Barriers and facilitators to the recruitment of disabled people to clinical trials: a scoping review

Introduction Underrepresentation of disabled groups in clinical trials results in an inadequate evidence base for their clinical care, which drives health inequalities. This study aims to review and map the potential barriers and facilitators to the recruitment of disabled people in clinical trials to identify knowledge gaps and areas for further extensive research. The review addresses the question: ‘What are the barriers and facilitators to recruitment of disabled people to clinical trials?’. Methods The Joanna Briggs Institute (JBI) Scoping review guidelines were followed to complete the current scoping review. MEDLINE and EMBASE databases were searched via Ovid. The literature search was guided by a combination of four key concepts from the research question: (1) disabled populations, (2) patient recruitment, (3) barriers and facilitators, and (4) clinical trials. Papers discussing barriers and facilitators of all types were included. Papers that did not have at least one disabled group as their population were excluded. Data on study characteristics and identified barriers and facilitators were extracted. Identified barriers and facilitators were then synthesised according to common themes. Results The review included 56 eligible papers. The evidence on barriers and facilitators was largely sourced from Short Communications from Researcher Perspectives (N = 22) and Primary Quantitative Research (N = 17). Carer perspectives were rarely represented in articles. The most common disability types for the population of interest in the literature were neurological and psychiatric disabilities. A total of five emergent themes were determined across the barriers and facilitators. These were as follows: risk vs benefit assessment, design and management of recruitment protocol, balancing internal and external validity considerations, consent and ethics, and systemic factors. Conclusions Both barriers and facilitators were often highly specific to disability type and context. Assumptions should be minimised, and study design should prioritise principles of co-design and be informed by a data-driven assessment of needs for the study population. Person-centred approaches to consent that empower disabled people to exercise their right to choose should be adopted in inclusive practice. Implementing these recommendations stands to improve inclusive practices in clinical trial research, serving to produce a well-rounded and comprehensive evidence base

COVID-19 vaccines effectiveness against symptomatic disease and severe outcomes, 2021-2022: a test-negative case-control study

Objectives: This study evaluated the effectiveness of COVID-19 vaccines in preventing symptomatic and severe disease.Study design: This was an observational test-negative case-control study.Methods: Study participants were adults with at least one symptom included in the World Health Or-ganization COVID-19 definition who sought health care in a public emergency department between 1 November 2021 and 2 March 2022 (corresponding with the fifth pandemic wave in Portugal dominated by the Omicron variant). This study used multivariable logistic regression models to estimate and compare the odds ratio of vaccination between test-positive cases and test-negative controls to calculate the absolute and relative vaccine effectiveness.Results: The study included 1059 individuals (522 cases and 537 controls) with a median age of 56 years and 58% were women. Compared with the effectiveness of the primary vaccination scheme that had been completed >= 180 days earlier, the relative effectiveness against symptomatic infection of a booster administered between 14 and 132 days earlier was 71% (95% confidence interval [CI]: 57%, 81%; P = 180 days.Conclusions: Despite the known immunological evasion characteristics of the Omicron variant, results from this study show that vaccine effectiveness increases after booster administration. COVID-19 vaccine effectiveness decreases to less than 50% between 3 and 6 months after completion of the primary cycle; therefore, this would be an appropriate time to administer a booster to restore immunity.(c) 2023 The Authors. Published by Elsevier Ltd on behalf of The Royal Society for Public Health. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).Ana Aguiar holds a PhD grant (Reference: 2020.09390.BD) , co-funded by the Fundacao para a Ciencia e a Tecnologia (FCT) and the Fundo Social Europeu (FSE) Program

Community partnerships in medical education: Narratives of medical students

While medical education has traditionally been designed, led and delivered exclusively by clinicians and academics, there has been an increasing shift towards diversifying actors involved in training future generations of health professionals. Public and patient involvement in learning increases the likelihood that learning is relevant to the communities we purport to serve. This article explores the experiences of medical students who were partnered with a community-based organisation (CBOs) as part of the intercalated Global Health BSc at Imperial College London. Students involved in this programme highlight opportunities to understand the needs of communities they were placed with, beyond what is possible to understand in clinical practice; this is essential to support them in becoming holistic, patient-centred practitioners. Students also found this opportunity helpful to gain insight into the role and value of the voluntary sector in healthcare and develop transferrable skills in project leadership and management. It is hypothesised that the benefits of this partnership extend to community-organisations; they gain experience working with students, who provide an external view of their services and may be helpful in the delivery of quality-improvement projects. Communities could also benefit from interactions with students by sharing insight into their needs and priorities, and in turn, shaping students’ priorities as future health professionals and co-designers of voluntary-sector initiatives within the community. Whilst the establishment of these partnerships does not come without its challenges, this article also highlights lessons for students and institutions undergoing similar programmes, including clarification of goals, stakeholder consultation, sustainability of interventions, voicing the community, timetable flexibility and funding

Quality of life following liver transplantation: a comparative study between Familial Amyloid Neuropathy and liver disease patients

<p>Abstract</p> <p>Background</p> <p>It has been demonstrated in many studies that quality of life can be improved after liver transplantation in patients with liver disease. Nevertherless quality of life improvement in specific groups of transplantated patients such as those with Familial Amyloid Polineuropathy hasn't yet been explored. The present study aimed to compare the change in quality of life following liver transplantation between patients with Familial Amyloid Polineuropathy (FAP) and patients with liver disease.</p> <p>Results</p> <p>Patient's mental quality of life showed an improvement in all liver disease patients, and a worsening in FAP patients, resulting in a significant difference between the two groups. Regarding physical quality of life, although a similar improvement was seen in both groups, FAP patients had significantly less improvement than the sub-group of decompensated liver disease (Child-Pugh B and C).</p> <p>Conclusion</p> <p>It is concluded that liver transplantation has a less beneficial impact in FAP patient's physical quality of life, probably because they are not so much disabled by their disease at the moment of liver transplantation. The lesser improvement in mental quality of life of FAP patients may be due to their particular psychological profile and greater expectations towards transplantation.</p

Monitoring Adherence to Asthma Inhalers Using the InspirerMundi App: Analysis of Real-World, Medium-Term Feasibility Studies

Background: Poor medication adherence is a major challenge in asthma and objective assessment of inhaler adherence is needed. InspirerMundi app aims to monitor inhaler adherence while turning it into a positive experience through gamification and social support. Objective: We assessed the medium-term feasibility of the InspirerMundi app to monitor inhaler adherence in real-world patients with persistent asthma (treated with daily inhaled medication). In addition, we attempted to identify the characteristics of the patients related to higher app use. Methods: Two real-world multicenter observational studies, with one initial face-to-face visit and a 4-month telephone interview, were conducted in 29 secondary care centers from Portugal. During an initial face-to-face visit, patients were invited to use the app daily to register their asthma medication intakes. A scheduled intake was considered taken when patients took a photo of the medication (inhaler, blister, or others) using the image-based medication detection tool. Medication adherence was calculated as the number of doses taken as a percentage of the number scheduled. Interacting with the app ≥30 days was used as the cut-off for higher app use. Results: A total of 114 patients {median 20 [percentile 25 to percentile 75 (P25-P75) 16-36] years, 62% adults} were invited, 107 (94%) installed the app and 83 (73%) completed the 4-month interview. Patients interacted with the app for a median of 18 [3-45] days, translated on a median use rate of 15 [3-38]%. Median inhaler adherence assessed through the app was 34 [4-73]% when considering all scheduled inhalations for the study period. Inhaler adherence assessed was not significantly correlated with self-reported estimates. Median adherence for oral and other medication was 41 [6-83]% and 43 [3-73]%, respectively. Patients with higher app use were slightly older (p = 0.012), more frequently taking medication for other health conditions (p = 0.040), and more frequently prescribed long-acting muscarinic antagonists (LAMA, p = 0.024). After 4 months, Control of Allergic Rhinitis and Asthma Test (CARAT) scores improved (p < 0.001), but no differences between patients interacting with the app for 30 days or less were seen. Conclusions: The InspirerMundi app was feasible to monitor inhaler adherence in patients with persistent asthma. The persistent use of this mHealth technology varies widely. A better understanding of characteristics related to higher app use is still needed before effectiveness studies are undertaken.info:eu-repo/semantics/publishedVersio