Search

Background: Hot flashes are a common side effect of endocrine therapy (ET) that contribute to poor quality of life and decreased treatment adherence. Methods: Patients with breast cancer wo were receiving ET and experiencing hot flashes were enrolled through three parallel, randomized trials conducted in the United States, China, and South Korea. Participants were randomized to either immediate acupuncture (IA) or delayed acupuncture control (DAC). IA participants received 20 acupuncture sessions over 10 weeks, whereas DAC participants received usual care, then crossed over to acupuncture with a reduced intensity. The primary end point was a change in score on the endocrine symptom subscale of the Functional Assessment of Cancer Therapy (FACT)‐Endocrine Symptoms between baseline and week 10. Secondary end points included the hot flash score and the FACT‐Breast score. A planned pooled analysis of individual patient data was performed using longitudinal mixed models. Results: In total, 158 women with stage 0–III breast cancer were randomized (United States, n = 78; China, n = 40; South Korea, n = 40). At week 10, IA participants reported statistically significant improvements in the endocrine symptom subscale score (mean change ± standard error: 5.1 ± 0.9 vs. 0.2 ± 1.0; p =.0003), the hot flash score (−5.3 ± 0.9 vs. −1.4 ± 0.9; p <.003), and the FACT‐Breast total score (8.0 ± 1.6 vs. −0.01 ± 1.6; p =.0005) compared with DAC participants. The effect of the acupuncture intervention differed by site (p =.005). Conclusions: Acupuncture led to statistically and clinically meaningful improvements in hot flashes, endocrine symptoms, and breast cancer‐specific quality of life in women undergoing ET for breast cancer in the United States, China, and South Korea. In a pooled analysis of three parallel trials, acupuncture significantly reduced hot flashes and other endocrine symptoms in women with stage 0–III breast cancer undergoing endocrine therapy in the United States, China, and South Korea. In the women studied, acupuncture led to statistically and clinically meaningful improvements in hot flashes, endocrine symptoms, and breast cancer‐specific quality of life. [ABSTRACT FROM AUTHOR]

With scientific advances during the COVID-19 pandemic and expansion of artificial intelligence (AI) in research, there has been a simultaneous increase in misinformation about data collection, privacy, and sharing in clinical trials. This increase has been com-pounded by general mistrust in the clinical research industry partly because of problematic practices, such as data manipulation, withholding of safety information, and inaccurate or even non-existent results reporting. All these issues contribute to the public, patients, caregivers, and even healthcare professionals being inadequately informed about clinical research and related data usage. Through transparency, clarity, and honesty, trust can be rebuilt. Recognising the clinical research landscape has changed over the last decade and that currently available information is not developed or formatted in ways that can be easily understood, we describe creating widely accessible videos and infographics to support data literacy, utilising the most recent tools and technology for content development and dissemination. [ABSTRACT FROM AUTHOR]

With disparate rates of morbidity and mortality among minoritized communities, COVID-19 illuminated the need for equity-informed practices in public health. Pacia et al posit FQHCs as entities that addressed inequity when others failed. This commentary further situates how FQHCs address the public health crisis of institutional racism and related health inequities every day and presents a FQHC-led Ethics and Equity Framework and Workflow Checklist to guide ethical and equitable engagement with FQHCs. [ABSTRACT FROM AUTHOR]

Clear communication with the public and with potential clinical trial participants and their caregivers is foundational to the ethical tenets of respect, justice, and beneficence. However, health literacy, even of highly edu - cated individuals, often declines when pre - sented with complex content in unfamiliar contexts and in times of stress, all of which are characteristic of the types of situations people find themselves in when considering and participating in a research study. Here we describe an initiative to pilot the development of a cross-organisational plain language clinical research glossary to promote clarity, consistency, and transparency. The goal is to develop a common resource that can be used across clinical research stakeholder groups to increase understanding of clinical research and empower sound individual decision making. [ABSTRACT FROM AUTHOR]

Competing Interests: Conflict-of-Interest Disclosures: Laurie Myers is an employee and stock holder of Merck Sharp & Dohme Corporation, a subsidiary of Merck & Co. Christopher Trudeau reports grants and personal fees from UAMS Translational Research Institute. Trudeau also has various independent consulting relationships with IRBs from Tufts University and the University of North Texas Health Science Center. Trudeau also does consulting work with CISCRP (the Center for Information and Study on Clinical Research Participation). Finally, Trudeau is a special government consultant for the FDA’s Risk Communication Advisory Committee.