Health-Related Quality of Life and Cost-Effectiveness Components of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial: Rationale and Design

Sullivan, Mark D.; Anderson, Roger T.; Aron, David C.; Atkinson, Hal H.; Bastien, Arnaud; Chen, G. John; Feeney, Patricia; Gafni, Amiram; Hwang, Wenke; Katz, Lois A.; Narayan, K.M. Venkat; Nwachuku, Chuke; O’Connor, Patrick J.; Zhang, Ping

doi:10.1016/j.amjcard.2007.03.027

Cited by 25 publications

(17 citation statements)

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“…The first year of the trial was selected for detailed exploration as the major reductions in glycaemia in both study arms were achieved in this period. Assessment of diabetes symptom burdens is considered indicative of patient discomfort, but also effectiveness of treatment [2]. Meanwhile, because occurrence and severity of diabetes‐related complications is a major focus of the ACCORD study, and these have been reported to be negatively associated with patient‐perceived health status [11], we investigated general physical and mental health [12].…”

Section: Introductionmentioning

confidence: 99%

“…The intensive arm of the glycaemia trial was discontinued in 2008 because of higher mortality in subjects randomized to intensive control [target HbA 1c < 6% (< 42 mmol ⁄ mol)] compared with standard therapy [target HbA 1c 7.0-7.9% (53-63 mmol ⁄ mol)] [1]. This report focuses on the health-related quality of life and cost-effectiveness substudy which was integrated into the main study design [2] and offers opportunities to investigate a variety of short-and long-term PROs that contribute to patients' HRQoL across a spectrum of treatment intensity and levels of risk factor control achieved.…”

Section: Introductionmentioning

confidence: 99%

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Glycaemia and correlates of patient‐reported outcomes in ACCORD trial participants

et al. 2012

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Glycaemia and correlates of patient‐reported outcomes in ACCORD trial participants

et al. 2012

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“…It also allowed us to examine how the effect of depression on mortality and CVD differs between those with and without previous CVD and examine whether any effect of depression on mortality or CVD is modified by randomization to intensive versus standard glucose control. Specific hypotheses from the ACCORD Health-Related Quality of Life (HRQL) substudy examined in this epidemiological analysis are as follows (13). After controlling for baseline factors, depression will be associated with the following: 1 ) primary composite outcome (death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke); 2 ) all-cause mortality; 3 ) composite macrovascular outcome (primary outcome plus any revascularization plus hospitalization for congestive heart failure [CHF]); and 4 ) composite microvascular outcome (fatal or nonfatal renal failure or retinal photocoagulation or vitrectomy for diabetic retinopathy).…”

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confidence: 99%

Depression Predicts All-Cause Mortality

et al. 2012

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OBJECTIVEDepression affects up to 20–25% of adults with type 2 diabetes and may increase all-cause mortality, but few well-designed studies have examined the effects of depression on the full range of cardiovascular disease outcomes in type 2 diabetes.RESEARCH DESIGN AND METHODSA total of 2,053 participants in the ACCORD (Action to Control Cardiovascular Risk in Diabetes) Health-Related Quality of Life substudy completed the Patient Health Questionnaire (PHQ)-9 measure of depression symptoms at baseline and 12, 36, and 48 months. Cox proportional hazards regression models were used to estimate hazard ratios (HRs) (95% CI) for the time-varying impact of depression on protocol-defined clinical outcomes with and without adjustment for demographic, trial-related, clinical, and behavioral variables.RESULTSIn fully adjusted models, depression was not significantly related to the ACCORD primary composite outcome (cardiovascular death, nonfatal heart attack, or stroke) (HR 1.53 [95% CI 0.85–2.73]) or to the ACCORD microvascular composite outcome (0.93 [0.53–1.62]), but all-cause mortality was significantly increased both in those with PHQ-assessed probable major depression (2.24 [1.24–4.06]) and PHQ score of ≥10 (1.84 [1.17–2.89]). The effect of depression on all-cause mortality was not related to previous cardiovascular events or to assignment to intensive or standard glycemia control. Probable major depression (by PHQ-9) had a borderline impact on the ACCORD macrovascular end point (1.42 [0.99–2.04]).CONCLUSIONSDepression increases the risk of all-cause mortality and may increase the risk of macrovascular events among adults with type 2 diabetes at high risk for cardiovascular events.

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“…All participants were also randomized to the blood pressure or lipid trial arms. An ACCORD substudy focused on health-related quality of life (HRQL) outcomes associated with intensive versus standard glycemic control strategies (2). The rationale for the HRQL substudy was the need to consider the impact or potential benefit of intensive glycemia management from the participants’ point of view.…”

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confidence: 99%

Effect of Intensive Glycemic Lowering on Health-Related Quality of Life in Type 2 Diabetes

et al. 2011

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OBJECTIVETo 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 METHODSA randomly selected subsample of 2,053 ACCORD participants enrolled in 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.RESULTSA 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.CONCLUSIONSThe 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.

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Health-Related Quality of Life and Cost-Effectiveness Components of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial: Rationale and Design

Cited by 25 publications

References 17 publications

Glycaemia and correlates of patient‐reported outcomes in ACCORD trial participants

Glycaemia and correlates of patient‐reported outcomes in ACCORD trial participants

Depression Predicts All-Cause Mortality

Effect of Intensive Glycemic Lowering on Health-Related Quality of Life in Type 2 Diabetes

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