Although decentralized research is being used more frequently, few data are available regarding barriers for potential subjects related to engaging in decentralized research with remote biospecimen collection, especially within pregnancy and birth cohorts that include individuals of diverse racial and ethnic backgrounds.

Focus groups and individual interviews with pregnant and postpartum women were conducted in English and Spanish. Thematic analysis was used to identify motivators and barriers to participation in decentralized research involving biospecimens.

Sixty women (35% Hispanic/Latino, 23% Black, 18% Asian, 15% non-Hispanic White) participated in 10 focus groups (English = 8, Spanish = 2) and 11 individual interviews (English = 7, Spanish = 4). Three themes emerged about factors that could promote participation in decentralized biospecimen collection: 1) convenience, 2) autonomy, and 3) benefit (to self, community or society). Four themes emerged about potential barriers: 1) lack of interaction with trained professionals, 2) inability to coordinate with existing clinical care, 3) discomfort and invasiveness, and 4) concerns about data transparency and security. Overall, participants felt more comfortable providing biospecimens for themselves compared to their child and with biospecimens perceived as less painful or invasive to obtain.

Our findings suggest that transparency about the purposes and use of collecting biospecimen and clear instructions (such as written and instructional videos) could improve biospecimen collection in decentralized pregnancy and birth cohorts. Additionally, opportunities for virtual interaction with study staff and options related to collection of certain biospecimens such as blood (mobile collection unit with trained staff versus a self-collection device) may also improve participant engagement.

Individuals experiencing different medical conditions, as well as healthy volunteers, may often be interested in trial participation, and researchers similarly need to find participants to advance medical knowledge. The ResearchMatch (RM) Trials Today clinical trial searching tool leverages clinicaltrials.gov data to enable potential participants to look for trial opportunities relevant to their situation. To facilitate expanded use of this tool, we undertook a national digital public awareness campaign to increase awareness of Trials Today among members of the general public.

The awareness campaign promoted Trials Today using Facebook and digital banner messages in 2017, encompassing nine cities across the USA. The digital strategy was complemented by print media in several outlets. We employed descriptive statistics to summarize campaign metrics and site usage data during the campaign.

The campaign was successful in increasing visits to Trials Today, with 142,303 sessions logged during its run, as compared to pre-campaign data indicating 104,688 total sessions during the entire 2-year period since the site’s inception. The city-specific click-through rate for all digital impressions, combining Facebook and banner messaging, ranged from 0.50% to 1.09%, resulting in a cost-per-click range of $0.69–$1.15. In addition, visitors conducted 29,697 searches and viewed individual trial records 173,512 times.

The public awareness campaign was successful in increasing use of the RM Trials Today clinical trial searching tool. Our findings support the value of digital media messaging as a cost-effective vehicle for promoting clinical trial awareness, especially for chronic ailments.

Effective recruitment techniques are essential for researchers to recruit and retain potential participants in studies, particularly as recruitment numbers into clinical trials have decreased. While recruitment techniques have been investigated, there is a gap in understanding the perspectives of clinical trials recruiters. This paper examines recruiters’ usage and perceived effectiveness of various recruitment techniques, as well as their perspectives on related ethical issues.

We conducted a cross-sectional survey of 381 clinical trials recruiters. Closed-ended items examined whether recruiters had used 31 pre-defined recruitment techniques and their perceptions of the effectiveness of each technique. For techniques perceived to be highly effective or ineffective, open-ended items examined recruiter reasoning. The multiple methods analysis integrated the closed-ended and open-ended data.

Recruitment techniques such as reassured potential participants about confidentiality (96.3%) and reassured about data sharing (95.8%) had high usage, while techniques like having the PI approach and enroll had a high average perceived effectiveness (M = 4.23, SD = 0.91). Recruiters often rated techniques as more highly effective when they had prior experience using them. They also identified concerns about professionalism, ethics, and transparency in standard practice recruitment techniques.

Our findings indicate that there is significant variation in the usage of clinical trial recruitment techniques and how different recruiters view the effectiveness of each technique. The unique perspectives of those who recruit into clinical trials can help inform future decisions regarding which recruitment techniques to utilize, along with how and when to use particular recruitment techniques in an ethical manner.

Clinical trials, which are mainly conducted in urban medical centers, may be less accessible to rural residents. Our aims were to assess participation and the factors associated with participation of rural residents in clinical trials.

Using geocoding, the residential address of participants enrolled into clinical trials at Mayo Clinic locations in Arizona, Florida, and the Midwest between January 1, 2016, and December 31, 2017, was categorized as urban or rural. The distance travelled by participants and trial characteristics was compared between urban and rural participants. Ordinal logistic regression analyses were used to evaluate whether study location and risks were associated with rural participation in trials.

Among 292 trials, including 136 (47%) cancer trials, there were 2313 participants. Of these, 731 (32%) were rural participants, which is greater than the rural population in these 9 states (19%, P < 0.001). Compared to urban participants, rural participants were older (65 ± 12 years vs 64 ± 12 years, P = 0.004) and travelled further to the medical center (103 ± 104 vs 68 ± 88 miles, P < 0.001). The proportion of urban and rural participants who were remunerated was comparable. In the multivariable analysis, the proportion of rural participants was lower (P < 0.001) in Arizona (10%) and Florida (18%) than the Midwest (38%) but not significantly associated with the study-related risks.

Approximately one in three clinical trial participants were rural residents versus one in five in the population. Rural residents travelled further to access clinical trials. The study-associated risks were not associated with the distribution of rural and urban participants in trials.

Social determinants of health (SDOH) are an important contributor to health status and health outcomes. In this analysis, we compare SDOH measured both at the individual and population levels in patients with high comorbidity who receive primary care at Federally Qualified Health Centers in New York and Chicago and enrolled in the Tipping Points trial.

We analyzed individual- and population-level measures of SDOH in 1,488 patients with high comorbidity (Charlson Comorbidity Index ≥ 4) enrolled in Tipping Points. At the individual level, we used a standardized patient-reported questionnaire. At the population level, we employed patient addresses to calculate the Social Deprivation Index (SDI) and Area Deprivation Index. Multivariable regressions were conducted in addition to qualitative feedback from stakeholders.

Individual-level SDOH are distinct from population-level measures. Significant component predictors of population SDI are being unhoused, unable to pay for utilities, and difficulty accessing medical transportation. Qualitative findings mirrored these results. High comorbidity patients report significant SDOH challenges at the individual level. Fitting a binomial generalized linear model, the comorbidity score is significantly predicted by the composite individual SDOH index (p < 0.0001) controlling for age and race/ethnicity.

Individual- and population-level SDOH measures provide different risk assessments. The use of community-level SDI data is informative in the aggregate but should not be used to identify patients with individual unmet social needs. Health systems should implement a standardized individualized assessment of unmet SDOH needs and build strong, enduring partnerships with community-based organizations that can provide those services.

Growing recognition that collaboration among scientists from diverse disciplines fosters the emergence of solutions to complex scientific problems has spurred initiatives to train researchers to collaborate in interdisciplinary teams. Evaluations of collaboration patterns in these initiatives have tended to be cross-sectional, rather than clarifying temporal changes in collaborative dynamics. Mobile health (mHealth), the science of using mobile, wireless devices to improve health outcomes, is a field whose advancement needs interdisciplinary collaboration. The NIH-supported annual mHealth Training Institute (mHTI) was developed to meet that need and provides a unique testbed.

In this study, we applied a longitudinal social network analysis technique to evaluate how well the program fostered communication among the disciplinarily diverse scholars participating in the 2017−2019 mHTIs. By applying separable temporal exponential random graph models, we investigated the formation and persistence of project-based and fun conversations during the mHTIs.

We found that conversations between scholars of different disciplines were just as likely as conversations within disciplines to form or persist in the 2018 and 2019 mHTI, suggesting that the mHTI achieved its goal of fostering interdisciplinary conversations and could be a model for other team science initiatives; this finding is also true for scholars from different career stages. The presence of team and gender homophily effects in certain years suggested that scholars tended to communicate within the same team or gender.

Our results demonstrate the usefulness of longitudinal network models in evaluating team science initiatives while clarifying the processes driving interdisciplinary communications during the mHTIs.

Socially assistive robots (SARs) are a promising tool to manage children’s pain and distress related to medical procedures, but current options lack autonomous adaptability. The aim of this study was to understand children’s and caregivers' perceptions surrounding the use of an artificial intelligence (AI)-enhanced SAR to provide personalized procedural support to children during intravenous insertion (IVI) to inform the design of such a system following a user-centric approach.

This study presents a descriptive qualitative needs assessment of children and caregivers. Data were collected via semi-structured individual interviews and focus groups. Participants were recruited from two Canadian pediatric emergency departments (EDs) between April 2021 and January 2022.

Eleven caregivers and 19 children completed 27 individual interviews and one focus group. Three main themes were identified: A. Experience in the clinical setting, B. Acceptance of and concerns surrounding SARs, and C. Features that support child engagement with SARs. Most participants expressed comfort with robot technology, however, concerns were raised about sharing personal information, photographing/videotaping, and the possibility of technical failure. Suggestions for feature enhancements included increasing movement to engage a child’s attention and tailoring language to developmental age. To enhance the overall ED experience, participants also identified a role for the SAR in the waiting room.

Artificial intelligence-enhanced SARs were perceived by children and caregivers as a promising tool for distraction during IVIs and to enhance the overall ED experience. Insights collected will be used to inform the design of an AI-enhanced SAR.

Pragmatic trials involve patient recruitment, intervention delivery, and data collection leveraging usual systems and processes of care. Yet pragmatic does not mean easy, such that enacting pragmatic trial protocols requires considerable effort to engage patients and practice members. Home versus Office versus Telehealth for Medication Enhanced Recovery (HOMER) was a national pragmatic trial testing comparative effectiveness of office, home-based, and telehealth induction of medications for opioid use disorder (MOUD). Research implementation practice and patient liaisons (RIPPLs) were employed to support pragmatic trial conduct across 100 participating practices nationwide. The objective of this paper is to report on RIPPL roles and impact.

Fourteen RIPPLs were matched to practices based on geographic proximity, research network membership, and caseload. Study records, field notes, and a qualitative survey were used to describe RIPPL processes and experiences and to assess impact.

RIPPLs had backgrounds in research coordination, project management, primary care delivery support, and adult learning. RIPPL activities supported practice motivation, follow-through, and protocol fidelity, and included several elements of practice facilitation. RIPPLs provided real-time feedback to the research team on opportunities for research protocol adaptations. Impact of the RIPPLs included protocol adaptations to decrease practice burden and improve ease of patient participation, regular eligible criteria fidelity monitoring, data completeness, and quality, and educating clinicians and staff on MOUD delivery.

RIPPLs can effectively support pragmatic trial conduct in primary care. HOMER RIPPLs enabled the research protocol to be iteratively more pragmatic (both feasible and aligned with the primary care context) while maintaining rigor and fidelity of intervention implementation.

The time required to obtain Institutional Review Board (IRB) approval is a frequent subject of efforts to reduce unnecessary delays in initiating clinical trials. This study was conducted by and for IRB directors to better understand factors affecting approval times as a first step in developing a quality improvement framework.

807 IRB-approved clinical trials from 5 University of California campuses were analyzed to identify operational and clinical trial characteristics influencing IRB approval times.

High workloads, low staff ratios, limited training, and the number and types of ancillary reviews resulted in longer approval times. Biosafety reviews and the need for billing coverage analysis were ancillary reviews that contributed to the longest delays. Federally funded and multisite clinical trials had shorter approval times. Variability in between individual committees at each institution reviewing phase 3 multisite clinical trials also contributed to delays for some protocols. Accreditation was not associated with shorter approval times.

Reducing unnecessary delays in obtaining IRB approval will require a quality improvement framework that considers operational and study characteristics as well as the larger institutional regulatory environment.

Understanding how different symptoms co-occur and are correlated may provide insights into the pathophysiology of disease. The lack of group-to-individual generalizability of co-occurrence of symptoms was recently demonstrated by comparing intra-individual and inter-individual correlations in several psychological studies. Here, we investigate this phenomenon for lower urinary tract symptoms (LUTS).

We analyzed data collected in the Symptoms of Lower Urinary Tract Dysfunction Research Network Recall Study. Participants responded to questions about their urinary symptoms for 25 consecutive days. These questions queried urologic symptoms including storage (urinary urgency, frequency, nocturia, and urinary incontinence), voiding (slow/weak stream), and post-micturition (incomplete emptying and post-micturition dribble) symptoms. We calculated Pearson correlation coefficients and cosine similarity measures and compared distributions of intra-individual and inter-individual (cohort) metrics.

Among 234 participants, distributions of intra-individual measures were 10-fold wider than those of inter-individual correlations. There are pairs of questions with distributions of correlations and cosine similarities containing individuals with extreme positive (>0.8) and extreme negative values (<–0.8). There are groups of participants with strong positive and negative correlations of urinary frequency and nocturia, urinary incontinence and weak flow, as well as strong negative and positive correlations of urinary frequency and dribbling. Information on these extreme groups is averaged out and lost in the inter-individual correlations.

Lack of group-to-individual generalizability previously shown for psychological symptoms is confirmed for LUTS. Wealth of information on the co-occurrence and co-evolution of LUTS in the intra-individual correlations and cosine similarities corroborates heterogeneity of LUTS and can be useful for deep phenotyping and for identifying personalized treatments of LUTS.