Mulpuri Kishore, Schaeffer Emily K, Graham H Kerr, Kocher Mininder S, Sanders James, Zaltz Ira
Department of Orthopaedic Surgery, BC Children's Hospital.
Department of Orthopaedics, University of British Columbia, Vancouver, BC, Canada.
J Pediatr Orthop. 2018 Apr;38(4):e225-e229. doi: 10.1097/BPO.0000000000000876.
Evidence-based medicine has become the cornerstone to guide clinical practice decision-making. Evidence-based medicine integrates the strongest available evidence with clinical expertise to make decisions about clinical care. The quality of the evidence depends upon the soundness of the study methodology to allow for meaningful interpretation of the clinical results. The purpose of this review is to analyze the methodological design and clinical findings of published pediatric orthopaedic studies to determine their ability to change or influence clinical practice.
This is the first in a series of evidence-based reviews in pediatric orthopaedics. The pediatric orthopaedic literature was reviewed for randomized controlled trials (RCTs) published in 2013 to 2014. Two RCTs were selected from the Journal of Bone and Joint Surgery for in depth methodological review and analysis. Methodological reviews were performed by 2 orthopaedic surgeons with advanced research degrees. Following this, 2 clinical experts reviewed the articles to rate the clinical impact or value of each study. Methodological and clinical reviews were compiled, and a final recommendation on impact to change clinical practice was made based on both review components at the consensus of the panel.
The first study reviewed investigated the impact of physical therapy on function following supracondylar humeral fractures in children. The reviewers deemed the superiority study to of sound design, and conclusions appropriate for the methodology used and clinical findings. The results do not compel a recommendation to change clinical practice. The second study investigated the impact of Botulinum Toxin A with casting for the treatment of idiopathic toe-walking in children. Although of relatively sound design, the sample size was too small to appropriately perform some statistical comparisons. No recommendation to change clinical practice could be made.
Both RCTs reviewed were superiority studies with a negative result. No recommendation to change clinical practice could be made.
Interpretation of superiority studies with nonsignificant findings must be done with caution. The findings of both of these RCTs highlight the need for more noninferiority trials in the pediatric orthopaedic literature in order to appropriately demonstrate no difference between 2 treatment options.
循证医学已成为指导临床实践决策的基石。循证医学将可得的最有力证据与临床专业知识相结合,以做出有关临床护理的决策。证据的质量取决于研究方法的合理性,以便对临床结果进行有意义的解读。本综述的目的是分析已发表的儿科骨科研究的方法设计和临床发现,以确定它们改变或影响临床实践的能力。
这是儿科骨科循证综述系列中的第一篇。对2013年至2014年发表的儿科骨科文献中的随机对照试验(RCT)进行了综述。从《骨与关节外科杂志》中选取了两项RCT进行深入的方法学综述和分析。方法学综述由两名拥有高级研究学位的骨科医生进行。在此之后,两名临床专家对文章进行评审,以评估每项研究的临床影响或价值。对方法学和临床综述进行整理,并根据专家组的共识,基于两个评审部分对改变临床实践的影响做出最终建议。
第一项综述研究调查了物理治疗对儿童肱骨髁上骨折后功能的影响。评审人员认为该优越性研究设计合理,结论与所采用的方法和临床发现相符。结果并不足以促使推荐改变临床实践。第二项研究调查了肉毒杆菌毒素A联合石膏固定治疗儿童特发性足尖行走的效果。尽管设计相对合理,但样本量过小,无法适当地进行一些统计比较。无法做出改变临床实践的推荐。
所综述的两项RCT均为优越性研究且结果为阴性。无法做出改变临床实践的推荐。
对结果无统计学意义的优越性研究进行解读时必须谨慎。这两项RCT的结果凸显了儿科骨科文献中需要更多非劣效性试验,以便适当地证明两种治疗方案之间无差异。