A Consistent Lack of Consistency: Definitions, Evidentiary Expectations and Potential Use of Meaningful Change Data in Clinical Outcome Assessments Across Stakeholders. Results from a DIA Working Group Literature Review and Survey.

Background: Clinical outcome assessments (COAs) measure how patients feel or function and can be used to understand which patients experience benefits of treatment and which do not. Interpretation of COA data is influenced by how meaningful change is defined. We aimed to compare how different stakeholders define, assess, and use meaningful change for decisions that impact patients.

Gender representation in cardiothoracic surgical academia: a call to support women across the globe.

Underrepresentation of women in surgical specialties persists, especially in academic leadership roles. Efforts to better understand disparities and support women cardiothoracic surgeons are ongoing.

Accelerating evidence generation: Addressing critical challenges and charting a path forward.

Efficient evidence generation to assess the clinical and economic impact of medical therapies is critical amid rising healthcare costs and aging populations. However, drug development and clinical trials remain far too expensive and inefficient for all stakeholders. On October 25-26, 2023, the Duke Clinical Research Institute brought together leaders from academia, industry, government agencies, patient advocacy, and nonprofit organizations to explore how different entities and influencers in drug development and healthcare can realign incentive structures to efficiently accelerate evidence generation that addresses the highest public health needs.

Which Chemotherapy-Related Terms were Difficult for Cancer Patients, and Who Would Have the Most Difficulties?

Purpose: This cross-sectional study aimed to examine which chemotherapy (CTx) terms were most difficult to understand for cancer patients and identify vulnerable patient populations who might need extra support to understand the terms.

Materials And Methods: We listed 56 CTx-related terms based on the experts' review, then 300 cancer patients and their caregivers completed a questionnaire that assessed literacy in CTx terms (LCT), functional health literacy, and empowerment. Descriptive analysis was performed to examine which CTx-related terms were most difficult for them.

The factor structure of the Patient Health Questionnaire-9 in stroke: A comparison with a non-stroke population.

Background: It is unclear if certain post-stroke somatic symptoms load onto items of the Patient Health Questionnaire-9 (PHQ-9), a self-report depression questionnaire. We investigated these concerns in a stroke sample using factor analysis, benchmarked against a non-stroke comparison group.

Methods: The secondary dataset constituted 787 stroke and 12,016 non-stroke participants.

Patient-reported outcomes in early phase trials for patients with myelodysplastic syndromes.

Patients with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) experience a wide range of symptoms due both to their underlying disease and the effects of treatment. Designing early phase trials to explore effective therapies in these patients should not only examine anti-tumor activity, but also consider the effects of treatments on how patients feel and function. Assessing symptomatic toxicities associated with new therapies in early phase trials from the patient perspective is best measured using patient-reported outcomes (PROs) and offers valuable insight and complementary information to the traditional adverse event reporting in cancer clinical trials.

Navigating the Path to Inclusion: Understanding Barriers and Facilitators to Clinical Trial Participation Among Chinese Older Adults in the United States with Multimorbidity.

Context: Older adults with multimorbidity are underrepresented in clinical trials, with enrollment of Asians particularly low.

Objective: Understand perspectives of US Chinese older adults regarding clinical trial participation.

Study Design And Analysis: Focus group interviews analyzed using thematic analysis.

Researcher and partner perspectives on the relationship between engagement in research and three uses of patient-centered comparative clinical effectiveness research study findings.

Background: The uptake of research findings into clinical practice is critical to providing health care that improves health outcomes for patients. This study explored how Patient-Centered Outcomes Research Institute (PCORI) awardees perceive the relationship between engagement of patients and other partners in research and three uses, or applications, of patient-centered comparative clinical effectiveness research (CER) study findings, which may lead to uptake in clinical practice: (1) Integration into clinical practice guidelines, recognized point-of-care decision tools, or documents that may inform policy; (2) Implementation beyond the study, including at sites outside of the study setting or patient populations; and (3) Active dissemination of findings to specific audiences by parties external to the study team.

Methods: This exploratory qualitative study examined awardee and partner perceptions of what led to each use of study findings and how engaged partners contributed.

Wearable Device-Based Intervention for Promoting Patient Physical Activity After Lung Cancer Surgery: A Nonrandomized Clinical Trial.

Importance: Emerging evidence suggests that wearable devices are feasible for monitoring physical activity among patients with lung cancer. However, the association between wearable devices and improvement in patient recovery after surgery remains underexplored.

Objective: To evaluate the effects of a wearable device intervention on the recovery of physical activity, cardiopulmonary function, and health-related quality of life (HRQOL) after lung cancer surgery.