TY - JOUR

T1 - The effectiveness of structured personal care of type 2 diabetes on recurrent outcomes

T2 - a 19 year follow-up of the study Diabetes Care in General Practice (DCGP)

AU - Lundström, Hanna Maria

AU - Siersma, Volkert Dirk

AU - Nielsen, Anni Brit Sternhagen

AU - Brodersen, John

AU - Reventlow, Susanne

AU - Andersen, Per Kragh

AU - Olivarius, Niels

PY - 2014/6

Y1 - 2014/6

N2 - AbstractAIMS/HYPOTHESIS:The estimation of effect size in clinical trials commonly disregards recurrent outcomes. We investigated the effectiveness of a complex intervention on recurrent outcomes in patients with type 2 diabetes.METHODS:In the Diabetes Care in General Practice (DCGP) randomised controlled trial, 1,381 patients newly diagnosed with type 2 diabetes were randomised to 6 years of structured personal care or routine care (ClinicalTrials.gov NCT01074762). The trial had 19 years of registry-based follow-up and was analysed with Cox regression models. Repeated occurrences in the same patient of outcomes (any diabetes-related endpoint, myocardial infarction [MI], stroke, peripheral vascular disease and microvascular disease) were accounted for with the Wei, Lin and Weissfeld method.RESULTS:As previously shown, the intervention reduced the rates of first occurrence of both MI and any diabetes-related endpoint. However, for all outcomes, the HR for a second event showed a statistically non-significant tendency to be increased. We estimated a combined HR for all marginal failure times, regardless of whether they were first, second or later events. This showed that the intervention had no effect on the rate of any of the outcomes, including MI (HR 0.89, 95% CI 0.76, 1.05) and any diabetes-related endpoint (HR 0.98, 95% CI 0.87, 1.09).CONCLUSIONS/INTERPRETATION:In the DCGP study, a smaller proportion of patients who received structured care experienced a first occurrence of MI or any diabetes-related endpoint compared with patients who received routine care. However, the patients who received structured care tended to experience more recurrent outcomes, so the total outcome rate was not affected by the intervention.

AB - AbstractAIMS/HYPOTHESIS:The estimation of effect size in clinical trials commonly disregards recurrent outcomes. We investigated the effectiveness of a complex intervention on recurrent outcomes in patients with type 2 diabetes.METHODS:In the Diabetes Care in General Practice (DCGP) randomised controlled trial, 1,381 patients newly diagnosed with type 2 diabetes were randomised to 6 years of structured personal care or routine care (ClinicalTrials.gov NCT01074762). The trial had 19 years of registry-based follow-up and was analysed with Cox regression models. Repeated occurrences in the same patient of outcomes (any diabetes-related endpoint, myocardial infarction [MI], stroke, peripheral vascular disease and microvascular disease) were accounted for with the Wei, Lin and Weissfeld method.RESULTS:As previously shown, the intervention reduced the rates of first occurrence of both MI and any diabetes-related endpoint. However, for all outcomes, the HR for a second event showed a statistically non-significant tendency to be increased. We estimated a combined HR for all marginal failure times, regardless of whether they were first, second or later events. This showed that the intervention had no effect on the rate of any of the outcomes, including MI (HR 0.89, 95% CI 0.76, 1.05) and any diabetes-related endpoint (HR 0.98, 95% CI 0.87, 1.09).CONCLUSIONS/INTERPRETATION:In the DCGP study, a smaller proportion of patients who received structured care experienced a first occurrence of MI or any diabetes-related endpoint compared with patients who received routine care. However, the patients who received structured care tended to experience more recurrent outcomes, so the total outcome rate was not affected by the intervention.

KW - Faculty of Health and Medical Sciences

KW - Any diabetes-related endpoint

KW - Myocardial Infarction

KW - Randomised controlled trial

KW - Recurrent events

KW - Type 2 diabetes

KW - Wei, Lin and Weissfeld method

U2 - 10.1007/s00125-014-3204-1

DO - 10.1007/s00125-014-3204-1

M3 - Journal article

C2 - 24599111

VL - 57

SP - 1119

EP - 1123

JO - Diabetologia

JF - Diabetologia

SN - 0012-186X

IS - 6

ER -