IRB Administrator Lakeland Regional Health, United States
Background: Medical chart review research frequently lacks sound methods and has a high potential for bias which restricts the scientific utility. If recommended standards for quality reporting and publication are incorporated into chart review templates, research design and the importance of knowledge gained can improve relative to subject risks.
Methods: A Google internet search using “retrospective chart review template” was conducted on February 24, 2024. These words were chosen since they represent a likely phrase that someone searching for chart review protocol guidance would use. The first 25 templates were selected for inclusion since they would likely represent the most frequently selected resources. Each template was evaluated for the presence of subheadings or prompts to provide protocol information addressing how risks concerning privacy or confidentiality would be minimized. In order to assess for the requirements of sound research design, templates were evaluated for the presence of subheadings or prompts for the first 12 topic recommendations from the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist which guides researchers on the reporting of descriptive, cohort, case-control and cross-sectional studies. Institutional characteristics, such as AAHRPP accreditation, were also included.
Results: Twenty-Five templates were evaluated. Fourteen were from AAHRPP accredited institutions and one was from a CARE-Q certified IRB. Privacy and/or confidentiality language was required in 96% of the templates. Regarding sound research design, over 75% of the templates required an explanation of background information, specific objectives, participant eligibility criteria, and data sources. However, less than 25% of the templates required a title describing the study design, efforts to address sources of bias, how missing data would be addressed, methods of assessment/measurement, and potential confounders. The 2-6 templates that succeeded in addressing less frequently addressed topics were predominantly from AAHRPP accredited institutions and/or CARE-Q certified.
Limitations: There was a high degree of variability in the formatting, terminology and extent of instructions used in the templates. In the absence of a relevant topic subheading, instructional text containing minimally applicable content from the STROBE checklist was included in the data if present. Some templates stated that a statistician would do the statistical analysis. In these cases, it was assumed that statistical methods would be appropriately addressed.
Discussion: The vast majority of medical chart review templates addressed the information necessary for the IRB to ensure that risks to subjects are minimized. However, the majority of templates did not require information that is routinely used to assure quality study design. There is a potential for improvement of the knowledge gained by chart review research and IRB submission template designs can help to ensure that success. Other authors have published studies evaluating the quality of chart review articles. Future directions include evaluating the impact of IRB template design on research publication quality.
