Browsing by Author "Hess, Lisa M."

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    Community-Based Exercise Program Attendance and Exercise Self-Efficacy in African American Women
    (2014-01-29) Virgil, Kisha Marie; Mikesky, Alan E.; Keith, NiCole R.; De Groot, Mary K.; Hess, Lisa M.; Mushi-Brunt, Christina R.
    Rates of chronic disease and physical inactivity are disproportionately high among African American women. Despite the known benefits of physical activity and an increasing number of programs designed to increase activity, attendance rates to many exercise programs remain low. There is much to learn about program types, such as healthy lifestyle programs (HLP); individual factors, such as self-efficacy; and mediating variables that may influence exercise program attendance. An observational study design was used to compare exercise self-efficacy and attendance in a community-based exercise program in African American women who were enrolled in a HLP (N = 53) to women who were not (N = 27). Exercise program attendance was gathered across six months; demographics, self-efficacy and physical activity behaviors were assessed through surveys; and physiological variables (resting heart rate and blood pressure, height, and weight) and physical fitness (muscular strength and endurance and cardiovascular endurance) were measured at baseline. Descriptive statistics were used to describe participants and groups were compared using T-tests, chi-square and non-parametric statistics. Finally, mediation analyses were conducted using multiple regression models to assess self-efficacy as a potential mediator to exercise program attendance. Women who enrolled in this study were of low income (61% having an annual income less than $20,000), obese with a mean (standard deviation) body mass index (BMI) of 37.7 (7.6), pre-hypertensive with a mean (standard deviation) systolic blood pressure of 125.9 (14.4), and scored poorly and marginally on two fitness tests. On average, women reported being Moderately Confident in their ability to exercise regularly, yet had low attendance in the exercise program with a median number .5 days over six months and there were no significant differences in exercise self-efficacy (p = .23) or attendance in the exercise program between groups (p = .79). Additionally, exercise self-efficacy was not a mediating variable to program attendance. Women in this study had little discretionary income and several chronic disease risk factors, yet exercise program attendance was low even in those enrolled in a HLP. Identifying factors that increase exercise self-efficacy and factors that influence attendance beyond self-efficacy may help future program design and attendance.
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    Preference Elicitation Tool for Abnormal Uterine Bleeding Treatment: A Randomized Controlled Trial
    (Springer, 2015-04) Hess, Lisa M.; Litwiller, Abigail; Byron, John; Stutsman, John; Kasper, Kelly; Learman, Lee A.; Department of Epidemiology, Richard M. Fairbanks School of Public Health
    Background It is estimated that one-third of women will experience abnormal menstrual bleeding. The majority of these cases are not due to cancer or pregnancy complications and, as a result, women are faced with a variety of treatment alternatives, the selection of which is largely dependent on personal preferences for care rather than clinical outcomes. Objective This randomized trial was designed to evaluate a preference elicitation tool to promote physician–patient collaborative decision making for treatment of abnormal uterine bleeding (AUB). Methods Adaptive conjoint analysis (ACA) was used to create a preference elicitation tool in English and in Spanish. Women with AUB were enrolled to the study and randomly assigned to ACA or usual counseling at the initial clinic visit at four clinics (three in Indianapolis, IN, USA, and one in Southern Pines, NC, USA). The ACA tool elicited preferences across eight attributes: treatment efficacy; sexual function; medical care; cost; fertility; frequency of medication use; permanence; and recovery time. t tests were used to compare differences in the primary outcomes of decision regret and treatment satisfaction at the follow-up visit. The study was designed to have 80 % power to detect significant differences between groups for the primary outcomes of regret and satisfaction. Results Women were enrolled in the study between September 2009 and March 2012. 183 participants were randomized to ACA and 191 to usual counseling. Overall, mean (standard deviation) treatment satisfaction was high at 35.71 (9.72) (scale of 0–44), and decision regret was low at 25.9 (21.0) (scale of 0–100), creating ceiling effects for the selected outcome variables; there were no significant differences between the ACA and control groups at the follow-up assessment. There was a strong inverse relationship between age and decision regret (p = 0.007). Exploratory subgroup analysis in the youngest quartile comprising 64 women aged 19–35 years showed a statistically non-significant difference in mean regret scores for the ACA group versus usual counseling (24.6 vs. 34.6, respectively; p = 0.08). Conclusions A preference elicitation tool at the initial consultation visit did not reduce decision regret or improve treatment satisfaction among patients with AUB; however, there is a need for additional research to further understand this tool’s potential role in promoting collaborative decision making, which may be particularly important among younger women.
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    Regulatory Acceptable Real-World Effectiveness Endpoints: How Clarity Can Best be Achieved in the United States
    (2023-12) Beyrer, Julie; Hess, Lisa M.; Nan, Hongmei; Lederer, Nirosha M.
    Background: The therapies many patients need do not exist today. Real-world evidence (RWE) can accelerate patient access to treatment. However, lack of clarity on regulatory acceptable realworld effectiveness endpoints can result in delayed or lost new therapy opportunities to bring new treatments to patients. Research question: How can clarity on regulatory acceptable real-world effectiveness endpoints in the United States best be achieved? Methods: A qualitative research study was conducted by interviewing expert informants from diverse stakeholder types to explore their perceptions of gaps, solutions, action needed, and determinants for achieving clarity. Themes were derived using an inductive coding approach, followed by an appraisal of the potential macro-level solutions using Bardach's criteria for policy analysis. Results: Four macro-level solutions were identified: Food and Drug Administration (FDA) Advancing RWE Program, FDA report or dashboard for stakeholders to more easily locate FDA reviews and decisions about RWE, a tool to help stakeholders apply existing related FDA guidance, and FDA guidance on real-world effectiveness endpoints. Plan for Change: Recommended actions for implementing the four solutions and potential evaluation measures were derived from interview themes and Expert Recommendations for Implementing Change. Of the four solutions, an immediate opportunity that FDA and non-FDA stakeholders could initiate is a tool to help stakeholders apply existing FDA guidance, precedent, and endpoint validation principles from the scientific literature. Conclusion: Two solutions are already in progress to increase stakeholders experiences with RWE for regulatory decision making (e.g., FDA Advancing RWE Program and FDA report on RWE submitted for regulatory review). Parallel implementation of other solutions is likely needed (e.g., developing a tool to help stakeholders navigate the existing guidance and precedents on real-world effectiveness endpoints), with regulatory guidance on real-world effectiveness endpoints to follow. Good engagement and transparency across the stakeholder communities are essential to make the most meaningful impact.
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    Utilization Patterns of Lymph Node Dissection in Endometrial Cancer Patients Without Distant Metastasis in the United States
    (2021-06) Alyea, Jennifer Marie; Dixon, Brian E.; Song, Yiqing; Zhang, Jianjun; Hess, Lisa M.; Method, Michael W.
    Endometrial cancer is the most common gynecologic cancer in the United States, and patients with early-stage endometrioid adenocarcinoma have a favorable prognosis. Over the past decade, the gynecologic oncology community has debated whether potential harms of systematic lymph node dissection (LND) outweigh potential benefits for these patients. To minimize number of nodes removed, sentinel lymph node dissection (SLND) is under investigation as an alternative. However, ongoing uncertainty of LND/SLND best practices may result in variations in disease management and discrepant outcomes. Methods Three retrospective cohort studies examined LND/SLND use in patients with endometrioid adenocarcinoma. Two examined temporal and geographic variations, respectively, utilizing the Surveillance, Epidemiology, and End Results (SEER) 18 dataset for the years 2004 through 2015. The third used the SEER-Medicare dataset from 2003 through 2016 to quantify and compare the risk of developing 6-month post-surgical lymphedema, lymphocele, hemorrhage, ileus, infection, thrombosis, and all-cause death by number of lymph nodes removed (0, 1-4, 5-9, or 10+). Results Time trend analyses found LND increased from 2004 through 2008, followed by a significant decline through 2015. SLND was rare and did not increase significantly. Significant geographic variation existed for LND use but not SLND. Per 1,000 patients, analyses of 6-month post-surgical complications found 6.5 experienced lymphedema, 3.9 experienced lymphocele, 15.7 experienced hemorrhage, 28.7 experienced ileus, 37.1 experienced infection, 18.6 experienced thrombosis, and 19.8 died. Controlling for size of primary tumor, tumor grade, comorbidities, race/ethnicity, age at diagnosis, adjuvant chemotherapy, and radiotherapy, adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) showed greater risk for ileus (HR: 1.53; 95% CI: 1.24-1.90), infection (HR: 1.52; 95% CI: 1.25-1.83), and thrombosis (HR: 1.41; 95% CI: 1.09-1.82) when comparing removal of 10+ nodes versus 0 nodes. Conclusion Overall, these studies found significant temporal and geographic variation in LND, as well as increasing risk of post-surgical complications associated with increasing numbers of lymph nodes removed. Should continued research into SLND find strong evidence that it effectively detects cancer spread, patients may benefit through decreased risk of post-surgical ileus, infection, and thrombosis.