Ruth Warwick
NHSBT Consultant Specialist for Tissue Services
ruth.warwick@nhsbt.nhs.uk

Dear Colleagues,

NHSBT/BASK Service Evaluation

BASK has developed, over 6 years, a working group with NHSBT, the lead NHS provider of soft tissue allografts of the knee. We have been working together to devise a Service Evaluation that assesses the efficacy and safety of these tissue allografts. This evaluation can be applied to both NHSBT supplied grafts and grafts from other sources and will be a means of evaluating whether grafts using different types of processing methodology, including gamma irradiation or other chemical decontamination, may have an impact on the quality of the graft and their efficacy in vivo. This Service Evaluation is a BASK sponsored study and utilises 4 forms. One of these forms, Form 2, needs to be completed by you, your delegate or your nurse. The other 3 are completed by the patient either before or after the operation. They are provided for your information only

The four forms are:

• Form 1: Knee evaluation before your operation:
  This is completed by the patient when in hospital prior to their operation. It captures the patient's pre-injury and pre-operative Tegner activity scores and the information required to calculate a pre-operative IKDC score and pre-injury and pre-operative Tegner activity scores.
• Form 2: Soft tissue allograft information:
  Completed by the surgeon after the operation. This is a single page form that captures clinical information about the operation and some patient demographics.
• Form 3: Knee evaluation 12 months after operation:
  This is completed by the patient at home one year after their operation. It captures the patient;s current Tegner activity score and the information required to calculate a current IKDC score.
• Form 4: Knee evaluation 5 years after operation:
  This is completed by the patient at home five years after their operation. It captures the patient's current Tegner activity score and the information required to calculate a current IKDC score.

It is important that the surgeon talks to the patient about the Service Evaluation and obtains the patient's consent to participate in the study and for their data to be held at NHSBT. A Patient Information leaflet (Leaflet 1) has been prepared to help with this. It explains the data collection process, where the data will be stored and what the patient needs to do to participate in the study. The patient indicates their consent to providing their data by signing the leaflet. The leaflet is issued with all NHSBT grafts and is on the website as below. Patient consent must be obtained.

For patients who have agreed to participate, we ask that the surgeon passes them Form 1 to complete. The surgeon should then return the completed Form 1 and the completed Form 2 to NHSBT. NHSBT will monitor when theone-year and five-year follow-up is due and will send Forms 3 & 4 to the patient at their home address with a stamped addressed envelope for the patient to return the completed form.

To this end, the forms described above are being sent to all members of BASK and the Meniscal Study Group and it is possible that you may receive these through a number of other portals as well.

Please complete Form 2 each time you use an allograft, from wherever you source the allograft, and return it to NHSBT as described above. Forms 1 – 2 and Leaflet 1 will be provided to you each time you order an allograft from NHSBT for use in the knee, whether a tendon or a meniscus or for multiple grafts in a single operation. If you order a graft from another source then you can get all these forms and the leaflet which are available on the BASK website at the NHSBT/BASK link.

With many thanks for your cooperation.

Yours faithfully