User Engagement, Acceptability, and Clinical Markers in a Digital Health Program for Nonalcoholic Fatty Liver Disease: Prospective, Single-Arm Feasibility Study.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) has become the most common chronic liver disease in the world. Common comorbidities are central obesity, type 2 diabetes mellitus, dyslipidemia, and metabolic syndrome. Cardiovascular disease is the most common cause of death among people with NAFLD, and lifestyle changes can improve health outcomes. OBJECTIVE: This study aims to explore the acceptability of a digital health program in terms of engagement, retention, and user satisfaction in addition to exploring changes in clinical outcomes, such as weight, cardiometabolic risk factors, and health-related quality of life. METHODS: We conducted a prospective, open-label, single-arm, 12-week study including 38 individuals with either a BMI >30, metabolic syndrome, or type 2 diabetes mellitus and NAFLD screened by FibroScan. An NAFLD-specific digital health program focused on disease education, lowering carbohydrates in the diet, food logging, increasing activity level, reducing stress, and healthy lifestyle coaching was offered to participants. The coach provided weekly feedback on food logs and other in-app activities and opportunities for participants to ask questions. The coaching was active throughout the 12-week intervention period. The primary outcome was feasibility and acceptability of the 12-week program, assessed through patient engagement, retention, and satisfaction with the program. Secondary outcomes included changes in weight, liver fat, body composition, and other cardiometabolic clinical parameters at baseline and 12 weeks. RESULTS: In total, 38 individuals were included in the study (median age 59.5, IQR 46.3-68.8 years; n=23, 61% female). Overall, 34 (89%) participants completed the program and 29 (76%) were active during the 12-week program period. The median satisfaction score was 6.3 (IQR 5.8-6.7) of 7. Mean weight loss was 3.5 (SD 3.7) kg (P<.001) or 3.2% (SD 3.4%), with a 2.2 (SD 2.7) kg reduction in fat mass (P<.001). Relative liver fat reduction was 19.4% (SD 23.9%). Systolic blood pressure was reduced by 6.0 (SD 13.5) mmHg (P=.009). The median reduction was 0.14 (IQR 0-0.47) mmol/L for triglyceride levels (P=.003), 3.2 (IQR 0.0-5.4) µU/ml for serum insulin (s-insulin) levels (P=.003), and 0.5 (IQR -0.7 to 3.8) mmol/mol for hemoglobin A1c (HbA1c) levels (P=.03). Participants who were highly engaged (ie, who used the app at least 5 days per week) had greater weight loss and liver fat reduction. CONCLUSIONS: The 12-week-long digital health program was feasible for individuals with NAFLD, receiving high user engagement, retention, and satisfaction. Improved liver-specific and cardiometabolic health was observed, and more engaged participants showed greater improvements. This digital health program could provide a new tool to improve health outcomes in people with NAFLD. TRIAL REGISTRATION: Clinicaltrials.gov NCT05426382; https://clinicaltrials.gov/study/NCT05426382.

CT doses based on clinical indications. New national DRL's in Iceland.

A diagnostic reference level (DRL) is an investigation level to use in the optimization of a medical exposure using ionizing radiation. The aim of this project was to gather dose data from computed tomography (CT) studies in Iceland with the purpose of updating existing national DRL and proposing DRLs based on clinical indications. Dose data (total dose length product (DLP) and CT dose index) were retrospectively collected from all CT scanners in Iceland for 50 patients for all common CT studies. After cleaning the data, the data set contained total DLP for 8129 patients. Considering dose-relevant parameters such as the number of phases and scan length, each CT study was assigned to one of 42 study types and (at least) one clinical indication. Data were received from seven or more scanners for 13 clinical indications and from all scanners providing coronary angiography. There was considerable variation in the median total DLP from different scanners, e.g., from 13 to 139 mGycm for Sinusitis, and, the range of individual total DLPs varied between scanners. This underscores the importance of monitoring patients' exposure. The study shows that there is room for optimization. New Icelandic NDRLs were proposed for the total DLP of CT examinations based on ten different indications, including: Brain ischemia (1060 mGycm), Interstitial lung disease (310 mGycm) and Appendicitis (690 mGycm). The proposed NDRLs were the first clinical indication based NDRLs in Iceland. The Icelandic Radiation Safety Authority has decided to update the NDRLs based on the results of this study.

[The relationship between lack of educational attainment, cardiovascular risk factors, atherosclerosis and coronary artery disease].

INTRODUCTION: Educational attainment is related to improved health and longevity. We investigated the relationship between educational attainment and cardiovascular risk factors, subclinical atherosclerosis, and incidence of coronary artery disease. MATERIAL AND METHODS: The Reykjavik REFINE study is a population-based study recruiting 6616 subjects, 25-69 years of age from the greater Reykjavik area in 2005-2011. Baseline measurements of cardiovascular risk factors were performed, and all participants had a carotid ultrasound examination to detect subclinical atherosclerotic lesions. Clinical follow-up of cardiovascular disease during a ten-year period was performed. Educational attainment was related to clinical outcome measures. RESULTS: The study population comprised of 3251 men and 3365 women. The proportion of the study population with primary school education only was 20.1%, 31.2% had vocational training, 12.3% had high school education and 36.4% were university graduates. Traditional cardiovascular risk factors were generally higher among subjects with primary school education only. Compared to subjects with university education, the odds ratio of having severe atherosclerotic plaque was 1.84 (95% CI 1.40-2.43) among those with primary school education only and 1.49 (95% CI 1.16-1.91) among subjects with vocational training. The subjects with high school or university education were less likely to develop significant cardiovascular disease during the 10-year follow-up period. CONCLUSION: Primary school and vocational training compared to university education are associated with risk factors of atherosclerotic disease, subclinical carotid plaque, and incidence of cardiovascular disease. The reason for this disparity remains to be clarified but socioeconomic inequality related to less educational attainment might be involved.

Carotid plaque is strongly associated with coronary artery calcium and predicts incident coronary heart disease in a population-based cohort.

BACKGROUND AND AIMS: Coronary artery calcium (CAC) and carotid plaque are markers of atherosclerosis and predict future coronary heart disease (CHD) events. The aim of this study was to investigate associations between CAC and carotid plaque in asymptomatic individuals, also in relation to predicted CHD-risk and incident events. A secondary aim was to compare predictive value between CAC, carotid plaque, and total carotid plaque area (TPA) as predictors for future CHD-events. METHODS: The REFINE-Reykjavik study is prospective and population-based with CAC-scoring and carotid plaque ultrasound assessment, both presence and area. A total of 948 individuals without clinical CHD were included in the study. CAC scores were categorized into 0,1-100,101-300 and > 300, and carotid plaque into none, minimal and significant. Three models were applied adjusted for age, sex, and each of the Framingham risk score (FRS), local CHD risk score and established CHD risk factors. RESULTS: Combined carotid plaque- and CAC-presence was highly prevalent, 69.5% for males and 41.7% for females (54.5% overall). TPA outperformed base models in CHD prediction, resulting in statistically significant area under the receiver operator characteristic curve (AUC) increase ranging from 0.02 to 0.05. Most CHD-events in females occurred in individuals classified as low-risk with respect to traditional risk factors but with a gradient in observed risk across carotid plaque categories. CONCLUSIONS: Carotid plaque was strongly associated with the presence and extent of CAC in asymptomatic individuals in a population-based cohort. Carotid plaque predicts incident CHD events over risk scores and may be useful for refined risk prediction in females.

Predictors of carotid plaque progression over a 4-year follow-up in the Reykjavik REFINE-study.

BACKGROUND AND AIMS: Carotid plaque is an arterial marker suggested as a surrogate end point for cardiovascular disease. The aim of this study was to examine the association of risk factors at visit 1 with plaque formation and progression of total plaque area (TPA) during follow-up. METHODS: We examined 1894 participants (50-69 years of age) in the population-based REFINE (Risk Evaluation For INfarct Estimates)-Reykjavik study. RESULTS: Among those with no plaque at baseline, plaque formation was associated with low density lipoprotein, sex, waist, former smoker and physical activity. Furthermore, both the Icelandic Heart Association (IHA) coronary heart disease (CHD) risk score and the atherosclerotic cardiovascular disease (ASCVD) risk score were highly associated with plaque formation in these individuals (p < 0.001) and a better cardiovascular health score was protective. In those with plaque present at baseline, metabolic syndrome was associated with increased risk, while older age and statin use were associated with reduced risk of new plaque formation. Statin use was the only factor associated with the relative TPA progression, where participants not on treatment had 5.7% (p=0.029) greater rate of progression compared with statin users. CONCLUSIONS: A number of conventional risk factors at visit 1 were individually associated with plaque formation, also when combined into CHD and ASCVD risk scores, but not with the relative progression in TPA. Medical intervention with statins can reduce the relative progression rate of TPA in the general population with low grade of atherosclerosis, supporting statin use to slow progression of atherosclerosis.

Prevalence and determinants of carotid plaque in the cross-sectional REFINE-Reykjavik study.

OBJECTIVE: Carotid plaque and intima-media thickness are non-invasive arterial markers that are used as surrogate end points for cardiovascular disease. The aim was to assess the prevalence and severity of carotid plaque, and examine its determinant risk factors and their association to the common carotid artery intima-media thickness (CCA-IMT) in a general population. METHODS: We examined 6524 participants aged 25-69 years in the population-based REFINE (Risk Evaluation For INfarct Estimates)-Reykjavik study. Plaques at the bifurcation and internal carotid arteries were evaluated. Mean CCA-IMT was measured in the near and far walls of the common carotid arteries. RESULTS: The prevalence of minimal, moderate and severe plaque was 35.0%, 8.9% and 1.1%, respectively, and the mean CCA-IMT was 0.73 (SD 0.14) mm. Age, sex, smoking and type 2 diabetes mellitus (T2DM) were the strongest risk factors associated with plaque, followed by systolic blood pressure, total cholesterol, body mass index and family history of myocardial infarct. Low educational level was also strongly and independently associated with plaque. CCA-IMT shared the same risk factors except for a non-significant association with T2DM and family history of myocardial infarction (MI). Participants with T2DM had greater plaque prevalence, 2-fold higher in those <50 years and 17-30% greater in age groups 50-54 to 60-64, and more significant plaques (moderate or severe) were the difference in prevalence was 24% in age group 50-54 and ≥60% in older age groups, compared with non-T2DM. CONCLUSIONS: Carotid plaque and CCA-IMT have mostly common determinants. However, T2DM and family history of MI were associated with plaque but not with CCA-IMT. Greater prevalence and more severe plaques in individuals with T2DM raise the concern that with increasing prevalence of T2DM we may expect an increase in atherosclerosis and its consequences.

Carotid atherosclerosis and cardiovascular health metrics in old subjects from the AGES-Reykjavik study.

BACKGROUND: Ideal cardiovascular (CV) health by simultaneous presence of 7 ideal health metrics (blood pressure, cholesterol, glucose, smoking, BMI, physical activity and diet) has been defined by the American Heart Association. In the current study we investigated the association of a CV health score (range 0-14), on the extent and progression of carotid atherosclerosis, assessed as carotid intima-media thickness (cIMT) and total plaque area (TPA) by ultrasound at 5 years interval. METHODS AND RESULTS: A total of 219 participants (age 75.6 ± 5.1) from the Age, Gene/Environment Susceptibility (AGES)-Reykjavik study were studied. Men with poor (low) CV health score had greater TPA than those with more optimal (high) score (61.5 (SD: 32.3), 44.4 (24.2) and 37.7 (23.2) mm(2) for those with CV health score ≤6, 7-9 and ≥10 respectively, p < 0.05). In linear analysis for men, log TPA was 0.088 mm(2) (SE: 0.040 p < 0.05) smaller for each additional point in the CV health score. CV health score was not associated with TPA in women, or cIMT in either sex. TPA increased in both sexes between visits. However, CV health score did not predict carotid atherosclerosis progression. CONCLUSIONS: CV health score is associated with TPA in older men but not in women. Men with poor CV health score at the baseline visit had more extensive carotid atherosclerosis than those with better CV health score, although it did not predict the progression of carotid atherosclerosis.