Name:

ADDITION Europe

Parent study:

Addition, Anglo Danish Dutch study of Intensive Treatment In People with screen detected diabetes in primary care

Other names:

N/A

Description:

ADDITION is the Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care.

ADDITION-Europe is a basic data set containing information at baseline and 5-year follow-up from all four European centres: Cambridge, Leicester, Denmark and the Netherlands. We also hold more extensive data sets for Cambridge; see the ADDITION-Cambridge, ADDITION-Plus, ADDITION-Cambridge-screening and ADDITION-10% pages.

The database follows the Unit's generic model and standardises its structure and management to match other studies for data sharing.

Abstract:

The multi-centre Anglo-Danish-Dutch Study of Intensive Treatment In People with Screen Detected Diabetes in Primary Care (ADDITION-Europe) was established in 2001. It consists of a screening phase, and (ii) a pragmatic, cluster-randomised parallel group trial of intensive multifactorial treatment versus routine care in four centres (Denmark, Cambridge UK, the Netherlands and Leicester UK). Following screening in 343 practices, 3,057 eligible participants with screen-detected diabetes agreed to take part in the treatment trial. Participants were followed-up after five years to examine CVD events (99.9% endpoint ascertainment), microvascular outcomes and health status in the two groups.

Locations:

Location 1: Cambridge, UK The Centre	Location 2 : Leicester, UK The Centre
Location 3: Denmark	Location 4 : The Netherlands The Centre

Keywords:

Type 2 diabetes, screening, cardiovascular disease, randomised trial, intensive treatment, primary care

Research areas:

the scientific research areas that the study covers include screening for undiagnosed diabetes patients, and treatment of newly-diagnosed diabetes patients.

Research purposes:

The study aimed to examine the effects of intensive treatment (IT) vs routine care (RC) on patient-reported outcomes after 5 years in screen-detected diabetes patients.

Population:

People aged 40-69 years without known diabetes.

Status:

Data collection and cleaning is finished for baseline and five-year datasets. Ten-year follow-up is planned for 2014-15. Data cleaning has been carried out by ADDITION Denmark and ADDITION Cambridge staff.

Recruitment:

No longer recruiting.

Between April 2001 and December 2006, 3,057 people with screen-detected diabetes were recruited to the study (mean age 59.7 years, 58% men) after a stepwise screening programme involving 76,308 people screened in 334 general practices in three countries.

Start date:

Recruitment start: April 2001

End date:

Recruitment end: December 2006

Links:

Title	Five-year trial results
Publication	http://www.sciencedirect.com/science/article/pii/S0140673611606983
Website	http://addition.au.dk/
PubMed	http://www.ncbi.nlm.nih.gov/pubmed/21705063

Identifiers:

Identifier	Description
NCT00237549	at ClinicalTrials.gov

Approvals required:

Approval	Details
Ethics	The study was approved by the local scientific ethics committees in the specific countries and counties and was conducted in accordance with the principles of the 1996 Helsinki Declaration. All participants provided informed consent.

Funding required: details of financial support required for data access/sharing

Funding	Details
Denmark	The ADDITION study in Denmark was supported by the National Health Services in the counties of Copenhagen, Aarhus, Ringkøbing, Ribe and South Jutland, together with the Danish Research Foundation for General Practice, Danish Centre for Evaluation and Health Technology Assessment, the diabetes fund of the National Board of Health, the Danish Medical Research Council, the Aarhus University Research Foundation and the Novo Nordisk Foundation. The study received unrestricted grants from Novo Nordisk, Novo Nordisk Scandinavia, Astra Denmark, Pfizer Denmark, GlaxoSmithKline Pharma Denmark, Servier Denmark and HemoCue Denmark.
Cambridge	ADDITION-Cambridge was supported by the Wellcome Trust, the Medical Research Council, the NIHR Health Technology Assessment Programme, National Health Service R&D support funding and the National Institute for Health Research. SJG received support from the Department of Health NIHR grant funding scheme.
Leicester	ADDITION-Leicester was supported by Department of Health, the NIHR Health Technology Assessment Programme, National Health Service R&D support funding and the National Institute for Health Research and an unrestricted grant from Servier UK.
Netherlands	ADDITION-Netherlands was supported by unrestricted grants from Novo Nordisk, Glaxo Smith Kline and Merck, and by the Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht.

Data access:

This is an international collaboration. Data requests are submitted to the ADDITION-Europe international trial steering committee (TSC) for approval is available and once completed should be sent in the first instance to datasharing@mrc-epid (or alternatively please print, complete, scan and submit using this PDF). The ADDITION-Europe PI, Dr Rebecca Simmons, will manage the processing of your data request.

Data Collection

Data collected:

details of financial support required for data access/sharing

A broad categorisation of the data collected covers; anthropometry, biochemistry (blood and urine), self-report demographics, self-report medical history (inc. Rose angina questionnaire), self-report health service use, self-report medication use, self-report alcohol intake, self-report smoking, self-report neuropathy (Michigan questionnaire), self-report physical activity (IPAQ questionnaire), self-report anxiety, self-report health state (EuroQoL questionnaire, SF-36 questionnaire, ADDQoL questionnaire, WBQ12 questionnaire), self-report diabetes treatment satisfaction, retinopathy, ECGs, cardio-vascular events, deaths.

Sample size:

By the end of the screening phase of the ADDITION study, 343 general practices (182 in Denmark, 49 in Cambridge, 24 in Leicester and 79 in the Netherlands) had screened 76,308 people (28,031 in Denmark, 24,654 in Cambridge, 5,740 in Leicester and 17,883 in the Netherlands). In total, 3,233 individuals with screen-detected diabetes were identified and a total of 3,057 individuals (1,771 men, 1,286 women) (1,533 in Denmark, 867 in Cambridge, 159 in Leicester and 498 in the Netherlands) were recruited to the ADDITION study. There were no significant differences in the characteristics of the 3,057 participants recruited to the trial compared with the 176 patients with screen-detected diabetes who were eligible but chose not to participate.

Sampling method:

Screening programmes, which varied by centre, included a risk score (Cambridge) or self-completion questionnaires (Denmark and the Netherlands) followed by capillary glucose testing, or invitation to attend an oral glucose tolerance test without prior risk assessment (Leicester). Individuals were diagnosed with diabetes according to WHO criteria, including the requirement for confirmatory tests on separate occasions.

Participation type:

Opt in

Inclusion criteria:

People aged 40 to 69 years who were not known to have diabetes but who are at high risk of diabetes.

Exclusion criteria:

General practitioners assessed patients against exclusion criteria: an illness with a life expectancy of less than twelve months, housebound, pregnancy or lactation, or psychological or psychiatric problems that might invalidate informed consent.

Current size:

3057 participants (release data sets contain all 3057 participants)

Data collection events:

Name	Description	Collection type	Categories
Baseline clinic	Baseline anthropometry, biochemistry, questionnaires	Clinic measurement
5 year clinic	5-year anthropometry, biochemistry, retinopathy, ECGs, questionnaires	Clinic measurement
5 year CV events	5 year vital status and CV event history	Medical record / database search

Accountable people:

Role	Name (follow link for contact details)
Chief Investigator	Prof Simon Griffin
Principal Investigator	Dr Rebecca Simmons
Data Analyst	Dr Clare Boothby
Senior Data Manager	Tony Webb

Data sources:

• Access overview study details by following the OVERVIEW link for a study
• Access the details of a studies data and releases by following the RELEASE link for a study
• Access the latest study data dictionary by following the DICTIONARY link for a study
• Access the study questionaiires by following the QUESTIONNAIRES link for a study

OVERVIEW

RELEASE

DICTIONARY

QUESTIONNAIRES

Related parties:

N/A

Additional information:

N/A

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