Exercising works

Not a surprise, but the study approach used by Kulaja et al. (2022) is interesting. They examine identical twins an examine how early adult exercise habits impact long term health outcomes. The abstract is below. …monozygotic (MZ) twin pairs discordant for health habits provide an interesting natural experiment. Twin pairs discordant for leisure‐time physical activity…

It gets better

Many studies (e.g., Okui 2020, Le Bon 2014, Blanchflower and Oswald 2009) have claimed that mental health exhibits a U shape where mental health decrease with a nadir at middle age and then increases as people grow into their elderly years. However, a recent study by Dijk and Mierau (2022) finds that mental health may…

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…

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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.…

Are Integrated Medicare Advantage Plans better?

That is the question Park, Langellier, and Meyers (2022) aim to estimate in their recent Health Services Research publication. The authors use 2015-2017 data from the Centers for Medicare and Medicaid services and control for other differences between integrated and non-integrated Medicare Advantage (MA) plans using state fixed effects and contract random effects. Using this…

What is DARWIN EU?

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…