PANORAMA: A European study to evaluate quality of life and treatment satisfaction in patients with type-2 diabetes mellitus - Study design

Abstract

Aim: Type-2 diabetes mellitus (T2DM) is a major cause of disability reaching epidemic proportions worldwide. The disease burden of T2DM is commonly characterised using health status measures, but few European-wide data are available concerning patients' views of their quality of life (QoL) and other patient-reported outcomes (PROs). Despite evidence supporting benefits of glycaemic control, many patients are currently not treated to recommended HbA(1c) targets (<7%). Consequently, the prevalence of T2DM-related chronic complications remains high, impacting negatively on patients' health status. Hypoglycaemia is a side effect associated with some antidiabetes medications that may also diminish QoL and treatment satisfaction. The aim of the PANORAMA study (NCT00916513) is to evaluate QoL and other PROs in patients with T2DM. It will investigate the association between these variables, the different diabetes treatment regimens used and levels of glycaemic control achieved across Europe. This report describes the rationale for conducting the PANORAMA study, and the study design.Methods: PANORAMA is an observational, multicentre, multinational, cross-sectional study. Approximately 5000 patients with T2DM currently treated with diet, oral antidiabetes agents and/or injectables (insulin and/or glucagon-like peptide-1 [GLP-1] analogues), >= 1-year follow up, will be randomly selected from a representative sample of mainly primary care practices across nine countries. Patient demographics; HbA(1c) level (standardised measurement); PROs, including QoL (ADDQoL), health status (EQ-5D), treatment satisfaction (DTSQ) and fear of hypoglycaemia (HFS-II); disease-related variables; health-economic variables; physician demographics and physician-reported outcomes will be collected.Discussion: The large-scale, European-wide PANORAMA study is designed to evaluate QoL and other PROs in patients with T2DM.