Distributional Cost Effectiveness Analysis: A simple example

I have written previously about the need for distributional cost-effectiveness analysis (DCEA) which would increase the value of treatments who improve the health for individuals who currently have the worst expected quality-adjusted life expectancy (QALE). I’ve written about this in AJMC and Health Affairs among other places. One key question many individuals may have is…

Should you adjust for covariates when analyzing data from randomized controlled trials?

FDA draft guidance published this month says you should. In most cases, adjusting for covariates is not necessary. Randomization generally insurers that covariates are balanced across clinical trial arms. Randomization, however, may not always result in perfectly balanced trial arms. In these cases, the FDA notes that covariate adjustment is perfectly acceptable. There are some…

What is immortal time bias?

A recent JAMA paper by Yadav and Lewis (2021) provide the answer: Bias from immortal time periods is the error in estimating the association between the exposure and the outcome that results from misclassification or exclusion of time intervals Yadav and Lewis (2021) Sounds simple but how do these errors occur in practice? Here are…

Did your real-world study follow STROBE guidelines?

Is your observational research study following best practices? Is your methodology transparent? To help answer these questions, the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network created the STROBE guidelines. The STROBE guidelines–an acronym for The Strengthening the Reporting of Observational Studies in Epidemiology–aim to improve the transparency of the methods behind observational…

When (and how) to use population-adjusted indirect comparisons?

Population-adjusted indirect comparisons (PAICs) include both matching-adjusted indirect comparisons (MAICs) and Simulated treatment comparisons (STCs). The key data requirement for these methods is that they have individual patient data (IPD) from at least one clinical trial. This means the methods are most useful for studied funded by the clinical trial sponsor or when IPD clinical…