Significant Differences In Patient Outcomes Research Articles

Impact of selexipag maintenance dose on persistence, adherence, and hospitalization in US patients with pulmonary arterial hypertension.

Selexipag is an oral selective agonist of the prostacyclin receptor approved to treat adults with pulmonary arterial hypertension (PAH). Selexipag is initiated at a dose of 200 μg twice daily (bid) and usually titrated up by 200 μg bid weekly (per label) or more slowly (e.g., every other week in real-world clinical practice) to the highest tolerated individualized dose (ID) ranging from 200 to 1600 µg bid. In the Phase 3 GRIPHON trial, selexipag delayed disease progression and reduced risk of PAH-related hospitalization compared with placebo; the effect was consistent across three prespecified ID groups: low (200-400 µg bid), medium (600-1000 µg bid), and high (1200-1600 µg bid). This study evaluated patient outcomes across selexipag dose ranges in real-world practice. Data were analyzed from 1186 US adult patients with PAH on selexipag from the Komodo closed-claims database (2015‒2022). Of these, 634 (53.5%) patients completed titration and reached their selexipag ID (43.8% high ID, 29.8% medium ID, 26.3% low ID). Subsequently, 72.4% of patients in the low ID group had dose adjustments compared with 61.9% (medium ID) and 34.5% (high ID; standardized mean difference 0.63). There were no significant differences in patient outcomes, i,e, persistence (time to discontinuation) and risk of all-cause and PAH-related hospitalization across ID groups. The findings in this diverse, real-world population of patients with PAH reinforced an individualized approach to the dosing scheme to maximize benefit-risk and achieve the highest tolerated dose with selexipag similar to findings from the GRIPHON trial and other studies.

Impact of Centrifugation Parameters on Platelet-Rich Plasma Injection for Patella Tendinopathy: A Systematic Review and Meta-Analysis.

Patellar tendinopathy (PT) is a chronic, degenerative form of tendinitis commonly affecting young, active individuals. Numerous nonsurgical treatments exist, of which platelet-rich plasma (PRP) is a frontrunner. However, heterogeneity among various PRP preparation techniques results in a large variation in treatment efficacy. This review and meta-analysis aims to investigate the effect of PRP centrifugation factors, specifically centrifuge speed and duration, on functional outcomes in patients with PT. A systematic search of the literature was performed in April 2024 on Medline and Embase. Articles involving the use of PRP in the treatment of PT were included. The risk of bias was assessed using the Risk of Bias 2 (RoB 2; the Cochrane Collaboration, England, UK) and Risk of Bias in Non-randomised Studies of Intervention (ROBINS-I; the Cochrane Collaboration, England, UK) tools. Comparative meta-analysis between the different centrifugation speeds and the different centrifugation durations was performed on articles reporting Victorian Institute of Sports Assessment - Patellar tendon (VISA-P) and visual analogue scale (VAS) scores for PT. Seventeen studies consisting of 360 participants were included in the analysis. The mean follow-up duration was 13.2 months (95% CI: 8.81 to 17.7). The mean VAS reduction was 3.85 (95% CI: -4.63 to -3.08; P < 0.01). VISA-P scores improved by 32.03 (95% CI: 24.29 to 39.78; P < 0.01). There were no significant differences between centrifuge speeds for VAS (P = 0.17) and VISA-P (P = 0.18) and between centrifuge durations for VAS (P = 0.25) and VISA-P (P = 0.27). Centrifuge speed and duration and number of centrifuge cycles did not show any significant differences in patient outcomes. There were no significant differences observed in outcomes for the different preparations of PRP. There remains a need for further high-quality RCTs using standardized PRP preparations with long-term follow-up for the development of a consensus method of PRP preparation for the treatment of PT.

Comparison and Utility of Intravenous Iodinated Contrast in Chest, Abdomen, Pelvis Computerized Tomography for Trauma Patients With Blunt Mechanism of Injury Before and After the May 9, 2022 Global Contrast Shortage at a Level II Trauma Center.

Background: Intravenous (IV) contrast improves the sensitivity and specificity of injury detection in computerized tomography (CT). Its use is recommended in the workup of trauma patients by the American College of Surgeons and American College of Radiology. On May 9, 2022, the Food and Drug Administration declared a shortage of iodinated contrast due to the COVID-19 pandemic. Although the shortage has ended, the temporary lack of IV contrast forced physicians to be prudent in ordering CT scans with IV contrast. We sought to determine if there was a change in the percentage of CT contrast studies performed during the contrast shortage and if this change affected patient outcomes.Methods: Retrospective chart review was performed on all adult tier 2 trauma patients at a 619-bed community-based level II trauma center who received CT chest, abdomen, and pelvis imaging as initial workup for blunt trauma from 5/9/2021-6/30/2021 (pre-shortage) and 5/9/2022-6/30/2022 (during shortage).Results: Patients were predominantly male with median age of 31-52 and of White or Hispanic ethnicity. Before the contrast shortage, all 110 trauma patients were scanned with contrast. During the shortage, 29 of 114 patients were scanned with contrast (P < 0.001). Injuries were identified in 59% of patients scanned with contrast (P < 0.001). There were no significant differences in blood transfusion needs, repeat CT, disposition, or mortality when comparing pre-shortage to during shortage or when comparing between non-contrast and contrast studies during the shortage.Discussion: There was a decrease in the percentage of CT contrast studies performed during the shortage. A higher percentage of injuries were identified in the patients scanned with contrast. However, there were no significant differences in patient outcomes. Certain trauma patients may be safely scanned without contrast.

Reprocessed Single-Use Semicritical and Critical Medical Devices

What Is the Issue?&#x0D; &#x0D; Reprocessing a medical device includes cleaning, reconditioning, testing, and disinfection to ensure the device can safely be reused. In contrast to reusable medical devices, manufacturers are not required to provide instructions for properly cleaning and sterilizing single-use medical devices (SUMDs).&#x0D; Health Canada regulates third-party device reprocessors and requires they meet the same requirements as new device manufacturers. Health Canada does not provide oversight for hospital onsite reprocessing, deferring to the oversight provided at the provincial and territorial levels. Given the potential economic and environmental benefits of using reprocessed SUMDs, there is a growing interest in determining the clinical safety of reprocessed SUMDs.&#x0D; Current standards for reprocessing medical devices use definitions for sterilization and disinfection based on measurement of bioburden, but not necessarily clinical outcomes such as infection.&#x0D; &#x0D; What Did We Do?&#x0D; &#x0D; To inform decisions about the appropriate use of reprocessed critical and semicritical SUMDs, CADTH sought to identify and summarize literature evaluating the clinical safety of reprocessed SUMDs, defined as infections, mortality, or other adverse events, compared with nonreprocessed (new) SUMDs. Microbiological outcomes, such as bacterial colony counts, were not included. An information specialist searched for peer-reviewed and grey literature sources.&#x0D; This report does not provide a comprehensive list of device reprocessors in Canada or recommend any specific methods of reprocessing medical devices.&#x0D; &#x0D; What Did We Find?&#x0D; &#x0D; We identified 8 studies, including one study based in Canada, that evaluated the use of reprocessed SUMDs compared with new SUMDs; most did not report statistically significant differences in patient outcomes between groups.&#x0D; Most of the included studies were of very low to moderate quality, which limits confidence in the observed outcomes resulting from the reuse of these devices. Half of the included studies were published before the year 2005, which may limit applicability given potential improvements and changes over time in reprocessing standards, surgical approaches, device specifications, and patient care protocols.&#x0D; Most of the studies evaluated a different type of reprocessed single-use medical device for different surgical populations, so there is very limited evidence for the use of a specific device in a specific population or intervention of interest. All included studies evaluated SUMDs classified as critical, and all were conducted in surgical settings; however, it is unclear whether patient risk levels would be different for semicritical devices or in nonsurgical settings.&#x0D; &#x0D; What Does it Mean?&#x0D; &#x0D; Given various devices, clinical applications, and reprocessing methods, it is difficult to draw broad conclusions about the appropriateness of reprocessing SUMDs.&#x0D; While the evidence base in this review was insufficient to conclude whether reprocessed critical SUMDs in surgical settings affect patient outcomes, Canadian standards and other resources exist to help inform decisions around medical device reprocessing based on infection risk.&#x0D; To ensure patient safety, any reprocessing of SUMDs should meet standards for safety, effectiveness, and labelling that follow Health Canada regulations.&#x0D;

Locating the ventral intermediate thalamic nucleus for deep brain stimulation surgery: analysis of a case series comparing CT and MR targeting.

Deep brain stimulation (DBS) surgery targeting the ventral intermediate thalamic nucleus (Vim) has proven efficacy in the treatment of tremor. The primary aim is to investigate whether there is a statistically significant difference in patient outcomes when CT-guided targeting of the Vim is compared with MRI-guided targeting. This is a retrospective study concerning patients undergoing Vim-targeted DBS at the Department of Neurosurgery, Royal Victoria Infirmary in Newcastle (9th August 2012 to 4th January 2019). Fahn-Tolosa-Marin Tremor Scale (FTM TS) and EQ-5D scores were collected from patient notes. Statistical analysis was performed using IBM® SPSS® Statistics Version 24. Independent samples t-tests were used to compare means. Independent samples t-test did not reveal a statistically significant difference between CT (n = 10; FTM TS mean = 65.40, SD = 11.40; EQ-5D mean = 39.50, SD = 17.87) and MR (n = 7; FTM TS mean = 60.57, SD = 7.50; EQ-5D mean = 32.14, SD = 9.94) groups in pre-surgery FTM TS (t(15) = 0.977, p = 0.344) and EQ-5D (t(15) = 0.982, p = 0.342) scores. No statistically significant difference between the CT (FTM TS mean = 24.12, SD = 20.47; EQ-5D mean = 75.56, SD = 15.63) and MR (FTM TS mean = 22.86, SD = 6.72; EQ-5D mean = 70.43, SD = 15.48) groups was revealed at 1 year assessment of FTM TS (t(14) = 0.155, p = 0.879) and EQ-5D (t(14) = 0.654, p = 0.524). The median difference between pre- and post-surgery FTM TS and EQ-5D scores in the CT group at 1 year was 43.00 and 35.00, respectively. The MR patient group median difference in pre- and post-surgery at 1 year was 35.00 and 35.00 respectively. No statistically significant difference between CT and MR image-guided targeting patient groups was detected.

Unlocking the Battle-Clipping vs. Endovascular Therapy for Shunt-Dependent Hydrocephalus After Aneurysm Rupture: An In-Depth Institutional Analysis.

To compare microsurgical clipping and endovascular therapy (EVT) for the management of shunt-dependent hydrocephalus (SDH) in patients with subarachnoid hemorrhage (SAH) and hydrocephalus. This retrospective study was conducted from July 2018 to December 2022 and included 67 patients with SAH accompanied by acute hydrocephalus. Patients' demographic, clinical, and radiological data, such as age, sex, Glasgow Coma Scale scores, Hunt and Hess scale, Fischer grade, external ventricular drain (EVD) duration, complications, Ommaya reservoir placement, cerebrospinal fluid drainage, and outcomes, were obtained. Statistical analyses, including univariate analysis and stepwise logistic regression, revealed significant risk factors for shunt dependence. Of the 67 patients, 33 underwent microsurgical clipping and 34 received EVT. Spasmolysis reduced shunt dependency, whereas early EVD placement correlated with reduced shunt dependence (p=0.002). The Ommaya reservoir helped in the management of meningitis but was found to be associated with shunt dependency (p=0.04). Multiple logistic regression analysis revealed that perioperative infarct was a significant risk factor for shunt dependence (p=0.05). No significant difference in patient outcomes was observed between the two treatment groups. However, patients who received EVT had shorter intensive care unit and hospital stays. This study shows that managing clinical vasospasm with spasmolysis may reduce shunt dependency. Overall, both microsurgical clipping and EVT offer similar long-term outcomes and efficacy in preventing shunt dependence, but the latter has the advantage of shorter hospital stay. These findings provide crucial insights for clinical decision-making and patient care in SDH after SAH.

Effective prognostic risk model with cuproptosis-related genes in laryngeal cancer

ObjectiveLaryngeal cancer, characterized by high recurrence rates and a lack of effective biomarkers, has been associated with cuproptosis, a regulated cell death process linked to cancer progression. In this study, we aimed to explore the roles of cuproptosis-related genes in laryngeal cancer and their potential as prognostic markers and therapeutic targets. MethodsWe collected comprehensive data from The Cancer Genome Atlas and Gene Expression Omnibus databases, including gene expression profiles and clinical data of laryngeal cancer patients. Using clustering and gene analysis, we identified cuproptosis-related genes with prognostic significance. A risk model was constructed based on these genes, categorizing patients into high- and low-risk groups for outcome comparison. Univariate and multivariate analyses were conducted to identify independent prognostic factors, which were then incorporated into a nomogram. Gene Set Enrichment Analysis was employed to explore pathways distinguishing high- and low-risk groups. ResultsOur risk model, based on four genes, including transmembrane 2, dishevelled binding antagonist of β-catenin 1, stathmin 2, and G protein-coupled receptor 173, revealed significant differences in patient outcomes between high- and low-risk groups. Independent prognostic factors were identified and integrated into a nomogram, providing a valuable tool for prognostic prediction. Gene Set Enrichment Analysis uncovered up-regulated pathways specifically associated with high-risk patient samples. ConclusionThis study highlights the potential of cuproptosis-related genes as valuable prognostic markers and promising therapeutic targets in the context of laryngeal cancer. This research sheds light on new avenues for understanding and managing this challenging disease. Level of evidenceLevel 4.

Identification of a Relapse Signature in t(8;21) Pediatric AML

Pediatric acute myeloid leukemia (AML) is a malignancy of the blood in which myeloid progenitor cells are interrupted in their normal course of development and proliferate out of control. Recent studies such as the TARGET initiative, have revealed pediatric AML to be driven by relatively few molecular abnormalities when compared to adult AML. Most frequently occurring in genes directly involved in or regulating transcription. These molecular aberrations are drivers of disease, inform patient risk stratification and are transcriptomically unique from one another. Of these events, RUNX1-RUNX1T1 is the most common, evident in approximately 15% of pediatric AML cases. While RUNX1-RUNX1T1 is a positive outcome prognosticator, 20% of these patients go on to relapse with significantly poorer outcomes. Our objective was to identify a relapse signature that could be identified at the time of diagnosis so that alternative therapeutic strategies can be employed. Here we report the investigation of RNAseq data from 3,022 pediatric AML patient samples and identification of a transcriptomic relapse-signature (TRS) via differential expression analysis, supervised clustering and machine learning modelling. We performed differential gene expression analysis comparing diagnostic t(8;21) patient samples for those who relapsed (R) (n=38)vs. those who did not relapse (NR) (n=111). Analysis was performed using DESeq2 in R 4.3.0. P-values were adjusted with Benjamini-Hochberg correction to control for false discovery rate a significance threshold for padj of &amp;lt; 0.05 was applied. A list of 462 differentially genes was returned. Hierarchical clustering of the 462 differentially expressed genes revealed 4 patient clusters, each with a distinct transcriptomic signature ( Fig 1A). K-means (n=4) also returned similar results to the hierarchical clustering. Kaplan-Meier analysis of the 4 clusters showed a significant difference in patient outcomes both in terms of overall survival (P &amp;lt; 0.001) and event-free survival (P &amp;lt; 0.05) ( Fig 1B). In marked contrast to clusters 1-3, cluster 4 was highly enriched in patients who relapsed at a rate of 86%. Clusters 1, 2 and 3 had relapse rates of 36, 29 and 38 percent respectively. To identify the most relevant genes that could serve as a TRS, we trained a random forest (RF) model using transcript per million (TPM) transformed and length normalized counts for each of the 462 differentially expressed genes at the time of diagnosis between the R and NR cohort; the response variable was patient relapse outcome. Data was split into 70% training and 30% testing cohorts. As the small size of our cohort was a potentially limiting factor, we utilized 5-fold cross validation in the training of our model. Recursive feature selection was applied to the model and was iteratively trained using subsets of features (predictor genes) ranging from 1 to 100. Features were then recursively sorted by importance and an optimal number of 30 predictors were chosen. Application of our model to the testing dataset of 45 patients (R = 12, NR = 33) allowed us to accurately predict the outcome in 40 of 45 patients. This model accurately predicted 33 of 33 NR and 7 of 12 R patients. This model was both specific and sensitive for NR and specific to R but lacked sensitivity as we were only able to identify 58% of relapse patients. Finally, this 30-gene list was then compared to survival analysis on a by-gene basis which yielded a final panel of 16 genes which we call our TRS. These genes were; PRDM8, RARG, CSF1, PDE4B, CCL3, NAB1, WHRN, SGSM2, LPIN3, CHARLIE1B, SATB1, ZNF441, ZNF521, AL451123.1, TSPYL4 and B3GNT5. The RF model was re-trained on this smaller panel and re-tested with similar results. By applying differential expression analysis, K-means clustering and machine learning to RNAseq data from a cohort of 149 pediatric AML patients we successfully identified a relapse-signature using a panel of 16 genes evident at the time of diagnosis and prognostic of patient outcomes. Future efforts will focus on increasing the sensitivity of our model to relapse prediction and further validation on other pediatric t(8;21) cohorts.

Emergency Medicine Perspectives: The Importance of Bystanders and Their Impact on On-Site Resuscitation Measures and Immediate Outcomes of Out-of-Hospital Cardiac Arrest.

Out-of-hospital cardiac arrests (OHCAs) represent critical medical emergencies in which timely interventions can make a significant difference in patient outcomes. Despite their importance, the role of on-scene witnesses during such events remains relatively unexplored. This research seeks to shed light on the influence of witnesses, especially family members, during OHCAs and the effect of their interventions, or the absence thereof, on outcomes. Drawing from existing literature, our working hypothesis suggests that the presence of a witness, particularly one who is knowledgeable about CPR, can increase the likelihood of obtaining the return of spontaneous circulation (ROSC), potentially enhancing overall survival rates. Using a retrospective analytical method, we thoroughly reviewed medical records from the Lublin Voivodeship between 2014-2017. Out of 5111 events identified using ICD-10 diagnosis codes and ICD-9 medical procedure codes, 4361 cases specifically related to sudden cardiac arrest were chosen. Concurrently, 750 events were excluded based on predefined criteria. Both basic and advanced EMS teams showed higher rates of CPR initiation and an increased likelihood of obtaining ROSC. Notably, the presence of a trained EMS professional as a witness significantly increased the chances of CPR initiation. The presenting rhythms most often detected were ventricular tachycardia (VT) and ventricular fibrillation (VF). Different urgency codes were directly linked to varying ROSC outcomes. When witnesses, especially family members, began chest compressions, the use of amiodarone was notably higher. A significant finding was that 46.85% of OHCA patients died without witnesses, while family members were present in 23.87% of cases. Actions taken by witnesses, especially chest compressions, generally extended the overall duration of patient care. The crucial influence of witnesses, particularly family members, on OHCA outcomes is evident. Therefore, it is essential to increase public awareness of CPR techniques and rapid intervention strategies to improve outcomes in emergency situations.

Retrospective comparison of outcomes of patients undergoing omental patch versus falciform patch repair of perforated peptic ulcers.

The omental patch repair is the gold standard for the repair of perforated peptic ulcers. This can be performed open or laparoscopically. However, in the event of non-viable or inadequate omentum available at the time of surgery the falciform ligament has been reportedly used to as an alternative. Nonetheless, evidence for its safety is scant. This study aims to determine differences in patient outcomes when comparing the two repair techniques. Following ethics approval, patients who underwent surgical repair of perforated peptic ulcers using omental or falciform patch repair, between 1 January 2010 and 31 December 2017, across all three Western Australian tertiary hospital services and at least 18 years of age were included. Data were collected by reviewing medical records of included patients. Three hundred twenty-nine patients who underwent either open or laparoscopic repairs were included. Thirty-seven patients had falciform repairs and were mostly ASA of 2 compared to 292 patients receiving omental patch repair who were mostly ASA 3. Falciform patch repairs were more commonly used in duodenal ulcer perforations. There were no statistically significant differences in patient outcomes between the omental patch and falciform ligament groups. This included post-operative intra-abdominal sepsis, return to theatre, post-operative ICU admission, inpatient mortality, 30-day readmission and ulcer healing on follow-up gastroscopy. This study demonstrates safety, efficacy and similar outcomes for patients receiving the falciform ligament patch repair compared with omental patch repair.

Standardized Protocol for Chest Tube Management for Trauma Patients Significantly Decreases Complications.

As health care shifts to a value-based model with a focus on patient outcomes per dollar spent, it is important to develop and evaluate standardized protocols that ultimately lead to improved patient outcomes and decreased hospital complications. Prior to our chest tube protocol, chest tube management at our Trauma Center was nonuniform and surgeon-specific. The aim of this study was to (1) develop an institutional standardized protocol for chest tube management at our Level II Trauma Center and (2) compare patient outcomes before and after the implementation of our protocol. An institutional, standardized protocol was initiated at our Level II-Certified Trauma Center teaching hospital in 2014. An IRB-approved, single-institution retrospective chart review was performed between January 2011 and May 2017, in order to capture the 3 years prior and 3 years after protocol implementation. All patients with a diagnosis of hemothorax or pneumothorax (H/PTX) from blunt or penetrating trauma that resulted in a >24 French chest tube placement were included in the study. Patients were excluded if interventional radiology (IR) placed the chest tube, the mechanism was nontraumatic, or the patient expired at index hospitalization. Univariate analyses were performed to evaluate significant differences in patient outcomes before and after the implementation of the protocol. A total of 143 patients were analyzed for this study, with 43 preprotocol patients and 100 postprotocol patients. Hospital length of stay (LOS), persistent H/PTX, and the need for further surgical intervention all improved after the implementation of the standardized protocol (p < 0.04). Our standardized protocol for chest tube management at our Level II Trauma Center significantly improved patient outcomes and can serve as a model for similar institutions.

The Impact of the Addition of a Physical Therapy Assistant to the Treatment Team for Management of Neck Pain: A Retrospective Analysis of Outpatient Physical Therapy Clinics.

Introduction The impact of physical therapy assistants (PTAs) on patient outcomes, mostly in the acute and subacute setting, is well known in the literature. However, no study to date has examined the impact of using PTAs as part of a treatment team in the outpatient setting for common musculoskeletal conditions. The purpose of this study is to determine if physical therapy team composition, either physical therapists (PTs) only or a team consisting of PTs and PTAs, has a significant impact on patient outcomes in adult patients with musculoskeletal neck pain to help investigate an ideal practice pattern for outpatient physical therapy. Methods This is a retrospective cohort study analyzing the impact of physical therapy treatment team composition (PTs only, or team consisting of PTs and PTAs) on pain, active range-of-motion (AROM), and disability outcomes via the Neck Disability Index (NDI) in the conservative treatment of neck pain. All patients were treated with usual physical therapy care. Inclusion criteria involved patients with a diagnosis of neck pain (M48.2), older than 18 years old, a physical therapy evaluation procedure code (97161, 97162, 97163), and at least two visits per bout of physical therapy. Primary outcome measures were pain, bilateral rotation AROM, disability, and number of visits. Results Included patients (n=195) had an average age of 60.8 years ± 16.1 years with an average number of total physical therapy visits of 7.4 visits ± 4.3 visits (range, 2 visits - 22 visits) with 120 patients (61.5%) treated by a PT only (PT-only group) and 75 patients (38.5%) treated by a team consisting of a PT and a PTA (PTA group). The PT-only group had significantly fewer visits than the PTA group (p<0.001). The PT-only group had a pain improvement of 2.1 points ± 2.3 points whereas the PTA group had a pain improvement of 2.2 points ± 2.4 points with no significant difference between the two groups (p=0.573). The PT-only group (n=46 patients) had an average rotation AROM improvement of 20.0 ± 17.4 degrees whereas the PTA group (n=40 patients) had an average rotation AROM improvement of 16.8 degrees ± 23.0 degrees with no significant difference between the level of rotation AROM improvement between the two groups (p=0.408). Furthermore, there was also no significant difference in the amount of NDI improvement seen in both groups (p=0.594). Conclusion There was no significant difference in patient outcomes for pain, AROM, and disability when PTAs were added to the physical therapy treatment team in the conservative management of neck pain in the outpatient setting. However, patients treated with a treatment team consisting of PTAs had significantly more visits, despite no significant change in outcomes. Randomized controlled trials are needed as the reasons for these findings can be many and require further research.

External Ventricular Drains versus Intraparenchymal Pressure Monitors in the Management of Moderate to Severe Traumatic Brain Injury: Experience at Two Academic Centers over a Decade

The choice between external ventricular drain (EVD) and intraparenchymal monitor (IPM) for managing intracranial pressure in moderate-to-severe traumatic brain injury (msTBI) patients remains controversial. This study aimed to investigate factors associated with receiving EVD versus IPM and to compare outcomes and clinical management between EVD and IPM patients. Adult msTBI patients at 2 similar academic institutions were identified. Logistic regression was performed to identify factors associated with receiving EVD versus IPM (model 1) and to compare EVD versus IPM in relation to patient outcomes after controlling for potential confounders (model 2), through odds ratios (ORs) and 95% confidence intervals (CIs). Of 521 patients, 167 (32.1%) had EVD and 354 (67.9%) had IPM. Mean age, sex, and Injury Severity Score were comparable between groups. Epidural hemorrhage (EDH) (OR 0.43, 95% CI 0.21-0.85), greater midline shift (OR 0.90, 95% CI 0.82-0.98), and the hospital with higher volume (OR 0.14, 95% CI 0.09-0.22) were independently associated with lower odds of receiving an EVD whereas patients needing a craniectomy were more likely to receive an EVD (OR 2.04, 95% CI 1.12-3.73). EVD patients received more intense medical treatment requiring hyperosmolar therapy compared to IPM patients (64.1% vs. 40.1%). No statistically significant differences were found in patient outcomes. While EDH, greater midline shift, and hospital with larger patient volume were associated with receiving an IPM, the need for a craniectomy was associated with receiving an EVD. EVD patients received different clinical management than IPM patients with no significant differences in patient outcomes.

Poster 208: Clinical Outcomes Following Ulnar Collateral Ligament Reconstructions with Concomitant Ulnar Nerve Transposition in Overhead Athletes: A Matched Cohort Analysis

Objectives: Injury of the ulnar collateral ligament (UCL) has become increasingly common, particularly in overhead athletes. There is no consensus on management of the ulnar nerve in UCL reconstruction (UCLR) in patients with pre-operative ulnar nerve symptoms, as literature supports both not decompressing the nerve as well as ulnar nerve transposition (UNT). The purpose of this study is to compare subjective clinical outcomes and return to play metrics between patients who received UNT during UCLR and a matched cohort who underwent UCLR alone. We hypothesized that there would be no significant difference in patient outcomes or return to sport (RTS) metrics between the cohorts. Methods: Using an institutional database, patients who underwent UCLR with UNT between 2007 and 2017 were retrospectively identified. These patients were matched based on sex, age at surgery (± 3 years), and BMI (± 2) to a comparison group that underwent UCLR alone. Patients completed the Kerlan Jobe Orthopaedic Clinic Shoulder &amp; Elbow score (KJOC), the Timmerman and Andrews elbow score, the Conway-Jobe scale, and custom patient satisfaction and return to play questionnaires. Results: Thirty patients who underwent UCLR with concomitant UNT and 30 matched patients who underwent UCLR without UNT were available for follow up at a mean of 6.9 and 8.1 years respectively. The UNT group reported similar KJOC (78.4 in UNT vs 76.8; P=0.780), Conway-Jobe (60% excellent in UNT vs 77% excellent; P=0.504), Timmerman and Andrews (86.2 in UNT vs. 88.8; P=0.496), and satisfaction scores (85.3% in UNT vs. 89.3%; P=0.512) compared to UCLR group. In terms of RTS rate (84% in UNT vs 93%; P=0.289) and duration required to RTS (11.1 months in UNT vs 12.5 months; P=0.176), the two groups did not significantly differ. Finally, despite significant differences in preoperative ulnar nerve symptoms (100% in UNT vs 7% in UCLR; P&lt;0.001), the two groups did not statistically differ in the proportion of patients that experienced post-operative ulnar nerve symptoms (13% in UNT vs 0%; P=0.112) Conclusions: This matched cohort analysis showed no statistically significant differences in patient reported outcomes and return to sport between patients undergoing UCLR with and without UNT. [Table: see text]

CLONAL ARCHITECTURE OF RELAPSED OR REFRACTORY FOLLICULAR HELPER T‐CELL LYMPHOMA: AN ANCILLARY STUDY OF THE ORACLE TRIAL, A LYSA STUDY

Follicular helper T-cell lymphoma (TFHL) results from the oncogenic transformation of a TFH cell, driven by mutations in genes involved in epigenetic regulation (TET2, DNMT3A, IDH2) and T-cell signaling (RHOA). Demonstration of TET2 and DNMT3A mutations in B cells, myeloid cells, or hematopoietic progenitor cells have suggested that TFHL can emerge from clonal hematopoiesis (CH) in a multi-step process. However, the frequency, the extension, and the relevance of such CH in TFHL oncogenesis are unclear. To describe and characterize the clonal architecture of refractory/relapsed (R/R) TFHL, we collected bone marrow samples of patients included in the ORACLE trial (NCT03593018), a phase 3 trial evaluating the oral 5-azacitidine (CC-486) compared to single-agent chemotherapy in patients with R/R TFHL. Bone marrow (BM) cells from 32 patients at inclusion were cultured in methylcellulose supplemented with standard growth factors. BFU-E, CFU-GM, and CFU-GEMM were counted and individually harvested. A total of 517 colonies derived from the 32 patients were then individually genotyped by next-generation sequencing (NGS) using a capture-based panel (limit of detection: 1%) covering 43 genes recurrently mutated in CH and/or TFHL, including TET2, DNMT3A, IDH2, and RHOA. Meanwhile, bulk BM cells from 29 patients were sequenced with the same NGS panel and then compared to the mutations found in cfDNA (31 patients) and tumor biopsies (28 patients). Overall, the frequency of CH and the phylogenetic link between the myeloid progenitors and the TFHL was evaluable in 30 TFHL patients. We successfully genotyped 471/517 (91%) colonies. CH defined by at least one somatic mutation detected in at least one myeloid colony or total BM cells was found in 29/30 (97%) patients. Among the 26/29 patients with mutated myeloid colonies, the median percentage of mutated colonies was 21% (IQR 7%–53%) and 7 had subclonal architecture with a median of 3 different clones. The 2 most frequent mutations were DNMT3A and TET2, detected in 24/30 (80%) and 18/30 (60%) patients' BM, respectively. We confirmed the absence of RHOAG17V and IDH2R172 mutations in BM cells of TFHL patients. While 17/18 patients with a detectable TET2 mutation in CH had a TET2 mutated TFHL, only 13/23 patients with a DNMT3A mutated CH had a DNMT3A mutated TFHL. We thus identified 3 groups of patients according to the distribution of mutations found in the BM and the LN lymph nodes: 16/30 (53.3%) patients had a TFHL clonally derived from CH (CH-related TFHL), 13 (43.3%) had TFHL, and clonally distinct CH (CH-unrelated TFHL), and one patient (3.3%) had undetectable CH. No significant difference in patient outcome was observed regarding the presence of CH-related or unrelated TFHL, but our results are limited by the small number of patients and treatment heterogeneity. Encore Abstract—previously submitted to EHA 2023 Keywords: aggressive T-cell non-Hodgkin lymphoma, tumor biology and heterogeneity No conflicts of interests pertinent to the abstract.

Effect of Autograft CD34+ Dose on Outcome in Pediatric Patients Undergoing Autologous Hematopoietic Stem Cell Transplant for Central Nervous System Tumors

Consolidation with autologous hematopoietic stem cell transplantation (HSCT) has improved survival for patients with central nervous system tumors (CNSTs). The impact of the autologous graft CD34+ dose on patient outcomes is unknown. We wanted to analyze the relationship between CD34+ dose, total nucleated cell (TNC) dose, and clinical outcomes, including overall survival (OS), progression-free survival (PFS), relapse, non-relapse mortality (NRM), endothelial-injury complications (EIC), and time to neutrophil engraftment in children undergoing autologous HSCT for CNSTs. A retrospective analysis of the CIBMTR database was performed. Children aged <10 years who underwent autologous HSCT between 2008 to 2018 for an indication of CNST were included. An optimal cut point was identified for patient age, CD34+ cell dose, and TNC, using the maximum likelihood method and PFS as an endpoint. Univariable analysis for PFS, OS, and relapse was described using the Kaplan-Meier estimator. Cox models were fitted for PFS and OS outcomes. Cause-specific hazards models were fitted for relapse and NRM. One hundred fifteen patients met the inclusion criteria. A statistically significant association was identified between autograft CD34+ content and clinical outcomes. Children receiving >3.6×106/kg CD34+ cells experienced superior PFS (p = .04) and OS (p = .04) compared to children receiving ≤3.6 × 106/kg. Relapse rates were lower in patients receiving >3.6 × 106/kg CD34+ cells (p = .05). Higher CD34+ doses were not associated with increased NRM (p = .59). Stratification of CD34+ dose by quartile did not reveal any statistically significant differences between quartiles for 3-year PFS (p = .66), OS (p = .29), risk of relapse (p = .57), or EIC (p = .87). There were no significant differences in patient outcomes based on TNC, and those receiving a TNC >4.4 × 108/kg did not experience superior PFS (p = .26), superior OS (p = .14), reduced risk of relapse (p = .37), or reduced NRM (p = .25). Children with medulloblastoma had superior PFS (p < .001), OS (p = .01), and relapse rates (p = .001) compared to those with other CNS tumor types. Median time to neutrophil engraftment was 10 days versus 12 days in the highest and lowest infused CD34+ quartiles, respectively. For children undergoing autologous HSCT for CNSTs, increasing CD34+ cell dose was associated with significantly improved OS and PFS, and lower relapse rates, without increased NRM or EICs.

Clinical Outcomes After Ulnar Collateral Ligament Reconstructions With Concomitant Ulnar Nerve Transposition in Overhead Athletes: A Matched Cohort Analysis

Background: Injury of the ulnar collateral ligament (UCL) has become increasingly common, particularly in overhead athletes. There is no consensus on management of the ulnar nerve in UCL reconstruction (UCLR) in patients with preoperative ulnar nerve symptoms, as literature supports both not decompressing the nerve as well as ulnar nerve transposition (UNT). Hypothesis/Purpose: The purpose of this study was to compare subjective clinical outcomes and return-to-sports (RTS) metrics between patients who received UNT during UCLR and a matched cohort who underwent UCLR alone. We hypothesized that there would be no significant difference in patient outcomes or RTS metrics between the cohorts. Study Design: Cohort study; Level of evidence, 3. Methods: Using an institutional database, patients who underwent UCLR with UNT between 2007 and 2017 were retrospectively identified. These patients were matched based on sex, age at surgery (±3 years), and body mass index (±2 kg/m2) to a comparison group that underwent UCLR alone. Patients completed the Kerlan-Jobe Orthopaedic Clinic Shoulder & Elbow (KJOC) score, the Timmerman and Andrews elbow score, the Conway-Jobe scale, and custom patient satisfaction and RTS questionnaires. Results: Thirty patients who underwent UCLR with concomitant UNT and 30 matched patients who underwent UCLR without UNT were available for follow-up at a mean of 6.9 (3.4-9.9) and 8.1 (3.4-13.9) years, respectively. The UNT group reported similar KJOC (78.4 in UNT vs 76.8; P = .780), Conway-Jobe (60% excellent in UNT vs 77% excellent; P = .504), Timmerman and Andrews (86.2 in UNT vs 88.8; P = .496), and satisfaction scores (85.3% in UNT vs 89.3%; P = .512) compared with UCLR group. In terms of RTS rate (84% in UNT vs 93% in UCLR; P = .289) and duration required to RTS (11.1 months in UNT vs 12.5 months in UCLR; P = .176), the 2 groups did not significantly differ. Finally, despite significant differences in preoperative ulnar nerve symptoms (100% in UNT vs 7% in UCLR; P < .001), the 2 groups did not statistically differ in the proportion of patients who experienced postoperative ulnar nerve symptoms (13% in UNT vs 0% in UCLR; P = .112). Conclusion: This matched cohort analysis showed no statistically significant differences in patient-reported outcomes and RTS between patients undergoing UCLR with and without UNT.

Muscle recovery after total hip arthroplasty: prospective MRI comparison of anterior and posterior approaches.

The direct anterior approach (DAA) and the posterior approach (PA) are 2 common total hip arthroplasty (THA) exposures. This prospective study quantitatively compared changes in periarticular muscle volume after DAA and PA THA. 19 patients undergoing THA were recruited prospectively from the practices of 3 fellowship-trained hip surgeons. Each surgeon performed a single approach, DAA or PA. Enrolled patients underwent a preoperative MRI of the affected hip and two subsequent postoperative MRIs at around 6 weeks and 6 months after surgery. Clinical evaluations were done by Harris Hip Score at each follow-up interval. MRIs or 10 DAA and 9 PA patients were analysed. Groups did not differ significantly with regard to BMI, age, or preoperative muscle volume. 1 DAA patient suffered a periprosthetic fracture and was excluded from the study. DAA hips showed significant atrophy in the obturator internus (-37.3%) muscle at early follow-up, with persistent atrophy of this muscle at the final follow-up. PA hips showed significant atrophy in the obturator internus (-46.8%) and externus (-16.0%), piriformis (-8.12%), and quadratus femoris muscles (-13.1%) at early follow-up, with persistent atrophy of these muscles at final follow-up. Loss of anterior capsular integrity was present at final follow-up in 2/10 DAA hips while loss of posterior capsular integrity was present in 5/9 PA hips. There was no difference in clinical outcomes. This study demonstrates that DAA showed less persistent muscular atrophy than PA. Regardless of surgical approach, a muscle whose tendon is detached from its insertion is likely to demonstrate persistent atrophy 6 months following THA. Although the study was not powered to compare clinical outcomes, it should be noted that no significant difference in patient outcomes was observed.

Clinical implication of radiologic complete remission on Crohn’s Disease: Compared with endoscopic remission

ObjectivesTo determine the clinical implications of radiologic complete remission (CR) in Crohn’s disease (CD) evaluated by computed tomography (CT) or magnetic resonance enterography (MRE) in comparison with endoscopic CR. MethodsTwenty-five CD patients who achieved endoscopic CR after medical treatment were retrospectively enrolled in this study. All patients underwent ileocolonoscopy, CT, or MRE at baseline, at the time of endoscopic CR, and during follow-up. Two radiologists assessed the mural and perienteric abnormalities on pre- and post-treatment CT or MRE in consensus. Patients were divided into radiologic CR and non-CR groups at the time of endoscopic CR. CD recurrence during subsequent follow-up periods was evaluated using clinical, laboratory, and CT/MRI findings. Statistical analysis was performed to assess whether there were significant differences in patient outcomes between the groups. ResultsAt the time of endoscopic CR, nine patients (mean age, 36.6 years) showed normalization of all radiologic features and were designated as the radiologic CR group. However, 16 patients (mean age: 32.9 years) showed residual CT/MRE abnormalities, suggesting persistent active inflammation, and were designated as the radiologic non-CR group. During follow-up, there was a significant difference between the groups regarding clinical outcomes (deep CR, 8/9 vs 5/16, P = 0.011; CD recurrence, 1/9 vs 14/16, P < 0.001). The mean fecal calprotectin level was significantly lower in the radiologic CR group (287.5 ug/g) than in the non-CR group (652.4 ug/g) (P = 0.023). ConclusionsRadiologic CR can represent a better therapeutic endpoint in CD, showing superiority over endoscopic CR in predicting both clinical and biochemical outcomes.

Immediate Catheter Drainage Versus Delayed Drainage in the Management of Infected Necrotizing Pancreatitis.

Background: Immediate or delayed catheter drainage of infected pancreatic necrosis remains a subject of debate. The present study aimed to evaluate the optimum timing for drainage in patients with infected necrotizing pancreatitis. Methods: A prospective, observational study was undertaken at the Department of Surgery, Liaquat University of Medical & Health Sciences (LUMHS), between 1st March 2018 and 6th July 2020. All patients 18 years or older presenting with acute pancreatitis (AP) in whom necrotizing pancreatitis was confirmed or suspected were enrolled in the study. The exclusion criteria included prior intervention for necrotizing pancreatitis. Those who were diagnosed with infected necrotizing pancreatitis were labeled as Group A and Group B. Group A patients underwent immediate catheter drainage (within 24 h of admission) while Group B patients underwent delayed drainage (after 24 h). Clinical outcome variables including complication rate, mortality, length of hospital, and intensive care unit (ICU) stay were collected in a predefined pro forma.Results: One hundred and thirty patients were enrolled in the study. There were 65 patients in each group. The present study revealed no significant differences in patient outcomes in the immediate drainage group vs. the postponed drainage group. Overall, the mortality rate was 15.38% in Group A while the mortality rate was a little lower in Group B, i.e. 10.77% (p=0.44). The acute onset multiple organ failure was lower in Group A as compared to Group B, however, the difference was statistically insignificant (p=0.08). The rate of wound infection rate was 10.77% and 15.38% in Group A and Group B, respectively (p=0.61).Conclusion: In the present study, we failed to find any significant difference between the immediate and postponed drainage group in terms of patient outcome. As per current findings, the timing of drainage did not impact the prognosis of patients with necrotizing pancreatitis.