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.

An Evaluation of Research Publications for General Surgery Residents And its Influence on the Future Pursuit of Fellowship or Academic Career.

INTRODUCTION: Traditionally, the Accreditation Council for Graduate Medical Education (ACGME) requires residency programs to implement research and other scholarly activities into their training curriculum. Encouraging residents to publish during residency is believed to promote research throughout their careers; however, the rate of research outcomes among general surgery residents remains unknown. Our study aims to determine associated factors that influence publication rates before, during, and after general surgery residency. METHODS: This observational study employed a cross-sectional design. We examined whether research outcomes during general surgery residency was associated with academic advancement or continued research involvement after residency. We identified 321 general surgery residency programs on the Doximity website and randomly selected 50 to include in our sample. Of these programs, graduate rosters for 31 programs were located and subsequently included. Of the 405 residency graduates identified, we recorded the number of peer-reviewed publications, H-indices, fellowships, and whether the graduate pursued a career in private practice or academia. RESULTS: Among the 405 physicians analyzed, 3815 total publications were identified with a mean of 9.4 (SD 11.8) per person. The most reported study design was observational studies (46.5%; 1775/3815) and the least reported was systematic reviews/meta-analyses (1.4%; 52/3815). The number of publications before residency positively correlated with having a higher h-index (r = 0.4). We also found that physicians who completed a fellowship had more publications during residency (mean = 4.7, SD = 6.5) than those not pursuing a fellowship (mean = 1.5, SD = 2.7; t= -4.3. p ≤ 0.001). We observed a statistically significant increase in the likelihood a physician pursued a career in academic medicine if they pursued a fellowship (OR: 3.77, 95% CI: 2.0-7.2) and if they had published research as a primary author (OR 1.25, 95% CI: 1.0-1.5). CONCLUSION: Increased research productivity was associated with continued academic pursuits and an increased likelihood of pursuing fellowship training after residency.

Analysis of Systematic Reviews in Clinical Practice Guidelines for Head and Neck Cancer.

OBJECTIVE: Clinical practice guidelines (CPGs) are essential to clinical decision-making as their recommendations are supported by published literature. Systematic reviews are considered the highest quality of evidence used to underpin these guidelines. However, research to support these recommendations may lack compliance to quality reporting among systematic reviews (SRs). Here, we aim to evaluate the quality of SRs underpinning CPG recommendations for the management of head and neck cancer (HNC). STUDY DESIGN: Retrospective cross-sectional analysis. METHODS: Using PubMed, we searched for CPGs pertinent to the management of head and neck cancer published between January 2017 and May 2021. Relevant guidelines were analyzed for all SRs. Cited SRs in CPGs were evaluated using A Measurement Tool to Assess Systematic Reviews-2 (AMSTAR-2) and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) instruments. Study characteristics were extracted in a masked triplicate fashion. RESULTS: A total of 16 CPGs and 142 unique SRs were included in our study. PRISMA completion ranged from 67.15% to 87.65% across CPGs with a mean of 76.41% (SD = 16.9). AMSTAR-2 completion ranged from 34.38% to 84.38% across CPGs with a mean of 67.55% (SD = 20.9) among all SRs. The lowest rated items included funding sources and publication bias. A higher score was achieved in SR done by Cochrane group and it was only 2.11% (3/142) of all SR's quoted in CPG. CONCLUSION: Adherence to AMSTAR-2 and PRISMA items exhibits a variation among SRs cited in CPGs for the management of HNC. The mature underpinning CPG recommendation of SRs cited as supportive evidence could be enhanced in reporting quality. LEVEL OF EVIDENCE: NA Laryngoscope, 132:1976-1983, 2022.

An analysis of publication trends of orthopedic surgery residency graduates in relation to academic achievement.

CONTEXT: Traditionally, the Accreditation Council for Graduate Medical Education (ACGME) requires residency programs to implement research and other scholarly activities into their training curriculum. Encouraging residents to publish during residency is believed to promote research throughout their careers; however, no study has attempted to quantify research productivity among orthopedic surgery residents before, during, and after residency. OBJECTIVES: To determine whether publishing in peer-reviewed journals during orthopedic residencies was an indicator of continued academic achievement after graduation. METHODS: This study was observational in nature and employed a cross-sectional design. We examined whether research outcomes during orthopedic residency was associated with academic advancement or continued research involvement after residency. We identified 201 orthopedic residency programs on the Doximity website and randomly selected 50 to include in our sample. Of these programs, graduate rosters for 31 programs were located and subsequently included. Of the 341 graduates identified, we recorded the number of peer-reviewed publications, H-indices, fellowships, and whether the graduate pursued a career in private practice or academia. RESULTS: Orthopedic residency graduates from 31 programs published a total of 1923 peer-reviewed manuscripts. On average, residents had a total of 5.6 publications and an h-index of 3.2. Residents entering academia and pursuing fellowships had a significantly higher total number of publications, higher number of first-author publications, and greater H-indices compared to those who did not enter academia or pursue a fellowship. CONCLUSIONS: Increased research productivity was associated with continued academic pursuits and an increased likelihood of pursuing fellowship training after residency.

The Potential Effect of Lowering the Threshold of Statistical Significance From P < .05 to P < .005 in Orthopaedic Sports Medicine.

PURPOSE: To determine how changing the P value threshold of statistical significance from .05 to .005 could affect the statistical significance of findings in previously published orthopaedic sports medicine randomized controlled trials (RCTs). METHODS: The authors searched PubMed from January 1, 2016, to December 31, 2017, for RCTs published in the American Journal of Sports Medicine, Arthroscopy, and Knee Surgery, Sports Traumatology, Arthroscopy. Data were extracted blinded and in duplicate fashion by 2 of us. The authors then extracted P value data for primary end points, since RCTs are most often powered for these end points. Discrepancies were resolved by consensus. Google Forms were used for data extraction and STATA 15.1 for the data analysis. RESULTS: In total, 275 primary end points were identified from 132 trials. Analysis of primary end points found 45.8% (126/275) had a P value less than .05 and were classified as statistically significant under the current threshold, whereas 54.2% (149/275) had a P value greater than .05 and were not classified as suggestive. Of those end points that were previously considered statistically significant, 38.9% (49/126) were less than .005, whereas 61.1% (77/126) were between .005 and .05 and thereby would be reclassified as suggestive rather than statistically significant under the proposed threshold. Overall, when analyzing the 275 primary end points, we found only 49 (17.8%) of the end points were less than .005 and would hold statistical significance with the proposed threshold. CONCLUSIONS: The results suggest that if the threshold of statistical significance were to change to .005, the significance of orthopaedic sports medicine RCTs would be heavily altered. The authors also acknowledge the many issues research faces in regard to P value reliability and therefore interpretation of study results. Because P values from RCTs can often influence the ways physicians choose interventions, it is important to implement methodology that decreases incidence of bias and misrepresentation of these results. However, the authors also understand that lowering the P value could increase the needed sample size and by consequence increase study costs as well, while not directly correlating to clinical significance. Thus, the authors recommend that this proposed threshold should be further evaluated and cautiously interpreted. CLINICAL RELEVANCE: If the statistical significance threshold is changed, clinical practice guideline recommendations also may be affected.

Analyzing Spin in Abstracts of Orthopaedic Randomized Controlled Trials with Statistically Insignificant Primary Endpoints.

PURPOSE: Our primary aim of our study is to evaluate the prevalence of spin among abstracts in orthopaedic randomized controlled trials (RCTs) with nonsignificant primary endpoints. METHODS: This study was conducted in accordance with a previously written protocol publicly available via the Open Science Framework. PubMed (which includes Medline) was searched for RCTs in orthopaedic surgery. The articles that were identified were then uploaded to Rayyan, and the abstracts were screened for inclusion. To be included, a trial had to have randomized the patients for intervention, statistically compare multiple groups, and had a primary endpoint that was not significant. Odds ratios and summary statistics (frequencies and proportions) were then calculated for spin in the abstracts. RESULTS: Of the 780 articles retrieved from our search string, 250 articles met the inclusion criteria. Analysis resulted in 112/250 (44.80%; [95% CI, 38.64-50.96]) RCTs that containing spin within the abstract. Of the 112 RCTs, 52 (46.43%; [95% CI, 37.19-55.66]) had spin in the results, and 89 (79.46%; [95% CI, 71.98-86.95]) had spin in the conclusion of the abstract. The Journal of Bone and Joint Surgery was found to have the highest prevalence of spin (21/37, 56.76% [95% CI, 40.79%-72.72%]) while Arthroscopy: The Journal of Arthroscopic & Related Surgery had the lowest prevalence of spin (5/15, 33.33% [95% CI, 9.48%-57.19%]). No correlation was found between industry funding and increased odds of spin in the abstract (uOR, 1.10; 95% CI, 0.45-2.63). Discrepancies for our primary endpoint, prevalence of spin among abstracts, were analyzed with Gwet's AC1 inter-rater statistic and found to be 81% [95% CI, 0.75-0.87]. CONCLUSION: Spin was found in 44.8% of the abstracts within our sample of orthopaedic RCTs. Nonsignificant primary data were often represented to seem significant, many orthopaedic RCTs did not indicate primary endpoints, and orthopaedic RCTs infrequently reported trial registration.

Rates of Discontinuation and Nonpublication of Head and Neck Cancer Randomized Clinical Trials.

Importance: Randomized clinical trials (RCTs) play an important role in clinical decision-making, and discontinuation or nonpublication of these trials are causes of great concern. The extent of discontinued or unpublished RCTs about head and neck cancer remains unclear. Objective: To assess the rate of discontinuation or nonpublication of RCTs involving patients with head and neck cancer. This objective was measured by observing 3 domains: discontinuation of trial, nonpublication of trial data, and feasibility of contacting trial investigators of aforementioned trials. Evidence Review: For this study, the sample was derived using the ClinicalTrials.gov advanced search feature on March 18, 2019, to locate completed and discontinued RCTs pertaining to head and neck cancer registered before this date. Trials were analyzed to identify reasons for trial discontinuation and publication status of each trial. If publication status or reason for trial discontinuation was not allocated through the systematic search of ClinicalTrials.gov, the corresponding author was emailed to determine publication status. Findings: After exclusions, 130 RCTs were included. Of these trials, 92 (70.8%) were completed and 38 (29.2%) were discontinued for various reasons. The most common reason for discontinuation of trials was committee recommendations. Of the 130 analyzed trials, 67 (51.5%) were published in a peer-reviewed journal and 63 (48.5%) were unpublished trials. Of the 92 completed trials, 55 (59.8%) were published and 37 (40.2%) remained unpublished 3 or more years after trial completion. Trials funded by other sources (private, nonprofit, or the National Institutes of Health) were more likely to reach publication than industry-funded RCTs (unadjusted odds ratio, 4.3 [95% CI, 1.3-14.0]; adjusted odds ratio, 4.1 [95% CI, 1.2-14.3]). Conclusions and Relevance: Of RCTs in head and neck cancer, 29.2% were discontinued and 40.2% completed trials never reached publication. The findings suggest that needs exist for RCT guidance of head and neck cancer. The reporting of reasons for trial discontinuation appears to be lacking, and trial publication rates were low. This study is relevant to many physicians and researchers because it identifies potential sources of decreased research productivity and ethics.

Reporting of Clinical Trial Interventions Published in Leading Otolaryngology-Head and Neck Surgery Journals.

OBJECTIVES/HYPOTHESIS: Randomized controlled trials (RCTs) play a crucial role in advancing patient care within otolaryngology-head and neck surgery (OTL-HNS), yet studies have shown the reporting of these trials needs improvement. Here, we evaluate the completeness of intervention reporting of RCTs in OTL-HNS and evaluate whether the publication of the Template for Intervention Description and Replication (TIDieR) checklist has influenced intervention reporting. STUDY DESIGN: Retrospective Cross-Sectional Analysis. METHODS: We searched PubMed for RCTs published in top OTL-HNS journals in two cohorts, one before the release of the TIDieR and one afterward. A sample of 300 RCTs was randomly selected and screened for inclusion. Once the dataset was finalized, we extracted trial characteristics and assessed each trial's adherence to the TIDieR checklist. We then used descriptive characteristics, a generalized estimated equation, time-series analysis, and a two-sample t test to analyze our data. RESULTS: After screening was completed, 173 RCTs were included in our analysis. Of these RCTs, 103 (59.5%) showed <60% adherence to the TIDieR checklist. We found a slight increase in adherence to TIDieR items after the checklist was released, although this was not statistically significant (P = .91). In addition, we found that trials with a crossover study design or multiple interventions and those that provided a Consolidated Standards for Reporting Trials statement were associated with greater adherence to the TIDieR checklist. CONCLUSIONS: The majority of OTL-HNS RCTs included in our analysis showed suboptimal reporting factors related to the TIDieR checklist. Requiring a TIDieR statement and automating the journal requirements process for all OTL-HNS clinical trials would be a worthwhile, efficient approach to improving research quality and ultimately patient care within OTL-HNS. LEVEL OF EVIDENCE: NA Laryngoscope, 130:E507-E514, 2020.

Trial Registry Use in Surgery Systematic Reviews: A Cross-Sectional Study.

OBJECTIVE: To determine the extent to which systematic reviews published in surgery journals reported a clinical trial registry search as part of their search strategy and whether systematic reviews that omitted such searches would have located additional trials for inclusion. BACKGROUND: Systematic reviews are used by clinicians to guide clinical decision making. When conducting systematic reviews, the comprehensive search strategy is particularly critical to identify all studies-whether published or not-for producing an overall summary effect. Inclusion of only published studies may lead to overestimated and inaccurate summary effects; thus, it is important to consider unpublished studies. Here, we investigate the extent of clinical trial registry searches performed in surgical systematic reviews because trial registries may be the most viable approach to locate unpublished trial data. METHODS: We retrieved systematic reviews from the top surgery journals and the Cochrane Collaboration. Each was reviewed to determine which bibliographic databases were used and which, if any, trial registries were searched. RESULTS: Of 996 total systematic reviews, 252 (25.3%) reported having included a clinical trial registry search, with systematic reviews published in journals reporting searches of unpublished research at a rate of 6.4% (47/737). Reviews published by the Cochrane Collaboration included searches of unpublished research 79.2% of the time (205/259). CONCLUSIONS: Many systematic reviews published in surgery journals include only published research, which may contribute to publication bias. We recommend that authors maximize available information by using unpublished trial data found in clinical trial registries.

Effects of a proposal to alter the statistical significance threshold on previously published orthopaedic trauma randomized controlled trials.

INTRODUCTION: A recent proposal suggests changing the threshold for statistical significance from a P value of .05 to .005 to minimize bias and increase reproducibility of future studies. P values less than .05 but greater than .005 would be reclassified as "suggestive", whereas P values less than .005 would be considered significant. The present study explores how lowering the P value threshold would affect the interpretation of previously published orthopaedic trauma randomized controlled trials (RCTs) and whether outcomes from these trials would maintain statistical significance under the proposed P value threshold. METHODS: All RCTs published between January 01, 2016 and January 31, 2018 in the Journal of Orthopaedic Trauma, Injury, and Archives of Orthopaedic and Trauma Surgery were screened by at least 2 authors. Data from included trials were extracted in blinded and duplicate fashion. All P values for primary endpoints were included from each study. RESULTS: We identified 124 primary endpoints from 48 trials: 39.5% (49/124) of endpoints had a P value less than .05 and 60.5% (75/124) had a P value greater than .05. Overall, 51.0% (25/49) of statistically significant primary endpoints were less than .005, while 49.0% (24/49) would be reclassified as suggestive. CONCLUSION: Based on our results, adopting a lower threshold of significance would heavily alter the significance of orthopaedic trauma RCTs and should be further evaluated and cautiously considered when viewing the effect such a proposal on orthopaedic practice.