Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, vali...

BACKGROUND As the USA seeks to expand the conduct and dissemination of comparative effectiveness research (CER), views of key stakeholders will help guide the way. METHODS We surveyed 60 medical and pharmacy directors from 46 state Medicaid programs. RESULTS Over 90% felt that CER would lead to better clinical decision-making and overall value within 5 years and were willing to consider cos...

The Patient Protection and Affordable Care Act (PPACA), as amended by the Health Care and Education Reconciliation Act of 2010, initiated comprehensive health reform for the healthcare sector of the United States. PPACA includes strategies to make the American healthcare sector more efficient and effective. PPACA's comparative effectiveness research initiative and the establishment of the Patie...

BACKGROUND Comparative effectiveness research (CER) often includes observational studies utilizing administrative data. Multiple conditioning methods can be used for CER to adjust for group differences, including difference-in-differences (DiD) estimation. OBJECTIVE This study presents DiD and demonstrates how to apply this conditioning method to estimate treatment outcomes in the CER setting...

Recent calls for value in the US healthcare system have spurred an increase in comparative effectiveness research, which generates evidence on competing treatment options to inform healthcare stakeholders. As a large healthcare purchaser, the federal government has made several significant investments in comparative effectiveness research. Notably, in 2009 the American Recovery and Reinvestment...

The goal of comparative effectiveness research (CER) is to support evidence-based choices of treatments. Currently the majority of randomized trials for CER are designed to demonstrate superiority, which often require large sample size because the effect sizes between treatments in current use are typically small to moderate and there are usually more than two treatments to be compared. We prop...

Introduction Traumatic Brain Injury (TBI) research is evolving. The quest for level-1 evidence through randomised prospective interventional trials, while useful to establish safety and efficacy, is changing to an era of big data observational studies. Comparative Effectiveness Research (CER) utilises the observation of differences between treatments and centres without strict inclusion/exclusi...

BACKGROUND Randomized clinical trials, particularly for comparative effectiveness research (CER), are frequently criticized for being overly restrictive or untimely for health-care decision making. PURPOSE Our prospectively designed REsearch in ADAptive methods for Pragmatic Trials (RE-ADAPT) study is a 'proof of concept' to stimulate investment in Bayesian adaptive designs for future CER tri...

Comparative effectiveness research (CER) has received widespread attention and federal funding because of its potential to inform and improve treatment decisions. Since 2005, patients and their ophthalmologists have faced a dilemma in treating age-related macular degeneration (AMD)--the leading cause of blindness in the United States. Two closely related drugs have produced dramatic improvement...

Two key challenges related to conducting comparative effectiveness research are the lack of available data and the lack of rigorous techniques for efficiently and quickly testing the effectiveness of the many possible ways of implementing components of care. The confluence of two things offers the promise of overcoming these challenges: (1) the increased adoption of electronic health records (E...