CONTEXT: Very interesting peer reviewed paper looking at RWD in randomised trials | A huge amount of information to get your teeth into here, but the conclusions suggest RCT fans are  fighting back against the wave of RWE optimism | RCTs using routinely collected data versus those that don’t (i.e., more experiment [pure?]) show smaller treatment effects, which shouldn’t be surprising

IMPACT:  High

READ TIME:  2 or 3 days. This is a serious piece of research

Quality Level Mean [1 – 10]:  9! {we don’t give many of these}

1. “Eligibility criteria for study selection Randomised clinical trials using any type of routinely collected data for outcome ascertainment, including from registries, electronic health records, and administrative databases, that were included in a meta-analysis of a Cochrane review on any clinical question and any health outcome together with traditional trials not using routinely collected data for outcome measurement.” 

2. “We systematically obtained a large sample of randomised clinical trials that used routinely collected data to measure study outcomes (RCD-RCTs), identified trials that explored the same clinical question but measured outcomes using traditional methods (not based on routinely collected data), and then we compared their treatment effect estimates.” 

3. “RCD-RCTs were eligible if they used the data for measurement of any binary clinical outcome and were included in a Cochrane review meta-analysis together with at least one other trial not using routinely collected data for measuring the same outcome.” 

4. “We searched for randomised clinical trials published in English between 2000 and 2015 because of the emerging availability of electronic health records and other sources of routinely collected data in the past two decades and because more recent trials were less likely to be included in Cochrane reviews.” 

5. “One reviewer (KAM) determined if the trial was an index RCD-RCT (ie, measured at least one pertinent outcome using routinely collected data and was included in a meta-analysis evaluating this outcome together with other trials).” 

Source URL: https://www.bmj.com/content/372/bmj.n450