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. Watt, F. E., Corp, N., Kingsbury, S. R., Frobell, R., Englund, M., Felson, D., Levesque, M., Majumdar, S., Wilson, C., Beard, D. J., Lohmander, S., Kraus, V. B., Roemer, F., Conaghan, P. G., Mason, D. J., Adams, J., Blank, M., Mark Batt, Biggs, P., Busse-Morris, M., Button, K., Calder, J., Jonathan Cook, Christopher Edwards, Fisheleva, E., David F Hamilton, Harrison, H., Cathy Holt, Jones, M., Richard Jones, Kluzek, S., Knight, T., George Nuki, Parekh, S., George Peat, Pothet, C., Timothy Rainer, Robinson, N., Sawle, L., Tonia Vincent, Williams, A., Wise, E., Weiya Zhang, & Sita Bierma-Zeinstra Osteoarthritis and Cartilage, 27(1):23–33, January, 2019.
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 [link]Paper  doi  abstract   bibtex   
Summary 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. 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. Results The evidence review identified 37 studies. Study duration and outcomes varied widely and 70% examined surgical interventions. Considerations were grouped into 3 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. Conclusions These considerations represent the first international consensus on the conduct of interventional studies following acute knee joint trauma.
@article{watt_towards_2019,
	title = {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},
	volume = {27},
	issn = {1063-4584},
	shorttitle = {Towards prevention of post-traumatic osteoarthritis},
	url = {http://www.sciencedirect.com/science/article/pii/S1063458418314122},
	doi = {10.1016/j.joca.2018.08.001},
	abstract = {Summary
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.
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.
Results
The evidence review identified 37 studies. Study duration and outcomes varied widely and 70\% examined surgical interventions. Considerations were grouped into 3 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.
Conclusions
These considerations represent the first international consensus on the conduct of interventional studies following acute knee joint trauma.},
	number = {1},
	urldate = {2018-09-03},
	journal = {Osteoarthritis and Cartilage},
	author = {Watt, Fiona E. and Corp, Nadia and Kingsbury, Sarah R. and Frobell, Richard and Englund, Martin and Felson, David and Levesque, Marc and Majumdar, Sharmila and Wilson, Chris and Beard, David J. and Lohmander, Stefan and Kraus, Virginia B. and Roemer, Frank and Conaghan, Philip G. and Mason, Deborah J. and Adams, Jo and Blank, Mike and {Mark Batt} and Biggs, Paul and Busse-Morris, Monica and Button, Kate and Calder, James and {Jonathan Cook} and {Christopher Edwards} and Fisheleva, Elena and {David F Hamilton} and Harrison, Heather and {Cathy Holt} and Jones, Mary and {Richard Jones} and Kluzek, Stefan and Knight, Thomas and {George Nuki} and Parekh, Sanjay and {George Peat} and Pothet, Caroline and {Timothy Rainer} and Robinson, Nicky and Sawle, Leanne and {Tonia Vincent} and Williams, Andy and Wise, Elspeth and {Weiya Zhang} and {Sita Bierma-Zeinstra}},
	month = jan,
	year = {2019},
	keywords = {Clinical trial, Considerations, Injury, Knee, Osteoarthritis, Outcome},
	pages = {23--33},
}

Downloads: 0