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Aim <p>This study aimed to analyze the evolution of study sizes in published research on pilonidal sinus over the past 100&#xa0;years, with a&#xa0;focus on differences between randomized controlled trials (RCTs) and non-RCT studies and their changing trends over time.</p> Methods <p>A&#xa0;comprehensive analysis of pilonidal sinus disease study sizes was conducted comparing RCTs and non-RCT studies published between 1930 and 2023. Studies were identified through systematic data extraction from the Stauffer extended database [<CitationRef CitationID="CR2">2</CitationRef>], and their sample sizes were categorized accordingly. The statistical computing software&#xa0;R was used for data processing, trend analysis, and visualization, enabling an assessment of changes in study sizes over time.</p> Results <p>The findings demonstrate a&#xa0;consistent overall increase in study size, with the average number of patients per study rising from&#xa0;33 (1930) to&#xa0;96 (2020). A&#xa0;notable surge in study size was observed from the 21st&#xa0;century onward, primarily driven by an expansion in non- -RCT cohort sizes. By contrast, the average sample size of RCTs has remained relatively stable at approximately 47&#xa0;patients per study over the past four decades. The proportion of RCTs relative to all studies increased until 1990, peaking at 24.8% in the decade of 2000. However, in the subsequent two decades, the share of RCTs showed a&#xa0;steady decline, reaching 15.6%.</p> Conclusion <p>There has been a&#xa0;significant increase in study sizes, predominantly driven by the expansion of non-RCT studies, whereas the sample size of RCTs has remained unchanged. Concurrently, the proportion of RCTs conducted has declined over time.</p> What does this paper add to the literature? <p>This study provides evidence that, despite the increasing urgency for high-quality evidence, the proportion of RCTs has not increased over the past 30&#xa0;years. This trend persists despite the absence of patient scarcity, indicating that factors other than patient availability may be limiting the growth of RCTs in the field.</p>

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One century of pilonidal sinus research: trends in study size and the declining share of randomized controlled trials

  • 期刊论文

  • 发表日期：

    2025年7月22日

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  • Dietrich Doll,
  • Jannik Seifert,
  • Matthias Maak,
  • Christina Oetzmann von Sochaczewski,
  • Dietrich Doll,
  • Matthias Maak,
  • Susanne Haas,
  • Ida Farschou,
  • Helene Hougaard,
  • Marlene Julia Sørensen,
  • Anne Vestbjerg Thyø,
  • Theo Hackmann,
  • Henrike Heitmann,
  • Jannik Seifert,
  • Marius Dettmer,
  • Christina Oetzmann von Sochaczewski,
  • Jan Jongen,
  • Igors Iesalnieks

摘要

Aim

This study aimed to analyze the evolution of study sizes in published research on pilonidal sinus over the past 100 years, with a focus on differences between randomized controlled trials (RCTs) and non-RCT studies and their changing trends over time.

Methods

A comprehensive analysis of pilonidal sinus disease study sizes was conducted comparing RCTs and non-RCT studies published between 1930 and 2023. Studies were identified through systematic data extraction from the Stauffer extended database [2], and their sample sizes were categorized accordingly. The statistical computing software R was used for data processing, trend analysis, and visualization, enabling an assessment of changes in study sizes over time.

Results

The findings demonstrate a consistent overall increase in study size, with the average number of patients per study rising from 33 (1930) to 96 (2020). A notable surge in study size was observed from the 21st century onward, primarily driven by an expansion in non- -RCT cohort sizes. By contrast, the average sample size of RCTs has remained relatively stable at approximately 47 patients per study over the past four decades. The proportion of RCTs relative to all studies increased until 1990, peaking at 24.8% in the decade of 2000. However, in the subsequent two decades, the share of RCTs showed a steady decline, reaching 15.6%.

Conclusion

There has been a significant increase in study sizes, predominantly driven by the expansion of non-RCT studies, whereas the sample size of RCTs has remained unchanged. Concurrently, the proportion of RCTs conducted has declined over time.

What does this paper add to the literature?

This study provides evidence that, despite the increasing urgency for high-quality evidence, the proportion of RCTs has not increased over the past 30 years. This trend persists despite the absence of patient scarcity, indicating that factors other than patient availability may be limiting the growth of RCTs in the field.