UCL Discovery
UCL home » Library Services » Electronic resources » UCL Discovery

Use of NHS Digital datasets as trial data in the UK: a position paper

Murray, Macey L; Pinches, Heather; Mafham, Marion; Hartley, Suzanne; Carpenter, James; Landray, Martin J; Love, Sharon B; ... Sydes, Matthew; + view all (2022) Use of NHS Digital datasets as trial data in the UK: a position paper. Zenodo.org: UK. Green open access

[thumbnail of Position paper on NHSD data v2.0 20220211 final.pdf]
Preview
Text
Position paper on NHSD data v2.0 20220211 final.pdf - Published Version

Download (1MB) | Preview

Abstract

Background: Clinical trial teams increasingly want to make use of data from healthcare systems (“healthcare data”), particularly to enhance recruitment and follow-up of participants, to reduce time and cost, and to stop the duplication of effort. However, there is continued uncertainty of how regulators regard healthcare data used for trial purposes, in terms of provenance, quality and reliability. Objectives: There were two key objectives: First, to demonstrate the data integrity of two datasets held by NHS Digital (NHSD) that are most requested by trial teams; and second, to set out an approach by which any other healthcare systems datasets can be similarly evaluated. Method: The data lifecycles of the datasets were carefully documented, mapping the flow of data from the originating healthcare provider’s databases to NHSD warehouses and onwards to clinical trials teams. These were assessed for evidence of whether the datasets are accurate, reliable, complete, contemporaneous, and well-governed. Result: The assessment method was applied to (a) the Hospital Episode Statistics Admitted Patient Care (HES APC) dataset and (b) the Civil Registration of Deaths (CRD) dataset. This paper clearly demonstrates that their collection and management through NHSD systems ensure their integrity and reliability. The datasets are accurate representations of the data held by the originating providers (acute NHS trusts and local registrars). Conclusion: Based on these findings, the HES APC and CRD datasets satisfy the assessment criteria that demonstrate they are reliable transcribed copies of the original source data. Implications: First, these datasets can be used directly for clinical trial data, with trial teams focusing on the accuracy of algorithms and processes to identify particular outcomes rather than on the integrity of the data flow. Second, this assessment approach should be used to assess whether other healthcare systems datasets are ready to be used as transcribed copies of source data, and for data providers to take appropriate steps to redress this matter if they are not.

Type: Report
Title: Use of NHS Digital datasets as trial data in the UK: a position paper
Open access status: An open access version is available from UCL Discovery
DOI: 10.5281/zenodo.6047154
Publisher version: https://doi.org/10.5281/zenodo.6047154
Language: English
Additional information: This is an open access publication distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/)
Keywords: clinical trials, routinely collected health data, healthcare systems data, routine health data, data integrity
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
URI: https://discovery.ucl.ac.uk/id/eprint/10145243
Downloads since deposit
434Downloads
Download activity - last month
Download activity - last 12 months
Downloads by country - last 12 months

Archive Staff Only

View Item View Item