Table 2.

Information gaps and approaches to resolution in patient-reported health data

Cause	Example	Approach to resolution
Event occurred at different health system	Patient hospitalized while on vacation, heart attack captured in EHR of external health system	Include questions on recent hospitalizations in follow-up contacts directly with patient via call center or web portal
Event occurred, but not recorded	Patient has racing pulse, but does not seek treatment; patient in inpatient unit with vitals recorded every 15 minutes. Racing pulse occurs and subsides in between recordings.	Consider use of PRH data as the primary data source for events that are unlikely to be routinely available in EHR data
Event occurred, does not appear in data source due to other events of higher priority	Event recorded as diagnosis, but does not appear on bill because of other diagnoses with higher reimbursement	Sensitivity analysis treating PRH data as the primary source of information on events for scenarios where patient reports event not apparent in billing data. Consider concordance with EHR data for final determination
Event occurred, but recorded as different/unexpected code or field	Procedure coded as X when trial is looking for code Y Vital signs typically recorded in standard flowsheet, but clinic has custom field to use for their own patients EHR is upgraded and new fields created—trial is unaware.	Sensitivity analysis treating PRH data as the primary source of information on events for scenarios where patient report contradicts EHR data
Event not recorded reliably	Trial is looking for height at most recent encounter; patient was seen the previous week & had height recorded then. Height not recorded a second time. Trial is looking at smoking status, but field is not recorded reliably for young adults seen in pediatric clinics	Consider targeted capture of patient-reported data in scenarios where key data elements are at high risk of missingness; look for data collected previously using a look-back period as defined in the study protocol (ie, height within 2 weeks of visit)
Lag in process to extract EHR data to research database	Process to refresh research database runs quarterly; database only includes EHR data at least a month old.	Employ more frequent, consistent PRH data capture for trial monitoring purposes with confirmation of safety signals through targeted medical record review