Diane Marie St. George

Research expectations among African American church leaders in the PRAISE! project: A randomized trial guided by community-based participatory research

OBJECTIVES This study sought to examine the expectations and satisfaction of pastors and lay leaders regarding a research partnership in a randomized trial guided by community-based participatory research (CBPR) methods. METHODS Telephone and self-administered print surveys were administered to 78 pastors and lay leaders. In-depth interviews were conducted with 4 pastors after study completion. RESULTS The combined survey response rate was 65%. Research expectations included honest and frequent communication, sensitivity to the church environment, interaction as partners, and results provided to the churches. Satisfaction with the research partnership was high, but so was concern about the need for all research teams to establish trust with church partners. CONCLUSIONS Pastors and lay leaders have high expectations regarding university obligations in research partnerships. An intervention study based on CBPR methods was able to meet most of these expectations.

Trust, Benefit, Satisfaction, and Burden: A Randomized Controlled Trial to Reduce Cancer Risk Through African- American Churches

BACKGROUND: Community-based participatory research (CBPR) approaches that actively engage communities in a study are assumed to lead to relevant findings, trusting relationships, and greater satisfaction with the research process.OBJECTIVE: To examine community members’ perceptions of trust, benefit, satisfaction, and burden associated with their participation.DESIGN, SETTING, AND PARTICIPANTS: A randomized controlled trial tested a cancer prevention intervention in members of African-American churches. Data were collected at baseline and 1-year follow-up.MEASUREMENTS: Subscales measured perception of trust in the research project and the project team, benefit from involvement with the project, satisfaction with the project and the team, and perception of burden associated with participation.MAIN RESULTS: Overall, we found high levels of trust, perceived benefit, and satisfaction, and low perceived burden among community members in Partnership to Reach African Americans to Increase Smart Eating. In bivariate analyses, participants in the intervention group reported more perceived benefit and trust (P<.05). Participants in smaller churches reported more benefit, satisfaction and trust, while participants from churches without recent health activities perceived greater benefit, greater satisfaction, and lower burden with the project and the team (P<.05). Participants whose pastors had less educational attainment noted higher benefit and satisfaction; those whose pastors were making personal lifestyle changes noted higher benefit and satisfaction, but also reported higher burden (P<.05).CONCLUSIONS: A randomized clinical trial designed with a CBPR approach was associated with high levels of trust and a perceived benefit of satisfaction with the research process. Understanding variations in responses to a research partnership will be helpful in guiding the design and implementation of future CBPR efforts.

Adequacy of reporting race/ethnicity in clinical trials in areas of health disparities

Although federal initiatives have mandated broader inclusion of minorities in clinical research on diseases that have disparities in health by race and ethnicity, it is not clear whether these initiatives have affected reporting of trial results. The objective of this study was to examine the reporting of race/ethnicity in clinical trials reports in areas of known disparities in health (i.e., diabetes, cardiovascular disease, HIV/AIDS, and cancer) and to determine what factors were associated with reporting of race/ethnicity in results. We performed a Medline search covering the period January 1989 to Oct 2000 to identify clinical trials of diabetes, cardiovascular disease, HIV/AIDS, and cancer published in the Annals of Internal Medicine, JAMA, and New England Journal of Medicine. The main outcome measure was the reporting of participation and of results by race/ethnicity of trial participants. Of 253 eligible trials, 40% (n=102) were non race-focused yet did not report race, while 2% (n=4) were non gender-focused and did not report gender. Forty-six percent of trials that reported the race/ethnicity of the sample reported only one or two racial/ethnic categories, and in 43% of these trials the total number of individuals reported in each race/ethnicity category did not equal the total reported sample size. Analysis of results by race/ethnicity was reported in only two trials, and by gender in only three trials. In diseases with known racial and ethnic disparities, many clinical trials do not report the race/ethnicity of the study participants, and almost none report analyses by race/ethnicity. Although federal initiatives mandate inclusion of minority groups in research, that inclusion has not translated to reporting of results that might guide therapeutic decisions.

Pesticides, Gene Polymorphisms, and Bladder Cancer Among Egyptian Agricultural Workers

This study examined the associations between pesticide exposure, genetic polymorphisms for NAD(P)H:quinone oxidoreductase I (NQO1) and superoxide dismutase 2 (SOD2), and urinary bladder cancer risk among male agricultural workers in Egypt. Logistic regression was used to analyze data from a multicenter case-control study and estimate adjusted odds ratio (OR) and 95% confidence interval (CI). Exposure to pesticides was associated with increased bladder cancer risk (odds ratio (95% confidence interval): 1.68 (1.23–2.29)) in a dose-dependent manner. The association was slightly stronger for urothelial (1.79 (1.25–2.56)) than for squamous cell (1.55 (1.03–2.31)), and among participants with combined genotypes for low NQO1 and high SOD2 (2.14 (1.19–3.85)) activities as compared with those with high NQO1 and low SOD2 genotypes (1.53 (0.73–3.25)). In conclusion, among male agricultural workers in Egypt, pesticide exposure is associated with bladder cancer risk and possibly modulated by genetic polymorphism.

Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014

We ascertained a comprehensive list of postmarket safety outcomes, defined as a safety‐related market withdrawal or an update to a safety‐related section of product label for 278 new molecular entity drugs (NMEs) with a follow‐up period of up to 13 years. At least one safety‐related update was added to 195 (70.1%) labels of the drugs studied. Updates occurred as early as 160 days after approval and throughout the follow‐up period. The period between the second and eighth postapproval year was the most active, with a slight attenuation thereafter. The times to the first safety outcome were significantly shorter for NMEs approved with a fast‐track designation (P = 0.02) or under an accelerated approval using a surrogate endpoint (P = 0.03). Our findings underscore the importance of a robust safety surveillance system throughout a drugs lifecycle and for practitioners and patients to remain updated on drug safety profiles.

Nonoccupational exposure to agricultural work and risk of urinary bladder cancer among Egyptian women.

ABSTRACT This study examined the associations between nonoccupational exposure to agricultural work, through husband or head of household (H/HH) occupation, and urinary bladder cancer risk among Egyptian women. A total of 1,167 women (388 bladder cases and 779 age- and residence-matched, population-based controls) from a multicenter case-control study were included in the analysis. Adjusted odds ratios (AORs) and 95% confidence intervals (CIs) were estimated using logistic regression. Among married women, those who reported H/HH to be an agricultural worker were at increased risk for bladder cancer as compared to those with H/HH in other occupations, AOR = 1.54, 95% CI [1.09, 2.18]; among unmarried women the risk was not increased, AOR = 0.77, 95% CI [0.45, 1.32]. Nonoccupational exposure to agricultural work, defined as living with an agricultural worker, increased the risk for bladder cancer among married Egyptian women.