Using a population-based observational cohort study to address difficult comparative effectiveness research questions: the CEASAR study

Abstract

Background While randomized controlled trials represent the highest level of evidence we can generate in comparative effectiveness research, there are clinical scenarios where this type of study design is not feasible. The Comparative Effectiveness Analyses of Surgery and Radiation in localized prostate cancer (CEASAR) study is an observational study designed to compare the effectiveness and harms of different treatments for localized prostate cancer, a clinical scenario in which randomized controlled trials have been difficult to execute and, when completed, have been difficult to generalize to the population at large. Methods CEASAR employs a population-based, prospective cohort study design, using tumor registries as cohort inception tools. The primary outcome is quality of life after treatment, measured by validated instruments. Risk adjustment is facilitated by capture of traditional and nontraditional confounders before treatment and by propensity score analysis. Results We have accrued a diverse, representative cohort of 3691 men in the USA with clinically localized prostate cancer. Half of the men invited to participate enrolled, and 86% of patients who enrolled have completed the 6-month survey. Conclusion Challenging comparative effectiveness research questions can be addressed using well-designed observational studies. The CEASAR study provides an opportunity to determine what treatments work best, for which patients, and in whose hands.

Self-Reported Health Status Predicts Other-Cause Mortality in Men with Localized Prostate Cancer: Results from the Prostate Cancer Outcomes Study

“…The nomogram should eventually be evaluated in more recently assembled cohorts collecting health status data, such as the Comparative Effectiveness of Surgery and Radiation in localized prostate cancer (CEASAR) study. 40 Nevertheless, the nomogram can provide men with a gist understanding of their risk for non-cancer death. 41 Older men with localized prostate cancer who self-report fair or poor health have substantial risks for other-cause deaths and are unlikely to survive long enough to benefit from aggressive treatment.…”

Prostate Cancer Registries: Current Status and Future Directions

“…Such studies are usually characterized by lower costs, higher patient numbers, more rapid accrual, and consequently a shorter time for identification and dissemination of results [15,16]. However, despite statistical controls, selection bias may affect results from single-and multi-institutional series [16,17].…”

“…PCa registries provide such an alternative. The democratization of patient management to a larger or general population creates a more generalizable pool for analysis and subsequent conclusions [3,4,15].…”

“…Certain disease-specific registries contain data on all the patients diagnosed with PCa in a given geographic area and thus are tantamount to population-based cohorts [15].…”

“…More recently, the Comparative Effectiveness Analysis of Surgery and Radiation (CAESAR) study established a prospective population-based cohort of patients with newly diagnosed, clinically localized PCa [15]. The CAESAR cohort includes patients diagnosed in five SEER registries, as well as those included in the CaPSURE program during 2011-2012.…”