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Table 3 Additional Comments from Delphi Process

From: Consensus on draft OMERACT core domains for clinical trials of Total Joint Replacement outcome by orthopaedic surgeons: a report from the International consensus on outcome measures in TJR trials (I-COMiTT) group

Main core domains Additional domains
AAOS-Outcomes SIG/ORS Orthopaedic surgeon group
Change in function, change in pain duration of improvement Cost is a very nebulous area, particularly since cost varies by how you measure it and what part of the country the research is performed in
Patient satisfaction is nebulous unless everyone is using the same instrument to measure it. I am not sure what patient participation means, so I stayed neutral. I suspect this refers to charges and in that case, there needs to be a cost to charge ratio applied
I believe that limping is important and has a tendency to drown in the available scores used Limping for total hip and stiffness (joint fibrosis) for TKA
Patient-reported outcomes using validated instruments should have a very high priority and would cover the upper (first) two items. Unclear what is meant by patient participation so unable to score
PROM function and patient satisfaction are important but both are often affected by factors not directly related to the outcome of surgery. Thus it depends on the type of clinical trial if they are essential or not. Revision surgery indicates that both the patient and the physician agreed on that the initial procedure had been unsuccessful, Death and adverse events are very important but uncommon. For a new technique or approach such information is essential but maybe not for every clinical trial. Participation in rehabilitation is important to functional outcome, but the trial focus may or may not require collection of these data. If patients are randomized to a drug trial, for example, then participation levels should be random and the focus is on the endpoints/outcomes (pain, function, AE) not on the level of participation.
Family function; Caregiver impact Medical and surgical complications should be reported separately
Venous thromboembolism occurrence–What is the Best VTE prophylaxis? Need more definition around how cost will be measured and reported Cost is variable from state to state and center to center within a state or city
Revision should probably be re-designated as “reoperation for any reason” as patients often care more if they had to have repeat surgery for what ever the reason, and not as much whether implant parts (if any) are swapped out or exchanged Patient participation is very unreliable on higher levels of participation
Implant revision is impractical unless the trial involves many years of follow-up. However, surgical AEs (manipulation, etc.) are important. Death is important, but very rare  
Of importance for the patient: To which degree are expectations fulfilled  
Return to work or avoidance of environment modification for the older patient  
Quality of life, 8 Work disability and employability are very culture- and society-dependent issues and therefore suit poorly as core domains. Function should be assessed in more general and patient-specific terms  
Range of motion  
Patient Satisfaction should not be a core domain and should not be reported by all arthroplasty trials should be optional  
Longevity of arthroplasty–similar to revision surgery  
For the first two listed (joint pain and function), I think it would be very important to measure those outcomes not only at 6–12 months after surgery, but also at an earlier time interval after surgery (ex. 6 weeks) for patients interested in the extent to which they can expect rapid recovery.  
My rating is in part weighted by how accessible the information is. For example, revision surgery or death may take place years or decades after the initial surgery, and hence may not be related or the index procedure may not be available to the researcher. Secondly, there is little consensus of what is a “revision surgery”. A German colleague demonstrated that an I & D was considered a revision surgery in France, but not in other countries. Similar for “adverse events”. Would this include a post-op infection resulting in an infection? Obviously you have a lot of work here—what periods are being suggested? I know that the spine surgeons may consider 2 years as acceptable follow-up. Not sure what this group is considering. 1 year? 2 years? 5 years? At what point is the patient’s status no longer relevant to the surgery? Good luck Mike. These are my perspectives and may not be representative of the physicians involved. Stan  
Orthopaedic leadership group
The importance of death is social situation dependent. For two identical patients but for one having dependent family and the other not, the impact of death would be different, and might affect the decision to have surgery Cost should be cost-effectiveness. These two terms are not necessarily interchangeable and there is an important difference in arthroplasty. A cheaper cemented stem and cup in a young person is not cost effective
Death as long as related to surgery. Patient satisfaction probably one question item. Link revision to joint registries if they exist in the country–a better question may be any other surgery related to joint where revision surgery not an option (i.e. ankle arthroplasty) Cost is such a veritable worldwide. It will be difficult to quantify it accurately based on the various deals and accountancy practices in different hospitals. I’m not sure as part of a clinical review of the performance
I believe patient satisfaction and function of secondary only to the relief of osteoarthritic pain.. Adverse events I think a slightly less important as they reflect on the anesthetic care and this is going ability rather than the prosthetic  
Function domain needs to be relative to the involved joint and attempt to capture non joint limiting disabilities