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1. Towards prevention of post-traumatic osteoarthritis: report from an international expert working group on considerations for the design and conduct of interventional studies following acute knee injury

Author

Watt, FE, Corp, N, Kingsbury, SR, Frobell, R, Englund, M, Felson, DT, Levesque, M, Majumdar, S, Wilson, C, Beard, DJ, Lohmander, LS, Kraus, VB, Roemer, F, Conaghan, PG, Mason, DJ, Group, Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Study Group Expert Working, Adams, J, Blank, M, Batt, M, Biggs, P, Busse-Morris, M, Button, K, Calder, J, Cook, J, Edwards, C, Fisheleva, E, Hamilton, DF, Harrison, H, Holt, C, Jones, M, Jones, R, Kluzek, S, Knight, T, Nuki, G, Parekh, S, Peat, G, Pothet, C, Rainer, T, Robinson, N, Sawle, L, Vincent, T, Williams, A, Wise, E, Zhang, W, and Bierma-Zeinstra, S

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Health Sciences, Aging, Clinical Trials and Supportive Activities, Arthritis, Osteoarthritis, Patient Safety, Prevention, Physical Injury - Accidents and Adverse Effects, Clinical Research, Musculoskeletal, Good Health and Well Being, Acute Disease, Clinical Trials as Topic, Evidence-Based Medicine, Humans, Knee Injuries, Osteoarthritis, Knee, Research Design, Treatment Outcome, Injury, Outcome, Clinical trial, Knee, Considerations, Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Study Group Expert Working Group, Biomedical Engineering, Human Movement and Sports Sciences, Arthritis & Rheumatology, Clinical sciences, Sports science and exercise
Abstract

ObjectiveThere are few guidelines for clinical trials of interventions for prevention of post-traumatic osteoarthritis (PTOA), reflecting challenges in this area. An international multi-disciplinary expert group including patients was convened to generate points to consider for the design and conduct of interventional studies following acute knee injury.DesignAn evidence review on acute knee injury interventional studies to prevent PTOA was presented to the group, alongside overviews of challenges in this area, including potential targets, biomarkers and imaging. Working groups considered pre-identified key areas: eligibility criteria and outcomes, biomarkers, injury definition and intervention timing including multi-modality interventions. Consensus agreement within the group on points to consider was generated and is reported here after iterative review by all contributors.ResultsThe evidence review identified 37 studies. Study duration and outcomes varied widely and 70% examined surgical interventions. Considerations were grouped into three areas: justification of inclusion criteria including the classification of injury and participant age (as people over 35 may have pre-existing OA); careful consideration in the selection and timing of outcomes or biomarkers; definition of the intervention(s)/comparator(s) and the appropriate time-window for intervention (considerations may be particular to intervention type). Areas for further research included demonstrating the utility of patient-reported outcomes, biomarkers and imaging outcomes from ancillary/cohort studies in this area, and development of surrogate clinical trial endpoints that shorten the duration of clinical trials and are acceptable to regulatory agencies.ConclusionsThese considerations represent the first international consensus on the conduct of interventional studies following acute knee joint trauma.

Published
2019

2. Towards prevention of post-traumatic osteoarthritis: report from an international expert working group on considerations for the design and conduct of interventional studies following acute knee injury

Author

Adams, J., Blank, M., Batt, M., Biggs, P., Busse-Morris, M., Button, K., Calder, J., Cook, J., Edwards, C., Fisheleva, E., Hamilton, D.F., Harrison, H., Holt, C., Jones, M., Jones, R., Kluzek, S., Knight, T., Nuki, G., Parekh, S., Peat, G., Pothet, C., Rainer, T., Robinson, N., Sawle, L., Vincent, T., Williams, A., Wise, E., Zhang, W., Bierma-Zeinstra, S., Watt, F.E., Corp, N., Kingsbury, S.R., Frobell, R., Englund, M., Felson, D.T., Levesque, M., Majumdar, S., Wilson, C., Beard, D.J., Lohmander, L.S., Kraus, V.B., Roemer, F., Conaghan, P.G., and Mason, D.J.

Published
2019
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6. Gout, Hyperuricemia, and Crystal-Associated Disease Network Consensus Statement Regarding Labels and Definitions for Disease Elements in Gout

Author

Bursill, D, Taylor, W, Terkeltaub, R, Kuwabara, M, Merriman, T, Grainger, R, Pineda, C, Louthrenoo, W, Edwards, N, Andres, M, Vargas-Santos, A, Roddy, E, Pascart, T, Lin, C, Perez-Ruiz, F, Tedeschi, S, Kim, S, Harrold, L, Mccarthy, G, Kumar, N, Chapman, P, Tausche, A, Vazquez-Mellado, J, Gutierrez, M, da Rocha Castelar-Pinheiro, G, Richette, P, Pascual, E, Fisher, M, Burgos-Vargas, R, Robinson, P, Singh, J, Jansen, T, Saag, K, Slot, O, Uhlig, T, Solomon, D, Keenan, R, Scire, C, Biernat-Kaluza, E, Dehlin, M, Nuki, G, Schlesinger, N, Janssen, M, Stamp, L, Sivera, F, Reginato, A, Jacobsson, L, Liote, F, H. -K., E, Rosenthal, A, Bardin, T, Choi, H, Hershfield, M, Czegley, C, Choi, S, Dalbeth, N, Bursill D., Taylor W. J., Terkeltaub R., Kuwabara M., Merriman T. R., Grainger R., Pineda C., Louthrenoo W., Edwards N. L., Andres M., Vargas-Santos A. B., Roddy E., Pascart T., Lin C. -T., Perez-Ruiz F., Tedeschi S. K., Kim S. C., Harrold L. R., McCarthy G., Kumar N., Chapman P., Tausche A. -K., Vazquez-Mellado J., Gutierrez M., da Rocha Castelar-Pinheiro G., Richette P., Pascual E., Fisher M. C., Burgos-Vargas R., Robinson P. C., Singh J. A., Jansen T. L., Saag K. G., Slot O., Uhlig T., Solomon D. H., Keenan R. T., Scire C. A., Biernat-Kaluza E., Dehlin M., Nuki G., Schlesinger N., Janssen M., Stamp L. K., Sivera F., Reginato A. M., Jacobsson L., Liote F., Ea H. -K., Rosenthal A., Bardin T., Choi H. K., Hershfield M. S., Czegley C., Choi S. J., Dalbeth N., Bursill, D, Taylor, W, Terkeltaub, R, Kuwabara, M, Merriman, T, Grainger, R, Pineda, C, Louthrenoo, W, Edwards, N, Andres, M, Vargas-Santos, A, Roddy, E, Pascart, T, Lin, C, Perez-Ruiz, F, Tedeschi, S, Kim, S, Harrold, L, Mccarthy, G, Kumar, N, Chapman, P, Tausche, A, Vazquez-Mellado, J, Gutierrez, M, da Rocha Castelar-Pinheiro, G, Richette, P, Pascual, E, Fisher, M, Burgos-Vargas, R, Robinson, P, Singh, J, Jansen, T, Saag, K, Slot, O, Uhlig, T, Solomon, D, Keenan, R, Scire, C, Biernat-Kaluza, E, Dehlin, M, Nuki, G, Schlesinger, N, Janssen, M, Stamp, L, Sivera, F, Reginato, A, Jacobsson, L, Liote, F, H. -K., E, Rosenthal, A, Bardin, T, Choi, H, Hershfield, M, Czegley, C, Choi, S, Dalbeth, N, Bursill D., Taylor W. J., Terkeltaub R., Kuwabara M., Merriman T. R., Grainger R., Pineda C., Louthrenoo W., Edwards N. L., Andres M., Vargas-Santos A. B., Roddy E., Pascart T., Lin C. -T., Perez-Ruiz F., Tedeschi S. K., Kim S. C., Harrold L. R., McCarthy G., Kumar N., Chapman P., Tausche A. -K., Vazquez-Mellado J., Gutierrez M., da Rocha Castelar-Pinheiro G., Richette P., Pascual E., Fisher M. C., Burgos-Vargas R., Robinson P. C., Singh J. A., Jansen T. L., Saag K. G., Slot O., Uhlig T., Solomon D. H., Keenan R. T., Scire C. A., Biernat-Kaluza E., Dehlin M., Nuki G., Schlesinger N., Janssen M., Stamp L. K., Sivera F., Reginato A. M., Jacobsson L., Liote F., Ea H. -K., Rosenthal A., Bardin T., Choi H. K., Hershfield M. S., Czegley C., Choi S. J., and Dalbeth N.

Abstract

Objective: The language currently used to describe gout lacks standardization. The aim of this project was to develop a consensus statement on the labels and definitions used to describe the basic disease elements of gout. Methods: Experts in gout (n = 130) were invited to participate in a Delphi exercise and face-to-face consensus meeting to reach consensus on the labeling and definitions for the basic disease elements of gout. Disease elements and labels in current use were derived from a content analysis of the contemporary medical literature, and the results of this analysis were used for item selection in the Delphi exercise and face-to-face consensus meeting. Results: There were 51 respondents to the Delphi exercise and 30 attendees at the face-to-face meeting. Consensus agreement (≥80%) was achieved for the labels of 8 disease elements through the Delphi exercise; the remaining 3 labels reached consensus agreement through the face-to-face consensus meeting. The agreed labels were monosodium urate crystals, urate, hyperuric(a)emia, tophus, subcutaneous tophus, gout flare, intercritical gout, chronic gouty arthritis, imaging evidence of monosodium urate crystal deposition, gouty bone erosion, and podagra. Participants at the face-to-face meeting achieved consensus agreement for the definitions of all 11 elements and a recommendation that the label “chronic gout” should not be used. Conclusion: Consensus agreement was achieved for the labels and definitions of 11 elements representing the fundamental components of gout etiology, pathophysiology, and clinical presentation. The Gout, Hyperuricemia, and Crystal-Associated Disease Network recommends the use of these labels when describing the basic disease elements of gout.

Published
2019

7. Gout, Hyperuricaemia and Crystal-Associated Disease Network (G-CAN) consensus statement regarding labels and definitions of disease states of gout

Author

Bursill, D, Taylor, W, Terkeltaub, R, Abhishek, A, A. K., S, Vargas-Santos, A, Gaffo, A, Rosenthal, A, Tausche, A, Reginato, A, Manger, B, Scire, C, Pineda, C, Van Durme, C, Lin, C, Yin, C, Albert, D, Biernat-Kaluza, E, Roddy, E, Pascual, E, Becce, F, Perez-Ruiz, F, Sivera, F, Liote, F, Schett, G, Nuki, G, Filippou, G, Mccarthy, G, Da Rocha Castelar Pinheiro, G, H. -K., E, Tupinamba, H, Yamanaka, H, Choi, H, Mackay, J, Odell, J, Vazquez Mellado, J, Singh, J, Fitzgerald, J, Jacobsson, L, Joosten, L, Harrold, L, Stamp, L, Andres, M, Gutierrez, M, Kuwabara, M, Dehlin, M, Janssen, M, Doherty, M, Hershfield, M, Pillinger, M, Edwards, N, Schlesinger, N, Kumar, N, Slot, O, Ottaviani, S, Richette, P, Macmullan, P, Chapman, P, Lipsky, P, Robinson, P, Khanna, P, Gancheva, R, Grainger, R, Johnson, R, Te Kampe, R, Keenan, R, Tedeschi, S, Kim, S, Choi, S, Fields, T, Bardin, T, Uhlig, T, Jansen, T, Merriman, T, Pascart, T, Neogi, T, Kluck, V, Louthrenoo, W, Dalbeth, N, Bursill D., Taylor W. J., Terkeltaub R., Abhishek A., So A. K., Vargas-Santos A. B., Gaffo A. L., Rosenthal A., Tausche A. -K., Reginato A., Manger B., Scire CA., Pineda C., Van Durme C., Lin C. -T., Yin C., Albert D. A., Biernat-Kaluza E., Roddy E., Pascual E., Becce F., Perez-Ruiz F., Sivera F., Liote F., Schett G., Nuki G., Filippou G., Mccarthy G., Da Rocha Castelar Pinheiro G., Ea H. -K., Tupinamba H. D. A., Yamanaka H., Choi H. K., Mackay J., Odell J. R., Vazquez Mellado J., Singh J. A., Fitzgerald J. D., Jacobsson L. T. H., Joosten L., Harrold L. R., Stamp L., Andres M., Gutierrez M., Kuwabara M., Dehlin M., Janssen M., Doherty M., Hershfield M. S., Pillinger M., Edwards N. L., Schlesinger N., Kumar N., Slot O., Ottaviani S., Richette P., Macmullan P. A., Chapman P. T., Lipsky P. E., Robinson P., Khanna P. P., Gancheva R. N., Grainger R., Johnson R. J., Te Kampe R., Keenan R. T., Tedeschi S. K., Kim S., Choi S. J., Fields T. R., Bardin T., Uhlig T., Jansen T., Merriman T., Pascart T., Neogi T., Kluck V., Louthrenoo W., Dalbeth N., Bursill, D, Taylor, W, Terkeltaub, R, Abhishek, A, A. K., S, Vargas-Santos, A, Gaffo, A, Rosenthal, A, Tausche, A, Reginato, A, Manger, B, Scire, C, Pineda, C, Van Durme, C, Lin, C, Yin, C, Albert, D, Biernat-Kaluza, E, Roddy, E, Pascual, E, Becce, F, Perez-Ruiz, F, Sivera, F, Liote, F, Schett, G, Nuki, G, Filippou, G, Mccarthy, G, Da Rocha Castelar Pinheiro, G, H. -K., E, Tupinamba, H, Yamanaka, H, Choi, H, Mackay, J, Odell, J, Vazquez Mellado, J, Singh, J, Fitzgerald, J, Jacobsson, L, Joosten, L, Harrold, L, Stamp, L, Andres, M, Gutierrez, M, Kuwabara, M, Dehlin, M, Janssen, M, Doherty, M, Hershfield, M, Pillinger, M, Edwards, N, Schlesinger, N, Kumar, N, Slot, O, Ottaviani, S, Richette, P, Macmullan, P, Chapman, P, Lipsky, P, Robinson, P, Khanna, P, Gancheva, R, Grainger, R, Johnson, R, Te Kampe, R, Keenan, R, Tedeschi, S, Kim, S, Choi, S, Fields, T, Bardin, T, Uhlig, T, Jansen, T, Merriman, T, Pascart, T, Neogi, T, Kluck, V, Louthrenoo, W, Dalbeth, N, Bursill D., Taylor W. J., Terkeltaub R., Abhishek A., So A. K., Vargas-Santos A. B., Gaffo A. L., Rosenthal A., Tausche A. -K., Reginato A., Manger B., Scire CA., Pineda C., Van Durme C., Lin C. -T., Yin C., Albert D. A., Biernat-Kaluza E., Roddy E., Pascual E., Becce F., Perez-Ruiz F., Sivera F., Liote F., Schett G., Nuki G., Filippou G., Mccarthy G., Da Rocha Castelar Pinheiro G., Ea H. -K., Tupinamba H. D. A., Yamanaka H., Choi H. K., Mackay J., Odell J. R., Vazquez Mellado J., Singh J. A., Fitzgerald J. D., Jacobsson L. T. H., Joosten L., Harrold L. R., Stamp L., Andres M., Gutierrez M., Kuwabara M., Dehlin M., Janssen M., Doherty M., Hershfield M. S., Pillinger M., Edwards N. L., Schlesinger N., Kumar N., Slot O., Ottaviani S., Richette P., Macmullan P. A., Chapman P. T., Lipsky P. E., Robinson P., Khanna P. P., Gancheva R. N., Grainger R., Johnson R. J., Te Kampe R., Keenan R. T., Tedeschi S. K., Kim S., Choi S. J., Fields T. R., Bardin T., Uhlig T., Jansen T., Merriman T., Pascart T., Neogi T., Kluck V., Louthrenoo W., and Dalbeth N.

Abstract

Objective There is a lack of standardisation in the terminology used to describe gout. The aim of this project was to develop a consensus statement describing the recommended nomenclature for disease states of gout. Methods A content analysis of gout-related articles from rheumatology and general internal medicine journals published over a 5-year period identified potential disease states and the labels commonly assigned to them. Based on these findings, experts in gout were invited to participate in a Delphi exercise and face-to-face consensus meeting to reach agreement on disease state labels and definitions. Results The content analysis identified 13 unique disease states and a total of 63 unique labels. The Delphi exercise (n=76 respondents) and face-to-face meeting (n=35 attendees) established consensus agreement for eight disease state labels and definitions. The agreed labels were as follows: asymptomatic hyperuricaemia', asymptomatic monosodium urate crystal deposition', asymptomatic hyperuricaemia with monosodium urate crystal deposition', gout', tophaceous gout', erosive gout', first gout flare' and recurrent gout flares'. There was consensus agreement that the label gout' should be restricted to current or prior clinically evident disease caused by monosodium urate crystal deposition (gout flare, chronic gouty arthritis or subcutaneous tophus). Conclusion Consensus agreement has been established for the labels and definitions of eight gout disease states, including gout' itself. The Gout, Hyperuricaemia and Crystal-Associated Disease Network recommends the use of these labels when describing disease states of gout in research and clinical practice.

Published
2019

12. 2018 updated European League Against Rheumatism evidence-based recommendations for the diagnosis of gout

Author

Richette P, Doherty M, PASCUAL E, Barskova V, Becce F, Castaneda J, Coyfish M, Guillo S, Jansen T, Janssens H, Liote F, Mallen C, Nuki G, Perez-Ruiz F, Pimentao J, Punzi L, Pywell A, So A, Tausche A, Uhlig T, Zavada J, Zhang W, Tubach F, and Bardin T

Subjects
musculoskeletal diseases, congenital, hereditary, and neonatal diseases and abnormalities, nutritional and metabolic diseases
Abstract

Although gout is the most common inflammatory arthritis, it is still frequently misdiagnosed. New data on imaging and clinical diagnosis have become available since the first EULAR recommendations for the diagnosis of gout in 2006. This prompted a systematic review and update of the 2006 recommendations. A systematic review of the literature concerning all aspects of gout diagnosis was performed. Recommendations were formulated using a Delphi consensus approach. Eight key recommendations were generated. A search for crystals in synovial fluid or tophus aspirates is recommended in every person with suspected gout, because demonstration of monosodium urate (MSU) crystals allows a definite diagnosis of gout. There was consensus that a number of suggestive clinical features support a clinical diagnosis of gout. These are monoarticular involvement of a foot or ankle joint (especially the first metatarsophalangeal joint); previous episodes of similar acute arthritis; rapid onset of severe pain and swelling; erythema; male gender and associated cardiovascular diseases and hyperuricaemia. When crystal identification is not possible, it is recommended that any atypical presentation should be investigated by imaging, in particular with ultrasound to seek features suggestive of MSU crystal deposition (double contour sign and tophi). There was consensus that a diagnosis of gout should not be based on the presence of hyperuricaemia alone. There was also a strong recommendation that all people with gout should be systematically assessed for presence of associated comorbidities and risk factors for cardiovascular disease, as well as for risk factors for chronic hyperuricaemia. Eight updated, evidence-based, expert consensus recommendations for the diagnosis of gout are proposed.

Published
2020

13. 2018 updated European League Against Rheumatism evidence-based recommendations for the diagnosis of gout

Author

Richette, P., Doherty, M., Pascual, E., Barskova, V., Becce, F., Castaneda, J., Coyfish, M., Guillo, S., Jansen, T., Janssens, H., Lioté, F., Mallen, C.D., Nuki, G., Perez-Ruiz, F., Pimentao, J., Punzi, L., Pywell, A., So, A.K., Tausche, A.K., Uhlig, T., Zavada, J., Zhang, W., Tubach, F., Bardin, T., Richette, P., Doherty, M., Pascual, E., Barskova, V., Becce, F., Castaneda, J., Coyfish, M., Guillo, S., Jansen, T., Janssens, H., Lioté, F., Mallen, C.D., Nuki, G., Perez-Ruiz, F., Pimentao, J., Punzi, L., Pywell, A., So, A.K., Tausche, A.K., Uhlig, T., Zavada, J., Zhang, W., Tubach, F., and Bardin, T.

Abstract

Contains fulltext : 225037.pdf (Publisher’s version ) (Closed access), Although gout is the most common inflammatory arthritis, it is still frequently misdiagnosed. New data on imaging and clinical diagnosis have become available since the first EULAR recommendations for the diagnosis of gout in 2006. This prompted a systematic review and update of the 2006 recommendations. A systematic review of the literature concerning all aspects of gout diagnosis was performed. Recommendations were formulated using a Delphi consensus approach. Eight key recommendations were generated. A search for crystals in synovial fluid or tophus aspirates is recommended in every person with suspected gout, because demonstration of monosodium urate (MSU) crystals allows a definite diagnosis of gout. There was consensus that a number of suggestive clinical features support a clinical diagnosis of gout. These are monoarticular involvement of a foot or ankle joint (especially the first metatarsophalangeal joint); previous episodes of similar acute arthritis; rapid onset of severe pain and swelling; erythema; male gender and associated cardiovascular diseases and hyperuricaemia. When crystal identification is not possible, it is recommended that any atypical presentation should be investigated by imaging, in particular with ultrasound to seek features suggestive of MSU crystal deposition (double contour sign and tophi). There was consensus that a diagnosis of gout should not be based on the presence of hyperuricaemia alone. There was also a strong recommendation that all people with gout should be systematically assessed for presence of associated comorbidities and risk factors for cardiovascular disease, as well as for risk factors for chronic hyperuricaemia. Eight updated, evidence-based, expert consensus recommendations for the diagnosis of gout are proposed.

Published
2020

20. The British Society for Rheumatology Guideline for the Management of Gout

Author

Hui, M, Carr, A, Cameron, S, Davenport, G, Doherty, M, Forrester, H, Jenkins, W, Jordan, KM, Mallen, CD, McDonald, TM, Nuki, G, Pywell, A, Zhang, W, Roddy, E, and British Society for Rheumatology Standards, Audit and Guidelines

Subjects
0301 basic medicine, medicine.medical_specialty, Gout, Alternative medicine, Gout suppressants, Gout Suppressants, 03 medical and health sciences, 0302 clinical medicine, RC925, Rheumatology, Internal medicine, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Disease management (health), Life Style, 030203 arthritis & rheumatology, business.industry, Life style, Disease Management, Guideline, medicine.disease, R1, Urate level, Diet, 030104 developmental biology, Family medicine, Physical therapy, business
Abstract

No abstract

Published
2017

24. Spontaneous dog osteoarthritis — a One Medicine vision

Author

Meeson, R L, Todhunter, R J, Blunn, G, Nuki, G, and Pitsillides, A A

Abstract

Osteoarthritis (OA) is a global disease that, despite extensive research, has limited treatment options. Pet dogs share both an environment and lifestyle attributes with their owners, and a growing awareness is developing in the public and among researchers that One Medicine, the mutual co-study of animals and humans, could be beneficial for both humans and dogs. To that end, this Review highlights research opportunities afforded by studying dogs with spontaneous OA, with a view to sharing this active area of veterinary research with new audiences. Similarities and differences between dog and human OA are examined, and the proposition is made that suitably aligned studies of spontaneous OA in dogs and humans, in particular hip and knee OA, could highlight new avenues of discovery. Developing cross-species collaborations will provide a wealth of research material and knowledge that is relevant to human OA and that cannot currently be obtained from rodent models or experimentally induced dog models of OA. Ultimately, this Review aims to raise awareness of spontaneous dog OA and to stimulate discussion regarding its exploration under the One Medicine initiative to improve the health and well-being of both species.

Published
2019

25. Towards prevention of post-traumatic osteoarthritis: report from an international expert working group on considerations for the design and conduct of interventional studies following acute knee injury

Author

Watt, F.E., Corp, N., Kingsbury, S.R., Frobell, R., Englund, M., Felson, D.T., Levesque, M., Majumdar, S., Wilson, C., Beard, D.J., Lohmander, L.S., Kraus, V.B., Roemer, F., Conaghan, P.G., Mason, D.J., Adams, J., Blank, M., Batt, M., Biggs, P., Busse-Morris, M., Button, K., Calder, J., Cook, J., Edwards, C., Fisheleva, E., Hamilton, D.F., Harrison, H., Holt, C., Jones, M., Jones, R, Kluzek, S., Knight, T., Nuki, G., Parekh, S., Peat, G., Pothet, C., Rainer, T., Robinson, N., Sawle, L., Vincent, T., Williams, A., Wise, E., Zhang, W., and Bierma-Zeinstra, S.

Subjects
Osteoarthritis, Injury, Outcome, Clinical trial, Knee, Considerations
Abstract

Objective: There are few guidelines for clinical trials of interventions for prevention of post-traumatic osteoarthritis (PTOA), reflecting challenges in this area. An international multi-disciplinary expert group including patients was convened to generate points to consider for the design and conduct of interventional studies following acute knee injury.\ud \ud Design: An evidence review on acute knee injury interventional studies to prevent PTOA was presented to the group, alongside overviews of challenges in this area, including potential targets, biomarkers and imaging. Working groups considered pre-identified key areas: eligibility criteria and outcomes, biomarkers, injury definition and intervention timing including multi-modality interventions. Consensus agreement within the group on points to consider was generated and is reported here after iterative review by all contributors.\ud \ud Results: The evidence review identified 37 studies. Study duration and outcomes varied widely and 70% examined surgical interventions. Considerations were grouped into three areas: justification of inclusion criteria including the classification of injury and participant age (as people over 35 may have pre-existing OA); careful consideration in the selection and timing of outcomes or biomarkers; definition of the intervention(s)/comparator(s) and the appropriate time-window for intervention (considerations may be particular to intervention type). Areas for further research included demonstrating the utility of patient-reported outcomes, biomarkers and imaging outcomes from ancillary/cohort studies in this area, and development of surrogate clinical trial endpoints that shorten the duration of clinical trials and are acceptable to regulatory agencies.\ud \ud Conclusions: These considerations represent the first international consensus on the conduct of interventional studies following acute knee joint trauma.

Published
2019

29. EULAR evidence based recommendations for gout: Management. Report of a task force of the EULAR Standing Committee For International Clinical Studies Including Therapeutics (ESCISIT)

Author

Zhang, W., Doherty, M., Bardin, T., Pascual, E., Barskova, V., Conaghan, P., Gerster, J., Jacobs, J., Leeb, B., Liote, F., McCarthy, G., Netter, P., Nuki, G., Perez-Ruiz, F., Pignone, A., Pimentao, J., Punzi, L., Roddy, E., Uhlig, T., and Zimmermann-Gorska, I.

Subjects
Gout -- Research, Gout -- Diagnosis, Gout -- Care and treatment, Clinical trials -- Evaluation, Health
Published
2006

30. EULAR evidence based recommendations for gout: diagnosis. Report of a task force of the standing committee for international clinical studies including therapeutics (ESCISIT)

Author

Zhang, W., Doherty, M., Pascual, E., Bardin, T., Barskova, V., Conaghan, P., Gerster, J., Jacobs, J., Leeb, B., Liote, F., McCarthy, G., Netter, P., Nuki, G., Perez-Ruiz, F., Pignone, A., Pimentao, J., Punzi, L., Roddy, E., Uhlig, T., and Zimmermann-Gorska, I.

Subjects
Gout -- Research, Gout -- Diagnosis, Gout -- Risk factors, Gout -- Care and treatment, Health
Published
2006

41. Interleukin 1 beta, hand and foot bone mineral content and the development of joint erosions in rheumatoid arthritis

Author

North, J., Situnayake, R.D., Tikly, M., Cremona, A., Nicoll, J., Kumararatne, D.S., and Nuki, G.

Subjects
Interleukin-1 -- Physiological aspects, Rheumatoid arthritis -- Development and progression, Joint diseases -- Physiological aspects, Bone resorption -- Measurement, Health
Abstract

The amount of interleukin-1 beta (IL-1 beta) may indicate only weakly how much rheumatoid arthritis (RA) has progressed. The relationship between blood levels of IL-6 and progression of RA appear to be less than that between the erythrocyte sedimentation rate (ESR). IL-6 is one of many kinds of cells involved in the immune process. Rheumatoid arthritis is an autoimmune disorder that affects the connective tissues and joints. ESR is a standard measure of inflammation. A study of 106 RA patients divided them into two groups: one with low ESR and one with high ESR. The blood levels of IL-6 were measured and analyzed as was the amount of mineral content in the bones of the hands and feet. Both groups lost noticeable amounts of mineral, but the group with high ESR lost more than the other group.

Published
1994

45. Academic Medicine And The New Consultant Contract

Author

Baum, M., Bloom, A. L., Davies, W. T., Dodge, J. A., Elder, G. H., Evans, K. T., Graham, J. D. P., Hales, C. N., Harper, P., Hayes, T. M., Henderson, A., Hibbard, B., Hughes, L. E., Jacobs, A., Leopold, J. G., Lunn, J. N., Mahler, R., Nuki, G., Pearson, J. F., Roberts, G. M., Smith, P., Stark, J. M., Vickers, M. D., Wardrop, C. A. J., Watkins, J. F., Whittaker, J. A., and Williams, E. D.

Published
1977

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