BackgroundTranscutaneous electrical nerve stimulation (TENS) is a non-invasive pain therapy with few adverse events (AEs) reporting. Despite updated CONSORT Harms 2022 standards, no study has evaluated AE documentation quality using it in TENS research.ObjectivesThis meta-epidemiological study aimed to (1) assess the safety profile of TENS, (2) evaluate the quality of AE reporting in randomized controlled trials (RCTs), (3) identify factors associated with reporting quality, and (4) examine changes in reporting practices following the publication of the CONSORT Harms 2022 guideline.MethodsWe searched PubMed, CENTRAL, and Cochrane Library for RCTs reporting TENS-related adverse events. Quality was assessed using the CONSORT Harms 2022 checklist. Mann-Whitney U test was used to investigate whether there was a significant difference between the reporting quality of AE before and after the publication of the checklist. Multivariable linear regression identified factors associated with overall CONSORT score (OCS) and AE documentation quality.ResultsSeventy four studies were included with a mean AE reporting compliance of 64.2%. Higher OCS (p < 0.001), larger sample size (p < 0.05), governmental funding (p < 0.05), and diverse funding sources (p < 0.05) were significantly associated with better AE reporting quality. Studies published after the release of the CONSORT Harms 2022 guideline had significantly higher reporting scores than those published earlier (p < 0.05).ConclusionThe CONSORT Harms 2022 guideline has had a measurable impact on AE reporting quality in TENS trials. The observed frequency of AEs underscores the need for robust safety monitoring protocols in this therapy.
Li et al. (Fri,) studied this question.