Harms-related data are poorly reported among randomized controlled trials underpinning the American Academy of Orthopaedic Surgeons clinical practice guideline recommendations for rotator cuff injuries

Anderson, Jon; Howard, Conner; Hardin, Jessica; Phelps, Cole R.; Hanson, Chad; Anderson, Reece; Vassar, Matt; Checketts, Jake X.

doi:10.1016/j.jse.2022.06.021

Cited by 6 publications

(2 citation statements)

References 19 publications

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“…[38][39][40] However, despite being published almost 2 decades ago, studies assessing the quality of reporting before and after the publication of the CONSORT-Harms extension and found that there was minimal to no significant change in the reporting of harms. [41][42][43] These findings, combined with our work, suggests that the guidelines are overall underutilized among researchers, despite being required by publishers. Studies postulated reasons for the low number of reporting; (1) selection bias, (2) unsure about the connection between the medication and the adverse reaction observed, and (3) inadequate training.…”

Section: Discussionsupporting

confidence: 55%

“…Since its development, the CONSORT Statement has been widely adopted by well‐known otolaryngology publishers including JAMA‐OTO, laryngoscope, and the White Journal 38‐40 . However, despite being published almost 2 decades ago, studies assessing the quality of reporting before and after the publication of the CONSORT‐Harms extension and found that there was minimal to no significant change in the reporting of harms 41‐43 . These findings, combined with our work, suggests that the guidelines are overall underutilized among researchers, despite being required by publishers.…”

Section: Discussionmentioning

confidence: 50%

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Reporting of Complications in Rhinoplasty Randomized Controlled Trials: An Analysis Using the CONSORT Extension for Harms Checklist

Hemmerich,

Corcoran,

Johnson

et al. 2024

Otolaryngol.--head neck surg.

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ObjectiveThis study aimed to assess the completeness of adverse event (AE) reporting in randomized control trials (RCTs) focused on rhinoplasty, using the Consolidated Standards for Reporting (CONSORT) Extension for Harms checklist.Study DesignA cross‐sectional design was employed to review RCTs related to rhinoplasty published between January 1, 2005, and January 28, 2022.SettingThe study analyzed clinical trials on rhinoplasty retrieved from PubMed.MethodsWe performed a comprehension search on PubMed, blind and duplicate screening, and data extraction. Adherence to the 18 recommendations of the CONSORT Extension for Harms was evaluated, with 1 point assigned for each adhered item. Percent adherence was calculated based on the 18 points, taking into account the multiple subcategories within some recommendations. Descriptive statistics were used to summarize adherence—including frequencies, percentages, and 95% confidence intervals.ResultsOur search returned 240 articles, of which 56 met inclusion criteria. No RCTs adhered to all 18 CONSORT Extension for Harms items. Twenty‐six (26/56, 46.4%) adhered to ≥50% of the items, and 30 (30/56, 53.6%) adhered to ≥33.3% of the items. Seven (7/56, 12.5%) RCTs adhered to no items. Across all RCTs, the average number of CONSORT‐Harms items adhered to was 7.2 (7.2/18, 40.0%). The most adhered to item was item 10. Discussion balanced with regard to efficacy and AEs (80.4%, [70.0‐90.8]).ConclusionThis study highlights the inadequacy of AE reporting in rhinoplasty RCTs according to CONSORT‐Harms guidelines. Urgent efforts are required to bridge this reporting gap and enhance transparency in surgical research, ultimately safeguarding patient well‐being.

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