Wales Electronic Cohort for Children (WECC)
| Tracking Information | |||||
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| First Received Date ICMJE | June 2, 2010 | ||||
| Last Updated Date | January 28, 2013 | ||||
| Start Date ICMJE | April 2009 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Birth weight [ Time Frame: not applicable due to routine data usage ] [ Designated as safety issue: No ] Birth weight derived from routine data |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01136681 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Wales Electronic Cohort for Children | ||||
| Official Title ICMJE | Wales Electronic Cohort for Children (WECC) | ||||
| Brief Summary | The investigators are developing a research platform capable of improving children's health through the generation of knowledge from analysis of routinely collected data from within and outside the health service. The investigators are using the data that are routinely collected in Wales to answer specific questions about child health and well-being, with the aim of informing policy and practice in Wales, whilst also being internationally relevant. Routinely collected datasets are publicly funded, and have already been incorporated into the Secure Anonymised Information Linkage databank. The investigators are combining these datasets on children from health and social care to establish an anonymised Wales wide Electronic Cohort for Children (WECC). WECC will serve as the platform for future work in translating information into child population health policy. There are 35,000 births in Wales per year, and data are available for the previous ten years. Thus, WECC will be sufficiently powered to answer important social, economic and health policy questions. WECC will also act as a demonstration project which would inform the development of e-cohorts to support translational research across the life course and disease spectrum. |
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| Detailed Description | Lack of access to the enormous amount of information collected on children's health status and treatment has been a major contributor to both gaps in the translational pathway to improving child health at individual and population levels. The creation of the Wales Electronic Child Cohort is designed to remove this block and support both explanatory and interventional studies. This proposal is considered to be the best way to address this issue as it is built upon previous strategic investments by WORD and thus should achieve its goals in a very cost effective manner. This type of E-Cohort with 35,000 additional children every year can answer questions where exposures, outcomes and potential confounders are routinely collected or available through individual or ecological linkages. This is a retrospective and prospective cohort, however, both cohort and nested case-control studies can be supported. Developments in geographical information systems (GIS), network analysis and the creation of a system for anonymising households means that is possible to anonymously link environmentally derived data to health data. The huge numbers of individuals involved in WECC means that the study has enormous power to answer important social, economic and health policy questions. Examples of research questions which can be answered are:
In this first instance we will focus on answering the first two questions. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 730,000 children born from 1990-2009, or subsequently resident, in Wales |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 350000 | ||||
| Estimated Completion Date | March 2013 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 25 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01136681 | ||||
| Other Study ID Numbers ICMJE | TPR08-006 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr Sarah E. Rodgers, Swansea University | ||||
| Study Sponsor ICMJE | Swansea University | ||||
| Collaborators ICMJE | Cardiff University | ||||
| Investigators ICMJE |
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| Information Provided By | Swansea University | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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