Harnessing electronic healthcare data for wound care research: Standards for reporting observational registry data obtained directly from electronic health records

Abstract

The United States Food and Drug Administration will consider the expansion of coverage indications for some drugs and devices based on real‐world data. Real‐world data accrual in patient registries has historically been via manual data entry from the medical chart at a time distant from patient care, which is fraught with systematic error. The efficient automated transmission of data directly from electronic health records is replacing this labor‐intensive paradigm. However, real‐world data collection is unfamiliar. The potential sources of bias arising from the source of data and data accrual, documentation, and aggregation have not been well defined. Furthermore, the technological aspects of data acquisition and transmission are less transparent. We explore opportunities for harnessing direct‐from‐electronic health record registry reporting and propose the ABCs of Registries (Analysis of Bias Criteria of Registries), which are an evaluation framework for publications to minimize potential bias of real‐world data obtained directly from an electronic health record method. These standards are based on a point‐of‐care data documentation process using a common definitional framework and data dictionaries. By way of example, we describe a wound registry obtained directly from electronic health records. This qualified clinical data registry minimizes bias by ensuring complete and accurate point‐of‐care data capture, standardizes usual care linked to quality reporting, and prevents post‐hoc vetting of outcomes. The resulting data are of high quality and integrity and can be used for comparative effectiveness research in wound care. In this way, the effort needed to succeed with the Quality Payment Program is leveraged to obtain the real‐world data needed for comparative effectiveness research.

The Hyperbaric Oxygen Therapy Registry: Driving quality and demonstrating compliance

“…The HBOTR (via the USWR) harnesses the requirements of MIPS to automate registry data submission directly from any certified EHR so that no secondary data entry is required, enabling a viable and enduring hyperbaric specialty registry despite the absence of a monetary incentive to participate in one and the absence of the funding model that exists in other specialties [10]. A complete description of how the USWR harnesses EHR data to fulfill quality reporting requirements was recently published [3]. Computerized systems parse the structured clinical data accrued at point of care, which are transmitted to the USWR and stored in one or more of the appropriate specialty registry databases.…”

“…It is no coincidence that the pace of health care payment reform gained momentum after the 2009 passage of the HITECH Act (Health Information Technology for Economic and Clinical Health), as demonstrated by the timeline in Figure 1. As practitioners and hospitals in the United States were compelled to purchase and use certified electronic health records (EHRs) in specific Clinicians willingly participate in registries whenever substantial reimbursement is tied to participation (e.g., implanted defibrillators, venous ablation, prosthetic joints, stroke, and trauma center recognition) [3]. Registries created by some specialties (e.g., cardiology and orthopedic surgery) have received ample funding from the device and drug manufacturers wishing to utilize their data.…”

“…The 2013 study questioned the effectiveness of HBO 2 for DFUs, but, frustratingly, the dataset did not contain basic information such as the patient comorbid conditions and medications needed for patient risk stratification. This is a puzzling omission, because diagnosis codes and medications are easily obtained from any certified EHR, and it is a powerful example of why standards are needed for the use of registry data in wound care [3].…”

“…As shown in Figure 1, for more than a decade, the US Wound Registry (USWR) has evolved amidst the dynamic implementation of health care reform to ensure that wound care and hyperbaric medicine practitioners could participate in a registry, regardless of which EHR product they utilize, and not be left behind in the transition to value-based payment [3]. In 2008, the USWR was among the first registries recognized by CMS for the fledgling Physician Quality Reporting Initiative.…”

Comparative cost and clinical effectiveness of clostridial collagenase ointment for chronic dermal ulcers

“…These studies may be more generalizable to actual practice in hospital outpatient clinics compared with analyses based on RCTs, as the registry includes typical patients often excluded from RCTs [31,32]. As such, the USWR, which harnesses electronic healthcare data at point of care, offers ideal opportunities for comparative effectiveness research in wound care [31][32][33].…”