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Digital therapeutics (DTx) are an emerging medical therapy comprising evidence-based interventions that are regulatory approved for patient use, or are under development, for a variety of medical conditions, including hypertension, cancer, substance use disorders and mental disorders. DTx have significant potential to reduce the overall burden on healthcare systems and offer potential economic benefits. There is currently no specific legal regulation on DTx in the EU. Although European countries have similar approaches to digital health solutions, the adoption of DTx varies across the continent. The aim of this narrative review is to discuss the levels of adoption of DTx in Europe, and to explore possible strategies to improve adoption, with the goal of higher rates of adoption, and more consistent use of DTx across the continent. The article discusses the regulatory and reimbursement landscape across Europe; validation requirements for DTx, and the importance of co-design and an ecosystem-centric approach in the development of DTx. Also considered are drivers of adoption and prescription practices for DTx, as well as patient perspectives on these therapeutics. The article explores potential factors that may contribute to low rates of DTx adoption in Europe, including lack of harmonisation in regulatory requirements and reimbursement; sociodemographic factors; health status; ethical concerns; challenges surrounding the use and validation of AI; knowledge and awareness among healthcare professionals (HCPs) and patients, and data standards and interoperability. Efforts to improve rates of access to DTx and adoption of these therapeutics across Europe are described. Finally, a framework for improved uptake of DTx in Europe is proposed.

[...]we highlight the importance of collaboration in interdisciplinary large-scale consortia to enable precision medicine trials. [...]basic research to fully elucidate type 2 pathways in severe asthma, combined with the development of more precise companion diagnostics that dissect these pathways, are urgently required. Targeting the Systemic Inflammation of Obesity Obesity is a key risk factor for developing severe asthma, and patients with severe asthma are frequently characterized by high body mass index and other obesity-associated comorbidities. Because obesity induces a state of low-grade systemic inflammation, it is intriguing to consider the possibility that obesity-associated inflammation may cause airway pathology in asthma. The Unbiased Biomarkers in Prediction of Respiratory Disease Outcomes-Innovative Medicines Initiative and Severe Asthma Research Program projects have been deemed as highly successful collaborative projects (54). [...]future joint efforts in severe asthma clinical trials will reach their full potential only if they follow established principles for collaboration in a consortium.

Introduction The impact of chronic spontaneous urticaria (CSU) on patients’ health-related quality of life (HRQoL) is well documented. However, considerable gaps remain in understanding the experience, perception and needs of patients with CSU. In this study, we investigate the perspective of patients with CSU about the disease journey, treatment and management of the condition as well as the physical and psychosocial impact of the disease. Methods A multinational, cross-sectional online survey was completed by patients with chronic urticaria (CU) and physicians treating CU. This analysis focuses on data from the patients with CSU. The patient survey included customized questions and a validated patient-reported outcomes measure, the Urticaria Control Test (UCT). Results A total of 582 patients with CSU (62% women; mean [standard deviation, SD] age: 42.2 [11.9] years) completed the online survey. Patients reported a mean (SD) diagnostic delay of 2 (5.4) years and saw 6.1 (8.9) physicians. The majority (79%) of patients were on antihistamines, of which 84% were inadequately controlled (UCT score of < 12) and reported a significantly higher negative impact of CSU on the HRQoL domains than adequately controlled patients, with the highest impact on mental and emotional well-being and social life and intimate relationships. More than half (55%) of the patients experienced angioedema with a mean (SD) of 7.7 (14.0) episodes per year. In addition, sleeping problems (62%), pain (55%) and fatigue (49%) were frequently reported physical symptoms during an exacerbation. Conclusion Patients with CSU experience substantial burden due to delayed diagnosis, insufficient symptom control (despite treatment) as well as mental and emotional well-being and social impact, particularly when uncontrolled. Early diagnosis and patient-centered approaches to symptom management and disease control should be prioritized to minimize the negative impact of CSU on patients’ life.

Background In response to racial inequity in asthma, asthma-related research among diverse patients is vital. However, people from historically marginalized groups are underrepresented in clinical and patient-centered outcomes research (PCOR). The “Black People Like Me” (BPLM) virtual conference series was developed to: (1) engage Black patients with asthma and their caregivers in education and discussions about asthma, and (2) encourage involvement in PCOR. Education about COVID-19 and COVID-19 vaccination was also incorporated. Methods The Project Advisory Group consisting of Black patients, clergy, physicians, and a program evaluator met monthly to develop BPLM. The program consisted of free one-hour virtual sessions held monthly for 6 months. BPLM was promoted through the Allergy & Asthma Network website, emails, social media, and personal contacts with a recruitment goal of ≥ 100 Black patients with asthma or caregivers. Program evaluations, interactive polling questions during each session, and participant pre- and post-session tests were conducted. Results Sessions averaged 658 participants including Black patients, family members, caregivers, Black clergy, health care providers, and other concerned community. Overall, 77% of participants strongly agreed with satisfaction with the sessions. Pre- and post-tests demonstrated that participants exhibited growth in knowledge regarding asthma risk, PCOR, and PCOR research opportunities for patients, exhibited preexisting and sustained knowledge regarding COVID-19 vaccination and side effects, and demonstrated an increased sense of empowerment during healthcare visits. Conclusions BPLM demonstrated that a virtual platform can successfully engage Black communities. Incorporating clergy and religious organizations was critical in developing the trust of the Black community towards BPLM. Plain English summary There are more Black people with asthma in the US than White people. Black people have more hospital stays or deaths from asthma than White people. This highlights the need for Black people to be involved in research. Black people are missing from research. Patient centered outcomes research (PCOR) looks at patient treatment results. A webinar series titled “Black People Like Me” (BPLM) was developed for the Black community. This was a discussion about asthma, COVID-19, and PCOR between patients and experts. BPLM was a free, one-hour, virtual meeting held once a month for 6 months. BPLM was developed by Black patients, clergy, physicians, and a program evaluator. The goal was to meet the needs of the Black community. An average of 658 people participated in each virtual meeting. BPLM found that 77% of attendees were highly satisfied with the sessions. BPLM increased attendee knowledge of asthma, COVID-19, and PCOR. Attendees reported an increased willingness to be involved in PCOR. Including Black clergy helped BPLM be successful by encouraging trust in the program within the Black community. Future programs like BPLM may be developed to help people make decisions about being involved in their health care and PCOR.

Exacerbations negatively impact quality of life of people living with chronic obstructive pulmonary disease (COPD) and can accelerate disease progression. Studies suggest that patients find it difficult to recognize exacerbations and, therefore, under-report exacerbations. We aimed to understand how people living with COPD perceive and communicate their experiences of exacerbations. A cross-sectional survey including one open-ended question was developed using a targeted literature review, with input from patients and clinicians. People diagnosed with COPD were recruited from online consumer research panels in Brazil, China, France, Spain, UK, and USA and completed the survey. Responses were described overall and in specific subgroups; thematic analysis was used for the open-ended question. Of 857 respondents (median age 58 years; 50.5% male), 623 (72.7%) reported daily shortness of breath; 417 (48.7%) that daily symptoms changed \"a little\". In the open-ended question, exacerbations were described through a narrative lens detailing subjective experiences of symptoms, their management, potential causes, and emotions felt during exacerbations, with no single preferred term. In the 671 (78.3%) respondents who reported ever having an exacerbation, these were identified as symptoms being \"worse than usual\" (52.8%) or because respondents had \"more trouble than usual with daily activities\" (50.1%). While people living with COPD report confidence in their ability to identify exacerbations, there is a disconnect between their experience of exacerbations and the language and definitions used in clinical practice. A discussion guide emphasizing the use of plain language could improve communication between healthcare providers and patients.

Background: The Global Initiative for Asthma 2024 report recommends a shared decision-making approach to guide treatment choice, encompassing patients’ goals, beliefs and concerns about asthma and medications (GINA. Global Strategy for Asthma Management and Prevention, 2024). There is limited guidance on ways to achieve this goal. This consensus programme aimed to create recommendations on optimal selection of inhaler treatment while considering patient perspectives and needs. Methods: A literature review was conducted on literature published between 01/01/2014 and 23/04/2024 using agreed keywords and search parameters in PubMed and Cochrane databases. Evidence on impact of patient factors on adherence and asthma control, plus inhaler preference data, was analysed. A consensus voting panel was selected via screening questionnaire, with 50 patients with asthma duration ≥5 years and 39 healthcare professionals with expertise in asthma from five European countries (Germany, France, Czechia, Italy, Greece). A two-round Delphi method was used. Results: 40/135 papers were considered relevant. From these, 20 consensus statements were developed in four areas: patient-centred treatment selection, medication/asthma beliefs, patient preference + shared decision-making, and tools for patient-centred care. 18/20 consensus statements were accepted with an agreement threshold >85% on the first round of voting. Two revised statements underwent a second Delphi round, again failing to reach consensus. Conclusions: This important initiative generated much-needed guidance on integrating patient views and needs into treatment decision-making following a well-established methodology through 18 consensus statements, with nearly equal input from patients and healthcare professionals.

Over-use of SABA is associated with poor asthma control and greater risk of exacerbations and death. Identifying and addressing the beliefs driving SABA over-reliance is key to reducing over-use. This study aimed to assess the utility, impact and acceptability of the Reliever Reliance Test (RRT), a brief patient self-test behaviour-change tool to identify and address SABA over-reliance. Patients with asthma who completed the RRT in Argentina were invited to an online survey exploring the acceptability of the RRT, and its impact on patients’ perceptions of SABA and intention to discuss asthma treatment with a doctor. 93 patients completed the questionnaire. The RRT classified 76/93 (82%) as medium-to-high risk of SABA over-reliance (a mindset where SABA is perceived as the most important aspect of asthma treatment), with 73% of these reporting SABA overuse (3 or more times a week). 75% intended to follow the RRT recommendations to review their asthma treatment with their doctor. The RRT is acceptable to patients and was effective at raising awareness of, identifying and addressing SABA over-reliance and encouraging patients to review their treatment with their doctor.

Chronic obstructive pulmonary disease (COPD) is a prevalent condition characterized by persistent airflow obstruction and respiratory symptoms. Single-Inhaler Triple Therapy (SITT) has been shown to improve patient adherence, reduce exacerbations, and lower healthcare resource utilization in patients who are not controlled despite being on dual therapy or Multiple-Inhaler Triple Therapy (MITT). Despite evidence supporting SITT, payer-driven access rules across Europe sometimes limit its use in primary care, creating barriers to optimal COPD management. Through expert consensus, the study seeks to generate a shared understanding of the unintended consequences of payer-driven access criteria for SITT in managing moderate-to-severe COPD in primary care. A targeted literature review (TLR) was conducted to assess SITT initiation in primary care across Europe and examine the impact of access criteria. Semi-structured interviews were held with 14 experts from nine European countries, including clinicians, health economists, and patient advocacy representatives. A consensus generation workshop was conducted, where experts evaluated the findings and developed position statements to highlight the challenges posed by payer-driven access criteria. The TLR identified variability in access to SITT in Europe, with several countries restricting its initiation to specialists, thus limiting primary care physicians' (PCPs) ability to prescribe SITT. The expert panel generated seven consensus points stating that enabling PCPs to step up or switch eligible patients to SITT has the potential to support care continuity, enhance clinical autonomy for PCPs, reduce reliance on potentially less effective treatment options, improve patient and healthcare system outcomes, avoid unnecessary referrals to specialists, enable prompt initiation of guideline-directed medical therapy for COPD in primary care and reduce access inequalities. Restrictions for SITT initiation in primary care may need to be revisited to mitigate their unintended health and cost consequences and improve equitable access to treatment. This should take into consideration each country's unique healthcare system.

Primary care clinicians play a key role in asthma and asthma exacerbation management worldwide because most patients with asthma are treated in primary care settings. The high burden of asthma exacerbations persists and important practice gaps remain, despite continual advances in asthma care. Lack of primary care-specific guidance, uncontrolled asthma, incomplete assessment of exacerbation and asthma control history, and reliance on systemic corticosteroids or short-acting beta 2 -agonist-only therapy are challenges clinicians face today with asthma care. Evidence supports the use of inhaled corticosteroids (ICS) + fast-acting bronchodilator treatments when used as needed in response to symptoms to improve asthma control and reduce rates of exacerbations, and the symptoms that occur leading up to an asthma exacerbation provide a window of opportunity to intervene with ICS. Incorporating patient perspectives and preferences when designing asthma regimens will help patients be more engaged in their therapy and may contribute to improved adherence and outcomes. This expert consensus contains 10 Best Practice Advice Points from a panel of primary care clinicians and a patient representative, formed in collaboration with the International Primary Care Respiratory Group (IPCRG), a clinically led charitable organization that works locally and globally in primary care to improve respiratory health. The panel met virtually and developed a series of best practice statements, which were drafted and subsequently voted on to obtain consensus. Primary care clinicians globally are encouraged to review and adapt these best practice advice points on preventing and managing asthma exacerbations to their local practice patterns to enhance asthma care within their practice.

Background The purpose of this paper is to provide an overview of key aspects of specialised dermatology nursing practice in the management of patients with moderate to severe atopic dermatitis. The role of dermatology nurse specialists in supporting patients and promoting disease understanding, education and treatment adherence continues to evolve. As features of specialised nursing care can also inform other nursing staff in a wide range of care settings, an overview of key components is examined. Observations presented are from a pan-European perspective and represent the collected view of a group of dermatology nurse specialists, dermatologists and patient advocates following two round-table discussions. Main body Atopic dermatitis is a common, chronic, inflammatory disease characterised by erythematous/scaling skin lesions, with often intense pruritus. Disease course is cyclic with periodic disease flares of varying intensity, presenting management challenges to patients and families. Dermatology nurse specialists play a key role in providing education and substantial patient support to improve treatment outcomes and quality of life to patients and their family, delivered within a multidisciplinary team framework. Nurse-led education and 'eczema schools’ are of benefit in reducing disease severity and improving quality of life by enhancing self-management, adherence and patient engagement. eHealth tools, such as patient portals or online training platforms, can provide online learning, individualised education, and help to improve engagement. These and other initiatives, such as written action plans, are all essential to improve or maintain treatment adherence, self-management and quality of life. Conclusions Dermatology nurse specialists play a central role in the assessment and management of moderate to severe atopic dermatitis patients and families. This places them in an ideal position to build strong and often long-term relationships with patients and parents. Such engagement promotes trust, assists in setting realistic expectations of treatment and outcomes, and enhances self-management and engagement in their own care. Providing emotional support, as well as formal and systematic education (including individualised practical advice) all contribute to improved treatment adherence and can enhance the quality of life of patients and their families throughout the course of this long-term condition.