Towards a core outcome set for hemorrhoidal disease-a systematic review of outcomes reported in literature

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R R van Tol1, E van Zwietering1, J Kleijnen2

  • 1Department of Surgery, Maastricht University Medical Centre, P. Debyelaan 25, 6202, AZ, Maastricht, The Netherlands.

International Journal of Colorectal Disease
|April 23, 2018
PubMed

Insights

This study highlights the inconsistent outcomes reported in hemorrhoidal disease (HD) research. Standardizing outcome definitions is crucial for comparing treatment effectiveness in clinical trials.

Area of Science:

  • Medical research methodology
  • Clinical trial design
  • Hemorrhoidal disease (HD) management

Background:

  • Published literature on hemorrhoidal disease (HD) treatment lacks uniform outcome definitions.
  • This heterogeneity hinders transparency and comparability of study results.

Purpose of the Study:

  • To systematically identify and list the diverse outcomes utilized in hemorrhoidal disease (HD) studies.
  • To establish a foundation for developing a core outcome set (COS) for HD research.

Main Methods:

  • Systematic literature search of Medline, Embase, and Cochrane for interventional studies on adult HD patients.
  • Independent review of eligible studies by two authors to extract reported outcomes.
  • Categorization of identified outcomes using the OMERACT filter 2.0 framework.

Main Results:

  • 34 studies (RCTs and prospective observational) yielded 59 distinct outcome types.
  • Commonly reported outcomes included pain (91%), blood loss (94%), prolapse (71%), and incontinence (56%).
  • Significant variation in outcome definitions, with many lacking clear definitions.

Conclusions:

  • Substantial heterogeneity exists in outcome reporting for hemorrhoidal disease (HD) studies.
  • An overview of reported outcomes was generated, identifying key outcomes for a future core outcome set (COS).
Abstract

Keywords:
Core outcome setHemorrhoidsOMERACTOutcomesReview

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