Intelligent digital tools for screening of brain connectivity and dementia risk estimation in people affected by mild cognitive impairment: the AI-Mind clinical study protocol.

More than 10 million Europeans show signs of mild cognitive impairment (MCI), a transitional stage between normal brain aging and dementia stage memory disorder. The path MCI takes can be divergent; while some maintain stability or even revert to cognitive norms, alarmingly, up to half of the cases progress to dementia within 5 years. Current diagnostic practice lacks the necessary screening tools to identify those at risk of progression. The European patient experience often involves a long journey from the initial signs of MCI to the eventual diagnosis of dementia. The trajectory is far from ideal. Here, we introduce the AI-Mind project, a pioneering initiative with an innovative approach to early risk assessment through the implementation of advanced artificial intelligence (AI) on multimodal data. The cutting-edge AI-based tools developed in the project aim not only to accelerate the diagnostic process but also to deliver highly accurate predictions regarding an individual's risk of developing dementia when prevention and intervention may still be possible. AI-Mind is a European Research and Innovation Action (RIA H2020-SC1-BHC-06-2020, No. 964220) financed between 2021 and 2026. First, the AI-Mind Connector identifies dysfunctional brain networks based on high-density magneto- and electroencephalography (M/EEG) recordings. Second, the AI-Mind Predictor predicts dementia risk using data from the Connector, enriched with computerized cognitive tests, genetic and protein biomarkers, as well as sociodemographic and clinical variables. AI-Mind is integrated within a network of major European initiatives, including The Virtual Brain, The Virtual Epileptic Patient, and EBRAINS AISBL service for sensitive data, HealthDataCloud, where big patient data are generated for advancing digital and virtual twin technology development. AI-Mind's innovation lies not only in its early prediction of dementia risk, but it also enables a virtual laboratory scenario for hypothesis-driven personalized intervention research. This article introduces the background of the AI-Mind project and its clinical study protocol, setting the stage for future scientific contributions.

BeyondSilos, a Telehealth-Enhanced Integrated Care Model in the Domiciliary Setting for Older Patients: Observational Prospective Cohort Study for Effectiveness and Cost-Effectiveness Assessments.

BACKGROUND: Information and communication technology may provide domiciliary care programs with continuity of care. However, evidence about the effectiveness and cost-effectiveness of information and communication technology in the context of integrated care models is relatively scarce. OBJECTIVE: The objective of our study was to provide evidence on the clinical effectiveness and cost-effectiveness of the BeyondSilos project for patients enrolled in the Badalona city pilot site in Spain. METHODS: A quasi-experimental study was used to assess the cost-effectiveness of information and communication technology-enhanced integration of health and social care, including the third sector (intervention), compared to basic health and social care coordination (comparator). The study was conducted in Badalona between 2015 and 2016. Participants were followed for 8 months. RESULTS: The study included 198 patients: 98 in the intervention group and 100 in the comparator group. The mean Barthel index remained unchanged in the intervention group (mean change 0.14, 95% CI -4.51 to 4.78; P=.95) but decreased in the comparator group (mean change -3.23, 95% CI -5.34 to -1.11; P=.003). Instrumental Activities of Daily Living significantly decreased in both groups: mean changes of -0.23 (95% CI -0.44 to -0.02; P=.03) and -0.33 (95% CI -0.46 to -0.20; P<.001) in the intervention and comparator groups, respectively. No differences were found in the Geriatric Depression Scale (intervention: mean change 0.28, 95% CI -0.44 to 1.01, P=.44; comparator: mean change -0.29, 95% CI -0.59 to 0.01, P=.06). The intervention showed cost-effectiveness (incremental cost-effectiveness ratio €6505.52, approximately US $7582). CONCLUSIONS: The information and communication technology-enhanced integrated domiciliary care program was cost-effective. The beneficial effects of this approach strongly rely upon the commitment of the professional staff involved. TRIAL REGISTRATION: ClinicalTrials.gov NCT03111004; http://clinicaltrials.gov/ct2/show/ NCT03111004.

Beliefs towards vaccination and trust in the scientific community in Italy.

BACKGROUND: In 2017 the Italian government introduced compulsory vaccination for Italian school children for ten diseases, in response to an alarmingly decrease in coverage and measles outbreak. A hot social debate arose around the issue of the law. Studies on the opinion of Italians on this topic are rare, so we investigated the socio-cultural profile of Italians about beliefs towards vaccination. METHODS: Data were extracted from the Italian section of the European Social Survey (ESS), conducted by the Italian National Institute for Public Policies Analysis during 2017. The main outcome assessed was the opinion about the supposed harmfulness of vaccines. We analysed the association between the outcome and a selected group of socio-cultural characteristics, with a specific interest in examining the interaction between our main outcome and the perceived trust in the scientific community in regards to vaccines. A principal component analysis was then performed for determining the socio-cultural profile of respondents. RESULTS: Among the 2,626 subjects interviewed face to face, 19% believed that vaccines were harmful and 10% did not have trust in the scientific community in regards to vaccines. Out of the respondents who believed in the harmfulness of vaccines, 29% neither had trust in the scientific community. Principal Component Analysis suggested that this group (Anti-vax/science sceptic) was characterised by low participation in political and cultural life, being male, older of age and politically oriented towards the right. People agreeing about harmfulness of vaccines are mostly males, have a lower education level, poor attendance in political and cultural life and are politically oriented to the right. CONCLUSIONS: The ESS survey is unique in its capacity to deal with emerging themes of the social debates. Results paint a picture of the opinions of Italians on vaccines. This profile may be useful for policymakers to design targeted vaccination campaigns and to intervene more efficaciously in the public debate.

Impact Assessment of an Innovative Integrated Care Model for Older Complex Patients with Multimorbidity: The CareWell Project.

OBJECTIVES: To evaluate the impact in terms of use of health services, clinical outcomes, functional status, and patient's satisfaction of an integrated care program, the CareWell program, for complex patients with multimorbidity, supported by information and communication technology platforms in six European regions. DATA SOURCES: Primary data were used and the follow-up period ranged between 8 and 12 months. STUDY DESIGN: A quasi-experimental study, targeting chronic patients aged 65 or older, with 2 or more conditions - one of them necessarily being diabetes, congestive heart failure or congestive obstructive pulmonary disease. The intervention group received the integrated care program and the control group received usual care. Generalized mixed regression models were used. DATA COLLECTION: Data were obtained from individual interviews and electronic clinical records. PRINCIPAL FINDINGS: Overall, 856 patients were recruited (475 intervention and 381 control). In the intervention group, the number of visits to emergency rooms was significantly lower, and the number of visits to the general practitioners and primary care nurses was higher than in the control group. CONCLUSION: The CareWell program resulted in improvements in the use of health services, strengthening the role of PC as the cornerstone of care provision for complex patients with multimorbidity.

Effect of socioeconomic position on patient outcome after hysterectomy.

OBJECTIVE: To investigate the association between socioeconomic position (assessed by education, employment and income) and complications following hysterectomy and assess the role of lifestyle, co-morbidity and clinical conditions on the relationship. DESIGN: Register-based cohort study. SETTING AND POPULATION: The study included nearly all Danish women (n = 22 150) registered with a benign elective hysterectomy in the Danish Hysterectomy Database in 2004-2008. METHODS: Data were analyzed using logistic regression models estimating the odds ratio with 95% confidence intervals. MAIN OUTCOME MEASURES: Complications following hysterectomy. RESULTS: Seventeen percent of the women experienced complications in relation to the hysterectomy. Women with less than high school education and unemployed women had higher odds of infection, complications and readmission than women with more than high school education and employed women. Furthermore, unemployed women had higher odds of hospitalization >4 days than women in employment. Lifestyle factors (smoking and body mass index) and co-morbidity status seemed to explain most of the social differences. However, an association between women with less than high school education and all complications remained unexplained. Furthermore, differences in lifestyle and co-morbidity status only partially explained the higher odds of infection, complications and hospitalization >4 days for unemployed than employed women. CONCLUSION: Women with a low socioeconomic position have significantly higher odds of complications following hysterectomy compared with women with a high socioeconomic position. Unhealthy lifestyle and presence of co-morbidity in women with low socioeconomic position partially explains the differences in complications.

The impact of socioeconomic and clinical factors on purchase of prescribed analgesics before and after hysterectomy on benign indication.

OBJECTIVE: Pelvic pain is a primary symptom of women referred for hysterectomy. This study identified risk factors for purchase of prescribed analgesics before and after hysterectomy and examined purchase changes after hysterectomy, specifically focusing on socioeconomic effects. METHODS: Nearly all Danish women (n=13,420) with a hysterectomy on benign indication between 2004 and 2006 were included in a registry-based follow-up study. Information on prescription analgesic purchase was from the Danish National Prescription Registry. Factors associated with a purchase and associations between socioeconomic factors and changes in analgesic purchase were assessed. RESULTS: Analgesic purchase after hysterectomy was independently predicted by age below 35 or above 65 years, body mass index >29.9, high American Society of Anesthesiologists (ASA) score, uterus weight <300 g, comorbidity, and less than high school education. In this study, 15% of women initiated or increased analgesic purchase after hysterectomy, whereas 50% with a purchase before hysterectomy ceased buying afterward. Women with low socioeconomic status (SES) (assessed by education, employment, and income) were more likely to increase purchase of analgesics than women with high SES (odds ratio for less than high school vs. more than high school=1.58; 95% confidence interval, 1.31-1.91) and less likely to cease use than women with high SES (odds ratio=0.67; confidence interval, 0.52-0.86 for low vs. high education). DISCUSSION: These results suggest that purchase of analgesics after hysterectomy is related to preoperative factors. Compared with women with high SES, women with low SES had less favorable changes in analgesic purchase after hysterectomy.

Socioeconomic factors may influence the surgical technique for benign hysterectomy.

INTRODUCTION: Owing to significantly improved outcomes, vaginal hysterectomy is the recommended standard approach when feasible in preference to abdominal hysterectomy. It is, however, not clear whether the use of vaginal hysterectomy varies with the women's socioeconomic background. MATERIAL AND METHODS: All 22,150 women registered in the Danish Hysterectomy Database in the 2004-2008-period were included in this cohort study and linked to central registers providing information on education, income and employment. Analyses were carried out using multiple logistic regression models. RESULTS: Among the 16,645 patients with information on all variables, 34% had a vaginal hysterectomy, while 60% had an abdominal and 6% a laparoscopic procedure. Women with a short education were more likely to undergo vaginal hysterectomy (30%) than women with a higher education (28%) (odds ratio (OR): 1.23; 95% confidence interval (CI): 1.10-1.38), but this association seemed to be fully explained by differences in surgery indication (OR: 0.99; CI: 0.87-1.13). Women out of work less often had a vaginal hysterectomy than women in work when adjusting for surgery indication (OR: 0.79; CI: 0.70-0.88). CONCLUSION: Small socioeconomic differences in surgical approach in hysterectomy were observed and were seemingly explained by clinical surgery indications, with the exception of women out of work for whom vaginal hysterectomy is used less often.

Use of vaginal hysterectomy in Denmark: rates, indications and patient characteristics.

OBJECTIVE: To describe the use of vaginal, abdominal and laparoscopic hysterectomy in Denmark from 1999 to 2008, the influence of national guidelines and the patient and procedure-related characteristics associated with the choice of vaginal hysterectomy. Design. Nationwide register-based cohort study. SETTING: Danish Hysterectomy Database and Danish National Patient Registry. POPULATION: All women with a hysterectomy for benign indications in Denmark from 1999 to 2008. METHODS: The incidence rate/100,000 women was used to describe the route of surgery in hysterectomies of 50,755 women. A multiple logistic regression analysis was done to examine the association between patient- and procedure-related characteristics and choice of surgical procedure including 20,486 women. MAIN OUTCOME MEASURES: Trends in surgical approach from 1999 to 2008. Patient- and surgery-related characteristics associated with vaginal hysterectomy from 2004 to 2008. RESULTS: There was an overall increase in the use of vaginal hysterectomies from 12 to 34%, a decrease in the use of abdominal hysterectomies and a consistent number of laparoscopic hysterectomies. The number of vaginal hysterectomies varied between regions, ranging from 2 to 86%. The use of vaginal hysterectomy was not dependent on the total number of hysterectomies performed at the hospital. The characteristics associated with vaginal hysterectomy were higher age, smaller uterus size, indications for surgery (genital prolapse and severe uterine bleeding), less smoking and moderate alcohol intake. CONCLUSIONS: Vaginal hysterectomy has replaced abdominal hysterectomy increasingly but cannot be directly correlated to the implementation of national guidelines as there was large national variation. Several characteristics are significantly associated with vaginal hysterectomy.

Body mass and risk of complications after hysterectomy on benign indications.

BACKGROUND: This study examines BMI in relation to risk of complications after hysterectomy on benign indications, and explores whether any associations vary by route of surgery. METHODS: In this cohort study, we included data on health and lifestyle collected prospectively for all hysterectomy referrals for benign indications in Denmark from 2004 to 2009. Logistic regression was used to investigate relationship between BMI and complications reported at surgery or during the first 30 days after surgery. RESULTS; Of the 20 353 women with complete data, 6.0% had a BMI < 20 kg/m(2), 31.9% with BMI between 25 and 30 kg/m(2) (classified as overweight) and 17.5% with a BMI ≥ 30 kg/m(2) (categorized as obese). The overall rate of complications was 17.6%, with bleeding being the most common specific complication (6.8%). After adjustment for age, ethnicity, education, indication for surgery, uterus weight, use of prophylaxis, American Society of Anaesthesiologists classification, co-morbidity status and route of hysterectomy, obesity was associated with an increased risk of heavy bleeding during surgery [odds ratio (OR) = 3.64 (2.90-4.56)], all bleeding complications [OR = 1.27 (1.08-1.48)] and infection [OR = 1.47 (1.23-1.77)]. The risk of all bleeding complications [OR = 1.48 (1.28-1.82)] and re-operation [OR = 1.66 (1.26-2.17)] were also increased among women with a BMI < 20. This U-shaped relation between BMI and bleeding, and the association between high BMI and infections were only seen for the abdominal route [abdominal hysterectomy (AH)]. The risk of infections was elevated among women with BMI<20 who underwent laparoscopic surgery [laparoscopic hysterectomy (LH)]. CONCLUSIONS; Obesity increases the risks of bleeding and infections after AH. A BMI below 20 seems to increase the risks of bleeding and infection after AH and LH, respectively.

Hospital variation in 30-day mortality after colorectal cancer surgery in denmark: the contribution of hospital volume and patient characteristics.

OBJECTIVE: This study examines variation between hospitals in 30-day mortality after surgery for colorectal cancer (CRC) in Denmark and explores whether hospital volume and patient characteristics contribute to any variation between hospitals. BACKGROUND: Little is known about the variation between hospitals in 30-day mortality after CRC surgery, and the impact of treatment and patient characteristics that might contribute to such variation. METHODS: Hospital variation was quantified using a multilevel approach on data derived from a nationwide database of all adenocarcinomas of colon and rectum diagnosed in Denmark in 2001 to 2004. These data were linked to several central registers providing information on patient's socioeconomic status, comorbidity, and use of medication. In total 11,287 patients, who underwent surgery at any of the 43 surgical departments were included. RESULTS: Hospitals varied from 3.5% to 44.1% in 30-day mortality after emergency colon cancer surgery, and the multilevel analysis showed that emergency patients were 5 times [odd ratio (OR) = 4.6)] as likely to die within 30 days in hospitals with the worst performance compared to those with the best performance. The American Society of Anesthesiologists (ASA) score increased the variation between hospitals (OR = 5.8), whereas the other potential explanatory variables had no effect on the variation. For patients who had elective surgery for colon and rectal cancer the variation in 30-day mortality between hospitals was small and nonsignificant. CONCLUSION: Hospital variation in 30-day mortality after CRC surgery are due to differences in hospitals' ability to take care of emergency patients, especially those with high ASA scores.

Promotion of physical activity in the European region: content analysis of 27 national policy documents.

BACKGROUND: Over the past years there has been increasing interest in physical activity promotion and the development of appropriate policy. So far, there has been no comprehensive overview of the activities taking place in Europe in this area of public health policy. METHODS: Using different search methods, 49 national policy documents on physical activity promotion were identified. An analysis grid covering key features was developed for the analysis of the 27 documents published in English. RESULTS: Analysis showed that many general recommendations for policy developments are being followed, for example: general goals were formulated, an implementation plan was included, a timeframe and a responsible body for the implementation was often specified. However, limited evidence for intersectoral collaboration was found. Quantified goals for physical activity were the exception. Population groups most in need such as people with low levels of physical activity were rarely specifically targeted. Most policies emphasized the importance of an evaluation. However, only about half of them indicated a related intention or requirement. CONCLUSION: In recent years there has been a noticeable development of national policy documents on physical activity promotion. Following principles for policy development more closely could increase the effectiveness of their preparation and implementation further.

Establishment of a national Danish hysterectomy database: preliminary report on the first 13,425 hysterectomies.

OBJECTIVE: To describe the concept and early results from the Danish Hysterectomy Database (DHD). DESIGN: Nationwide prospective cohort. SETTING: Denmark. POPULATION: All women who had undergone an elective hysterectomy for benign indication carried out in 2004-2006. METHODS: Structured data are registered prospectively by the surgeons involved in the treatment. Data is reported using the Danish National Patient Registry (LPR) and feedback is provided as clinical indicators with well-defined goals. The DHD concept includes annual plenary meetings, elaboration of national clinical guidelines and parallel causal studies. MAIN OUTCOME MEASURES: Completeness, data validation and department-identifiable clinical indicators (surgical volume, method of hysterectomy, use of antibiotic and thromboembolic prophylaxis, postoperative hospitalization and bleeding complications, surgical infections, reoperations, readmissions and death within 30 days postoperatively). RESULTS: A total of 13,425 hysterectomies were performed in Denmark from 2004 to 2006. In 2005, all gynecological departments in Denmark (n=31) were included in the database collaboration and the national response rate was 99%. Data validity was good in general (82-100% agreement and kappa=0.40-1.00) and data completeness was high (92-100% in 2006). From 2004 to 2006, two clinical guidelines were implemented, the postoperative hospitalization was stable at median 2 days, the rate of postoperative surgical infections was reduced from 4 to 2%, the rate of bleeding complications from 8 to 6%, the reoperation rate from 5 to 4%, and the readmission rate from 7 to 5%. CONCLUSIONS: Clinical performance indicators, audit meetings and nationwide collaboration are useful in monitoring and improving outcome after hysterectomy on a national level. In addition, the DHD offers scope for causal studies about perioperative management.