Alleviation of symptom severity for major depressive disorder (MDD) is known to be associated with a lagged improvement of functioning. Pharmacotherapy guidelines support algorithms for MDD treatment. However, it is currently unclear whether concordance with guidelines influences functional recovery. A guideline concordance algorithm (GCA-8) was used to measure this pathway in a naturalistic clinical setting.

Data from 1403 adults (67% female, 84% non-Hispanic/Latino White, mean age of 43 years) with nonpsychotic MDD from the Penn State Psychiatry Clinical Assessment and Rating Evaluation System registry (visits from 02/01/2015 to 04/13/2021) were evaluated. Multivariable linear regression measured associations between GCA-8 and World Health Organization Disability Assessment Schedule 2.0 (WHODAS) scores. Mediation by MDD symptom severity using the Patient Health Questionnaire depression module (PHQ-9) was also evaluated.

This study found a statistically significant improvement in WHODAS scores (functioning) between baseline and final measures (−2 points, P < .001) within one year. A one standard deviation increase in the GCA-8 score was associated with a 0.48-point reduction in mean disability score (total effect; P = .02) with significant mediation by the change in MDD symptom severity (coefficient = −0.51, P < .001) and a nonsignificant natural direct effect of the GCA-8 independent of PHQ-9 change (coefficient = −0.02, P = .92).

Higher pharmacotherapy guideline concordance is associated with better functioning for MDD patients; this association likely occurs through improvement in MDD symptom severity rather than directly.

Clinical research trials rely on informed consent forms (ICFs) to explain all aspects of the study to potential participants. Despite efforts to ensure the readability of ICFs, concerns about their complexity and participant understanding persist. There is a noted gap between Institutional Review Board (IRB) standards and the actual readability levels of ICFs, which often exceed the recommended 8th-grade reading level. This study evaluates the readability of over five thousand ICFs from ClinicalTrials.gov in the USA to assess their literacy levels.

We analyzed 5,239 US-based ICFs from ClinicalTrials.gov using readability metrics such as the Flesch Reading Ease, Flesch-Kincaid Grade Level, Gunning Fog Index, and the percentage of difficult words. We examined trends in readability levels across studies initiated from 2005 to 2024.

Most ICFs exceeded the recommended 8th-grade reading level, with an average Flesch-Kincaid Grade Level of 10.99. While 91% of the ICFs were written above the 8th-grade level, there was an observable improvement in readability, with fewer studies exceeding a 10th-grade reading level in recent years.

The study reveals a discrepancy between the recommended readability levels and actual ICFs, highlighting a need for simplification. Despite a trend toward improvement in more recent years, ongoing efforts are necessary to ensure ICFs are comprehensible to participants of varied educational backgrounds, reinforcing the ethical integrity of the consent process.

Disclosing individual research results to participants is not standard practice. The return of individual research results to participants may increase recruitment, retention, and engagement in research. This study’s objective was to explore the preferences, expectations, and experiences of research participants receiving individual research results.

A mixed-methods approach, consisting of semi-structured interviews and a health literacy assessment, was used with participants enrolled in a cohort study. The interviews were analyzed to produce an understanding of current experiences. Using descriptive analyses, responses were compared to identify alignments and divergences among participants.

Forty-three English-speaking and 16 Spanish-speaking participants enrolled. Ninety-eight percent of participants wanted to receive their individual research results. Seventy-five percent of participants reported they shared results with their healthcare providers. More participants aged 18–65 reported the need to follow up with their provider (70%) as compared to participants > 65 (20%). Two-thirds of participants reported a positive experience receiving their research results; however, 22% reported anxiety and worry. Most participants (69%) described the electronic medical record (EMR) as their preferred method for receiving their results. Yet only 50% of Spanish speakers preferred receiving research results through the EMR compared to 77% of English speakers. Participants with low health literacy preferred receiving study results in person or by phone.

Research participants value receiving their individual research results, and this may increase recruitment and retention within the research enterprise. While more research is needed, the lessons learned from this study lay the groundwork for developing best practices and policies around the return of individual research results.

Metabolic and bariatric surgery (MBS) is safe and efficacious for adolescents with severe obesity. Pairing MBS with behavioral lifestyle interventions may be effective for optimizing treatment outcomes. However, no standardized program exists. Adolescent perspectives are critical to understanding how to design interventions to enhance engagement, sustain motivation, and meet informational needs for pre- and post-MBS self-management behaviors. The aim of this study was to develop an MBS lifestyle support intervention built on evidence-based content with input from adolescents and their families.

A mixed-methods design identified adolescent preferences for MBS lifestyle support. Data were collected from a racially and ethnically diverse sample of adolescents (N = 17, 76% females, 24% males 41.2% non-Hispanic Black, 41.2% Hispanic/Latino, 11.8% non-Hispanic White, 5.8% Other) and their mothers (N = 13, 38.4% Hispanic) recruited from an MBS clinic. Quantitative surveys and qualitative interviews assessed preferred types of pre-post MBS content, modality, frequency, and delivery platforms to inform the design of the intervention. Mixed methods data were triangulated to provide a comprehensive understanding of adolescent/parent preferences.

Adolescents prioritized eating well, managing stress, and maintaining motivation as desired support strategies. Parents identified parental support groups and nutrition guidance as priorities. Peer support and social media platforms were identified as key approaches for boosting motivation and engagement.

The patient voice is an important first step in understanding how, and whether behavioral lifestyle programs combined with MBS for weight management can be optimized. Adolescent preferences may enhance program fit and identify health behavior supports needed to sustain behavior change.

Central venous lines (CVLs) are frequently utilized in critically ill patients and confer a risk of central line-associated bloodstream infections (CLABSIs). CLABSIs are associated with increased mortality, extended hospitalization, and increased costs. Unnecessary CVL utilization contributes to CLABSIs. This initiative sought to implement a clinical decision support system (CDSS) within an electronic health record (EHR) to quantify the prevalence of potentially unnecessary CVLs and improve their timely removal in six adult intensive care units (ICUs).

Intervention components included: (1) evaluating existing CDSS’ effectiveness, (2) clinician education, (3) developing/implementing an EHR-based CDSS to identify potentially unnecessary CVLs, (4) audit/feedback, and (5) reviewing EHR/institutional data to compare rates of removal of potentially unnecessary CVLs, device utilization, and CLABSIs pre- and postimplementation. Data was evaluated with statistical process control charts, chi-square analyses, and incidence rate ratios.

Preimplementation, 25.2% of CVLs were potentially removable, and the mean weekly proportion of these CVLs that were removed within 24 hours was 20.0%. Postimplementation, a greater proportion of potentially unnecessary CVLs were removed (29%, p < 0.0001), CVL utilization decreased, and days between CLABSIs increased. The intervention was most effective in ICUs staffed by pulmonary/critical care physicians, who received monthly audit/feedback, where timely CVL removal increased from a mean of 18.0% to 30.5% (p < 0.0001) and days between CLABSIs increased from 17.3 to 25.7.

A significant proportion of active CVLs were potentially unnecessary. CDSS implementation, in conjunction with audit and feedback, correlated with a sustained increase in timely CVL removal and an increase in days between CLABSIs.

The progression of long-term diabetes complications has led to a decreased quality of life. Our objective was to evaluate the adverse outcomes associated with diabetes based on a patient’s clinical profile by utilizing a multistate modeling approach.

This was a retrospective study of diabetes patients seen in primary care practices from 2013 to 2017. We implemented a five-state model to examine the progression of patients transitioning from one complication to having multiple complications. Our model incorporated high dimensional covariates from multisource data to investigate the possible effects of different types of factors that are associated with the progression of diabetes.

The cohort consisted of 10,596 patients diagnosed with diabetes and no previous complications associated with the disease. Most of the patients in our study were female, White, and had type 2 diabetes. During our study period, 5928 did not develop complications, 3323 developed microvascular complications, 1313 developed macrovascular complications, and 1129 developed both micro- and macrovascular complications. From our model, we determined that patients had a 0.1334 [0.1284, .1386] rate of developing a microvascular complication compared to 0.0508 [0.0479, .0540] rate of developing a macrovascular complication. The area deprivation index score we incorporated as a proxy for socioeconomic information indicated that patients who reside in more disadvantaged areas have a higher rate of developing a complication compared to those who reside in least disadvantaged areas.

Our work demonstrates how a multistate modeling framework is a comprehensive approach to analyzing the progression of long-term complications associated with diabetes.

Phase I clinical trials aim to find the highest dose of a novel drug that may be administrated safely without having serious adverse effects. Model-based designs have recently become popular in dose-finding procedures. Our objective is to provide an overview of phase I clinical trials in oncology.

A retrospective analysis of phase I clinical trials in oncology was performed by using the PubMed database between January 1, 2020, and December 31, 2022. We extracted all papers with the inclusion of trials in oncology and kept only those in which dose escalation or/ and dose expansion were conducted. We also compared the study parameters, design parameters, and patient parameters between industry-sponsored studies and academia-sponsored research.

Among the 1450 papers retrieved, 256 trials described phase I clinical trials in oncology. Overall, 71.1% of trials were done with a single study cohort, 56.64% of trials collected a group of at least 20 study volunteers, 55.1% were sponsored by industry, and 99.2% of trials had less than 10 patients who experienced DLTs.

The traditional 3 + 3 (73.85%) was still the most prevailing method for the dose-escalation approach. More than 50% of the trials did not reach MTDs. Industry-sponsored study enrolled more patients in dose-escalation trials with benefits of continental cooperation. Compared to previous findings, the usage of model-based design increased to about 10%, and the percentage of traditional 3 + 3 design decreased to 74%.

Phase I traditional 3 + 3 designs perform well, but there is still room for development in novel model-based dose-escalation designs in clinical practice.

This study assesses the feasibility of biomedical informatics resources for efficient recruitment of rural residents with cancer to a clinical trial of a quality-of-life (QOL) mobile app. These resources have the potential to reduce costly, time-consuming, in-person recruitment methods.

A cohort was identified from the electronic health record data repository and cross-referenced with patients who consented to additional research contact. Rural–urban commuting area codes were computed to identify rurality. Potential participants were emailed study details, screening questions, and an e-consent link via REDCap. Consented individuals received baseline questionnaires automatically. A sample minimum of n = 80 [n = 40 care as usual (CAU) n = 40 mobile app intervention] was needed.

N = 1298 potential participants (n = 365 CAU; n = 833 intervention) were screened for eligibility. For CAU, 68 consented, 67 completed baseline questionnaires, and 54 completed follow-up questionnaires. For intervention, 100 consented, 97 completed baseline questionnaires, and 58 completed follow-up questionnaires. The CAU/intervention reached 82.5%/122.5% of the enrollment target within 2 days. Recruitment and retention rates were 15.3% and 57.5%, respectively. The mean age was 59.5 ± 13.5 years. The sample was 65% women, 20% racial/ethnic minority, and 35% resided in rural areas.

These results demonstrate that biomedical informatics resources can be highly effective in recruiting for cancer QOL research. Precisely identifying individuals likely to meet inclusion criteria who previously indicated interest in research participation expedited recruitment. Participants completed the consent and baseline questionnaires with zero follow-up contacts from the research team. This low-touch, repeatable process may be highly effective for multisite clinical trials research seeking to include rural residents.

The expansion of electronic health record (EHR) data networks over the last two decades has significantly improved the accessibility and processes around data sharing. However, there lies a gap in meeting the needs of Clinical and Translational Science Award (CTSA) hubs, particularly related to real-world data (RWD) and real-world evidence (RWE).

We adopted a mixed-methods approach to construct a comprehensive needs assessment that included: (1) A Landscape Context analysis to understand the competitive environment; and (2) Customer Discovery to identify stakeholders and the value proposition related to EHR data networks. Methods included surveys, interviews, and a focus group.

Thirty-two CTSA institutions contributed data for analysis. Fifty-four interviews and one focus group were conducted. The synthesis of our findings pivots around five emergent themes: (1) CTSA segmentation needs vary according to resources; (2) Team science is key for success; (3) Quality of data generates trust in the network; (4) Capacity building is defined differently by researcher career stage and CTSA existing resources; and (5) Researchers’ unmet needs.

Based on the results, EHR data networks like ENACT that would like to meet the expectations of academic research centers within the CTSA consortium need to consider filling the gaps identified by our study: foster team science, improve workforce capacity, achieve data governance trust and efficiency of operation, and aid Learning Health Systems with validating, applying, and scaling the evidence to support quality improvement and high-value care. These findings align with the NIH NCATS Strategic Plan for Data Science.

The proportion of physician-investigators involved in biomedical research is shrinking even as the need for high-quality, interdisciplinary research is growing. Building the physician-investigator workforce is thus a pressing concern. Flexible, “light-weight” training modalities can help busy physician-investigators prepare for key stages of the research life cycle and personalize their learning to their own needs. Such training can also support researchers from diverse backgrounds and lighten the work of mentors.

The University of Pittsburgh’s Institute for Clinical Research Education designed the Stackables Microcredentials in Clinical and Translational Research (Stackables) program to provide flexible, online training to supplement and enhance formal training programs. This training utilizes a self-paced, just-in-time format along with an interactive, storytelling approach to sustain learner engagement. Learners earn badges for completing modules and certificates for completing “stacks” in key competency areas. In this paper, we describe the genesis and development of the Stackables program and report the results of a pilot study in which we evaluated changes in confidence in key skill areas from pretest to posttest, as well as engagement and perceived effectiveness.

Our Stackables pilot study showed statistically significant gains in learner confidence in all skill areas from pretest to posttest. Pilot participants reported that the module generated high levels of engagement and enhanced their skills, knowledge, and interest in the subject.

Stackables provide an important complement to formal coursework by focusing on discrete skill areas and allowing learners to access the training they need when they need it.