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.

Harnessing Digital Health Technologies During and After the COVID-19 Pandemic: Context Matters.

A common development observed during the COVID-19 pandemic is the renewed reliance on digital health technologies. Prior to the pandemic, the uptake of digital health technologies to directly strengthen public health systems had been unsatisfactory; however, a relentless acceleration took place within health care systems during the COVID-19 pandemic. Therefore, digital health technologies could not be prescinded from the organizational and institutional merits of the systems in which they were introduced. The Italian National Health Service is strongly decentralized, with the national government exercising general stewardship and regions responsible for the delivery of health care services. Together with the substantial lack of digital efforts previously, these institutional characteristics resulted in delays in the uptake of appropriate solutions, territorial differences, and issues in engaging the appropriate health care professionals during the pandemic. An in-depth analysis of the organizational context is instrumental in fully interpreting the contribution of digital health during the pandemic and providing the foundation for the digital reconstruction of what is to come after.

High rate of subcutaneous implantable cardioverter-defibrillator sensing screening failure in patients with Brugada syndrome: a comparison with other inherited primary arrhythmia syndromes.

Aims: Subcutaneous implantable cardioverter-defibrillator (S-ICD) can avoid important complications associated with transvenous leads in patients with inherited primary arrhythmia syndromes, who do not need pacing therapy. Few data are available on the percentage of patients with inherited arrhythmia syndromes eligible for S-ICD implantation. Aim of this study was to analyse the eligibility for S-ICD in a series of patients with Brugada syndrome (BrS), and to compare it with patients with other channelopathies. Methods and results: Patients presenting with BrS, long-QT syndrome (LQTS), early repolarization syndrome (ERS), and idiopathic ventricular fibrillation (IVF) were considered eligible for this study. ECG screening was performed by analysis of QRS complex and T wave morphology recorded in standing and supine position. Eligibility was defined when ≥1 sense vector was acceptable in both supine and standing position. A total of 100 patients (72 males; mean age: 46 ± 17 years) underwent S-ICD sensing screening. Sixty-one patients presented with BrS, 21 with LQTS, 14 with IVF, and 4 with ERS. Thirty-four patients with BrS (56%) presented with spontaneous type 1 ECG. In the other 27 patients (44%), type 1 ECG was unmasked by ajmaline. Overall, rate of screening failure was 13%. Patients with BrS had a higher rate of inappropriate morphology analysis as compared with other channelopathies (18% vs. 5%, P = 0.07) and had a lower number of suitable sensing vectors (49.6% vs. 84.7% vs. P < 0.001). Ajmaline challenge unmasked sensing failure in 14.8% of drug-induced BrS patients previously considered eligible. In all patients, the reason for sensing inappropriateness was due to the presence of high T wave voltages. Conclusion: S-ICD screening failure occurs in up to 13% of patients with inherited primary arrhythmia syndromes. Patients with BrS present a higher rate of screening failure as compared with other cardiac channelopathies.

Analysis of High-Density Surface EMG and Finger Pressure in the Left Forearm of Violin Players: A Feasibility Study.

Wrist and finger flexor muscles of the left hand were evaluated using high-density surface EMG (HDsEMG) in 17 violin players. Pressure sensors also were mounted below the second string of the violin to evaluate, simultaneously, finger pressure. Electrode grid size was 110x70 mm (12x8 electrodes with interelectrode distance=10 mm and Ø=3 mm). The study objective was to observe the activation patterns of these muscles while the violinists sequentially played four notes--SI (B), DO# (C#), RE (D), MI (E)--at 2 bows/s (one bow up in 0.5 s and one down in 0.5 s) and 4 bows/s on the second string, while producing a constant (CONST) or ramp (RAMP) sound volume. HDsEMG images obtained while playing the notes were compared with those obtained during isometric radial or ulnar flexion of the wrist or fingers. Two image descriptors provided information on image differences. Results showed that the technique was reliable and provided reliable signals, and that recognizably different sEMG images could be associated with the four notes tested, despite the variability within and between subjects playing the same note. sEMG activity of the left hand muscles and pressure on the string in the RAMP task were strongly affected in some individuals by the sound volume (controlled by the right hand) and much less in other individuals. These findings question whether there is an individual or generally optimal way of pressing violin strings with the left hand. The answer to this question might substantially modify the teaching of string instruments.

Management of ventricular tachycardia in the setting of a dedicated unit for the treatment of complex ventricular arrhythmias: long-term outcome after ablation.

BACKGROUND: We investigated the impact of catheter ablation on ventricular tachycardia (VT) recurrence and survival in a large number of patients with structural heart disease treated in the setting of a dedicated multiskilled unit. METHODS AND RESULTS: Since January 2007, we have implemented a multidisciplinary model, aiming for a comprehensive management of VT patients. Programmed ventricular stimulation was used to assess acute outcome. Primary end points were VT recurrence and the occurrence of cardiac and sudden cardiac death. Overall, 528 patients were treated by ablation (634 procedures; 1-4 procedures per patient). Among 482 tested with programmed ventricular stimulation after the last procedure, a class A result (noninducibility of any VT) was obtained in 371 patients (77%), class B (inducibility of nondocumented VT) in 12.4%, and class C (inducibility of index VT) in 10.6%. After a median follow-up time of 26 months, VT recurred in 164 (34.1%) of 472 patients. VT recurrence was documented in 28.6% of patients with a class A result versus 39.6% of patients with class B and 66.7% with class C result (log-rank P<0.001). The incidence of cardiac mortality was lower in class A patients than in those with class B and class C (8.4% versus 18.5% versus 22%, respectively; log-rank P=0.002). On the basis of multivariate analysis, postprocedural inducibility of index VT was independently associated both with VT recurrence (hazard ratio, 4.030; P<0.001) and with cardiac mortality (hazard ratio, 2.099; P=0.04). CONCLUSIONS: Within a dedicated VT unit, catheter ablation prevents long-term VT recurrences, which may favorably affect survival in a large number of patients who have VT.

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.

Implementation of Machine Learning Applications in Health Care Organizations: Protocol for a Systematic Review of Empirical Studies.

BACKGROUND: An increasing interest in machine learning (ML) has been observed among scholars and health care professionals. However, while ML-based applications have been shown to be effective and have the potential to change the delivery of patient care, their implementation in health care organizations is complex. There are several challenges that currently hamper the uptake of ML in daily practice, and there is currently limited knowledge on how these challenges have been addressed in empirical studies on implemented ML-based applications. OBJECTIVE: The aim of this systematic literature review is twofold: (1) to map the ML-based applications implemented in health care organizations, with a focus on investigating the organizational dimensions that are relevant in the implementation process; and (2) to analyze the processes and strategies adopted to foster a successful uptake of ML. METHODS: We developed this protocol following the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) guidelines. The search was conducted on 3 databases (PubMed, Scopus, and Web of Science), considering a 10-year time frame (2013-2023). The search strategy was built around 4 blocks of keywords (artificial intelligence, implementation, health care, and study type). Based on the detailed inclusion criteria defined, only empirical studies documenting the implementation of ML-based applications used by health care professionals in clinical settings will be considered. The study protocol was registered in PROSPERO (International Prospective Register of Systematic Reviews). RESULTS: The review is ongoing and is expected to be completed by September 2023. Data analysis is currently underway, and the first results are expected to be submitted for publication in November 2023. The study was funded by the European Union within the Multilayered Urban Sustainability Action (MUSA) project. CONCLUSIONS: ML-based applications involving clinical decision support and automation of clinical tasks present unique traits that add several layers of complexity compared with earlier health technologies. Our review aims at contributing to the existing literature by investigating the implementation of ML from an organizational perspective and by systematizing a conspicuous amount of information on factors influencing implementation. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47971.

Promoting the systematic use of real-world data and real-world evidence for digital health technologies across Europe: a consensus framework.

Despite the acceleration in the use of digital health technologies across different aspects of the healthcare system, the full potential of real-world data (RWD) and real-world evidence (RWE) arising from the technologies is not being utilised in decision-making. We examine current national efforts and future opportunities to systematically use RWD and RWE in decision-making in five countries (Estonia, Finland, Germany, Italy and the United Kingdom), and then develop a framework for promotion of the systematic use of RWD and RWE. A review assesses current national efforts, complemented with a three-round consensus-building exercise among an international group of experts (n1 = 44, n2 = 24, n3 = 24) to derive key principles. We find that Estonia and Finland have invested and developed digital health-related policies for several years; Germany and Italy are the more recent arrivals, while the United Kingdom falls somewhere in the middle. Opportunities to promote the systematic use of RWD and RWE were identified for each country. Eight building blocks principles were agreed through consensus, relating to policy scope, institutional role and data collection. Promoting post-market surveillance and digital health technology vigilance ought to rely on clarity in scope and data collection with consensus reached on eight principles to leverage RWD and RWE.

Late potentials abolition as an additional technique for reduction of arrhythmia recurrence in scar related ventricular tachycardia ablation.

RATIONALE: To evaluate the efficacy of radiofrequency ventricular tachycardia (VT) ablation targeting complete late potential (LP) activity. METHODS AND RESULTS: Sixty-four consecutive patients (pts) with recurrent VTs and coronary artery disease or idiopathic dilated cardiomyopathy were evaluated. Fifty patients (47 male; 66.2 ± 10.1 years) had LPs at electroanatomical mapping; 35 patients had at least 1 VT inducible at basal programmed stimulation. After substrate mapping, radiofrequency ablation was performed with the endpoint of all LPs abolition. LPs could not be abolished in 5 patients despite extensive ablation, in 1 patient because of localization near an apical thrombus, and in 2 patients because of possible phrenic nerve injury. At the end of procedure, prevention of VT inducibility was achieved in 25 of 35 patients (71.4%) with previously inducible VT; VT was still inducible in 5 of 8 patients with incomplete LP abolition; and in 5 of 42 patients (16.1%) with complete LP abolition (P < 0.01). After a follow-up of 13.4 ± 4.0 months, 10 patients (20.0%) had VT recurrences and one of them died after surgical VT ablation; VT recurrence was 9.5% in patients with LPs abolition (4/42 pts) and 75.0% (6/8 pts) in those with incomplete abolition [positive predictive value (PPV): 75%, negative predictive value (NPV): 90.4%, sensibility: 60.0%, and specificity: 95.0%, P < 0.0001); although it was 12.5% (5/40 pts) in patients without inducibility VT after the ablation, and 50% (5/10 pts) in those with inducible VT (PPV: 50%, NPV: 87.5%, sensitivity: 50.0%, and specificity: 87.5%, P = 0.008). CONCLUSIONS: LP abolition is an effective endpoint of VT ablation and its prognostic value compares favorably to that achieved by programmed electrical stimulation.

Therapeutic innovation in high-prevalence chronic diseases: Challenges and opportunities for specialist care models.

Therapeutic innovation is expected to change if not disrupt present care models for several chronic diseases in the coming years, as suggested by recent clinical trials. New drugs that anticipate and possibly delay the full expression of a disease will likely face some common challenges, such as the need of designing and implementing large scale interventions; the necessary engagement of multiple specialties for both diagnosis and treatment; the shift from specialist to non-specialist interventions and secondary prevention. Building on the case of HCV and other innovation in hepatology, we discuss common challenges caused by disruptive change that other chronic conditions faced in the past. The recent history of hepatology shows interesting examples of disruptive innovations that completely reverted traditional treatment approaches. As we learned from the slow early diffusion of antiviral drugs, without a clear information and a prompt design of the appropriate delivery modalities, the effectiveness of new treatments is undermined and care risk to be postponed for long time. This implies the definition of (i) new service models diversified by care phases and patients' target; (ii) horizontal integration: to go beyond the professional boundaries to build solid alliances; (iii) vertical integration between primary and secondary care.

Welcoming teleretinography into diabetes integrated care.

Integrated Care (IC) is a perfect fit for people with diabetes. Fundus examination (FE) is a disease marker for diabetologists and identifies potentially blinding complications (Diabetic Retinopathy, DR). In our Diabetes Clinic (DC) in Pescara, Italy, FE is possibly provided with telemedicine in same day as other exams, avoiding it to be a standalone clinical one; images taken with a retinal digital camera are graded by a remote ophthalmologist within a shared Electronic Health Record (EHR), immediately readable by other stakeholders; a dedicated care path to the Eye Clinic, University of Chieti-Pescara is provided for urgent cases. Personnel's worktime shortening allows gaining time for ophthalmologists' eye examinations in outpatient settings and other stakeholders' work in the DC. The need for a DR digital screening system is growing worldwide: our experience confirms the ease of implementation, and the advantage of sharing clinical data with all stakeholders when working within an EHR, aiming to optimize an IC effective system.

Development features and study characteristics of mobile health apps in the management of chronic conditions: a systematic review of randomised trials.

COVID-19 pandemic challenges have accelerated the reliance on digital health fuelling the expanded incorporation of mobile apps into healthcare services, particularly for the management of long-term conditions such as chronic diseases (CDs). However, the impact of health apps on outcomes for CD remains unclear, potentially owing to both the poor adoption of formal development standards in the design process and the methodological quality of studies. A systematic search of randomised trials was performed on Medline, ScienceDirect, the Cochrane Library and Scopus to provide a comprehensive outlook and review the impact of health apps on CD. We identified 69 studies on diabetes (n = 29), cardiovascular diseases (n = 13), chronic respiratory diseases (n = 13), cancer (n = 10) or their combinations (n = 4). The apps rarely adopted developmental factors in the design stage, with only around one-third of studies reporting user or healthcare professional engagement. Apps differed significantly in content, with a median of eight behaviour change techniques adopted, most frequently pertaining to the 'Feedback and monitoring' (91%) and 'Shaping knowledge' (72%) categories. As for the study methodologies, all studies adopted a traditional randomised control trial (RCT) design, with relatively short follow-ups and limited sample sizes. Findings were not significant for the majority of studies across all CD, with most RCTs revealing a high risk of bias. To support the adoption of apps for CD management, this review reinforces the need for more robust development and appropriate study characteristics to sustain evidence generation and elucidate whether study results reflect the true benefits of apps or a biased estimate due to unsuitable designs.

Distinguishing features in the assessment of mHealth apps.

Introduction: The unparalleled surge in digital health adoption during the COVID-19 pandemic has emphasized the potential of mHealth apps. However, the quality of available evidence is generally low, and regulatory frameworks have focused on apps with medical purposes only, overlooking apps with significant interactions with patients that may require stronger oversight.Areas covered: To support this expanded evidence generation process, we identified the reasons that distinguish mHealth apps compared to medical devices at large and that should differentially feature their assessment. mHealth apps are characterized by the iterative nature of the corresponding interventions, frequent user interactions with a non-linear relationship between technology usage, engagement and outcomes, significant organizational implications, as well as challenges associated with genericization, their broad diagnostic potential, and price setting.Expert Opinion: The renewed reliance experienced during the pandemic and the unprecedented injection of resources through recovery instruments can further boost the development of apps. Only robust evidence of the benefits of mHealth apps will persuade health-care professionals and beneficiaries to systematically deploy them. Regulatory bodies will need to question their current approaches by adopting comprehensive evaluation processes that adequately consider the specific features of mHealth apps.

Role of Breast-Conserving Surgery on the National Health System Economy From and to SARS-COVID-19 Era.

Day surgery breast-conserving surgery (DS-BCS) is a surgical approach applied in many specialized breast surgery departments. This study demonstrates the benefits of this approach from the perspectives of patients and of the Hospital/National Health System compared to ordinary breast-conserving surgery (ORD-BCS) under general anesthetic. A comparison of costs and diagnosis-related group (DRG) reimbursement demonstrated improved cost-effectiveness in DS-BCS compared to ORD-BCS.

An Electronic Patient-Reported Outcome Mobile App for Data Collection in Type A Hemophilia: Design and Usability Study.

BACKGROUND: There is currently limited evidence on the level and intensity of physical activity in individuals with hemophilia A. Mobile technologies can offer a rigorous and reliable alternative to support data collection processes but they are often associated with poor user retention. The lack of longitudinal continuity in their use can be partly attributed to the insufficient consideration of stakeholder inputs in the development process of mobile apps. Several user-centered models have been proposed to guarantee that a thorough knowledge of the end user needs is considered in the development process of mobile apps. OBJECTIVE: The aim of this study is to design and validate an electronic patient-reported outcome mobile app that requires sustained active input by individuals during POWER, an observational study that aims at evaluating the relationship between physical activity levels and bleeding in patients with hemophilia A. METHODS: We adopted a user-centered design and engaged several stakeholders in the development and usability testing of this mobile app. During the concept generation and ideation phase, we organized a need-assessment focus group (FG) with patient representatives to elicit specific design requirements for the end users. We then conducted 2 exploratory FGs to seek additional inputs for the app's improvement and 2 confirmatory FGs to validate the app and test its usability in the field through the mobile health app usability questionnaire. RESULTS: The findings from the thematic analysis of the need-assessment FG revealed that there was a demand for sense making, for simplification of app functionalities, for maximizing integration, and for minimizing the feeling of external control. Participants involved in the later stages of the design refinement contributed to improving the design further by upgrading the app's layout and making the experience with the app more efficient through functions such as chatbots and visual feedback on the number of hours a wearable device had been worn, to ensure that the observed data were actually registered. The end users rated the app highly during the quantitative assessment, with an average mobile health app usability questionnaire score of 5.32 (SD 0.66; range 4.44-6.23) and 6.20 (SD 0.43; range 5.72-6.88) out of 7 in the 2 iterative usability testing cycles. CONCLUSIONS: The results of the usability test indicated a high, growing satisfaction with the electronic patient-reported outcome app. The adoption of a thorough user-centered design process using several types of FGs helped maximize the likelihood of sustained retention of the app's users and made it fit for data collection of relevant outcomes in the observational POWER study. The continuous use of the app and the actual level of engagement will be evaluated during the ongoing trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT04165135; https://clinicaltrials.gov/ct2/show/NCT04165135.

The impact of food reformulation on nutrient intakes and health, a systematic review of modelling studies.

BACKGROUND: Unhealthy diet is a risk factor for adverse health outcomes. Reformulation of processed foods has the potential to improve population diet, but evidence of its impact is limited. The purpose of this review was to explore the impact of reformulation on nutrient intakes, health outcomes and quality of life; and to evaluate the quality of modelling studies on reformulation interventions. METHODS: A systematic review of peer-reviewed articles published between January 2000 and December 2017 was performed using MEDLINE, ScienceDirect, Embase, Scopus, Cochrane, and the Centre for Reviews and Dissemination of the University of York. Additional studies were identified through informal searches on Google and specialized websites. Only simulation studies modelling the impact of food reformulation on nutrient intakes and health outcomes were included. Included articles were independently extracted by 2 reviewers using a standardized, pre-piloted data form, including a self-developed tool to assess study quality. RESULTS: A total of 33 studies met the selected inclusion criteria, with 20, 5 and 3 studies addressing sodium, sugar and fats reformulation respectively, and 5 studies addressing multiple nutrients. Evidence on the positive effects of reformulation on consumption and health was stronger for sodium interventions, less conclusive for sugar and fats. Study features were highly heterogeneous including differences in methods, the type of policy implemented, the extent of the reformulation, and the spectrum of targeted foods and nutrients. Nonetheless, partial between-study comparisons show a consistent relationship between percentages reformulated and reductions in individual consumption. Positive results are also shown for health outcomes and quality of life measures, although comparisons across studies are limited by the heterogeneity in model features and reporting. Study quality was often compromised by short time-horizons, disregard of uncertainty and time dependencies, and lack of model validation. CONCLUSIONS: Reformulation models highlight relevant improvements in diets and population health. While models are valuable tools to evaluate reformulation interventions, comparisons are limited by non-homogeneous designs and assumptions. The use of validated models and extensive scenario analyses would improve models' credibility, providing useful insights for policy-makers. REVIEW REGISTRATION: A research protocol was registered within the PROSPERO database (ID number CRD42017057341).

Correction to: The impact of food reformulation on nutrient intakes and health, a systematic review of modelling studies.

[This corrects the article DOI: 10.1186/s40795-018-0263-6.].

Mobile Health Divide Between Clinicians and Patients in Cancer Care: Results From a Cross-Sectional International Survey.

BACKGROUND: Mobile technologies are increasingly being used to manage chronic diseases, including cancer, with the promise of improving the efficiency and effectiveness of care. Among the myriad of mobile technologies in health care, we have seen an explosion of mobile apps. The rapid increase in digital health apps is not paralleled by a similar trend in usage statistics by clinicians and patients. Little is known about how much and in what ways mobile health (mHealth) apps are used by clinicians and patients for cancer care, what variables affect their use of mHealth, and what patients' and clinicians' expectations of mHealth apps are. OBJECTIVE: This study aimed to describe the patient and clinician population that uses mHealth in cancer care and to provide recommendations to app developers and regulators to generally increase the use and efficacy of mHealth apps. METHODS: Through a cross-sectional Web-based survey, we explored the current utilization rates of mHealth in cancer care and factors that explain the differences in utilization by patients and clinicians across the United States and 5 different countries in Europe. In addition, we conducted an international workshop with more than 100 stakeholders and a roundtable with key representatives of international organizations of clinicians and patients to solicit feedback on the survey results and develop insights into mHealth app development practices. RESULTS: A total of 1033 patients and 1116 clinicians participated in the survey. The proportion of cancer patients using mHealth (294/1033, 28.46%) was far lower than that of clinicians (859/1116, 76.97%). Accounting for age and salary level, the marginal probabilities of use at means are still significantly different between the 2 groups and were 69.8% for clinicians and 38.7% for patients using the propensity score-based regression adjustment with weighting technique. Moreover, our analysis identified a gap between basic and advanced users, with a prevalent use for activities related to the automation of processes and the interaction with other individuals and a limited adoption for side-effect management and compliance monitoring in both groups. CONCLUSIONS: mHealth apps can provide access to clinical and economic data that are low cost, easy to access, and personalized. The benefits can go as far as increasing patients' chances of overall survival. However, despite its potential, evidence on the actual use of mobile technologies in cancer care is not promising. If the promise of mHealth is to be fulfilled, clinician and patient usage rates will need to converge. Ideally, cancer apps should be designed in ways that strengthen the patient-physician relationship, ease physicians' workload, be tested for validity and effectiveness, and fit the criteria for reimbursement.

Lung Cancer App (LuCApp) study protocol: a randomised controlled trial to evaluate a mobile supportive care app for patients with metastatic lung cancer.

INTRODUCTION: Mobile health technologies may enhance patient empowerment and data integration along the whole care continuum. However, these interventions pose relatively new regulatory, organisational and technological challenges that limit appropriate evaluation. Lung Cancer App (LuCApp) is a mobile application developed by researchers and clinicians to promote real-time monitoring and management of patients' symptoms. This protocol illustrates a clinical trial designed to evaluate the usability, effectiveness and cost-effectiveness of LuCApp versus standard of care. METHODS AND ANALYSIS: This is a 24-week two-arm non-blinded multicentre parallel randomised controlled trial. A total of 120 adult patients diagnosed with small or non-small cell lung cancer and eligible for pharmaceutical treatments will be allocated 1:1 to receiving either standard care or LuCApp in addition to standard care at three oncology sites in Northern Italy. During the treatment period, LuCApp allows daily monitoring and grading of a list of symptoms, which trigger alerts to the physicians in case predefined severity thresholds are met. Patients will complete a baseline assessment and a set of valid and reliable patient-reported outcome measures every 3±1 weeks, and up to 24 weeks. The primary outcome is the change in the score of the Trial Outcome Index in the Functional Assessment of Cancer Therapy (Lung) questionnaire from baseline to 12 weeks. Secondary outcomes are the Lung Cancer Subscale, the EuroQoL 5D-5L questionnaire, the Hospital Anxiety and Depression Scale, the Supportive Care Needs Survey Short Form, the app usability questionnaire and the Zarit Burden Interview for the main caregiver. ETHICS AND DISSEMINATION: The trial received ethical approval from the three clinical sites. Trial results will be disseminated through peer-reviewed publications and conference presentations. CONCLUSIONS: This trial makes a timely contribution to test a mobile application designed to improve the quality of life and delivery of care for patients with lung cancer. TRIAL REGISTRATION NUMBER: NCT03512015; Pre-results.

Access Sites for TAVI: Patient Selection Criteria, Technical Aspects, and Outcomes.

During the last ten years, transcatheter aortic valve implantation (TAVI) has become a reliable and valid alternative treatment for elderly patients with severe symptomatic aortic valve stenosis requiring valve replacement and being at high or intermediate surgical risk. While common femoral arteries are the access site of choice in the vast majority of TAVI patients, in up to 15-20% of TAVI candidates this route might be precluded due to the presence of diffuse atherosclerotic disease, tortuosity or small vessel diameter. Therefore, in order to achieve an antegrade or retrograde implant, several alterative access routes have been described, namely trans-axillary, trans-aortic, trans-apical, trans-carotid, trans-septal, and trans-caval. The aim of this paper is to give a concise overview on vascular access sites for TAVI, with a particular focus on patient's selection criteria, imaging, technical aspects, and clinical outcome.