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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Impact of elections on health care.  “This is our COVID” Are patient satisfaction scores harming patients and physicians? The cost of satisfaction. Proposal for a healthcare minimum wage. Crypto news: Don’t regulate crypto. SBF interview.

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…

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Costs and benefits of advance preparations for future pandemics. ISPOR Europe Round-ups: Day 1, 2 and 3 Impending intergenerational crisis. Limited COVID-19 vaccine externalities? Free insulin (not real) Puerto Rico’s health success in the mid-20th century.

Real-World Patient-Centered Research: Is It Possible Across Countries

That was the title of the second plenary at ISPOR Europe this year. One interesting slide from Nancy Devlin who outlined how different countries used different patient-reported outcome measures (PROMs). English NHS PROMs programme. Variation in provider performance linked to reimbursement UK Private Healthcare Information Network (PHIN). Part of an initiative to improve patient choice…