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.
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.
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DOI：
10.1016/j.joca.2018.08.001
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发表时间：
2019-01
影响因子：
7
通讯作者：
Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Study Group Expert Working Group
中科院分区：
文献类型：
--
作者：
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;Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Study Group Expert Working Group
关于预防创伤后骨关节炎（PTOA）干预措施的临床试验指南很少，反映了该领域的挑战。召集了一个包括患者在内的国际多学科专家组，以产生在急性膝关节损伤后设计和进行干预性研究时需要考虑的要点。向该小组提交了关于预防PTOA的急性膝关节损伤干预性研究的证据审查，以及该领域挑战的概述，包括潜在靶点，生物标志物和成像。工作组审议了预先确定的关键领域：资格标准和结果、生物标志物、损伤定义和干预时机，包括多模式干预。在所有贡献者反复审查后，在小组内就需要考虑的问题达成了共识，并在此报告。证据审查确定了37项研究。研究持续时间和结局差异很大，70%的研究对象为手术干预。考虑因素分为三个方面：纳入标准的合理性，包括损伤分类和参与者年龄（因为35岁以上的人可能患有既存OA）;仔细考虑结局或生物标志物的选择和时间;干预/对照药物的定义和适当的干预时间窗（考虑因素可能特定于干预类型）。进一步研究的领域包括证明该领域辅助/队列研究的患者报告结局、生物标志物和成像结局的效用，以及开发替代临床试验终点，缩短临床试验持续时间并为监管机构所接受。这些考虑代表了在急性膝关节创伤后进行介入研究的第一个国际共识。
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. 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. 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. These considerations represent the first international consensus on the conduct of interventional studies following acute knee joint trauma.
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DOI：
10.1136/bmj.f232
发表时间：
2013-01-24
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Frobell RB;Roos HP;Roos EM;Roemer FW;Ranstam J;Lohmander LS
通讯作者：
Lohmander LS
影响因子：
7
作者：
Jordan, J. M.;Sowers, M. F.;Wahba, M.
通讯作者：
Wahba, M.
影响因子：
4.8
作者：
Lattermann, Christian;Jacobs, Cale A.;Spindler, Kurt P.
通讯作者：
Spindler, Kurt P.
影响因子：
4.8
作者：
Amano, Keiko;Li, Alan K.;Majumdar, Sharmila
通讯作者：
Majumdar, Sharmila
影响因子：
5.5
作者：
Felson, David T.;Redmond, Anthony C.;Conaghan, Philip G.
通讯作者：
Conaghan, Philip G.