Real World Evidence in Diabetes
Research type
Research Study
Full title
Real World Evidence in Diabetes
IRAS ID
162485
Contact name
Srikanth Bellary
Contact email
Sponsor organisation
Heart of England NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The purpose of this study is to identify opportunities to improve patient outcomes and healthcare system efficiency through the use of a real world data. Specifically, we are seeking to use pseudonymised routinely collected data to build a data-driven description of actual patient pathways across primary, secondary and community care. This data will be analysed to identify opportunities to improve care and to demonstrate the potential impact of such improvement: by identifying variations in how patients engage with the healthcare system, and in outcomes (including underserved patient groups); by measuring the effectiveness of current interventions; by identifying opportunities to improve care coordination; and by identifying variations against current best practice pathways.
The initial therapeutic area focus of this study will be diabetes mellitus, but expansion to other disorders are planned in the future as a working proof of concept is demonstrated. This submission only refers to the diabetes study. Any extension of the scope of the study to additional therapeutic areas will be covered under a separate Ethics review submission.
We will achieve our aims by constructing a technological platform to link pseudonymised clinical and administrative data across primary, secondary, and community care for our studied cohorts. We plan to undertake an extract of retrospective data in Early 2015 – whilst the length of that dataset will vary depending on historic IT systems, we hope to collect around 10 years of data. We will seek to refresh the dataset on a regular basis in order to both extend the length of the dataset and also to ensure it remains in line with current treatment practice – our current expectation is to refresh the dataset on a quarterly basis over a time period of three years.
This will be governed in line with strict information governance agreements with each participating NHS institution and by substantial national policy and legislation. Furthermore, a cross institution Governance Board including clinical, managerial and patient representatives will ensure questions are appropriate and balance the interests of the parties without compromising patient benefit. The Governance Board will review and approve the analyses to be conducted as part of the study. Further details about the role and composition of the Board are provided in section A74.
Findings will be used by Heart of England NHS Foundation Trust(HEFT), Birmingham Cross City CCG, Solihull CCG and Birmingham Community Healthcare Trust to improve care provision. Where possible findings will be published in peer reviewed academic journals to ensure the outcomes of this research can have broader patient benefit both within the NHS and elsewhere.REC name
London - Surrey Research Ethics Committee
REC reference
15/LO/0623
Date of REC Opinion
1 Jul 2015
REC opinion
Further Information Favourable Opinion