Literature DB >> 34420111

Randomized controlled trials published on patients with hernias have a high percentage of unreproducible statistics.

Naila H Dhanani1, Oscar A Olavarria2, Cynthia S Bell3, Julie L Holihan2, Mike K Liang4.   

Abstract

INTRODUCTION: Surgeons rely on randomized controlled trials (RCT) to compare the effectiveness of treatments. RCTs require careful planning and substantial effort to complete. Because of the careful study design, statistics performed are often easy to reproduce such as Chi-squared or t-test. Issues such as statistical discordance, or reporting statistical results that cannot be reproduced, should be uncommon.
METHODS: RCTs pertaining to hernias were identified in PubMed using the search terms "hernia" and "randomized controlled trial." Studies were selected using a random number generator. Studies were included if the primary outcome could be reproduced using the data and statistical test reported in the manuscript. Discordance between the obtained p-value from our analysis and the published p-value was assessed. Primary outcome was the number of studies that reported p-values that crossed the level of statistical significance (p-value = 0.05) but on reproduction analysis did not.
RESULTS: Of the 100 included RCTs, five reported p-values that crossed the "p = 0.05" threshold that our team was unable to reproduce using the statistical test reported in the manuscript. An additional three studies reported p-values that crossed the "p = 0.05" threshold that our team was unable to reproduce using the appropriate statistical test (i.e., Fisher's exact test when all expected cell counts < 5). All eight studies published p-values < 0.05, whereas, our re-analysis demonstrated p ≥ 0.05.
CONCLUSION: Eight percent of the RCTs analyzed in this study reported p-values < 0.05 that on reproduction analysis was ≥ 0.05. The next steps should be to determine reasons for discordance and how to prevent this from happening.
© 2021. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.

Entities:  

Keywords:  Discordance; Hernia; Randomized controlled trials; Statistics; p-value

Mesh:

Year:  2021        PMID: 34420111     DOI: 10.1007/s10029-021-02488-4

Source DB:  PubMed          Journal:  Hernia        ISSN: 1248-9204            Impact factor:   2.920


  11 in total

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Authors:  R W Luijendijk; W C Hop; M P van den Tol; D C de Lange; M M Braaksma; J N IJzermans; R U Boelhouwer; B C de Vries; M K Salu; J C Wereldsma; C M Bruijninckx; J Jeekel
Journal:  N Engl J Med       Date:  2000-08-10       Impact factor: 91.245

2.  Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias.

Authors:  Robert J Fitzgibbons; Bala Ramanan; Shipra Arya; Scott A Turner; Xue Li; James O Gibbs; Domenic J Reda
Journal:  Ann Surg       Date:  2013-09       Impact factor: 12.969

3.  Update of Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society (IEHS))-Part A.

Authors:  R Bittner; K Bain; V K Bansal; F Berrevoet; J Bingener-Casey; D Chen; J Chen; P Chowbey; U A Dietz; A de Beaux; G Ferzli; R Fortelny; H Hoffmann; M Iskander; Z Ji; L N Jorgensen; R Khullar; P Kirchhoff; F Köckerling; J Kukleta; K LeBlanc; J Li; D Lomanto; F Mayer; V Meytes; M Misra; S Morales-Conde; H Niebuhr; D Radvinsky; B Ramshaw; D Ranev; W Reinpold; A Sharma; R Schrittwieser; B Stechemesser; B Sutedja; J Tang; J Warren; D Weyhe; A Wiegering; G Woeste; Q Yao
Journal:  Surg Endosc       Date:  2019-06-27       Impact factor: 4.584

4.  Short-term outcomes for open and laparoscopic midline incisional hernia repair: a randomized multicenter controlled trial: the ProLOVE (prospective randomized trial on open versus laparoscopic operation of ventral eventrations) trial.

Authors:  Peder Rogmark; Ulf Petersson; Sven Bringman; Arne Eklund; Emmanuel Ezra; Dan Sevonius; Sam Smedberg; Johanna Osterberg; Agneta Montgomery
Journal:  Ann Surg       Date:  2013-07       Impact factor: 12.969

Review 5.  Guidelines for treatment of umbilical and epigastric hernias from the European Hernia Society and Americas Hernia Society.

Authors:  N A Henriksen; A Montgomery; R Kaufmann; F Berrevoet; B East; J Fischer; W Hope; D Klassen; R Lorenz; Y Renard; M A Garcia Urena; M P Simons
Journal:  Br J Surg       Date:  2020-01-09       Impact factor: 6.939

6.  Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: a randomized trial.

Authors:  Kamal M F Itani; Kwan Hur; Lawrence T Kim; Thomas Anthony; David H Berger; Domenic Reda; Leigh Neumayer
Journal:  Arch Surg       Date:  2010-04

7.  Watchful Waiting Versus Surgery of Mildly Symptomatic or Asymptomatic Inguinal Hernia in Men Aged 50 Years and Older: A Randomized Controlled Trial.

Authors:  Barry de Goede; Arthur R Wijsmuller; Gabrielle H van Ramshorst; Bob J van Kempen; Wim C J Hop; Pieter J Klitsie; Marc R Scheltinga; Jeroen de Haan; Walter J B Mastboom; Erwin van der Harst; Maarten P Simons; Gert-Jan Kleinrensink; Johannes Jeekel; Johan F Lange
Journal:  Ann Surg       Date:  2018-01       Impact factor: 12.969

8.  Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia.

Authors:  Jacobus W A Burger; Roland W Luijendijk; Wim C J Hop; Jens A Halm; Emiel G G Verdaasdonk; Johannes Jeekel
Journal:  Ann Surg       Date:  2004-10       Impact factor: 12.969

9.  Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial.

Authors:  Ruth Kaufmann; Jens A Halm; Hasan H Eker; Pieter J Klitsie; Jeroen Nieuwenhuizen; Dick van Geldere; Maarten P Simons; Erwin van der Harst; Martijne van 't Riet; Bronno van der Holt; Gert Jan Kleinrensink; Johannes Jeekel; Johan F Lange
Journal:  Lancet       Date:  2018-02-17       Impact factor: 79.321

10.  Laparoscopic vs. open incisional hernia repair: a randomized clinical trial.

Authors:  Hasan H Eker; Bibi M E Hansson; Mark Buunen; Ignace M C Janssen; Robert E G J M Pierik; Wim C Hop; H Jaap Bonjer; Johannes Jeekel; Johan F Lange
Journal:  JAMA Surg       Date:  2013-03       Impact factor: 14.766

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  1 in total

1.  Randomized controlled trials in surgery for inguinal hernias.

Authors:  S Huerta
Journal:  Hernia       Date:  2021-11-22       Impact factor: 2.920

  1 in total

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