Smith M M, Clarke E C, Little C B
Raymond Purves Bone and Joint Research Laboratories, Institute of Bone and Joint Research, Kolling Institute (University of Sydney), Level 10, Kolling Building, Royal North Shore Hospital, St Leonards, NSW 2065, Australia.
Murray Maxwell Biomechanics Laboratory, Institute of Bone and Joint Research, Kolling Institute (University of Sydney), Level 10, Kolling Building, Royal North Shore Hospital, St Leonards, NSW 2065, Australia.
Osteoarthritis Cartilage. 2017 Mar;25(3):354-363. doi: 10.1016/j.joca.2016.10.016. Epub 2016 Nov 2.
To review the factors in experimental design that contribute to poor translation of pre-clinical research to therapies for patients with osteoarthritis (OA) and how this might be improved.
Narrative review of the literature, and evaluation of the different stages of design conduct and analysis of studies using animal models of OA to define specific issues that might reduce quality of evidence and how this can be minimised.
Preventing bias and improving experimental rigour and reporting are important modifiable factors to improve translation from pre-clinical animal models to successful clinical trials of therapeutic agents. Despite publication and adoption by many journals of guidelines such as Animals in Research: Reporting In Vivo Experiments (ARRIVE), experimental animal studies published in leading rheumatology journals are still deficient in their reporting. In part, this may be caused by researchers first consulting these guidelines after the completion of experiments, at the time of publication. This review discusses factors that can (1) bias the outcome of experimental studies using animal models of osteoarthritis or (2) alter the quality of evidence for translation. We propose a checklist to consult prior to starting experiments; in the Design and Execution of Protocols for Animal Research and Treatment (DEPART).
Following DEPART during the design phase will enable completion of the ARRIVE checklist at the time of publication, and thus improve the quality of evidence for inclusion of experimental animal research in meta-analyses and systematic reviews: "DEPART well-prepared and ARRIVE safely".
回顾实验设计中导致临床前研究难以转化为骨关节炎(OA)患者治疗方法的因素,以及如何改善这一情况。
对文献进行叙述性综述,并评估使用OA动物模型进行研究的设计、实施和分析的不同阶段,以确定可能降低证据质量的具体问题以及如何将其降至最低。
预防偏倚、提高实验严谨性和报告质量是改善从临床前动物模型到治疗药物成功临床试验转化的重要可改变因素。尽管许多期刊发表并采用了如《研究中的动物:体内实验报告》(ARRIVE)等指南,但在领先的风湿病学杂志上发表的实验动物研究报告仍存在不足。部分原因可能是研究人员在实验完成后、发表时才首次查阅这些指南。本综述讨论了可能(1)使使用骨关节炎动物模型的实验研究结果产生偏倚或(2)改变转化证据质量的因素。我们提出了一个在开始实验前参考的清单;在《动物研究与治疗方案的设计与执行》(DEPART)中。
在设计阶段遵循DEPART将能够在发表时完成ARRIVE清单,从而提高将实验动物研究纳入荟萃分析和系统评价的证据质量:“做好准备再出发,安全抵达ARRIVE”。