Which behaviour change techniques work best for diabetes self-management mobile apps? Results from a systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: Self-management is pivotal in addressing noncommunicable diseases, such as diabetes. The increased availability of digital behaviour change interventions (DBCIs) delivered through mobile health apps offers unprecedented opportunities to enhance self-management and improve health outcomes. However, little is known about the characteristics of DBCIs for diabetes that significantly impact glycaemic control. Therefore, our systematic review with meta-analysis aimed to summarize characteristics and behaviour change components in DBCIs for diabetes self-management and explore potential associations with metabolic outcomes. METHODS: A systematic search was conducted in PubMed, Embase, the Cochrane Central Register of Controlled Trials, and Scopus to identify randomized controlled trials published until November 2023. The main outcome variable was the change in the mean difference of HbA1c levels between baseline and follow-up across intervention and control groups. Random-effects meta-regression was used to explore variation in glycaemic control as a function of prespecified characteristics of study designs and app interventions. FINDINGS: A total of 57 studies was included in the analysis, showing a statistically significant percentage point reduction in HbA1c for the intervention group compared to the control arm (-0.36, 95% CI = -0.46 to -0.26, p < 0.001). The inclusion of "self-monitoring of behaviour" as a behaviour change technique (ß = -0.22, p = 0.04) and "taking medication" as a target behaviour (ß = -0.20, p = 0.05) was associated with improved metabolic outcomes. INTERPRETATION: Our analyses endorse the use of diabetes self-management apps, highlighting characteristics statistically associated with intervention effectiveness and guiding the design of more effective DBCIs. FUNDING: This project received funding from the European Union's Horizon 2020 programme.

Economic value of diastasis repair with the use of mesh compared to no intervention in Italy.

AIM: Rectus abdominal diastasis (RAD) can cause mainly incontinence and lower-back pain. Despite its high incidence, there is no consensus regarding surgical indication. We aimed at comparing RAD repair (minimally invasive technique with mesh implant) with no treatment (standard of care - SOC) through cost-effectiveness and budget impact analyses from both National Healthcare Service (NHS) and societal perspectives in Italy. METHODS: A model was developed including social costs and productivity losses derived by the online administration of a socio-economic questionnaire, including the EuroQol for the assessment of quality of life. Costs for the NHS were based on reimbursement tariffs. RESULTS: Over a lifetime horizon, estimated costs were 64,115€ for SOC and 46,541€ for RAD repair in the societal perspective; QALYs were 19.55 and 25.75 for the two groups, respectively. Considering the NHS perspective, RAD repair showed an additional cost per patient of 5,104€ compared to SOC, leading to an ICUR of 824€. RAD repair may be either cost-saving or cost-effective compared to SOC depending on the perspective considered. Considering a current scenario of 100% SOC, an increased diffusion of RAD repair from 2 to 10% in the next 5 years would lead to an incremental cost of 184,147,624€ for the whole society (87% borne by the NHS) and to incremental 16,155 QALYs. CONCLUSION: In light of the lack of economic evaluations for minimally invasive RAD repair, the present study provides relevant clinical and economic evidence to help improving the decision-making process and allocating scarce resources between competing ends.

Systematic review for the development of a core outcome set for monofocal intraocular lenses for cataract surgery.

Introduction: The aim of the study was to define a core outcome set (COS) to be measured following cataract surgery for the postoperative evaluation of monofocal intraocular lenses (IOLs). Compared to current COSs, the present work provides updates considering the advances in the technology due to the development of new generation monofocal IOLs, which are characterized by a safety profile comparable to standard monofocal IOLs but with an extended range of intermediate vision. Methods: Healthcare professionals (ophthalmologist surgeons) and patients were involved in the selection of outcomes to be included in the COS, starting from a list of indicators retrieved from a systematic literature search. The search considered observational studies with both a retrospective or prospective design, case studies and classic randomized controlled trials (RCTs). A mixed methodology integrating a Delphi-driven and an expert panel approach was adopted to reach an agreement among clinicians, while patients were involved in the completion of a questionnaire. Results: The final COS included 15 outcomes. Eleven outcomes, all clinical, were considered for inclusion after a joint discussion among ophthalmologists; seven outcomes were linked to visual acuity, while the remaining to contrast sensitivity, refractive errors, aberrations and adverse events. Measurement metrics, method of aggregation and measurement time point of these outcomes were specified. The most important aspects for the patients were (1) quality of life after cataract surgery, (2) the capacity to perform activities requiring good near vision (e.g., reading), (3) spectacle independence, and (4) safety of movements without fear of getting hurt or falling (intermediate vision). Discussion: In a context with limited healthcare resources, it is important to optimize their use considering also the preferences of end-users, namely patients. The proposed COS, developed involving both ophthalmologists and patients, provides an instrument for the postoperative evaluation of different technologies in the context of monofocal IOLs, which can be used not only in clinical trials but also in clinical practice to increase the body of real-world evidence.

Health system quality and COVID-19 vaccination: a cross-sectional analysis in 14 countries.

The social and behavioural determinants of COVID-19 vaccination have been described previously. However, little is known about how vaccinated people use and rate their health system. We used surveys conducted in 14 countries to study the health system correlates of COVID-19 vaccination. Country-specific logistic regression models were adjusted for respondent age, education, income, chronic illness, history of COVID-19, urban residence, and minority ethnic, racial, or linguistic group. Estimates were summarised across countries using random effects meta-analysis. Vaccination coverage with at least two or three doses ranged from 29% in India to 85% in Peru. Greater health-care use, having a regular and high-quality provider, and receiving other preventive health services were positively associated with vaccination. Confidence in the health system and government also increased the odds of vaccination. By contrast, having unmet health-care needs or experiencing discrimination or a medical mistake decreased the odds of vaccination. Associations between health system predictors and vaccination tended to be stronger in high-income countries and in countries with the most COVID-19-related deaths. Access to quality health systems might affect vaccine decisions. Building strong primary care systems and ensuring a baseline level of quality that is affordable for all should be central to pandemic preparedness strategies.

Population confidence in the health system in 15 countries: results from the first round of the People's Voice Survey.

Population confidence is essential to a well functioning health system. Using data from the People's Voice Survey-a novel population survey conducted in 15 low-income, middle-income, and high-income countries-we report health system confidence among the general population and analyse its associated factors. Across the 15 countries, fewer than half of respondents were health secure and reported being somewhat or very confident that they could get and afford good-quality care if very sick. Only a quarter of respondents endorsed their current health system, deeming it to work well with no need for major reform. The lowest support was in Peru, the UK, and Greece-countries experiencing substantial health system challenges. Wealthy, more educated, young, and female respondents were less likely to endorse the health system in many countries, portending future challenges for maintaining social solidarity for publicly financed health systems. In pooled analyses, the perceived quality of the public health system and government responsiveness to public input were strongly associated with all confidence measures. These results provide a post-COVID-19 pandemic baseline of public confidence in the health system. The survey should be repeated regularly to inform policy and improve health system accountability.

Collecting Physicians' Preferences on Medical Devices: Are We Doing It Right? Evidence from Italian Orthopedists Using 2 Different Stated Preference Methods.

OBJECTIVES: Physician preference items (PPIs) are high-cost medical devices for which clinicians express firm preferences with respect to a particular manufacturer or product. This study aims to identify the most important factors in the choice of new PPIs (hip or knee prosthesis) and infer about the existence of possible response biases in using 2 alternative stated preference techniques. METHODS: Six key attributes with 3 levels each were identified based on a literature review and clinical experts' opinions. An online survey was administered to Italian hospital orthopedists using type 1 best-worst scaling (BWS) and binary discrete choice experiment (DCE). BWS data were analyzed through descriptive statistics and conditional logit model. A mixed logit regression model was applied to DCE data, and willingness-to-pay (WTP) was estimated. All analyses were conducted using Stata 16. RESULTS: A sample of 108 orthopedists were enrolled. In BWS, the most important attribute was "clinical evidence," followed by "quality of products," while the least relevant items were "relationship with the sales representative" and "cost." DCE results suggested instead that orthopedists prefer high-quality products with robust clinical evidence, positive health technology assessment recommendation and affordable cost, and for which they have a consolidated experience of use and a good relationship with the sales representative. CONCLUSIONS: The elicitation of preferences for PPIs using alternative methods can lead to different results. The BWS of type 1, which is similar to a ranking exercise, seems to be more affected by acquiescent responding and social desirability than the DCE, which introduces tradeoffs in the choice task and is likely to reveal more about true preferences. HIGHLIGHTS: Physician preference items (PPIs) are medical devices particularly exposed to physicians' choice with regard to type of product and supplier.Some established techniques of collecting preferences can be affected by response biases such as acquiescent responding and social desirability.Discrete choice experiments, introducing more complex tradeoffs in the choice task, are likely to mitigate such biases and reveal true physicians' preferences for PPIs.

Economic Evaluation of a Bioinductive Implant for the Repair of Rotator Cuff Tears Compared with Standard Surgery in Italy.

INTRODUCTION: Rotator cuff tear (RCT) is a painful, progressive condition resulting from damage to the rotator cuff tendons and is the leading cause of shoulder-related disability. Surgical repair of rotator cuff is an established standard of care (SOC); however, failure of the procedure can occur. In this context, the use of collagen-based bioinductive implant REGENETEN showed long-term improvements in clinical scores. The aim of the study was to assess the cost-effectiveness of REGENETEN combined with SOC (SOC + REGENETEN) compared to SOC alone from both National Healthcare Service (NHS) and societal perspectives in Italy. METHODS: A decision analytic model was developed to estimate the number of tears healed and costs for the two considered treatment strategies over 1 year. Clinical data were retrieved from the literature, and the clinical pathways for the management of patients with RCTs were retrieved from four key opinion leaders in Italy. RESULTS: Over a 1-year time horizon, healed lesions were 90.70% and 72.90% for surgical repair of RCTs with and without REGENETEN, respectively. Considering the NHS perspective, mean costs per patient were €7828 and €4650 for the two strategies, respectively, leading to an incremental cost-effectiveness ratio (ICER) of €17,857 per healed tear. From the societal perspective, the mean costs per patient were €12,659 for SOC and €11,784 for REGENETEN, thus showing savings of €4918 per healed tear when the bioinductive implant is used. The sensitivity analyses confirmed the robustness of the model results. CONCLUSION: In the context of paucity of cost-effectiveness studies, our findings provide additional evidence for clinicians and payers regarding the value of a new treatment option that supports a tailored approach for the management of patients with RCTs.

The rotator cuff refers to a group of four muscles, with tendons connected to the upper arm bone, which act together to allow lifting and rotating the shoulder. A tear of the rotator cuff can affect either a single tendon or multiple tendons. Typical first-line treatment includes conservative therapies, which aim to alleviate pain and reduce functional impairment, but are often ineffective. Persisting disease is usually managed through conventional surgical repair. Recently, REGENETEN, a collagen-based bioinductive implant derived from purified bovine Achilles tendon, positioned over the site of the damaged rotator cuff, achieved successful rotator cuff tendon repair with an increase in healed tears of 17.80% at 1 year compared to conventional surgery. Considering the National Healthcare Service perspective in Italy, the cost needed to achieve one additional healed tear using REGENETEN compared to conventional surgery is €17,857. From the societal perspective, which includes patients' productivity losses from hospital admission to return to work, the use of REGENETEN may be cost-saving compared to conventional surgery. The findings of our study provide evidence for clinicians and payers to support the value of a new treatment option for patients with rotator cuff lesions.

Implementing preconception expanded carrier screening in a universal health care system: A model-based cost-effectiveness analysis.

PURPOSE: The limited evidence available on the cost-effectiveness (CE) of expanded carrier screening (ECS) prevents its widespread use in most countries, including Italy. Herein, we aimed to estimate the CE of 3 ECS panels (ie, American College of Medical Genetics and Genomics [ACMG] Tier 1 screening, "Focused Screening," testing 15 severe, highly penetrant conditions, and ACMG Tier 3 screening) compared with no screening, the health care model currently adopted in Italy. METHODS: The reference population consisted of Italian couples seeking pregnancy with no increased personal/familial genetic risk. The CE model was developed from the perspective of the Italian universal health care system and was based on the following assumptions: 100% sensitivity of investigated screening strategies, 77% intervention rate of at-risk couples (ARCs), and no risk to conceive an affected child by risk-averse couples opting for medical interventions. RESULTS: The incremental CE ratios generated by comparing each genetic screening panel with no screening were: -14,875 ± 1,208 €/life years gained (LYG) for ACMG1S, -106,863 ± 2,379 €/LYG for Focused Screening, and -47,277 ± 1,430 €/LYG for ACMG3S. ACMG1S and Focused Screening were dominated by ACMG3S. The parameter uncertainty did not significantly affect the outcome of the analyses. CONCLUSION: From a universal health care system perspective, all the 3 ECS panels considered in the study would be more cost-effective than no screening.

Time-Driven Activity-Based Costing for Capturing the Complexity of Healthcare Processes: The Case of Deep Vein Thrombosis and Leg Ulcers.

Time-driven activity-based costing (TDABC) is suggested to assess costs within the value-based healthcare approach, but there is a paucity of applications in chronic diseases such as deep vein thrombosis (DVT) and leg ulcers. In this context, we applied TDABC in a cost-effectiveness analysis comparing venous stenting to compression ± anticoagulation (standard of care-SOC) from both hospital and societal perspectives in Italy. TDABC was applied to both treatments to assess costs that were included in a cost-effectiveness model. Clinical inputs were retrieved from the literature and integrated with real-world data. The Incremental Cost Utility Ratio (ICUR) of stenting compared to SOC was EUR 10,270/QALY and EUR 8962/QALY for hospital and societal perspectives, respectively. The mean cost per patient for venous stenting of EUR 5082 was higher than the Diagnosis-Related Group (DRG) reimbursement (EUR 4742). For SOC, an ulcer healing in 3 months costs EUR 1892, of which EUR 302 (16%) is borne by the patient versus a reimbursement of EUR 1132. TDABC showed that venous stenting may be cost-effective compared with SOC but that reimbursement rates may not completely cover the real costs, which are partially sustained by the patients. A more efficient policy for covering the real costs may be beneficial for both clinical centers and patients.

Impella Versus VA-ECMO for Patients with Cardiogenic Shock: Comprehensive Systematic Literature Review and Meta-Analyses.

Impella and VA-ECMO are two possible therapeutic courses for the treatment of patients with cardiogenic shock (CS). The study aims to perform a systematic literature review and meta-analyses of a comprehensive set of clinical and socio-economic outcomes observed when using Impella or VA-ECMO with patients under CS. A systematic literature review was performed in Medline, and Web of Science databases on 21 February 2022. Nonoverlapping studies with adult patients supported for CS with Impella or VA-ECMO were searched. Study designs including RCTs, observational studies, and economic evaluations were considered. Data on patient characteristics, type of support, and outcomes were extracted. Additionally, meta-analyses were performed on the most relevant and recurring outcomes, and results shown using forest plots. A total of 102 studies were included, 57% on Impella, 43% on VA-ECMO. The most common outcomes investigated were mortality/survival, duration of support, and bleeding. Ischemic stroke was lower in patients treated with Impella compared to the VA-ECMO population, with statistically significant difference. Socio-economic outcomes including quality of life or resource use were not reported in any study. The study highlighted areas where further data collection is needed to clarify the value of complex, new technologies in the treatment of CS that will enable comparative assessments focusing both on the health impact on patient outcomes and on the financial burden for government budgets. Future studies need to fill the gap to comply with recent regulatory updates at the European and national levels.

An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations.

INTRODUCTION: The new European Union (EU) Regulations for medical devices (MDs) and health technology assessment (HTA) are welcome developments that should increase the quality of clinical evidence for MDs and reduce fragmentation in the EU market access process. To fully exploit anticipated benefits, their respective assessment processes should be closely coordinated, particularly for promising, highly innovative MDs. Accelerated approval is worth exploring for certain categories of high-risk MDs to keep the EU regulatory process competitive compared to accelerated MD approval programs elsewhere (e.g. US). AREAS COVERED: Problems observed in worldwide accelerated drug and MD regulatory approval programs are reviewed, including greater uncertainty in premarket clinical evidence generation and lack of oversight for post approval evidence requirements. Implications for MD approval, HTA and coverage are explored. EXPERT OPINION: Through analysis of two decades of drug and MD accelerated approval programs worldwide, recommendations for an Accelerated Access Pathway for select innovative, high-risk MDs are proposed to fit the EU context, leverage the two new regulations, increase opportunities for Expert Panels to provide timely advice regarding manufacturers' evidence generation plans along the MD lifecycle (pre, postmarket), and safely speed patient access while promoting increased collaboration among Member States on coverage decisions.

Evaluating Barriers and Facilitators to the Uptake of mHealth Apps in Cancer Care Using the Consolidated Framework for Implementation Research: Scoping Literature Review.

BACKGROUND: Mobile health (mHealth) solutions have proven to be effective in a wide range of patient outcomes and have proliferated over time. However, a persistent challenge of digital health technologies, including mHealth, is that they are characterized by early dropouts in clinical practice and struggle to be used outside experimental settings or on larger scales. OBJECTIVE: This study aimed to explore barriers and enablers to the uptake of mHealth solutions used by patients with cancer undergoing treatment, using a theory-guided implementation science model, that is, the Consolidated Framework for Implementation Research (CFIR). METHODS: A scoping literature review was conducted using PubMed (MEDLINE), Web of Science, and ScienceDirect databases in March 2022. We selected studies that analyzed the development, evaluation, and implementation of mHealth solutions for patients with cancer that were used in addition to the standard of care. Only empirical designs (eg, randomized controlled trials, observational studies, and qualitative studies) were considered. First, information on the study characteristics, patient population, app functionalities, and study outcomes was extracted. Then, the CFIR model was used as a practical tool to guide data collection and interpretation of evidence on mHealth uptake. RESULTS: Overall, 91 papers were included in the data synthesis. The selected records were mostly randomized controlled trials (26/91, 29%) and single-arm, noncomparative studies (52/91, 57%). Most of the apps (42/73, 58%) were designed for both patients and clinicians and could be used to support any type of cancer (29/73, 40%) and a range of oncological treatments. Following the CFIR scheme (intervention, outer setting, inner setting, individuals, process), multistakeholder co-design, codevelopment, and testing of mHealth interventions were identified as key enablers for later uptake. A variety of external drivers emerged, although the most relevant outer incentive fostering mHealth use was addressing patient needs. Among organizational factors likely to influence technology uptake, interoperability was the most prominent, whereas other providers' dimensions such as managerial attitudes or organizational culture were not systematically discussed. Technology-related impediments that could hamper the use of mHealth at the individual level were considered least often. CONCLUSIONS: The hype surrounding mHealth in cancer care is hindered by several factors that can affect its use in real world and nonexperimental settings. Compared with the growing evidence on mHealth efficacy, knowledge to inform the uptake of mHealth solutions in clinical cancer care is still scarce. Although some of our findings are supported by previous implementation research, our analysis elaborates on the distinguishing features of mHealth apps and provides an integrated perspective on the factors that should be accounted for implementation efforts. Future syntheses should liaise these dimensions with strategies observed in successful implementation initiatives.

The Impact of Surgical Experience in VATS Lobectomy on Conversion and Patient Quality of Life: Results from a Comprehensive National Video-Assisted Thoracic Surgical Database.

OBJECTIVES: Although unexpected conversion during Video-Assisted Thoracic Surgery (VATS) lobectomy is up to 23%, the effects on postoperative outcomes remain debatable. This retrospective study aimed: (i) to identify potential preoperative risk factors of VATS conversion to standard thoracotomy; (ii) to assess the impact of surgical experience in VATS lobectomy on conversion rate and patient health-related quality of life. METHODS: We extracted detailed information on VATS lobectomy procedures performed consecutively (2014-2019). Predictors of conversion were assessed with univariable and multivariable logistic regressions. To assess the impact of VATS lobectomy experience, observations were divided according to surgeons' experiences with VATS lobectomy. The impact of VATS lobectomy experience on conversion and occurrence of postoperative complications was evaluated using logistic regressions. The impact of VATS lobectomy experience on EuroQoL-5D (EQ-5D) scores at discharge was assessed using Tobit regressions. RESULTS: A total of 11,772 patients underwent planned VATS for non-small-cell lung cancer (NSCLC), with 1074 (9.1%) requiring conversion to thoracotomy. The independent predictors at multivariable analysis were: FEV1% (OR = 0.99; 95% CI: 0.98-0.99, p = 0.007), clinical nodal involvement (OR = 1.43; 95% CI: 1.08-1.90, p = 0.014). Experienced surgeons performed 4079 (34.7%) interventions. Experience in VATS lobectomy did not show a relevant impact on the risk of open surgery conversion (p = 0.13) and postoperative complications (p = 0.10), whereas it showed a significant positive impact (p = 0.012) on EQ-5D scores at discharge. CONCLUSIONS: Clinical nodal involvement was confirmed as the most critical predictor of conversion. Greater experience in VATS lobectomy did not decrease conversion rate and postoperative complications but was positively associated with postoperative patient quality of life.

Cost-effectiveness analysis of personalised versus standard dosimetry for selective internal radiation therapy with TheraSphere in patients with hepatocellular carcinoma.

Aims: To perform a cost-effectiveness analysis (CEA) comparing personalised dosimetry with standard dosimetry in the context of selective internal radiation therapy (SIRT) with TheraSphere for the management of adult patients with locally advanced hepatocellular carcinoma (HCC) from the Italian Healthcare Service perspective. Materials and methods: A partition survival model was developed to project costs and the quality-adjusted life years (QALYs) over a lifetime horizon. Clinical inputs were retrieved from a published randomised controlled trial. Health resource utilisation inputs were extracted from the questionnaires administered to clinicians in three oncology centres in Italy, respectively. Cost parameters were based on Italian official tariffs. Results: Over a lifetime horizon, the model estimated the average QALYs of 1.292 and 0.578, respectively, for patients undergoing personalised and standard dosimetry approaches. The estimated mean costs per patient were €23,487 and €19,877, respectively. The incremental cost-utility ratio (ICUR) of personalised versus standard dosimetry approaches was €5,056/QALY. Conclusions: Personalised dosimetry may be considered a cost-effective option compared to standard dosimetry for patients undergoing SIRT for HCC in Italy. These findings provide evidence for clinicians and payers on the value of personalised dosimetry as a treatment option for patients with HCC.

Pushing the boundaries of evaluation, diffusion, and use of medical devices in Europe: Insights from the COMED project.

The field of medical devices has attracted considerable interest from scholarly research in health economics in recent years. Medical devices are indispensable tools for quality health care delivery, but their assessment and appropriate use pose significant challenges to healthcare systems. More research is needed to overcome existing gaps associated with evaluation of digital technologies, address challenges in the use of real-world data in generating evidence for decision-making and to uncover drivers of variation in access to medical devices across countries. Furthermore, the translation of the results and recommendations stemming from research projects into health technology assessment practices needs to be strengthened. The European Union (EU) project COMED aimed to address these gaps by improving existing research and developing new research streams on the methods for evaluation and diffusion of medical devices. The project also intended to provide directly applicable policy advice and tools to inform decision-making, with the aim of impacting public health in the EU. This Health Economics Supplement, together with references of other published outputs of the project, is intended to be the main source for researchers and policy makers seeking information on the COMED project.

How to improve efficiency in cancer care: Dimensions, methods, and areas of evaluation.

Efficiency in healthcare is crucial since available resources are scarce, and the cost of inefficient allocation is measured in prior outcomes. This is particularly relevant for cancer. The aim of this paper is to gain a comprehensive overview of the areas and dimensions to improve efficiency, and establish the indicators, different methods, perspectives, and areas of evaluation, to provide recommendations for how to improve efficiency and measure gains in cancer care. METHODS: We conducted a two-phase design. First, a comprehensive scoping literature review was conducted, searching four databases. Studies published between 2000 and 2021 were included if they described experiences and cases of efficiency in cancer care or methods to evaluate efficiency. The results of the literature review were then discussed during two rounds of online consultation with a panel of 15 external experts invited to provide insight and comments to deliberate policy recommendations. RESULTS: 46 papers met the inclusion criteria. Based on the papers retrieved we identified six areas for achieving efficiency gains throughout the entire care pathway and, for each area of efficiency, we categorized the methods and outcomes used to measure efficiency gain. CONCLUSION: This is the first attempt to systemize a scattered body of literature on how to improve efficiency in cancer care and identify key areas of improvement. POLICY SUMMARY: There are many opportunities to improve efficiency in cancer care. We defined seven policy recommendations on how to improve efficiency in cancer care throughout the care pathway and how to improve the measurement of efficiency gains.

Recommendations for the design and implementation of an Early Feasibility Studies program for medical devices in the European Union.

INTRODUCTION: Early Feasibility Studies (EFS) are among the pre-market clinical investigations allowed by the International Standard for Clinical investigation of medical devices (MD) for human subjects. The Food and Drug Administration (FDA) introduced an EFS program in the US in 2013. The European Union (EU) MD Regulation, that entered into force in May 2021, opened the possibility of EFS in the EU. However, European countries at present have no standardized procedural framework for EFS. In this paper, we address the desirability of a European EFS program. AREAS COVERED: Characteristics of EFS conducted so far are reviewed, and perceptions of an expert, multidisciplinary panel of key stakeholders are explored regarding desirability and feasibility of a European EFS program and critical factors favoring or hampering its implementation. EXPERT OPINION: Implementing an EFS program in the EU would contribute to creating a favorable environment for early-stage clinical investigations, with positive effects on the quality and timeliness of clinical evidence for novel MDs, and attractiveness of the European system for pre- and post-market clinical research. Based on discussion with experts, also leveraging on the US experience, three dimensions should be considered for effective design and implementation: process, resources, and ethical issues.

Recommendations for developing a lifecycle, multidimensional assessment framework for mobile medical apps.

Digital health and mobile medical apps (MMAs) have shown great promise in transforming health care, but their adoption in clinical care has been unsatisfactory, and regulatory guidance and coverage decisions have been lacking or incomplete. A multidimensional assessment framework for regulatory, policymaking, health technology assessment, and coverage purposes based on the MMA lifecycle is needed. A targeted review of relevant policy documents from international sources was conducted to map current MMA assessment frameworks, to formulate 10 recommendations, subsequently shared amongst an expert panel of key stakeholders. Recommendations go beyond economic dimensions such as cost and economic evaluation and also include MMA development and update, classification and evidentiary requirements, performance and maintenance monitoring, usability testing, clinical evidence requirements, safety and security, equity considerations, organizational assessment, and additional outcome domains (patient empowerment and environmental impact). The COVID-19 pandemic greatly expanded the use of MMAs, but temporary policies governing their use and oversight need consolidation through well-developed frameworks to support decision-makers, producers and introduction into clinical care processes, especially in light of the strong international, cross-border character of MMAs, the new EU medical device and health technology assessment regulations, and the Next Generation EU funding earmarked for health digitalization.

How to Reduce Inequity of Access to Cardiac Rehabilitation After Surgical Aortic Valve Replacement. Recommendations for the Post-COVID-19 Era From a Real-World, Population-Based Study.

PURPOSE: Cardiac rehabilitation (CR) is a class I recommendation after valvular surgery. Few data exist on the level of access to CR after surgical aortic valve replacement (SAVR), and the factors affecting the probability of timely access to CR after SAVR have never been empirically investigated. This study aims at estimating the proportion of SAVR patients who initiated timely CR and understanding to what extent timely access to CR for SAVR patients is influenced by specific characteristics of patients and hospitals. METHODS: We conducted a real-world, retrospective, population-based study by identifying from the Italian National Hospital Discharge Records all the discharged alive SAVR patients who accessed timely CR from 2009-2016. Two different cutoffs for timely access were considered, i.e. one and 21 days after discharge. A unique dataset was constructed by merging several data sources. Multiple logistic regressions were performed to identify the factors influencing the probability to access to timely CR. FINDINGS: 107,545 patients underwent SAVR in Italy from 2009-2016 and were discharged alive. Overall, 71,593 SAVR patients (66.6%) accessed timely CR, with an increasing trend over time. Additional 6,149 patients (5.7%) started CR from 2-21 days after discharge, slightly decreasing over time. The probability of timely CR (one-day cutoff) was significantly higher in older (OR=1.025, p<0.001) female patients (OR = 1.003, p<0.05) and patients with cardiovascular and cerebrovascular comorbidities. Presence of rehabilitation wards and number of rehabilitation beds in the index hospital significantly increased the probability of timely access to CR (OR = 1.105, p<0.001 and OR = 1.006, p<0.001 respectively). Patients hospitalized in private teaching hospitals had the highest predicted probability of timely CR after SAVR. A substantial variation in access to CR was found across Italian regions. Similar results were obtained with the alternative 21-days cutoff. IMPLICATIONS: Approximately one-third of SAVR patients did not benefit from CR in Italy, mainly due to shortness of rehabilitation facilities, with relevant disparities across the country. The cessation of CR services during the COVID-19 pandemic provides the opportunity to re-think and innovate CR, shifting from center-based to home-based models. Digital health technologies can supplement traditional health services and grant safe, effective, and equitable access to care, especially for countries with insufficient rehabilitation bed capacity. As CR is associated with better outcomes, we recommend decision-makers to use our results to plan adequate healthcare services, also investing in digital health, to ensure patients' access to cost-effective care.