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White J. et al., 2023: A fragility index analysis of clinical trials evaluating low-intensity extracorporeal shockwave therapy for erectile dysfunction.

University of Miami Miller School of Medicine, Urology, Miami, FL, USA.
McGill University, Urology, Montreal, QC, Canada.
Wake Forrest University, Urology, Winston-Salem, NC, USA.
Florida International University, Undergraduate Education, Miami, FL, USA.
University of Miami Miller School of Medicine, Urology, Miami, FL, USA.
John Hopkins University, Urology, Baltimore, MD, USA.

Abstract

Erectile dysfunction is a common sexual dysfunction that affects a significant proportion of men. Low-intensity extracorporeal shockwave therapy has been evaluated in multiple clinical trials as a therapeutic option for men with erectile dysfunction. The robustness of these clinical trials is not well defined, as the trials are hindered by inconsistent treatment protocols, small study arm size and short follow-up intervals. The fragility index is a statistical analysis which is used to evaluate the robustness of clinical trials. It is calculated by evaluating the minimum number of patients in a given trial arm that would be required to have an alternative outcome to alter the statistical significance of the results. The lowest fragility index in statistically significant trials is 1, meaning that if just one participant experienced an alternate outcome, the results would no longer achieve statistical significance. The upper limit is determined by the number of participants in a given arm of the trial. Herein, a scoping review of clinical trials evaluating the efficacy of low-intensity extracorporeal shockwave therapy in erectile dysfunction to determine the fragility index of trials with clinically significant results. We hypothesized that the fragility index would be low, indicating the results are less robust and generalizable.

Sex Med. 2023 May 22;11(2):qfad023. doi: 10.1093/sexmed/qfad023. eCollection 2023 Apr.PMID: 37228769
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Comments 1

Jens Rassweiler on Tuesday, 07 November 2023 08:45

This study focuses on evaluating the robustness of clinical trials that have investigated the use of low-intensity extracorporeal shockwave therapy (LI-ESWT) as a treatment for erectile dysfunction (ED). The authors aim to determine the fragility index of these trials to assess the stability of their results.

Erectile dysfunction is a common condition that affects many men, and LI-ESWT has been studied as a potential therapeutic option. However, the trials evaluating LI-ESWT for ED often have small study sizes, inconsistent treatment protocols, and short follow-up periods, which can impact the reliability of their findings.

The fragility index is a statistical measure that indicates how robust the results of a clinical trial are. It represents the minimum number of participants in a trial arm whose outcomes would need to change to alter the statistical significance of the results. A low fragility index suggests that the results are sensitive to small changes in the data.

The authors performed a scoping review of clinical trials that evaluated the efficacy of LI-ESWT for ED with statistically significant results
(P https://www.storzmedical.com/images/blog/sonderzeichen.jpg 0.05). They calculated the fragility index for each trial to determine the stability of the treatment effect. The fragility index values ranged from 1 to 21, with a median value of 2 for studies using objective measures and 15 for studies using non-standardized outcomes.

https://www.storzmedical.com/images/blog/Table1.png

The findings of the study indicate that the fragility index of the trials evaluating LI-ESWT for ED is generally low, suggesting that the results of these trials are sensitive to small changes in sample size or outcome. The authors suggest that larger sample sizes, more consistent treatment protocols, and more representative study populations are needed to improve the robustness of future trials in this area. Additionally, the fragility index could be a valuable tool for evaluating the reliability of clinical trial results in other medical contexts as well.

This study focuses on evaluating the robustness of clinical trials that have investigated the use of low-intensity extracorporeal shockwave therapy (LI-ESWT) as a treatment for erectile dysfunction (ED). The authors aim to determine the fragility index of these trials to assess the stability of their results. Erectile dysfunction is a common condition that affects many men, and LI-ESWT has been studied as a potential therapeutic option. However, the trials evaluating LI-ESWT for ED often have small study sizes, inconsistent treatment protocols, and short follow-up periods, which can impact the reliability of their findings. The fragility index is a statistical measure that indicates how robust the results of a clinical trial are. It represents the minimum number of participants in a trial arm whose outcomes would need to change to alter the statistical significance of the results. A low fragility index suggests that the results are sensitive to small changes in the data. The authors performed a scoping review of clinical trials that evaluated the efficacy of LI-ESWT for ED with statistically significant results (P [img]https://www.storzmedical.com/images/blog/sonderzeichen.jpg[/img] 0.05). They calculated the fragility index for each trial to determine the stability of the treatment effect. The fragility index values ranged from 1 to 21, with a median value of 2 for studies using objective measures and 15 for studies using non-standardized outcomes. [img]https://www.storzmedical.com/images/blog/Table1.png[/img] The findings of the study indicate that the fragility index of the trials evaluating LI-ESWT for ED is generally low, suggesting that the results of these trials are sensitive to small changes in sample size or outcome. The authors suggest that larger sample sizes, more consistent treatment protocols, and more representative study populations are needed to improve the robustness of future trials in this area. Additionally, the fragility index could be a valuable tool for evaluating the reliability of clinical trial results in other medical contexts as well.
Sunday, 03 March 2024