Quality Assessment and Relevant Clinical Impact of Randomized Controlled Trials of Varicocele: Next Step to

Kyu Shik Kim1, Jae Hoon Chung2, Hyung Joon Park3

  • 1Department of Urology, Hanyang University Medical Center, Hanyang University College of Medicine, Seoul, Korea.

Insights

Quality of randomized controlled trials on varicocele has improved over time, with increasing Institutional Review Board approval and funding. Surgical treatments remain common, though methodological limitations persist.

Area of Science:

  • Urology
  • Clinical Trials Methodology
  • Evidence-Based Medicine

Background:

  • Varicocele, a common cause of male infertility, is often treated surgically.
  • Randomized controlled trials (RCTs) are crucial for evaluating treatment efficacy.
  • Assessing the methodological quality of varicocele RCTs is essential for reliable evidence.

Purpose of the Study:

  • To evaluate the quality of randomized controlled trials (RCTs) concerning varicocele treatments.
  • To analyze trends in RCT quality from 1979 to 2017.
  • To identify factors influencing the quality of varicocele research.

Main Methods:

  • Systematic search for varicocele RCTs published between 1979 and 2017.
  • Quality assessment using Jadad scale, van Tulder scale, and Cochrane Risk of Bias Tool.
  • Analysis of quality trends, funding sources, Institutional Review Board (IRB) approval, and intervention details.

Main Results:

  • RCT quality, measured by Jadad and van Tulder scores, significantly improved from 1979 to 2017.
  • Funded RCTs and those with IRB approval demonstrated higher quality.
  • While blinding and allocation concealment improved, allocation concealment showed a notable decline in recent years.

Conclusions:

  • The quantity and quality of varicocele RCTs have increased between 1979 and 2017.
  • Improvements in quality are linked to increased IRB approval, funding, and multicenter participation.
  • Despite methodological challenges, surgical treatment RCTs show evolving quality standards.
Abstract

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