Association of Trial Registration With Reporting of Primary Outcomes in Protocols and Publications

Abstract

cannabidiolic acid (up to 55.73 mg/mL) in 13 of the 84 samples tested (15.48% [95% CI, 9.28%-24.70%]), and cannabigerol (up to 4.67 mg/mL) in 2 of the 84 samples tested (2.38% [95% CI, 0.65%-8.27%]).Discussion | Among CBD products purchased online, a wide range of CBD concentrations was found, consistent with the lack of an accepted dose. Of tested products, 26% contained less CBD than labeled, which could negate any potential clinical response. The overlabeling of CBD products in this study is similar in magnitude to levels that triggered warning letters to 14 businesses in 2015-2016 from the US Food and Drug Administration 3 (eg, actual CBD content was negligible or less than 1% of the labeled content), suggesting that there is a continued need for federal and state regulatory agencies to take steps to ensure label accuracy of these consumer products. Underlabeling is less concerning as CBD appears to neither have abuse liability nor serious adverse consequences at high doses 4,5 ; however, the THC content observed may be sufficient to produce intoxication or impairment, especially among children. 6 Although the exclusive procurement of products online is a study limitation given the frequently changing online marketplace, these products represent the most readily available to US consumers. Additional monitoring should be conducted to determine changes in this marketplace over time and to compare internet products with those sold in dispensaries. These findings highlight the need for manufacturing and testing standards, and oversight of medicinal cannabis products.

Reporting of sample‐size calculations for randomized trials in dermatology: comparison of publications with registries

“…Our findings support the need to improve reporting of sample‐size determinations in published articles through adherence to the CONSORT guidelines, prospective registration of all clinical trials and public availability of trial protocols that adhere to the SPIRIT guidance . Complete reporting will help ensure that trial results can be properly evaluated and applied to patient care.…”

“…Dermatologic Surgery is the only journal in our cohort that does not have an editorial policy requiring authors to adhere to the CONSORT Statement, which may explain why sample‐size justifications were reported less often for its trials compared with the other journals. To improve transparency and reduce selective reporting, four of the six journals in our cohort (all except Dermatologic Surgery and Acta Dermato‐Venereologica ) also require that trials be publicly registered prior to participant enrolment to be considered for publication …”

Quality of reporting in systematic reviews published in dermatology journals

“…It is important to note that protocol preregistration and prespecification of key outcomes is not meant to limit analysis, but improves transparency and serves to minimize selection bias by ensuring that deviations are clearly delineated in the methodology and justified. Outside of SRs, RCT protocol registration has also been shown to significantly improve reporting of predefined primary outcomes and limit selective outcome reporting …”

AAN position statement: Ethical issues in clinical research in neurology

“…reduced through the open sharing of research protocols. [48][49][50][51] The AAN also recommends the use of peer-reviewed checklists for the reporting of all clinical neuroscience studies, such as the Consolidated Standards of Reporting Trials 2010 checklist for randomized trials (consort-statement.org) and the Strengthening the Reporting of Observational Studies in Epidemiology checklist for observational studies (strobestatement.org). In keeping with Ioannidis 52 and the New England Journal of Medicine and Neurology ® guidelines for statistical reporting, the AAN endorses supplementing or replacing reported p values with measures of effect size or association and measures of uncertainty (such as 95% confidence intervals), when the statistical analysis plan does not prespecify methods to adjust for multiple tests.…”