Understanding what drives genetic study participation: Perspectives of patients, carers, and relatives.

Genetic research's growing importance in understanding pulmonary arterial hypertension (PAH) and developing effective treatments prompted the RAPID-PAH study. This study sought feedback from stakeholders who participated in two genomic studies to enhance genetic study delivery and clinical integration. Stakeholders from nine UK PH centres, representing various roles, ages, genders, and mutation statuses, took part in 53 semi-structured interviews and focus groups. Transcripts were thematically coded using inductive analysis. Clustering analysis was conducted to identify patient groups that shared attitudes. In this paper, we focus on patients', carers', and relatives' perspectives. The key interview themes revealed insights into participants' attitudes toward genetic research and testing more generally, expertise and knowledge of the disease itself, motivations and barriers to participating in genetic research, awareness of and interest in consent procedures and the use of personal and genetic data, as well as the process of communicating individual genetic results. Factors influencing genetic research participation included altruistic motives, personal diagnostic experiences, and family-related hopes. Clustering analysis produced distinct clusters based on the presence of barriers and motivators for research participation; however, hardly any patients shared identical sets of attitudes, emphasising the need for personalised approaches to recruitment. Most patients reported poor engagement with study-related materials. Patients who received individual genetic results expressed satisfaction with the process, whereas those who did not were disappointed with the lack of feedback. Reflecting on patient perspectives, we offer recommendations to improve the genetic study delivery process. Enhancing genetic research integration into clinical practice requires tailored engagement, clear communication, and support from healthcare stakeholders.

Trial staff and community member perceptions of barriers and solutions to improving racial and ethnic diversity in clinical trial participation; a mixed method study.

Background: The lack of racial and ethnic diversity in clinical trials leads to skewed findings, limited generalizability, inequitable health outcomes for people of color, and insufficient access to innovative therapies. Our objective was to compare perceptions of barriers to participation in trials for people of color and trial staff to provide tangible solutions for improving diversity among study participants. Methods: This mixed method study utilized semi-structured interviews and surveys to evaluate barriers to participation and solutions to improve racial and ethnic diversity in clinical trials among healthcare system trial staff and community members from the same region. Through thematic analysis via coded transcripts and quantitative analysis via survey data, social support theory constructs were identified to evaluate where perceptions of barriers and solutions overlap and where they diverge. Results: A total of 55 trial staff and 75 community members participated in the study. Trial staff identified logistics and patients' unwillingness to receive additional treatments as perceived barriers to participation, while community members stated lack of information and lack of trust in their care team. Both groups identified hesitance toward research as a prominent barrier. Solutions related to informational support demonstrated the most overlap between groups, while instrumental support showed the most discordance. Conclusion: Solutions for improving racial and ethnic diversity in clinical trial participation are multi-faceted and have various levels of impact. Overlap and discordance of opinions regarding solutions should be further evaluated, and implementation of solutions should be carefully considered.

Disability-related inequalities in health and well-being are mediated by barriers to participation faced by people with disability. A causal mediation analysis.

Large inequalities in health and well-being exist between people with and without disability, in part due to poor socio-economic circumstances, and potentially also related to societal factors including issues associated with accessibility and participation. To better understand the contribution of societal factors, we used a unique longitudinal survey of disability in Great Britain to quantify the extent to which barriers to participation contribute to poorer health and well-being. We used data from 2354 individuals who participated in three waves of the Life Opportunities Survey between 2009 and 2014 and compared five health and well-being outcomes (self-rated health, anxiousness, life satisfaction, life worth, happiness) between adults who acquired an impairment and those who remained disability-free. Causal mediation analysis was conducted to quantify how much of the effect of disability acquisition on each outcome was explained by barriers to participation in employment, economic life, transport, community, leisure and civic activities, social contact, and accessibility. People who recently acquired a disability had poorer health and well-being compared to people with no disability. Barriers to participation explained 15% of inequalities in self-rated health, 28% for anxiousness, 32% for life satisfaction, 37% for life worth, and 70% for happiness. A substantial proportion of the inequalities in health and well-being experienced by people with recently acquired disability were socially produced, driven by barriers to participation in different life domains. Furthermore, there was evidence that barriers to participation mediated the effect of well-being measured to a greater extent than the more clinically aligned measures, self-reported health and anxiousness. These findings highlight modifiable factors amenable to public health interventions that could lead to substantial improvements in health and well-being for people with disability.

The post 16 gap: how do young people conceptualise PE? An exploration of the barriers to participation in physical education, physical activity and sport in senior school pupils.

Previous studies have identified several key barriers to Physical Education, Physical activity and Sport (PEPAS). However, there is a paucity of qualitative evidence investigating why young people do and do not participate in PA and the relationship between their levels of participation at different stages of life. This study builds on a previous study and aims to investigate the barriers to PEPAS in adolescents at transition stage. The extant literature highlights that instilling regular PA throughout life strongly relies on developing physical literacy through participation in high quality physical education. Despite the understanding of the importance of high quality physical education, there is an over emphasis on the short term outcomes of physical education (PE) sessions which have been noted to overemphasise immediate physical activity rather than focus on educational outcomes important to physical literacy. Anecdotally, the recent Covid 19 Global pandemic and subsequent lockdown has resulted in a digitalisation of PE in schools and a subsequent reliance of PA programmes based on adult fitness classes, which may not necessarily be categorised as PE in its true sense. Twenty-four respondents aged 16-19 were divided into five focus groups. Data were analysed verbatim using NVivo following the guidelines by Braun and Clark (2006) on thematic analysis. The findings indicated that most respondents equated PE with team sports. Findings suggest that Physical Educators need to acknowledge how past and present experience of PE impacts young people's future motivation to continue PA beyond school. Delivery of traditional PE lessons, prioritising sporting ability, can act as a participation barrier to pupils who consider themselves "non-sporty". Accordingly, a shift towards inclusive pedagogical models with an emphasis on a holistic approach, may best promote the physical literacy necessary for the competence and confidence to continue movement in a lifelong capacity.

Retaining diverse adults with diabetes in a long-term trial: Strategies, successes, and lessons learned.

Background Retention can be difficult in longitudinal trials, especially among minoritized groups and individuals with low socioeconomic status (SES) who may experience more barriers to research participation. Organized retention strategies may help; however, limited research has reported on this in detail. Methods We employed several strategies throughout a 15-month randomized controlled trial to encourage retention among a diverse sample of adults with type 2 diabetes. Participants were randomized to receive mobile health support for diabetes self-care for 12 months or an attention control. Participants completed assessments at 3, 6, 12, and 15 months post-baseline. We used three main categories of retention strategies: flexibility in participation (e.g., multiple methods for data collection), communication (e.g., tracking contacts), and community building (e.g., study branding, newsletters). We monitored participants' use of strategies and examined associations between participant characteristics and retention. Results Retention remained high (≥90%) at each follow-up assessment. Participants used various methods for survey completion: online (34%), in-person (31%), and mail (30%). Most (73%) used a mail-in A1c kit at least once. Multiple completion methods were important for retaining minoritized and lower SES participants who completed assessments in-person more frequently. Communication also facilitated retention; 39% of participants used a study Helpline and tracking systems helped maintain contact. Conclusions Retaining disadvantaged patients in clinical trials is necessary so findings generalize to and can benefit these populations. Retention strategies that reduce barriers to participation and engage participants and community partners can be successful. Future studies should assess the impact of retention strategies.

Exploring the Engagement of Racial and Ethnic Minorities in HIV Treatment and Vaccine Clinical Trials: A Scoping Review of Literature and Implications for Future Research.

HIV disproportionately impacts US racial and ethnic minorities but they participate in treatment and vaccine clinical trials at a lower rate than whites. To summarize barriers and facilitators to this participation we conducted a scoping review of the literature guided by the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines. Studies published from January 2007 and September 2019 were reviewed. Thirty-one articles were identified from an initial pool of 325 records using three coders. All records were then assessed for barriers and facilitators and summarized. Results indicate that while racial and ethnic minority participation in these trials has increased over the past 10 years, rates still do not proportionately reflect their burden of HIV infection. While many of the barriers mirror those found in other disease clinical trials (e.g., cancer), HIV stigma is a unique and important barrier to participating in HIV clinical trials. Recommendations to improve recruitment and retention of racial and ethnic minorities include training health care providers on the importance of recruiting diverse participants, creating interdisciplinary research teams that better represent who is being recruited, and providing culturally competent trial designs. Despite the knowledge of how to better recruit racial and ethnic minorities, few interventions have been documented using these strategies. Based on the findings of this review, we recommend that future clinical trials engage community stakeholders in all stages of the research process through community-based participatory research approaches and promote culturally and linguistically appropriate recruitment and retention strategies for marginalized populations overly impacted by HIV.

Perceived influence of intrinsic/extrinsic factors on participation in life activities after spinal cord injury.

BACKGROUND: Various types of limitations on community participation are experienced by people with spinal cord injury (SCI). OBJECTIVES: To determine: 1) the perceived influence of six intrinsic/extrinsic factors (i.e. physical impairment, emotional condition, thinking skills, environment, lack of assistance, discrimination) on participation in 26 life activities, 2) if this influence varied based on extent of participation, and 3) if personal or environmental characteristics influenced perceptions. METHODS: Secondary analysis of a cohort (SCI Community Survey, n = 1508) using the SCI Person-Perceived Participation in Daily Activities Questionnaire. Frequency tables, Fisher's exact tests and correspondence analyses. RESULTS: Respectively, 79.6% and 38.5% of respondents perceived that their physical impairment and the natural and/or built environment were the main factors that limited participation across all activities. Considering participation between three groups (no participation; less than wanted; as much as wanted), significant differences (p < 0.001) of perceptions were observed in 65% of the combinations (26 activities x 6 factors). The hypothesis that respondents who did not participate would perceive the highest proportion of limitations was confirmed in 41% of the combinations. Perceived influence of the intrinsic/extrinsic factors on participation was not significantly influenced by other personal or environmental characteristics. CONCLUSION: A majority of people with SCI perceived that their participation is limited by one or more of intrinsic/extrinsic factors. Perceptions regarding which factors influence participation differ between activities and these perceptions appear related to the extent of participation suggesting that those who actively participate could be the most sensitive to limitations in certain activities.

Leveraging National Cancer Institute Programmatic Collaboration for Uterine Cervix Cancer Patient Accrual in Puerto Rico.

Women in the U.S. Commonwealth of Puerto Rico (PR) have a higher age-adjusted incidence rate for uterine cervix cancer than the U.S. mainland as well as substantial access and economic barriers to cancer care. The National Cancer Institute (NCI) funds a Minority/Underserved NCI Community Oncology Research Program in PR (PRNCORP) as part of a national network of community-based health-care systems to conduct multisite cancer clinical trials in diverse populations. Participation by the PRNCORP in NCI's uterine cervix cancer clinical trials, however, has remained limited. This study reports on the findings of an NCI site visit in PR to assess barriers impeding site activation and accrual to its sponsored gynecologic cancer clinical trials. Qualitative, semi-structured individual, and group interviews were conducted at six PRNCORP-affiliated locations to ascertain: long-term trial accrual objectives; key stakeholders in PR that address uterine cervix cancer care; key challenges or barriers to activating and to enrolling patients in NCI uterine cervix cancer treatment trials; and resources, policies, or procedures in place or needed on the island to support NCI-sponsored clinical trials. An NCI-sponsored uterine cervix cancer radiation-chemotherapy intervention clinical trial (NCT02466971), already activated on the island, served as a test case to identify relevant patient accrual and site barriers. The site visit identified five key barriers to accrual: (1) lack of central personnel to coordinate referrals for treatment plans, medical tests, and medical imaging across the island's clinical trial access points; (2) patient insurance coverage; (3) lack of a coordinated brachytherapy schedule at San Juan-centric service providers; (4) limited credentialed radiotherapy machines island-wide; and (5) too few radiology medical physicists tasked to credential trial-specified positron emission tomography scanners island-wide. PR offers a unique opportunity to study overarching and tactical strategies for improving accrual to NCI-sponsored gynecologic cancer clinical trials. Interview findings support adding and re-tasking personnel for coordinated trial-eligible patient referral, accrual, and treatment.

Feasibility of a randomized single-blind crossover trial to assess the effects of the second-generation slow-release dopamine agonists pramipexole and ropinirole on cued recall memory in idiopathic mild or moderate Parkinson's disease without cognitive impairment.

BACKGROUND: The aim was to assess the feasibility of a single-centre, single-blind, randomized, crossover design to explore the effects of two slow-release dopamine agonists, ropinirole and pramipexole, on cued recall in Parkinson's disease. As the design required a switch from the prescribed agonist (pramipexole-to-ropinirole, or ropinirole-to-pramipexole), the primary objectives were to (a) examine the efficacy of processes and procedures used to manage symptoms during the washout period and (b) to use cued recall estimates to inform a power calculation for a definitive trial. Secondary objectives were to assess consent and missing data rates, acceptability of clinical support for the OFF sessions, experience of the OFF sessions and of agonist switching, barriers-to-participation for patients and informal caregivers. METHODS: Patients were randomized in a 1:1 ratio to two treatment arms and stabilized on each agonist for 6 weeks. The arms differed only in the sequence in which the agonists were administered. Cued recall was assessed ON medication and, following a washout period resulting in 93.75% agonist elimination, OFF medication. RESULTS: A total of 220 patients were screened: 145 were excluded and 75 invitations to participate were sent to eligible patients. Fifty-three patients declined, 22 consented and 16 completed the study. There were no serious adverse events, and rates of non-serious adverse events were equivalent between the agonists. Using the largest standard deviation (SD) of the ON-OFF difference cued recall score (inflated by ~25% to give a conservative estimate of the SD in a definitive trial) and assuming an effect of at least 10% of the observed range of OFF medication cued recall scores for either agonist to be clinically important, a main trial requires a sample size of just under 150 patients. The consent and missing data rates were 29 and 27% respectively. The washout period and the preparation for the OFF sessions were acceptable, and the sessions were manageable. The experience of switching was also manageable. Barriers to participation included concerns about disease stability, side effects, research process, carer workload and accessibility of the information sheet. CONCLUSIONS: This study presented challenges to recruitment both in design and execution, and while it was a major aim of the study to assess this, evaluation of these challenges provided the opportunity to explore how they could be overcome for future studies. TRIAL REGISTRATION: EudraCT 2012-000801-64.

Which Obstacles Prevent Us from Recruiting into Clinical Trials: A Survey about the Environment for Clinical Studies at a German University Hospital in a Comprehensive Cancer Center.

BACKGROUND: Prospective clinical studies are the most important tool in modern medicine. The standard in good clinical practice in clinical trials has constantly improved leading to more sophisticated protocols. Moreover, translational questions are increasingly addressed in clinical trials. Such trials must follow elaborate rules and regulations. This is accompanied by a significant increase in documentation issues which require substantial manpower. Furthermore, university-based clinical centers are interested in increasing the amount of patients treated within clinical trials, and this number has evolved to be a key quality criterion. The present study was initiated to elucidate the obstacles that limit clinical scientists in screening and recruiting for clinical trials. METHODS: A specific questionnaire with 28 questions was developed focusing on all aspects of clinical trial design as well as trial management. This included questions on organizational issues, medical topics as well as potential patients' preferences and physician's goals. The questionnaire was established to collect data anonymously on a web-based platform. The survey was conducted within the Klinikum rechts der Isar, Faculty of Medicine, Technical University of Munich; physicians of all levels (Department Chairs, attending physicians, residents, as well as study nurses, and other study-related staff) were addressed. The answers were analyzed using the Survio analyzing tool (http://www.survio.com/de/). RESULTS: We collected 42 complete sets of answers; in total 28 physicians, 11 study nurses, and 3 persons with positions in administration answered our survey. The study centers reported to participate in a range of 3-160 clinical trials with a recruitment rate of 1-80%. Main obstacles were determined: 31/42 (74%) complained about limited human resources and 22/42 (52%) reported to have a lack on technical resources, too. 30/42 (71%) consented to the answer, that the documentation effort of clinical trials is too large. A possible increase of the patients' study participation rate up to over 20% was deemed to be possible if the described limitations could be overcome. DISCUSSION: The increasing documentation effort in clinical trials has led to a strong increase in the work load of scientific personnel. Recruiting of patients into clinical trials therefore is not only limited by patient issues, but also by the infrastructure of the centers. Especially the lack of study nurses is likely to be a major limitation. Furthermore, technical resources for time efficient and safe documentation within clinical routine as well as in clinical trials are required. By optimization of these factors, a significant increase in the amount of patients treated in clinical trials seems to be possible.

Recruitment challenges in clinical research: Survey of potential participants in a diagnostic study of ovarian cancer.

OBJECTIVE: Recruiting participants in clinical research is challenging. Certain groups, such as older adults, rural residents, and individuals with lower socio-economic status, are typically underrepresented. Here, we explore perceived motivators and barriers among potential participants in a diagnostic study of ovarian cancer. METHODS: Women aged 50 and older who answered a mail survey in Montreal, Canada, were asked to assess their eligibility to participate in the ongoing Diagnosing Ovarian cancer Early (DOvE) Study. If 'eligible', they were asked whether they planned to participate in DOvE. Using modified Poisson regression, we examined responders' self-assessment of eligibility, intention to participate, and reasons for why or why not, as a function of socio-demographic and health indicators. RESULTS: Of 826 responders, 33.1% misclassified themselves with respect to eligibility. Among 532 self-assessed eligible women, 56.4% planned to participate in the study. The majority of women not planning to participate preferred to be assessed by their physicians (a reason more commonly reported by those with lower education or income) or believed they were not at risk of ovarian cancer (despite having no fewer risk factors). "Inconvenience" was also a commonly reported reason, especially among rural residents. Women who planned to participate often perceived a benefit (e.g. to rule out ovarian cancer, or to receive a quick check-up). CONCLUSIONS: Recruitment, particularly of underrepresented groups, in clinical studies may be enhanced by involving primary care providers, facilitating access to study sites, and providing clear information about the disease under study (including risk factors) and eligibility criteria.

Embracing an "African Ethos" to facilitate African immigrants participation in medical genetics and genomics research.

BACKGROUND: Limited published research exists on perceptions and potentials for black African immigrants' participation in medical genetics and genomics research. PURPOSE: This study explores the inclination and disinclination of African immigrants to be involved in genetics and genomics research. METHODS: In-depth qualitative interviews were employed in which a sample of black African immigrants 18 years and older (n = 34) were interviewed. DISCUSSION: Barriers included contrary beliefs and customs about disease and the human body that differs from Western conceptions, and lack of genuine connection to the health care system. Facilitators included promotion of an "African ethos," wherein Africans unite with one another in a communal extension of self and robust community involvement across the life span of genetic studies. CONCLUSION: It is important for researchers and genetic counselors to understand the sociocultural underpinnings of African immigrants about genetics and genomics research as an initial step to encouraging their participation.

Surrendering control, or nothing to lose: Parents' preferences about participation in a randomised trial of childhood strabismus surgery.

BACKGROUND: Intermittent exotropia is the most common form of divergent strabismus (squint) in children. Evidence regarding its optimum management is limited. A pilot randomised controlled trial has recently been completed (Surgery versus Active Monitoring in Intermittent Exotropia trial) to determine the feasibility of a full randomised controlled trial. PURPOSE: To identify drivers for and barriers against parents' participation in Surgery versus Active Monitoring in Intermittent Exotropia and to seek their views on information received, the need for randomisation, and enhancing acceptability. METHODS: Multiple method qualitative study using semi-structured telephone interviews to explore parents' motivations and trial screening logs to provide an indication of common barriers. Exploratory thematic analysis identified key themes. RESULTS: A total of 48 interviews were conducted (14 participants; 34 non-participants). Barriers included no desire for surgery/preference to 'wait and see', wanting surgery immediately, feeling uncomfortable about 'surrendering control' over decision-making/being managed 'at random', lack of confidence in the effectiveness of surgery, believing the risks outweighed the benefits, and lack of trust. Drivers included desiring surgery, 'nothing to lose', benefits offsetting the risks, and being in a trial would result in better care. Some also mentioned 'doing their bit' for research. Suggestions for enhancing acceptability included allowing choice of treatment group, giving more time for decision-making, expanding on information given, and improving communication. Many felt the necessity of randomisation was adequately explained, but there was some indication that it was misunderstood. Information extracted from the screening logs of 80/89 eligible non-participants indicated the most prevalent barrier was not wanting surgery/preferring to observe (56%), followed by desiring surgery straightaway (15%). Opposition to randomisation/wanting to retain control was recorded in 9% of cases as was the belief that the child's squint was not severe enough to warrant surgery. LIMITATIONS: Interviews were not audio-recorded. Not all who consented to interview could be contacted, although the response/contact rate was good (48/62). A few parents did not provide reasons for refusing the trial. CONCLUSION: Opposition to surgery and concerns about surrendering control were common obstacles to participation, whereas parents keen for their child to undergo the operation but happy to defer tended to embrace a 'nothing to lose' attitude. Many non-participants would have consented if allowed to choose group, although most of these would have chosen observation. While most parents felt happy with information given and that randomisation was adequately explained, it is of concern that there may be some misunderstanding, which should be addressed in any trial. These findings will inform future trials in childhood exotropia, for example, consideration of preference arms and improving communication. Lessons learnt from the Surgery versus Active Monitoring in Intermittent Exotropia trial could prove valuable to paediatric and surgical trials generally.

Evaluation of the factor structure of the obstacles to engagement scale with low-income african american parents.

OBJECTIVE: Parenting anticipatory guidance is one way to promote optimal child health and development and minimize disparities between children from lower socio-economic status families and their higher income peers. However, low rates of attendance at and completion of parenting programs has been demonstrated. Understanding barriers to participation has important implications. The Obstacles to Engagement Scale (OES) has been used in some populations but it has not been evaluated for use with low-income African American samples. The aim of the current study is to evaluate the factor structure of the OES with a sample of low-income, African American parents. METHOD: Parents or legal guardians with children aged 3-8 years completed a survey in the waiting room of a primary care pediatric academic practice in an urban location in the southern United States of America (N = 114). Almost 87% had <12th grade education and 93% of the children received Medicaid services. The OES was one measure from a larger study and only participants with complete data on the OES were included in the exploratory factor analysis (EFA). RESULTS: The EFA did not support the previous 4-factor solution (intervention demands, personal or family stressors or obstacles, relevance of or trust in intervention, and time and scheduling demands. Instead, a 3-factor statistical solution emerged but not all items held together conceptually. CONCLUSION: The current study supports the necessity for evaluating study instruments for use with specific populations. Larger samples are needed to disentangle the effects of educational and poverty status from race and ethnicity and to develop and validate instruments that are appropriate for the study population.