NHS National Data Opt-Outs: trends and potential consequences for health data research

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.