LSHTM Research Online

Craig, P; Dieppe, P; MacIntyre, S; Mitchie, S; Nazareth, I; Petticrew, M; (2008) Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ, 337 (7676). ISSN 0959-8138 DOI: 10.1136/bmj.a918

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Abstract

OBJECTIVE: To examine the relation between blood pressure and the development of early retinopathy in adolescents with childhood onset type 1 diabetes. DESIGN: Prospective cohort study. SETTING: Diabetes Complications Assessment Service at the Children's Hospital at Westmead, Sydney, Australia. PARTICIPANTS: 1869 patients with type 1 diabetes (54% female) screened for retinopathy with baseline median age 13.4 (interquartile range 12.0-15.2) years, duration 4.9 (3.1-7.0) years, and albumin excretion rate of 4.4 (3.1-6.8) microg/min plus a subgroup of 1093 patients retinopathy-free at baseline and followed for a median 4.1 (2.4-6.6) years. MAIN OUTCOME MEASURES: Early background retinopathy; blood pressure. RESULTS: Overall, retinopathy developed in 673 (36%) participants at any time point. In the retinopathy-free group, higher systolic blood pressure (odds ratio 1.01, 95% confidence interval 1.003 to 1.02) and diastolic blood pressure (1.01, 1.002 to 1.03) were predictors of retinopathy, after adjustment for albumin excretion rate (1.27, 1.13 to 1.42), haemoglobin A(1c) (1.08, 1.02 to 1.15), duration of diabetes (1.16, 1.13 to 1.19), age (1.13, 1.08 to 1.17), and height (0.98, 0.97 to 0.99). In a subgroup of 1025 patients with albumin excretion rate below 7.5 microg/min, the cumulative risk of retinopathy at 10 years' duration of diabetes was higher for those with systolic blood pressure on or above the 90th centile compared with those below the 90th centile (58% v 35%, P=0.03). The risk was also higher for patients with diastolic blood pressure on or above the 90th centile compared with those below the 90th centile (57% v 35%, P=0.005). CONCLUSIONS: Both systolic and diastolic blood pressure are predictors of retinopathy and increase the probability of early retinopathy independently of incipient nephropathy in young patients with type 1 diabetes.

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