Perspectives of European Patient Advocacy Groups on Volunteer Registries and Vaccine Trials: VACCELERATE Survey Study.

BACKGROUND: The VACCELERATE Pan-European Scientific network aims to strengthen the foundation of vaccine trial research across Europe by following the principles of equity, inclusion, and diversity. The VACCELERATE Volunteer Registry network provides access to vaccine trial sites across the European region and supports a sustainable volunteer platform for identifying potential participants for forthcoming vaccine clinical research. OBJECTIVE: The aim of this study was to approach members of patient advocacy groups (PAGs) across Europe to assess their willingness to register for the VACCELERATE Volunteer Registry and their perspectives related to participating in vaccine trials. METHODS: In an effort to understand how to increase recruitment for the VACCELERATE Volunteer Registry, a standardized survey was developed in English and translated into 8 different languages (Dutch, English, French, German, Greek, Italian, Spanish, and Swedish) by the respective National Coordinator team. The online, anonymous survey was circulated, from March 2022 to May 2022, to PAGs across 10 European countries (Belgium, Cyprus, Denmark, France, Germany, Greece, Ireland, Italy, Spain, and Sweden) to share with their members. The questionnaire constituted of multiple choice and open-ended questions evaluating information regarding participants' perceptions on participating in vaccine trials and their willingness to become involved in the VACCELERATE Volunteer Registry. RESULTS: In total, 520 responses were collected and analyzed. The PAG members reported that the principal criteria influencing their decision to participate in clinical trials overall are (1) the risks involved, (2) the benefits that will be gained from their potential participation, and (3) the quality and quantity of information provided regarding the trial. The survey revealed that, out of the 520 respondents, 133 individuals across all age groups were "positive" toward registering in the VACCELERATE Volunteer Registry, with an additional 47 individuals reporting being "very positive." Respondents from Northern European countries were 1.725 (95% CI 1.206-2.468) times more likely to be willing to participate in the VACCELERATE Volunteer Registry than respondents from Southern European countries. CONCLUSIONS: Factors discouraging participants from joining vaccine trial registries or clinical trials primarily include concerns of the safety of novel vaccines and a lack of trust in those involved in vaccine development. These outcomes aid in identifying issues and setbacks in present registries, providing the VACCELERATE network with feedback on how to potentially increase participation and enrollment in trials across Europe. Development of European health communication strategies among diverse public communities, especially via PAGs, is the key for increasing patients' willingness to participate in clinical studies.

'They don't think I can do it': Experiences of self-advocates, employment specialists, and employers on employment of adults with intellectual disability.

BACKGROUND: A multi-phase Canadian study was conducted as part of a large-scale community and academic research partnership focused on understanding and improving the employment experiences of people with intellectual disabilities. METHOD: This multi-method study utilized a sequential approach, using findings from qualitative interviews (n = 28) to inform an online survey (n = 149). Participants were invited to share their experiences with paid employment or with persons with intellectual disabilities. RESULTS: Thematic analysis of data across interview and survey findings resulted in six themes: (1) assumptions and attitudes, (2) knowledge and awareness, (3) accessibility of processes, (4) use of accommodations, (5) workplace relationships, and (6) supports and resources. CONCLUSIONS: A holistic and systemic approach has the potential to improve inclusive employment experiences of people with intellectual disabilities. Action is needed mainly at the policy and employer level to reduce barriers and improve on facilitating measures reinforced by the themes shared in this study.

Inclusion in an Interdisciplinary Leadership Training Program: Perspectives From Self-Advocates.

Leadership Education in Neurodevelopmental and Related Disabilities (LEND) programs are interdisciplinary, graduate-level training programs that seek to promote improved outcomes for individuals with disabilities and their families. Many of these programs include individuals with disabilities as members of the self-advocacy discipline. In this study, 10 self-advocate trainees were interviewed to provide insight into the value of including self-advocates in training and the kinds of accommodations and supports that facilitated their success and inclusion. Interviewees endorsed the importance of including self-advocates in LEND programs. Although several accommodations were discussed as helpful, interpersonal supports from faculty and peers were equally important in ensuring their success and inclusion in LEND. The findings from this study provide support for the expansion of self-advocacy as a formal discipline in LEND programs.

The TTP specialist nurse: an advocate for patients and professionals.

Thrombotic thrombocytopenic purpura (TTP) is a rare and life-threatening blood disorder with a mortality rate of over 90% if left untreated, multiple long-term complications for survivors, and a lifelong risk of relapse. There is a valuable role for the clinical nurse specialist in both the acute and long-term care of patients with TTP. Historically part of the team caring for patients with TTP, specialist nurses have played a vital role in co-ordinating and facilitating treatment for patients, promoting patient advocacy, supporting continuous service improvement, and delivering education to the wider clinical team to disseminate best practice. In 2021, the TTP specialist nurse role was commissioned within the NHS England National Service Framework for TTP Specialist Centres. This article aims to appraise the role of the TTP specialist nurse and share the multidimensional reach of the role in achieving better outcomes for patients with TTP.

Meaningful Endpoints for Idiopathic Pulmonary Fibrosis (IPF) Clinical Trials: Emphasis on 'Feels, Functions, Survives'. Report of a Collaborative Discussion in a Symposium with Direct Engagement from Representatives of Patients, Investigators, the National Institutes of Health, a Patient Advocacy Organization, and a Regulatory Agency.

Background: Idiopathic pulmonary fibrosis (IPF) carries significant mortality and unpredictable progression, with limited therapeutic options. Designing trials with patient-meaningful endpoints, enhancing the reliability and interpretability of results, and streamlining the regulatory approval process are of critical importance to advancing clinical care in IPF. Methods: A landmark in-person symposium in June 2023 assembled 43 participants from the US and internationally, including patients with IPF, investigators, and regulatory representatives, to discuss the immediate future of IPF clinical trial endpoints. Patient advocates were central to discussions, which evaluated endpoints according to regulatory standards and the FDA's 'feels, functions, survives' criteria. Results: Three themes emerged: 1) consensus on endpoints mirroring the lived experiences of patients with IPF; 2) consideration of replacing forced vital capacity (FVC) as the primary endpoint, potentially by composite endpoints that include 'feels, functions, survives' measures or FVC as components; 3) support for simplified, user-friendly patient-reported outcomes (PROs) as either components of primary composite endpoints or key secondary endpoints, supplemented by functional tests as secondary endpoints and novel biomarkers as supportive measures (FDA Guidance for Industry (Multiple Endpoints in Clinical Trials) available at: https://www.fda.gov/media/162416/download). Conclusions: This report, detailing the proceedings of this pivotal symposium, suggests a potential turning point in designing future IPF clinical trials more attuned to outcomes meaningful to patients, and documents the collective agreement across multidisciplinary stakeholders on the importance of anchoring IPF trial endpoints on real patient experiences-namely, how they feel, function, and survive. There is considerable optimism that clinical care in IPF will progress through trials focused on patient-centric insights, ultimately guiding transformative treatment strategies to enhance patients' quality of life and survival.

Engaging healthcare professionals and patient representatives in the development of a quality model for hospitals: a mixed-method study.

Top-down and externally imposed quality requirements can lead to improvement but do not seem as sustainable as intended. There is a need for a quality model that intrinsically motivates healthcare professionals to contribute to quality and safe care in hospitals. This study shows how a quality model that matches the identity and the quality vision of the organization was developed. A multimethod design with three phases was used in the development of the model at a large teaching hospital in Belgium. In the first phase, 14 focus groups and 19 interviews with staff members were conducted to obtain an overview of the quality and safety challenges, complemented by a plenary discussion with the members of the patient advisory council. In the second phase, the challenges that had been captured were further assessed using a hospital-wide survey for all hospital staff. Finally, a newly established quality review board (with internal and external stakeholders) critically evaluated the input of Phases 1 and 2 and defined the basic quality standards to be implemented in the hospital. A first evaluation 2 years after the implementation was conducted based on (i) patients' perceptions of quality of care and patient safety by publicly available indicators collected in 2016, 2019, and 2022 and (ii) staff experiences and perceptions regarding the acceptability of the new model gathered through (grouped) interviews and an open questionnaire. The quality model consists of eight broad themes, including norms for the hospital staff (n = 27), sustained with quality systems (n = 8), and organizational support (n = 6), with aid from adequate management and leadership (n = 6). The themes were converted into 46 standards. These should be supported within a safe, efficient, and caring work environment. The new model was launched in the hospital in June 2021. The evaluation shows a significant difference in quality and safety on different dimensions as perceived by hospitalized patients. The perceived added value of the participatory model is a better fit with the needs of employees and the fact that the model can be adjusted to the specific context of the different hospital departments. The lack of hard indicators is seen as a challenge in monitoring quality and safety. The participation of various stakeholders inside and outside the organization in defining the quality challenges resulted in the creation of a participatory quality model for the hospital, which leads towards a better-supported quality policy in the hospital.

Which History and Social Science Concepts Should Inform Health Professions Education?

Teaching and learning patient advocacy in academic health centers requires critical engagement with social, political, and cultural conceptions of racial difference. This article considers understandings of race and racism typically drawn upon in health care and suggests which historical and social science-based approaches should be used in health professions teaching and learning.

Lights and shadows in the early-onset colorectal cancer management and research: An integrative perspective - Physician scientist with patient advocates.

Early-onset colorectal cancer (age under 50 years) (EOCRC) is an entity of undeniable importance, both because of its growing incidence, and the population it affects. Other current reviews emphasize the essential points regarding the clinical management and knowledge of its molecular bases. However, we intend to go one step further. With the increased significance of patient participation and disease experience in mind, we have integrated the voice of the patient to show the weaknesses and the needs, and next steps in the advancement of knowledge and management of EOCRC. This integrative review of the different perspectives, clinical, research and the patients themselves, can therefore be defined as an integrative needs assessment. Hence, this may be a first step in working towards an essential homogeneity of definitions and action.

Development of the Patient Advocacy Scale for Intensive Care Nurses.

Background and Purpose: To describe the process of developing and validating the content of the Patient Advocacy Scale for Nurses in Intensive Care (EAPEnf-UTI). Methods: Methodological research. To achieve the elaboration objective, five stages were developed: (a) definition of the theme, (b) generation of the number of items, (c) determination of the measurement format, (d) validation of face and content, and (e) content adjustment. Results: The instrument elaborated from a survey and integrative literature review, and the measurement format chosen was the 5-point Likert scale. The validation of face and content was performed by expert judges and by pretest. The final instrument had 57 items. Conclusion: EAPEnf-UTI is a pioneering instrument built in the Brazilian context, whose future validation will allow the capturing of situations specific to intensive care units and the professional practice of intensive care nurses.