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Related Experiment Video

Updated: Sep 12, 2025

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Adherence to CONSORT-PRO Extension Guidelines for Patient-Reported Outcomes in Randomized Controlled Trials Focused

Adam Khan1, Tiffany Nguyen2, Bryan Dunford3

  • 1Office of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17th St., Tulsa, OK, 74107, USA. Adam.khan@okstate.edu.

Pain and Therapy
|August 6, 2025
PubMed
Summary

Peripheral nerve block trials show poor adherence to patient-reported outcome reporting guidelines. Improving reporting quality requires diverse measures and consistent application of CONSORT-PRO standards.

Keywords:
Adherence to reporting guidelinesCONSORT-PROPatient-reported outcomePeripheral nerve blockQuality of lifeRandomized controlled trialsRegional anesthesiaRisk of bias

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Area of Science:

  • Anesthesiology
  • Clinical Trial Methodology
  • Health Outcomes Research

Background:

  • Patient-reported outcomes (PROs) are vital for assessing patient experiences in regional anesthesia.
  • The CONSORT statement and its PRO extension (CONSORT-PRO) provide guidelines for transparent PRO reporting.
  • Adherence to CONSORT-PRO in peripheral nerve block (PNB) trials is not well understood.

Purpose of the Study:

  • To evaluate adherence to CONSORT-PRO reporting guidelines in PNB randomized controlled trials (RCTs).
  • To identify trial characteristics influencing the quality of PRO reporting in PNB studies.

Main Methods:

  • A meta-epidemiological, cross-sectional study was conducted.
  • Searched CENTRAL, Embase, and MEDLINE for PNB RCTs published between 2006 and 2020 that included PROs.
  • Included RCTs with PROs as primary or secondary outcomes; excluded studies without PROs.

Main Results:

  • 65 RCTs met the inclusion criteria, with mean CONSORT-PRO adherence of 46.8%.
  • Trials designating PROs as primary endpoints showed higher adherence (49.3%) than those with secondary PROs (38.6%).
  • Longer follow-up (≥6 months) and combined PRO measures (e.g., VAS/NRS with others) correlated with better adherence.

Conclusions:

  • Significant nonadherence to CONSORT-PRO guidelines was observed in PNB RCTs.
  • Under-reporting of PROs, particularly secondary ones, highlights a need for improvement.
  • Enhancing reporting quality requires diverse measures, consistent CONSORT-PRO application, and targeted education for researchers and clinicians.