jueves, 29 de octubre de 2026
Mental health disparities among gynecologic cancer survivors: a cross-sectional analysis of the Canadian Longitudinal Study on Aging Melissa Lavecchia1ORCID iD , Alison Shea2,3ORCID iD , Maura Marcucci3,4,5ORCID iD , Parminder Raina3,4ORCID iD , Waldo Jimenez6ORCID iD , Julie M. V. Nguyen (++...)
https://www.academia.edu/2998-7741/3/3/10.20935/AcadOnco8456
Introduction: Mental health outcomes among gynecologic cancer survivors remain under-investigated. Using the Canadian Longitudinal Study on Aging (CLSA), a population-based cohort of over 50,000 individuals, we evaluated differences in mental health outcomes between gynecologic cancer survivors and those without a history of gynecologic cancer.
Materials and methods: Cross-sectional data from 26,155 female participants were analyzed. Mental health outcomes included depression (Center for Epidemiologic Studies Depression Scale, CES-D10), psychological distress (Kessler Psychological Distress Scale, K10), and self-rated mental health (SRMH: five-point Likert scale). Regression models were used to describe associations between history of a gynecologic cancer and the three mental health outcomes.
Results: Participants with a history of gynecologic cancer (n = 765, weighted prevalence 2.9%, 95% confidence interval (CI) 2.4–3.3) showed a non-significant directional shift toward higher odds of screening positive for depression (adjusted odds ratio (aOR) CES-D10 1.2, 95% CI 0.9–1.5) than those without. However, among participants with any history of cancer, those with a gynecologic cancer were at higher risk of depression (aOR 1.6, 95% CI 1.1–2.5). Among gynecologic cancer survivors, lower household income showed a strong, graded association with all outcomes: income < 20,000 Canadian dollars was associated with elevated odds of depression (odds ratio (OR) 8.4, 95% CI 2.8–25.7), poor SRMH (OR 26.5, 95% CI 4.0–176.2), and psychological distress (OR 22.0, 95% CI 1.3–366.9). Within this group, current smoking was associated with increased odds of depression (OR 4.9, 95% CI 2.5–9.7) and psychological distress (OR 3.6, 95% CI 1.2–10.9).
Conclusions: Gynecologic cancer survivors tend to experience a higher burden of depressive symptoms, particularly those facing socioeconomic disadvantage. These findings support routine mental health screening and underscore the need for targeted interventions and sustained psychosocial support throughout treatment and survivorship.
https://www.academia.edu/journals/academia-oncology/articles?source=journal-top-nav
miércoles, 28 de octubre de 2026
Accountable Care in 2027: Building the Evidence Base and Driving Practical Policy Solutions (+... +...)
RISE to the Challenge: Statistical Considerations for Rare Disease Clinical Investigations
RISE to the Challenge: Statistical Considerations for Rare Disease Clinical Investigations (+... ... ...) video and more
This public workshop, co-convened by Duke Margolis and the FDA Rare Disease Innovation Hub, will explore statistical considerations in the design, conduct, and analysis of clinical investigations for rare disease medical products. The small patient populations inherent to rare disease present unique challenges that increase the risk of obtaining inconclusive trial results. Addressing these challenges requires careful attention to statistical rigor while utilizing tailored approaches that are necessary to make medical product development feasible in this space. Reliable and timely evidence that relies on data from all available information is critically important to patients and families affected by rare diseases, making the optimization of clinical investigation design, conduct, and analysis a matter of both scientific and ethical urgency.
The workshop will focus on key statistical considerations for tailored approaches employed across the full arc of rare disease development programs. Topics will include the role of randomization and blinding, strategies for enhancing efficiency, and factors specific to medical devices. Discussions will explore these statistical considerations with the goal of identifying efficient approaches that maintain scientific rigor and produce meaningful results for rare disease product development.
Statistical considerations affect every aspect of drug development, testing, and review, including clinical trial design and measuring product effectiveness; understanding the role of statistical review is important for sponsors, patients, and disease advocates alike. All members of the rare disease community, regardless of prior familiarity with statistical approaches, are encouraged to attend.
https://healthpolicy.duke.edu/events/rise-challenge-statistical-considerations-rare-disease-clinical-investigations?utm_medium=email&utm_source=govdelivery
Patient Voice in Rare Disease Medical Product Development
October 16, 2026
https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/patient-voice-rare-disease-medical-product-development-10162026?utm_medium=email&utm_source=govdelivery
FDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Development
Effort begins by Soliciting Public Feedback
https://www.fda.gov/news-events/press-announcements/fda-launches-rare-disease-framework-initiative-develop-holistic-fit-purpose-framework-rare-disease?utm_medium=email&utm_source=govdelivery
A New Framework for
Rare Disease Review
October 2026
https://www.fda.gov/media/195694/download?attachment=&utm_medium=email&utm_source=govdelivery
FDA Rare Disease Framework Initiative Public Meeting
October 28, 2026
https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-rare-disease-framework-initiative-public-meeting-10282026?utm_medium=email&utm_source=govdelivery
CDRH Rare Disease Impact Initiative
https://www.fda.gov/about-fda/center-devices-and-radiological-health/cdrh-rare-disease-impact-initiative?utm_medium=email&utm_source=govdelivery
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