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

Patient-reported outcomes (PROs), such as peri- and postoperative pain scores, capture patient perspectives in regional anesthesia trials. However, whether these outcomes are reported according to established guidelines remains unclear. The CONSORT statement and its PRO extension (CONSORT-PRO) aim to enhance transparency in reporting PROs, yet no study has investigated adherence in peripheral nerve block (PNB) trials. Our meta-epidemiological investigation evaluated how well PNB randomized controlled trials (RCTs) adhere with CONSORT-PRO and explored whether trial characteristics affect reporting quality.

We performed a cross-sectional, meta-epidemiological study to determine adherence to CONSORT-PRO reporting guidelines in RCTs. We searched Cochrane Central Register of Controlled Trials (CENTRAL), Embase, and MEDLINE for RCT publications investigating PNBs between 2006 and 2020. RCTs investigating PNBs that incorporated PROs as a primary or secondary outcome were included. All other studies, reviews, or publications without a PRO were excluded.

In total, 65 RCTs met the inclusion criteria. Mean CONSORT-PRO adherence was 46.80 ± 17.36%, and trials that designated a PRO as the primary endpoint were more adherent than those in which the PRO was secondary (49.27 ± 16.58% versus 38.57 ± 17.92%; P = 0.035). Trials with ≥ 6-month follow-up were 16.24% more adherent than those with ≤ 3-month follow-up (P = 0.006). Studies that used a visual analog scale (VAS) or numeric rating scale (NRS) in combination with other PRO instruments were significantly more adherent than trials using VAS alone (P = 0.028).

Our meta-epidemiological review reveals substantial nonadherence to CONSORT-PRO guidelines in PNB trials. Although PROs are crucial for capturing patient-centered outcomes, they remain under-reported, especially when treated as secondary endpoints. Using diverse, validated measures beyond VAS/NRS and consistently applying CONSORT-PRO can enhance the quality, transparency, and clinical relevance of future trials. Targeted education for authors, editors, and clinicians-and expanded research on neuraxial techniques-will further strengthen reporting standards and the interpretability of anesthesia evidence.