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 HbA1c 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; HbA1c 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.
Abbreviations: ADDQoL, Audit of Diabetes-Dependent Quality of Life, AWI, average weighted impact, CI, confidence interval, CV, cardiovascular, DTSQ, Diabetes Treatment Satisfaction Questionnaire, EQ-5D, European Quality of Life-5 Dimensions, EQ-VAS, EQ-5D Visual Analogue Scale, HbA1c, glycated haemoglobin, HCP, healthcare professional, HFS-II, Hypoglycaemia Fear Survey-II, PROs, patient-reported outcomes, QoL, quality of life, SD, standard deviation, SF-36, Medical Outcomes Study 36-Item Short Form, T2DM, type-2 diabetes mellitus
Keywords: Type-2 diabetes mellitus, Epidemiology, Quality of life, Hypoglycaemia, Treatment satisfaction
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☆ Results from PANORAMA were presented at the 46th Annual European Association for the Study of Diabetes (EASD) Meeting, 2010 September 20–24, Stockholm, Sweden; and generated considerable interest and further feedback which has partly guided subsequent data analyses [P. de Pablos-Velasco, C. Bradley, E. Eschwège, L. Gönder-Frederick, K. Parhofer, H. Vandenberghe, D. Simon, The PANORAMA pan-European study: glycaemic control and treatment patterns in patients with type 2 diabetes, Diabetologia 53 (Suppl. 1) (2010) 1–556 (abstract no. A-10-685); C. Bradley, E. Eschwège, P. de Pablos-Velasco, K. Parhofer, D. Simon, M. Tafalla, E. Pascual, L. Gönder-Frederick, The PANORAMA pan-European study: impact of severe and non-severe hypoglycaemia on quality of life and other patient-reported outcomes in patients with type 2 diabetes, Diabetologia 53 (Suppl. 1) (2010) 1–556 (abstract no. A-10-1900)].
☆☆ NB In any future translations of this paper the titles and acronyms of all questionnaires for evaluating patient-reported outcomes must remain in English, unless the copyright holder has provided the relevant translation resulting from the linguistic validation of the questionnaire.
PII: S1751-9918(11)00030-1
doi:10.1016/j.pcd.2011.04.004
© 2011 Clare Bradley. Published by Elsevier Inc. All rights reserved.
