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.