Background: Incomplete or inconsistent reporting of adverse events (AEs) undermines the interpretability of randomized trials. In interventional regional anesthesia (RA), where procedural risks must be clearly communicated, such discrepancies may obscure safety profiles. This study evaluates concordance between AE data reported in ClinicalTrials.gov and corresponding peer-reviewed publications. Methods: We conducted a systematic review of interventional RA trials registered on ClinicalTrials.gov with published results. AE data were extracted in duplicate across four domains: serious adverse events, other adverse events, treatment-related discontinuations, and all-cause mortality. Descriptive statistics characterized trial features. Bland–Altman and funnel plots assessed reporting concordance and bias. χ² tests compared reporting completeness by regulatory status. A composite 0–7 AE reporting score, derived from Food and Drug Administration Amendments Act Final Rule–mandated fields, was analyzed using linear and segmented regressions to identify predictors of reporting and temporal trends. Results: Among included trials, substantial discrepancies were observed in AE counts between ClinicalTrials.gov and publications. Funnel plot asymmetry suggested possible underreporting in smaller studies. Trials subject to FDA reporting requirements were significantly more likely to report complete AE data (p<0.05). Composite AE reporting scores were higher in industry-sponsored and drug-focused trials. Segmented regression identified a modest post-Final Rule increase in reporting completeness, though recent-year instability limits interpretation. Discussion: In RA trials, AE reporting is frequently incomplete or discordant across sources, with regulatory oversight linked to greater transparency. These findings highlight the need for standardized safety reporting and alignment between registries and publications to ensure accurate risk communication in anesthesiology research.

Type 1 Diabetes Mellitus (T1D) is a disease characterized by the destruction of pancreatic beta cells. The subsequent loss of insulin production results in hyperglycemia, muscle wasting, and vascular dysfunction. Due to an inability to appropriately maintain glucose homeostasis, patients afflicted with T1D suffer from increased morbidity and early mortality. Skeletal muscle is the body’s largest metabolic reservoir, absorbing significant amounts of glucose from the bloodstream and physical exercise is known to improve and prevent the progression of pathological outcomes, but many T1D patients are unable to exercise at a level that conveys benefit. Thus, directly targeting muscle mass and function may prove beneficial for improving T1D patient outcomes, independent of exercise. A potent negative regulator of skeletal muscle has been identified as being upregulated in T1D patients, namely the myokine myostatin. Our hypothesis is that targeting myostatin (via genetic deletion) will prevent glucose dysfunction in a T1D model, preserve skeletal muscle function, and protect against vascular and renal dysfunction. Our methods utilized adult male mice with (WT) and without myostatin (Myo KO), in combination with the chemical induction of T1D (streptozotocin). Experimental outcomes included the assessment of glucose homeostasis (plasma glucose, HbA1c, IGTT), metabolism, muscle function (in vivo plantarflexion), and skeletal muscle vascular function (ex vivo pressure myography). Our results described systemic benefits from myostatin deletion in the T1D model, independent of insulin, including the following: inhibition of T1D-induced increases in plasma glucose, prevention of functional deficits in muscle performance, and preservation of fluid dynamics. Further, endothelial function was preserved with myostatin deletion. Taken together, these data inform upon the use of myostatin inhibition as a therapeutic target for effective treatment and management of the cardiometabolic and skeletal muscle dysfunction that occurs with T1D.

Background: Total knee arthroplasty (TKA) clinical trials inform surgical decisions by reporting adverse events (AEs), including serious adverse events (SAEs), other adverse events (OAEs), and deaths. However, concerns persist regarding discrepancies in AE reporting between trial registries, such as ClinicalTrials.gov, and peer-reviewed publications, even after the implementation of Food and Drug Administration Amendments Act Section 801 and the Final Rule of 2017, laws introduced to mitigate selective reporting and enhance public transparency. Methods: We conducted a systematic registry-to-publication comparison of 92 TKA-focused clinical trials with posted results on ClinicalTrials.gov between 2009 and 2024. Data on SAEs, OAEs, and deaths were extracted from registries and matched peer-reviewed publications using a pre-registered protocol. Descriptive statistics were used to evaluate discrepancies and trends over time. Regression analysis was used to assess the impact of the Final Rule and variables associated with changes in reporting score. Results: AE reporting was consistently more complete in ClinicalTrials.gov entries than in publications. SAE count mismatches were present in 95% of trials, and mortality data were omitted from 87% of pre-Final Rule Applicable Clinical Trial (ACT) publications. Post-Final Rule trials continued to underreport SAEs and deaths in publications, with no significant improvement in reporting completeness. Only 15% of trials listed AEs as formal outcomes in registries, and 66% of post-Final Rule ACTs omitted SAE reporting in the publication. Conclusion: Despite regulatory mandates, AE reporting in TKA trials remains inconsistent and incomplete across publications. These discrepancies risk undermining surgical decision-making and evidence-based guidelines. Enhanced enforcement, editorial accountability, and stricter adherence to reporting standards such as Consolidated Standards of Reporting Trials Harms are necessary to improve transparency and patient safety in orthopaedic research. Level of Evidence: Level II . See Instructions for Authors for a complete description of levels of evidence.

To assess the concordance of adverse event reporting between clinical trial registries and their corresponding publications for interventions treating beni

Background: Adverse event reporting is critical for interpreting and applying findings from HIV/AIDS clinical trials. Although registries such as ClinicalTrials.gov provide structured safety data, clinicians and guideline developers often rely primarily on peer-reviewed publications, which may selectively report harms. Prior research across multiple specialties has documented incomplete or inconsistent adverse event reporting in publications relative to registry entries, including incomplete reporting of serious harms. The consistency of adverse event reporting between registries and publications in HIV/AIDS trials has not been systematically evaluated. Main Body: We conducted a registry-to-publication comparison study of interventional HIV/AIDS trials with results posted on ClinicalTrials.gov between September 27, 2009, and December 31, 2024. Corresponding publications were identified through ClinicalTrials.gov, PubMed, and Google Scholar. Eligible studies were Phase 2– 4 (or not applicable), enrolled individuals living with HIV, evaluated therapeutic, preventive, or adherence-related interventions, and had both publicly posted registry results and a full-length English-language publication. Two independent reviewers extracted adverse event data using a standardized form. Outcomes included serious adverse events, other adverse events, treatment discontinuations, and mortality. Among 129 eligible trials, 62% showed mismatched serious adverse event counts between registry entries and publications, with registries more often reporting higher counts. An additional 28% of trials failed to report serious adverse event counts in either source — a distinct category of dual-source non-reporting. Across all reporting domains, registries more consistently reported complete safety data than publications. Following implementation of the 2017 Food and Drug Administration Amendments Act Final Rule, reporting improved within ClinicalTrials.gov (serious adverse events reported in 74% of trials) but remained low in publications (26%). Regression analyses demonstrated a significant increase in overall adverse event reporting completeness after the Final Rule (p < 0.001). Sponsor type was not associated with reporting completeness, whereas larger enrollment was associated with modestly lower completeness (p = 0.02). Conclusion: Substantial discrepancies persist between registry and publication reporting of adverse events in HIV/AIDS trials. Regulatory requirements were associated with changes in registry reporting patterns but did not eliminate inconsistencies in the published literature. Greater alignment between registry and journal reporting standards is needed to strengthen the transparency and reliability of safety evidence.