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document
The ADDITION-Cambridge trial protocol : a cluster -- randomised controlled trial of screening for type 2 diabetes and intensive treatment for screen-detected patients . BACKGROUND The increasing prevalence of type 2 diabetes poses a major public health challenge . Population-based screening and early treatment for type 2 diabetes could reduce this growing burden . However , the benefits of such a strategy remain uncertain . METHODS AND DESIGN The ADDITION-Cambridge study aims to evaluate the effectiveness and cost-effectiveness of ( i ) a stepwise screening strategy for type 2 diabetes ; and ( ii ) intensive multifactorial treatment for people with screen-detected diabetes in primary care . 63 practices in the East Anglia region participated . Three undertook the pilot study , 33 were allocated to three groups : no screening ( control ) , screening followed by intensive treatment ( IT ) and screening plus routine care ( RC ) in an unbalanced ( 1:3:3 ) randomisation . The remaining 27 practices were randomly allocated to IT and RC . A risk score incorporating routine practice data was used to identify people aged 40-69 years at high-risk of undiagnosed diabetes . In the screening practices , high-risk individuals were invited to take part in a stepwise screening programme . In the IT group , diabetes treatment is optimised through guidelines , target-led multifactorial treatment , audit , feedback , and academic detailing for practice teams , alongside provision of educational materials for newly diagnosed participants . Primary endpoints are modelled cardiovascular risk at one year , and cardiovascular mortality and morbidity at five years after diagnosis of diabetes . Secondary endpoints include all-cause mortality , development of renal and visual impairment , peripheral neuropathy , health service costs , self-reported quality of life , functional status and health utility . Impact of the screening programme at the population level is also assessed through measures of mortality , cardiovascular morbidity , health status and health service use among high-risk individuals . DISCUSSION ADDITION-Cambridge is conducted in a defined high-risk group accessible through primary care . It addresses the feasibility of population-based screening for diabetes , as well as the benefits and costs of screening and intensive multifactorial treatment early in the disease trajectory . The intensive treatment algorithm is based on evidence from studies including individuals with clinically diagnosed diabetes and the education materials are informed by psychological theory . ADDITION-Cambridge will provide timely evidence concerning the benefits of early intensive treatment and will inform policy decisions concerning screening for type 2 diabetes . TRIAL REGISTRATION Current Controlled trials ISRCTN86769081 .
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Intervention_Educational
intensive multifactorial treatment
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Intervention_Control
no screening ( control )
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Intervention_Educational
screening followed by intensive treatment ( IT )
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Intervention_Educational
screening plus routine care
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Outcome_Other
effectiveness
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Outcome_Other
cost-effectiveness
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Outcome_Physical
modelled cardiovascular risk at one year
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Outcome_Mortality
cardiovascular mortality and morbidity at five years
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Outcome_Mortality
all-cause mortality
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Outcome_Physical
development of renal and visual impairment
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Outcome_Physical
peripheral neuropathy
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Outcome_Other
health service costs
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Outcome_Physical
self-reported quality of life
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Outcome_Physical
functional status
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Outcome_Physical
health utility
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Outcome_Mortality
mortality
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Outcome_Physical
cardiovascular morbidity