Prabhjot Singh, Mark Kurapatti, Niklas Koehne, Ishandeep Singh, Jennifer Yu, Gray W Ricca, Nicholas Richardson, Robert L Parisien
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引用次数: 0
Abstract
Background: Extracorporeal shockwave therapy (ESWT) is widely used in the treatment of plantar fasciitis; however, the statistical robustness of randomized controlled trials (RCTs) supporting its use remains unclear. This study evaluates the fragility of dichotomous outcomes in RCTs on ESWT for plantar fasciitis using fragility index (FI) and fragility quotient (FQ) metrics.
Methods: A systematic search of PubMed and Scopus was conducted on March 1, 2025, to identify RCTs investigating ESWT for plantar fasciitis. Eligible studies included dichotomous outcomes in comparison to no treatment or alternative interventions. FI was calculated using two-tailed Fisher's exact tests. FQ was computed by dividing FI by the study's sample size. Subgroup analyses were conducted based on outcome type.
Results: Nineteen RCTs met inclusion criteria, yielding 159 dichotomous outcomes. Of these, 20 outcomes were statistically significant (p < 0.05) and 139 were nonsignificant. The overall median FI was 5 (IQR:3-6) and FQ was 0.061 (IQR:0.040-0.108), indicating that reversal of 6.1% of patient outcomes could change statistical significance. Among significant outcomes, the median FI was 5 (IQR:2-11) and FQ was 0.029 (IQR:0.016-0.212). Pain outcomes were most frequently reported (n = 112). Subgroup analysis revealed that outcomes related to physical function were most fragile (FQ:0.036), while ultrasound-based outcomes were least fragile (FQ:0.081). In 20.75% of outcomes, the number of patients lost to follow-up exceeded the FI, suggesting that outcome significance could be altered by follow-up alone.
Conclusions: Dichotomous outcomes in RCTs evaluating ESWT for plantar fasciitis demonstrate notable statistical fragility. Given that a small number of event reversals can shift the interpretation of many findings, clinicians should interpret statistically significant ESWT outcomes with caution. Future studies should incorporate fragility metrics to improve transparency and support more reliable clinical decision-making.
期刊介绍：
The Journal of Foot & Ankle Surgery is the leading source for original, clinically-focused articles on the surgical and medical management of the foot and ankle. Each bi-monthly, peer-reviewed issue addresses relevant topics to the profession, such as: adult reconstruction of the forefoot; adult reconstruction of the hindfoot and ankle; diabetes; medicine/rheumatology; pediatrics; research; sports medicine; trauma; and tumors.
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