As a surgeon adopting the use of a Beyond Compliance product, you play an important role in supporting the ongoing monitoring and assessment of the product in the market. This may require additional data collection, over and above that which is routinely collected by your healthcare institution. However, the collection process will be made as simple as possible, and will build on data from the National Joint Registry, without requiring you to re-enter this data. Beyond Compliance will provide you, the manufacturer, and independent assessors from the Beyond Compliance Advisory Group with valuable information about the ongoing performance of the product you have chosen to use.
You will be required to have undergone the training programme designated by the implant manufacturer and/or champion surgeons in the use of the product. An assessor surgeon may join you for your first use of the product.
You will be required to capture explicit patient consent for Beyond Compliance from patients for whom you intend to use the product. This captures the patient’s consent for their data to the stored and used by the Beyond Compliance service. All other local consent processes and forms, such as consent to operate and NJR consent forms that your hospital currently use remain unchanged.
The National Research Ethics Service (NRES) have advised that Beyond Compliance data collection process falls under the definition of a “service evaluation”, meaning it is not classified as research.
Recording data about your patients
You will be given a unique username and password for the Beyond Compliance system. You may also nominate staff members at your institution to enter data on your behalf. You will be provided with a User Guide for the Beyond Compliance system for you and any approved support staff you have nominated. The Beyond Compliance system brings together routinely collected data about the patient, from the National Joint Registry, and enables you and approved support staff to upload additional information relevant to the performance and outcome of the product. For each patient for whom you intend to use the Beyond Compliance product, you will be required to:
Ensure that an NJR record for the procedure is recorded in the normal way as quickly as possible after the operation;
Request an email address from each patient so that they can be invited to complete longer-term PROMs surveys.
In addition you may upload the operation note, pre-operative and post-operative X-rays, and operation video (if applicable) via the secure Beyond Compliance system. You will need to remove any patient identifiable data from these files prior to upload;
Pre and post operative PROMs data that is routinely collected from your patients will automatically be added to the patient's BC record when available;
It is planned that HES data will be automatically added to the patient's record, but if one of your patients did have a complication then this data should be added to the patient's record (as above);
Death records will be linked from the Office of National Statistics data;
Should any implants be explanted they should be kept, pending further analysis. Explants are to be collected from you by the manufacturer's agent, decontaminated and taken to a retrieval centre.
The Beyond Compliance system provides facilities to enable you to review your results, and also those of other surgeons using the product. You will play an important part in the ongoing assessment of the product. You will be invited to:
Take part in regular meetings with the manufacturer, independent assessors from the Beyond Compliance Advisory Group, and other surgeons using the device (usually by conference call) to discuss results;
Use an agreed post operative evaluation from for outpatient assessments;
Agree to share your results (through the secure system) with the other members of the group;
Agree to the recommended rate of introduction (number of procedures) for the new implant;
Make any suggestions about the process whenever it is appropriate.
Your participation in Beyond Compliance is voluntary, and is an agreement between yourself and the product manufacturer. You are able to withdraw from the study at any time. If you do withdraw we ask that you notify us, stating the reason.