Should you adjust for baseline characteristics within randomized controlled trials?

At first glance, one may think the answer is no. Randomization should insure that baseline characteristics are balanced across trial arms. In practice, however, sometimes baseline characteristics due differ somewhat by trial arm simply by chance, especially in smaller randomized controlled trials (RCTs). A JAMA Guide to Statistics and Methods by Holmberg et al. 2022…

HARmonized Protocol Template to Enhance Reproducibility (HARPER)

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.…

What is the Yost Index?

The Yost Index is a measure of socioeconomic status (SES) across geographic areas. The index was developed by Kathleen Yost and coauthors in their 2001 paper titled “Socioeconomic status and breast cancer incidence in California for different race/ethnic groups.” There are seven key inputs to creating the Yost index were calculated at the Census block…

Are health care prices falling?

It seems like everything just gets more and more expensive.  But are prices for medical care declining?  Cutler et al. (1998) found in seminal paper “Are medical prices declining? Evidence for heart attack treatments” that while unadjusted prices of medical care were in fact rising, quality-adjusted health care costs actually were falling.  In my own…