Participant Recruitment Research Articles

Bots and fake participants: ensuring valid and reliable data collection using online participant recruitment methods

ABSTRACT Recruitment for successful health sciences research requires balancing efficiency, cost, accessibility, and reliability of available recruitment methods. Our case-control study used online recruitment methods, which broadened our reach to potential participants across the United States. However, this approach also exposed us to challenges associated with bot interference and fraudulent participation. This paper focuses on maintaining data integrity, specifically when utilizing online participant recruitment methods. Drawing from our experience, we propose The Swiss Cheese Model of Study Participant Fraud Prevention, adapted from Reason’s Swiss Cheese Model, and illustrate 10 prevention and verification measures that can be taken to minimize fraud in research studies that rely on online recruitment. We emphasize the importance of a layered approach, including carefully designed recruitment media and compensation protocols, vetting of participant eligibility, and data verification protocols to ensure the validity and reliability of research findings in the digital age.

Not me-search, you-search: Ethical considerations for research involving marginalized outgroups

ABSTRACT Background:This study explored experiences of quantitative researchers who work with marginalized populations. Methods/materials: Participants were recruited from the Society for Personality and Social Psychology forum, and asked questions regarding their struggles and best practices while working with marginalized populations in which they are or are not a member. Results: Responses included concerns regarding bidirectional trust, community norms, perceived bias, diversity and participant recruitment and compensation. We explore the benefits of qualitative understandings of bias (i.e. positionality, reflexivity), salient concerns reported by quantitative researchers, and our recommendations for the ethical inclusion of these practices across quantitative work. Conclusions: This paper contributes to understanding of current struggles and best practices while conducting research among marginalized populations. Additionally, we encourage quantitative researchers to engage in reflexive research practices, particularly for the benefit of marginalized group research. We extend the insider-outsider researcher discussion to quantitative researchers.

Sampling Strategies for Assessing Male Clients of Female Sex Workers in Public Health Research: A Compilation of Global Evidence.

Clients of Female Sex Workers (FSWs) are major bridge population in HIV transmission. Any research among them remains challenging because they are hidden within society. The objective of this review was tocompile the global evidence on different sampling strategies used to access male clients of female sex workers for research purpose, the challenges faced during the sampling process andpossible sources of bias. Original articles and reports published globally in last 10years, in English language and those with full text freely available online were included in this scoping review. A comprehensive search was carried out among the electronic peer-reviewed literature database (Pubmed and Web of Science) using a pre-designed peer reviewed search strategy. Narrative synthesis was applied out across all such articles. A total of 36 articles were finally included in this review. The common sampling techniques used include convenience sampling, referral by FSWs/ pimp/brothel manager/clients, time location cluster sampling, use of virtual network, anonymous telephone survey, referred by clinicians of STI clinic etc. Overall response rate varied between 35 and 90%. Major challenges in participant recruitment included non-response, feasibility issue specially to cater non-brothel-based clients, safety issue for investigators, over-representation of clients with lower socio-economic status, higher refusal rate for known HIV positive clients to provide biological sample etc. As different sampling techniques have comparable response rate, it can be recommended that a pilot study should be carried out in local context to finalise appropriate participant recruitment technique for a given population.

Developmental Differences in a Hippocampal–Cingulate Pathway Involved in Learned Safety Following Interpersonal Trauma Exposure

Nearly 65% of youth experience trauma, and up to one-third of youth with trauma exposure face profound mental health sequelae. There remains a need to elucidate factors that contribute to psychopathology following trauma exposure, and to optimize interventions for youth who do not benefit sufficiently from existing treatments. Here, we probe safety signal learning (SSL), which is a mechanism of fear reduction that leverages learned safety to inhibit fear in the presence of threat-associated stimuli and has been shown to attenuate fear via a hippocampal-cingulate--specifically, a dorsal anterior cingulate cortex (dACC)--pathway. The present study used behavioral and task-based functional magnetic resonance imaging data to examine age-related associations between interpersonal trauma exposure and the behavioral and neural correlates (ie, activation and functional connectivity) of SSL in a group of 102 youth (aged 9-19 years; 46 female, 56 male) with (n= 52) and without (n= 50) interpersonal trauma exposure. Primary analyses examined anterior hippocampal activation and anterior hippocampus-dACC functional connectivity. Exploratory analyses examined centromedial (CMA) and laterobasal (LBA) amygdala activation and anterior hippocampal, CMA, and LBA functional connectivity with additional anterior cingulate subregions (ie, subgenual anterior cingulate cortex [sgACC] and rostral anterior cingulate cortex [rosACC]). Both youth with and without interpersonal trauma exposure successfully learned conditioned safety, which was determined by using self-report of contingency awareness. Youth with interpersonal trauma exposure (relative to youth in the comparison group) exhibited age-specific patterns of lower hippocampal activation (F2,96= 3.75, pFDR= .049, ηp2= 0.072), and, in exploratory analyses, showed heightened centromedial amygdala activation (F1,96= 5.37, pFDR= .046, ηp2= 0.053) and an age-related decrease in hippocampal-sgACC functional connectivity during SSL (F1,94= 10.68, pFDR= .015, ηp2= 0.102). We also show that hippocampal-sgACC functional connectivity mediated the association between interpersonal trauma exposure and post-traumatic stress disorder symptoms in an age-specific manner in the overall sample. Together, these findings suggest that although age- and trauma-specific differences in the neural correlates of SSL may relate to the development of psychopathology, youth with interpersonal trauma exposure demonstrate successful learning of conditioned safety over time. We worked to ensure that the study questionnaires were prepared in an inclusive way. We worked to ensure sex and gender balance in the recruitment of human participants. We worked to ensure race, ethnic, and/or other types of diversity in the recruitment of human participants. While citing references scientificall`y relevant for this work, we also actively worked to promote sex and gender balance in our reference list. While citing references scientifically relevant for this work, we also actively worked to promote inclusion of historically underrepresented racial and/or ethnic groups in science in our reference list. We actively worked to promote sex and gender balance in our author group. We actively worked to promote inclusion of historically underrepresented racial and/or ethnic groups in science in our author group. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented racial and/or ethnic groups in science. One or more of the authors of this paper received support from a program designed to increase minority representation in science.

Three-Year Effects of Motivational Interviewing–Enhanced Behavior Therapy for Adolescents With ADHD: A Randomized Community-Based Trial

This study reports 3-year effects of a parent-teen cognitive/behavioral treatment for adolescent attention-deficit/hyperactivity disorder (ADHD), blended with Motivational Interviewing (Supporting Teens' Autonomy Daily [STAND]), vs Usual Care (UC) in 4 community clinics. This was a randomized clinical trial with double randomization of adolescents and therapists to STAND vs UC. Participants were 278 culturally diverse adolescents diagnosed with DSM-5 ADHD and 82 community therapists. Long-term effects on outcomes and theorized mechanisms were assessed at approximately 3 years post baseline (mean age= 16.94 years, SD= 1.69): ADHD severity (parent-rated), parent-teen conflict (parent/adolescent-rated), organization, time management, and planning skills (OTP; parent-rated), treatment and school enrollment (parent/adolescent-reported), and ADHD diagnostic persistence (clinician-determined). Therapist licensure was examined as a treatment moderator. Intent-to-treat (ITT) and per protocol analyses (n = 225; participants initiating treatment after agency intake) were conducted. As in the original trial, ITT analyses indicated no long-term group by time effects. However, STAND (vs UC) led to superior long-term outcomes when therapists were licensed (22% of sample) vs unlicensed for parent-rated hyperactivity/impulsivity (d= 0.39; adolescent-rated parent-teen conflict: d= 0.27, and parent-rated OTP skills: d= 0.79). Previously reported post-treatment group differences on medication engagement were non-significant at the 3-year follow-up. Although STAND did not outperform UC overall, group by licensure interactions indicate specific long-term impacts on ADHD symptoms, executive function skills such as OTP, and parent-teen conflict, extending this trial's acute effects and replicating previous findings. Clinicians in community settings might recommend adjunctive cognitive/behavioral treatment to adolescents with ADHD to maximize long-term outcomes. However, additional efforts are needed to facilitate effective implementation by unlicensed clinicians. STAND Community Trial (STAND); https://clinicaltrials.gov; NCT02694939. Long-term Follow-up of MI-based Behavioral Intervention Delivered in Community Mental Health; https://osf.io; h5w6f. We worked to ensure sex and gender balance in the recruitment of human participants. We worked to ensure race, ethnic, and/or other types of diversity in the recruitment of human participants. We worked to ensure that the study questionnaires were prepared in an inclusive way. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented racial and/or ethnic groups in science. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented sexual and/or gender groups in science. One or more of the authors of this paper self-identifies as living with a disability. We actively worked to promote sex and gender balance in our author group. We actively worked to promote inclusion of historically underrepresented racial and/or ethnic groups in science in our author group. While citing references scientifically relevant for this work, we also actively worked to promote sex and gender balance in our reference list. The author list of this paper includes contributors from the location and/or community where the research was conducted who participated in the data collection, design, analysis, and/or interpretation of the work.

ACUpuncture In The EmergencY Department (ACUITY): Results from a BraveNet Multi-Center Feasibility Randomized Controlled Trial

BackgroundPain plays a significant role in emergency department (ED) visits, however safe and effective nonpharmacologic options are needed. Prior studies of acupuncture in the ED reported pain reduction with minimal side effects, but most were small and single site. MethodsWe conducted ACUITY, a prospectively designed multi-center feasibility RCT. Our goal was to recruit 165 adults with acute non-emergent pain ≥4 on a 0-10-point scale at three EDs affiliated with BraveNet Practice Based Research Network. At baseline and 45-60 minutes later (post), participants self-assessed their pain and anxiety using a 0-10 rating scale. The primary feasibility outcome was recruitment of participants, whereas secondary outcomes were retention, and participant/provider acceptability. ResultsFrom May 3, 2021, to September 24, 2022, 632 eligible individuals were approached and 165 enrolled (165/632: 26.1%), meeting our recruitment goal. Notably, 42.4% of enrollees were Black/African American, 42.4% were White/Caucasian, and 13.9% were Hispanic/Latino. Participants were randomized to Acupuncture (n = 83) or Usual care (n = 82), of which 151 (91.5%) and 128 (77.6%) provided pain and anxiety scores at post-treatment and 1-week respectively. Acupuncture was rated acceptable to participants and providers. Mean pain ratings (pre-to-post) were 7.4 (2.2) to 4.8 (2.8) for acupuncture and 7.1 (2.3) to 6.4 (2.5) for usual care. Mean anxiety ratings (pre-to-post) were 4.5 (3.4) to 2.5 (2.6) for acupuncture and 4.1 (3.4) to 3.5 (3.2) for usual care. ConclusionSuccessful completion of ACUITY indicates we have the expertise and preliminary data to conduct a future definitive, multi-center RCT. Clinical Trials.govNCT04880733

Challenges and barriers in conducting school-based physical activity research: A narrative review

ABSTRACT Physical activity (PA) is associated with numerous mental and physical health benefits. But it has been observed that young people and children frequently participate in low levels of PA, which is especially noticeable when they progress from primary to secondary school. Thus, in order to improve physical health among school-going children, different schools should put in place school-based PA intervention programs. The researchers designing PA intervention protocols for school children encounter various challenges during implementation; hence, this narrative review determines the challenges and barriers faced by the researchers during data collection on PA of school-going adolescent children. The review highlighted the challenges encountered during implementation of school-based PA and fitness among school children. The key issues mentioned in the review involved problems related to communication with schools, recruitment of participants along with the informed consent, implementation and data collection, environment of school, and barriers to PA in school. The documentation of these difficulties can help advance knowledge of the researchers and their efficacy, which will finally result in the development of strengthened and close relationships with school-based educational institutions, leading to implementation of intervention protocols and enhancing physical fitness in school children.

Specific phobias in children with moderate to severe intellectual disabilities: SPIRIT, an adaptation and feasibility study.

There is a lack of interventions for specific phobia in children and adolescents with moderate to severe intellectual disabilities. The objectives were to: (a) develop an intervention for specific phobia, together with an intervention fidelity checklist and logic model, and evaluate candidate outcome measures, together with parents/carers and clinicians; (b) describe treatment as usual; (c) model the intervention to determine the acceptability and feasibility for all stakeholders, judge the appropriateness of outcome measures, explore recruitment pathways, and examine the feasibility and acceptability of consent and associated processes; and (d) describe factors that facilitate or challenge the intervention. Phase 1a: using consensus methods, an Intervention Development Group was established who met to develop the intervention, review candidate outcome measures and contribute to the development of the intervention fidelity checklists and logic model. Phase 1b: a national online survey was conducted with parents and professionals to describe treatment as usual. Phase 2: a single-group non-randomised feasibility study was designed to model the intervention and to test intervention feasibility and acceptability, outcome measures and aspects of the research process. Phase 2: participants were recruited from National Health Service community child learning disabilities teams and special schools in England. Treatment was delivered in the child learning disabilities teams. Children aged 5-15 years with moderate to severe learning disability and specific phobia, and their parents/carers. The SPIRIT intervention comprised two half-day workshops and eight support sessions plus treatment as usual. The feasibility and acceptability of the intervention and research processes, recruitment, outcome measure completion rates and acceptability, and intervention adherence. Parents completed all of the outcome measures, with very low rates of missing data. The recruitment of sites and participants was impacted by the COVID-19 pandemic. The intervention was successfully developed and modelled with 15 participants with moderate to severe learning disabilities and their parents. The intervention was judged to be feasible and acceptable by parents/carers and therapists. Parents/carers and therapists suggested minor intervention revisions. Randomisation was not modelled within this feasibility study, although the majority of parents and therapists indicated that this would be acceptable. The SPIRIT intervention and associated study processes were judged to be feasible and acceptable. The intervention requires minor revisions. The SPIRIT intervention should be tested further within a clinical trial. Current Controlled Trials ISRCTN34766613. This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR130177) and is published in full in Health Technology Assessment; Vol. 28, No. 64. See the NIHR Funding and Awards website for further award information.

Leveraging the electronic health record patient portal to enhance clinical trial recruitment.

387 Background: The increasing prevalence of video/remote visits in the clinical setting has posed researchers with unique challenges related to clinical trial recruitment. Without the ability to speak to potential participants face to face, researchers rely on making phone calls which are frequently screened, declined, or never returned. Patients contacted in this way may never access the trials and care opportunities available to them. Electronic health record (EHR) patient portals, such as MyChart (Epic), allow individuals to access their medical records and communicate with their providers via instant messaging. This EHR tool may offer researchers a new method of participant recruitment to clinical trials. Methods: An electronic report, built around the Five- or Ten-Year Colonoscopy Trial’s (FORTE/NRG-CC005) eligibility criteria, was used to identify potential study participants. The local research team then generated an investigator endorsed, IRB-approved introductory script to send to patients via the MyChart instant messaging function. Once delivered, the message status was monitored to determine whether the patient had opened/read the introductory message. Patients who responded and expressed interest in trial participation were then sent additional information through MyChart and asked to schedule a time to speak to research staff over the phone. Results: In the two years that the FORTE trial was opened at our institution (October 2021 to August 2023), prior to implementing this MyChart practice, the research team attempted to contact 108 eligible patients via outreach phone calls. Of the 108, only 10 were reached by the study team and 0 consented to the trial. Between August 2023 and May 2024, 28 eligible patients were sent the MyChart script resulting in a response rate of 85.7% (24/28). Of the respondents, 20.8% (5/24) declined participation and did not want additional study information; 41.7% (10/24) requested more information but later declined participation, and 37.5% (9/24) expressed interest in trial participation. To date, of these 9 interested patients, 4 have enrolled to FORTE, and 5 are in the screening process. Conclusions: Preliminary observations suggest that recruiting patients to clinical trials through an electronic health record portal is an effective tool for enhancing enrollment. Further research is warranted to prospectively evaluate this recruitment strategy.

An Interactive Vision-Based 3D Augmented Reality System for In-Home Physical Rehabilitation: A Qualitative Inquiry to Inform System Development.

Postoperative physical rehabilitation is crucial after total joint replacement (TJR). However, completing the recommended levels of postoperative physical exercise is challenging for many older adults with TJR. Lack of adequate postoperative physical exercise has negative consequences on rehabilitation outcomes. Innovative rehabilitation tools for postoperative physical exercises are needed to ensure successful rehabilitation outcomes among older adults with TJR. The aim of this study is to explore key knowledge users' perspectives about how to design an interactive vision-based three-dimensional augmented reality system (3D ARS) to support in-home postoperative physical rehabilitation for older adults with TJR. We conducted a qualitative descriptive study involving 11 semi-structured interviews and six focus groups with 42 older adults with TJR and four unrelated family caregivers. Data were analysed using thematic analysis. Participant insights were grouped into two main themes: (1) dreaming up possibilities and (2) being pragmatic. The first theme captured participants' reflections on the potential utility of a 3D ARS for postoperative physical rehabilitation and features that could be embedded in the 3D ARS to support successful postoperative physical rehabilitation. The second theme captured participants' reflections on practical issues and considerations that could impact access and usage of the 3D ARS. These findings provide researchers, rehabilitation providers and system developers with the foundations for designing, implementing and evaluating innovative augmented reality tools that support effective in-home physical rehabilitation among older adults with TJR. Research users (i.e., individuals and organisations invested in and using the research findings) were actively engaged throughout this work. Specifically, a meeting was held between the research team and representatives of an Expert by Experience team (individuals with lived experience), which was established to support the National Research Council's (organisation) Aging in Place programme. During this meeting, the idea to develop and evaluate an ARS for postoperative physical rehabilitation of older adults with TJR was supported. Research users had the opportunity to review the current study protocol and provide feedback on the study design, offering direction to maximize the relevance and usefulness of our findings to the National Research Council Canada's Aging in Place programme. Research users contributed to participant recruitment efforts and the development of the interview guide. Two Experts by Experience also agreed to be on the Advisory Panel for this multi-phased study, supporting active engagement and centring the voice of research users in knowledge creation and implementation. These experts reviewed a brief report of the current study findings, and continue to guide how the study findings are used to inform the next phase of this multi-phased research.

Pelatihan Pembuatan Kaligrafi Sistem Totol Spons di Pesantren Modern Nuur Ar-Radhiyyah

Calligraphy plays a very important role in the development of Islamic civilization. In the current era of globalization, young people are exposed to a variety of knowledge, cultures, perspectives, and ethics that influence changes within them. This training was conducted with the aim of introducing the art of calligraphy to the students (santri), which they can develop as part of their future careers. The training activities were carried out by members of the field experience practice team, who are students of the Islamic College (Sekolah Tinggi Agama Islam) Jam'iyah Mahmudiyah Tanjung Pura. The activity included planning, implementation, and evaluation. The methods used in this training were lectures, demonstrations, and hands-on practice. The results of this community service activity showed that: (1) The planning stage included initial observation, needs analysis, participant recruitment, and scheduling; (2) The training consisted of a one-time session using lectures, demonstrations, and writing practice; and (3) Evaluation was conducted during the training process, at the end of each session, and at the conclusion of the overall training. The dotted sponge calligraphy training left a unique impression and challenge for the students, fostering enthusiasm. It also brought about positive outcomes, such as helping students to develop calmness and concentration.

Prevalence of Cardiometabolic Risk Factors in Women: Insights From the Houston HeartReach Study.

Cardiovascular disease is the leading cause of death among women in the United States. Past research has highlighted the importance of the relationship between female-specific demographics and traditional risk factors. The present analysis aimed to identify the prevalence of modifiable risk factors in women attending a community cardiovascular health screening. Data collected between 2011 and 2019 were obtained from the Houston HeartReach Registry. Participants were classified as having or not having each of 4 traditional cardiometabolic risk factors: hypertension, diabetes, body mass index indicating overweight or obesity, and dyslipidemia. Differences in prevalence were compared using the Pearson χ2 test. Most participants had hypertension, overweight or obesity, and dyslipidemia. Older women (≥65 years) had the highest prevalence of all cardiometabolic risk factors. Black participants had a higher prevalence of hypertension (P = .006) and a lower prevalence of dyslipidemia (P = .009) than non-Black participants. Hispanic participants had a lower prevalence of hypertension (P < .001) and a higher prevalence of overweight or obesity (P = .03) than non-Hispanic participants. Participants in the lowest household income bracket (<$25,000) were more likely to have diabetes (P = .001) and overweight or obesity (P = .004) than participants in the highest income bracket (≥$50,000). Unemployed participants had a higher prevalence of diabetes (P < .001), overweight or obesity (P = .004), and dyslipidemia (P < .001) than employed participants. Comorbidity analysis revealed clustering of multiple cardiometabolic risk factors. Moreover, risk factor hot spots were identified by zip code, which could help select future sites for targeted screening. The analysis found that cardiometabolic risk factor prevalence varies with demographic and socioeconomic status. Geographic areas where cardiometabolic risk factor prevalence was highest were also identified. Further participant recruitment and analysis are required to create predictive models of cardiovascular disease risk in women.

Qualitative perspectives of Medicaid-insured patients on ambulatory care at an academic medical center: challenges and opportunities

BackgroundAmbulatory access to academic medical centers (AMCs) for patients insured with Medi-Cal (i.e., Medicaid in California) is understudied, particularly among the 85% of beneficiaries enrolled in managed care plans. As more AMCs develop partnerships with these plans, data on patient experiences of access to care and quality are needed to guide patient-centered improvements in care delivery.MethodsThe authors conducted semi-structured, qualitative interviews with Medi-Cal-insured patients with initial visits at a large, urban AMC during 2022. Participant recruitment was informed by a database of ambulatory Medi-Cal encounters. The interview guide covered Medi-Cal enrollment, scheduling, and visit experience. Interviews were transcribed and inductively coded, then organized into themes across four domains: access, affordability, patient-provider interactions, and continuity.ResultsTwenty participant interviews were completed (55% female, 85% English speaking, 80% self-identified minority or “other” race, and 30% Hispanic or Latino) with primary and/or specialty care visits. Within the access domain, participants reported delays with Medi-Cal enrollment and access to specialist care or testing, though appointment scheduling was reported to be easy. Affordability concerns included out-of-pocket medical and parking costs, and missed income when patients or families skipped work to facilitate care coordination. Participants considered clear, bilateral communication with providers fundamental to positive patient-provider interactions. Some participants perceived discrimination by providers based on their insurance status. Participants valued continuity, but experienced frustration arising from frequent and unexpected health plan changes that disrupted care with their established AMC providers.ConclusionsThe missions of AMCs typically focus on clinical care, education, research, and equity. However, reports from Medi-Cal insured patients receiving care at AMCs highlight their stress and confusion related to inconsistent provider access, uncompensated costs, variability in perceptions of quality, and fragmented care. Recommendations based upon patient-reported concerns suggest opportunities for AMC health system-level improvements that are compatible with AMC missions.

Development and evaluation of an external second victim support program for nurses: a single-group feasibility study

BackgroundPsychological support programs can help nurses who involved in patient safety incidents. However, most of these programs are operated internally by healthcare providers and utilize peer supporters, which may take a long time to implement. Therefore, there is a need to develop programs that can be used by healthcare providers in healthcare institutions that have difficulty implementing their own programs. This feasibility study aimed to develop an external support program for nurses as second victims and to examine the feasibility, acceptability, and impact of the program.MethodsThis study was conducted using a single-group pretest-posttest design. Nurses who experienced patient safety incidents were recruited through posters at three advanced general hospitals, as well as open online recruitment and via a research agency panel from September 2020 to April 2021. The 11 participants attended a total of three one-on-one counseling sessions. Feasibility was evaluated based on participant recruitment and retention, resource availability, program procedures, and the practicability of data collection. Acceptability was assessed through program satisfaction and participant feedback. Psychological impact was measured using the Impact of Event Scale-Revised Korean version.ResultsOut of 26 applicants, 11 (42.3%) completed the program, with 10 (38.5%) participants completing both pre and post-program surveys. Most participants responded that they were satisfied with the program and expressed their intention to recommend the program to others and participate in it again if similar situations arise. The participants’ median total IES-R-K score decreased significantly from 30.0 to 16.0 (p = 0.028, r = 0.67).ConclusionThis study demonstrates the feasibility of an external second victim support program and provides preliminary data suggesting its potential to alleviate the psychological impact of participants. To overcome the limitations of this study, it is necessary to conduct additional controlled trials with a longer follow-up period and a larger sample size.

Comparing modalities of opioid education in patients undergoing total knee arthroplasty: a randomized pilot trial

BackgroundPatients undergoing total knee arthroplasty (TKA) experience significant postoperative pain and routinely require opioids, yet they often lack knowledge regarding appropriate use and handling of these medications. Evidence suggests that...

Review article: A primer for clinical researchers in the emergency department: Part XIII. Strategies to engage staff and enhance participant recruitment in emergency department research.

Conducting research in ED is important and necessary to improve emergency care. Effective recruitment is an essential ingredient for the success of a research project and must be carefully monitored. Research coordinators are focused on optimising recruitment to research studies while also ensuring that the needs of participants and their families are met, and the research is acceptable to ED staff. In this paper, a group of experienced research coordinators from Australia and New Zealand have shared their strategies to engage staff and enhance recruitment of participants in emergency research. Although this paper is from a paediatric research network, the findings are applicable for EDs in general, both in Australasia and elsewhere.

Can technology be good for health? Investigating health-promoting strategies in the private sector.

This research investigates what might motivate tech companies and impact-driven investors to adopt a health-promoting strategy in their product development and capital allocation strategies. Participants were recruited for semi-structured interviews through purposive and snowball sampling. From 83 outreach attempts, thematic saturation required 19 completed interviews out of the 46 consumer technology executives and impact-focused investors who responded. Interviews were analyzed using grounded theory-based content analysis. Seven coding categories resulted from inductive coding, with 83 sub-codes. The primary themes were: product-based health impact is magnified when matched to user demographics (making an equity mindset important); stakeholders are eager for reliable health metrics, especially those that hold across industry verticals; when capturing health impact, it is critical to include positive (i.e., economically beneficial) externalities. These results allowed for the creation of a logic model with a recommended theory of change for the private sector to develop health strategy. Intentional integration of impact strategy with business priorities will allow teams to design products that promote health, driving buy-in and resource allocation while attracting investment and double returns. For policymakers, it is clear that tech policy and regulation for corporate reporting need to keep pace. These findings are limited by the purposive recruitment of participants, introducing potential bias and risk to generalizability.

Establishment of a Mesoamerican-Caribbean south-south research platform: Challenges in the Meriva (curcuminoids) Gastric Cancer Chemoprevention Trial.

Gastric adenocarcinoma (GAC) is the fourth-leading global cause of cancer mortality and leading infection-associated cancer. High incidence regions include Latin America and Eastern Asia. Immigrants from high incidence regions maintain their GAC risk. GAC is a major U.S. cancer disparity, incidence rates are 2-10 time higher in non-white populations. Emerging guidelines recommend 3-year surveillance endoscopy for patients with high-risk gastric premalignant conditions (GPMCs). Clinical trials of GPMC chemoprevention agents are lacking. We conducted an NCI Division of Cancer Prevention-funded, phase II placebo-controlled chemoprevention trial in patients with GPMCs (atrophic gastritis, intestinal metaplasia) with a highly bioavailable preparation of curcuminoids (Meriva®). The trial sites in Puerto Rico and rural Honduras had important characteristics: (1) representative Caribbean and Mesoamerican populations, linked to large U.S. immigrant populations; (2) high prevalence of H. pylori infection and GPMCs; (3) absence of turmeric and curcuminoids in the local diets; (4) proven bidirectional collaboration with U.S. academic institutions. H. pylori-negative GPMC patients were randomized to study drug (500 mg po bid) or placebo for 180 days (NCT02782949), with primary outcomes based upon histologic parameters. Principal study challenges included: (1) international regulatory environment; (2) research infrastructure strengthening, particularly in Central America; (3) participant recruitment in Honduras wherein only 10-15% are H. pylori negative; (4) the Covid-19 pandemic; and (5) natural disasters (3 hurricanes). There were no losses to follow-up related to the pandemic or natural disasters. In conclusion, the south-south partnership provides a model for chemoprevention and translational studies in Latino populations with prevalent cancers such as GAC.

Financial analysis of a locomotor exercise trial for post-stroke recovery: insights from the HIT Stroke Trial

BackgroundNavigating the complexities of post-stroke recovery trials requires addressing challenges in participant recruitment and retention and effective resource management to ensure trial success. The aim of this study was to examine the financial requirements associated with conducting the Moderate-Intensity Exercise vs. High-Intensity Interval Training to Recover Walking Post-Stroke (HIT Stroke Trial) at a single site encompassing a wide catchment area, recognizing the intricate challenges of participant recruitment and retention inherent in post-stroke recovery trials.MethodsTo determine cost, study expense reports were gathered and divided into seven categories: recruitment, screening assessments, baseline assessments, intervention, outcome assessments, retention, and oversight. Categories were then further divided into chronological order for initial contact and prescreening, consenting, initial screening, and baseline testing. The 12-week intervention was divided into 4-week blocks: intervention block 1, post 4-week outcome testing, intervention block 2, post 8-week outcome testing, intervention block 3, and post 12-week outcome testing.ResultsTotal direct cost for site execution was $539,768 with cost per participant approximated as $35,984. Oversight costs accounted for 65.8% of the budget at $355,661. To achieve goals related to inclusive participant recruitment ($21,923) and retention ($28,009), our site costs totaled $49,932. Direct study-related costs included screening assessments ($5,905), baseline assessments ($15,028), intervention ($76,952), and outcome assessments ($36,288).DiscussionClinical trials focusing on walking rehabilitation and exercise, particularly those requiring multiple assessment visits, demand rigorous oversight. This cost analysis provides important and critical insight into the expenses required to successfully execute an exercise-based walking rehabilitation trial in the United States.

A roadmap for improving representation in clinical trials

Clinical trials continue to struggle with recruiting diverse participants that include historically underrepresented and minoritized patients, who are typically patients in non-white racial and ethnic groups and have low income (Medicaid). Enrolling diverse participants will benefit the health sciences by providing more generalizable findings. The Cancer Financial Experience project (CAFÉ) study sought to improve financial distress by providing financial navigation for newly diagnosed cancer patients, and intentionally recruited diverse participants. All diverse participants consented at slightly higher rates than non-diverse participants (21.3 % vs. 20.1 %). Spanish-speaking patients consented at a much higher rate than non-Spanish speakers (36.4 % vs. 20.2 % respectively). Here we discuss how we increased our recruitment of diverse participants. Obtaining diverse participation is achievable and will provide more meaningful findings.