SLR - July 2014 - Khoa Vuong
What are the Levels of Evidence on Which We Base Decisions for Surgical Management of Lower extremity Bone Tumors?
Reference: Evaniew N, Nuttal J, Farrokhyar F, Bhandari M, Ghert M. Clinical Orthopaedics and Related Research. 2014 Jan; 472(1):8-15.
Scientific Literature Review
Reviewed By: Khoa D. Vuong, DPM
Residency Program: Pinnacle Health Hospital System- Harrisburg, PA
Podiatric Relevance: Lower extremity primary bone tumors are very rare occurrences with up to four patients per million each year (Ottaviani 2009). Even with this rare occurrence, it is important to know what surgical treatments are available and have been supported with evidence based medicine. The purpose of this systematic review was to determine the overall levels of evidence published regarding the surgical management of lower extremity bone tumors, the quality of these studies based on the STROBE criteria, and what pitfalls were noted in published studies regarding surgical management of lower extremity tumors.
Methods: A systematic review was performed that included all clinical studies describing the surgical management of lower extremity primary bone tumors from 2002-2012. The levels of evidence were evaluated by two independent authors who used the STROBE checklist to determine the quality of the published literature regarding surgical management of bone tumors. The STROBE checklist was used as a standard for quantifying underreported elements of research study design. Six hundred and seven out of one thousand three hundred and eighty-seven studies met the STROBE criteria for inclusion of this systematic review. The mean percentage of STROBE points in each article was noted to be 53 percent (orthopaedic literature, in general, tends to have a mean score of 58 percent overall).
Results: In the systematic literature review, there were no Level I studies concerning surgical management of lower extremity bone tumors. There were two Level II and 47 Level III studies. Overall, 92 percent of the literature reviewed concerning this topic fell into the Level IV and V category (308 and 250 studies respectively). Using the STROBE criteria, it is noted that the most common issues concerning these published studies involve failure to justify sample size (2.2 percent), examine sensitivity (2.2 percent), accounting for missing data (9.8 percent), and discussion sources of bias (14 percent). Follow-up (66 percent), eligibility criteria (55 percent), and methodological limitations (53 percent) were also variably reported in these published studies.
Conclusions: Literature concerning the surgical management of lower extremity bone tumors exists predominately in the form of observational studies. Please note that literature regarding the podiatric profession, in general, consists of 89 percent of observational studies (Zaidi et al 2012). With that being said, there are multiple issues regarding the low level evidence-based studies that are published regarding management of lower extremity bone tumors that were identified by the authors. Due to ethical concerns such as use of control (non-surgical or sham treatments), difficulty applying a randomized control trial for varied surgical procedures, and high expense regarding setting up a randomized control trial, it is very unlikely that future literature concerning this issue take form of Level I or II studies. Due to the fact that literature concerning surgical treatment is among the lower tiers of evidence based medicine, it is very important that when dealing and discussing with patient’s regarding the treatment options for lower extremity bone tumors, that physicians are upfront about the lack of randomized controlled trials and evidence supporting any planned surgical intervention.