Female Risk Factors for Post-Infarction Depression and Anxiety: Trial Design.

INTRODUCTION: Female patients are at elevated risk for adverse mental health outcomes following hospital admission for ischemic heart disease. These psychosocial characteristics are correlated with unacceptably higher rates of cardiovascular (CV) morbidity and mortality. Guidelines to address mental health following acute coronary syndrome (ACS) can only be developed with the aid of studies elucidating which subgroups of female patients are at the highest risk. METHODS/DESIGN: The Female Risk factors for post-Infarction Depression and Anxiety (FRIDA) Study is a prospective multicenter questionnaire-based study of female participants admitted to hospital with ACS. Data are collected within 72 h of admission as well as at 3 and 6 months. At baseline, participants complete a sociodemographic questionnaire, social support survey, and Hospital Depression and Anxiety Scale (HADS). Follow-up will consist of a demographic questionnaire, HADS, changes to health status, and quality of life indicators. Statistical analysis will include descriptive and inferential methods to observe baseline distributions and significance between groups. DISCUSSION/CONCLUSION: Our primary outcome is to determine if specific CV and sociodemographic factors correlate with increased depression and anxiety scores (HADS-D >7; HADS-A >7) at baseline. Our secondary aim is to determine if increased HADS scores at baseline and follow-up correlate with 3 and 6-month health and quality of life outcomes. A total of 2,000 patients will be enrolled across seven study sites. The aim of the FRIDA Study is to understand which groups of female patients have the highest rates of depression and anxiety following ACS to better inform care.

What is the future of treatment de-escalation for HPV-positive oropharyngeal cancer? A review of ongoing clinical trials.

Background: Human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC) has increased in incidence in recent decades. With higher cure rates in younger populations, long-term survivors may live with acute- and long-term toxicity, leading to increased interest in de-escalation treatment strategies for HPV-related OPSCC. Herein, we have examined the current landscape of clinical trials in this context. Methods: A review of active clinical trials related to de-escalation of HPV-associated OPSCC treatment was performed using the clinicaltrials.gov database from inception to January 2022. A search using the key words "oropharyngeal cancer" and "HPV" was completed. Three investigators independently reviewed each trial, with any discrepancies settled by a fourth. Data collected from each study included study phase, study design, primary, and secondary endpoints, and de-escalation treatment strategies. A final 24 articles were selected for full text review. Results: Many trials (n=19, 79%) were non-randomized, and most studies employed a phase II design (n=14, 58%). Only 13% (n=3) were randomized trials, and 8% (n=2) included a phase III component. The most frequent primary endpoint was progression-free survival (PFS) (n=9, 37.5%). With regards to the identified de-escalation strategies, all the studies (n=24) had at least one component assessing changes in RT dose/fractionation and/or a reduction in RT volumes. A smaller percentage of trials assessed surgical interventions (n=9, 37.5%) and/or changes in systemic therapy (n=8, 33.3%). Conclusion: A small number of randomized trials are underway, and a transition to more randomized phase III trials in the future will be important to change clinical practice.