期刊
DIABETES CARE
卷 34, 期 4, 页码 807-812出版社
AMER DIABETES ASSOC
DOI: 10.2337/dc10-1926
关键词
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资金
- National Heart, Lung, and Blood Institute [N01-HC-95178, N01-HC-95179, N01-HC-95180, N01-HC-95181, N01-HC-95182, N01-HC-95183, N01-HC-95184, IAA-Y1-HC-9035, IAA-Y1-HC-1010]
- National Institutes of Health
- National Institute of Diabetes and Digestive and Kidney Diseases
- National Institute on Aging
- National Eye Institute
- Centers for Disease Control and Prevention
- General Clinical Research Centers
- Merck
- GSK
- Lilly
- Abbott Laboratories through HealthPartners Research Foundation
- Amylin
- Abbott
- Bayer
- Daiichi Sankyo
- Dexcom
- Edwards Life-sciences
- Eli Lilly
- Hygeia
- Intarcia
- Johnson and Johnson/LifeScan
- MannKind
- Medtronic
- Novo Nordisk
- Quotient Diagnostics
- ResMed
- Roche
- sanofi-aventis
- Schering-Plough
- Takeda
- Valeritas
OBJECTIVE-To compare the effect of intensive versus standard glycemic control strategies on health-related quality of life (HRQL) in a substudy of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. RESEARCH DESIGN AND METHODS-A randomly selected subsample of 2,053 ACCORD participants enrolled fit the HRQL substudy was assessed at baseline and 12-, 36-, and 48-month visits. HRQL assessment included general health status (the 36-Item Short Form Health Survey [SF-36]), diabetes symptoms (the Diabetes Symptom Distress Checklist), depression (Patient Health Questionnaire [PHQ]-9), and treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire [DTSQ]). Repeated-measures ANOVA models were used to estimate change in HRQL outcomes by treatment group over 48 months adjusting for model covariates. The effects of early discontinuation of the ACCORD intensive glycemic control arm on study results were explored. RESULTS-A total of 1,956 (95%) completed the self-report HRQL instrument (s) at baseline. The intensive arm had a larger decrease in SF-36 physical health component score than the standard arm (-1.6 vs. -1.1, P = 0.0345). Treatment satisfaction (DTSQ) showed larger improvement with intensive than standard (P = 0.0004). There were no differences in mean scores of the Diabetes Symptom Checklist and PHQ-9. Effects of participant transition following discontinuation of the intensive arm on HRQL were not significant. CONCLUSIONS-The ACCORD trial strategy of intensive glycemic control did not lead to benefits in HRQL and was associated with modest improvement in diabetes treatment satisfaction. Thus patient acceptability was apparently not compromised with intensive and complex interventions such as those used in ACCORD. Diabetes Care 34:807-812, 2011
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