Hypoglycemia symptoms and awareness of hypoglycemia in type 1 diabetes mellitus: cross-cultural adaptation and validation of the Portuguese version of three questionnaires and evaluation of its risk factors

Paula Stefenon,André Luís Marques Da Silveira,Luana Seminotti Giaretta,Cristiane Bauermann Leitão,Andrea Carla Bauer

doi:10.1186/s13098-020-0521-z

Abstract

BackgroundTo adapt and validate the Clarke and Gold questionnaires and the Edinburgh Hypoglycemia Symptom Scale (EHSS) to Brazilian Portuguese and to determine the prevalence and risk factors associated with impaired awareness of hypoglycemia (IAH) in patients with type 1 diabetes mellitus (T1DM).MethodsThe process of translation, cultural adaptation, and validation of the questionnaires followed the recommendations of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR)-Task Force for Translation and Cultural Adaptation. Patients with T1DM for a minimum of 12 months, aged 18 years or older, and with Brazilian nationality were selected to participate.ResultsA total of 123 patients were enrolled. The Clarke and Gold questionnaires as well as the EHSS exhibited adequate internal consistency, test–retest reliability, and convergent validity. The prevalence of IAH was 38.3% with the Clarke questionnaire and 25.2% with the Gold questionnaire. The prevalence increased with longer duration of diabetes, lower HbA1c, and lower eGFR.ConclusionsThe validation and cross-cultural adaptation of the proposed questionnaires to Brazilian Portuguese were adequate. In this sample of T1DM, the prevalence of IAH was high and associated with a longer duration of T1DM, lower HbA1C and lower eGFR.

Highlights

To adapt and validate the Clarke and Gold questionnaires and the Edinburgh Hypoglycemia Symptom Scale (EHSS) to Brazilian Portuguese and to determine the prevalence and risk factors associated with impaired awareness of hypoglycemia (IAH) in patients with type 1 diabetes mellitus (T1DM)
Translation and cultural adaptation During the debriefing step, one patient did not understand the meaning of the word “palpitations” in the EHSS; the expert committee decided to include an explanation of this word in parentheses following the “palpitation” symptom in the questionnaire
Fourteen of the 40 T1DM patients that completed the pre-test questionnaires had an initial difficulty understanding the relevance of the numerical scale on the Likert scale of the EHSS and the Gold questionnaire

Summary

Introduction

To adapt and validate the Clarke and Gold questionnaires and the Edinburgh Hypoglycemia Symptom Scale (EHSS) to Brazilian Portuguese and to determine the prevalence and risk factors associated with impaired awareness of hypoglycemia (IAH) in patients with type 1 diabetes mellitus (T1DM). McCoy et al showed that patients with severe hypoglycemia had a 3.4-fold higher risk of death compared to those with no or mild hypoglycemia [3]. Impaired awareness of hypoglycemia (IAH) is a syndrome in which the ability to detect warning symptoms are reduced or absent. These patients exhibit a nearly sixfold higher frequency of severe hypoglycemia than patients without IAH [5]

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