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

Abstract

IntroductionTo 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.MethodsWe 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.ResultsStatistical 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.ConclusionThe DTBQ has adequate reproducibility and validity as a measurement scale for treatment burden on T2DM patients.Trial RegistrationUniversity Hospital Medical Information Network (UMIN) 000026382.FundingEli Lilly Japan.Electronic supplementary materialThe online version of this article (10.1007/s13300-018-0414-4) contains supplementary material, which is available to authorized users.

Effect of Orally Administered Semaglutide Versus Dulaglutide on Diabetes-Related Quality of Life in Japanese Patients with Type 2 Diabetes: The PIONEER 10 Randomized, Active-Controlled Trial

“…The change from baseline scores for the domain “burden on social activities and daily activities” were numerically (but not statistically) higher (better) with orally administered semaglutide 7 and 14 mg compared with dulaglutide 0.75 mg, indicating that patients considered the once-daily orally administered semaglutide schedule to be, at least, no more burdensome than a once-weekly injection of dulaglutide. This clinically important observation is supported by previous work suggesting that the treatment burden associated with once-daily oral therapy may be similar to that for once-weekly injections [ 32 ]. Individual question scores for this domain indicated concerns around managing injectable treatment and any associated pain or discomfort.…”

Measurement Properties of Patient-Reported Outcome Measures for Diabetes: Systematic Review

“…Ch-ASIQ df [176]; MIAS dg [177]; IMDSES dh (Brazilian version) [178]; ITSQ di [179]; OHA-Q dj [180]; DMSRQ dk [181] • PROMs that assess the treatment experience in general [168] or specifically the level of satisfaction with treatment [79] or treatment burden [169] or treatment with specific modalities of treatment (eg, with pharmacotherapy [169] or insulin therapy [170]).…”

“…cj (Persian version)[145]; T2DHPS (Turkish version)[146]; DHPSC ck (Chinese version)[147]; PDQ-11cl [148];C-PDQ cm[149] •PROMs that assess health-promoting lifestyle behaviours of patients with diabetes.•Examples of domains assessed include physical activity, risk reduction, stress management, health responsibility, enjoyment of life, and healthy diet.Health-promoting lifestyle behaviorsHealth Belief Measures[150]; Given Health Belief Instrument (Spanish version)[151]; Health Belief Model Scale (Turkish version)[152]; Diabetes Health Belief Measure[153] • PROMs that assess diabetes-specific health beliefs of patients.•Examples of domains assessed include perceived benefits of and barriers to treatment and perceived severity of and vulnerability to complications.Health beliefsDiabetes Questionnaire[154]; Diabetes Questionnaire (Spanish version)[154]; Diabetes Knowledge Questionnaire (Spanish version)[31]; DKQ-24 cn[153]; DMKT co[155]; PCSD-P cp[156]; Miller et al[157]; Miller and Edwards[158]; PDDC cq[159]; DRNK cr[160]; FCCHL cs (Norwegian version)[161];KHLS-DM ct[162]; HLS-K cu[163]; HLS/SNS cv[164]; Ashok et al 1[165]; Ashok et al 2[166]; HLS-EU-Q47 cw[167] • PROMs that assess the level of diabetes knowledge, whether in general or for specific areas of knowledge such as nutrition knowledge.•Examples of domains assessed include symptoms (eg, frequent hunger), causes and risk factors (eg, lack of physical activity), complications (eg, kidney failure), and management (eg, reduced consumption of rice). cx[79]; DTSQ (Greek version)[171]; DiabMedSat cy[172]; DTBQ cz[169]; ITEQ da[168]; IITQ db[170]; ITAS dc[173]; C-ITAS-HK...…”

A systematic literature review of the assessment of treatment burden experienced by patients and their caregivers

“…Many instruments and measures used to assess treatment burden were disease-specific (e.g. the Quality of Life-Bronchiectasis (QOL-B) questionnaire [35], the Dermatology Life Quality Index [36] or the Diabetic Treatment Burden Questionnaire [37]). In general, these instruments assessed treatment burden as part of longer quality of life questionnaires [33, 36–39].…”