The Knee 20 (2013) 365–366
Contents lists available at ScienceDirect
The Knee
Editorial
The UK National Ligament Registry
Despite Codman recognising the importance of recording the outcome of surgical intervention [1] we have been slow to realise the true empowerment that can result from accumulating such data. As a result, newer techniques and devices have been developed and promoted which may not have had any significant benefit to patient outcome. Recent reports such as ‘Getting it right first time’ by Professor Briggs [2] and an apparent change in the political ‘drivers’ have supported the creation of surgical Registries and the creation of a National Ligament Registry (NLR). At present we do not know how many surgeons routinely perform anterior cruciate ligament (ACL) reconstruction surgery in the UK or the volume of output. Our only guide at present is the notoriously unreliable hospital episode statistics (HES) data and we do not have any information regarding the surgical outcome. We must be mindful of the arthroplasty publications that report poorer outcomes with lower volume surgery and determine how that translates into soft tissue knee surgery. Whilst in the NJR the end point is implant failure, this seems less relevant in soft tissue knee surgery where an understanding of the functional outcome for each patient undergoing such a procedure may be of equal importance. Differing graft options – including the apparent re-emergence of synthetic grafts – and fixations must all be included and evaluated in a fair and equitable way. We are enormously indebted and grateful to our forerunners the Scandinavian Registries. They were established in 2005 and have produced several annual reports to date. We must learn from some of their experiences, cost and follow up rate in particular, and hopefully develop an improved and reproducible model. Similarly the NJR is a great success in many ways and we should applaud its achievements but there are many who feel the NJR has missed an opportunity. There still seems to be little information available regarding the functional outcome of the majority of patients who have ‘successful’ surgery and do not require a revision procedure. Outcomes are important — not only for surgeons but also for politicians and decision-makers who will use the information, irrespective of ‘quality’, to determine who we treat and who actually treats patients. It is important that surgeons lead on determining ‘accurate’ and meaningful data collection from the outset. Any data collection system must be established to answer clear questions. A simple aim, but hard when trying to predict the future issues. Simple questions need robust systems to provide valid answers. For this very reason, as developers of the NJR, we have concentrated on a single procedure, primary ACL reconstruction, and we are confident that the results will benefit future surgeons and patients alike. When established it will ease the journey to develop similar pathways for the revision of ACL procedures, conservative treatment of ACL rupture and other ligament reconstructions. This will only succeed if all partners (patients, surgeons and industry) are involved, feel valued and benefit. The Registry is 0968-0160/$ – see front matter © 2013 Published by Elsevier B.V. http://dx.doi.org/10.1016/j.knee.2013.10.001
established as a surgeon led entity without the initial involvement of governmental agencies. This approach therefore requires external financial support and we have received sponsorship from 8 companies involved in ACL reconstruction as well as a ‘priming’ grant from BASK. In return the companies will be provided with information on the performance of their particular products, but will not be able to access other company data. We need surgeon support to ensure we achieve a critical number of surgeons and procedures. At the time of writing we have 159 registered surgeons who will be defined as the enthusiasts. This is already a huge endorsement for the early phase of this project. This number should steadily increase as surgeons and orthopaedic departments see the advantage of having a readymade tool for use in governance and revalidation. In addition, at least two private hospital companies are trialling the registry as part of their governance procedures and commissioning groups have shown a similar interest. The population undergoing ACL reconstructions are typically younger, more mobile and busy. This makes them difficult to trace and track which is why two of the key elements of information are the NHS number and an email address. This is the electronic age and email and text communication is the norm and must be acknowledged. Bluespier was selected as the company to collect and host the data utilising their newly developed Amplitude system. With their help, we have established a new model for this Registry which involves automated online (paperless) data entry. It enables surgeons, patients and support staff to access/register online in a straightforward manner with easy access guidelines. The Scandinavian experience stresses the importance of compliance and for their efforts the patient will need something in return — comparison of their scores to the average for their peer group and reviewing graphically how their scores have changed over time should provide the carrot. Yes, it will take some effort and vigilance to enter patients but with automated follow up the process is simple and appealing. The outcome measures chosen are the knee injury and osteoarthritis outcome score (KOOS), subjective International Knee Documentation Committee (IKDC), Euroqol (EQ5D) and the Tegner activity score. These scores allow comparison and communication with existing Registries as well as allowing potential ‘generic health benefit’ comparisons to other non-Orthopaedic procedures. With the Registry surgeons should strive to achieve the primary aim of a (complete) database of the ‘functional’ outcome of ACL reconstruction in the UK — it will then enable some secondary gains which could include uses in surgeon revalidation and the establishment of a platform to allow the controlled introduction of new products, possibly in association with ‘Beyond Compliance’. The interpretation of the outcome scores and deciding what constitutes a ‘normal outcome’ will be challenging. Selection to the steering and research committees will be open and advertised to all
366
Editorial
BASK members. All surgeons are empowered to feedback their views. BASK has shown excellent support to date and must continue to do so because we have an opportunity to establish something we can all be proud of. Sean O'Leary Chairman on behalf of the NLR Steering Group (Tim Spalding, Steve Bollen, Fares Haddad, Andrew Price).
References [1] Mallon Bill. Ernest Amory Codman: the end result of a life in medicine. Philadelphia: W. B. Saunders; 1999. [2] Briggs, TWR. Getting it right first time. Improving the quality of orthopaedic care within the National Health Service in England.
Contents lists available at ScienceDirect
The Knee
Editorial
The UK National Ligament Registry
Despite Codman recognising the importance of recording the outcome of surgical intervention [1] we have been slow to realise the true empowerment that can result from accumulating such data. As a result, newer techniques and devices have been developed and promoted which may not have had any significant benefit to patient outcome. Recent reports such as ‘Getting it right first time’ by Professor Briggs [2] and an apparent change in the political ‘drivers’ have supported the creation of surgical Registries and the creation of a National Ligament Registry (NLR). At present we do not know how many surgeons routinely perform anterior cruciate ligament (ACL) reconstruction surgery in the UK or the volume of output. Our only guide at present is the notoriously unreliable hospital episode statistics (HES) data and we do not have any information regarding the surgical outcome. We must be mindful of the arthroplasty publications that report poorer outcomes with lower volume surgery and determine how that translates into soft tissue knee surgery. Whilst in the NJR the end point is implant failure, this seems less relevant in soft tissue knee surgery where an understanding of the functional outcome for each patient undergoing such a procedure may be of equal importance. Differing graft options – including the apparent re-emergence of synthetic grafts – and fixations must all be included and evaluated in a fair and equitable way. We are enormously indebted and grateful to our forerunners the Scandinavian Registries. They were established in 2005 and have produced several annual reports to date. We must learn from some of their experiences, cost and follow up rate in particular, and hopefully develop an improved and reproducible model. Similarly the NJR is a great success in many ways and we should applaud its achievements but there are many who feel the NJR has missed an opportunity. There still seems to be little information available regarding the functional outcome of the majority of patients who have ‘successful’ surgery and do not require a revision procedure. Outcomes are important — not only for surgeons but also for politicians and decision-makers who will use the information, irrespective of ‘quality’, to determine who we treat and who actually treats patients. It is important that surgeons lead on determining ‘accurate’ and meaningful data collection from the outset. Any data collection system must be established to answer clear questions. A simple aim, but hard when trying to predict the future issues. Simple questions need robust systems to provide valid answers. For this very reason, as developers of the NJR, we have concentrated on a single procedure, primary ACL reconstruction, and we are confident that the results will benefit future surgeons and patients alike. When established it will ease the journey to develop similar pathways for the revision of ACL procedures, conservative treatment of ACL rupture and other ligament reconstructions. This will only succeed if all partners (patients, surgeons and industry) are involved, feel valued and benefit. The Registry is 0968-0160/$ – see front matter © 2013 Published by Elsevier B.V. http://dx.doi.org/10.1016/j.knee.2013.10.001
established as a surgeon led entity without the initial involvement of governmental agencies. This approach therefore requires external financial support and we have received sponsorship from 8 companies involved in ACL reconstruction as well as a ‘priming’ grant from BASK. In return the companies will be provided with information on the performance of their particular products, but will not be able to access other company data. We need surgeon support to ensure we achieve a critical number of surgeons and procedures. At the time of writing we have 159 registered surgeons who will be defined as the enthusiasts. This is already a huge endorsement for the early phase of this project. This number should steadily increase as surgeons and orthopaedic departments see the advantage of having a readymade tool for use in governance and revalidation. In addition, at least two private hospital companies are trialling the registry as part of their governance procedures and commissioning groups have shown a similar interest. The population undergoing ACL reconstructions are typically younger, more mobile and busy. This makes them difficult to trace and track which is why two of the key elements of information are the NHS number and an email address. This is the electronic age and email and text communication is the norm and must be acknowledged. Bluespier was selected as the company to collect and host the data utilising their newly developed Amplitude system. With their help, we have established a new model for this Registry which involves automated online (paperless) data entry. It enables surgeons, patients and support staff to access/register online in a straightforward manner with easy access guidelines. The Scandinavian experience stresses the importance of compliance and for their efforts the patient will need something in return — comparison of their scores to the average for their peer group and reviewing graphically how their scores have changed over time should provide the carrot. Yes, it will take some effort and vigilance to enter patients but with automated follow up the process is simple and appealing. The outcome measures chosen are the knee injury and osteoarthritis outcome score (KOOS), subjective International Knee Documentation Committee (IKDC), Euroqol (EQ5D) and the Tegner activity score. These scores allow comparison and communication with existing Registries as well as allowing potential ‘generic health benefit’ comparisons to other non-Orthopaedic procedures. With the Registry surgeons should strive to achieve the primary aim of a (complete) database of the ‘functional’ outcome of ACL reconstruction in the UK — it will then enable some secondary gains which could include uses in surgeon revalidation and the establishment of a platform to allow the controlled introduction of new products, possibly in association with ‘Beyond Compliance’. The interpretation of the outcome scores and deciding what constitutes a ‘normal outcome’ will be challenging. Selection to the steering and research committees will be open and advertised to all
366
Editorial
BASK members. All surgeons are empowered to feedback their views. BASK has shown excellent support to date and must continue to do so because we have an opportunity to establish something we can all be proud of. Sean O'Leary Chairman on behalf of the NLR Steering Group (Tim Spalding, Steve Bollen, Fares Haddad, Andrew Price).
References [1] Mallon Bill. Ernest Amory Codman: the end result of a life in medicine. Philadelphia: W. B. Saunders; 1999. [2] Briggs, TWR. Getting it right first time. Improving the quality of orthopaedic care within the National Health Service in England.
