Abstract

To develop, adapt and validate an instrument named "CSII - Brazil" to assess users' conceptual and procedural knowledge of continuous subcutaneous insulin infusion systems. Methodological and exploratory study developed in three stages: a) instrument development; b) content validation and cultural adaptation (evaluation by a committee of experts and pre-test with CSII users); c) psychometric validation through instrument application in a sample of 60 patients by means of the web tool e-Surv. Internal consistency and reproducibility analyses were performed within IBM SPSS Statistics 20 programming environment. The 16 multiple-choice question instrument successfully attained a content validity index of 0.97, showing satisfactory internal consistency, with 0.61 Cronbach's alpha [95% CI 0.462-0.746] and an intraclass correlation coefficient of 0.869 [95% CI: 0.789-0.919] between the test and retest scores. The CSII - Brazil instrument is considered adequate and validated to assess continuous subcutaneous infusion system users' conceptual and procedural knowledge.

Highlights

  • Treatment for type 1 diabetes mellitus (T1D) has made significant progress over the past 50 years, mainly with the advent of the continuous subcutaneous insulin infusion (CSII) in the 90’s, which allows for the patient to obtain more accurate doses of insulin, comfort and safety [1]

  • Implementing an instrument with psychometric qualities tested for the clinical practice of diabetes educators will enable a more efficient direction in patient follow-up

  • In addition to contributing to education of CSII users in the Brazilian cultural context, the design and development of such an instrument can be of fundamental importance in the identification of flaws in relation to the practices oriented to the use of CSII

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Summary

Introduction

Treatment for type 1 diabetes mellitus (T1D) has made significant progress over the past 50 years, mainly with the advent of the continuous subcutaneous insulin infusion (CSII) in the 90’s, which allows for the patient to obtain more accurate doses of insulin, comfort and safety [1].A number of patients with T1D can be candidates for CSII use, but for successful treatment, users need to be the target of continuous training and monitoring regarding proper use of the system [2].CSII users must be instructed about basic concepts related to terms appearing in the device menu and messages prompted by patient’s use (conceptual knowledge) as well as essential actions to be performed to use the device (procedural knowledge), such as to how to insert and connect the infusion system and how to set up basic parameters such as time, date, basal insulin doses, food and glycemic correction boluses. Treatment for type 1 diabetes mellitus (T1D) has made significant progress over the past 50 years, mainly with the advent of the continuous subcutaneous insulin infusion (CSII) in the 90’s, which allows for the patient to obtain more accurate doses of insulin, comfort and safety [1]. A number of patients with T1D can be candidates for CSII use, but for successful treatment, users need to be the target of continuous training and monitoring regarding proper use of the system [2]. CSII users must be instructed about basic concepts related to terms appearing in the device menu and messages prompted by patient’s use (conceptual knowledge) as well as essential actions to be performed to use the device (procedural knowledge), such as to how to insert and connect the infusion system and how to set up basic parameters such as time, date, basal insulin doses, food and glycemic correction boluses. Users must be instructed on how to properly dispose of waste yielded by supplies in proper packaging [3].

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