Remarkable study w/implications on the under-reporting of hospitalizations by study participants that I was privilege to do w/@CesarCaraballoC @rohan_khera @jspertus @wade_schulz PhilJones CaroleDecker @CircOutcomes ahajournals.org/eprint/FR7BZYY… @YaleMed @YaleCardiology 
@CesarCaraballoC @rohan_khera @jspertus @wade_schulz @CircOutcomes @YaleMed @YaleCardiology Many studies depend on contacting study participants and asking about clinical events as a trigger to requesting medical records to confirm the event. Labor-intensive, expensive… and we found…often yields incorrect information.
@CesarCaraballoC @rohan_khera @jspertus @wade_schulz @CircOutcomes @YaleMed @YaleCardiology In prospective studies, trials or observational, that depend on protocolized self-report to initiate ascertainment of events, over-reporting is not an issue because adjudication can screen out the false positives. It may waste time, but validity can be maintained. However… 3/
@CesarCaraballoC @rohan_khera @jspertus @wade_schulz @CircOutcomes @YaleMed @YaleCardiology In studies that contact participants to begin the process of ascertaining clinical events, under-reporting can be a big problem, because you can’t correct for it unless you have other streams of data. And many studies have depended on participant reporting. 4/
@CesarCaraballoC @rohan_khera @jspertus @wade_schulz @CircOutcomes @YaleMed @YaleCardiology In our study, we found: 'Self-reported hospitalization events after myocardial infarction are often in error, with nearly 1/3 not being reported.’ That is a huge amount of under-counting. In a trial that might not be bias, but it reduces power. In an obs study, it could bias. 5/
@CesarCaraballoC @rohan_khera @jspertus @wade_schulz @CircOutcomes @YaleMed @YaleCardiology Moreover… ‘...while there are differences in rates of underreported events by patient characteristics or event type—across all subgroups the rates [of undercounting clinical events] are high, increasing progressively as time between time of event and the interview increased.'
@CesarCaraballoC @rohan_khera @jspertus @wade_schulz @CircOutcomes @YaleMed @YaleCardiology In our survey of the literature we also found that for many studies it was hard to detemine how they ascertained outcomes beyond self-report…it may be that this problem is widespread…meaning studies are depending too much on self-report as the event ascertainment trigger.
@CesarCaraballoC @rohan_khera @jspertus @wade_schulz @CircOutcomes @YaleMed @YaleCardiology We concluded:'This evidence provides impetus to the need for better ascertainment methods beyond self-report.’ The patient perspective is important, esp for PROMs, but for determining events, there are limitations. Every study needs to describe in detail how it determined events.
@CesarCaraballoC @rohan_khera @jspertus @wade_schulz @CircOutcomes @YaleMed @YaleCardiology Kudos to @CesarCaraballoC for his leadership of this study - a remarkable physician scientist…will soon be applying for residency… he is outstanding. Honored to work with him.
