A participatory process to design an app to improve adherence to anti-osteoporotic therapies: A development and usability study.

Objective: The aim of the study was to develop an app to improve patients' adherence to therapy for osteoporosis and to test its usability. Methods: In Phase I, the app functions needed to improve medication adherence were identified through a focus group with six patients with osteoporosis and a joint interview with two bone specialists. The app prototype was then developed (Phase II) and refined after its feasibility testing (Phase III) for 13-25 days by eight patients. Finally, the app underwent usability testing (Phase IV) for 6 months by nine other patients. The mHealth App Usability Questionnaire (MAUQ) was used to collect the assessment of the app by the 17 patients. Results: The final version of the app provided information on osteoporosis, allowed patients to contact the bone specialist for an additional consultation, and generated a reminder for taking medications accompanied by feedback on adherence. The assessment of the app was positive but evaluations differed between the feasibility and usability testing, with the former displaying a significantly (p ≤ .05) better assessment across all MAUQ items. Conclusions: In this study, we tested an app for improving adherence to medical therapies in patients with osteoporosis. The usability testing revealed a lower "patient-centered" performance of the app as compared to that observed during the feasibility phase. Future developments of the study include increasing the testing cohort and adding a technical support during the usability testing.

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.

Patient characteristics associated with the acceptability of teleconsultation: a retrospective study of osteoporotic patients post-COVID-19.

BACKGROUND: Due to the COVID-19 pandemic, teleconsultations (TCs) have become common practice for many chronic conditions, including osteoporosis. While satisfaction with TCs among patients increases in times of emergency, we have little knowledge of whether the acceptability of TCs persists once in-person visits return to being a feasible and safe option. In this study, we assess the acceptability of TCs across five dimensions for osteoporosis care among patients who started or continued with TCs after the COVID-19 pandemic had waned. We then explore the patient characteristics associated with these perceptions. METHODS: Between January and April 2022, 80 osteoporotic patients treated at the Humanitas Hospital in Milan, Italy, were recruited to answer an online questionnaire about the acceptability of TCs for their care. The acceptability of TCs was measured using a modified version of the Service User Technology Acceptability Questionnaire (SUTAQ), which identifies five domains of acceptability: perceived benefits, satisfaction, substitution, privacy and discomfort, and care personnel concerns. Multivariable ordinary least squares (OLS) linear regression analysis was performed to assess which patient characteristics in terms of demographics, socio-economic conditions, digital skills, social support, clinical characteristics and pattern of TC use were correlated with the five domains of acceptability measured through the SUTAQ. RESULTS: The degree of acceptability of TCs was overall good across the 80 respondents and the five domains. Some heterogeneity in perceptions emerged with respect to TCs substituting for in-person visits, negatively impacting continuity of care and reducing the length of consultations. For the most part, acceptability was not affected by patient characteristics with a few exceptions related to treatment time and familiarity with the TC service modality (i.e., length of osteoporosis treatment and number of TCs experienced by the patient). CONCLUSIONS: TCs appear to be an acceptable option for osteoporosis care in the aftermath of the COVID-19 pandemic. This study suggests that other characteristics besides age, digital skills and social support, which are traditionally relevant to TC acceptability, should be taken into account in order to better target this care delivery modality.

Response to COVID-19: was Italy (un)prepared?

On 31st January 2020, the Italian cabinet declared a 6-month national emergency after the detection of the first two COVID-19 positive cases in Rome, two Chinese tourists travelling from Wuhan. Between then and the total lockdown introduced on 22nd March 2020 Italy was hit by an unprecedented crisis. In addition to being the first European country to be heavily swept by the COVID-19 pandemic, Italy was the first to introduce stringent lockdown measures. The SARS-CoV-2 outbreak and related COVID-19 pandemic have been the worst public health challenge endured in recent history by Italy. Two months since the beginning of the first wave, the estimated excess deaths in Lombardy, the hardest hit region in the country, reached a peak of more than 23,000 deaths. The extraordinary pressures exerted on the Italian Servizio Sanitario Nazionale (SSN) inevitably leads to questions about its preparedness and the appropriateness and effectiveness of responses implemented at both national and regional levels. The aim of the paper is to critically review the Italian response to the COVID-19 crisis spanning from the first early acute phases of the emergency (March-May 2020) to the relative stability of the epidemiological situation just before the second outbreak in October 2020.

Corona-regionalism? Differences in regional responses to COVID-19 in Italy.

The paper discusses the responses to the COVID-19 crisis in the acute phase of the first wave of the pandemic (February-May 2020) by different Italian regions in Italy, which has a decentralised healthcare system. We consider five regions (Lombardy, Veneto, Emilia-Romagna, Umbria, Apulia) which are located in the north, centre and south of Italy. These five regions differ both in their healthcare systems and in the extent to which they were hit by the first wave of COVID-19 pandemic. We investigate their different responses to COVID-19 reflecting on seven management factors: (1) monitoring, (2) learning, (3) decision-making, (4) coordinating, (5) communicating, (6) leading, and (7) recovering capacity. In light of these factors, we discuss the analogies and differences among the regions and their different institutional choices.

When peers count: The effects on integrated type II diabetes care of communication within general practitioner-only subgroups in interprofessional primary care teams.

BACKGROUND: Primary care teams (hereafter referred to as primary care units [PCUs]) composed of general practitioners (GPs), nurses, and specialist doctors have recently been established in the Italian context, with the main aim of improving integrated care for chronic diseases. PURPOSES: The aim of the study was to assess whether the increased professional diversity of PCUs has resulted in an improvement in the integrated care of type II diabetes and to identify a potential mechanism mediating this effect. METHODOLOGY/APPROACH: We analyzed 213 PCUs, comparing their performance in integrated type II diabetes care at two time points. Using social categorization theory and a fixed effects regression analysis, we tested a mediation model in which the frequency of communication among GPs in the PCUs, that is, within-subgroup communication, mediates the relationship between PCU professional diversity and team performance in diabetes care. FINDINGS: We show that when the professional diversity of the PCUs increases, integrated care of type II diabetes improves and better meets the standards of optimal care. Within-GP subgroup communication works as a mediating mechanism that translates the PCU professional diversity into better team performance. The mediation effect, however, is curvilinear. Beyond certain levels, within-subgroup communication can hamper PCUs' capacity to work collaboratively in integrated type II diabetes care. PRACTICE IMPLICATIONS: The article suggests that, when creating interprofessional primary care teams, managers might be able to steer teams toward a better performance by encouraging communication among peers of the same profession.

Multiprofessional Primary Care Units: What Affects the Clinical Performance of Italian General Practitioners?

Multiprofessional primary care models promise to deliver better care and reduce waste. This study evaluates the impact of such a model, the primary care unit (PCU), on three outcomes. A multilevel analysis within a "pre- and post-PCU" study design and a cross-sectional analysis were conducted on 215 PCUs located in the Emilia-Romagna region in Italy. Seven dimensions captured a set of processes and services characterizing a well-functioning PCU, or its degree of vitality. The impact of each dimension on outcomes was evaluated. The analyses show that certain dimensions of PCU vitality (i.e., the possibility for general practitioners to meet and share patients) can lead to better outcomes. However, dimensions related to the interaction and the joint works of general practitioners with other professionals tend not to have a significant or positive impact. This suggests that more effort needs to be invested to realize all the potential benefits of the PCU's multiprofessional approach to care.

Genetic screening for the predisposition to venous thromboembolism: a cost-utility analysis of clinical practice in the Italian health care system.

OBJECTIVES: In the Italian health care system, genetic tests for factor V Leiden and factor II are routinely prescribed to assess the predisposition to venous thromboembolism (VTE) of women who request oral contraception. With specific reference to two subpopulations of women already at risk (i.e., familial history or previous event of VTE), the study aimed to assess whether current screening practices in Italy are cost-effective. METHODS: Two decisional models accrued costs and quality-adjusted life-years (QALY) annually from the perspective of the National Health Service. The two models were derived from a decision analysis exercise concerning testing practices and consequent prescribing behavior for oral contraception conducted with 250 Italian gynecologists. Health care costs were compiled on the basis of 10-year hospital discharge records and the activities of a thrombosis center. Whenever possible, input data were based on the Italian context; otherwise, the data were taken from the international literature. RESULTS: Current testing practices on women with a familial history of VTE generate an incremental cost-effectiveness ratio of €72,412/QALY, which is well above the acceptable threshold of cost-effectiveness of €40,000 to €50,000/QALY. In the case of women with a previous event of VTE, the most frequently used testing strategy is cost-ineffective and leads to an overall loss of QALY. CONCLUSIONS: This study represents the first attempt to conduct a cost-utility analysis of genetic screening practices for the predisposition to VTE in the Italian setting. The results indicate that there is an urgent need to better monitor the indications for which tests for factor V Leiden and factor II are prescribed.

Sustaining universal health coverage: the interaction of social, political, and economic sustainability.

The sustainability of health care systems, particularly those supporting universal health care, is a matter of current discussion among policymakers and scholars. In this article, we summarize the controversies around the economic sustainability of health care. We attempt to extend the debate by including a more comprehensive conceptualization of sustainability in relation to health care systems and by examining the dimensions of social and political sustainability. In conclusion, we argue that policymakers when taking decisions around universal health care should carefully consider issues of social, political, and economic sustainability, their interaction, and often their inherent trade-offs.

General practitioners' adherence to evidence-based guidelines: a multilevel analysis.

BACKGROUND: The growing burden of chronic diseases encourages health care systems to shift services and resources toward primary care. In this sector, general practitioners (GPs) play a key role, and several collaborative organizational models have been implemented in the attempt to improve the clinical effectiveness of GPs, their adherence to evidence-based guidelines, and their capacity to work in multiprofessional teams. However, evidence of the impact of different organizational models is sparse, and little is known about the contribution of these models to the good management of chronic diseases. PURPOSE: The aim of this study was to examine the relationship of individual sociodemographic characteristics of GPs and collaborative organizational models with the adherence of physicians to evidence-based guidelines for four major chronic diseases (diabetes, heart failure, stroke, and post-acute myocardial infarction). METHODOLOGY: Evidence-based indicators for the management of the selected chronic diseases were identified on the basis of the most recent international guidelines. Multilevel logistic regression models were used to identify the correlates of adherence to guidelines, taking into account patient characteristics and comorbidities. FINDINGS: Participation in group practice was associated with different indicators of adherence to guidelines for the management of diabetes and one indicator of post-acute myocardial infarction, whereas other organizational arrangements were linked to GPs' clinical behavior to a lesser degree. Female gender and younger age of GPs were associated with good management of diabetes. PRACTICE IMPLICATIONS: The relative impact of efforts at organizational design in primary care should be evaluated in more detail before further investments are made in this direction. Our findings suggest that the professional attitude of GPs (of which gender and age can be considered proxies) is equally, if not more, important than their organizational arrangement. Hence, attention should be paid to how organizations and managerial tools can support the consolidation and spread of this attitude.

The interplay between policy guidelines and local dynamics in shaping the scope of networks: the experience of the Italian Departments of Mental Health.

In the mental health field, the creation of networks that can guarantee the smooth coordination of services and organizations across sectors is a priority in the policy agenda of several countries. In Italy, Departments of Mental Health (DMHs) have been designated responsible for the system of specialist mental health services, and also mandated as the conveners and leaders of interorganizational and cross-sectoral networks, by a system-wide reform. This study aims to understand how mental health networks have been assembled in this context and the factors and motivations that have shaped their scope. By combining an analysis of policies with a survey of DMH directors, we have determined that DMHs have preferentially formed collaborative relationships with social service providers (local governments) and the voluntary sector. In contrast, relationships with substance abuse and addiction services and primary care providers were weak and stifled by a lack of trust and by conflict about respective contributions to mental care. We explore the reasons for this selectivity in interorganizational relationships and propose that a lack of targeted incentives in policy guidelines, on the one hand, and the existence of a mandated network leadership, on the other, have led to a rather narrow range of collaborations.

Explaining the unexpected success of the smoking ban in Italy: political strategy and transition to practice, 2000­2005.

The approval (2003) and enforcement (2005) of a smoking ban in Italy have been viewed by many as an unexpectedly successful example of policy change. The present paper, by applying a processualist approach, concentrates on two policy cycles between 2000 and 2005. These had opposing outcomes: an incomplete decisional stage and an authoritative decision, enforced two years later. Through the analysis of the different phases of agenda setting, alternative specification and decision making, we have compared the quality of participation of policy entrepreneurs in the two cycles, their political strategies and, in these, the relevance of issue image. The case allows us to direct the attention of scholars and practitioners to an early phase of the policy implementation process ­ which we have named "transition to practice". This, managed with political strategy, might have strongly contributed to the final successful policy outcome.

Orphan drug legislation: lessons for neglected tropical diseases.

In the last 20 years, orphan drug legislation (ODL) has been adopted in several countries around the world (USA, Japan, Australia, and the European Union) and has successfully promoted R&D investments to develop new pharmaceutical products for the treatment of rare diseases. Without these incentives, many life-saving new drugs would have not been developed and produced. For economic reasons, the development of medicines for the treatment of diseases prevalent in the developing world (or tropical diseases) is lagging behind. Among several factors, the low average per-capita income makes pharmaceutical markets in developing countries appear relatively unprofitable and therefore unattractive for R&D-oriented companies. The case of ODL may offer some useful insights and perspectives for the fight against neglected tropical diseases. First, the measures used in ODL may also be effective in boosting R&D for neglected tropical diseases, if appropriately adapted to this market. Second, small-sized companies, which have played a successful role in the development of orphan drugs for rare diseases, may also represent a good business strategy for the case of tropical diseases.

Avoiding adverse drug reactions by pharmacogenetic testing: a systematic review of the economic evidence in the case of TPMT and AZA-induced side effects.

OBJECTIVES: The study aims at evaluating the economic evidence related to testing for genetic variants of the drug-metabolizing enzyme, TPMT. Detecting TPMT genetic variants before the administration of azathioprine (AZA) has the potential to prevent serious and costly adverse drug reactions (ADRs), such as neutropenia. In particular, our analysis concentrated on assessing the reliability of data on costs of neutropenia and performing the tests, the two main cost categories that could inform an economic evaluation of TPMT pharmacogenetic testing. METHODS: A systematic literature review was performed to gather evidence on the costs of testing and neutropenia. Articles were critically appraised for their comprehensiveness and quality. To better estimate costs of TPMT tests, a small-scale survey of European diagnostic laboratories was conducted. RESULTS: Only seven articles were retrieved specifying the costs associated with the management and treatment of AZA-induced neutropenia. Most of these studies are based on theoretical modeling reconstructed with key-informants or on very few cases of ADRs, and either the methodology for cost calculation is not specified or costs are based on national cost databases and tariffs. After critical appraisal of these studies, we considered 2,116 euros as the most reliable estimate for the cost of a case of neutropenia. Literature review accompanied by the survey of several diagnostic laboratories also provided an estimate (68 euros) for TPMT testing. Based on these values, the net cost per prevented case of neutropenia equals to 5,300 euros. CONCLUSIONS: Solid economic considerations related to TPMT pharmacogenetic testing are still limited by underreporting of ADRs and high level of approximation related to cost data. Ad hoc observational studies and the ADR recording process embedded in pharmacovigilance systems, established across Europe, should represent more reliable sources of cost data in the future.

Pharmaceutical companies and Italian Regional Governments: managing relationships in an increasing institutional complexity.

In Italy, the process of power decentralization to Regional Governments has particularly affected pharmaceutical care policies. Regions are experimenting with various strategies to govern drugs utilization and expenditure, and differentiating their approaches, leading to an ever-changing and complex institutional scenario. Pharmaceutical companies have created new professional roles, the Regional Affairs Managers (RAM), with the mandate to monitor the different regional contexts and measures, and to establish relationships with the public actors in charge of pharmaceutical policies. This analysis shows how public affairs/lobbying actions at regional level and the creation of a solid political competence within companies are still in an early phase. The activities carried out by RAMs remain limited to an exchange of information and only rarely are perceived by Regional public servants (RRs) as giving support to their work or influence decisions. The interaction with RAMs is often seen as little relevant and still too concentrated on products and a marketing/commercial approach rather than on broader issues of interest to RRs who need to manage the pharmaceutical care system at large. The level of acceptance of this type of activity is also variable and RRs' attitudes alternate between diffidence, polite tolerance, and openness to a constructive dialogue about pharmaceuticals and their management in a regional healthcare system.

A neuroscientist-consumer alliance to transform mental health care.

The field of mental health has long suffered from a lack of convergence of disciplines that deal with the mind, the brain, and behavior. This mind-brain dualism has been particularly detrimental for consumers and their families who daily face stigma and discrimination. The understanding of the brain and its dysfunctions has benefited from the study of the human genome and, in particular, of the mutations and variations in its code. This analysis permits a better understanding of the biological basis of mental disease and will soon inform a generation of new diagnostic tools and individualized pharmacological therapies. A biological perspective on mental illness will be complemented by the analysis of the social factors influencing people's behavior and their impact on brain biology and gene function. Neurobiology has progressed to a level for which the knowledge that is generated, even if still colored with uncertainty, could represent a catalyst for the creation of an alliance between neuroscientists and consumers. This partnership has the potential to benefit both parties but will require some concrete steps that might be outside of the usual courses of action for both consumers and scientists. It is by building collaborations based on personal contact and information sharing that a transformation of the mental health care system can occur.

Ephrin-B2 controls cell motility and adhesion during blood-vessel-wall assembly.

New blood vessels are initially formed through the assembly or sprouting of endothelial cells, but the recruitment of supporting pericytes and vascular smooth muscle cells (mural cells) ensures the formation of a mature and stable vascular network. Defective mural-cell coverage is associated with the poorly organized and leaky vasculature seen in tumors or other human diseases. Here we report that mural cells require ephrin-B2, a ligand for Eph receptor tyrosine kinases, for normal association with small-diameter blood vessels (microvessels). Tissue-specific mutant mice display perinatal lethality; vascular defects in skin, lung, gastrointestinal tract, and kidney glomeruli; and abnormal migration of smooth muscle cells to lymphatic capillaries. Cultured ephrin-B2-deficient smooth muscle cells are defective in spreading, focal-adhesion formation, and polarized migration and show increased motility. Our results indicate that the role of ephrin-B2 and EphB receptors in these processes involves Crk-p130(CAS) signaling and suggest that ephrin-B2 has some cell-cell-contact-independent functions.

Convergence of service, policy, and science toward consumer-driven mental health care.

BACKGROUND: A common theme is emerging in sentinel reports on the United States health care system. Consumer relevance and demands on service systems and practices are influencing how mental health care is delivered and how systems will be shaped in the future. AIMS OF THE STUDY: The present report seeks to assemble a confluence of consumer-driven themes from noteworthy reports on the state of the mental health system in the U.S. It also explores innovative efforts, promising practices, collaborative efforts, as well as identification of barriers to consumer-directed care, with possible solutions. METHOD: The report reviews the relevant public mental health policy and data used in published work. RESULTS: The findings indicate an increasing public and private interest in promoting consumer-driven care, even though historical systems of care predominate, and often create, barriers to wide-spread redesign of a consumer-centered mental health care system. Innovative consumer-driven practices are increasing as quality, choice, and self-determination become integral parts of a redesigned U.S. mental health care system. DISCUSSION AND LIMITATIONS: The use of consumer-driven approaches in mental health is limited at best. These programs challenge industry norms and traditional practices. Limitations include the need for additional and thorough evaluations of effectiveness (cost and clinical) and replicability of consumer-directed programs. IMPLICATIONS FOR HEALTH CARE PROVISION AND USE: Consumer-driven services indicate that mental health consumers are expecting to be more participative in their mental health care. This expectation will influence how traditional mental health services and providers become more consumer-centric and meet the demand. IMPLICATIONS FOR HEALTH POLICIES: Public and private interest in consumer-driven health care range from creating cost-conscious consumers to individualized control of recovery. The health care sector should seek to invest more resources in the provision of consumer-driven health care programs. The results of this study have implications and are informative for other countries where consumer-directed care is delivered in either the private or public health care systems. IMPLICATIONS FOR FURTHER RESEARCH: More research is needed to obtain further evidence on the use of consumer-driven services and their overall effectiveness.

Control of skeletal patterning by ephrinB1-EphB interactions.

We report that targeted inactivation of the Eph receptor ligand ephrinB1 in mouse caused perinatal lethality, edema, defective body wall closure, and skeletal abnormalities. In the thorax, sternocostal connections were arranged asymmetrically and sternebrae were fused, defects that were phenocopied in EphB2/EphB3 receptor mutants. In the wrist, loss of ephrinB1 led to abnormal cartilage segmentation and the formation of additional skeletal elements. We conclude that ephrinB1 and B class Eph receptors provide positional cues required for the normal morphogenesis of skeletal elements. Another malformation, preaxial polydactyly, was exclusively seen in heterozygous females in which expression of the X-linked ephrinB1 gene was mosaic, so that ectopic EphB-ephrinB1 interactions led to restricted cell movements and the bifurcation of digital rays. Our findings suggest that differential cell adhesion and sorting might be relevant for an unusual class of X-linked human genetic disorders, in which heterozygous females show more severe phenotypes than hemizygous males.