Patient-reported hard events are underreported in pragmatic RCTs

For all hard endpoints, 90% of events were recorded in claims data or EHR, with a minority arising from patient reports.

Analysis of the ADAPTABLE trial has shown that patient-reported events in pragmatic RCTs contribute less to clinical endpoint analysis compared with those obtained from electronic health records (EHRs) or claims data.

Many of us are interested in understanding clinical trial data sources and which data sources are most effective because obviously any type of data source you use can be costly, Jennifer A. Reimer, MD (Duke Clinical Research Institute, Durham, North Carolina), told TCTMD, so you want to make sure you're getting the maximum number of events from the sources you have and getting the appropriate clinical event ascertainment.

Participant-reported data in the ADAPTABLE trial were collected, with patient consent, through an internet portal platform that collected information on risk factors, medications, and events. This information was used by the study investigators along with EHR and claims data. ADAPTABLE compared high-dose and low-dose aspirin in patients with atherosclerotic cardiovascular disease (ASCVD) and found that 81 mg aspirin was as effective as 325 mg in preventing major cardiovascular events in the entire cohort and in a recently published sex-specific analysis.

In a paper published this week in JAMA Cardiology , Rymer and the ADAPTABLE researchers concluded that for all endpoints (all-cause mortality, hospitalization for myocardial infarction, hospitalization for stroke, severe bleeding, or a composite), participant-reported data contributed less than 10% of clinical events not found in EHRs or claims data.

Reimer told TCTMD that the findings suggest that the most complete ascertainment comes from claims and EHRs, but especially from claims. At least in the cardiovascular field, many clinical trials are done in Medicare-covered patients, so claims data is very useful in that sense.

Practical but problematic

The analysis included 15,006 ADAPTABLE participants, the majority of whom had one other data source (EHR or claims) in addition to participant-reported data, but less than one-third of patients had all three sources available.

Where EHR and claims data were available, 92%–100% of events could be identified in EHR or claims data, regardless of the presence or absence of participant-reported data. For the composite endpoint, EHR data accounted for 71% of events and claims accounted for 28%.

Reimer said that with an endpoint like ADAPTABLE, patient recall can be part of the problem, but another key issue is the need to get approved releases for any hospitalizations that patients report.

It's difficult and tough and I think we miss out on a lot because we have to go back home and maybe we can't get in touch with them. [or] At that point, patients may not be willing to consent to anything extra, she said, and one lesson from that is to try to get all the information and consent during the initial appointment, she added.

As for what the findings mean for ongoing pragmatic trials, Reimer and colleagues note that where access to EHR and claims data is available, respondent burden should be considered compared with the lower yield of participant portal (or other self-reported) data.

But Reimer said the findings don't make the information participants reported any less important in specific situations or for softer outcomes such as health-related quality of life.

I don’t mean to discount the voice of patients, but when patients are sick or hospitalized; [for] “For illnesses like myocardial infarction or stroke, patients may not remember all the data or endpoints, and if they didn't communicate clearly or were critically ill during their hospital stay, they may not fully understand what happened,” she added. “What we're saying is that the most cost-effective way to validate is with claims data and electronic medical records.”

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