression Rating Scale-Self (MADRS-S) and the Beck Depression Inventory II (BDI-II) are commonly used self-assessment instruments for screening and diagnosis of depression. The BDI-II has 21 items and the MADRS-S has 9 items. These instruments have been tested with psychiatric inpatients but not in outpatient primary care, where most patients with symptoms of depression initially seek treatment. The purpose of this study was to compare these 2 instruments in the primary care setting. METHOD: Data were collected from 2 primary care randomized controlled trials that were performed from 2010 to 2013 in Sweden: the Primary Care Self-Assessment MADRS-S Study and Primary Care Internet-Based Cognitive Behavioral Therapy Study. There were 146 patients (73 patients each from both trials) who had newly diagnosed mild or moderate depression (per DSM-IV recommendations) and who had assessment with both the MADRS-S and BDI-II at primary care centers. Comparability and reliability of the instruments were estimated by Pearson product moment correlation and Cronbach α. RESULTS: A good correlation was observed between the 2 instruments: 0.66 and 0.62 in the 2 study cohorts. The reliability within the 2 study cohorts was good for both MADRS-S (Cronbach α: 0.76 for both cohorts) and BDI-II items (Cronbach α: 0.88 and 0.85). CONCLUSIONS: The 2 instruments showed good comparability and reliability for low, middle, and high total depression scores. The MADRS-S may be used as a rapid, easily administered, and inexpensive tool in primary care and has results comparable to the BDI-II in all domains.

Quality of life and health care consumption in primary care patients with elevated serum calcium concentrations in - a prospective, case control, study.

BACKGROUND: Patients with elevated calcium concentrations have an increased morbidity due to various underlying illnesses. However, there is a lack of studies of quality of life and health care consumption in patients with hypercalcaemia per se. The study aims to investigate quality of life and health care consumption, as measured by, sick leave, drug prescriptions and the number of visits and admissions to health care centres and hospitals, in primary care patients with elevated calcium concentrations. METHODS: A prospective, case control, study in primary care centre, in Sweden. Patients with elevated, (n=127, 28 men), and normal calcium concentrations, (n=254, 56 men), mean age 61.4 year, were recruited in the study and followed during 10 years. Eighty-six percent of those alive at the time of follow up participated in a follow up visit. The study participants completed a quality of life survey, SF-36, which also were compared with the Swedish SF-36 national normative database. RESULTS: Patients with elevated calcium concentrations had significantly lower quality of life both compared with the control group (patients with normal calcium concentrations) and compared with age and gender-matched reference material from the Swedish SF-36 national normative database. The group with elevated calcium concentrations had significantly more hospitalisations (p=0.017), subsequently cancer diagnoses (p<0.003), sick leave (p=0.007) and medication (p=0.002) compared with patients with normal calcium concentrations. Men with elevated calcium concentrations had more contacts with the psychosocial team (p=0.02) at the health care centre. CONCLUSIONS: Elevated calcium concentrations are associated with significantly reduced quality of life and increased health care consumption and should therefore be an important warning flag that should alert the physician to further investigate and care for the patient. This is the first study in this field and the results need to be confirmed in further studies.

Evaluation of a tailored, multi-component intervention for implementation of evidence-based clinical practice guidelines in primary care physical therapy: a non-randomized controlled trial.

BACKGROUND: Clinical practice guidelines are important for transmitting research findings into practice and facilitating the application of evidence-based practice (EBP). There is a paucity of knowledge about the impact of guideline implementation strategies in primary care physical therapy. The aim of this study was to evaluate the effect of a guideline implementation intervention in primary care physical therapy in western Sweden. METHODS: An implementation strategy based on theory and current evidence was developed. A tailored, multi-component implementation intervention, addressing earlier identified determinants, was carried out in three areas comprising 28 physical therapy practices including 277 physical therapists (PTs) (intervention group). In two adjacent areas, 171 PTs at 32 practices received no intervention (control group). The core component of the intervention was an implementation seminar with group discussions. Among other components were a website and email reminders. Data were collected at baseline and follow-up with a web-based questionnaire. Primary outcomes were the self-reported awareness of, knowledge of, access to, and use of guidelines. Secondary outcomes were self-reported attitudes toward EBP and guidelines. Analyses were performed using Pearson's χ2 test and approximative z-test. RESULTS: 168 PTs (60.6%) in the intervention group and 88 PTs (51.5%) in the control group responded to the follow-up questionnaire. 186/277 PTs (67.1%) participated in the implementation seminars, of which 97 (52.2%) responded. The proportions of PTs reporting awareness of (absolute difference in change 20.6%, p = 0.023), knowledge where to find (20.4%, p = 0.007), access to (21.7%, p < 0.001), and frequent use of (9.5%, NS) guidelines increased more in the intervention group than in the control group. The proportion of PTs reporting frequent guideline use after participation in the implementation seminar was 15.2% (p = 0.043) higher than the proportion in the control group. A higher proportion considered EBP helpful in decision making (p = 0.018). There were no other significant differences in secondary outcomes. CONCLUSIONS: A tailored, theory- and evidence-informed, multi-component intervention for the implementation of clinical practice guidelines had a modest, positive effect on awareness of, knowledge of, access to, and use of guidelines, among PTs in primary care in western Sweden. In general, attitudes to EBP and guidelines were not affected.

Long-term follow-up of patients with elevated serum calcium concentrations in Swedish primary care.

OBJECTIVE: To follow up patients with elevated calcium concentrations after 10 years. DESIGN: Longitudinal, using medical records, questionnaires, and clinical investigation. SETTING: Primary care in Tibro, Sweden, 2008-2010. SUBJECTS: 127 patents with elevated calcium concentrations and 254 patients with normal calcium concentrations from the local community, attending the health care centre. MAIN OUTCOME MEASURES: Diagnoses and mortality in patients with elevated calcium concentrations in 1995-2000, compared with patients with normal calcium concentrations and the background population. RESULTS: The proportion of patients for whom no underlying cause was detected decreased from 55% at baseline to 12% at follow-up. Primary hyperparathyroidism was most common in women, 23% at baseline and 36% at follow-up, and the cancer prevalence increased from 5% to 12% in patients with elevated calcium concentration. Mortality tended to be higher in men with elevated calcium concentrations compared with men with normal calcium concentrations, and was significantly higher than in the background population (SMR 2.3, 95% CI 1.3-3.8). Cancer mortality was significantly increased in men (p = 0.039). Low calcium concentrations were also associated with higher mortality (p = 0.004), compared with patients with normal calcium concentrations. CONCLUSION: This study underscores the importance of investigating patients with increased calcium concentrations suggesting that most of these patients--88% in our study--will turn out to have an underlying disease associated with hypercalcaemia during a 10-year follow-up period. Elevated calcium concentrations had a different disease pattern in men and women, with men showing increased cancer mortality in this study.

No changes of cholesterol levels with a commercially available glucosamine product in patients treated with lipid lowering drugs: a controlled, randomised, open cross-over trial.

BACKGROUND: The widespread use of natural health products is also a problem, as they could interact with prescribed drugs in patients. One commonly used product is glucosamine for osteoarthritis and some reports have found increased values of cholesterol and other lipids in patients treated with simvastatin for hypercholesterolemia. The aim of this trial was to investigate the effects of glucosamine on s-cholesterol levels (total s-cholesterol, s-HDL, s-LDL) in primary care patients on treatment with simvastatin or atorvastatin. METHODS: Controlled, randomized, open, crossover pharmacodynamic study in two primary health care centres. Patients were treated with Artrox(®) (glucosamine) 625 mg twice daily and control (a commercially available multivitamin tablet Vitamineral(®)). The study started with a run-in period of four weeks followed by control or active treatment with randomization of sealed envelopes. Each treatment period was four weeks and the treatment with simvastatin or atorvastatin was unchanged during the study (12 weeks). 34 patients were treated with a stable dose of simvastatin (n=21) or atorvastatin (n=13) for at least three months. Assessments of total s-cholesterol, s-HDL, S-LDL and s-triglycerides were performed in the morning with the patients in a fasting condition. T-tests for paired samples were used for statistical analyses and a p-value <0.05 was considered significant. Endpoints were the differences in lipid values at week 8 and week 12. RESULTS: All patients completed the study. No significant changes were seen on any of lipid levels in the simvastatin group. CONCLUSION: The actual glucosamine product did not change lipid levels of patients treated with simvastatin. Atorvastatin group was too small for safe calculations but was also without changes. TRIAL REGISTRATION: EUDRACT2006-001458-28.