PRM208 - Important Methodological Considerations and Strategies for Resolution for Multinational Retrospective Chart Review Studies

Abstract

In the absence of secondary sources of health care data, chart review studies are necessary to fulfill peri- and post-approval evidence gaps such as informing on patient profiles, treatment effectiveness, and clinical and safety outcomes. Multinational studies (conducted in more than one country) are essential in understanding how to best address global medical needs; however the conduct of these studies poses its own set of challenges. Our objective was to explore the design and operational challenges and strategies to overcome these challenges in order to ensure successful conduct of multinational chart review studies. Fourteen recent multinational chart review case studies were evaluated to describe lessons learned in terms of key methodological considerations and strategies for resolution. Eight studies (57%) were comprised of 3 or more countries and 7 studies (50%) were comprised of European countries only. Across studies, common scientific and operational considerations included identifying country-specific ethics and privacy regulations (including patient informed consent) and accounting for variance in treatment patterns and safety reporting. Recommendations include pilot-testing the case report form (CRF) in participating countries to ensure data points of interest are available, sufficient staff training on study purpose, outcomes and electronic CRF navigation, and creation of detailed training materials and guidelines for data abstraction. Additionally, in order to ensure uniformity of data collection across sites, the use of a standardized data collection tool and the implementation of quality control guidelines for data cleaning and query resolution is recommended. Multinational chart reviews are an effective methodology for capturing tailored, patient-level data and offer an important opportunity to inform on global clinical data. While the conduct of multinational chart review studies can be challenging due to inter-country variance, careful consideration of key design and operational challenges can allow for successful study implementation.