To compare healthcare survey response rates using two widely utilized recruitment methods: email and the electronic health record (EHR) patient portal.

Adults with a prior history of any bariatric surgery were randomly assigned (1:1) to receive a survey invitation via email or through the EHR patient portal. A second reminder was sent using the same method. A third invitation used a crossover approach, switching to the alternate method. We compared survey completion rates, changes in research preference status, and time to survey completion. Predictors of response were assessed using multivariable logistic regression.

The email group had a 9.9% response rate after the first invitation and 6.5% after the second. The EHR portal group had 8.4% and 4.5% response rates, respectively. Following crossover, the third invitation yielded a 4.4% response for those switched to the EHR portal and 7.5% for those switched to email. The EHR portal group was 27% less likely to complete the survey compared to the email group. Respondents were more likely to be female, non-Hispanic, White, have a recent healthcare encounter, and have recently logged into the portal. Median time to completion was under 24 hours in both groups, with over two-thirds of responses received on the day of or the day after the invitation. A change in research preference status was observed in 2.5% of email and 4.0% of portal participants.

Email-based recruitment yielded higher response rates than EHR portal-based recruitment, with most responses occurring shortly after invitation.

Engaging patients, caregivers, and other stakeholders to help guide the research process is a cornerstone of patient-centered research. Lived expertise may help ensure the relevance of research questions, promote practices that are satisfactory to research participants, improve transparency, and assist with disseminating findings.

Traditionally engagement has been conducted face-to-face in the local communities in which research operates. Decentralized platform trials pose new challenges for the practice of engagement. We used a remote model for stakeholder engagement, relying on Zoom meetings and blog communications.

Here we describe the approach used for research partnership with patients, caregivers, and clinicians in the planning and oversight of the ACTIV-6 trial and the impact of this work. We also present suggestions for future remote engagement.

The ACTIV-6 experience may inform proposed strategies for future engagement in decentralized trials.

To enhance representation in LCS research, we examined associations between participant characteristics and their preferred mode of survey completion among individuals eligible for LCS.

Between February 2023 and April 2024, prospective participants were identified using electronic healthcare records from Mass General Brigham and the University of Oklahoma Health Sciences (OUHSC). We offered three modes of survey completion: online, by mail, or by phone. Eligible participants were 50–80 years old, had smoked within the past 15 years, and spoke English or Spanish. We used multinomial logistic regression to estimate relative risk ratios (RRR).

Outreach to 2,822 individuals resulted in a sample of 315 participants. The mean age was 61.7 years (SD = 10.9). Most respondents were women (63.0%) and identified as White (63.3%), 29.8 % were Hispanic. The most common survey completion mode was mail (37.1%), followed by online (35.9%) and phone (27.0%). Characteristics associated with completion by mail were study site (RRR = 6.86, 95%CI:3.10–15.14), and race (RRR = 3.63, 95%CI:1.53–8.61); with respondents at OUHSC or who did not identify as White being more likely to choose mail over online modality. Characteristics associated with phone completion, included older age (RRR = 1.11, 95% CI: 1.03–1.20), Spanish language preference (RRR = 9.28, 95%CI:2.38–36.09), and with local government or community insurance (RRR = 9.91, 95% CI:1.92–51.3).

The current trend toward online surveys may not fully account for individual preferences for LCS research engagement, and could limit the representativeness in LCS studies if offline alternatives are not offered.

Integrating social and environmental determinants of health (SEDoH) into enterprise-wide clinical workflows and decision-making is one of the most important and challenging aspects of improving health equity. We engaged domain experts to develop a SEDoH informatics maturity model (SIMM) to help guide organizations to address technical, operational, and policy gaps.

We established a core expert group consisting of developers, informaticists, and subject matter experts to identify different SIMM domains and define maturity levels. The candidate model (v0.9) was evaluated by 15 informaticists at a Center for Data to Health community meeting. After incorporating feedback, a second evaluation round for v1.0 collected feedback and self-assessments from 35 respondents from the National COVID Cohort Collaborative, the Center for Leading Innovation and Collaboration’s Informatics Enterprise Committee, and a publicly available online self-assessment tool.

We developed a SIMM comprising seven maturity levels across five domains: data collection policies, data collection methods and technologies, technology platforms for analysis and visualization, analytics capacity, and operational and strategic impact. The evaluation demonstrated relatively high maturity in analytics and technological capacity, but more moderate maturity in operational and strategic impact among academic medical centers. Changes made to the tool in between rounds improved its ability to discriminate between intermediate maturity levels.

The SIMM can help organizations identify current gaps and next steps in improving SEDoH informatics. Improving the collection and use of SEDoH data is one important component of addressing health inequities.

The United States Congress passed the 21st Century Cures Act mandating the development of Food and Drug Administration guidance on regulatory use of real-world evidence. The Forum on the Integration of Observational and Randomized Data conducted a meeting with various stakeholder groups to build consensus around best practices for the use of real-world data (RWD) to support regulatory science. Our companion paper describes in detail the context and discussion of the meeting, which includes a recommendation to use a causal roadmap for study designs using RWD. This article discusses one step of the roadmap: the specification of a sensitivity analysis for testing robustness to violations of causal model assumptions.

We present an example of a sensitivity analysis from a RWD study on the effectiveness of Nifurtimox in treating Chagas disease, and an overview of various methods, emphasizing practical considerations on their use for regulatory purposes.

Sensitivity analyses must be accompanied by careful design of other aspects of the causal roadmap. Their prespecification is crucial to avoid wrong conclusions due to researcher degrees of freedom. Sensitivity analysis methods require auxiliary information to produce meaningful conclusions; it is important that they have at least two properties: the validity of the conclusions does not rely on unverifiable assumptions, and the auxiliary information required by the method is learnable from the corpus of current scientific knowledge.

Prespecified and assumption-lean sensitivity analyses are a crucial tool that can strengthen the validity and trustworthiness of effectiveness conclusions for regulatory science.

Nurses are critical to the research enterprise. However all nurses are not prepared to participate as members of the research team since education and training in clinical research nursing and nurse-specific Good Clinical Practice are not consistently included in nursing curricula. The lack of nurse education and training in clinical research and Good Clinical Practice leaves research participants vulnerable with a nursing workforce that is not prepared to balance fidelity to protocol and patient quality care and safety.

A collaborative network of nurses within Clinical and Translational Science Awards and beyond was established to address this education and training need. Over a 2-year period, using expert opinion, Delphi methods, and measures of validity and reliability the team constructed curriculum and knowledge test items.

A pilot modular electronic curriculum, including knowledge pretest and post-tests, in clinical research nursing and nurse-specific Good Clinical Practice competencies was developed.

As the scope and setting of clinical research changes, it is likely that all practicing nurses, regardless of their practice setting or specialty, will care for patients on research protocol, making all nurses, in essence, clinical research nurses. The curriculum developed by this protocol will address that workforce education and training need.

Canada is facing its worst crisis among healthcare workers in recent healthcare history. Anxiety, depression, suicidal ideation, and severe burnout are higher than before the COVID-19 pandemic. University Faculties of Medicine (FoMs) are vital to healthcare systems. Not only are they responsible for training personnel, but clinicians and staff from FoMs often work directly within healthcare systems. FoMs include students, staff, residents, faculty members, residents, researchers, and others, many experiencing higher stress levels due to pandemic tensions. Most FoMs emphasize cognitive and psychomotor learning needs. On the other hand, affective learning needs are not as well addressed within most FoMs. Finding innovative means to ameliorate mental and emotional health status, particularly at this critical juncture, will improve health and wellness, productivity, and retention. This article discusses a pilot program, Wellbeing Convene during COVID-19, in a Canadian FoM, which aimed to (1) provide staff, faculty, residents, and students with a toolkit for greater wellbeing and (2) build a sense of community during isolating times.

Participants found the program beneficial in both regards. We recommend that these kinds of programs be permanently available to all members in FoMs, at no cost. Wellness programs alone, however, will not solve the root causes of mental and emotional stress, often based on concerns related to finances, hierarchical workplace structures, and nature of the work itself, among other factors.

Addressing the mental and emotional health of people in FoMs is vital to improving productivity and reducing stress of FoMs, healthcare professionals, and, ultimately, patients.

Most students in MD-PhD programs take a leave of absence from medical school to complete PhD training, which promotes a natural loss of clinical skills and knowledge and could negatively impact a student’s long-term clinical knowledge. To address this concern, clinical refresher courses in the final year of PhD training have traditionally been used; however, effectiveness of such courses versus a longitudinal clinical course spanning all PhD training years is unclear.

The University of Alabama at Birmingham MD-PhD Program implemented a comprehensive continuing clinical education (CCE) course spanning PhD training years that features three course components: (1) clinical skills; (2) clinical knowledge; and (3) specialty exposure activities. To evaluate course effectiveness, data from an anonymous student survey completed at the end of each semester were analyzed.

Five hundred and ninety-seven surveys were completed by MD-PhD students from fall 2014 to 2022. Survey responses indicated that the majority of students found the course helpful to: maintain clinical skills and knowledge (544/597, 91% and 559/597, 94%; respectively), gain exposure to clinical specialties (568/597, 95%), and prepare them for responsibilities during clinical clerkships. During semesters following lockdowns from the COVID-19 pandemic, there were significant drops in students’ perceived preparedness.

Positive student survey feedback and improved preparedness to return to clinic after development of the course suggests the CCE course is a useful approach to maintain clinical knowledge during research training.