AIMS: To describe the proportion of people with Type 2 diabetes living in Scotland who meet eligibility criteria for inclusion in several large randomized controlled trials of glycaemic control to inform physicians and guideline developers about the generalizibility of trial results. METHODS: A literature review was performed to identify large trials assessing the impact of glycaemic control on risk of macrovascular disease. Inclusion and exclusion criteria from each trial were applied to data on the population of people with a diagnosis of Type 2 diabetes living in Scotland in 2008 (n = 180,590) in a population-based cross-sectional study and the number and proportion of people eligible for each trial was determined. RESULTS: Seven trials were identified. The proportion of people with Type 2 diabetes who met the eligibility criteria for the trials ranged from 3.5 to 50.7%. Trial participants were younger at age of diagnosis of diabetes and at time of trial recruitment than in the Scottish study population. The application of upper age criteria excluded the largest proportion of patients, with up to 39% of people with Type 2 diabetes ineligible for a trial with the most stringent criteria based on age alone. CONCLUSIONS: We found that many of the large trials of glycaemic control among people with Type 2 diabetes have limited external validity when applied to a population-based cohort of people with Type 2 diabetes. In particular, the age distribution of trial participants often does not reflect that of people with Type 2 diabetes in a contemporary British population.
AIMS: To describe the proportion of people with Type 2 diabetes living in Scotland who meet eligibility criteria for inclusion in several large randomized controlled trials of glycaemic control to inform physicians and guideline developers about the generalizibility of trial results. METHODS: A literature review was performed to identify large trials assessing the impact of glycaemic control on risk of macrovascular disease. Inclusion and exclusion criteria from each trial were applied to data on the population of people with a diagnosis of Type 2 diabetes living in Scotland in 2008 (n = 180,590) in a population-based cross-sectional study and the number and proportion of people eligible for each trial was determined. RESULTS: Seven trials were identified. The proportion of people with Type 2 diabetes who met the eligibility criteria for the trials ranged from 3.5 to 50.7%. Trial participants were younger at age of diagnosis of diabetes and at time of trial recruitment than in the Scottish study population. The application of upper age criteria excluded the largest proportion of patients, with up to 39% of people with Type 2 diabetes ineligible for a trial with the most stringent criteria based on age alone. CONCLUSIONS: We found that many of the large trials of glycaemic control among people with Type 2 diabetes have limited external validity when applied to a population-based cohort of people with Type 2 diabetes. In particular, the age distribution of trial participants often does not reflect that of people with Type 2 diabetes in a contemporary British population.
Authors: Gijs F N Berkelmans; Soffia Gudbjörnsdottir; Frank L J Visseren; Sarah H Wild; Stefan Franzen; John Chalmers; Barry R Davis; Neil R Poulter; Annemieke M Spijkerman; Mark Woodward; Sara L Pressel; Ajay K Gupta; Yvonne T van der Schouw; Ann-Marie Svensson; Yolanda van der Graaf; Stephanie H Read; Bjorn Eliasson; Jannick A N Dorresteijn Journal: Eur Heart J Date: 2019-09-07 Impact factor: 29.983
Authors: Evangelos Kontopantelis; David A Springate; David Reeves; Darren M Ashcroft; Martin K Rutter; Martin Rutter; Iain Buchan; Tim Doran Journal: Diabetologia Date: 2014-12-16 Impact factor: 10.122
Authors: Shaun Treweek; Doug G Altman; Peter Bower; Marion Campbell; Iain Chalmers; Seonaidh Cotton; Peter Craig; David Crosby; Peter Davidson; Declan Devane; Lelia Duley; Janet Dunn; Diana Elbourne; Barbara Farrell; Carrol Gamble; Katie Gillies; Kerry Hood; Trudie Lang; Roberta Littleford; Kirsty Loudon; Alison McDonald; Gladys McPherson; Annmarie Nelson; John Norrie; Craig Ramsay; Peter Sandercock; Daniel R Shanahan; William Summerskill; Matt Sydes; Paula Williamson; Mike Clarke Journal: Trials Date: 2015-06-05 Impact factor: 2.279