Matteo Martinato

Background: Venous ulcers have a prevalence of 1% in Western countries, with a tendency to become chronic and recur frequently. The lengthy periods of healing required for the treatment of these lesions result in increased costs. It is possible that patient education may enhance patients’ understanding of their health condition, which could potentially lead to a reduction in recurrence rates. Nevertheless, it is uncertain whether this constitutes the optimal educational strategy. Objective: The objective of this study is to assess the superiority of an educational intervention delivered via video compared to an informative brochure in outpatient nursing clinics, focusing on patients’ knowledge of venous leg ulcers and their self-care skills. Methods: A total of 144 patients with venous leg ulcers who attend the outpatient nursing clinics will be recruited to participate in this randomized controlled trial. Individuals with cognitive impairment, an ankle-brachial index of less than 0.90, arterial insufficiency, and arterial ulcers or ulcers of mixed origin will be excluded from the study. The intervention comprises 4 short educational videos specifically created for this study, in which patients will be provided with information on disease knowledge, medication management, compression therapy, and the importance of adequate nutrition and physical activity. The control group will be provided with the standard education offered at the outpatient clinics participating in the study, which will be disseminated through an information leaflet. Patient assessments will be performed with standardized, validated tools at baseline; at 1, 3, and 6 months postenrollment; and at 12 months via telephone follow-up. The primary outcomes are the patient’s level of knowledge and their ability to self-care. The secondary outcomes are the patient’s level of well-being, the success rate of the treatment, and the recurrence rates. A preliminary feasibility study was conducted to methodologically refine the protocol. Results: A feasibility study was conducted to refine study procedures and data collection tools, confirming the acceptability of the questionnaires and the feasibility of digital data collection. The randomized controlled trial was funded in June 2025. It is currently pending ethics approval, and it is expected to start recruitment in spring 2026. Results from the main trial are expected to be available by the end of 2027. Conclusions: A video-based educational intervention may prove to be an effective, readily accessible, and replicable method of patient education. The findings of this study will inform the most effective method of patient education for this population, ensuring the delivery of high-quality care and enhancing the quality of services.

Background/Objectives: Alternative Tobacco and Nicotine Products (ATNPs) have gained widespread popularity. Although they are often promoted as lower-risk alternatives to traditional tobacco products, concerns remain regarding their association with risky behaviors among adolescents and young adults. This study examines the relationship between dietary and lifestyle habits and both ATNP use and intention to use ATNP among Italian participants in the MINERVA (My changINg lifEstyles our Research and eVeryone heAlth) international project. Methods: MINERVA is an observational, international, prospective cohort study. A study-specific questionnaire was administered to participants, who were recruited through informal snowball sampling. The questionnaire collected information on sociodemographic characteristics, lifestyle factors, dietary habits, and the use of both traditional tobacco products and ATNPs. Predictors of ATNP use and intention to use were assessed using logistic regression models. Results: Data from 7535 Italian participants were analyzed. Overall, 48% reported having ever used ATNP, and 14% of non-smokers and non-users expressed an intention to try these products. Significant predictors of ATNP use and intention to use included prior smoking, lower age, and having family members who smoke. Lifestyle factors such as frequent consumption of fast food, junk food, and alcoholic beverages were positively associated with both ATNP use and intention to use. Conversely, daily fruit and vegetable consumption was inversely associated with these outcomes. Conclusions: ATNP use and intention to use were associated with unhealthy dietary and lifestyle patterns. These findings highlight the importance of integrated public health strategies addressing substance use alongside broader lifestyle behaviors among adolescents and young adults.

Background: Traditional smoking is widely recognized as a public health issue, with established risks that include cardiovascular, respiratory, and cancer-related health impacts. Recently, alternative tobacco and nicotine products (ATNPs), such as electronic cigarettes, have gained popularity as potentially safer substitutes for traditional tobacco use. However, there remains uncertainty regarding the health effects of ATNPs, which require comprehensive research to evaluate their risks and potential benefits compared to conventional smoking. Objective: The aim of this multicenter observational study, MINERVA (My Changing Lifestyles Our Research and Everyone Health), is to examine the interplay between traditional smoking and the potential effect of switching to ATNPs in culturally diverse European countries. Methods: Data collection will be conducted through a structured web-based questionnaire and administered using a snowball sampling technique, which relies on the referrals and network connections of initial participants. A link will be provided for participants to access the questionnaire. Responders who express a willingness to participate in the study cohort will be recontacted at least twice a year to ensure continuity in their participation, and they will be asked to complete the same questionnaire during these follow-up assessments. This approach allows for the gathering of useful information over an extended period and the assessment of any changes or trends in the data that may emerge over time. Using social media for data collection, the research explores real-time attitudes and experiences related to smoking, with a particular focus on participants’ receptiveness to transitioning to nonconventional tobacco products. Statistical analysis will include descriptive statistics, and logistic regression models will examine associations. Nonlinear trends will be assessed using restricted cubic splines. Analyses will be conducted in R software with relevant statistical packages. Results: The MINERVA study began in June 2023, and data collection is still in progress. As of January 2025, 7535 participants had been enrolled in Italy, of whom 4862 have consented to a follow-up. Preliminary analyses are currently being conducted. Conclusions: The study underscores the importance of ongoing research to inform evidence-based policies and interventions, emphasizing the role of social media surveys in capturing diverse perspectives and facilitating longitudinal studies for a deeper understanding of the health implications of transitioning from traditional smoking to ATNPs. International Registered Report Identifier (IRRID): DERR1-10.2196/67163

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Traditional smoking is widely recognized as a public health issue, with established risks that include cardiovascular, respiratory, and cancer-related health impacts. Recently, alternative tobacco and nicotine products (ATNPs), such as electronic cigarettes, have gained popularity as potentially safer substitutes for traditional tobacco use. However, there remains uncertainty regarding the health effects of ATNPs, which require comprehensive research to evaluate their risks and potential benefits compared to conventional smoking. Objective: The aim of this multicenter observational study, MINERVA (My Changing Lifestyles Our Research and Everyone Health), is to examine the interplay between traditional smoking and the potential effect of switching to ATNPs in culturally diverse European countries. Methods: Data collection will be conducted through a structured web-based questionnaire and administered using a snowball sampling technique, which relies on the referrals and network connections of initial participants. A link will be provided for participants to access the questionnaire. Responders who express a willingness to participate in the study cohort will be recontacted at least twice a year to ensure continuity in their participation, and they will be asked to complete the same questionnaire during these follow-up assessments. This approach allows for the gathering of useful information over an extended period and the assessment of any changes or trends in the data that may emerge over time. Using social media for data collection, the research explores real-time attitudes and experiences related to smoking, with a particular focus on participants’ receptiveness to transitioning to nonconventional tobacco products. Statistical analysis will include descriptive statistics, and logistic regression models will examine associations. Nonlinear trends will be assessed using restricted cubic splines. Analyses will be conducted in R software with relevant statistical packages. Results: The MINERVA study began in June 2023, and data collection is still in progress. As of January 2025, 7535 participants had been enrolled in Italy, of whom 4862 have consented to a follow-up. Preliminary analyses are currently being conducted. Conclusions: The study underscores the importance of ongoing research to inform evidence-based policies and interventions, emphasizing the role of social media surveys in capturing diverse perspectives and facilitating longitudinal studies for a deeper understanding of the health implications of transitioning from traditional smoking to ATNPs. Trial Registration:

A prevalent symptom among Inflammatory Bowel Disease (IBD) patients is fatigue, characterized by a persistent sense of energy depletion that affects all aspects of daily life. This review aims to evaluate nursing interventions reported in the literature to alleviate fatigue in IBD patients. A comprehensive search was conducted across four electronic databases—PubMed, CINAHL, Cochrane, and Scopus—and four scientific journals: “Gastroenterology”, “Inflammatory Bowel Disease”, “Journal of Crohn’s and Colitis”, and “United European Gastroenterology Journal”. Inclusion criteria were clinical trials involving adult IBD patients in remission or mild disease activity. Out of 234 studies, 2 were selected for review. These studies assess the effectiveness of Solution-Focused Therapy (SFT) that emphasizes solving problems and developing strategies for improvement, and Problem-Solving Therapy (PST) that focuses on identifying problems and coping strategies. SFT showed a positive impact on fatigue with a significant improvement in the Checklist Individual Strength after three months: 45.5% in the control group, 85.7% in the SFT group, and 60% in the PST group, but its impact declined over time. Additionally, SFT demonstrated potential for reducing healthcare costs compared to standard of care and PST. Further research is needed to provide nurses interventions for managing fatigue in IBD patients. The review protocol has been registered at OSF.io.

Wearable devices (WDs) can objectively assess patient-reported outcomes (PROMs) in clinical trials. In this study, the feasibility and acceptability of using commercial WDs in elderly patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) will be explored. This is a prospective observational study. Participants were trained to use a WD and a smartphone to collect data on their physical activity, rest heart rate and number of hours of sleep. Validated questionnaires were also used to evaluate these outcomes. A technology acceptance questionnaire was used at the end of the follow up. In our participants an overall good compliance in wearing the device (75.1% vs. 79.8%, SAVR vs. TAVR) was assessed. Half of the patients were willing to continue using the device. Perceived ease of use is one of the domains that scored higher in the technology acceptance questionnaire. In this study we observed that the use of a WD is accepted in our frail population for an extended period. Even though commercial WDs are not tailored for clinical research, they can produce useful information on patient behavior, especially when coordinated with intervention tailored to the single patient.

(1) Background: Propensity score methods gained popularity in non-interventional clinical studies. As it may often occur in observational datasets, some values in baseline covariates are missing for some patients. The present study aims to compare the performances of popular statistical methods to deal with missing data in propensity score analysis. (2) Methods: Methods that account for missing data during the estimation process and methods based on the imputation of missing values, such as multiple imputations, were considered. The methods were applied on the dataset of an ongoing prospective registry for the treatment of unprotected left main coronary artery disease. The performances were assessed in terms of the overall balance of baseline covariates. (3) Results: Methods that explicitly deal with missing data were superior to classical complete case analysis. The best balance was observed when propensity scores were estimated with a method that accounts for missing data using a stochastic approximation of the expectation-maximization algorithm. (4) Conclusions: If missing at random mechanism is plausible, methods that use missing data to estimate propensity score or impute them should be preferred. Sensitivity analyses are encouraged to evaluate the implications methods used to handle missing data and estimate propensity score.

Recent literature has reported a high percentage of asymptomatic or paucisymptomatic cases in subjects with COVID-19 infection. This proportion can be difficult to quantify; therefore, it constitutes a hidden population. This study aims to develop a proof-of-concept method for estimating the number of undocumented infections of COVID-19. This is the protocol for the INCIDENT (Hidden COVID-19 Cases Network Estimation) study, an online, cross-sectional survey with snowball sampling based on the network scale-up method (NSUM). The original personal network size estimation method was based on a fixed-effects maximum likelihood estimator. We propose an extension of previous Bayesian estimation methods to estimate the unknown network size using the Markov chain Monte Carlo algorithm. On 6 May 2020, 1963 questionnaires were collected, 1703 were completed except for the random questions, and 1652 were completed in all three sections. The algorithm was initialized at the first iteration and applied to the whole dataset. Knowing the number of asymptomatic COVID-19 cases is extremely important for reducing the spread of the virus. Our approach reduces the number of questions posed. This allows us to speed up the completion of the questionnaire with a subsequent reduction in the nonresponse rate.

Background: Regular physical activity (PA) contributes to the primary and secondary prevention of several chronic diseases and reduces the risk of premature death. Physical inactivity is a modifiable risk factor for cardiovascular disease and a variety of chronic disorders such as diabetes, obesity, hypertension, bone and joint diseases (eg, osteoporosis and osteoarthritis), depression, and colon and breast cancer. Population aging and the related increase in chronic diseases have a major impact on the health care systems of most Western countries and will produce an even more significant effect in the future. Monitoring PA is a valuable method of determining whether people are performing enough PA so as to prevent chronic diseases or are showing early symptoms of those diseases. Objective: The aim of this study was to estimate the accuracy of wearable devices in quantifying the PA of elderly people in a real-life setting. Methods: Participants aged 70 to 90 years with the ability to walk safely without any walking aid for at least 300 meters, who had no walking disabilities or episodes of falling while walking in the last 12 months, were asked to walk 150 meters at their preferred pace wearing a vívoactive HR device (Garmin Ltd) and actual steps were monitored and tallied by a researcher using a hand-tally counter to assess the performance of the device at a natural speed. A Bland-Altman plot was used to analyze the difference between manually counted steps and wearable device–measured steps. The intraclass correlation coefficient (ICC) was computed (with a 95% confidence interval) between step measurements. The generalized linear mixed-model (GLMM) ICCs were estimated, providing a random effect term (random intercept) for the individual measurements (gold standard and device). Both adjusted and conditional ICCs were computed for the GLMM models considering separately the effect of age, sex, BMI, and obesity. Analyses were performed using R software (R Foundation for Statistical Computing) with the rms package. Results: A total of 23 females and 26 males were enrolled in the study. The median age of the participants was 75 years. The Bland-Altman plot revealed that, excluding one observation, all differences across measurements were in the confidence bounds, demonstrating the substantial agreement between the step count measurements. The results were confirmed by an ICC equal to .98 (.96-.99), demonstrating excellent agreement between the two sets of measurements. Conclusions: The level of accuracy of wearable devices in quantifying the PA of elderly people in a real-life setting that was found in this study supports the idea of considering wrist-wearable nonmedical devices (widely available in nonspecialized stores) as reliable tools. Both health care professionals and informal caregivers could monitor the level of PA of their patients.