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MRC Epidemiology Unit : Data Sharing

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ADDITION-Cambridge Study Level Descriptors

Name:
ADDITION-Cambridge

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-Cambridge is an extensive data set containing information from baseline, one-year and five-year follow-up from the Cambridge centre of the ADDITION-Europe trial.

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:

Cambridge Test Centre
The Centre

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

Research areas:
Screening for undiagnosed diabetes patients, and early treatment of newly-diagnosed diabetes patients.

Research purposes:
The study aimed to examine the effects of intensive treatment (IT) vs routine care (RC) on macrovascular, microvascular and patient-reported outcomes after one and five years in screen-detected diabetes patients.

Population:
People aged 40-69 years without known diabetes.

Status:
Data collection and cleaning is finished for baseline, one-year and five-year datasets. Ten-year follow-up is planned for 2014-15. Data cleaning has been carried out by 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. 867 individuals were recruited for ADDITION-Cambridge.

Start date:
Recruitment start: 2001/April

End date:
Recruitment end: 2006/December

Identifiers:

Identifier
Description
NCT00237549
ClinicalTrials.gov

Approvals required:

Approval
Details
Ethics
867 individuals agreed to participate and all respondents provided written informed consent. Ethics approval was granted by the Eastern Multi-Regional Ethics Committee (ref 02/5/54). The study was conducted in accordance with the principles of the 1996 Helsinki Declaration.

Funding required:

Funding
Details
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.

Data access:
Data requests are submitted to the ADDITION-Cambridge trial steering committee (TSC) for approval. A Data Request Form for submission to the ADDITION-Cambridge TSC 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-Cambridge data analyst, Dr Clare Boothby, will manage the processing of your data request.

Data collected:
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, EPAQ questionnaire), self-report anxiety, self-report health state (EuroQoL questionnaire, SF-36 questionnaire, ADDQoL questionnaire, WBQ12 questionnaire), self-report diabetes treatment satisfaction, self-report diet (EPIC FFQ questionnaire), retinopathy, ECGs, cardiovascular events, deaths, self-report treatment satisfaction, self-report diabetes knowledge.

Sample size:
867 individuals with screen-detected diabetes.

Sampling method:
The invitation list for screening was defined at the outset of the study; practices were asked to only invite the patients on the list that we provided. In the screening group (IT and RC), eligible individuals were sent a personal invitation from their general practitioner to attend their practice for stepwise screening including random capillary blood glucose and HbA1c tests, a fasting capillary blood glucose test, followed by a confirmatory oral glucose tolerance test (OGTT) undertaken in a local outpatient facility. Individuals attending the final OGTT stage also underwent assessment of cardiovascular risk factors including measurement of body mass index, waist circumference, blood pressure and blood lipids. Diagnosis of diabetes was based on the 1999 World Health Organisation criteria. Screening took place between January 2002 and March 2006.

Participation type:
Opt in

Inclusion criteria:
Individuals were eligible to be invited for screening if they were registered with one of the participating general practices, aged 40-69 years, not known to have diabetes and with a diabetes risk score of >0.17 (corresponding to the top 25% of the population distribution.

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:
867 participants

Data collection event:

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

Accountable people:

Role
Name (follow link for contact details)
Chief Investigator
Data Analyst

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

Related parties:
N/A

Additional information:
N/A


Information created: 2nd May 2014 by Dr R Simmons & C Boothby
Information last updated: 06 June 2014 by A Dickinson