HIV viral load self-testing could enable people living with HIV (PLHIV) to monitor their viral suppression status more easily, potentially facilitating medication adherence and safe behavior decision-making. Smartphone-based viral load testing innovations have the potential to reach resource-limited and vulnerable communities to address inequities in access to HIV care. However, successful development and translation of these tests requires meaningful investigation of end-user contexts and incorporation of those context-specific needs early in the design process. The objective of this study is to engage PLHIV and HIV healthcare providers in human-centered design research to inform key design and implementation considerations for a smartphone-based HIV viral load self-testing device prototype in development.

Semi-structured in-depth interviews were conducted with PLHIV (n = 10) and HIV providers (n = 4) in Indiana, a state with suboptimal viral suppression rates and marked disparities in access to HIV care. Interview guides were developed based on contextual investigation and human-centered design frameworks and included a demonstration of the device prototype with feedback-gathering questions.

Thematic analysis of interview transcripts revealed important benefits, concerns, and user requirements for smartphone-based HIV VL self-testing within the context of PLHIV lived experience, knowledge, and barriers to care in Indiana.

End-user needs and preferences were identified as key design specifications and implementation considerations to facilitate the acceptability and inform ongoing development and ultimately real-world translation of the HIV VL monitoring device prototype.

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.

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.

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.

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.

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.