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

OBJECTIVE: 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. STUDY DESIGN: A cross-sectional design was employed to review RCTs related to rhinoplasty published between January 1, 2005, and January 28, 2022. SETTING: The study analyzed clinical trials on rhinoplasty retrieved from PubMed. METHODS: 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. RESULTS: 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]). CONCLUSION: 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.

Prevalence of Adverse Event Reporting in Adolescents and Young Adults Enrolled in Cancer Clinical Trials.

PURPOSE: Survival for adolescents and young adults (AYAs) with cancer has improved over the past few decades, and targeted approaches are needed to further improve outcomes. Limited reports suggest that AYAs tolerate cancer treatment differently than older and younger patients. Lack of adverse event (AE) data prevents the optimization of treatment regimens for AYAs by maximizing drug delivery and minimizing treatment-related toxicity. The extent to which the frequency and severity of AEs are reported for AYAs in cancer trials is unknown. METHODS: Using a retrospective, observational design we reviewed all phase II/III clinical trials published in 2021 that included cancer-directed therapy and enrolled at least one patient age 15-39 years diagnosed with one of the five common AYA cancers: breast cancer, colorectal cancer, Hodgkin lymphoma, non-Hodgkin lymphoma, or melanoma. The primary outcome was to determine the proportion of phase II/III trials that report AEs for the AYA population. RESULTS: Of 2,540 publications identified, 182 were included in the final analysis. No studies reported AE data for AYAs separate from older adults. Given the lack of reporting of AEs by age, it was not possible to assess differences in AE frequency or severity or whether AEs were associated with differences in dose reductions, treatment delays, or discontinuation for AYAs. CONCLUSION: Reporting of AEs for AYAs with cancer is absent in the public domain. Failure to account for differences in treatment tolerance between AYAs and older adults may lead to undertreatment or overtreatment and delay progress toward further improving outcomes for AYAs.

Harms reporting by systematic reviews for functional endoscopic sinus surgery: a cross-sectional analysis.

OBJECTIVES: To evaluate the completeness of harms reporting in systematic reviews (SRs) pertaining to functional endoscopic sinus surgery (FESS). METHODS: Using a cross-sectional study design, we performed a comprehensive search using MEDLINE (PubMed and Ovid), EMBASE, Epistemonikos, and the Cochrane Database of Systematic Reviews databases for SRs regarding FESS on May 15th, 2022. Returns were screened and data were extracted in a masked, duplicate manner. Following established methodology, we extracted general study characteristics, harms items, and overall methodological quality for each SR in our sample. Corrected covered area (CCA) was calculated for SR dyads. For data analysis, using Stata 16.1 we performed a bivariate analysis between variables. RESULTS: Fifty-five SR's were included in our sample after excluding 375 studies that did not meet our inclusion criteria. Of the included SRs, 19 (19/55, 34.5%) did not report harms and 39 (39/55, 70.9%) reported half of the harms items or fewer. Our study found that 23 (23/55, 41.8%) of SRs demonstrated a method of harms data collection, 26 (26/55, 47.3%) of SRs had patients available for harms analysis in their results, and 25 (25/55, 45.5%) of SRs had a balanced discussion of harms and benefits of FESS. Fifty-two SRs were appraised as "critically low" quality using AMSTAR-2. A significant association was found between completeness of harms reporting (Mahady) and whether harms were listed as a primary outcome. No other associations were statistically significant. Two SR dyads had CCAs between 20% and 50% overlap and were compared for unique and shared harms. CONCLUSIONS: Our study demonstrates gaps in harms reporting regarding FESS in SRs. We recommend future studies implement guidelines such as the STROCCS guidelines or the harms extension of the PRISMA guidelines to improve harms reporting. Accurate harms reporting may advance patient safety and promote a more objective risk-benefit analysis for physicians and patients.

Inequities and Research Gaps in Ophthalmology: A Scoping Review.

Importance: Deficient ophthalmologic care is costly to patients, making the identification of groups not receiving adequate care of vital importance. The current landscape of equity in ophthalmic care has yet to be thoroughly investigated and is important to ensure inclusivity and patient-centered care. Objective: To perform a scoping review of the literature pertaining to health care inequities in the field of ophthalmology. Evidence Review: A comprehensive database search using MEDLINE (via PubMed) and Ovid Embase was done in July 2022. English-language articles published from 2016 to 2021 were included and encompassed all article types except commentaries or correspondence. The search modeled the National Institutes of Health list of designated US health inequity populations, which includes income, education level, occupational status, rural and underresourced area, sex and gender, lesbian, gay, bisexual, transgender, and queer (LGBTQ) identity, and race and ethnicity. A total of 8170 abstracts and titles were screened by 2 independent investigators, and 189 studies were assessed in full text for eligibility. For inclusion, articles needed to be an ophthalmic study discussing health inequities. In a masked, duplicate fashion, 2 independent investigators screened 75 full-text studies for data extraction using a pilot-tested form. Data extraction included general publication characteristics and health inequity data based on the National Institutes of Health's defined inequity groups. Findings: A total of 75 publications were included. Notable inequities were found among Black and Hispanic patients associated with negative ophthalmic outcomes and mixed associations regarding sex or gender. Overall, lower-income patients were more likely to have vision impairment, use eye care services less, and have lower adherence to eye examinations. No articles within our sample examined LGBTQ inequities among ophthalmology patients since the 2016 National Institutes of Health classification of sexual and gender minority populations. Substantial research gaps were observed within the ophthalmic literature pertaining to the LGBTQ community, race and ethnicity, and rural and underresourced areas. Conclusions and Relevance: This scoping review found substantial findings associated with the LGBTQ community, race and ethnicity, and the role of telemedicine in rural and underresourced areas. Because of the importance of ophthalmic care in overall patient health, it is vital to understand the various inequities present and strive to improve the current gaps in the literature. Future studies should (1) examine barriers to clinical study and medical trainee recruitment as well as patient values and preference studies and (2) investigate the implementation of telemedicine in underresourced areas.