Unbiased Analysis of Today's Healthcare Issues
A paper by Ng, Zhang and Kowal (2025) use the American Community Survey (ACS) data from 2016–2022 were used to construct Social Vulnerability Index (SVI). SVI is calculated from 16 social determinants of health (SDoH) variables that are grouped into 4 themes: socioeconomic status, household characteristics, racial and ethnic minority status, and housing type &…
Many researchers are interested in how cost sharing impacts health care utilization, cost and patient outcomes. This is especially true as high-deductible health plans (HDHP) have become more common in the US. In 2023, 29% of covered workers in the US had a HDHP. One helpful type of data for analyzing HDHPs is claims data.…
The Biden Administration promised more access to Medicare data. Then the reverse happened. ProPublica explains: In January, the Biden administration pledged to increase public access to a wide array of Medicare information to improve health care for America’s most sick and vulnerable. Some Medicare plans’ lack of transparency “deprives researchers and doctors of critical data…
That is the question posed by a paper by Wang, Sreedhara and Schneeweiss (2022). The authors replicate the findings from n=250 real-world data studies. The studies were replicated using 3 datasets: (i) Optum Clinformatics claims data, (ii) IBM MarketScan Research Database claims data, Medicare fee-for-service claims data, and (iii) CPRD electronic health records. Key paper…
Last month, FDA released guidance on the use of real-world evidence to support regulatory decision-making for new drugs. Below are some of the key points from this guidance document: Legislative mandate. The 21st Century Cures Act (Cures Act), signed December 2016, mandated that the FDA consider how to incorporate real world data (RWD) into regulator…
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…