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Background: Since the early 90s, patient navigation programs were introduced in the United States to address inequitable access to cancer care. Programs have since expanded internationally and in scope. The goals of patient navigation programs are to: a) link patients and families to primary care services, specialist care, and community-based health and social services (CBHSS); b) provide more holistic patient-centred care; and, c) identify and resolve patient barriers to care. This paper fills a gap in knowledge to reveal what is known about motivators and factors influencing implementation and maintenance of patient navigation programs in primary care that link patients to CBHSS. It also reports on outcomes from these studies to help identify gaps in research that can inform future studies.Methods: This scoping literature review involved: i) electronic database searches; ii) a web site search; iii) a search of reference lists from literature reviews; and, iv) author follow up. It included papers from Canada, the United States, the United Kingdom, Australia, New Zealand, and/or Western Europe published between January 1990 and June 2013 if they discussed navigators or navigation programs in primary care settings that linked patients to CBHSS.Results: Of 34 papers, most originated in the United States (n = 29) while the remainder were from the United Kingdom, Canada and Australia. Motivators for initiating navigation programs were to: a) improve delivery of health and social care services; b) support and manage specific health needs or specific population needs, and; c) improve quality of life and wellbeing of patients. Eleven factors were found to influence implementation and maintenance of these patient navigation programs. These factors closely aligned with the Diffusion of Innovation in Service Organizations model, thus providing a theoretical foundation to support them. Various positive outcomes were reported for patients, providers and navigators, as well as the health and social care system, although they need to be considered with caution since the majority of studies were descriptive.Conclusions: This study contributes new knowledge that can inform the initiation and maintenance of primary care patient navigation programs that link patients with CBHSS. It also provides directions for future research. [ABSTRACT FROM AUTHOR]

This systematic study aims at analyzing the differences between the approach of the European healthcare systems to the pharmaceutical market and the American one. This paper highlights the opportunities and the limitations given by the application of managed entry agreements (MEAs) in European countries as opposed to the American market, which does not regulate pharmaceutical prices. Data were collected from the Organisation for Economic Co-operation and Development (OECD), the European Medicines Agency, and the national healthcare agencies of US and European countries. A literature review was undertaken in PubMed, Scopus, MEDLINE, and Google for a period ten years (2010–2019). The period 2020–2021 was considered to compare health expenditure before and after the SARS-CoV-2 pandemic. Scarce information from national agencies has been given in terms of MEAs related to the COVID-19 pandemic. The comparison between the United States approach and the European one shows the importance of a market access regulation to reduce the cost of therapies, increasing the efficiency of national healthcare systems and the advantages in terms of quality and accessibility to the final users: patients. Nevertheless, it seems that the golden age of MEAs for Europe was during the examined period. Except for Italy, countries will move to other forms of reimbursements to obtain higher benefits, reducing the costs of an inefficient implementation and outcomes in the medium term. [ABSTRACT FROM AUTHOR]

Background: Health care organizations need to be responsive to the needs of increasingly diverse patient populations. We compared the contents of six publicly available approaches to organizational responsiveness to diversity. The central questions addressed in this paper are: what are the most consistently recommended issues for health care organizations to address in order to be responsive to the needs of diverse groups that differ from the majority population? How much consensus is there between various approaches?Methods: We purposively sampled six approaches from the US, Australia and Europe and used qualitative textual analysis to categorize the content of each approach into domains (conceptually distinct topic areas) and, within each domain, into dimensions (operationalizations). The resulting classification framework was used for comparative analysis of the content of the six approaches.Results: We identified seven domains that were represented in most or all approaches: organizational commitment, empirical evidence on inequalities and needs, a competent and diverse workforce, ensuring access for all users, ensuring responsiveness in care provision, fostering patient and community participation, and actively promoting responsiveness. Variations in the operationalization of these domains related to different scopes, contexts and types of diversity. For example, approaches that focus on ethnic diversity mostly provide recommendations to handle cultural and language differences; approaches that take an intersectional approach and broaden their target population to vulnerable groups in a more general sense also pay attention to factors such as socio-economic status and gender.Conclusions: Despite differences in labeling, there is a broad consensus about what health care organizations need to do in order to be responsive to patient diversity. This opens the way to full scale implementation of organizational responsiveness in healthcare and structured evaluation of its effectiveness in improving patient outcomes. [ABSTRACT FROM AUTHOR]

This article addresses the challenges solidarity poses for the development of Precision Medicine (PM). Solidarity is invoked in calls for a new 'social contract' for PM, seeking to promote participation in PM by emphasizing reciprocity between contributions to and benefits from this new branch of medicine. In this context, there is a need for further conceptualization with regard to what qualifies as solidarity and how solidarity is performed in Precision Medicine initiatives. We address these conceptual gaps that have important practical implications for PM's development, most notably for agendas of public engagement and trust. We argue that solidarity does not only represent a value but also takes on infrastructural forms, shaping how PM is practiced in, for example, healthcare delivery systems. Next, we empirically probe how solidarity is invoked in PM initiatives in the United States ('All of Us'-Program) and Europe (the UK 100,000 Genomes Project and the French 2025 Genomics Plan). Based on this analysis, we argue that the infrastructural dimension of solidarity forms a vital precondition to build trust in PM. Echoing the famous motto of The Three Musketeers, 'One for all, all for one', PM policies cannot just proclaim solidarity for the gathering of data alone ('One for all') without caring about delivery of benefits of PM ('All for one'). We conclude by proposing an empirical research agenda for studying infrastructural formations to secure solidarity in the implementation of PM practices across national contexts. [ABSTRACT FROM AUTHOR]

Introduction: Risk minimization programs are interventions mandated by regulatory agencies to ensure that benefits of pharmaceutical products outweigh risks. Many regulatory agencies require programs be evaluated for effectiveness; however, the quality of evidence has limited the ability to definitively determine if programs improve drug safety.Objective: The aim of this systematic review was to assess and describe the current status of reporting on the effectiveness of pharmaceutical risk management programs.Methods: Peer-reviewed articles published between January 2012 and December 2018 were selected from three online databases (MEDLINE, PubMed, Embase). Eligible studies reported on effectiveness evaluations of mandated risk minimization measures (beyond labeling) and were written in English. Two reviewers independently examined 2744 titles of articles and 52 full articles were included. Forty-eight sources of gray literature from conference abstract presentations and publicly available regulatory documents were also included.Results: Key opportunities for improvement in reporting included the provision of information regarding (1) selection, design, and testing of risk minimization measures, (2) implementation of programs, (3) process and outcome metrics, including the extent to which programs reached the intended audience, were integrated into the target healthcare settings, or were sustained over time, and (4) burden of the program on the healthcare system and implications for patient access.Conclusions: Gaps in reporting of risk minimization program evaluation studies were identified. Addressing gaps will help build the evidence base regarding risk minimization initiatives, as well as ensure that programs are maximally effective and minimally burdensome on the healthcare system, and do not unduly interfere with patient access to the medicine. [ABSTRACT FROM AUTHOR]

Purpose: Children with hypoplastic left heart syndrome (HLHS) experience numerous vulnerabilities during transitions from hospital to home during their first year of life. This paper examines the parents' responses to the situations they experience during the initial interstage transition as described through illness blogs. Design and methods: A qualitative descriptive design through inductive theme development using thematic analysis was performed for this study. Text data were used from publically available blogs written by parents of HLHS children on their feelings and experiences during transitions between hospital‐ and home‐care during the interstage period. Results: Six blogs were analyzed. Overall, the lack of difference in normalcy for these parents and their families was apparent. Major themes included: thoughts and feelings when discharged from the hospital, difficulties with hospital readmissions, protecting their child from infection, and developing a support system. Conclusions: Parents looked forward to going home and learned all they could about properly caring for their child before going home. They were disappointed and frustrated when returning to the hospital for either emergency or scheduled admissions and were not prepared to see their child in the intensive care unit environment again. Many parents isolated themselves and avoided the hospital as much as possible to avoid their child developing an infection. All parents had support systems through family and/or friends and found an unexpected sense of support through their blog families. [ABSTRACT FROM AUTHOR]

The rising prevalence of food allergy and specifically peanut allergy has had significant implications for affected patients, families, and society. The current standard of care remains strict avoidance and the use of emergency medications for accidental ingestions. There is recent evidence-based information to suggest that one approach to preventing peanut allergy lies in early introduction of peanut. This represents a paradigm shift from previous recommendations and has led to updated guidelines in the United States, Europe, and Australasia on the introduction of potentially allergenic foods in the infant diet. This new approach to prevention has some practical obstacles and challenges associated with its implementation. There is also growing interest in the role of maintaining a healthy skin barrier in prevention of sensitization and food allergy. Other approaches, including pro- and prebiotics, prenatal maternal dietary avoidance, breastfeeding, and the use of specific formulas, have not shown reproducibly favorable results. As children with peanut allergy are unlikely to outgrow their food allergy, early oral immunotherapy in those with established peanut allergy is being investigated with the hopes of altering the natural history of an otherwise lifelong disease. [ABSTRACT FROM AUTHOR]

Vulvar and vaginal atrophy (VVA) is a common complaint in postmenopausal women and consists of a variety of symptoms and strong repercussions that negatively affect comfort during sexual activity and ultimately impact quality of life. The EU and US REVIVE surveys have detected significant barriers in health-care professional management and educational programs that prevent correct diagnosis and effective treatment. This was common in both Europe and the US, but differential behaviors and patterns could be detected after reviewing the published results. The frequency of reporting VVA symptoms was lower in European participants. However, a better knowledge that VVA is a consequence of menopause was evident in Europe, probably in relation to more frequent gynecological visits and more frequent specialist visits as a referral health-care professional. Moreover, a trend towards an improved satisfaction with management by the health-care professional was observed in Europe. European participants acknowledged a significantly higher impact of VVA symptoms on sexual intercourse and partner interaction than North American (US) participants, and both cohorts were observed to have differences between their respective VVA symptom profiles. These observations have implications in the overall concerns that participants stated with long-term VVA medication and for the optimal therapeutic approach, providing evidence to support the concept that unexplored methods to improve management of patients with VVA remain. [ABSTRACT FROM AUTHOR]

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