التفاصيل البيبلوغرافية
| العنوان: |
Rationale and design of the ADDITION-Leicester study, a systematic screening programme and Randomised Controlled Trial of multi-factorial cardiovascular risk intervention in people with Type 2 Diabetes Mellitus detected by screening |
| المؤلفون: |
Webb, DR, Khunti, K, Srinivasan, B, Gray, LJ, Taub, N, Campbell, S, Barnett, J, Henson, J, Hiles, S, Farooqi, A, Griffin, SJ, Wareham, NJ, Davies, MJ |
| بيانات النشر: |
BioMed Central Ltd. |
| سنة النشر: |
2010 |
| المجموعة: |
BioMed Central |
| الوصف: |
Background Earlier diagnosis followed by multi-factorial cardiovascular risk intervention may improve outcomes in Type 2 Diabetes Mellitus (T2DM). Latent phase identification through screening requires structured, appropriately targeted population-based approaches. Providers responsible for implementing screening policy await evidence of clinical and cost effectiveness from randomised intervention trials in screen-detected T2DM cases. UK South Asians are at particularly high risk of abnormal glucose tolerance and T2DM. To be effective national screening programmes must achieve good coverage across the population by identifying barriers to the detection of disease and adapting to the delivery of earlier care. Here we describe the rationale and methods of a systematic community screening programme and randomised controlled trial of cardiovascular risk management within a UK multiethnic setting (ADDITION-Leicester). Design A single-blind cluster randomised, parallel group trial among people with screen-detected T2DM comparing a protocol driven intensive multi-factorial treatment with conventional care. Methods ADDITION-Leicester consists of community-based screening and intervention phases within 20 general practices coordinated from a single academic research centre. Screening adopts a universal diagnostic approach via repeated 75g-Oral Glucose Tolerance Tests within an eligible non-diabetic population of 66,320 individuals aged 40-75 years (25-75 years South Asian). Volunteers also provide detailed medical and family histories; complete health questionnaires, undergo anthropometric measures, lipid profiling and a proteinuria assessment. Primary outcome is reduction in modelled Coronary Heart Disease (UKPDS CHD) risk at five years. Seven thousand (30% of South Asian ethnic origin) volunteers over three years will be recruited to identify a screen-detected T2DM cohort (n = 285) powered to detected a 6% relative difference (80% power, alpha 0.05) between treatment groups at one year. Randomisation will ... |
| نوع الوثيقة: |
report |
| اللغة: |
English |
| العلاقة: |
http://www.trialsjournal.com/content/11/1/16Test |
| الإتاحة: |
http://www.trialsjournal.com/content/11/1/16Test |
| حقوق: |
Copyright 2010 Webb et al; licensee BioMed Central Ltd. |
| رقم الانضمام: |
edsbas.4F1C7086 |
| قاعدة البيانات: |
BASE |
