Vittorio Grieco

INTRODUCTION Multiple myeloma is a hematological malignancy associated with a marked immunosuppression state and a consequent increased risk of vaccine-preventable infections. In this vulnerable population, the main guidelines recommend specific vaccination strategies, including influenza, pneumococcal, herpes zoster, and SARS-CoV-2 vaccinations, but in clinical practice, the implementation of these recommendations is often incomplete and uneven for several reasons.OBJECTIVESTo describe vaccination coverage among patients with multiple myeloma treated at a referral center and to evaluate the level of implementation of recommended vaccination strategies in clinical practice. The impact of SARS-CoV-2 vaccination on overall coverage estimates and its relationship with survival was also analyzed.METHODSA retrospective observational study was conducted on a cohort of 379 patients diagnosed with multiple myeloma followed at the AOUP CT. For each patient, information regarding SARS-CoV-2, influenza, pneumococcal, herpes zoster, and meningococcal vaccinations was reconstructed from the clinical and vaccination database. Binary variables were created for each vaccine and an overall vaccination coverage variable, calculated both including and excluding SARS-CoV-2 vaccination. The demographic characteristics of the cohort and individual vaccine coverage were described. Associations between vaccination status, age groups (<50, 50–64, 65–74, ≥75 years), and gender were assessed using the chi-square test. An exploratory survival analysis using the Kaplan–Meier method was also performed, excluding SARS-CoV-2 vaccination.RESULTS The cohort included 379 patients with multiple myeloma, with a slight male predominance (54.5%) and a median age at diagnosis of 66 years (IQR 57–74). Overall vaccination coverage was 75.5%; however, excluding SARS-CoV-2 vaccination, it dropped to 47.0%, highlighting the crucial role of COVID-19 vaccination campaigns. SARS-CoV-2 vaccination was the most frequent (73%), followed by influenza vaccination (42%), while pneumococcal (23%), herpes zoster (15%), and meningococcal (4%) coverage were significantly lower. Considering overall coverage, the association with age groups was significant (χ² = 8.57; p = 0.036), but lost significance when excluding the anti-SARS-CoV-2 component (χ² = 4.16; p = 0.245). Anti-pneumococcal and anti-Herpes Zoster coverage showed significant differences between age groups (p = 0.018 and p = 0.027), with lower levels in older subjects; no differences emerged by gender (p=0.680). Exploratory survival analysis, conducted excluding the anti-SARS-CoV-2 vaccine, showed better survival in vaccinated patients compared to unvaccinated ones (log- rank χ² = 67.03; p < 0.001).CONCLUSIONS The results show that, in patients with multiple myeloma, overall vaccination coverage may mask insufficient implementation of recommended vaccinations other than the SARS-CoV-2 vaccine. The persistence of low coverage for some key vaccines and the observed improved survival rate among vaccinated subjects support the need to strengthen dedicated vaccination programs that are systematically integrated into hematology practice in this population.

BackgroundCare bundles (CBs) are structured sets of evidence-based interventions designed to enhance the quality and safety of care. Despite increasing diffusion, a lack of uniformity in development and implementation processes underscores the need for a standardised approach to evaluating methodological quality. To our knowledge, no widely accepted and standardised instrument is currently available to assess the methodological quality of CBs. To address this gap, we developed the Care Bundle Quality Assessment Tool (CBQuAT). It consists of 20 items grouped into five key dimensions.MethodsThe development of the tool was informed by the IHI guidelines published in 2001 and by evidence identified through a previously published systematic review. The preliminary checklist was subjected to content validation in two rounds by a panel of 12 experts, and the Content Validity Index (CVI) and Ratio (CVR) were then calculated. Subsequently, two reviewers applied CB-QuAT to the 20 CBs obtained through a systematic literature search to assess their reliability. The inter-rater reliability (IRR) was calculated using Cohen's weighted kappa and the intra-class correlation coefficient (ICC). All analyses were conducted using SPSS and RStudio.ResultsA total of 20 items were included in the final checklist, organised into five analytical domains that reflect key aspects of bundle quality. The analysis highlighted excellent reliability and strong content validity. Construct validity was not evaluated, as it was not necessary for the specific purpose of the instrument. The average weighted Cohen’s kappa was 0.860 (95% CI: 0.828–0.892), and the mean ICC was 0.918 (95% CI: 0.872–0.964), indicating almost perfect agreement between reviewers. Internal consistency was exceptional, with a Cronbach’s Alpha of 0.957 (95% CI: 0.936–0.979). Specific examples include the bundle for preventing viral infections in paediatrics (USA, 2018), which showed the highest reliability (ICC = 0.997), while some bundles for surgical site infections had lower but still substantial agreement.ConclusionsThe CB-QuAT has proven to be a valid and reliable tool for evaluating the methodological quality of CBs and for guiding their development across different clinical settings.

This umbrella review provides a comprehensive synthesis of the available evidence on the relationship between digital device use and adolescent sleep. It summarizes results from systematic reviews and meta-analyses, presenting the magnitude and direction of observed associations. A total of seven systematic reviews, including five qualitative reviews and two meta-analyses, were included, comprising 127 primary studies with a combined sample of 867,003 participants. The findings suggest a negative impact of digital device use on various sleep parameters, including sleep duration, bedtime procrastination, and sleep quality. Devices such as smartphones and computers were found to have a greater adverse effect, while television use showed a weaker association. The most significant disruptions were observed in relation to social media and internet use, with problematic usage leading to delayed bedtimes, shorter sleep duration, and increased sleep onset latency. The review also highlights the role of timing and duration of device use, with late-night use particularly contributing to sleep disturbances. Biological, psychological, and social mechanisms are proposed as potential pathways underlying these effects. Despite moderate evidence supporting the negative impact of digital media on sleep, there is considerable heterogeneity across studies, and many relied on self-reported data, which may limit the generalizability of the findings. Future research should aim to standardize exposure and outcome measures, incorporate objective data collection methods, and explore causal relationships through longitudinal studies. This umbrella review underscores the importance of developing targeted public health strategies, parental guidance, and clinical awareness to mitigate the potential adverse effects of digital device use on adolescent sleep and mental health.

Background: The rapid proliferation of medical apps has transformed the health care landscape by giving patients and health care providers unprecedented access to personalized health information and services. However, concerns regarding the effectiveness and safety of medical apps have raised questions regarding the efficacy of randomized controlled trials (RCTs) in the evaluation of such apps and as a requirement for their regulation as mobile medical devices. Objective: This study aims to address this issue by investigating alternative methods, apart from RCTs, for evaluating and regulating medical apps. Methods: Using a qualitative approach, a focus group study with 46 international and multidisciplinary public health experts was conducted at the 17th World Congress on Public Health in May 2023 in Rome, Italy. The group was split into 3 subgroups to gather in-depth insights into alternative approaches for evaluating and regulating medical apps. We conducted a policy analysis on the current regulation of medical apps as mobile medical devices for the 4 most represented countries in the workshop: Italy, Germany, Canada, and Australia. We developed a logic model that combines the evaluation and regulation domains on the basis of these findings. Results: The focus group discussions explored the strengths and limitations of the current evaluation and regulation methods and identified potential alternatives that could enhance the quality and safety of medical apps. Although RCTs were only explicitly mentioned in the German regulatory system as one of many options, an analysis of chosen evaluation methods for German apps on prescription pointed toward a “scientific reflex” where RCTs are always the chosen evaluation method. However, this method has substantial limitations when used to evaluate digital interventions such as medical apps. Comparable results were observed during the focus group discussions, where participants expressed similar experiences with their own evaluation approaches. In addition, the participants highlighted numerous alternatives to RCTs. These alternatives can be used at different points during the life cycle of a digital intervention to assess its efficacy and potential harm to users. Conclusions: It is crucial to recognize that unlike analog tools, digital interventions constantly evolve, posing challenges to inflexible evaluation methods such as RCTs. Potential risks include high dropout rates, decreased adherence, and nonsignificant results. However, existing regulations do not explicitly advocate for other evaluation methodologies. Our research highlighted the necessity of overcoming the gap between regulatory demands to demonstrate safety and efficacy of medical apps and evolving scientific practices, ensuring that digital health innovation is evaluated and regulated in a way that considers the unique characteristics of mobile medical devices.

BACKGROUND The rapid proliferation of medical apps has transformed the health care landscape by giving patients and health care providers unprecedented access to personalized health information and services. However, concerns regarding the effectiveness and safety of medical apps have raised questions regarding the efficacy of randomized controlled trials (RCTs) in the evaluation of such apps and as a requirement for their regulation as mobile medical devices. OBJECTIVE This study aims to address this issue by investigating alternative methods, apart from RCTs, for evaluating and regulating medical apps. METHODS Using a qualitative approach, a focus group study with 46 international and multidisciplinary public health experts was conducted at the 17th World Congress on Public Health in May 2023 in Rome, Italy. The group was split into 3 subgroups to gather in-depth insights into alternative approaches for evaluating and regulating medical apps. We conducted a policy analysis on the current regulation of medical apps as mobile medical devices for the 4 most represented countries in the workshop: Italy, Germany, Canada, and Australia. We developed a logic model that combines the evaluation and regulation domains on the basis of these findings. RESULTS The focus group discussions explored the strengths and limitations of the current evaluation and regulation methods and identified potential alternatives that could enhance the quality and safety of medical apps. Although RCTs were only explicitly mentioned in the German regulatory system as one of many options, an analysis of chosen evaluation methods for German apps on prescription pointed toward a “scientific reflex” where RCTs are always the chosen evaluation method. However, this method has substantial limitations when used to evaluate digital interventions such as medical apps. Comparable results were observed during the focus group discussions, where participants expressed similar experiences with their own evaluation approaches. In addition, the participants highlighted numerous alternatives to RCTs. These alternatives can be used at different points during the life cycle of a digital intervention to assess its efficacy and potential harm to users. CONCLUSIONS It is crucial to recognize that unlike analog tools, digital interventions constantly evolve, posing challenges to inflexible evaluation methods such as RCTs. Potential risks include high dropout rates, decreased adherence, and nonsignificant results. However, existing regulations do not explicitly advocate for other evaluation methodologies. Our research highlighted the necessity of overcoming the gap between regulatory demands to demonstrate safety and efficacy of medical apps and evolving scientific practices, ensuring that digital health innovation is evaluated and regulated in a way that considers the unique characteristics of mobile medical devices.