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In 1979, Kim Min Gi and other activists from South Korea's democracy and labour movements clandestinely released the collective radio play “Light of a Factory” (Kongchang'ui Bulbit). This work was used to mobilize factory workers into the broad-based minjung or people's movements that were challenging the dictatorship. The play documented the lives of Korean workers and the suppression of their desires under the authoritarian regime. The plot centered on female workers in an export factory who decide to organize a union. It was loosely based on real struggles such as the massive strike by female employees at the Y.H. Trading Company in 1978-9; a strike which spilled over into the struggles of the Korean democracy movement. The music was a cacophony of different styles and influences: from US camptown progressive rock, to Western and Korean folk music, to shaman ritual and other traditional styles. Cassettes of the play were rerecorded on home stereos and passed around from hand to hand.
Objectives/Goals: Clinical trial success requires recruiting and retaining diverse participants. The ER&R Certificate Program trains clinical research professionals (CRPs) in equity, diversity, and inclusion (EDI), addressing biases, and integrating regulatory knowledge with practical skills to foster inclusive research practices. Methods/Study Population: An interdisciplinary Steering Committee, supported by Duke CTSI and DOCR, developed and implemented an engagement, recruitment, and retention certificate program (ER&R) for CRPs. With expert-led instruction, including e-learning, group sessions, and hands-on activities, ER&R integrates EDI into participant engagement practices. Participants complete 7 core courses and at least 3 elective courses, reflecting their unique responsibilities. Program evaluation uses the Kirkpatrick model to assess participant learning, competency, and EDI integration into clinical research. Since launch, the program has expanded to include clinical research trainees from Durham Technical Community College. All elements of the program were designed to allow for sharing across academic medical institutions. Results/Anticipated Results: A total of 202 CRPs and trainees have participated since launch (2020), including 17 trainee participants from Durham Technical Community College (2022–2024). Post-program evaluations showed significant growth in recruitment and retention self-efficacy. An early evaluation of the first 2 cohorts (n = 59) included a self-assessment across defined competencies showing marked increases in comfort across all learning objectives, with notable gains in: Community and Stakeholder Engagement, Recruitment on a Shoestring Budget, Community-Engaged Research Initiatives, and Social Marketing. Participants valued the program’s focus on EDI and sought more practical strategies and peer collaboration. 50 additional institutions have engaged with our implementation consultations and program repository. Discussion/Significance of Impact: Barriers to equitable ER&R exist at the individual, study, and system levels. Addressing these requires more intentional engagement practices. The ER&R certificate program is an innovative model for integrating equity principles with practical and required knowledge and skills training for participant-facing research professionals.
Mass-gathering events (MGEs) such as sporting competitions and music festivals that take place in stadiums and arenas pose challenges to health care delivery that can differ from other types of MGEs. This scoping review aimed to describe factors that influence patient presentations to in-event health services, ambulance services, and emergency departments (EDs) from stadium and arena MGEs.
Method:
This scoping review followed the Preferred Reporting Items of Systematic Reviews and Meta-Analysis for Scoping Reviews (PRISMA-ScR) checklist and blended both Arksey and O’Malley methodology and the Joanna Briggs Institute’s (JBI’s) approach. Four databases (CINAHL, Embase, PubMed, and Scopus) were searched using keywords and terms about “mass gatherings,” “stadium” or “arena,” and “in-event health services.” In this review, the population pertains to the spectators who seek in-event health services, the concept was MGEs, and the context was stadiums and/or arenas.
Results:
Twenty-two articles were included in the review, most of which focused on sporting events (n = 18; 81.8%) and music concerts (n = 3; 13.6%). The reported patient presentation rate (PPR) ranged between one and 24 per 10,000 spectators; the median PPR was 3.8 per 10,000. The transfer to hospital rate (TTHR) varied from zero to four per 10,000 spectators, and the median TTHR was 0.35 per 10,000. Key factors reported for PPR and TTHR include event, venue, and health support characteristics.
Conclusions:
There is a complexity of health care delivery amid MGEs, stressing the need for uniform measurement and continued research to enhance predictive accuracy and advance health care services in these contexts. This review extends the current MGE domains (biomedical, psychosocial, and environmental) to encompass specific stadium/arena event characteristics that may have an impact on PPR and TTHR.
The success of clinical research studies depends on effective recruitment and retention of study participants, yet only a small fraction of patients engage in research studies, even in academic health systems. Increasing awareness of research opportunities and facilitating connections with clinical research study teams would help to improve the success of research programs. In this Special Communications, we describe the creation and evolution of and tools used for the My Research Partners Concierge Service (MRPcs) of an academic health system. The MRPcs provides a centralized point of contact or hub for patients and community members, as well as clinical research organizations and academic partners, who have research-related questions or interests. The MRPcs helps to connect the users of the service with relevant research study teams, personnel, or resources to facilitate their engagement in a clinical research program. Our experience with the MRPcs informs our recommendation that peer institutions organize similar research service hubs for their clinical research programs to help increase awareness of and participation in clinical research by the public and to help increase the success of research programs at fulfilling their ultimate goal of improving the health of their population.
Studies show stimulant medications are effective for different ADHD presentations (predominantly inattentive [IA], predominantly hyperactive-impulsive [HI] or combined [C]); however, few studies have evaluated nonstimulant efficacy in different ADHD presentations. Viloxazine ER [VLX ER] is a nonstimulant, FDA-approved medication for pediatric (≥6 yrs) and adult ADHD. This post-hoc analysis of 4 double-blind (DB), Phase 3, clinical trials (2 in adolescents [NCT03247517 and NCT03247556], 2 in children [NCT03247530 and NCT03247543]), evaluates VLX ER efficacy by ADHD presentation as derived from ADHD Rating Scale, 5th Edition (ADHD-RS-5) assessments at Baseline.
Methods
Children and adolescents with ADHD and an ADHD-RS-5 Total score ≥ 28 were eligible for enrollment. ADHD presentation was defined as a rating of ≥2 on at least 6 of 9 ADHD-RS-5 inattention items, or hyperactive-impulsive items or both. For each ADHD presentation, the change from Baseline (CFB) in ADHD-RS-5 Total score (primary outcome in each study) was assessed using mixed models for repeated measures (MMRM). Responder rate (secondary outcome), ≥50% reduction from baseline in ADHD-RS-5 Total score, was analyzed using generalized estimating equations (GEE).
Results
Of 1354 subjects [placebo N = 452, VLX ER N = 902], ADHD presentation was assigned as 288 (21.3%) [IA], 1010 (74.5%) [C], 40 (3.0%) [HI], 16 (1.2%) [none of these]. Due to the small sample size of [HI], only the [IA] and [C] results are presented. At Week 6 (pooled data endpoint), ADHD-RS-5 Total scores were significantly improved for VLX ER relative to placebo for both the [IA] and [C] ADHD presentations. LS mean (SE) treatment differences, p-values were: [IA] -3.1 (1.35), p = 0.0219, and [C] 5.8 (0.97), p < 0.0001. Responder rates were also significantly higher for VLX ER: 43.0% [IA] and 42.7% [C] relative to placebo 29.5% [IA] and 25.5 % [C] (p=.0311 and p<.0001).
Conclusions
Viloxazine ER significantly reduced ADHD symptoms in individuals meeting criteria for ADHD [IA] or [C] presentations at Baseline. Limitations include post-hoc methodology, smaller sample sizes of [IA] and [HI] groups, and the ADHD-RS-5 ≥ 28 eligibility requirement, that may favor enrollment of individuals with ADHD [C] over ADHD [IA] or [HI] presentations. Consistency of response during long-term use should be evaluated.
Research participants” feedback about their participation experiences offers critical insights for improving programs. A shared Empowering the Participant Voice (EPV) infrastructure enabled a multiorganization collaborative to collect, analyze, and act on participants’ feedback using validated participant-centered measures.
Methods:
A consortium of academic research organizations with Clinical and Translational Science Awards (CTSA) programs administered the Research Participant Perception Survey (RPPS) to active or recent research participants. Local response data also aggregated into a Consortium database, facilitating analysis of feedback overall and for subgroups.
Results:
From February 2022 to June 2024, participating organizations sent surveys to 28,096 participants and received 5045 responses (18%). Respondents were 60% female, 80% White, 13% Black, 2% Asian, and 6% Latino/x. Most respondents (85–95%) felt respected and listened to by study staff; 68% gave their overall experience the top rating. Only 60% felt fully prepared by the consent process. Consent, feeling valued, language assistance, age, study demands, and other factors were significantly associated with overall experience ratings. 63% of participants said that receiving a summary of the study results would be very important to joining a future study. Intersite scores differed significantly for some measures; initiatives piloted in response to local findings raised experience scores.
Conclusion:
RPPS results from 5045 participants from seven CTSAs provide a valuable evidence base for evaluating participants’ research experiences and using participant feedback to improve research programs. Analyses revealed opportunities for improving research practices. Sites piloting local change initiatives based on RPPS findings demonstrated measurable positive impact.
Latinx populations are underrepresented in clinical research. Asking Latinx research participants about their research experiences, barriers, and facilitators could help to improve research participation for these populations.
Methods:
The Salud Estres y Resilencia (SER) Hispano cohort study is a longitudinal cohort study of young adult Latinx immigrants whose design and conduct were tailored for their study population. We administered the Research Participant Perception Survey (RPPS) to SER Hispano participants to assess their experiences in the study. We describe overall results from the RPPS and compare results of surveys administered to SER Hispano participants via email versus telephone.
Results:
Of 340 participants who were contacted with the RPPS, 142 (42%) responded. Among respondents, 53 (37%) responded by initial email contact; and 89 (63%) responded by subsequent phone contact. The majority of respondents were between 35 and 44 years of age (54%), female (76%), and of Cuban origin (50%). Overall, research participants expressed high satisfaction with their research experience; 84% stated that they would “definitely” recommend research participation to friends and family, with no significant difference by method of survey administration (P = 0.45). The most common factor that was chosen that would influence future research participation was having summary results of the research shared with them (72%).
Conclusion:
We found that culturally tailored studies can be good experiences for Latinx research participants; and we found that use of the RPPS can be administered successfully, particularly when administered by more than one method, including telephone, to evaluate and to improve research experiences for this population.
Recovery colleges provide personalised educational mental health support for people who self-refer. The research evidence supporting them is growing, with key components and the positive experiences of attendees reported. However, the quantitative outcome evidence and impact on economic outcomes is limited.
Aims
To evaluate the impact of attending a UK recovery college for students who receive a full educational intervention.
Method
This is a pre- and post-intervention study, with predominantly quantitative methods. Participants recruited over an 18-month period (01.2020–07.2021) completed self-reported well-being (Short Warwick–Edinburgh Mental Wellbeing Scale (SWEMWBS)) and recovery (Process of Recovery (QPR)) surveys, and provided details and evidence of employment and educational status. Descriptive statistics for baseline data and Shapiro–Wilk, Wilcoxon signed-rank and paired t-tests were used to compare pre- and post-intervention scores, with Hedges’ g-statistic as a measure of effect size. Medical records were reviewed and a brief qualitative assessment of changes reported by students was conducted.
Results
Of 101 student research participants, 84 completed the intervention. Well-being (mean SWEMWBS scores 17.3 and 21.9; n = 80) and recovery (mean QPR scores 27.2 and 38.8; n = 75) improved significantly (P < 0.001; Hedges’ g of 1.08 and 1.03). The number of economically inactive students reduced from 53 (69%) to 19 (24.4%). No research participants were referred for specialist mental health support while students. ‘Within-self’ and ‘practical’ changes were described by students following the intervention.
Conclusions
Findings detail the largest self-reported pre–post data-set for students attending a recovery college, and the first data detailing outcomes of remote delivery of a recovery college.
Empowering the Participant Voice (EPV) is an NCATS-funded six-CTSA collaboration to develop, demonstrate, and disseminate a low-cost infrastructure for collecting timely feedback from research participants, fostering trust, and providing data for improving clinical translational research. EPV leverages the validated Research Participant Perception Survey (RPPS) and the popular REDCap electronic data-capture platform. This report describes the development of infrastructure designed to overcome identified institutional barriers to routinely collecting participant feedback using RPPS and demonstration use cases. Sites engaged local stakeholders iteratively, incorporating feedback about anticipated value and potential concerns into project design. The team defined common standards and operations, developed software, and produced a detailed planning and implementation Guide. By May 2023, 2,575 participants diverse in age, race, ethnicity, and sex had responded to approximately 13,850 survey invitations (18.6%); 29% of responses included free-text comments. EPV infrastructure enabled sites to routinely access local and multi-site research participant experience data on an interactive analytics dashboard. The EPV learning collaborative continues to test initiatives to improve survey reach and optimize infrastructure and process. Broad uptake of EPV will expand the evidence base, enable hypothesis generation, and drive research-on-research locally and nationally to enhance the clinical research enterprise.
Advance consent could allow individuals at high risk of stroke to provide consent before they might become eligible for enrollment in acute stroke trials. This survey explores the acceptability of this novel technique to Canadian Research Ethics Board (REB) chairs that review acute stroke trials. Responses from 15 REB chairs showed that majority of respondents expressed comfort approving studies that adopt advance consent. There was no clear preference for advance consent over deferral of consent, although respondents expressed significant concern with broad rather than trial-specific advance consent. These findings shed light on the acceptability of advance consent to Canadian ethics regulators.
The electronic health record (EHR) and patient portal are used increasingly for clinical research, including patient portal recruitment messaging (PPRM). Use of PPRM has grown rapidly; however, best practices are still developing. In this study, we examined the use of PPRM at our institution and conducted qualitative interviews among study teams and patients to understand experiences and preferences for PPRM.
Methods:
We identified study teams that sent PPRMs and patients that received PPRMs in a 60-day period. We characterized these studies and patients, in addition to the patients’ interactions with the PPRMs (e.g., viewed, responded). From these groups, we recruited study team members and patients for semi-structured interviews. A pragmatic qualitative inquiry framework was used by interviewers. Interviews were audio-recorded and analyzed using a rapid qualitative analysis exploratory approach.
Results:
Across ten studies, 35,037 PPRMs were sent, 33% were viewed, and 17% were responded to. Interaction rates varied across demographic groups. Six study team members completed interviews and described PPRM as an efficient and helpful recruitment method. Twenty-eight patients completed interviews. They were supportive of receiving PPRMs, particularly when the PPRM was relevant to their health. Patients indicated that providing more information in the PPRM would be helpful, in addition to options to set personalized preferences.
Conclusions:
PPRM is an efficient recruitment method for study teams and is acceptable to patients. Engagement with PPRMs varies across demographic groups, which should be considered during recruitment planning. Additional research is needed to evaluate and implement recommended changes by study teams and patients.
Advance consent presents a potential solution to the challenge of obtaining informed consent for participation in acute stroke trials. Clinicians in stroke prevention clinics are uniquely positioned to identify and seek consent from potential stroke trial participants. To assess the acceptability of advance consent to Canadian stroke clinic physicians, we performed an online survey. We obtained 58 respondents (response rate 35%): the vast majority (82%) expressed comfort with obtaining advance consent and 92% felt that doing so would not be a significant disruption to clinic workflow. These results support further study of advance consent for acute stroke trials.
This chapter explains the fundamental elements of resuscitation. Patients in cardiorespiratory arrest require prompt and effective resuscitation to improve chances of a good outcome. Identification of the underlying cardiac rhythm and treatment of any reversible causes is critical to achieve patient survival. A structured ABCDE approach and the ALS algorithm are commonly adopted to optimise patient assessment and management. An awareness of both technical and non-technical skills are important when dealing with the acutely deteriorating patient.
Adequate equitable recruitment of underrepresented groups in clinical research and trials is a national problem and remains a daunting challenge to translating research discoveries into effective healthcare practices. Engagement, recruitment, and retention (ER&R) training programs for Clinical Research Professionals (CRPs) often focus on policies and regulations. Although some training on the importance of diversity and inclusion in clinical research participation has recently been developed, there remains a need for training that couples critical equity, diversity, and inclusion (EDI) concepts with skill development in effective recruitment and retention strategies, regulations, and best practices.
Approach and methods:
We developed the ER&R Certificate program as a holistic approach to provide Duke University CRPs the opportunity to build competency in gap areas and to increase comfort in championing equitable partnerships with clinical research participants. The thirteen core and elective courses include blended learning elements, such as e-learning and wiki journaling prompts, to facilitate meaningful discussions. Pre- and post-assessments administered to CRP program participants and their managers assessed program impact on CRP skills in ER&R tasks and comfort in equitable, diverse, and inclusive engagement of clinical research participants.
Results and discussion:
Results from the first two cohorts indicate that CRPs perceived growth in their own comfort with program learning objectives, especially those centered on participant partnership and EDI principles, and most managers witnessed growth in competence and responsibility for ER&R-related tasks. Results suggest value in offering CRPs robust training programs that integrate EDI and ER&R training.
Current information about the prevalence of various mental health disorders in the general adult population of the Republic of Ireland is lacking. In this study, we examined the prevalence of 12 common mental disorders, the proportion of adults who screened positive for any disorder, the sociodemographic factors associated with meeting criteria for a disorder and the associations between each disorder and history of attempted suicide.
Methods
A non-probability nationally representative sample (N = 1110) of adults living in Ireland completed self-report measures of 12 mental health disorders. Effect sizes were calculated using odds ratios from logistic regression models, and population attributable risk fractions (PAFs) were estimated to quantify the associations between each disorder and attempted suicide.
Results
Prevalence rates ranged from 15.0% (insomnia disorder) to 1.7% (histrionic personality disorder). Overall, 42.5% of the sample met criteria for a mental health disorder, and 11.1% had a lifetime history of attempted suicide. Younger age, being a shift worker and trauma exposure were independently associated with a higher likelihood of having a mental health disorder, while being in university was associated with a lower likelihood of having a disorder. ICD-11 complex posttraumatic stress disorder, borderline personality disorder and insomnia disorder had the highest PAFs for attempted suicide.
Conclusions
Mental health disorder prevalence in Ireland is relatively high compared to international estimates. The findings are discussed in relation to important mental health policy implications.
Introduction. It has been estimated that smokers tend to fail to report unsuccessful quit attempts that lasted a short time and occurred a longer time ago. However, it is unclear whether the failure to report unsuccessful quit attempts varies by the type of cessation aid used. Methods. A total of 5,892 smokers aged 16+ years who had made 1+ quit attempts in the past year were surveyed between January 2014 and December 2020 as part of the Smoking Toolkit Study. Respondents indicated when their most recent quit attempt started, how long it lasted, and which cessation aid(s) were used (e.g., unaided, varenicline, and behavioural support). The percentage failure to report for each cessation aid and 95% bootstrap confidence intervals (CIs) were estimated with an established method. Test for equality of proportions was performed to examine whether quit attempts lasting between one day and one week and that started >6 months ago failed to be reported at a different rate depending on the cessation aid used. Results. We estimated that after three months, 97% (95% CI = 96%-98%) of unaided quit attempts lasting less than one day, 80% (95% CI = 79%-81%) of those lasting between one day and one week, and 60% (95% CI = 59%-61%) of those lasting between one week and one month fail to be reported. Compared with unaided attempts, the estimated percentage failure to report quit attempts that lasted between one day and one week and that started >6 months ago was significantly lower for attempts involving behavioural support (92% of unaided attempts vs. 75% of attempts involving behavioural support, , p = 0.002). No other significant differences were detected. Conclusions. Smokers in England appear to fail to report a substantial proportion of unsuccessful quit attempts. This failure appears particularly prominent for attempts that last a short time or occurred longer ago and appears lower for attempts involving behavioural support compared with unaided attempts.
Gall wasps in the cynipid genus Diplolepis Geoffroy (Hymenoptera: Cynipidae) attack various species of native and introduced roses in Canada. Although gall forms are diverse, gall wasps are parasitised by highly concordant complexes of parasitoids and inquilines. Many species of gall wasps attack the same host plants and develop over the same periods in the season, suggesting that opportunistic parasitoids may be exploiting a range of hosts rather than specialising. We sampled larvae of Eurytoma Illiger (Hymenoptera: Cynipidae) from galls of D. variabilis (Bassett) and D. rosaefolii (Cockerell), gall inducers that develop fairly synchronously late in the growing season on leaves of Rosa woodsii Lindl. (Rosaceae) in the Okanagan Valley of central British Columbia, Canada. Galls were sampled at five different sites along a gradient from the north end of the valley to the Canada–United States border, a distance of 100 km. We extracted DNA, then amplified and sequenced the cytochrome b segment for each Eurytoma larva. We identified two well-supported clades that were differentiated by neither sampling location nor host. Instead, at least two species of Eurytoma, E. imminuta Bugbee and E. longavena Bugbee, exist at these localities, and both exploit at least two of the Diplolepis hosts found at these sites.
SHEA endorses adhering to the recommendations by the CDC and ACIP for immunizations of all children and adults. All persons providing clinical care should be familiar with these recommendations and should routinely assess immunization compliance of their patients and strongly recommend all routine immunizations to patients. All healthcare personnel (HCP) should be immunized against vaccine-preventable diseases as recommended by the CDC/ACIP (unless immunity is demonstrated by another recommended method). SHEA endorses the policy that immunization should be a condition of employment or functioning (students, contract workers, volunteers, etc) at a healthcare facility. Only recognized medical contraindications should be accepted for not receiving recommended immunizations.
OBJECTIVES/GOALS: In March 2019, Duke updated recruitment guidelines and adopted an “Engagement” policy that requires patients to ‘opt-out’ of communications regarding potential research participation. This created an opportunity to evaluate recruitment for ongoing clinical studies pre and post implementation. METHODS/STUDY POPULATION: Implementation of the new policy required new training for study teams, modification to recruitment plans, and expansion of ongoing efforts to improve direct-to-patient messaging through EPIC/MyChart tools. The impact of this new policy on overall recruitment was monitored and characterized both prior to and after implementation of the policy. Customized MyChart messages have been generated for over 22 studies, with a total of 41,386 messages sent to potential participants. RESULTS/ANTICIPATED RESULTS: Only a small number of study teams have modified their recruitment plans with transition to the new policy. This may be related to lack of understanding about policy implementation, potential recruitment opportunities, required training, resource limitations, etc. However, our case study, TMIST, had an 48% improvement in average enrollment within the first 2 months of implementation, and an almost 40% improvement in recruitment efficiency. Since becoming an “opt-out” institution, 11 study teams have implemented direct-to-patient recruitment via the MyChart patient portal. One unintended consequence we’ve noted is several different study invitations to potential participants within some patient populations. DISCUSSION/SIGNIFICANCE OF IMPACT: The new policy allows study teams to engage in direct-to-patient outreach, leading to an increase in enrollment for some studies. Incorporation of direct-to-patient messaging strategies can be a cost and resource saving measure to improve recruitment. The need to recruit similar populations demonstrated that strategic, thoughtful approaches are needed.
Background: Advances in multiple sclerosis (MS) disease modifying therapy (DMT) have increased laboratory monitoring requirements. Our goal was to survey existing practices and perceptions of risk in laboratory monitoring throughout Canada and assess whether opportunities to improve patient care and safety exist. Methods: A web-based survey assessing prescriber demographics, current infrastructure, and concerns for lab monitoring was sent to the Canadian Network of MS Clinics (CNMSC) listserv, inviting MS clinicians across the country to participate. Results: Respondents included 32/65 CNMSC-affiliated neurologists (49%), 6 registered nurses (RN), 2 nurse practitioners (NP), and 2 non-neurologist physicians from 8/10 provinces. For some questions, analysis was limited to 34 DMT-prescribing clinicians only. Despite broad implementation of electronic medical records (25/34, 74%), many prescribers (15/34, 44%) still receive laboratory results in paper form. In terms of lab monitoring infrastructure, we noted regional variability in the employment of nursing to monitor patient compliance with required laboratory monitoring. There is also a gap in laboratory surveillance, as less than 5% of respondents reported regularly reviewing results on weekends. Providers’ length of practice and volume of MS patients were not associated with different perception of DMT laboratory monitoring risk. Conclusions: This nation-wide survey showed variability in infrastructure used in laboratory monitoring and regional variation in nursing involvement. Providers’ level of concern for laboratory monitoring for DMTs did not vary by years of experience or volume of MS patients followed, suggesting that improved systems, rather than education, could ameliorate perceptions of risk.