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Diabetes Ther. 2018 Jun;9(3):1001-1019. doi: 10.1007/s13300-018-0414-4. Epub 2018 Mar 29.

Reproducibility and Validity of a Questionnaire Measuring Treatment Burden on Patients with Type 2 Diabetes: Diabetic Treatment Burden Questionnaire (DTBQ).

Author information

1
Department of Diabetology, Nara Medical University, Nara, Japan. hits1@naramed-u.ac.jp.
2
Shin Clinic, Tokyo, Japan.
3
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology, Aichi, Japan.
4
Haga Diabetes Clinic, Aichi, Japan.
5
Nakajima Diabetes Clinic, Osaka, Japan.
6
Shiraiwa Medical Clinic, Osaka, Japan.
7
Watanabe Medical Clinic, Hyogo, Japan.
8
Department of Diabetology, Nara Medical University, Nara, Japan.

Abstract

INTRODUCTION:

To measure the burden of pharmacotherapy on patients with type 2 diabetes mellitus (T2DM), we developed the Diabetes Treatment Burden Questionnaire (DTBQ), a patient-administered questionnaire composed of 18 questions, and evaluated its reproducibility and validity.

METHODS:

We enrolled 240 patients with T2DM under pharmacotherapy over 20 years of age at seven institutes in Japan. Their physicians filled out report forms on patient backgrounds, and the patients answered both the DTBQ and the Diabetes Treatment Satisfaction Questionnaire (DTSQ). For evaluation of reproducibility, 48 of the enrolled subjects completed a 2nd DTBQ at home after leaving the medical institutes.

RESULTS:

Statistical analyses were performed for two sets of subjects, the validity analysis set (N = 236) and the reproducibility analysis set (N = 47). Factor analysis found a simple structure in the DTBQ item scores using a three-factor model with varimax rotation; the three subscales were designated as "implementation burden", "flexibility burden", and "blood glucose control burden". All intraclass correlation coefficients for the subscale scores were 0.8 or higher, indicating high reproducibility. Negative correlations were observed between the DTSQ satisfaction score and the DTBQ subscale scores. Moreover, as the dosing frequency of diabetic medicines increased, the DTBQ total score (total burden score) also became higher. Likewise, expected associations were observed between patient backgrounds and DTSQ scores.

CONCLUSION:

The DTBQ has adequate reproducibility and validity as a measurement scale for treatment burden on T2DM patients.

TRIAL REGISTRATION:

University Hospital Medical Information Network (UMIN) 000026382.

FUNDING:

Eli Lilly Japan.

KEYWORDS:

Pharmacotherapy; Questionnaire; Reproducibility; Treatment burden; Type 2 diabetes mellitus; Validity

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