Consolidated Standards For Reporting Research Articles

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

This 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. A cross-sectional design was employed to review RCTs related to rhinoplasty published between January 1, 2005, and January 28, 2022. The study analyzed clinical trials on rhinoplasty retrieved from PubMed. We 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. Our 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]). This 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.

Harms Reporting in the RCTs Underpinning the AAOS Clinical Practice Guidelines for Clavicle Fractures

Background: The American Academy of Orthopaedic Surgeons (AAOS) publishes clinical practice guidelines (CPGs) for various pathologies. An extension to the Consolidated Standards for Reporting (CONSORT) checklist provides authors with a framework for reporting harms in randomized controlled trials (RCTs). Objectives: The purpose of this study was to measure harms reporting among RCTs cited as supporting evidence for the AAOS CPG on the treatment of clavicle fractures. This study also sought to determine whether these reporting rates changed over time. Methods: Adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we used the AAOS CPG for clavicle fractures and conducted a linear regression analysis to model the relationship between the year of publication and the total CONSORT checklist percentage adherence over time. Results: There were 28 RCTs cited as supporting evidence for the clavicle fractures CPG included in the final sample. The average number of the 18 CONSORT Extension for Harms items appropriately reported across all included RCTs was 9.32 (51.8%). Nine checklist items had more than 50% compliance (50%), 3 items had between 20% and 50% compliance (16.7%), and 6 items had less than 20% compliance (33.3%). The linear regression model demonstrated no significant improvement in CONSORT Harms reporting over time. Conclusions: Adverse events are inadequately reported in RCTs cited as supporting evidence for the AAOS Treatment of Clavicle Fractures CPGs. We recommend the utilization of standardized adverse event reporting tools specific to orthopedic trauma literature to facilitate ease in adverse event reporting among RCTs.

Adherence to Complication Reporting for Randomized Controlled Trials Contained in Clinical Practice Guidelines for the Management of Carpal Tunnel Syndrome

Randomized controlled trials (RCTs) are frequently used in creating recommendations contained within clinical practice guidelines (CPGs). However, investigations outside of hand surgery have reported that RCTs within CPGs infrequently report complications and harms-related data. Our purpose was to assess adherence to complication reporting and harms-related outcomes contained in the Consolidated Standards for Reporting (CONSORT) Extension of Harms and Standards for Reporting of Diagnostic Accuracy Studies (STARD) reporting checklists for RCTs within the American Academy of Orthopaedic Surgery (AAOS) CPGs for carpal tunnel syndrome (CTS). We identified all RCTs within the AAOS CTS CPGs. All therapeutic RCTs and diagnostic studies were included. We used the CONSORT Harms Checklist criteria to assess adherence to the reporting of adverse events for therapeutic RCTs and the STARD criteria to assess the diagnostic accuracy of the articles. We defined adequate compliance as adherence to ≥50% of the checklist items. We identified 82 therapeutic RCTs and 90 diagnostic accuracy articles within the AAOS CTS CPG. For therapeutic RCTs, we found that the average compliance with the published checklists was 19%. For diagnostic studies, the average compliance with checklists was found to be 55%. Eleven therapeutic RCTs (13%) and 60 diagnostic studies (67%) were determined to have adequate compliance for the CONSORT and STARD checklists, respectively. Randomized controlled trials in the AAOS CPGs for CTS have low compliance with the CONSORT Extension for Harms Checklist. Although the overall adherence to the items published in the STARD statement for diagnostic accuracy evaluation remains higher, future efforts should be made to improve the adherence rates to both checklists. Improved standardization of complication reporting may aid in comparing outcomes across multiple clinical investigations of upper-extremity procedures.

Assessment of the quality of clinical therapeutic research published in Chinese Journal of Pediatrics

To evaluate the methodological qualities of clinical therapeutic research papers published in Chinese Journal of Pediatrics and find out the weaknesses and defects in the literature of clinical therapeutic research in China. The clinical therapeutic research articles from Chinese Journal of Pediatrics, which were published in the years 1999, 2000, 2001, 2009, 2010 and 2011, were analyzed manually, after dividing into randomized controlled trials (RCT) and non-randomized controlled trials. The methodological quality of RCT articles were evaluated by Consolidated Standards for Reporting of Trials (CONSORT) and Jadad scale, while non-RCT reports were assessed by specific evaluation standard criteria and analytical table. And the group A (1999 - 2001) and group B (2009 - 2011) of the quality documents were compared and analyzed. Seventeen RCTs were included. Based on the items in the CONSORT statement, the reporting quality of sample size determination, demographic baseline, random principle, blinding, lost to follow-up were all lower than 50%. Fourteen (82.4%) in the 17 RCTs mentioned 'eligibility criteria for participants', 11 (64.7%) RCTs mentioned 'details of the interventions', 15 (88.2%) RCTs mentioned 'adverse effects'. Compared with RCT reports in the year of 1999, 2000 and 2001, the methodological qualities of those in 2009, 2010 and 2011 were not improved. In the 17 RCTs, the total score achieved based on the Jadad scale, only 11.8% (2 out of 17) were high-quality trials (≥ 3 points). Analysis of the 28 non-RCTs, which were included and assessed by evaluation criteria and evaluation table, also showed some disadvantages on some key items. The methodological quality of clinical therapeutic research reports should be consistent with the standards of international evaluation, pediatric clinicians should improve know ledge in clinical epidemiology, clinical trial methodology, and improve the quality of research reports.