Observational study methods used to assess pharmacotherapy effects of type 2 diabetes on fracture risk: a scoping review protocol.

Objective The objective of this review is to summarize observational research methods employed to study fracture risk and the use of type 2 diabetes mellitus medications. The methods summary will be used as a case study to illustrate current practices in the study of medication effects on fracture risk. Introduction Observational studies examining drug effects on fracture risk fill knowledge gaps left by clinical trials but require specific design considerations. In recent years, several pharmacoepidemiologic studies have examined fracture risk as a possible adverse effect of type 2 diabetes mellitus medications using varying methodologies; these studies can illustrate design considerations for studies of fracture risk. Inclusion criteria This scoping review will consider peer-reviewed observational studies that examine the effects of type 2 diabetes mellitus medications on fracture risk. Primary literature comprising empirical pharmacoepidemiologic studies, such as cohort, case-control, case-crossover, self-controlled, case series, and case-cohort designs, that evaluate fracture risk associated with at least one type 2 diabetes mellitus medication will be eligible. Studies without use of an administrative database and those with an experimental, cross-sectional, or time-series design will be excluded. Methods This scoping review will follow JBI methodology for scoping reviews. MEDLINE (Ovid), Embase (Ovid), and CINAHL Plus with Full Text (EBSCO) will be searched from January 1, 2000 (to capture recent methodologies) to the present to identify eligible articles. After de-duplication, titles and abstracts will be screened independently by two reviewers, then full texts will be reviewed. Data on study methods will be extracted from eligible texts using a piloted form developed by the authors, and study methods will be aggregated in tabular format.