Unbiased Analysis of Today's Healthcare Issues
Let’s say you are interested in measuring the relationship between type 2 diabetes mellitus (T2DM) and depression. In many cases, one would use electronic health records data and conduct a logistic regression with depression as the dependent variable and T2DM (potentially along with demographics and other comorbidities) as the independent variables. However, the use of…
Clinical trials have detailed study protocols and are registered on ClinicalTrials.gov. What level of details are needed for real-world data (RWD) analyses that aim to estimate treatment effects? In Europe, the European Medicines Agency (EMA) requires registration of many study protocols using a template for observational post-authorization safety studies (PASS) conducted by marketing authorization holders.…
Real-world data is becoming increasingly important as the amount of data generation increases as does the speed of data processing. In the US, the 21st Century Cures Act was enacted in December 2016 and mandated that the Food and Drug Administration (FDA) create a framework for evaluating the use of real-world data help support the…
…well, at least fewer people are dying from natural disasters. This is from a recent New York Times article.
One of President Biden’s top priorities is reducing health disparities. In fact, President Biden created a Health Equity Task Force to address the issue; the Centers for Medicare and Medicaid Services (CMS) have created their own Framework for Health Equity 2022–2032. The 5 priories in this CMS Framework are: Expand the collection, reporting, and analysis…
What types of data capacity does the National Academies believe are needed to improve patient-centered outcomes research (PCOR), particularly with respect to health disparities. A report out this month (highlights) highlights some of the data capacity needs and also describes how U.S. Department of Health and Human Services (HHS)’s Office of the Assistant Secretary for…
In order for health care providers to be reimbursed for the services they provide, they need to input a variety of information into health insurance claims systems including what type of services were performed. The codes used to define the services provided are Current Procedural Terminology (CPT) or Healthcare Common Procedure Coding System (HCPCS) codes.…
Real-world evidence is often used to assess the safety of devices and diagnostics. For instance, the FDA’s , Postmarketing Surveillance Program includes the FDA Adverse Event Reporting System (FAERS); FDA may also require some MedTech companies to conduct Post-Approval Studies. However, as new legislation (e.g., 21st Century Cures Act) has passed and new technology has…
How do you evaluate treatment efficacy and safety outside of the clinical trial setting? This is not just a question of academic interest. In last week’s JAMA, Rubin 2021 writes about some of the challenges of evaluating COVID-19 vaccines outside of a clinical trial setting. In an interesting, two-day workshop last week, the Duke Margolis…
Poor, elderly individuals who may qualify for both Medicaid (for being poor) and Medicare (for being elderly, blind, disabled or have ESRD). In these cases, Medicaid serves as a supplemental insurer, covering Medicare coinsurance and deductibles. The generosity of this supplemental coverage for so-called ‘dual-eligibles’ varies across states. These differences in Medicaid payments arise from…