Collecting patient consent
Asking patients for their consent to be on the registry
Details of joint replacement operations are recorded in the National Joint Registry in order to ensure the safety of patients and help to monitor and improve patient outcomes. We also ask patients for consent for their details to be included in the registry so that should there ever be any problems with any implant or procedure type, they can easily be identified for follow-up through their hospital.
All patients having hip, knee, ankle, elbow and shoulder replacement surgery should be given the opportunity to have their procedure details captured in the registry
By consenting, the patient has given permission for specific details of their operation to be captured on the registry, with strict data protection and security measures in place. The information recorded is: the type of implant the patient received, which surgical technique was used, which side of their body the implant was used, as well as name, date of birth, gender, contact details, date of operation and NHS number. Capturing this information enables us to be more effective in our role in ensuring patient safety (and to get in touch later if there is ever a need).
Most patients are very happy to have their data included and to date around 3.7 million joint replacement records have been captured in the registry. This rich data set enables us to analyse outcomes and see trends, and we can share de-identified data with researchers under strict data sharing agreements. This research and analysis helps to improve patient outcomes and will improve knowledge and procedure outcomes for the benefit of generations of future patients.
By capturing this information we are able to:
- help identify patients who have received specific implants that are subsequently performing poorly.
- link patients’ primary and revision procedures via the NHS/national patient number, enabling us to determine how long different types of joint replacement implants last.
- invite patients to take part in feedback activities about their surgery, so that patient outcome and satisfaction can be assessed and monitored.
Collecting patient consent
Patients must give their consent in order for their personal data to be recorded in the registry. NJR consent forms should be signed by the same person signing the hospital operation consent form.
Patient consent (Section 251 Exemption)
The NJR has approval to record patient details where the indication for patient consent is ‘Not recorded’.
This permission is under the Health Service (Control of Patient Information) Regulations (2002), sometimes referred to as Section 251 support. We update and renew these permissions on an annual review basis.
These permissions enable patient details to be entered where ‘Don’t know’ is recorded for patient consent, which now ensures that all procedures recorded on the registry for a single patient can be linked, ultimately improving monitoring of the performance of medical device implants. It is important that patient consent has been sought and given for all procedures submitted to the registry. If it is discovered subsequently that a patient either gave their consent or positively declined it please ensure that you inform the NJR Service Desk immediately so that the appropriate changes can be made on the patient record.
Any queries regarding patient consent should be put to your NJR Compliance Officer, the contact details for whom can be obtained from the NJR Service Desk or on our ‘Regional Support’ pages.
Patient consent forms
As well as collecting patient consent, the NJR consent form also introduces the benefits of the NJR to the patient and explains how participation will benefit themselves and others. We recommend that you use this form to explain the benefits and to collect patient consent and to ensure that the patient is fully informed of the NJR’s purposes and aims to improve joint replacement surgery, to help prevent misconceptions about the use of data.
Keep patients informed
When collecting consent you should make sure that patients are aware:
- that they are consenting to being on the registry and why their consent is important to our aims, work and purpose.
- of the benefits of their procedure and implant type being recorded on the registry.
Ask for patient consent for each joint procedure
It is important to ask a patient for their consent in respect of each operation since:
- the patient may have consented in the past but does not want to have any further data entered against their name.
- the patient may have withdrawn consent (as is their right) and has asked the NJR to remove their personal details from the registry.
- at the time of data entry, it would be difficult to determine whether consent had been given previously.
Keep staff informed
It is important that all relevant staff are aware of how your hospital collects patient consent for the NJR.
Further advice and guidance
We have produced a range of materials to support your work, to help obtain patient consent and to help patients understand the work we do. You can ask your NJR Compliance Officer for these.
Retaining consent forms
NJR patient consent forms should be held by the hospital as part of a patient’s record and be made available to the NJR data entry staff who input the procedure data.
Staff should explain clearly to patients that it is the hospital who will be entering the patient’s personal details into the NJR data entry system. Patients should keep the duplicate copy for their own records.