Fracture outcome definitions in observational osteoporosis drug effects studies: a scoping review protocol.

Objective: The objective of this review is to describe fracture outcome definitions in observational osteoporosis drug effects studies from Canada and the United States.

Introduction: Health care administrative data are commonly utilized in pharmacoepidemiologic studies. These data are used to define outcomes, such as fractures, and are critical to determining real-world safety and effectiveness of medications. However, there is no current standard for fracture outcome definitions in observational studies. As a result, fractures are inconsistently defined. To inform future research, a synthesis of how fractures are defined in observational studies using health care administrative claims data is needed. Providing clarity on how fractures are defined will provide guidance for future research.

Inclusion Criteria: We will include observational studies from the United States and Canada that consider the impact of osteoporosis pharmacotherapies on fracture risk and leverage health care administrative data.

Methods: This review will follow the three-step JBI methodology for scoping reviews. We will search MEDLINE, Embase, and CINAHL for studies published in English from 2000 to the present. Following de-duplication, titles and abstracts will be screened independently by two reviewers. We will then conduct full-text screening for eligible studies. In addition, Canadian and US government pharmacovigilance websites will be searched to identify gray literature. Data extraction will be completed by two reviewers. Results will be presented in figures and in tabular format.