Quality of reporting electronic health record data in glaucoma: a systematic literature review

Author: Higgins BE, Leonard-Hawkhead B, Azuara-Blanco A.

Geographical coverage: United States, India, China, the Faroe Islands, Finland, Japan, South Korea, Spain, Taiwan, and the United Kingdom

Sector: Service delivery

Sub-sector: Quality of reporting electronic health records data

Equity focus: Not reported

Study population: Adult patients with glaucoma

Review type: Effectiveness review

Quantitative synthesis method: Narrative synthesis

Qualitative synthesis method: Not applicable

Background:

Electronic health records (electronic health records (EHRs)) have revolutionised ophthalmic research, offering extensive datasets for analysing glaucoma. These records eliminate manual data collection and enable efficient large-scale studies. Glaucoma, a primary cause of irreversible blindness, benefits greatly from electronic health record (EHR) research due to its complex nature. Large databases like the Intelligent Research in Sight (IRIS) Registry Registry and United Kingdom (UK) Biobank have led to significant advancements in glaucoma management. However, inconsistencies in EHR reporting challenge the reproducibility of research findings. The COnsensus on DEfinition and reporting of EHR studies (CODE‑EHR) framework, introduced in 2022, addresses these issues by promoting standardised reporting in line with Findable, Accessible, Interoperable and Re‑usable (FAIR) principles. This study evaluates the adherence of glaucoma research to the CODE-EHR framework, aiming to enhance data transparency and reliability.

Objectives:

To assess the reporting standards in glaucoma studies using EHR.

Main findings:

The authors concluded that adherence to CODE-EHR standards in EHR-based glaucoma studies needs improvement. Standardised reporting of EHR data is crucial for reliable research, aiding its clinical application and enhancing healthcare decisions for better patient outcomes.

The review included 31 studies. Data from the 31 included studies were sourced from the United States (18 studies, 58%), India (3 studies, 9%), and one study each from China, the Faroe Islands, Finland, Japan, South Korea, Spain, Taiwan, and the United Kingdom, with two studies not reporting their location. Most studies sourced EHR data from hospitals, Stanford clinical warehouse, the IRIS registry, and Duke Ophthalmic Registry. Commonly reported elements included age, gender, glaucoma diagnosis, and intraocular pressure. Only 5 studies (16%) fully adhered to CODE-EHR best-practice framework’s minimum standards, with none meeting preferred standards. All 31 studies met the minimum framework standard for analysis, and most of the studies (n=23, 75%) met minimum standards for Ethics and Governance. While statistical analysis and ethical considerations were relatively well-addressed, areas such as EHR data management and study design showed room for improvement. Patient and public involvement, and acknowledgment of data linkage processes, data security, and storage reporting were often missed.

Methodology:

The authors searched PubMed, Embase, CINHAL, and Web of Science databases. In addition, reference lists of the included studies were screened to identify additional relevant publications. Two reviewers independently screened the title and abstract, and full-text of potentially relevant articles against the eligibility criteria. Disagreements between the reviewers were resolved through discussion or by contacting a third reviewer. The CODE-HER best-practice framework was used to assess the risk of bias in the included studies. One reviewer extracted the relevant data. A meta-analysis was deemed inappropriate due to the diversity of study topics and outcome measures. One reviewer analysed the data based on adherence to the CODE-EHR best practice framework, assessing whether studies met the five minimum framework items, the five preferred items, and the required minimum information.

Applicability/external validity:

The review authors observed that 58% of the studies were from the United States, limiting their applicability to other healthcare settings. Differences in study designs and outcome measures restrict comparability. Concerns about reproducibility arise due to a lack of external validation in most studies. The absence of pre-published protocols or statistical analysis plans increases bias risk, and the lack of patient and public involvement reduces real-world relevance.

Geographic focus:

Included studies were conducted in the United States, India, China, the Faroe Islands, Finland, Japan, South Korea, Spain, Taiwan, and the United Kingdom.

Summary of quality assessment:

Overall, we have low confidence in the review’s conclusions because of methodological limitations: data extraction and synthesis were performed by a single reviewer, the search period was short (January 2022 – May 2023) with an English‑language restriction, reference‑list searches and expert contact were not reported, and no list of excluded studies was provided. These factors increase the risk of missed evidence and introduce potential bias.