Evaluation of a civic engagement approach to catalyze built environment change and promote healthy eating and physical activity among rural residents: a cluster (community) randomized controlled trial.

BACKGROUND: Prior studies demonstrate associations between risk factors for obesity and related chronic diseases (e.g., cardiovascular disease) and features of the built environment. This is particularly true for rural populations, who have higher rates of obesity, cancer, and other chronic diseases than urban residents. There is also evidence linking health behaviors and outcomes to social factors such as social support, opposition, and norms. Thus, overlapping social networks that have a high degree of social capital and community cohesion, such as those found in rural communities, may be effective targets for introducing and maintaining healthy behaviors. METHODS: This study will evaluate the effectiveness of the Change Club (CC) intervention, a civic engagement intervention for built environment change to improve health behaviors and outcomes for residents of rural communities. The CC intervention provides small groups of community residents (approximately 10-14 people) with nutrition and physical activity lessons and stepwise built environment change planning workshops delivered by trained extension educators via in-person, virtual, or hybrid methods. We will conduct process, multilevel outcome, and cost evaluations of implementation of the CC intervention in a cluster randomized controlled trial in 10 communities across two states using a two-arm parallel design. Change in the primary outcome, American Heart Association's Life's Simple 7 composite cardiovascular health score, will be evaluated among CC members, their friends and family members, and other community residents and compared to comparable samples in control communities. We will also evaluate changes at the social/collective level (e.g., social cohesion, social trust) and examine costs as well as barriers and facilitators to implementation. DISCUSSION: Our central hypothesis is the CC intervention will improve health behaviors and outcomes among engaged citizens and their family and friends within 24 months. Furthermore, we hypothesize that positive changes will catalyze critical steps in the pathway to improving longer-term health among community residents through improved healthy eating and physical activity opportunities. This study also represents a unique opportunity to evaluate process and cost-related data, which will provide key insights into the viability of this approach for widespread dissemination. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05002660 , Registered 12 August 2021.

Gender profile of principal investigators in a large academic clinical trials group.

Introduction: Gender equity in medicine has become a significant topic of discussion due to consistently low female representation in academia and leadership roles. Gender imbalance directly affects patient care. This study examined the gender and craft group of the Principal Investigators (PI) of clinical trials run by the Australasian Gastro-Intestinal Trials Group (AGITG). Methods: Publicly available data was obtained from the AGITG website. Trials were divided into upper, lower gastrointestinal cancer, miscellaneous (neuroendocrine and gastrointestinal stromal tumours). Where multiple PIs were listed, all were counted. Craft group was assigned as surgical, medical, radiation oncology or other. Results: There were 69 trials with 89 PI, where 52 trials were represented exclusively by male PIs. Of all PIs, 18 were women (20.2%); all were medical oncologists. Prior to 2005, all PIs were male. The craft group distribution of PIs was: 79% medical oncologists, 12% surgical oncologists, 8% radiation oncologist, 1% nuclear medicine physicians. Regarding trials with multiple PI's, there were 19 in total. Of these, 11 had only male PIs, which included 5 surgeons. Females were more likely to be a co-PI (42%) as opposed to sole PI (18%). There was no gender policy publicly available on the AGITG website. Conclusions: There is a low percentage of female PIs in academic oncology trials in the portfolio of this large international trials group. No trial was led by a female surgical or radiation oncologist. There is a need to understand the reasons driving the disparity so that specific strategies can be put in place.

Hypertensive/Microvascular Disease and COPD: a Case Control Study.

BACKGROUND/AIMS: This study tested the hypothesis that individuals with chronic obstructive pulmonary disease (COPD) have more small vessel disease and more severe disease than an age- and gender- matched hospital patient comparison group. METHODS: This was a single centre, case-control study of 151 individuals with COPD (FEV1/VC) < 0.7 recruited consecutively immediately after respiratory function tests at a Melbourne teaching hospital over a 4 month period in 2010. Controls were individuals with normal respiratory function tests recruited contemporaneously from the same centre. Retinal images were obtained with a nonmydriatic camera (KOWA or Canon CR5-45NM), deidentiifed and graded by two trained graders for microvascular retinopathy (Wong and Mitchell classification), and vessel calibre using a computer-assisted method and Knudtson's modification of the Parr-Hubbard formula. Differences in microvascular retinopathy and vessel calibre between COPD patients and the comparison group were examined using Fisher's exact test or the t test (StataCorp, Texas). RESULTS: Patients with COPD had more microvascular retinopathy (121, 80% and 76, 50%; OR 3.98, 95%CI 2.39 to 6.64) and more severe disease (42, 28% and 18, 12%; OR 2.85, 95% CI 1.55 to 5.23) than other hospital patients. COPD remained an independent determinant of microvascular retinopathy (OR 4.56, 95%CI 2.49 to 8.36) after adjusting for gender, hypertension, smoking, and diabetes duration. Retinal arterioles and venules were wider in patients with COPD than other hospital patients (mean difference +6.5 µm, 95% confidence interval 1.4 to 11.6; and +17.4 µm, 95%CI 9.4 to 25.5, respectively). Larger venules were more common in younger individuals (+0.6 µm, 0.1 to 1.17) with more cigarette exposure (+0.3 µm, 0.2 to 0.5) or a lower serum albumin (+23.0 µm, 6.0 to 40.0). Venular calibre was not different in current and former smokers (p=0.77). There were trends for venules to be larger with more severe COPD (lower FEV1/VC, p=0.09) and with CT-demonstrated emphysema (p=0.06). CONCLUSIONS: Hypertensive/microvascular disease is more common and more severe in patients with COPD. This is likely to contribute to the associated increase in cardiac risk.

Patient navigation moderates emotion and information demands of cancer treatment: a qualitative analysis.

PURPOSE: Patient navigation is increasingly employed to guide patients through cancer treatment. We assessed the elements of navigation that promoted patients' involvement in treatment among patients with breast and colorectal cancer that participated in a navigation study. METHODS: We conducted qualitative analysis of 28 audiotaped and transcribed semi-structured interviews of navigated and unnavigated cancer patients. RESULTS: Themes included feeling emotionally and cognitively overwhelmed and desire for a strong patient-navigator partnership. Both participants who were navigated and those who were not felt that navigation did or could help address their emotional, informational, and communicational needs. The benefits of logistical support were cited less often. CONCLUSIONS: Findings underscore the salience of personal relationships between patients and navigators in meeting patients' emotional and informational needs.