PMID- 29600503 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20200930 IS - 1869-6953 (Print) IS - 1869-6961 (Electronic) IS - 1869-6961 (Linking) VI - 9 IP - 3 DP - 2018 Jun TI - Reproducibility and Validity of a Questionnaire Measuring Treatment Burden on Patients with Type 2 Diabetes: Diabetic Treatment Burden Questionnaire (DTBQ). PG - 1001-1019 LID - 10.1007/s13300-018-0414-4 [doi] AB - 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. FAU - Ishii, Hitoshi AU - Ishii H AUID- ORCID: 0000-0002-6214-0557 AD - Department of Diabetology, Nara Medical University, Nara, Japan. hits1@naramed-u.ac.jp. FAU - Shin, Koki AU - Shin K AD - Shin Clinic, Tokyo, Japan. FAU - Tosaki, Takahiro AU - Tosaki T AD - TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology, Aichi, Japan. FAU - Haga, Tatsuya AU - Haga T AD - Haga Diabetes Clinic, Aichi, Japan. FAU - Nakajima, Yoshiki AU - Nakajima Y AD - Nakajima Diabetes Clinic, Osaka, Japan. FAU - Shiraiwa, Toshihiko AU - Shiraiwa T AD - Shiraiwa Medical Clinic, Osaka, Japan. FAU - Watanabe, Nobuaki AU - Watanabe N AD - Watanabe Medical Clinic, Hyogo, Japan. FAU - Koizumi, Miyuki AU - Koizumi M AD - Department of Diabetology, Nara Medical University, Nara, Japan. FAU - Nakajima, Hiroki AU - Nakajima H AD - Department of Diabetology, Nara Medical University, Nara, Japan. FAU - Okada, Sadanori AU - Okada S AD - Department of Diabetology, Nara Medical University, Nara, Japan. FAU - Mashitani, Tsuyoshi AU - Mashitani T AD - Department of Diabetology, Nara Medical University, Nara, Japan. FAU - Mohri, Takako AU - Mohri T AD - Department of Diabetology, Nara Medical University, Nara, Japan. FAU - Akai, Yasuhiro AU - Akai Y AD - Department of Diabetology, Nara Medical University, Nara, Japan. LA - eng PT - Journal Article DEP - 20180329 PL - United States TA - Diabetes Ther JT - Diabetes therapy : research, treatment and education of diabetes and related disorders JID - 101539025 EIN - Diabetes Ther. 2018 Aug;9(4):1719. PMID: 29909478 PMC - PMC5984917 OTO - NOTNLM OT - Pharmacotherapy OT - Questionnaire OT - Reproducibility OT - Treatment burden OT - Type 2 diabetes mellitus OT - Validity EDAT- 2018/03/31 06:00 MHDA- 2018/03/31 06:01 PMCR- 2018/03/29 CRDT- 2018/03/31 06:00 PHST- 2018/01/16 00:00 [received] PHST- 2018/03/31 06:00 [pubmed] PHST- 2018/03/31 06:01 [medline] PHST- 2018/03/31 06:00 [entrez] PHST- 2018/03/29 00:00 [pmc-release] AID - 10.1007/s13300-018-0414-4 [pii] AID - 414 [pii] AID - 10.1007/s13300-018-0414-4 [doi] PST - ppublish SO - Diabetes Ther. 2018 Jun;9(3):1001-1019. doi: 10.1007/s13300-018-0414-4. Epub 2018 Mar 29.