AIMS/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.
RCT Entities:
AIMS/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.
Authors: Shanthi Mendis; Kristian Thygesen; Kari Kuulasmaa; Simona Giampaoli; Markku Mähönen; Kathleen Ngu Blackett; Liu Lisheng Journal: Int J Epidemiol Date: 2010-10-05 Impact factor: 7.196
Authors: John C LaRosa; Prakash C Deedwania; James Shepherd; Nanette K Wenger; Heiner Greten; David A DeMicco; Andrei Breazna Journal: Am J Cardiol Date: 2009-12-22 Impact factor: 2.778
Authors: Payal Kohli; Lars Wallentin; Eric Reyes; Jay Horrow; Steen Husted; Dominick J Angiolillo; Diego Ardissino; Gerald Maurer; Joao Morais; José C Nicolau; Ali Oto; Robert F Storey; Stefan K James; Christopher P Cannon Journal: Circulation Date: 2012-12-31 Impact factor: 29.690
Authors: R K Simmons; S J Sharp; A Sandbæk; K Borch-Johnsen; M J Davies; K Khunti; T Lauritzen; G E H M Rutten; M van den Donk; N J Wareham; S J Griffin Journal: Diabet Med Date: 2012-11 Impact factor: 4.359
Authors: Simon J Griffin; Knut Borch-Johnsen; Melanie J Davies; Kamlesh Khunti; Guy E H M Rutten; Annelli Sandbæk; Stephen J Sharp; Rebecca K Simmons; Maureen van den Donk; Nicholas J Wareham; Torsten Lauritzen Journal: Lancet Date: 2011-06-24 Impact factor: 79.321
Authors: Sabina A Murphy; Elliott M Antman; Stephen D Wiviott; Govinda Weerakkody; Giorgio Morocutti; Kurt Huber; Jose Lopez-Sendon; Carolyn H McCabe; Eugene Braunwald Journal: Eur Heart J Date: 2008-08-05 Impact factor: 29.983
Authors: Amber A W A van der Heijden; Esther Van't Riet; Sandra D M Bot; Suzanne C Cannegieter; Coen D A Stehouwer; Caroline A Baan; Jacqueline M Dekker; Giel Nijpels Journal: Diabetes Care Date: 2013-07-22 Impact factor: 19.112