UCL, UCLH and Royal Free researchers have set out how to ensure information held in electronic health records (EHR) systems does not inadvertently ‘unblind’ hospital staff, trial staff and participants involved in ‘blinded’ trials.
Although the risk is low, researchers have outlined actions in a Research Letter published in the journal Clinical Trials. This includes the development of a ‘blinding matrix’ to ensure blinding can be implemented effectively at a hospital which has an EHR.
EHRs enhance patient and clinician access to healthcare information – which is hugely beneficial. But this transparency of information in these relatively new structures can mean that clinicians and trial participants could accidentally be exposed to information about a clinical trial they should not see while the trial is taking place.
Blinding, where the treatment allocation is not disclosed to certain people involved in the trial, is considered important for many clinical trials as it can prevents bias and ensures confidence in trial results. Where a blinded approach is taken, it is important to make sure it works.
Dr Ameet Bakhai, Clinical Research Director from the Royal Free, raised the potential for accidental unblinding at an MHRA meeting in 2020, attended by various EHR manufacturers, none of whom were aware of this issue.
Prof Matt Sydes from the MRC Clinical Trials Unit at UCL, who offered to further explore the issues, said: “We have set out steps that trial teams and EHR teams can take working together to ensure blinding of trials is preserved where needed, while ensuring patients benefit from the opportunities offered by EHRs in terms of transparency.
“The issue highlights the importance of EHRs being developed with the needs of research in mind.”
Read the paper in full: Sydes MR, Wong WK, Bakhai A, Joffe N, Love SB. Protecting blinded trials in electronic hospital systems. Clinical Trials. January 2022. doi:10.1177/17407745211069985
