Recruitment Barriers Research Articles

Scientific Validity and Fair Subject Selection: An Empirical Analysis of Recruitment Practices in Clinical Trials

This study investigates the relationship between scientific validity and fair subject selection in clinical trials, focusing on recruitment practices. By analyzing 200 clinical trials across oncology, cardiology, and neurology, this research identifies key barriers to diversity and assesses the effectiveness of institutional policies in promoting equitable recruitment. The findings reveal that despite efforts to improve inclusivity, demographic disparities persist, particularly in terms of racial and ethnic representation. Recruitment barriers, including logistical challenges, mistrust among minority groups, and insufficient outreach resources, are prevalent, with oncology trials exhibiting the most significant issues related to minority participation. Additionally, the study highlights that stronger Institutional Review Board (IRB) policies with enforced diversity guidelines lead to higher minority representation in trials. Through a mixed-methods approach, combining systematic trial reviews, surveys of recruitment personnel, and institutional policy assessments, the study emphasizes the importance of community engagement and culturally competent recruitment strategies. The research suggests that while progress has been made, greater transparency, targeted outreach, and mandatory diversity tracking are necessary to achieve equitable and scientifically valid clinical trial outcomes. The study concludes with recommendations for future research to explore technological innovations and broader therapeutic areas, offering potential solutions for overcoming the barriers to diversity in clinical trials.

A07 - EDI&S Outputs of appointing a Trainee Executive Group in delivering a multi-centre randomized controlled surgical trial: Lessons learnt from The Sunflower Study

Abstract Background Randomised controlled trials (RCTs) are widely accepted as the ‘gold standard’ for evaluating the effectiveness of health interventions. Trial recruitment is notoriously difficult, with approximately 57% of publicly funded RCTs not meeting recruitment target sample sizes. Trainee involvement can be crucial for large scale clinical studies. However, there remains limited knowledge about methods in which trainee collaboration can assist studies in achieving their aims. The Sunflower Study is the UKs largest surgical RCT and is unique in piloting the establishment of a Trainee Executive Group (TEG). Here we explore the outputs of the TEG and its impact on the study. Method The TEG consists of five trainee representatives of different training grades and research backgrounds, all appointed via national selection. The TEG held regular virtual meetings seeking to understand trainee perspectives on RCTs recruitment, champion and disseminate examples of good recruitment, indentify recruitment barriers, optimise The Sunflower Study's social media presence and update digital resources via a trainee section on its website. The TEG also established a network of regional representatives with the purpose of connecting neighbouring recruitment sites with one another, disseminating knowledge at a local level, sharing recruitment tips and encouraging local/national competition. All of these strategies aimed to ultimately boost patient recruitment. Results The regional representative network assisted with setting up a new recruitment site, who have since remained a top recruiter. The TEGs establishment saw the highest number of trainees attend the study's yearly ‘Investigators' Meeting’. The TEGs engagement with the study’s social media led to an increase in follower numbers and consistently maintained high tweet impressions. The Sunflower Study is affiliated with the NIHR API scheme and has 165 collaborators registered with the scheme - the highest of any UK study. Through this, trainees are able to develop leadership, communication and research skills; as well as gain competencies required for CCT. Conclusion The implementation of the TEG illustrates how innovative strategies can be utilised to actively involve trainees in research. Following the establishment of the TEG, new sites participated in the study, the study's social media impact increased and trainee engagement was optimised. The TEG also encouraged trainees' future involvement with research through the API scheme. In the post-COVID-19 era, collaborative studies have proven their role in providing high impact quality research. Future studies could foster the TEG model, with an appointed trainee leadership team focusing on maximising trainee output, providing benefits not only for the trainees themselves, but also recruitment sites and studies overall.

Abstract 4112952: Developing culturally informed materials to enhance Native Hawaiians' and Pacific Islanders’ participation in clinical trials

Background: Native Hawaiians and Pacific Islanders (NHPI) suffer disproportionately from cardiometabolic disorders and are underrepresented in related clinical trials, limiting our ability to control these disorders for this population. We identified recruitment and retention barriers (complicated clinical language) and facilitators (relationship-building opportunities). Addressing recruitment and retention barriers and facilitators can increase NHPI representation in clinical trials. Goal: To develop culturally informed, educational videos and infographics to improve NHPI trust and attitudes toward research and recruitment and retention in clinical trials. Methods: The videos and infographics are based on focus group data with NHPI past clinical trial participants or staff. The videos focus on recruitment. The infographics focus on recruitment and retention. The videos address the complicated clinical language and hesitancy in disclosing information while leveraging trial outcomes relevant to NHPI health concerns and cultural inclusiveness. The infographics build on the video content. Facilitators include relationship-building opportunities, seeking healthier outcomes for future generations, relationship-building opportunities, and sharing and learning opportunities provided in clinical trials. Results: The Co-Principal Investigators, NHPI clinical trial participants, and NHPI researchers and clinicians contributed to the videos. We created a 5-minute and a 10-minute video. The videos provide 1) an overview of clinical research, 2) considerations for participating in clinical trials, and 3) reasons to participate. Researchers present the first 2 topics, while past participants provide testimonials for the third topic. The 8 infographics include 1) an overview of clinical research, 2) the importance of randomization, 3) research benefits from NHPI participation, 4) the importance of a control group, 5) clinical trial outcomes, 6) individual benefits from research participation, 7) community benefits from research participation, and 8) trust in research. Discussion: We will test the impact of these materials on trust and attitudes towards research and recruitment and retention among NHPI in a randomized clinical trial (RCT). Half of the participants (n=104) will be recruited using traditional strategies and half (n=104) using our novel strategy. Rigorous qualitative (interviews with participants) and quantitative (retention rates) analysis will be conducted.

Strategies to improve recruitment to multimodal group programmes for obesity: a systematic review

Abstract Background The World Health Organization describes obesity as one of the greatest public health challenges in the 21st century. Possible therapies include multimodal (group) programmes with nutrition, exercise, and behavioural therapy elements. However, programme providers often have difficulties recruiting the target groups and motivating them to participate. This systematic review aimed to identify barriers and facilitators as well as strategies to improve recruitment. Methods We systematically searched five databases (Medline, CINAHL, Cochrane, PsycInfo, Web of Science). Based on predefined inclusion criteria, we selected primary studies of different study designs (e.g. [randomised] controlled trials, qualitative studies). We extracted barriers and facilitators as well as recruitment strategies into predefined tables, assessed the quality of the studies and summarised the results narratively. Results Of the 1,082 articles identified, 16 met the inclusion criteria. The main active recruitment strategies were writing directly to potential participants and referrals from health professionals. The most frequently reported passive strategies included media adverts, websites, flyers, social media, and word of mouth. The information on how many people approached actually participated was heterogeneous, which illustrates that recruitment depends on the setting/context and the people involved. Some studies came to contradictory results, e.g., regarding whether passive or active methods are more successful. In most cases, a combination of strategies was recommended. The studies reported numerous recruitment barriers, e.g., lack of staff time, lack of motivation, or fear of discrimination. Conclusions The review provides a broad overview of recruitment methods that can be applied depending on the framework conditions and target groups. The summary of possible barriers can serve as an overview of which aspects could be considered when designing or adapting a programme. Key messages • To improve recruitment to obesity programmes, a combination of several recruitment strategies, including active and passive methods, should be applied. • Results on the “effectiveness” of the strategies were inconclusive, which indicates that the success of methods depends on the context, setting and the people involved.

Ethnicity and Socioeconomic Disparities in Clinical Trial Participation for Ovarian Cancer: A Retrospective Observational Study in London.

Ethnic and socioeconomic disparities in cancer outcomes are exacerbated by clinical trial underrepresentation. This study aims to identify inequalities in ethnicity and socioeconomic features among ovarian cancer clinical trial participants in two London cancer centres. All ovarian cancer patients treated between 2017 and 2022 were included. Patients participating in clinical trials were classified as the trial population (TP); the remainder were considered the non-trial population (NTP). Data on disease characteristics and sociodemographic features, including ethnicity and Indices of Multiple Deprivation (IMD) deciles, were accessed from electronic patient records. Of the 892 patients, 212 (24%) were enrolled in trials: 87 in Phase II, 103 in Phase III, and 21 in prospective, non-investigational medicinal product trials. The TP were more likely to be of White ethnicity (72.6% vs. 57.5%; p < 0.001), younger (mean age 58 vs. 60; p = 0.003), living in less deprived areas (most deprived tercile: 21.2% vs. 34.0%; p = 0.004), and English-speaking (95.8% vs. 90.9%; p = 0.041). In the multivariate analysis, White ethnicity (p < 0.0001), age (p = 0.003), IMD decile (p = 0.007), and interpreter requirement (p = 0.037) were independent predictors of trial participation. Ethnic and socioeconomic inequalities affect trial participation, potentially worsening health disparities in ovarian cancer patients. Strategies to overcome trial recruitment barriers for underserved groups are needed to improve the equity of care.

'Facilitators and barriers to recruitment in mental health research: A survey of psychiatrists and psychiatry registrars in training'.

To explore the attitudes of Royal Australian and New Zealand College of Psychiatrists (RANZCP) consultants and registrars towards recruitment of patients in mental health research. Specifically, we aimed to measure potential barriers and facilitators for recruitment and comment on strategies for improvement. A survey was distributed to 287 consultant and trainee psychiatrists working across South Australian public mental health services. The survey was hosted via SurveyMonkey and ran for 5weeks from April to June 2023. Participant's attitudes were recorded through use of Likert scale, yes/no and free-text response. In total, 88 responses were collected, corresponding to a 30.7% response rate. Participants were interested in mental health research, with 90.7% reading articles and 61.4% reporting personal research engagement. The factors that rated most highly as recruitment barriers were unawareness of current studies, competing clinical demands and not prioritising recruitment. Factors felt most strongly to facilitate recruitment included the presence of an onsite research assistant and the clinician viewing the trial as clinically relevant. While attitudes towards research were generally positive, many barriers to recruitment were identified. Increased advertising of current studies, presence of an onsite research assistant and reduction in clinicians' workload are likely to improve clinicians' capacity to recruit.

Combination of the chemokine receptor type 2 (CCR2) antagonist DMX-200 and candesartan for COVID-19: a randomised controlled trial

ObjectiveTo determine whether a chemokine receptor type 2 antagonist, DMX-200 (repagermanium), in combination with an angiotensin receptor blocker, candesartan, improves clinical outcomes in people with COVID-19.DesignProspective, multicentre, double-blind, placebo-controlled trial.SettingTen...

Feasibility and Acceptability Study of a Culturally Adapted Web-Based Intervention to Reduce Suicidal Ideation for Syrian Asylum Seekers and Refugees in the United Kingdom: Protocol for a Mixed Methods Study.

The war in Syria has displaced over 6.8 million people, more than any other conflict since the Second World War. As a result, Syrian asylum seekers and refugees have experienced several life-changing events, resulting in high rates of anxiety, depression, posttraumatic stress disorder, and suicidal ideation (SI). To address the treatment gap and reduce the burden of help-seeking, a web-based intervention to reduce SI developed for general populations was culturally adapted for and with Syrian asylum seekers and refugees in the United Kingdom. The study revealed the importance of understanding their lived experience with migration and the acculturative process in providing treatment for SI. This study will now assess the feasibility and acceptability of the culturally adapted intervention for this population. The first phase of the study will include recruiting participants and delivering the web-based intervention (1) to assess the feasibility of meeting recruitment goals and recruitment rates and (2) to assess the feasibility of outcome measures. The second phase of the study will include one-to-one semistructured interviews (1) to assess the suitability of the culturally adapted intervention in terms of recruitment and adherence rates and barriers and facilitators to engagement and (2) to assess the acceptability of the intervention in terms of its cultural relevance and appropriateness. This is a protocol for a single-group, noncontrolled, mixed methods feasibility and acceptability study of a culturally adapted web-based intervention to reduce SI for Syrian asylum seekers and refugees in the United Kingdom. The study will assess the feasibility of recruitment goals, recruitment rates, adherence rates, and outcome measures using individual participant tracking forms, which will be analyzed quantitatively. The suitability and acceptability of the intervention will be assessed using one-to-one semistructured interviews with 12 participants who completed the intervention, which will be analyzed qualitatively. Recruitment began in February 2024 and will run until 30 participants are recruited to the study or until the end of July 2024. Thus far, 19 participants have provided informed consent, 16 were eligible and enrolled, and 12 have completed a postintervention interview. No data have been analyzed. The study, including the write-up period, is expected to end in December 2024. Despite experiencing several stressors related to forced displacement and high rates of mental health issues, access to treatment is still limited for Syrian asylum seekers and refugees in the United Kingdom. To address the treatment gap and reduce the burden of help-seeking, a web-based intervention to reduce SI was culturally adapted in collaboration with Syrian asylum seekers and refugees in the United Kingdom. This study will now assess the feasibility and acceptability of the intervention and culturally appropriate recruitment strategies. ISRCTN ISRCTN11417025; https://www.isrctn.com/ISRCTN11417025. PRR1-10.2196/56957.

Barriers and Facilitators to Recruitment of a Multifaceted Population of Opioid Use Disorder Community Stakeholders.

Opioid use disorder (OUD) research is essential to inform evidence-based responses to the OUD crisis in the United States. Individuals with OUD, their caregivers, and support group leaders are historically difficult to recruit for research studies. The purpose of this study was to describe barriers and facilitators in recruitment during the implementation of a qualitative study that sought to explore stigma, barriers, and facilitators to healthcare. Researchers engaged in the original study completed a retrospective reflection of their experience recruiting members of the OUD community. Recruitment data were analyzed thematically, and facilitators and barriers for recruitment were identified. Three key barriers to recruitment were identified: choice of community partners, access to technology, and impractical incentives. One key facilitator to recruitment was identified: being patient yet persistent and flexible. Investigators must design research studies mindful of avoiding societal privilege and cognizant of the lens of the individual living with OUD.

Clinical trial recruitment of people who speak languages other than English: a Children's Oncology Group report.

Persons who speak languages other than English are underrepresented in clinical trials, likely in part because of inadequate multilevel resources. We conducted a survey of institutions affiliated with the Children's Oncology Group (COG) to characterize current research recruitment practices and resources regarding translation and interpretation services. In October 2022, a 20-item survey was distributed electronically to institutions affiliated with COG to assess consent practices and resources for recruiting participants who speak languages other than English to COG trials. Descriptive statistics were used to summarize responses; responses were compared by institution size and type as well as respondent role. The survey was sent to 230 institutions, and the response rate was 60% (n = 139). In total, 60% (n = 83) of those respondents had access to short-form consent forms. Full consent form translation was required at 50% of institutions, and 12% of institutional review boards restricted use of centrally translated consent forms. Forty-six percent (n = 64) of institutions reported insufficient funding to support translation costs; 19% (n = 26) had access to no-cost translation services. Forty-four percent (n = 61) were required to use in-person interpreters for consent discussions; the most frequently cited barrier (56%) to obtaining consent was lack of available in-person interpreters. Forty-seven percent (n = 65) reported that recruiting persons who speak languages other than English to clinical trials was somewhat or very difficult. Institutions affiliated with COG face resource-specific challenges that impede recruitment of participants who speak languages other than English for clinical trials. These findings indicate an urgent need to identify strategies aimed at reducing recruitment barriers to ensure equitable access to clinical trials.

Racial disparities among triple negative breast cancer clinical trial enrollees between 2010-2023.

1093 Background: Despite the social construct of race lacking biological significance, it plays a significant role in health disparities and necessitates examination to address social stratification and health inequities. Not reporting race in medical research neglects the reality of social stratification, injustices, and implications for population health. Additionally, excluding racial demographic data from research publications may conceal health disparities. This study focuses on Triple Negative Breast Cancer (TNBC) clinical trials, aiming to meta-analyze the inclusion of racial data and assess racial representation. Methods: A meta-analysis of 81 completed TNBC trials (2011-2023) from ClinicalTrials.gov was conducted. Demographic data on race and sex were extracted and analyzed using Microsoft Excel. Two independent reviewers extracted study-level data for a random-effects analysis. The primary outcome was identifying the prevalence of studies lacking racial data. The secondary outcomes are the prevalence of each racial category (White, Black, Asian, Hispanic/Latino, and Combined Other) among all TNBC clinical trials that reported demographic information. The Combined Other category includes American Indian, Native Hawaiian, more than one race, and unknown/unreported. Results: Of 81 trials, 29.63% did not report racial data. The remaining 57 trials (8,196 participants) revealed 73.98% White, 10.29% Asian, 7.85% Black, 8.02% Hispanic/Latino, and 4.12% "combined other" participants. U.S.-based trials (36 studies, 3,348 participants) showed 77.96% White, 12.03% Black, 4.51% Asian, and 4.96% Hispanic/Latino participants. Moreover, we conducted a comparative analysis between the racial distribution in U.S. clinical trials and the prevalence of TNBC in the U.S. population, utilizing the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Public Use Datasets (2010-2019). The analysis revealed a significant discrepancy with White (p&lt;.001) participants being overrepresented, and Black (p&lt;.001), Asian (p&lt;.001), Hispanic/Latino (p&lt;.001), American Indian (p&lt;.001), more than one race (p&lt;.02), and Other/Unknown (p&lt;.001) populations being underrepresented. Conclusions: Globally, 29.63% of TNBC trials did not report racial data, raising concerns about generalizability. U.S.-based studies exhibited overrepresentation of White participants and underrepresentation of Black, Asian, Hispanic/Latino, American Indian, Native Hawaiian, and other categories. Notably, Black and Hispanic/Latino individuals, comprising a substantial portion of TNBC patients, were underrepresented. These findings underscore racial/ethnic disparities in breast cancer trial participation, warranting further investigation into recruitment barriers for equitable participation.

Diversity in atrial fibrillation trials: Assessing the role of language proficiency as a recruitment barrier

Diversity in atrial fibrillation trials: Assessing the role of language proficiency as a recruitment barrier

Recruitment Barriers and Potential Strategies for Inclusion of Older Asian Americans in Alzheimer's Disease Research.

The makeup of the US population of older adults continues to become more diverse as numbers from ethnic subgroups increase. However, these subgroups are generally underrepresented in research focused on Alzheimer's disease and related dementias (ADRD). This paper examines barriers to recruitment for older Asian Americans, to underpin potential strategies for future research, with particular emphasis on recruitment of Vietnamese Americans. The paper discusses three recommended strategies: implementing appropriate recruitment outreach methods, establishing and maintaining community partnerships, and adopting flexible and convenient assessment methods. All three complementary approaches may be applied to improve Vietnamese American aging research participation. This has the potential to promote early intervention, foster longevity, ameliorate health disparities, and reduce healthcare burdens for this population.

234 Translation of Community Engagement Studios into Practice: Increased Research Participation and Diversity in a Multicenter Trial

OBJECTIVES/GOALS: Women and healthcare providers from underserved rural and urban communities participated in Community Engagement (CE) studios to offer perspectives for increasing research participation of women from diverse backgrounds prior to initiating recruitment for a randomized-controlled trial comparing treatments for urgency urinary incontinence. METHODS/STUDY POPULATION: CE studios are listening sessions to gather patient or community input on specific study areas of interest before implementation. Ten CE studios were held via Zoom at five study sites (Rhode Island, Washington DC, Alabama, New Mexico, and Southern California). Each site held two studios: 1) women living with urgency urinary incontinence, 2) clinicians providing care in their areas. Participants gave recommendations on ways to increase study participation of women from diverse racial and ethnic backgrounds with a focus on recruitment and retention, identification of barriers to participation, and suggested approaches to overcome those barriers. Summaries were compiled from each CE studio to identify similar and contrasting recommendations across sites. RESULTS/ANTICIPATED RESULTS: A total of 80 participants (47 community women experiencing urgency urinary incontinence, and 33 healthcare professionals) participated across all sites. Studio participants discussed anticipated barriers for participant recruitment and retention with a focus on solutions to those barriers. Based on these suggestions, we created recruitment materials using pictures, videos, and simple terminology. We created educational content to help providers with current best practices for urinary urgency incontinence. We have allowed most study visits to be conducted virtually, identified affiliated clinics in various locations to improve proximity to undeserved communities, and have earmarked additional funds to help offset travel costs including gas, public transportation, and childcare. DISCUSSION/SIGNIFICANCE: CE studios have provided pragmatic patient- and provider-centered recommendations that have been incorporated into functional strategies to improve research participation and diversity. CTSA CE core expertise can support successful CE studio planning and implementation.

109 Age-Friendly Research Tools to Enhance Inclusion of Older Adults in Research

OBJECTIVES/GOALS: Older adults are often underrepresented in research due to recruitment and retention barriers, among others. Frameworks have been developed to address these barriers but have not been disseminated to research teams without aging expertise. We aimed to test Age-Friendly tools among non-aging-trained research teams. METHODS/STUDY POPULATION: Our team developed and/or adapted seven Age-Friendly research tools to improve inclusion of older adults in research. Tools included a communication guide, Age-Friendly research checklist, knowledge consent check, and condolence card template, among others. Non-aging-trained research team members (n= 21) were invited to pilot test them and share strengths, limitations, and areas for improvement for each tool. Feedback was collected for up to 4 months using REDCap surveys and analyzed for common themes. Participants provided written informed consent and received a stipend of $1000 upon the completion of the surveys. RESULTS/ANTICIPATED RESULTS: Sixteen participants (76%) from primarily cancer and neurology departments completed at least one survey. The communication guide, research checklist, and knowledge check were implemented the most within the participants' study populations. Participants shared that the tools were user-friendly, easy to access, and well-explained through webinar trainings (offered separately) or instruction sheets. The most frequently reported barriers were lack of time, industry-sponsored trial restrictions, and lack of age-appropriate study populations. DISCUSSION/SIGNIFICANCE: Age-Friendly tools were acceptable and valuable among non-aging-trained research members. Dissemination of these tools could improve the experience for research teams and older adults and help align demographics of enrolled study populations with demographics of the condition being studied.

Pneumococcal Meningitis Induces Hearing Loss and Cochlear Ossification Modulated by Chemokine Receptors CX3CR1 and CCR2.

Pneumococcal meningitis is a major cause of hearing loss and permanent neurological impairment despite widely available antimicrobial therapies to control infection. Methods to improve hearing outcomes for those who survive bacterial meningitis remains elusive. We used a mouse model of pneumococcal meningitis to evaluate the impact of mononuclear phagocytes on hearing outcomes and cochlear ossification by altering the expression of CX3CR1 and CCR2 in these infected mice. We induced pneumococcal meningitis in approximately 500 C57Bl6 adult mice using live Streptococcus pneumoniae (serotype 3, 1 × 105 colony forming units (cfu) in 10µl) injected directly into the cisterna magna of anesthetized mice and treated these mice with ceftriaxone daily until recovered. We evaluated hearing thresholds over time, characterized the cochlear inflammatory response, and quantified the amount of new bone formation during meningitis recovery. We used microcomputed tomography (microCT) scans to quantify cochlear volume loss caused by neo-ossification. We also performed perilymph sampling in live mice to assess the integrity of the blood-perilymph barrier during various time intervals after meningitis. We then evaluated the effect of CX3CR1 or CCR2 deletion in meningitis symptoms, hearing loss, macrophage/monocyte recruitment, neo-ossification, and blood labyrinth barrier function. Sixty percent of mice with pneumococcal meningitis developed hearing loss. Cochlear fibrosis could be detected within 4days of infection, and neo-ossification by 14days. Loss of spiral ganglion neurons was common, and inner ear anatomy was distorted by scarring caused by new soft tissue and bone deposited within the scalae. The blood-perilymph barrier was disrupted at 3days post infection (DPI) and was restored by seven DPI. Both CCR2 and CX3CR1 monocytes and macrophages were present in the cochlea in large numbers after infection. Neither chemokine receptor was necessary for the induction of hearing loss, cochlear fibrosis, ossification, or disruption of the blood-perilymph barrier. CCR2 knockout (KO) mice suffered the most severe hearing loss. CX3CR1 KO mice demonstrated an intermediate phenotype with greater susceptibility to hearing loss compared to control mice. Elimination of CX3CR1 mononuclear phagocytes during the first 2weeks after meningitis in CX3CR1-DTR transgenic mice did not protect mice from any of the systemic or hearing sequelae of pneumococcal meningitis. Pneumococcal meningitis can have devastating effects on cochlear structure and function, although not all mice experienced hearing loss or cochlear damage. Meningitis can result in rapid progression of hearing loss with fibrosis starting at four DPI and ossification within 2weeks of infection detectable by light microscopy. The inflammatory response to bacterial meningitis is robust and can affect all three scalae. Our results suggest that CCR2 may assist in controlling infection and maintaining cochlear patency, as CCR2 knockout mice experienced more severe disease, more rapid hearing loss, and more advanced cochlear ossification after pneumococcal meningitis. CX3CR1 also may play an important role in the maintenance of cochlear patency.

A273 A PILOT PROSPECITVE, MULTI-CENTRE, RANDOMIZED CONTROLLED TRIAL COMPARING FECAL MICROBIOTA TRANSPLANTATION (FMT) TO PLACEBO AT INDUCING REMISSION IN MILD TO MODERATE CROHN'S DISEASE

Abstract Background FMT has shown promise at inducing remission in ulcerative colitis. The effect of FMT on inducing remission in Crohn’s disease however remains unknown. Aims To evaluate the efficacy of FMT at inducing remission in mild-to-moderate Crohn’s disease Methods This double-blind, randomized, trial conducted at 3 Canadian academic centers (Edmonton, Hamilton and Calgary) randomized. Adult patients with mild-to-moderate Crohn’s disease with modified Harvey Bradshaw Index (mHBI) score of ampersand:003E5 and at least one objective measure of inflammation (CRP ≥ 8mg/L or fecal calprotectin (FCP) ≥ 250 ug/g) on stable dosing of concomitant therapy were assigned to FMT or placebo. First assigned treatment was by colonoscopy followed by 20 [DK1] capsules weekly for 7 weeks. Endoscopic severity (SES-CD) was assessed at baseline during colonoscopic delivery of assigned treatment and at week 8 by a blinded central reader using video recording. The primary endpoint was the proportion of patients in both clinical (mHBI ampersand:003C 5) and endoscopic remission (SES-CD ≤ 5) at week 8. Responders (reduction of HBI ≥ 3 or HBI ≤ 5 and reduction of CRP or FCP by ≥ 10%) in FMT group were eligible to continue with open-label FMT capsule every 2 weeks. Non-responders in the placebo group were permitted to restart the trial at week 0 with open-label FMT. Secondary outcomes included patient reported outcomes and safety outcomes. Results Between July 2017 to Jun 2021, 28 were randomized (16 to FMT and 12 to placebo). The study team voluntarily suspended the trial twice due to Health Canada safety warnings regarding potential transmission of multi-drug resistant organisms and SARS-CoV-2 through FMT. At week 8, 0% (0/16) of patients in the FMT group versus 8.3% (1/12) in the placebo group reached the primary endpoint of combined clinical and endoscopic remission. Of the 50% (8/16) in the FMT group who achieved a clinical response and continued on open-label FMT every 2 weeks, 12.5% (1/8) achieved the primary endpoint. Of the 7 non-responders in the placebo group who restarted the trial at week 0 and received open-label FMT, 28.6% (2/7) achieved primary endpoint at week 8 on open-label FMT. No death or hospitalization were observed. The study was terminated early at the recommendation of the Data Safety Monitoring Board. Conclusions FMT was not effective at inducing remission in Crohn’s disease using the FMT regimen in this study. However, this study was limited by a small sample size and recruitment barrier during the COVID pandemic. Future studies may consider other strategies to potentially enhance treatment response, including antibiotic pre-treatment, optimized donor-recipient pairing, and concomitant anti-inflammatory diet. Funding Agencies CIHR

Barriers to Enrollment in a Post-Stroke Neuromodulation and Walking Study: Implications for Recruiting Women

Background Women have a higher risk of stroke and related disability than men but are underrepresented in stroke clinical trials. Identifying modifiable recruitment and enrollment barriers for women can improve study generalizability, statistical power, and resource utilization. Objective In a post-stroke neuromodulation study, we determined the impact of sex on the occurrence of exclusion criteria and compared the sex distribution of screened and enrolled individuals with a broader stroke-affected population. Methods A total of 335 individuals with chronic stroke were screened for a study examining how neuromodulation and high-intensity treadmill training affect walking speed and corticomotor excitability. Demographics and exclusions were retrospectively gathered as a secondary dataset. Exclusion criteria consisted of 6 categories (not target population, unable to do treadmill protocol, unable to do non-invasive brain stimulation, insufficient ankle motion and disinterest, and cognitive impairment). Incidence of each exclusion criterion was compared between women and men. The sex distribution was compared to a dataset from Chicago primary stroke centers. Results A total of 81 individuals were enrolled and 254 were not. The percentage of women excluded was significantly greater than that of men (P = .04). No individual exclusion criterion or categories excluded women more frequently than men. Screened and enrolled individuals had a lower proportion of women and younger age than a representative stroke population (P < .001). Conclusions We identified exclusion criteria (ie, headaches, cognitive scores, and age) that are modifiable barriers to enrollment of women in this post-stroke neuromodulation study. Addressing underrepresentation of women in stroke research is pivotal for enhancing generalizability, achieving statistical power, and optimizing resources.

Strategies for recruiting adolescents in rural areas in firearm injury research

BackgroundParticipant recruitment is a central aspect of human sciences research. Barriers to participant recruitment can be categorised into participant, recruiter and institutional factors. Firearm injury research poses unique barriers to...

Recruitment Barriers of an mHealth Pediatric Asthma Pilot Study.

Successful participant recruitment for pediatric studies can be challenging and even result in study discontinuation. In conducting a 2-year pilot study for a pediatric mobile health (mHealth) asthma intervention, a group of researchers experienced multiple barriers and failures in all 4 areas of recruitment: generating initial contacts, screening, consenting, and enrollment and retention. The main failures that resulted in minimal participant enrollment were poor participation, communication issues, and difficulties related to recruiting in an emergency department during a pandemic. The following is a report on this study's recruitment efforts, including preliminary and adapted strategies, the results of these strategies, and considerations for researchers who conduct studies with children. The research team concluded that frequent and clear communication, flexibility, and a willingness to alter initial recruitment plans are essential elements for recruitment success in pediatric studies.