Development and validation of the Diabetes Quality of Life Clinical Trial Questionnaire.

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  • Additional Information
    • Source:
      Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 0230027 Publication Model: Print Cited Medium: Print ISSN: 0025-7079 (Print) Linking ISSN: 00257079 NLM ISO Abbreviation: Med Care Subsets: MEDLINE
    • Publication Information:
      Publication: Hagerstown, MD : Lippincott Williams & Wilkins
      Original Publication: Philadelphia, etc., Lippincott.
    • Subject Terms:
      Health Status Indicators* ; Quality of Life* ; Surveys and Questionnaires*; Diabetes Mellitus, Type 1/*psychology ; Diabetes Mellitus, Type 2/*psychology; Adult ; Canada ; Clinical Trials as Topic ; Diabetes Mellitus, Type 1/drug therapy ; Diabetes Mellitus, Type 2/drug therapy ; Female ; Focus Groups ; France ; Germany ; Humans ; Hypoglycemic Agents/therapeutic use ; Insulin/analogs & derivatives ; Insulin/therapeutic use ; Insulin Lispro ; Male ; Middle Aged ; Multicenter Studies as Topic ; Pilot Projects ; Psychometrics ; Reproducibility of Results ; United States
    • Abstract:
      Objective: The objective of this study was to develop a valid and reliable health-related quality of life (HRQOL) questionnaire for use in multinational clinical trials of patients with type I and type II diabetes.
      Methods: Through patient focus groups and expert clinician panels in the United States (US) and France, relevant HRQOL domains for patients with type I and type II diabetes were identified. A draft questionnaire was developed by including validated, widely used generic and diabetes-specific domains and by developing original questions as required. A pilot study (n = 123) was conducted to evaluate the psychometric properties of the draft questionnaire with revisions being subsequently made. Data collected from two multinational clinical trials of patients with type I and type II diabetes were used to further validate and enhance the questionnaire (DQLCTQ).
      Results: A total of 942 patients were recruited in the clinical trials from Canada, France, Germany, and the United States. The mean age was 33.8 years for patients with type I diabetes (n = 468) and 58.2 years for patients with type II diabetes (n = 474). The mean HbAlc level at baseline was 8.6. The revised version of the questionnaire (DQLCTQ-R) contains a total of 57 questions comprising 8 generic and disease-specific domains, as follows: Physical Function; Energy/Fatigue; Health Distress; Mental Health; Satisfaction; Treatment Satisfaction; Treatment Flexibility; and Frequency of Symptoms. Intraclass correlation coefficients range from 0.74 to 0.90 and Cronbach's alphas range from 0.77 to 0.90. With very few exceptions, all eight domains were able to discriminate between type I and type II diabetes, tight and poor metabolic control, male and female, and good and poor self perceived control of diabetes. Four domains (Treatment Satisfaction, Health/Distress, Mental Health, and Satisfaction) were responsive to clinical change in metabolic control.
      Conclusion: The DQLCTQ-R is a reliable, valid, and comprehensive HRQOL instrument. It is suitable in multinational clinical trials to evaluate new or alternative treatments for patients with type I and type II diabetes.
    • Accession Number:
      0 (Hypoglycemic Agents)
      0 (Insulin)
      0 (Insulin Lispro)
    • Publication Date:
      Date Created: 19990427 Date Completed: 19990520 Latest Revision: 20190822
    • Publication Date:
      20221213
    • Accession Number:
      10.1097/00005650-199904001-00008
    • Accession Number:
      10217393