Development and Validation of an Instrument to Assess the Safe Use of Antidiabetic Medication to Prevent Hypoglycemia Requiring Hospitalization Among Ambulatory Patients With Type 2 Diabetes Mellitus in Bali, Indonesia.

Abstract

Objectives: Ambulatory patients with type 2 diabetes mellitus (T2DM) require special attention when being discharged from the hospital with anti-diabetes medication. This necessity stems primarily from the risk of adverse drug reactions, particularly hypoglycemia. However, this risk is significantly influenced by the patients' knowledge and behavior regarding their medication use. This study aimed to develop instrument to assess the risk of medication-related hypoglycemia in ambulatory T2DM patients by clinical pharmacists.

Methods: The study was conducted using an observational design that included multiple stages. These stages involved item development through focus group discussions (FGDs), content validation by clinical pharmacists, and criterion and construct validation by ambulatory T2DM patients using a cross-sectional approach.

Results: A total of 10 question items were developed for assessment by clinical pharmacists following FGDs and content validation. Criterion and construct validation identified 8 valid question items through multivariate analysis (p<0.05). The scoring system developed demonstrated a linear relationship between the score and the number of items at risk in the instrument (p<0.05, R²=0.988). Additionally, the instrument was named "Medication-related Hypoglycemia Risk Score Assessment Tools (HYPOGLYRISK)."

Conclusions: The findings of this study suggest that HYPOGLYRISK may serve as a useful tool for clinical pharmacists to evaluate the risk of medication-related hypoglycemia in ambulatory T2DM patients. Additionally, this instrument could assist clinical pharmacists in identifying priority patients and tailoring educational services to meet their specific goals and needs.