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

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.

SUBMITTER: Ishii H

PROVIDER: S-EPMC5984917 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundA balanced diet is essential to slowing the progression of chronic kidney disease (CKD) and managing the symptoms. Currently, no tool is available to easily and quickly assess energy and macronutrient intake in patients with non end-stage CKD. We aimed to develop and evaluate the validity and reproducibility of a new short 49-item food frequency questionnaire (SFFQ) adapted to patients with CKD.MethodsThe CKD-REIN study is a prospective cohort that enrolled 3033 patients with moderate or advanced CKD from a national sample of nephrology clinics. A sub-sample of 201 patients completed the SFFQ twice, at a one-year interval and were included in the reproducibility study. During this interval, 127 patients also completed six 24-h recalls and were included in the validity study. Main nutrient and dietary intakes were computed. Validity was evaluated by calculating crude, energy-adjusted and de-attenuated correlation coefficients (CC) between FFQ and the mean of the 24-h recall results. Bland-Altman plots were performed and cross-classification into quintiles of consumption of each nutrient and food group was computed. Reproducibility between the two SFFQs was evaluated by intraclass CC (ICC).ResultsRegarding validity, CC ranged from 0.05 to 0.79 (unadjusted CC, median: 0.40) and 0.10 to 0.59 (de-attenuated CC, median: 0.35) for food group and nutrient intakes, respectively. Five of the most important nutrients of interest in CKD, i.e. protein, calcium, phosphorus, potassium, and sodium had de-attenuated CC of 0.46, 0.43, 0.39, 0.32, and 0.12, respectively. The median of classification into the same or adjacent quintiles was 68% and 65% for food and nutrient intakes, respectively, and ranged from 63% to 69% for the five nutrients mentioned before. Bland-Altman plots showed good agreement across the range of intakes. ICC ranged from 0.18 to 0.66 (median: 0.46).ConclusionsThe CKD-REIN SFFQ showed acceptable validity and reproducibility in a sample of patients with CKD, notably for CKD nutrients of importance. It can now be used in large-scale epidemiological studies to easily assess the relations between diet and CKD outcomes as well as in clinical routine. It may also serve as a basis for the development of FFQs in international CKD cohort networks.

Project description:Illness perceptions involve the personal beliefs that patients have about their illness and may influence health behaviours considerably. Since an instrument to measure these perceptions for Malay population in Malaysia is lacking, we translated and examined the psychometric properties of the Malay version of the Brief Illness Perception Questionnaire (MBIPQ) in adult patients with type 2 diabetes mellitus.The MBIPQ has nine items, all use a 0-10 response scale, except the ninth item about causal factors, which is an open-ended item. A standard procedure was used to translate and adapt the English BIPQ into Malay language. Construct validity was examined comparing item scores and scores on the Diabetes Management Self-Efficacy Scale, the Morisky Medication Adherence Scale, the World Health Organization Quality of Life-brief, the 9-item Patient Health Questionnaire, the 17-item Diabetes Distress Scale, HbA1c and the presence of complications. In addition, 2-week and 4-week test-retest reliability were studied.A total of 312 patients completed the MBIPQ. Out of this, 97 and 215 patients completed the 2- or 4-weeks test-retest reliability questionnaire, respectively. Moderate inter-items correlations were observed between illness perception dimensions (r = -0.31 to 0.53). MBIPQ items showed the expected correlations with self-efficacy (r = 0.35), medication adherence (r = 0.29), quality of life (r = -0.17 to 0.31) and depressive symptoms (r = -0.18 to 0.21). People with severe diabetes-related distress also were more concern (t-test = 4.01, p < 0.001) and experienced lower personal control (t-test = 2.07, p = 0.031). People with any diabetes-related complication perceived the consequences as more serious (t-test = 2.04, p = 0.044). The 2-week and 4-week test-retest reliabilities varied between ICCagreement 0.39 to 0.70 and 0.58 to 0.78, respectively.The psychometric properties of items in the MBIPQ are moderate. The MBIPQ showed good cross-cultural validity and moderate construct validity. Test-retest reliability was moderate. Despite the moderate psychometric properties, the MBIPQ may be useful in clinical practice as it is a useful instrument to elicit and communicate on patient's personal thoughts and feelings. Future research is needed to establish its responsiveness and predictive validity.ClinicalTrials.gov NCT02730754 registered on March 29, 2016; NCT02730078 registered on March 29, 2016.

Project description:BACKGROUND: A new caregiver burden questionnaire for heart failure (CBQ-HF v1.0) was developed based on previously conducted qualitative interviews with HF caregivers and with input from HF clinical experts. Version 1.0 of the CBQ-HF included 41 items measuring the burden associated with caregiving in the following domains: physical, emotional/psychological, social, and impact on caregiver's life. Following initial development, the next stage was to evaluate caregivers' understanding of the questionnaire items and their conceptual relevance. METHODS: To evaluate the face and content validity of the new questionnaire, cognitive interviews were conducted with caregivers of heart failure patients. The cognitive interviews included a "think aloud" exercise as the patient completed the CBQ-HF, followed by more specific probing questions to better understand caregivers' understanding, interpretation and the relevance of the instructions, items, response scales and recall period. RESULTS: Eighteen caregivers of heart failure patients were recruited. The mean age of the caregivers was 50 years (SD?=?10.2). Eighty-three percent of caregivers were female and most commonly the patient was either a spouse (44%) or a parent (28%). Among the patients 55% were NYHA Class 2 and 45% were NYHA Class 3 or 4. The caregiver cognitive interviews demonstrated that the CBQ-HF was well understood, relevant and consistently interpreted. From the initial 41 item questionnaire, fifteen items were deleted due to conceptual overlap and/or item redundancy. The final 26-item CBQ-HF (v3.0) uses a 5-point Likert severity scale, assessing 4 domains of physical, emotional/psychological, social and lifestyle burdens using a 4-week recall period. CONCLUSIONS: The CBQ-HF (v3.0) is a comprehensive and relevant measure of subjective caregiver burden with strong content validity. This study has established that the CBQ-HF (v3.0) has strong face and content validity and should be valuable as an outcomes measure to help understand and monitor the relationship between patient heart failure severity and caregiver burden. A Translatability AssessmentSM of the measure has since been performed confirming the cultural appropriateness of the measure and psychometric validation is planned for the future to further explore the reliability, and validity of the new questionnaire in a larger caregiver sample.

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

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