Fragility index of urological literature regarding medical expulsive treatment.

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Tytuł:: Fragility index of urological literature regarding medical expulsive treatment.
Autorzy:: Tzelves L; Second Department of Urology, Sismanogleio General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Chatzikrachtis N; Second Department of Urology, Sismanogleio General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Lazarou L; Second Department of Urology, Sismanogleio General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Mourmouris P; Second Department of Urology, Sismanogleio General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Pinitas A; Second Department of Urology, Sismanogleio General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Tsirkas K; Second Department of Urology, Sismanogleio General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Petropoulos O; Second Department of Urology, Sismanogleio General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Berdempes M; Second Department of Urology, Sismanogleio General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Feretzakis G; Department of Quality Control, Research and Continuing Education, Sismanogleio General Hospital, 15126, Marousi, Greece.
Glykas I; Department of Urology, General Hospital of Athens 'G. Gennimatas', Athens, Greece. .
Fragkoulis C; Department of Urology, General Hospital of Athens 'G. Gennimatas', Athens, Greece.
Varkarakis I; Second Department of Urology, Sismanogleio General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Skolarikos A; Second Department of Urology, Sismanogleio General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Źródło:: World journal of urology [World J Urol] 2021 Oct; Vol. 39 (10), pp. 3741-3746. Date of Electronic Publication: 2021 May 12.
Typ publikacji:: Journal Article
Język:: English
Imprint Name(s):: Original Publication: [Berlin ; New York] : Springer International, 1983-
MeSH Terms:: Conservative Treatment*
Statistics as Topic*
Adrenergic alpha-Antagonists/*therapeutic use
Ureteral Calculi/*drug therapy
Humans ; Randomized Controlled Trials as Topic ; Sample Size ; Statistics, Nonparametric ; Treatment Outcome ; Urolithiasis/drug therapy
References:: Turney BW, Reynard JM, Noble JG, Keoghane SR (2012) Trends in urological stone disease. BJU Int 109(7):1082–1087. (PMID: 10.1111/j.1464-410X.2011.10495.x)
Türk C, Petřík A, Sarica K, Seitz C, Skolarikos A, Straub M et al (2016) EAU guidelines on diagnosis and conservative management of urolithiasis. Eur Urol 69(3):468–474. (PMID: 10.1016/j.eururo.2015.07.040)
Türk C, Petřík A, Sarica K, Seitz C, Skolarikos A, Straub M et al (2016) EAU guidelines on interventional treatment for urolithiasis. Eur Urol 69(3):475–482. (PMID: 10.1016/j.eururo.2015.07.041)
Mourmouris P, Tzelves L, Skolarikos A (2020) Complications after active stone removal. Curr Opin Urol 30(2):135–143. (PMID: 10.1097/MOU.0000000000000728)
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Vassileva J, Zagorska A, Karagiannis A, Petkova K, Sabuncu K, Saltirov I et al (2020) Radiation exposure of surgical team during endourological procedures: International Atomic Energy Agency-South-Eastern European Group for Urolithiasis Research Study. J Endourol. (Online Ahead of Print).
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Contributed Indexing:: Keywords: Fragility index; Medical expulsive treatment; Randomized controlled trials; Ureteral stones; Urolithiasis
Substance Nomenclature:: 0 (Adrenergic alpha-Antagonists)
Entry Date(s):: Date Created: 20210512 Date Completed: 20220218 Latest Revision: 20220218
Update Code:: 20240105
DOI:: 10.1007/s00345-021-03725-2
PMID:: 33978811
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Introduction: The role of medical expulsive treatment (MET) is controversial. Fragility index is an additional metric to assess randomized controlled trials (RCTs) outcome validity and indicates how many patients would be required to convert a trial from being statistically significant, to not significant. The larger is the FI, the better the trial's data. The aim of this study is to assess FI of RCTs regarding MET for ureteral stones.
Materials and Methods: A systematic literature search was performed. RCTs, reporting stone expulsion as a dichotomous outcome, showing statistical significance were eligible. FI (the number of patients needed to change from a non-event to event group, to lose statistical significance) and Fragility quotient (FI divided by total sample size), were calculated while Pearson's correlation and Mann-Whitney U test were used as appropriate.
Results: Thirty-six RCTs were eligible, with median FI = 3.5 and fragility quotient = 0.042, median sample size = 81, median journal impact factor = 1.73 and median reported p value = 0.008. In 33.3% of the studies, number of patients lost during follow-up was larger than FI, while in 13.89% of the studies, FI was 0, indicating use of inappropriate statistical method. Pearson's correlation showed significant positive association between FI and sample size (r = 0.981), number of events (r = 0.982) and impact factor (r = 0.731), while no association was found with p value or publication year.
Conclusions: In this analysis, a calculated FI of 3.5 indicates that findings from RCTs on MET for ureteral stones are fragile and should be interpreted in combination with clinical thinking and expertise.
(© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

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