Abstract
BACKGROUND: The English National Health Service (NHS) data opt-out allows people to prevent use of their health data for purposes other than direct care. In 2021, the number of opt-outs increased in response to government-led proposals to create a centralised pseudonymised primary care record database.
AIM: To describe the potential impact of NHS National Data Opt-outs in 2021 on health data research.
DESIGN & SETTING: We conducted a descriptive analysis of opt-outs using publicly available data and discuss the potential consequences on research.
METHOD: Trends in opt-outs in England were described by age, sex and region. Using a hypothetical study, we explored statistical and epidemiological implications of opt-outs.
RESULTS: During the lead up to a key government-led deadline for registering opt-outs (from 31 May 2021 to 30 June 2021), 1,339,862 national data opt-outs were recorded; increasing the percentage of opt-outs in England from 2.77% to 4.97% of the population. Amongst females, percentage opt-outs increased by 83% (from 3.02% to 5.53%) compared to 75% in males (2.51%-4.41%). Across age-groups, the highest relative increase was among people aged 40-49 years which rose from 2.89% to 6.04%. Considerable geographical variation was not clearly related to deprivation. Key research consequences of opt-outs include reductions in sample size and unpredictable distortion of observed measures of the frequency of health events or associations between these events.
CONCLUSIONS: Opt-out rates varied by age, sex and place. The impact of this and variation by other characteristics on research is not quantifiable. Potential effects of opt-outs on research and consequences for health policies based on this research must be considered when creating future opt-out solutions.
| Original language | English |
|---|---|
| Number of pages | 20 |
| Journal | British Journal of General Practice Open |
| Early online date | 4 Mar 2024 |
| DOIs | |
| Publication status | Published - 10 Jul 2024 |
Data Availability Statement
The data used for analysis is provided at https://www. github. com/ johntaz/ nhs-opt-outsFunding
Helen Strongman is funded by the National Institute for Health Research (NIHR) through an Advanced Fellowship (NIHR301730) for this research project. Helen Blake is supported by the NIHR Applied Research Collaboration North Thames. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR, NHS or the UK Department of Health and Social Care. John Tazare and Elizabeth Williamson were funded by the Wellcome Trust [grant 224485/Z/21/Z held by Elizabeth Williamson]. For the purpose of open access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission.
