Research Spotlight

Kitzman, H., Mamun, A., Dodgen, L., Slater, D., King, G., King, A., Slater, J.L. and DeHaven, M. (2020). “Better Me Within Randomized Trial: Faith-Based Diabetes Prevention Program for Weight Loss in African American Women.” Am J Health Promot Sep 18;890117120958545. [Epub ahead of print.]. 890117120958545.

Full text of this article.

PURPOSE: Previous DPP translations in African American women have been suboptimal. This trial evaluated a community-based participatory research developed faith-based diabetes prevention program (DPP) to improve weight loss in African American women. DESIGN: This cluster randomized trial allocated churches to faith-based (FDPP) or standard (SDPP) DPP interventions. Setting. African American churches. Subjects. Eleven churches with 221 African American women (aged 48.8 ± 11.2 years, BMI = 36.7 ± 8.4) received the FDPP (n = 6) or SDPP (n = 5) intervention. INTERVENTION: FDPP incorporated 5 faith-based components, including pastor involvement, into the standard DPP curriculum. The SDPP used the standard DPP curriculum. Lay health leaders facilitated interventions at church sites. MEASURES: Weight and biometrics were collected by blinded staff at baseline, 4- and 10-months. ANALYSIS: A multilevel hierarchical regression model compared the FDPP and SDPP groups on outcomes. RESULTS: FDPP and SDPP churches significantly lost weight at 10-months (overall -2.6%, p < .01). Women in FDPP churches who attended at least 15 sessions lost an additional 6.1 pounds at 4-months compared to SDPP corresponding to a 5.8% reduction at 10-months (p < .05). Both groups had significant improvements in health behaviors and biometrics. CONCLUSIONS: Faith-based and standard DPP interventions led by lay health leaders successfully improved weight, health behaviors, and chronic disease risk. However, the faith-based DPP when fully implemented met the CDC's recommendation for weight loss for diabetes prevention in African American women.

DeHaven, M.J., Gimpel, N.A., Gutierrez, D., Kitzman-Carmichael, H. and Revens, K. (2020). “Designing health care: A community health science solution for reducing health disparities by integrating social determinants and the effects of place.” J Eval Clin Pract 26(5): 1564-1572.

Full text of this article.

BACKGROUND: In the United States chronic illnesses have become a way of life for multiple generations – they are the number one cause of death and disability (accounting for more than 70% of deaths), 60% of American adults have at least one chronic disease, and 40% have multiple chronic conditions. Although multiple factors contribute to the growth in chronic disease prevalence, a major factor has been overreliance on health care systems for promoting health and preventing disease. Large health care systems are ill equipped for this role since they are designed to detect, treat, and manage disease, not to promote health or address the underlying causes of disease. METHODS: Improving health outcomes in the U.S. will require implementing broad-based prevention strategies combining biological, behavioral, and societal variables that move beyond clinical care. According to community medicine, clinical care alone cannot create, support, or maintain health. Rather, health can only ensue from combining clinical care with epidemiology and community organization, because health is a social outcome resulting from a combination of clinical science, collective responsibility, and informed social action. RESULTS: During the past 20 years, our team has developed an operational community medicine approach known as community health science. Our model provides a simple framework for integrating clinical care, population health, and community organization, using community-based participatory research (CBPR) practices for developing place-based initiatives. In the present paper, we present a brief overview of the model and describe its evolution, applications, and outcomes in two major urban environments. CONCLUSION: The paper demonstrates means for integrating the social determinants of health into collaborative place-based approaches, for aligning community assets and reducing health disparities. It concludes by discussing how asset-based community development can promote social connectivity and improve health, and how our approach reflects the emerging national consensus on the importance of place-based population system change

Wilkoff, B.L., Boriani, G., Mittal, S., Poole, J.E., Kennergren, C., Corey, G.R., Krahn, A.D., Schloss, E.J., Gallastegui, J.L., Pickett, R.A., Evonich, R.F., Roark, S.F., Sorrentino, D.M., Sholevar, D.P., Cronin, E.M., Berman, B.J., Riggio, D.W., Khan, H.K., Silver, M.T., Collier, J., Eldadah, Z., Holbrook, R., Lande, J.D., Lexcen, D.R., Seshadri, S. and Tarakji, K.G. (2020). “Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial.” Circ Arrhythm Electrophysiol 13(10): e008503. /p>

Full text of this article.

BACKGROUND: In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system. METHODS: A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years were discounted at 3%. An upper willingness-to-pay threshold of $150 000 per quality-adjusted life year was used to determine cost-effectiveness, in alignment with the American College of Cardiology/American Heart Association practice guidelines and as supported by the World Health Organization and contemporary literature. RESULTS: The base case incremental cost-effectiveness ratio of the antibacterial envelope compared with standard-of-care was $112 603/quality-adjusted life year. The incremental cost-effectiveness ratio remained lower than the willingness-to-pay threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost. CONCLUSIONS: The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02277990.

Abraham, P., Wang, L., Jiang, Z., Gricar, J., Tan, H. and Kelly, R.J. (2020). “Healthcare utilization and total costs of care among patients with advanced metastatic gastric and esophageal cancer.” Future Oncol Sep 30. [Epub ahead of print.].

Full text of this article.

Aim: Study first-line (1L) treatment patterns and economic outcomes among patients with advanced metastatic gastric cancer (GC) and esophageal cancer (EC). Materials & methods: Newly diagnosed patients with systemic GC and EC treatments were identified between 1 January 2011 and 31 July 2017; costs were presented as per patient per month (PPPM) basis. Results: Study included 392 GC and 436 EC patients. Most frequently used 1L regimens were: 5-fluorouracil (5-FU) + oxaliplatin (22.5%) and epirubicin + cisplatin + 5-FU (ECF)/ECF modifications (21.9%) in patients with GC; and carboplatin + paclitaxel (29.6%) and 5-FU + oxaliplatin (11.5%) in EC patients. Mean all-cause costs were US$16,242 PPPM for GC, and $18,384 PPPM for EC during 1L treatment. Conclusion: GC and EC were resource intensive and costly. High costs and short treatment durations underscored a gap in care in 1L treatment.

Pal, S.K., Escudier, B.J., Atkins, M.B., Hutson, T.E., Porta, C., Verzoni, E., Needle, M.N., Powers, D., McDermott, D.F. and Rini, B.I. (2020). “Final Overall Survival Results from a Phase 3 Study to Compare Tivozanib to Sorafenib as Third- or Fourth-line Therapy in Subjects with Metastatic Renal Cell Carcinoma.” Eur Urol Sep 13;S0302-2838(20)30624-2. [Epub ahead of print.].

Full text of this article.

Tivozanib is a potent and selective inhibitor of the VEGF receptor. In an open-label, randomized phase 3 trial, we compared tivozanib to sorafenib in patients with metastatic renal cell carcinoma (mRCC) who had received two or three prior therapies. We have previously reported that the study met its primary endpoint, demonstrating an improvement in progression-free survival with tivozanib versus sorafenib (5.6 mo vs 3.9 mo; hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.56-0.94; p=0.016). The current report reflects the final assessment of overall survival, showing no difference between treatment with tivozanib and sorafenib (HR 0.97, 95% CI 0.75-1.24). Given its activity and distinct tolerability profile, tivozanib represents a treatment option for patients with previously treated mRCC. PATIENT SUMMARY: We show that tivozanib, a targeted therapy, can delay tumor growth relative to an already approved targeted therapy (sorafenib) in patients with kidney cancer who have received two or three prior treatments. No difference in survival was observed.