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1.
Am J Clin Nutr ; 119(4): 990-1006, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38569789

ABSTRACT

BACKGROUND: Consumption of sugar-sweetened beverages (SSBs) has been linked to several adverse health outcomes, thus many countries introduced taxation to reduce it. OBJECTIVES: To summarize national SSB taxation laws and to assess their association with obesity, overweight and diabetes. METHODS: We conducted a systematic scoping review up to January 2022 on PubMed, Web of Science, Embase, and Google Search to identify taxes on SSBs. An interrupted time series analysis (ITSA) was conducted on 17 countries with taxation implemented in 2013 or before to evaluate the level and slope modifications in the rate of change of standardized prevalence rates of overweight, obesity, and diabetes. Random-effects meta-regression was used to assess whether year of entry into force of the law, national income, and tax design affected observed results. RESULTS: We included 76 tax laws issued between 1940 and 2020 by 43 countries, which were heterogeneous in terms of tax design, amount, and taxed products. Among children and adolescents, ITSA showed level or slope reduction for prevalence of overweight and obesity in 5 (Brazil, Samoa, Palau, Panama, Tonga) and 6 (El Salvador, Uruguay, Nauru, Norway, Palau, Tonga) countries out of 17, respectively. No clear pattern of modification of results according to investigated factors emerged from the meta-regression analysis. CONCLUSIONS: Taxation is highly heterogeneous across countries in terms of products and design, which might influence its effectiveness. Our findings provide some evidence regarding a deceleration of the increasing prevalence rates of overweight and obesity among children occurring in some countries following introduction of taxation. PROSPERO registration number: CRD42021233309.


Subject(s)
Diabetes Mellitus , Sugar-Sweetened Beverages , Adolescent , Child , Humans , Overweight/epidemiology , Sugar-Sweetened Beverages/adverse effects , Obesity/epidemiology , Obesity/etiology , Taxes , Beverages/adverse effects
2.
J Epidemiol Community Health ; 78(6): 388-394, 2024 May 09.
Article in English | MEDLINE | ID: mdl-38485217

ABSTRACT

BACKGROUND: Evidence on the association between smoke-free policies and per-capita cigarette consumption and mortality due to acute myocardial infarction (AMI) in Europe is limited. Hence, we aimed to assess this association and to evaluate which factors influence it. METHODS: We performed an interrupted time series analysis, including 27 member states of the European Union and the UK, on per-capita cigarette consumption and AMI mortality.A multivariate meta-regression was used to assess the potential influence of other factors on the observed associations. RESULTS: Around half of the smoke-free policies introduced were associated with a level or slope change, or both, of per-capita cigarette consumption and AMI mortality (17 of 35). As for cigarette consumption, the strongest level reduction was observed for the smoking ban issued in 2010 in Poland (rate ratio (RR): 0.47; 95% CI: 0.41, 0.53). Instead, the largest level reduction of AMI mortality was observed for the intervention introduced in 2012 in Bulgaria (RR: 0.38; 95% CI: 0.34, 0.42).Policies issued more recently or by countries with a lower human development index were found to be associated with a larger decrease in per-capita cigarette consumption. In addition, smoking bans applying to bars had a stronger inverse association with both cigarette consumption and AMI mortality. CONCLUSIONS: The results of our study suggest that smoke-free policies are effective at reducing per-capita cigarette consumption and AMI mortality. It is extremely important to monitor and register data on tobacco, its prevalence and consumption to be able to tackle its health effects with concerted efforts.


Subject(s)
Myocardial Infarction , Smoke-Free Policy , Humans , Myocardial Infarction/mortality , Europe/epidemiology , Interrupted Time Series Analysis , Smoking/epidemiology , Smoking/mortality , Male , Female , Tobacco Smoke Pollution/adverse effects , Tobacco Smoke Pollution/prevention & control
3.
EClinicalMedicine ; 71: 102551, 2024 May.
Article in English | MEDLINE | ID: mdl-38533128

ABSTRACT

Background: To receive the best care, people share their health data (HD) with their health practitioners (known as sharing HD for primary purposes). However, during the past two decades, sharing for other (i.e., secondary) purposes has become of great importance in numerous fields, including public health, personalized medicine, research, and development. We aimed to conduct the first comprehensive overview of all studies that investigated people's HD sharing attitudes-along with associated barriers/motivators and significant influencing factors-for all data types and across both primary and secondary uses. Methods: We searched PubMed, MEDLINE, PsycINFO, Web of Science, EMBASE, and CINAHL for relevant studies published in English between database inception and February 28, 2023, using a predefined set of keywords. Studies were included, regardless of their design, if they reported outcomes related to attitudes towards sharing HD. We extracted key data from the included studies, including the type of HD involved and findings related to: HD sharing attitudes (either in general or depending on type of data/user); barriers/motivators/benefits/concerns of the study participants; and sociodemographic and other variables that could impact HD sharing behaviour. The qualitative synthesis was conducted by dividing the studies according to the data type (resulting in five subgroups) as well as the purpose the data sharing was focused on (primary, secondary or both). The Newcastle-Ottawa Scale (NOS) was used to assess the quality of non-randomised studies. This work was registered with PROSPERO, CRD42023413822. Findings: Of 2109 studies identified through our search, 116 were included in the qualitative synthesis, yielding a total of 228,501 participants and various types of HD represented: person-generated HD (n = 17 studies and 10,771 participants), personal HD in general (n = 69 studies and 117,054 participants), Biobank data (n = 7 studies and 27,073 participants), genomic data (n = 13 studies and 54,716 participants), and miscellaneous data (n = 10 studies and 18,887 participants). The majority of studies had a moderate level of quality (83 [71.6%] of 116 studies), but varying levels of quality were observed across the included studies. Overall, studies suggest that sharing intentions for primary purposes were observed to be high regardless of data type, and it was higher than sharing intentions for secondary purposes. Sharing for secondary purposes yielded variable findings, where both the highest and the lowest intention rates were observed in the case of studies that explored sharing biobank data (98% and 10%, respectively). Several influencing factors on sharing intentions were identified, such as the type of data recipient, data, consent. Further, concerns related to data sharing that were found to be mutual for all data types included privacy, security, and data access/control, while the perceived benefits included those related to improvements in healthcare. Findings regarding attitudes towards sharing varied significantly across sociodemographic factors and depended on data type and type of use. In most cases, these findings were derived from single studies and therefore warrant confirmations from additional studies. Interpretation: Sharing health data is a complex issue that is influenced by various factors (the type of health data, the intended use, the data recipient, among others) and these insights could be used to overcome barriers, address people's concerns, and focus on spreading awareness about the data sharing process and benefits. Funding: None.

4.
Syst Rev ; 13(1): 84, 2024 Mar 09.
Article in English | MEDLINE | ID: mdl-38461297

ABSTRACT

OBJECTIVE: Sudden cardiac death (SCD) is a rare and yet unexplained condition. The most frequent cause is myocardial infarction, while a small proportion is due to arrhythmogenic syndromes (e.g., channelopathies). This systematic review and meta-analysis aimed to provide a comprehensive overview of the prevalence and risk factors associated with SCD in workers. MATERIAL AND METHODS: A search for eligible studies was performed utilizing three databases (PubMed, ISI Web of Knowledge, and Scopus). The inclusion criteria were fulfilled if sudden cardiac death due to channelopathy in workers was mentioned. RESULTS: Out of the 1408 articles found across three databases, 6 articles were included in the systematic review but the meta-analysis was conducted on 3 studies The total sample included was 23,450 participants. The pooled prevalence of channelopathies in employees was 0.3% (95% CI 0.07-0.43%), of sudden cardiac death in employees was 2.8% (95% CI 0.37-5.20%), and of sudden cardiac death in employees with a diagnosis of cardiac channelopathies was 0.2% (95% CI 0.02- 0.30%). CONCLUSIONS: SCD is a serious and potentially preventable condition that can occur among workers. By identifying and addressing work-related risk factors, providing appropriate screening and interventions, and promoting healthy lifestyle behaviors, we can work to reduce the incidence of SCD and improve the cardiovascular health and well-being of workers.


Subject(s)
Channelopathies , Myocardial Infarction , Humans , Channelopathies/complications , Death, Sudden, Cardiac/epidemiology , Death, Sudden, Cardiac/etiology , Death, Sudden, Cardiac/prevention & control , Risk Factors , Myocardial Infarction/complications , Incidence
5.
EClinicalMedicine ; 69: 102450, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38333363

ABSTRACT

Large seasonal outbreaks of bronchiolitis put pressure on healthcare systems and particularly on intensive care units (ICUs). ICU admission is necessary to provide respiratory support to the severest cases, otherwise bronchiolitis can result in substantial mortality. ICU resources are often insufficient and there is scant evidence to guide the ICU clinical management. Most available studies do not cover the ICU-admitted cases and do not consider the associated public health issues. We review this topic through a multidisciplinary approach from both the clinical and public health perspectives, with an analysis based on pathophysiology and cost-effectiveness. We suggest ways to optimise respiratory care, minimise ICU stay, "protect" ICU beds and, whenever possible, make them available for other critically ill children. We also provide guidance on how to prepare ICUs to work under stressful conditions due to outbreaks and to reduce the risk of nosocomial cross-contamination, particularly in ICUs caring for high-risk children. Funding: None.

6.
BMC Public Health ; 24(1): 464, 2024 Feb 14.
Article in English | MEDLINE | ID: mdl-38355452

ABSTRACT

BACKGROUND: The advent of Personalized Medicine (PM) holds significant promise in revolutionizing healthcare by tailoring treatments to individual patients based on their data. However, its successful implementation requires the seamless integration of innovative technologies and presents formidable challenges in terms of sustainability. To tackle these challenges head-on, the International Consortium for Personalized Medicine (ICPerMed) was established, and the IC2PerMed project, as part of this consortium, seeks to foster collaboration between the European Union (EU) and China in the field of Personalized Medicine. Based on the results collected by the project, the objective of this study is to discern the key priorities for the implementation of Personalised Medicine concerning Information and Communication Technologies (ICT) and Big Data and digital solutions, with a particular emphasis on data management and protection. METHODS: A Delphi survey was conducted to gather expert's consensus on the main priorities for actions on Information and Communication Technologies (ICT) and Big Data and digital solutions in the field of Personalized Medicine. RESULTS: The survey identified seven priorities in the area of Big Data and digital solutions, including data interoperability, standards, security measures, and international partnerships. Additionally, twelve priorities were identified for the innovation-to-market process, emphasizing cost-effectiveness, need assessment, and value definition in resource allocation. CONCLUSIONS: The effective implementation of new technologies in Personalized Medicine research and practice is essential for the advancement of healthcare systems in both the European and Chinese contexts. The identified priorities play a pivotal role in promoting the sustainability of health systems and driving innovation in the implementation of Personalized Medicine. Addressing challenges related to data interoperability, standards, security, international collaboration, cost-effectiveness, and value assessment is of utmost importance in order to propel the progress of Personalized Medicine in healthcare systems.


Subject(s)
Delivery of Health Care , Precision Medicine , Humans , European Union , China
7.
HERD ; 17(2): 24-37, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38259242

ABSTRACT

OBJECTIVES: A working group conducted a survey on the use of the principle of buffer space (BS), which in case of emergencies, could benefit healthcare settings. The aim of the preliminary investigation is to define new research lines in hospitals' functional design. BACKGROUND: The global experience of the COVID-19 pandemic highlighted challenges faced by hospitals when responding promptly to emergencies, including spatial reorganization and suspension of ordinary medical activities for ensuring adequate management of the emergency surge of patients. METHODS: The group designed questionnaires to be administered to healthcare staff and healthcare designers aimed at understanding varied conceptions and features of BSs. Content across the two surveys overlapped significantly, allowing for direct comparisons of responses, while also including tailored questions in relation to the respective experience and skills of the two groups of respondents. RESULTS: 102 healthcare professionals and 56 designers took part to the survey. Analysis of the responses permitted for initial recommendations regarding BS typology including (a) proximity to the emergency department (ED), intensive care units (ICUs), and inpatient wards (IWs); (b) location within hospitals but separate from other medical areas; (c) need for independent access; (d) organizational and spatial features similar to ED, ICUs, and IWs; (e) existing as a fully flexible operational space; and (f) BS bed capacity to be approximately 12% of ED beds. CONCLUSIONS: Although the analysis is related to the Italian context, the expansion of this preliminary research to alternate healthcare facilities and geographic areas is necessary for reaching a wide consensus by different professionals on this field. It serves as a starting point for future investigations regarding the implementation of BS in hospital settings.


Subject(s)
COVID-19 , Hospital Design and Construction , Humans , COVID-19/epidemiology , Hospital Design and Construction/methods , Surveys and Questionnaires , SARS-CoV-2 , Emergency Service, Hospital/organization & administration , Pandemics
8.
Article in English | MEDLINE | ID: mdl-38225891

ABSTRACT

The COVID-19 pandemic revealed major failings in many countries. We argue that one of the reasons, at global, national, and local levels, was that those involved were working in silos, unable to bring together the many diverse perspectives needed to respond to this complex problem. This is despite a growing recognition of the importance of adopting a Health For All Policies approach. Silo working, and the problems it creates, are not unique to health policy so there are opportunities to learn from those organisations that have tackled this issue.

9.
BMJ Open ; 14(1): e076739, 2024 01 04.
Article in English | MEDLINE | ID: mdl-38176866

ABSTRACT

INTRODUCTION: Surgical site infections still remain a major public health challenge and have become an increasing universal risk, especially for the implantation of orthopaedic devices.Unfortunately, the discovery and increasingly widespread use (especially the misuse) of antibiotics have led to the rapid appearance of antibiotic-resistant strains today; more and more infections are caused by microorganisms that fail to respond to conventional treatments.Oxygen-ozone therapy has been extensively used and studied for decades across various potential medical applications and has provided consistent effects with minimal side effects.This study aims to determine the superiority of oxygen-ozone therapy in combination with oral antibiotic therapy in patients with wound infections after an orthopaedic device implantation when compared with antibiotic therapy alone. METHODS AND ANALYSIS: This is an open-label, multicentre, randomised, parallel-group study that aims to assess the efficacy and safety of oxygen-ozone therapy in combination with oral antibiotic therapy to treat infections in patients (male or female aged ≥18 years) having undergone surgery for the implant of an orthopaedic device. Patients must have at least one (but no more than three) postoperative wounds in the site of surgery (ulcers, eschars and sores) and at least one symptom (pain, burning, redness and malodour) and at least one sign (erythema, local warmth, swelling and purulent secretion) of infection of at least moderate intensity (score ≥2) in the target lesion at the screening visit (patients with wounds without signs of localised infection or with undermining wounds will be excluded).Patients (n=186) will be recruited from five Italian hospitals and studied for 7 weeks. All will be assigned to one of the two treatment groups according to a web-based, centralised randomisation procedure and placed into either the (1) intervention: oxygen-ozone therapy 2-3 times a week for 6 weeks (for a maximum of 15 sessions) simultaneously with an appropriate oral antibiotic therapy prescribed at baseline or (2) control: oral antibiotic therapy prescribed at baseline.The primary outcome is the efficacy and superiority of the treatment (ozone and oral antibiotic therapies); secondary outcomes include the resolution of signs and symptoms, modifications in lesion size and the treatment's safety and tolerability. ETHICS AND DISSEMINATION: This study has been reviewed and approved by the responsible Independent Ethics Committee (IEC) of COMITATO ETICO CAMPANIA NORD, located at 'Azienda Ospedaliera San Giuseppe Moscati di Avellino'.After completion of the study, the project coordinator will prepare a draft manuscript containing the final results of the study on the basis of the statistical analysis. The manuscript will be derived by the co-authors for comments, and after revision, it will be sent to a major scientific journal. Findings will be disseminated via online and print media, events and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04787575.


Subject(s)
Oxygen , Ozone , Adolescent , Adult , Female , Humans , Male , Anti-Bacterial Agents , Arthroplasty , Multicenter Studies as Topic , Ozone/therapeutic use , Randomized Controlled Trials as Topic , Surgical Wound Infection/drug therapy , Surgical Wound Infection/prevention & control , Treatment Outcome , Equivalence Trials as Topic
10.
Public Health Genomics ; 27(1): 1-11, 2024.
Article in English | MEDLINE | ID: mdl-38061342

ABSTRACT

INTRODUCTION: Over the last decade, the emergence and spread of personalized medicine (PM) have defined a substantial revolution in healthcare. In principle, healthcare system sustainability is challenged by the investments required for research and development, as well as the adoption of PM techniques in routine clinical care. The "Integrating China in the International Consortium for Personalized Medicine" (IC2PerMed) EU-funded project aims to integrate China into the "International Consortium for Personalized Medicine" (ICPerMed). IC2PerMed aims to align the EU and China's research agendas in this field to enable a swift development of approaches in the EU and China with strong leverage upon EU-Chinese collaborations. METHODS: Within this project, we first mapped relevant policies on PM in both the EU and China, and then we involved European and Chinese experts in PM in workshops and Delphi surveys in order to identify relevant priorities for the implementation of PM in sustainable healthcare. RESULTS: As a result of this process, we identified nine overarching priorities, each addressing specific aspects of the sustainability of healthcare systems and PM implementation, with the main goal of supporting policymakers in integrating PM approaches in the EU and China. DISCUSSION/CONCLUSION: The implementation of PM in health systems is appealing in terms of improved accuracy in diagnostics, treatment, and prevention of disease, as well as reduction of the side effects resulting from inefficient use of drugs. Research, development, and implementation of needed techniques require time and resources that can slow the adoption of PM in healthcare systems. The nine priorities we identified address some of the most critical points, trying to lay the foundations for a comprehensive approach.


Subject(s)
Delivery of Health Care , Precision Medicine , Humans , China
14.
Acta Biomed ; 94(S3): e2023158, 2023 08 30.
Article in English | MEDLINE | ID: mdl-37695187

ABSTRACT

BACKGROUND AND AIM: The Decree of the President of the Italian Republic 14/01/1997 is the reference norm related to the accreditation of public and private healthcare structures. This guideline establishes the minimum structural, technological and organizational requirements that each structure operating in the Italian territory must comply with. METHODS: In occasion of the project work for the postgraduate training course in healthcare management by ALTEMS School, a team of researchers conducted a survey on the state of updating of the minimum structural requirements indicated in the norm-in particular those relating to hospital facilities- with those adopted by the individual regions through the analysis of the most up-to-date regional regulations. RESULTS: Precisely starting from the comparison of regional references and from the regulations on the subject of structural accreditation which suggest strategic environmental units and which address some key-aspects relating to the contemporary design of healing environments (i.e. semi-intensive care units, hybrid operating theatres, etc.), the outcome of the project work is to define a proposal to update the national reference document, also in the light of the currently changing needs in terms of hospital design. CONCLUSIONS: The research aims to become a starting milestone for future investigations. The team investigated - in this first phase - the functional areas listed in the norm, and the next step aims to extend the analysis also to the innovative functions (i.e. buffer spaces, hybrid operating theatres, sub-intensive care units, etc.) and/or introduced only the last years which have only been regulated in some regions.


Subject(s)
Health Facilities , Hospital Design and Construction , Humans , Hospitals , Intensive Care Units , Accreditation
15.
Ann Ist Super Sanita ; 59(3): 199-203, 2023.
Article in English | MEDLINE | ID: mdl-37712237

ABSTRACT

BACKGROUND: The presence in Italy of a significant foreign population (5-6 million including both formally residents and not officially registered ones) introduces significant transformations in the Italian demography with important challenges on ensuring fundamental rights including work, education and above all, health. Access to healthcare. Issues common to the entire migrant population concern the difficulty of accessing the health system of the host country due to the lack of knowledge of its rules and its functioning, the linguistic and cultural barriers and the distrust towards a system that is not recognized as his own, as well as the difficulties and misunderstandings encountered in the relationship with health professionals. Religion, culture and gender may even increase these difficulties. Conlusion and future perspective. Culture and religion should be taken into account when designing and implementing healthcare services and healthcare workers need to be trained in acknowledging these challenges. The National Health Service should become more sensitive to the increasing cultural and religious pluralism of patients starting with investing more in the training of health professionals.


Subject(s)
State Medicine , Transients and Migrants , Humans , Italy , Delivery of Health Care , Religion , Culture
16.
BMJ Lead ; 2023 Sep 14.
Article in English | MEDLINE | ID: mdl-37709494

ABSTRACT

The COVID-19 pandemic has put a lot of pressure on all the world's health systems and public health leaders who have often found themselves unprepared to handle an emergency of this magnitude. This study aims to bring together published evidence on the qualities required to leaders to deal with a public health issue like the COVID-19 pandemic. This scoping literature review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. A search of relevant articles was performed in the PubMed, Scopus and Web of Science databases. A total of 2499 records were screened, and 45 articles were included, from which 93 characteristics of effective leadership were extrapolated and grouped into 6 clusters. The qualities most frequently reported in the articles were human traits and emotional intelligence (46.7%) and communication skills such as transparency and reliability (48.9%). Responsiveness and preparedness (40%), management skills (33.3%) and team working (35.6%) are considered by a significant percentage of the articles as necessary for the construction of rapid and effective measures in response to the emergency. A considerable proportion of articles also highlighted the need for leaders capable of making evidence-based decisions and driving innovation (31.1%). Although identifying leaders who possess all the skills described in this study appears complex, determining the key characteristics of effective public health leadership in a crisis, such as the COVID-19 pandemic, is useful not only in selecting future leaders but also in implementing training and education programmes for the public health workforce.

17.
Health Policy ; 136: 104878, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37611521

ABSTRACT

We assessed challenges that the COVID-19 pandemic presented for mental health systems and the responses to these challenges in 14 countries in Europe and North America. Experts from each country filled out a structured questionnaire with closed- and open-ended questions between January and June 2021. We conducted thematic analysis to investigate the qualitative responses to open-ended questions, and we summarized the responses to closed-ended survey items on changes in telemental health policies and regulations. Findings revealed that many countries grappled with the rising demand for mental health services against a backdrop of mental health provider shortages and challenges responding to workforce stress and burnout. All countries in our sample implemented new policies or initiatives to strengthen mental health service delivery - with more than two-thirds investing to bolster their specialized mental health care sector. There was a universal shift to telehealth to deliver a larger portion of mental health services in all 14 countries, which was facilitated by changes in national regulations and policies; 11 of the 14 participating countries relaxed regulations and 10 of 14 countries made changes to reimbursement policies to facilitate telemental health care. These findings provide a first step to assess the long-term challenges and re-organizational effect of the COVID-19 pandemic on mental health systems in Europe and North America.


Subject(s)
COVID-19 , Humans , Mental Health , Pandemics , Health Policy , North America/epidemiology
18.
Front Public Health ; 11: 1147210, 2023.
Article in English | MEDLINE | ID: mdl-37404277

ABSTRACT

Background and objective: The capacity to promote and disseminate the best evidence-based practices in terms of digital health innovations and technologies represents an important goal for countries and governments. To support the digital health maturity across countries the Global Digital Health Partnership (GDHP) was established in 2019. The mission of the GDHP is to facilitate global collaboration and knowledge-sharing in the design of digital health services, through the administration of surveys and white papers. Objective: The scope of this study is to critically analyze and discuss results from the Evidence and Evaluation GDHP Work Stream's survey, understand how governments and countries intend to address main obstacles to the digital health implementation, identify their strategies for a communication of effective digital health services, and promote the sharing of international based best practices on digital health. Methods: This survey followed a cross-sectional study approach. A multiple-choice questionnaire was designed to gather data. Choices were extracted from research publications retrieved through a rapid review. Results: Out of 29 countries receiving the survey, 10 returned it. On a scale from 1 to 5, eHealth systems/platforms (mean = 3.56) were indicated as the most important tool for centralized infrastructure to collect information on digital health, while primary care (mean = 4.0) represented the most voted item for healthcare services to collect information on digital health. Seven Countries out of 10 identified lack of organization, skepticism of clinicians, and accessibility of the population as a barriers to adopt digital health implementation, resulting to be the most voted items. Finally, the most endorsed priorities in digital health for Countries were the adoption of data-driven approaches (6 Countries), and telehealth (5 Countries). Conclusion: This survey highlighted the main tools and obstacles for countries to promote the implementation of evidence-based digital health innovations. Identifying strategies that would communicate the value of health care information technology to healthcare professionals are particularly imperative. Effective communication programs for clinicians and the general population in addition to improved digital health literacy (both for clinicians and citizens) will be the key for the real implementation of future digital health technologies.


Subject(s)
Global Health , Health Personnel , Humans , Cross-Sectional Studies , Surveys and Questionnaires , Health Surveys
19.
BMJ Open ; 13(7): e072040, 2023 07 14.
Article in English | MEDLINE | ID: mdl-37451717

ABSTRACT

INTRODUCTION: Prevention of cardiovascular disease (CVD) is of key importance in reducing morbidity, disability and mortality worldwide. Observational studies suggest that digital health interventions can be an effective strategy to reduce cardiovascular (CV) risk. However, evidence from large randomised clinical trials is lacking. METHODS AND ANALYSIS: The CV-PREVITAL study is a multicentre, prospective, randomised, controlled, open-label interventional trial designed to compare the effectiveness of an educational and motivational mobile health (mHealth) intervention versus usual care in reducing CV risk. The intervention aims at improving diet, physical activity, sleep quality, psycho-behavioural aspects, as well as promoting smoking cessation and adherence to pharmacological treatment for CV risk factors. The trial aims to enrol approximately 80 000 subjects without overt CVDs referring to general practitioners' offices, community pharmacies or clinics of Scientific Institute for Research, Hospitalization and Health Care (Italian acronym IRCCS) affiliated with the Italian Cardiology Network. All participants are evaluated at baseline and after 12 months to assess the effectiveness of the intervention on short-term endpoints, namely improvement in CV risk score and reduction of major CV risk factors. Beyond the funded life of the study, a long-term (7 years) follow-up is also planned to assess the effectiveness of the intervention on the incidence of major adverse CV events. A series of ancillary studies designed to evaluate the effect of the mHealth intervention on additional risk biomarkers are also performed. ETHICS AND DISSEMINATION: This study received ethics approval from the ethics committee of the coordinating centre (Monzino Cardiology Center; R1256/20-CCM 1319) and from all other relevant IRBs and ethics committees. Findings are disseminated through scientific meetings and peer-reviewed journals and via social media. Partners are informed about the study's course and findings through regular meetings. TRIAL REGISTRATION NUMBER: NCT05339841.


Subject(s)
Cardiovascular Diseases , Humans , Prospective Studies , Cardiovascular Diseases/prevention & control , Diet , Exercise
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