Introduction to Evidence-based Recommendations for Pediatric Orthopaedic Practice
Evidence-based medicine (EBM) has become a firmly established foundation from which to guide clinical practice since its inception over 2 decades ago.1,2 At its core, EBM aims to integrate the strongest available evidence with clinical expertise to make decisions about medical care while also taking into account a patient’s wishes. The quality of evidence available depends upon the methodology of the study. Randomized controlled trials are considered the gold standard for high level evidence by rigorously controlling for bias and confounding factors. However, RCTs can also be susceptible to methodological flaws that weaken the quality of evidence they can provide to guide clinical practice.3
RCTs can be of superiority, noninferiority, or equivalence design. Superiority trials are used when intending to show a difference between 2 treatments; however, a type II error is often committed when no difference is found and the authors conclude equivalence between the 2. Noninferiority studies—powered to show that an experimental treatment is no worse than the standard treatment—are underutilized in pediatric orthopaedics. Many research questions in orthopaedics can be framed to allow for a noninferiority design to produce rigorous and reliable results. These questions are often not appropriate for a superiority design, leading to the assumption of equivalence where it may not truly exist.
Reporting of important methodological study aspects is often insufficient in the pediatric orthopaedic literature, which can lead to misinterpretation, overemphasis of findings, or lack of clarity in the evidence available for a certain treatment or condition.4,5 Careful analysis of the quality of both the methodological study design and clinical findings/recommendations are necessary to determine whether a study should change or influence clinical decision-making. Consequently, we are introducing a series of Evidence-based Medicine Reviews of the literature in pediatric orthopaedics. This will be a semiannual series in the Journal of Pediatric Orthopaedics, whereby a panel consisting of 2 methodological experts and 2 clinical experts will review 2 to 4 pediatric orthopaedic articles from other orthopaedic journals.
The articles selected for each evidence-based review will have the potential for practice changing impact. The emphasis in each article will largely be on therapeutic interventions emphasizing comparative effectiveness; however, diagnostic and prognostic studies with practice changing potential will also be considered. Journal sources include Journal of Pediatric Orthopaedics B, Journal of Children’s Orthopaedics, Journal of Bone and Joint Surgery, Bone and Joint Journal, Spine, Journal of the American Medical Association, Lancet, New England Journal of Medicine, and other high-impact medical journals.
The methodological quality of each article will be assessed by 2 orthopaedic surgeons with advanced research degrees. Particular consideration will be applied to critical quality components including the research question, study design, population and setting, outcomes assessed, results, and conclusion drawn. Criticisms or limitations commonly imposed on evaluation of medical studies should be given less impact in surgical studies as they are not attainable or pragmatic; for example blinding and efficacy versus effectiveness.
Following this comprehensive methodological assessment, 2 clinical experts will review the articles to rate the clinical impact or value of each study. The clinical review will involve a brief review of the relevant literature to provide context for the study within the existing knowledge of the field. Clinical impact and justification will then be provided.
Methodological and clinical reviews will be compiled, and a final recommendation on impact to change clinical practice will be provided on the foundations of EBM. Specifically, the final recommendation will be based on both the methodological review and the clinical expertise (experience, risks, burden, costs, generalizability), and patient preference (values and circumstances) perspective. This recommendation will be the consensus of the panel.
The final recommendation will represent 2 stages.