Adverse drug events in cost-effectiveness analyses of interventions for diabetic conditions: a scoping review protocol.

OBJECTIVE

The objective of this review is to provide an overview of adverse drug events in cost-effectiveness analyses related to the pharmacological treatments of diabetes and diabetes-related complications.

INTRODUCTION

The inclusion of adverse drug events in cost-effectiveness analyses is recognized in health technology assessments guidelines, but in practice, this is inconsistent. This inconsistency may affect the reliability of the evaluation and, therefore, indicate that the information provided for decision-making in health care is misleading. Reviewing if and how adverse drug events are incorporated in cost-effectiveness analyses is necessary to address this gap.

INCLUSION CRITERIA

Studies including participants who are receiving pharmacological interventions for diabetes, diabetic retinopathy, or diabetic macular edema will be considered for inclusion. We will include sources that focus on cost-effectiveness analyses using modeling framework, and are published in English between 2011 and the present. Other types of analyses and other types of conditions will be excluded.

METHODS

The information sources to be searched include MEDLINE, CINAHL, Scopus, Web of Science, the NHS Economic Evaluations Database, and the Health Technology Assessment Database. Studies in English will be considered for inclusion in the review. Potential sources will be assessed by 2 independent reviewers and imported into the JBI System for the Unified Management, Assessment and Review of Information. The results of the search and the study inclusion process will be reported in a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. A specific data extraction form will be used to extract and analyze the data. Results will be presented in tabular and graphic formats with a narrative summary, and will be discussed in the context of current literature and guidelines.