Subject Recruitment Research Articles

Promoting Inclusive Recruitment: a Qualitative Study of Black Adults' Decision to Participate in Genetic Research.

Underrepresentation of Black individuals in genetic research is a longstanding issue. There are well-documented strategies to improve the enrollment of Black participants; however, few studies explore these strategies—as well as the barriers and facilitators for participation—by sampling Black people who have previously participated in genetic research. This study explores the decision-making process of Black adults who have participated in genetic research to identify best practices in the recruitment of Black subjects in genetic research. We conducted 18 semi-structured interviews with Black adults with prior research participation in genetic studies housed at an urban academic medical center in the United States of America (USA). An online survey was conducted with the participants to gather demographic data and information on prior research participation. Trust in research was ascertained with the Corbie-Smith Distrust in Clinical Research Index. Two participants scored high levels of distrust using the validated index. Using thematic content analysis, 4 themes emerged from the interviews: (1) Participants are active players in health system, (2) information is power, and transparency is key, (3) therapeutic alliances and study characteristics facilitate participation, and (4) race pervades the research process. The decision to participate in genetic research for the participants in our study was prompted by participants’ internal motivations and facilitated by trust in their doctor, trust in the institution, and ease of participation. Most participants viewed their enrollment in genetic research in the context of their own racial identity and the history of medical racism in the USA.

Disrupted dynamic network reconfiguration of the brain functional networks of individuals with autism spectrum disorder.

Human and animal studies on brain functions in subjects with autism spectrum disorder have confirmed the aberrant organization of functional networks. However, little is known about the neural features underlying these impairments. Using community structure analyses (recruitment and integration), the current study explored the functional network features of individuals with autism spectrum disorder from one database (101 individuals with autism spectrum disorder and 120 healthy controls) and tested the replicability in an independent database (50 individuals with autism spectrum disorder and 74 healthy controls). Additionally, the study divided subjects into different age groups and tested the features in different subgroups. As for recruitment, subjects with autism spectrum disorder had lower coefficients in the default mode network and basal ganglia network than healthy controls. The integration results showed that subjects with autism spectrum disorder had a lower coefficient than healthy controls in the default mode network–medial frontal network and basal ganglia network–limbic networks. The results for the default mode network were mostly replicated in the independent database, but the results for the basal ganglia network were not. The results for different age groups were also analysed, and the replicability was tested in different databases. The lower recruitment in subjects with autism spectrum disorder suggests that they are less efficient at engaging these networks when performing relevant tasks. The lower integration results suggest impaired flexibility in cognitive functions in individuals with autism spectrum disorder. All these findings might explain why subjects with autism spectrum disorder show impaired brain networks and have important therapeutic implications for developing potentially effective interventions.

Using a Sociotechnical Model to Understand Challenges with Sepsis Recognition among Critically Ill Infants

Abstract Objective The aim of the study is to apply a sociotechnical model to the requirements phase of implementing a machine learning algorithm-based system to support sepsis recognition in the neonatal intensive care unit. Methods We incorporated components from the sociotechnical model, Safety in Engineering for Patient Safety 2.0, in three requirements phase activities: (1) semi-structured interviews, (2) user profiles, and (3) system use cases. Results Thirty-one neonatal intensive care unit clinicians participated in semi-structured interviews (11 nurses, 10 front line ordering clinician, five fellows, and five attending physician). Interview transcripts were coded and then compiled into themes deductively based on components from the sociotechnical model (persons, environment, organization, tasks, tools and technology, collaboration, and outcomes). The interview analysis was used to create four user profiles defining responsibilities in sepsis recognition, team collaboration, and attributes relevant to sepsis recognition. Two user profiles (nurse, front line ordering clinician) included variants based on experience relevant to sepsis recognition. The interview analysis was used to develop three system use cases representing clinical sepsis scenarios. Each use case defines the precondition, actors, and high-level sequence of actions, and includes variants based on sociotechnical works system factors that can complicate sepsis recognition. The interview analysis, user profiles, and use cases serve as the foundation for supporting sociotechnical design to all subsequent human-centered design methods including subject recruitment, formative design, summative user testing, and simulation testing. Conclusion Integration of the sociotechnical model-guided requirements gathering activities, analysis, and deliverables by framing a range of sociotechnical components and the interconnectedness of these components in the broader work system. Applying the sociotechnical model resulted in discovering work system, process, and outcome requirements that would otherwise be difficult to capture, or missed entirely, using traditional requirements gathering methods or approaches to clinical decision support design.

A novel simulation-based approach to training for recruitment of older adults to clinical trials

BackgroundThe need to engage adults, age 65 and older, in clinical trials of conditions typical in older populations, (e.g. hypertension, diabetes mellitus, Alzheimer’s disease and related dementia) is exponentially increasing. Older adults have been markedly underrepresented in clinical trials, often exacerbated by exclusionary study criteria as well as functional dependencies that preclude participation. Such dependencies may further exacerbate communication challenges. Consequently, the evidence of what works in subject recruitment is less generalizable to older populations, even more so for those from racial and ethnic minority and low-income communities.MethodsTo support capacity of research staff, we developed a virtual, three station simulation (Group Objective Structured Clinical Experience—GOSCE) to teach research staff communication skills. This 2-h course included a discussion of challenges in recruiting older adults; skills practice with Standardized Participants (SPs) and faculty observer who provided immediate feedback; and debrief to highlight best practices. Each learner had opportunities for active learning and observational learning. Learners completed a retrospective pre-post survey about the experience. SP completed an 11-item communication checklist evaluating the learner on a series of established behaviorally anchored communication skills (29).ResultsIn the research staff survey, 92% reported the overall activity taught them something new; 98% reported it provided valuable feedback; 100% said they would like to participate again. In the SP evaluation there was significant variation: the percent well-done of items by case ranged from 25–85%.ConclusionsResults from this pilot suggest that GOSCEs are a (1) acceptable; (2) low cost; and (3) differentiating mechanism for training and assessing research staff in communication skills and structural competency necessary for participant research recruitment.

Lived experiences of children and adolescents with obsessive–compulsive disorder: interpretative phenomenological analysis

BackgroundChildhood obsessive–compulsive disorder (OCD) is distinct from OCD in adults. It can be severely disabling and there is little qualitative research on OCD in children. The present study aims to explore the subjective experiences of diagnosis, treatment processes and meaning of recovery in children and adolescents suffering from OCD and provide a conceptual model of the illness.MethodsIt is a qualitative study of ten children and adolescents selected by purposive sampling. MINI KID 6.0, Children’s Yale-Brown Obsessive–Compulsive Scale and Clinical Global Impression-Severity Scale were administered at the time of recruitment of subjects into the study. Interviews were conducted using an in-depth semi-structured interview guide and audio-recorded. The transcribed interviews were analyzed using Interpretative Phenomenological Analysis (IPA). The study sought to explore participants’ sense-making of their world, their thoughts, feelings and perceptions through interpretative enquiry. The findings were confirmed by a process called investigator triangulation, member check and peer validation.ResultsIPA yielded five major themes—‘illness perception changes over time’, ‘disclosure on a spectrum’, ‘cascading effects of OCD’, ‘treatment infuses hope and helps’, and ‘navigating through OCD’. A summary of these themes and their subthemes is presented as a conceptual model. The essence of this model is to show the inter-relationship between themes and provide a comprehensive understanding of the phenomenon of OCD.ConclusionsTo the best of our knowledge, this is the first study to explore lived experiences of children and adolescents with OCD using interpretative phenomenological analysis (IPA). It was noted that perception of illness and treatment processes evolves over time, and recovery is viewed as a process. Future qualitative research can be carried out with a focus on ‘therapist-related barriers’ or ‘student–teacher dyads’ that can inform clinical practice and school policies respectively.Trial registration NIMH/DO/IEC (BEH. Sc. DIV)/2018, l1 April 2018.

Sex differences in the detection of motor unit action potentials identified using high-density surface electromyography

Sex-related disparities in force production of humans have been widely observed. Previous literature has attributed differences in peripheral traits, such as muscle size, to explain these disparities. However, less is known about potential sex-related differences in central neuromuscular traits and many comparable studies, not exploring sex-related differences, exhibit a selection-bias in the recruitment of subjects making the generalization of their findings difficult. Utilizing high-density electromyography arrays and motor unit (MU) decomposition, the aim of the current study is to compare MU yield and discharge properties of the tibialis anterior between male and female humans. Twenty-four subjects (10 females) performed two submaximal (20%) isometric dorsiflexion contractions. On average, males yielded nearly twice the amount of MUs as females. Further, females had significantly higher MU discharge rate, lower MU action potential amplitude, and lower MU action potential frequency content than males despite similar levels of torque and MU discharge variability. These findings suggest differences in central neuromuscular control of force production between sexes; however, it is unclear how lower yield counts affect the accuracy of these results.

Adjusting the TMIST study design to accommodate slower than expected accrual: ECOG-ACRIN EA1151.

TPS10614 Background: The ECOG-ACRIN Tomosynthesis Mammographic Imaging Screening Trial (TMIST), which opened in 2017, is a randomized trial designed to assess whether Tomosynthesis Mammography (TM) should replace Digital Mammography (DM) for breast cancer screening. It is hypothesized that women assigned to TM for 3-5 screening rounds will have fewer advanced breast cancers than the women assigned to DM. Advanced cancers are those that have distant metastases or positive nodes, are invasive tumors greater than or equal to 2.0 cm in size, or are invasive tumors greater than 1.0 cm in size that are triple negative or HER 2+. The initially planned enrollment of 164,946 women was due to be completed by the end of 2020, with follow-up concluded by 2025. There were substantial challenges in meeting this timeline, including the organizational and funding structure of the NCI National Clinical Trials Network which is dependent upon sites using their existing staffing resources (not always readily available at the time of study activation). This led to longer than anticipated start of enrollment for most interested sites and lower than anticipated annual enrollment per participating site based ultimately on the staffing support that could be allocated to manage TMIST. In addition, research staffing shortages and periodic research operations closures due to COVID-19 have also impacted enrolling TMIST sites, though unevenly, since the start of the pandemic. Enrollment plateaued at approximately 2,100 subjects per month by the end of 2020. With that accrual rate expected, the trial design was modified to reduce the sample size so that the study could be completed by 2027. Methods: With the approval of the NCI CIRB, we changed how the primary endpoint measure for TMIST is assessed from the number of advanced cancers that occur by 4.5 years after randomization to the time from randomization to occurrence of advanced cancers. All advanced cancers occurring within 7 years of randomization are now included and all participants followed for at least three years. In addition, the power of the study of the study was modified from 0.9 to 0.85, while the originally assumed effect size at 4.5 years was retained These changes allowed a reduction of sample size to 128,905, with subject recruitment projected to end in 2024. As of February 14, 2022, there are 125 sites open, 114 in the U.S. and 11 in other countries, with an additional 31 sites planning to open. As of February 14, 2022, a total of 63,845 women have been enrolled in the trial worldwide at 115 sites, with 20% of US participants self-identifying as belonging to minority racial and ethnic groups and 70% consenting to optional blood and/or buccal cell collection. Clinical trial information: NCT03233191.

JOB SATISFACTION OF OUTPATIENT PUSKESMAS AND INPATIENT PUSKESMAS STAFF IN KOTAWARINGIN BARAT REGENCY

Health staff job satisfaction impacts performance. Puskesmas have periodically measured customer satisfaction but staff job satisfaction has never been carried out. From a preliminary study, it was found that the job satisfaction of Puskesmas staff in Kotawaringin Barat Regency was still low. To find out the difference in job satisfaction of inpatient Puskesmas staff with outpatient health centers. Design cross-sectional research with quantitative approach. The research population of inpatient and outpatient health center staff in Kotawaringin Barat District. Recruitment of subjects is carried out through Puskesmas. From 14 outpatient health centers, 3 Puskesmas were selected and from 4 inpatient health centers, 2 Puskesmas were selected. A total of 40 subjects filled out the questionnaire which was distributed electronically. Data analysis was carried out with an independent t test to distinguish job satisfaction. High job satisfaction at outpatient health centers is on the supervision factor, and policies are 62%, motivation is 57%, respectively, while low satisfaction in the physical work environment is 19%, on occupational safety and security factors, incentives, capitation services are 33% each, and work culture is 38%. High job satisfaction at inpatient health centers in the form of work culture factors, and capitation services were 68%, respectively, work results were 63%, and 58% each in the factors of co-workers, occupational security and safety, opportunities to improve skills and skills, while low satisfaction in the physical work environment was 16%, incentives were 16%, workload was 37%, supervision was 42%, and policies were 42%. There is no significant differencebetween work complacencyin outpatient health centers and inpatient high school health centers (p=0.317).

The efficacy of probiotics in the management of intra-oral halitosis: a systematic review.

To evaluate the efficacy of probiotics in reducing halitosis of dental origin. MEDLINE, EMBASE, and CENTRAL were searched up to and including June 2020. Randomised placebo-controlled, double-blinded clinical trials in systemically healthy adult patients who were given any form of probiotics to manage halitosis of dental origin were included. Primary outcome measures were organoleptic scores and volatile sulphur concentration levels. Secondary outcome measures were microbiologic parameters and quality of life (QOL). Of the 301 potentially relevant articles, eight articles were selected for the review. The risk of bias assessment showed that two studies were of low risk of bias, four studies had some concerns, and two studies had a high risk of bias. The beneficial effect of probiotics could neither be confirmed in periodontally treated patients administered with up to 8weeks of probiotics, nor in periodontitis patients who received both non-surgical periodontal therapy and adjunctive probiotics up to 90days. Microbiological findings 1month after probiotics administration and QOL measures showed no significant differences compared to control. Considerable heterogeneity was observed among probiotic administration protocols. The available evidence suggests no convincing benefit for the use of probiotics in the management of halitosis. Standardised protocols on recruitment of halitosis subjects and organoleptic measurements are required for future studies on probiotics as an intervention. The lack of well-conducted studies with a low risk of bias precludes any clinical recommendation. Further research is needed to verify the efficacy of probiotics in the management of intra-oral halitosis.

Returning individual research results in international direct-to-participant genomic research: results from a 31-country study

This paper summarizes the results of a 31-country qualitative study of expert perspectives on the regulation of international “direct-to-participant” (DTP) genomic research. We outline how the practice of directly recruiting participants for genomic studies online complicates ethics and regulatory considerations for the return of individual research results. As part of a larger project supported by the National Human Genome Research Institute, National Institutes of Health, we prepared and distributed to 31 global legal experts a questionnaire intended to ascertain opinions and perspectives on the way international DTP genomic research is likely to be regulated. We found significant disagreement across jurisdictions on the most favorable approach to managing such results, with some countries favoring return by default and others preferring to return only with the express consent of research participants. We conclude by outlining policy considerations that should guide researcher practices in this context. As international DTP genomic research evolves, jurists and ethicists should be attentive to the ways novel approaches to subject recruitment align with existing ethical and regulatory norms in research with human participants. This paper is a preliminary step toward documenting such alignment in the context of the return of individual research results.

INFLUÊNCIA DAS CRENÇAS DO PÚBLICO EVANGÉLICO NA ADESÃO AO TRATAMENTO PSICOLÓGICO NA CIDADE DE IMPERATRIZ-MA

Throughout history, man has sought to limit the phenomena that involve human complexity to a single cause. Madness was seen merely as a sign of sin, thus instituting the stigma of mental disorders. Given this reality, the relevance of the present study is justified due to the prevalence of evangelicals in the city of Imperatriz-MA (31.9%), and the lack of studies aimed at this specific public. Aiming to identify if there is an influence of the system of beliefs and values of the evangelical public in the adherence to psychological treatment in the city of Imperatriz-MA, as well as to inform about the knowledge about mental illness for this public and to point out if there are stigmas associated with Psychology. Therefore, a field research was carried out, exploratory, descriptive and explanatory. The recruitment of the study subjects occurred through the invitation as a volunteer to the research in the city of Imperatriz-MA, using a structured questionnaire as a data collection instrument. The results help us to understand that values and beliefs significantly influence the process of adherence to psychological treatment by the evangelical public.

199 Diversity Among Research Coordinators in a Pediatric Emergency Medicine Collaborative Research Network

OBJECTIVES/GOALS: Our primary objective was to determine the demographic and linguistic characteristics of research coordinators (RCs) in a large pediatric emergency medicine research collaborative network. Our secondary objective was to determine if the RCs perceived any impact of those characteristics on their duties. METHODS/STUDY POPULATION: We conducted a 15-question electronic survey of RCs at the member institutions of the Pediatric Emergency Care Applied Research Network (PECARN). A total of 74 potential respondents were identified and received the survey. RESULTS/ANTICIPATED RESULTS: Fifty-three surveys (71.6%) were completed. Most respondents identified as female; white; and not Hispanic or Latino. Fourteen respondents (26.4%) identified as underrepresented minorities in medicine (UIM), which is similar to the percentage of UIM among the general population (30%). Twenty-eight respondents (52%) felt that their race/ethnicity positively impacted recruitment efforts. Twenty-three respondents (43%) felt that their ability to speak a language other than English positively impacted recruitment efforts. Four female respondents felt that their gender hindered their recruitment activities and impacted their sense of belonging within the research team. DISCUSSION/SIGNIFICANCE: RCs felt that their backgrounds and attributes positively impacted subject recruitment. However, some female coordinators felt negatively impacted by their gender. Increasing diversity amongst clinical research professionals and incorporating team cultural humility practices, may help increase diversity among clinical research subjects.

Cardiac Diseases among Children and its Impact on Family: a Cross Sectional Survey

Objective: To determine the impact of cardiac disease on family among children. Subjects and methods: A cross-sectional study was conducted with a sample of 405, raised through non-probability convenient sampling technique. The recruitment of subjects was undertaken within September 2019 to February 2020. Parents of children both male and female having age within 5-12 years with diagnosed cardiac diseases were included in our study. Tool for data collection used in our study was PedsQL™ Family impact Module version 2.0 (PARENT REPORT). Data analyzed through SPSS 21. Results: Most of the children diagnosed with congenital heart disease were 72.6% and others with acquired heart diseases were 27.4%). Physical functioning and emotional functioning domain showed moderate impact on family both in congenital and acquired diseases. All other domains demonstrated mild impact on family. Conclusion: According to results of current study it was concluded that children who are suffering from heart diseases also have impact of family with mild to moderate intensity. Keywords: Congenital Heart Defect, Cardiac Diseases, Quality of life

Should knee extension strength testing be implemented as a screening test for identifying probable and confirmed sarcopenia in older T2DM patients?

BackgroundThe accelerated loss of muscle strength and mass observed in older type 2 diabetes mellitus (T2DM) patients due to the combined effects of diabetes and obesity, greatly increases their risk for sarcopenia. Early detection and treatment of probable and confirmed sarcopenia is paramount to delay mobility disability. Using low handgrip strength cut-off points for the initial identification of sarcopenia according to the new European Working Group on Sarcopenia in Older People (EWGSOP2) guidelines may mask the presence of sarcopenia. Relative knee extension strength cut-off points using a simple hand-held dynamometer can assist clinicians in the diagnosis of probable and confirmed sarcopenia by possibly reducing false negative results.MethodsA cohort of one hundred T2DM older patients (60% women) (mean age 74.5 years) mostly obese community dwelling older adults were evaluated for body composition by Bioelectrical impedance analysis (BIA), yielding appendicular skeletal mass index (ASMI) results. Patients underwent handgrip strength (HGS) and knee extension strength (KES) tests as well as functional ability tests. Prevalence of probable and confirmed sarcopenia using HGS and KES cut-off points were calculated. Pearson correlations were performed to evaluate the relationship between ASMI and limbs strength. A regression analysis was conducted to examine which variables best predict ASMI values. A multivariate analysis of covariance was performed to assess the effect of independent variables on KES and HGS.ResultsUsing cutoff points for low KES identified 24 patients with probable sarcopenia and two with confirmed sarcopenia. Conversely, using the EWGSOP2 cut off points for low HGS, identified only one patient with probable sarcopenia and none of the patients with confirmed sarcopenia.ConclusionKES cut-off points using a simple hand-held dynamometer can assist in the identification of probable and confirmed sarcopenia using EWGSOP2 cut off points for low muscle mass in a population of older T2DM patients for further analysis and early treatment. This is notably true in patients possessing high body mass index (BMI) alongside normal ASMI and HGS, potentially reducing false positive sarcopenia screening results.Trial registrationClinicalTrials.gov PRS: NCT03560375. Last registration date (last update): 06/06/2018. The trial was a-priori registered before actual recruitment of subjects.

Reasons for and associated characteristics with early study termination: Analysis of ClinicalTrials.gov data on pregnancy topics

BackgroundPrematurely terminated studies are unlikely to provide data for evidence-based practice. There has been no systematic review on premature study termination on pregnancy-related research. PurposeThis study investigated the reasons why studies on pregnancy topics are terminated and the associated characteristics with early termination. MethodsA total of 3,623 studies (332 terminated and 3,291 completed) were retrieved from ClinicalTrials.gov registry. Reasons for termination were grouped into four categories, including accrual difficulty, research operation issues, data-related recommendations, and external factors. Study characteristics were statistically compared between terminated and completed studies. FindingsAccrual difficulty (44.6%) and research operation issues (21.4%) were most frequently cited reasons for termination. Study design characteristics of intervention, randomization, masking, treatment and drug trial, and low funding from federal agencies were significantly associated with early termination. DiscussionPopulation tailored subject recruitment strategies, scientifically sound research protocols, and well-planned research operations may mitigate premature study termination.

Amending Federal Regulations to Counteract Language Barriers in the Informed Consent Process

Amending Federal Regulations to Counteract Language Barriers in the Informed Consent Process

New Sri Lankan Crown Rump Length Chart

Introduction Accurate pregnancy dating is important for many aspects of obstetric care at individual level as well as population level. Traditionally, pregnancy dating has done by adding 9 months and 7 days to the last menstrual period (LMP) using Naegele’s formula. Determination of gestational age by ultrasound is more precise. Most commonly used parameters are mean sac diameter, gestation sac volume, crown-rump length (CRL), biparietal diameter (BPD), head circumference (HC) and femur length (FL). After 24 weeks, gestational age cannot be accurately determined by ultrasound scans. The biological variability of CRL is small and growth is very rapid. There are many factors that can affect CRL such as measurement errors, differences in growth rates between individuals, fetal sex and maternal conditions such as diabetes mellitus. A correctly performed measurement of CRL is the most accurate way of estimating the gestational age in early pregnancy from 8 weeks to 13 weeks + 6 days. Objectives Our study aims were to prepare a new Crown Rump Length chart with Sri Lankan population data and to compare new CRL chart with existing intergrowth CRL chart. Method Prospective observational study with recruitment of subjects by Quota sampling technique was carried out from April 2015 to March 2016. Spontaneously conceived uncomplicated singleton pregnancies with normal Body Mass Index (BMI) 18.5 - 23 kg/m2 were recruited at the time of registration to antenatal care. Consenting woman with known LMP with regular cycles in preceding 3 months were undergone ultrasound examination only once at gestational age (GA) ranging from 8 weeks to 13 weeks + 6 days. If ultrasound dating was different from LMP dating by more than 5 days in pregnancies with POA less than 9 weeks and dating differences more than 7 days in pregnancies between 9 weeks and 14 weeks were excluded. Pregnancies complicated with uncertain viability, congenital anomalies and spontaneous miscarriage were excluded from statistical analysis. Data collection done with pre-tested interviewer administered form and analysis was carried out using the Statistical Package for Social Sciences (SPSS) version 21. Results A total of 653 subjects were recruited for the study and 557 turned up for ultrasound dating assessment. Dating discrepancy and multiple pregnancies excluded 31 subjects, uncertain viability and spontaneous miscarriage excluded 15 subjects resulting 511 subjects for final statistical analysis. The mean CRL increased with GA almost linearly from day 56 to 97. Conclusions We have produced new CRL chart based on Sri Lankan data and it can be used for clinical practice in Sri Lanka. There is no statistically significant difference between our CRL chart and intergrowth CRL chart.

Abstract PO-081: Cancer clinical trial access during the COVID-19 pandemic

Abstract Introduction: Cancer clinical trial conduction during the COVID-19 pandemic required a rapid move to virtual engagement to support participant and research team safety. We were faced with the challenge of translating our approach from in-person to virtual engagement for recruitment, enrollment, and delivery of the study intervention. We present our strategies to conduct cancer clinical trials focused on cancer risk reduction during the COVID-19 pandemic. Subject Recruitment: Our multimodal approach utilized online platforms and established approaches like posters, flyers, and collaborating with community health workers to recruit participants. Our virtual engagement strategies include direct outreach to potential participants via email, the electronic medical record (EMR), and social media. Contact via email and the EMR was guided by study-defined eligibility criteria. Social media outreach was through institutional Twitter, Facebook, and video channel accounts. Twitter posts and chats were employed. Enrollment: e-consenting and remote consenting processes were instituted via REDCAP. Delivery of the Educational Risk Reduction Intervention: We also conducted the intervention using the Zoom platform and through a recorded video of the educational risk reduction intervention, which is shared with the participant via REDCAP. Challenges: As documented by others, the greatest challenge to virtual engagement is lack of internet access and lack of digital literacy. These factors have a greater impact on underserved populations, including the elderly, those with low socioeconomic status, those located farther from the cancer center, and racially/ethnically diverse populations. Conclusion: By translating study outreach and processes to virtual engagement, we were able to facilitate clinical trial access across diverse community subgroups and support subject participation in clinical trials during the COVID-19 pandemic. Citation Format: Ashithkumar Beloor Suresh, Subecha Dahal, Christopher Gantz, AnaMaria Lopez. Cancer clinical trial access during the COVID-19 pandemic [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-081.

Demographic Analysis of Industry-Sponsored Alzheimer's Disease Trial Populations in the United States.

The Food and Drug Administration has that "sponsors should enroll participants who reflect the characteristics of clinically relevant populations". Recent reports have noted that global Alzheimer's Disease trials have enrolled predominantly White subjects. However, a thorough analysis of industry-sponsored, United States-only Alzheimer's trials has yet to be performed. A search of the clinicaltrials.gov database and PubMed identified 101 industry-sponsored Alzheimer's trials, performed solely in the United States, with gender data. The percentage of male (46%) vs. female (54%) subjects was higher than expected compared to real-world data. There were 50 Alzheimer's trials with race data. There was a significant overrepresentation of White subjects (92%) compared to all other race groups. These data suggest that significant modifications of subject recruitment methods are needed to increase the enrollment of underrepresented populations into Alzheimer's trials of potential new therapeutic agents in the United States.

Implementing an evidence-based somatic acupressure intervention in breast cancer survivors with the symptom cluster of fatigue, sleep disturbance and depression: study protocol of a phase II randomised controlled trial

IntroductionThe fatigue-sleep disturbance-depression (FSD) symptom cluster, as one of the most common symptom clusters in breast cancer (BC) survivors, can significantly decrease patients’ quality of life. Since the management of...