Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair: International Cartilage Repair Society Recommendations Based on Current Scientific Evidence and Standards of Clinical Care.
Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair: International Cartilage Repair Society Recommendations Based on Current Scientific Evidence and Standards of Clinical Care.
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DOI：
10.1177/1947603510392913
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发表时间：
2011-04
期刊：
影响因子：
2.8
通讯作者：
Brittberg M
中科院分区：
文献类型：
--
作者：
Mithoefer K;Saris DB;Farr J;Kon E;Zaslav K;Cole BJ;Ranstam J;Yao J;Shive M;Levine D;Dalemans W;Brittberg M
总结当前的临床研究实践，并制定客观科学评价膝关节软骨修复程序和产品的方法标准。对高水平原始研究进行了全面的文献综述，为膝关节软骨修复临床研究的设计提供了相关信息。对软骨修复出版物和正在进行的试验概要的分析被用来确定该领域研究的设计、报告和解释的重要标准。目前的文献反映了可用于关节软骨修复的科学证据的方法学局限性。然而，正在进行的临床试验数据库记录了一种趋势，表明研究设计和临床评估方法得到了改进。根据当前的临床护理科学信息和标准，针对统计研究设计、患者招募、对照组考虑因素、研究终点定义、结果记录、经过验证的患者报告结果工具的使用以及设计和实施科学合理的软骨修复研究方案的纳入和排除标准制定了详细的方法学建议。国际软骨修复协会 (ICRS) 和具有临床试验设计和实施经验的贡献作者达成了共识声明。高质量的临床研究方法对于当前和新型软骨修复技术的最佳评估至关重要。除了骨科研究设计的普遍适用原则外，特定标准和考虑因素也适用于软骨修复研究。系统地应用这些标准和考虑因素可以促进科学严谨、符合道德、实用且适合任何给定软骨修复研究项目中要解决的问题的研究设计。
To summarize current clinical research practice and develop methodological standards for objective scientific evaluation of knee cartilage repair procedures and products. A comprehensive literature review was performed of high-level original studies providing information relevant for the design of clinical studies on articular cartilage repair in the knee. Analysis of cartilage repair publications and synopses of ongoing trials were used to identify important criteria for the design, reporting, and interpretation of studies in this field. Current literature reflects the methodological limitations of the scientific evidence available for articular cartilage repair. However, clinical trial databases of ongoing trials document a trend suggesting improved study designs and clinical evaluation methodology. Based on the current scientific information and standards of clinical care, detailed methodological recommendations were developed for the statistical study design, patient recruitment, control group considerations, study endpoint definition, documentation of results, use of validated patient-reported outcome instruments, and inclusion and exclusion criteria for the design and conduct of scientifically sound cartilage repair study protocols. A consensus statement among the International Cartilage Repair Society (ICRS) and contributing authors experienced in clinical trial design and implementation was achieved. High-quality clinical research methodology is critical for the optimal evaluation of current and new cartilage repair technologies. In addition to generally applicable principles for orthopedic study design, specific criteria and considerations apply to cartilage repair studies. Systematic application of these criteria and considerations can facilitate study designs that are scientifically rigorous, ethical, practical, and appropriate for the question(s) being addressed in any given cartilage repair research project.
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DOI：
10.1302/0301-620x.85b2.13543
发表时间：
2003-03-01
影响因子：
--
作者：
Bentley, G;Biant, LC;Pringle, J
通讯作者：
Pringle, J
DOI：
10.2106/00004623-200203000-00009
发表时间：
2002-03-01
影响因子：
5.3
作者：
Bhandari, M;Richards, RR;Schemitsch, EH
通讯作者：
Schemitsch, EH
影响因子：
7
作者：
Bekkers, J. E. J.;de Windt, Th. S.;Saris, D. B. F.
通讯作者：
Saris, D. B. F.
影响因子：
5.8
作者：
COLLIER, S;GHOSH, P
通讯作者：
GHOSH, P
DOI：
10.1016/j.arthro.2008.06.015
发表时间：
2008-11-01
影响因子：
4.7
作者：
Asik, Mehmet;Ciftci, Feyyaz;Atalar, Atacan
通讯作者：
Atalar, Atacan