Unmet social needs contribute to growing health disparities and rising health care costs. Strategies to collect and integrate information on social needs into patients’ electronic health records (EHRs) show promise for connecting patients with community resources. However, gaps remain in understanding the contextual factors that impact implementing these interventions in clinical settings.

We conducted qualitative interviews with patients and focus groups with providers (January−September 2020) in two primary care clinics to inform the implementation of a module that collects and integrates patient-reported social needs information into the EHR. Questions addressed constructs within the Theoretical Framework for Acceptability and the Consolidated Framework for Implementation Research. Data were coded deductively using team-based framework analysis, followed by inductive coding and matrix analyses.

Forty patients participated in interviews, with 20 recruited at the clinics and 20 from home. Two focus groups were conducted with a total of 12 providers. Factors salient to acceptability and feasibility included patients’ discomfort answering sensitive questions, concerns about privacy, difficulty reading/understanding module content, and technological literacy. Rapport with providers was a facilitator for patients to discuss social needs. Providers stressed that limited time with patients would be a barrier, and expressed concerns about the lack of available community resources.

Findings highlight the need for flexible approaches to assessing and discussing social needs with patients. Feasibility of the intervention is contingent upon support from the health system to facilitate social needs assessment and discussion. Further study of availability of community resources is needed to ensure intervention effectiveness.

Researchers and policymakers recognize that leveraging data routinely collected in clinical practice can support improved research and patient care. Embedding elements of clinical trials, such as patient identification and trial data acquisition, into clinical practice can enable research access and increase efficiencies by reducing duplication of trial and care activities. Yet, cultural, administrative, and data barriers exist. The Clinical Trials Transformation Initiative (CTTI) developed evidenced-based, multi-partner recommendations to facilitate embedding interventional, randomized trials into clinical practice.

We conducted in-depth interviews (IDIs) with trial designers and implementers to describe their motivations for embedding interventional, randomized trials into clinical practice. Additionally, we aimed to identify barriers and potential solutions to implementing such trials. Interviews were audio-recorded and analyzed using applied thematic analysis.

We conducted 16 IDIs with 18 trial designers and implementers. Motivations for embedding trials into clinical practice included the desire to implement a learning health system and evaluate trials in real-world settings. Barriers to trial implementation focused on limited staff time and availability, the lack of buy-in, and difficulties using electronic health record data. Solutions included minimizing healthcare settings and patient burden, having a sufficient data and research infrastructure in place, and creating a culture change.

The results informed CTTI recommendations to facilitate the design and operation of embedded trials. These recommendations emphasize areas where sponsors and investigators can rethink the design and conduct of clinical trials to ultimately realize an aligned system of research and care.

Ideally, real-world data (RWD) collected to generate real-world evidence (RWE) should lead to impact on the care and health of real-world patients. Deriving from care in which clinicians and patients try various treatments to inform therapeutic decisions, N-of-1 trials bring scientific methods to real-world practice.

These single-patient crossover trials generate RWD and RWE by giving individual patients various treatments in a double-blinded way in sequential periods to determine the most effective treatment for a given patient.

This approach is most often used for patients with chronic, relatively stable conditions that provide the opportunity to make comparisons over multiple treatment periods, termed Type 1 N-of-1 trials. These are most helpful when there is heterogeneity of treatment effects among patients and no a priori best option. N-of-1 trials also can be done for patients with rare diseases, potentially testing only one treatment, to generate evidence for personalized treatment decisions, designated as Type 2 N-of-1 trials. With both types, in addition to informing individual’s treatments, when uniform protocols are used for multiple patients with the same condition, the data collected in the individual N-of-1 trials can be aggregated to provide RWD/RWE to inform more general use of the treatments. Thereby, N-of-1 trials can provide RWE for the care of individuals and for populations.

To fulfill this potential, we believe N-of-1 trials should be built into our current healthcare ecosystem. To this end, we are building the needed infrastructure and engaging the stakeholders who should receive value from this approach.

The hidden curriculum encompasses the norms, values, and behaviors within a learning environment. Navigating the hidden curricula of academia is crucial for doctoral trainees, particularly those from underrepresented backgrounds. Faculty mentors have an important role in helping trainees uncover and cope with the hidden curriculum. The purpose of this paper is to explore perceptions of the hidden curriculum among diverse doctoral trainees and mentors.

Following a presentation on the hidden curriculum at the Association for Clinical and Translational Science annual meeting in March 2021, attendees were asked to brainstorm ideas for diverse trainees and their mentors. Breakout room discussions were held for specific hidden curriculum topics; participants voted on which topics to discuss from a list of topics defined during the presentation. Ideas from these discussions were presented to the larger group to upvote.

Participants (n = 116) voted to discuss the following hidden curriculum topics: “coping with bias,” “assertive communication,” “knowing how things work,” and “developing a career.” Many suggestions emphasized the role of institutions in empowering mentors to help diverse trainees and, more generally, to meaningfully support policies and programs that facilitate the career success of trainees and faculty from underrepresented backgrounds.

This work generated a list of suggested action items for trainees, mentors, and institutions to ameliorate the hidden curricula of academia, especially for diverse trainees. However, institutions need to support changes that will facilitate these discussions as well as more broadly enable the success of faculty and students from diverse backgrounds.

Researchers and research organizations acknowledge the importance of paying research participants but often overlook the process of providing participant payments as a locus for improving equity and inclusion in clinical research. In this conceptual paper, we argue that participants’ lived experiences and social context should be recognized and respected when developing these processes.

We consider how participant payment processes that require specific payment types, delay the timing of payment, or require sharing sensitive information may impose barriers to equitable research. Building on findings from empirical research of participants’ perspectives on respect in research and a relational ethics framework of person-oriented research ethics, we explore how researchers and research organizations can better demonstrate respect through the research participation payment process.

We propose five considerations for demonstrating respect when providing payment: (1) practice cultural humility, (2) be mindful of socioeconomic factors, (3) be flexible, (4) be transparent, and (5) maintain open communication. These considerations are intended to address the lack of existing ethical guidance around the process for participant payments and promote more inclusive clinical research. We provide a set of sample questions for research teams to consider how they could modify their payment processes to better demonstrate respect.

By better demonstrating respect for participants when providing payment, researchers can work toward ensuring that their research procedures are more inclusive, respond to the needs of diverse communities, and result in more equitable relationships with participants.

Social media is increasingly being used in research, including recruitment.

For the Bayley Short Form Formative Study, which was conducted under the the National Children’s Study, traditional methods of recruitment proved to be ineffective. Therefore, digital media were identified as potential channels for recruitment.

Results included successful recruitment of over 1800 infant and toddler participants to the Study.

This paper outlines the methods, results, and future research opportunities.

Along with the greater research enterprise, Institutional Review Boards (IRBs) had to quickly adapt to the COVID-19 pandemic. IRBs had to review and oversee COVID-related research, while navigating strict public health measures and a workforce largely relegated to working from home. Our objectives were to measure adjustments to standard IRB review processes, IRB turnaround time and document and any novel ethical issues encountered.

Structured data requests were sent to members of the Consortium to Advance Effective Research Ethics Oversight directing Human Research Protection Programs (HRPP).

Fourteen of the 32 HRPP director members responded to a questionnaire about their approach to review and oversight during COVID-19. Eleven of the 14 provided summary data on COVID-19-specific protocols and six of the 11 provided protocol-related documents for our review. All respondents adopted at least one additional COVID-19-specific step to their usual review process. The average turnaround time for convened and expedited IRB reviews was 15 calendar days. In our review of the documents from 194 COVID-19-specific protocols (n = 302 documents), we identified only a single review that raised ethical concerns unique to COVID-19.

Our data provide a snapshot of how HRPPs approached the review of COVID-19-specific protocols at the start of the pandemic in the USA. While not generalizable to all HRPPs, these data indicate that HRPPs can adapt and respond quickly response to a pandemic and likely need little novel expertise in the review and oversight of COVID-19-specific protocols.

iLookOut, a web-based child abuse training for early childcare professionals (ECPs), has been shown to improve knowledge and attitudes related to correctly identifying and reporting suspected cases of child abuse. The overarching goal of the present study is to examine “what works for whom” for iLookOut in order to identify strategies for optimizing learner outcomes.

This prospective study enrolled 12,705 ECPs who completed iLookOut (November 2014–December 2018). We used structural equation models to test whether learner demographic and professional characteristics were differentially associated with implementation outcomes (i.e., acceptability and appropriateness) and whether these mediated subsequent indicators of training effectiveness (i.e., gains in knowledge).

Consistent with previous research, individuals with lower baseline knowledge scores showed greater knowledge gains (β = −.57; p < .001). Greater knowledge gains were seen for learners who reported higher acceptability (β = .08; p < .001) or appropriateness (β = .14; p < .001). Implementation outcomes strongly associated with knowledge gains included acceptability for female learners and appropriateness for learners who had not completed high school or had >15 years of experience in childcare settings. Where mediation was found, for the majority of groups, appropriateness emerged as the driving mediator.

Implementation outcomes emerged as important drivers of knowledge change for most groups. The iLookOut Core Training’s use of a multimedia learning environment, video-based storylines, and game-based techniques were endorsed by learners and correlated with increases in knowledge. Future work should explore why aspects of the iLookOut training are rated as less acceptable or appropriate by some groups and what changes would improve efficacy for low performing learners.