As you are probably aware, the implementation deadline for the National data opt-out (NDOO) programme in England is 1st August 2022. To prepare for this, over recent months, we have been working with colleagues from the Department of Health and Social Care (DHSC) to apply to the Confidentiality Advisory Group (CAG) for exemption from the NDOO.
The reasons for us applying for this exemption are because:
- Data loss from opt-out is likely to result in the loss of around 1% of our registry records annually. In the context of NJR’s reporting of outcomes at a given hospital, surgeon or implant brand level, the loss of a handful of records can be the difference between an outlier finding or not. This represents a worrying safety concern if the ability to detect signals is compromised.
- There is evidence that opt-out will introduce biases into the data. The application of NDOO has been found to be not random, with some GP practices having more than half of their registered patients opted-out. The impact of these non-random effects is unknown and represents a risk to the integrity of the data.
We now have permission in place from the CAG to exempt us from NDOO for our non-research activities. This means that hospitals do not need to screen NJR data for opt-out before submitting to the registry. Opt-out will continue to apply for our research activities and the NJR will screen files of data for NDOO before making them available to researchers. Hospitals do not need to take any action on this.
We have updated the NJR patient information leaflet to indicate that NDOO does not apply. This is available to download from our website link below. You may also want to refer patients to our NDOO FAQs at National data opt-out – The National Joint Registry
Please note that consent continues to be the best way to secure a patient’s data for recording in the registry. Most hospitals are able to gain consent from more than 95% of patients, and many can achieve consent rates of 100%. We also have consultee consent forms for patients who lack capacity, and assent forms for children, which are also available for download from the NJR website. You may also want to watch our video about consenting patients here.