Observational Cohort Of Patients Research Articles

Early penumbral FLAIR changes predict tissue fate in patients with large vessel occlusions.

In patients with an acute ischemic stroke, the penumbra is defined as ischemic tissue that remains salvageable when reperfusion occurs. However, the expected clinical recovery congruent with penumbral salvage, is not always observed. We aimed to determine if the Magnetic Resonance Imaging (MRI) defined penumbra includes irreversible neuronal loss that impedes expected clinical recovery after reperfusion. In the prospective French Acute Multimodal Imaging Study to Select Patients for Mechanical Thrombectomy (FRAME) and an observational cohort of patients with large vessel occlusions undergoing endovascular treatment, we quantified penumbral integrity by FLAIR changes. We studied the influence of recanalization status on the evolution of penumbral FLAIR changes and studied penumbral FLAIR changes as predictor of tissue fate and functional outcome on the 90 days modified Rankin Scale (mRS). Recanalization status did not modify the evolution of rFLAIR signal intensity (SI) over time in the total cohort, but was associated with lower SI in the FRAME subset (b=-0.06, p for interaction=0.04). Median rFLAIR SI was higher at baseline in the subsequently infarcted penumbra compared to the salvaged (ratio=1.07, standard deviation [SD] 0.07 vs 1.03, SD 0.06 p<0.0001, n=150). The severity and extent of rFLAIR SI changes did not predict 90 day functional outcome in univariate (p=0.09) and multivariate logistic regression (p=0.4). Recanalization status did not influence the evolution of penumbral FLAIR changes. FLAIR SI changes in the baseline penumbra were associated with tissue fate, but not functional outcome. The data supporting the study are available upon reasonable request; following a signed data access agreement.

Spontaneous regression of Rathke's cleft cysts with conservative management: patient series.

Rathke's cleft cysts (RCCs) are benign fluid-filled cysts that develop in the pituitary gland because of the abnormal embryological development of Rathke's pouch. Most RCCs are small and asymptomatic; however, they can present with symptoms or documented growth, sometimes prompting surgical treatment. For smaller asymptomatic lesions, an unknown proportion demonstrates regression over time. This study describes 3 cases of spontaneous RCC regression. Three patients with a diagnosis of RCC demonstrated an average decrease of 78% in cyst volume over a mean interval of 3.7 months. One patient experienced the resolution of chronic headaches, whereas the other 2 patients had persistent headaches and endocrinopathies at follow-up. A systematic review included 9 studies that reported results from observational cohorts of patients with RCC, totaling 619 observed patients, with 158 (25.5%) patients demonstrating spontaneous cyst regression. In the patients with cyst regression, the majority had a resolution of symptoms. A substantial proportion of RCC patients managed nonsurgically demonstrated spontaneous regression. There is a role for the conservative management of RCCs in patients without significant symptoms, and surveillance should continue for a minimum of 5 years to confirm cyst stability. For patients undergoing planned surgery, same-day or recent imaging is recommended to prevent operating on involuted RCCs. https://thejns.org/doi/10.3171/CASE24268.

Effect of laparoscopic gastric sleeve vs. laparoscopic gastric bypass in Roux-Y on long-term weight loss in obese mexican population.

Compare the weight loss results between long-term procedures up to 5 years, after undergoing MGL and RYGB in Mexican patients with obesity and associated comorbidity. The most common bariatric surgical procedures worldwide are, laparoscopic gastric sleeve (MGL) and laparoscopic Roux-en-Y gastric bypass (RYGB), as a treatment for weight loss and remission of comorbidity associated with obesity; however, they are the long-term weight loss results in the Mexican population are unknown. Retrospective, observational cohort of patients with obesity undergoing MGL or RYGB in a private hospital Medica Sur, in Mexico City, in the period from 2013 to 2021. Instrumental variables analysis and standardized mean differences were used to calculate outcomes up to 5 years at 5 follow-up visits (S1-S5), at 7 days, 2 months, 6 months, 10 months and 2-5 years after surgery, to compare results of the groups. 104 patients were included in two groups: 31 (30.09%) with MG and 73 (70.87%) with RYGB. The last follow-up (S5), the MG group recorded a mean EW 9.61 kg, EW% 12.72% and EWL% 73.50%, and the RYGB group EW 10.1 kg, EW% 14.72% and EWL% 70.41%. No significant difference was found between groups for long-term EW loss (p = 0.082); however, there is a greater decrease in weight loss in RYGB at 6-12 months compared to MGL.

Temporal trajectory and left ventricular ejection fraction association of eight circulating biomarkers in first acute myocardial infarction patients: a 12-month prospective cohort study.

Our study aimed to explore the temporal trajectory of eight circulating biomarkers, measured serially over 12 months, in a prospective observational cohort of patients with acute myocardial infarction (AMI) and to investigate the association between these biomarkers and left ventricular ejection fraction (LVEF) during follow-up assessments. We enrolled 155 patients admitted for a first AMI requiring percutaneous coronary intervention (PCI). Baseline characteristics, laboratory test results, and cardiac ultrasound examinations were collected at pre-PCI (H0), immediately post-PCI (H24), at discharge (D3), and at 6 months (M6) and 12 months (M12) post-PCI. Blood samples were analysed for established and emerging biomarkers described in left ventricular dysfunction: soluble suppression of tumorigenicity 2 (sST2), interleukin-6 (IL-6), osteopontin, angiopoietin-2, insulin-like growth factor-binding protein 2 (IGFBP-2), growth differentiation factor 15 (GDF-15), hepcidin, and galectin-3. Values at H24, D3, M6, and M12 were compared with value at H0. Three kinetic profiles were identified, with six biomarkers peaking during the acute MI phase. Crude relationships between clinical variables and the peak values (highest observed between H0 and D3) of each biomarker were studied. Peak levels of sST2, IL-6, osteopontin, and angiopoietin-2 demonstrated significant correlations with both baseline and follow-up LVEF values. The assessment of the temporal trajectories of these biomarkers and their associations with LVEF suggests that sST2, IL-6, osteopontin, and angiopoietin-2 hold significant promise as companion biomarkers. These biomarkers may improve the identification of patients at risk for developing impaired LVEF following AMI, thereby enabling more targeted and effective management strategies.

An observational cohort of patients with colorectal peritoneal metastases or pseudomyxoma peritonei treated with CRS-HIPEC: Development and first results of the Dutch CRS-HIPEC quality registry

IntroductionTo improve care for patients with colorectal peritoneal metastases (CRC-PM) or pseudomyxoma peritonei (PMP), the Dutch CRS-HIPEC quality registry was initiated in 2019. The aims are to describe the development and content of this registry and to give insight into the data collected during the first years. Materials and methodsThe registry is an observational cohort in the Netherlands. All patients with CRC-PM or PMP who intend to undergo cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) from 6 hospitals are included. Clinical data and outcomes (including hospital variation) were analyzed. ResultsIn 2019–2022, 889 patients were included in the CRS-HIPEC quality registry: 749 (84 %) with CRC-PM and 140 (16 %) with PMP. Peritoneal metastases were diagnosed synchronously in 51 % of CRC-PM patients and in 94 % of PMP patients. In patients undergoing complete CRS, the median peritoneal cancer index was 8 (IQR 4–13) for CRC-PM and 15 (IQR 6–26) for PMP. Complete cytoreduction was achieved in 639 CRC-PM patients (97 %) and 108 PMP patients (82 %). HIPEC was mainly performed with mitomycin C (CRC-PM: 94 %, PMP: 92 %). Major postoperative complications (Clavien-Dindo grade ≥3) occurred in 148 CRC-PM patients (22 %) and 30 PMP patients (23 %) with 90-day mortality rates of 2 %. In CRC-PM, differences between hospitals were observed regarding proportions of diagnostic laparoscopies/laparotomies, (neo)adjuvant treatment, ostomy formations and re-admissions. ConclusionThe CRS-HIPEC quality registry provides insight into the outcomes of CRS-HIPEC and enables clinical auditing and observational cohort studies aiming to improve treatment outcomes for patients with CRC-PM and PMP.

RIPK3 causes mitochondrial dysfunction and albuminuria in diabetic podocytopathy through PGAM5-Drp1 signaling

BackgroundReceptor-interacting protein kinase (RIPK)3 is an essential molecule for necroptosis and its role in kidney fibrosis has been investigated using various kidney injury models. However, the relevance and the underlying mechanisms of RIPK3 to podocyte injury in albuminuric diabetic kidney disease (DKD) remain unclear. Here, we investigated the role of RIPK3 in glomerular injury of DKD. MethodsWe analyzed RIPK3 expression levels in the kidneys of patients with biopsy-proven DKD and animal models of DKD. Additionally, to confirm the clinical significance of circulating RIPK3, RIPK3 was measured by ELISA in plasma obtained from a prospective observational cohort of patients with type 2 diabetes, and estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR), which are indicators of renal function, were followed up during the observation period. To investigate the role of RIPK3 in glomerular damage in DKD, we induced a DKD model using a high-fat diet in Ripk3 knockout and wild-type mice. To assess whether mitochondrial dysfunction and albuminuria in DKD take a Ripk3-dependent pathway, we used single-cell RNA sequencing of kidney cortex and immortalized podocytes treated with high glucose or overexpressing RIPK3. ResultsRIPK3 expression was increased in podocytes of diabetic glomeruli with increased albuminuria and decreased podocyte numbers. Plasma RIPK3 levels were significantly elevated in albuminuric diabetic patients than in non-diabetic controls (p = 0.002) and non-albuminuric diabetic patients (p = 0.046). The participants in the highest tertile of plasma RIPK3 had a higher incidence of renal progression (hazard ratio [HR] 2.29 [1.05–4.98]) and incident chronic kidney disease (HR 4.08 [1.10–15.13]). Ripk3 knockout improved albuminuria, podocyte loss, and renal ultrastructure in DKD mice. Increased mitochondrial fragmentation, upregulated mitochondrial fission-related proteins such as phosphoglycerate mutase family member 5 (PGAM5) and dynamin-related protein 1 (Drp1), and mitochondrial ROS were decreased in podocytes of Ripk3 knockout DKD mice. In cultured podocytes, RIPK3 inhibition attenuated mitochondrial fission and mitochondrial dysfunction by decreasing p-mixed lineage kinase domain-like protein (MLKL), PGAM5, and p-Drp1 S616 and mitochondrial translocation of Drp1. ConclusionsThe study demonstrates that RIPK3 reflects deterioration of renal function of DKD. In addition, RIPK3 induces diabetic podocytopathy by regulating mitochondrial fission via PGAM5-Drp1 signaling through MLKL. Inhibition of RIPK3 might be a promising therapeutic option for treating DKD.

Extracranial Complications in Monitored and Nonmonitored Patients with Traumatic Brain Injury in the BEST TRIP Trial and a Companion Observational Cohort

Extracranial complications occur commonly in patients with traumatic brain injury (TBI) and can have implications for patient outcome. Patient-specific risk factors for developing these complications are not well studied, particularly in low and middle-income countries (LMIC). The study objective was to determine patient-specific risk factors for development of extracranial complications in TBI. We assessed the relationship between patient demographic and injury factors and incidence of extracranial complications using data collected September 2008-October 2011 from the BEST TRIP trial, a randomized controlled trial assessing TBI management protocolized on intracranial pressure (ICP) monitoring versus imaging and clinical exam, and a companion observational patient cohort. Extracranial infections (55%), respiratory complications (19%), hyponatremia (27%), hypernatremia (27%), hospital acquired pressure ulcers (6%), coagulopathy (9%), cardiac arrest (10%), and shock (5%) occurred at a rate of ≥5% in our study population; overall combined rate of these complications was 82.3%. Tracheostomy in the intensive care unit (P < 0.001), tracheostomy timing (P= 0.025), mannitol and hypertonic saline doses (P < 0.001), brain-specific therapy days and brain-specific therapy intensity (P < 0.001), extracranial surgery (P < 0.001), and neuroworsening with pupil asymmetry (P= 0.038) were all significantly related to the development of one of these complications by univariable analysis. Multivariable analysis revealed ICP monitor use and brain-specific therapy intensity to be the most common factors associated with individual complications. Extracranial complications are common following TBI. ICP monitoring and treatment are related to extra-cranial complications. This supports the need for reassessing the risk-benefit balance of our current management approaches in the interest of improving outcome.

Biological use influences the impact of inflammation on risk of major adverse cardiovascular events in rheumatoid arthritis

ObjectivesChronic inflammation promotes cardiovascular risk in rheumatoid arthritis (RA). Biological disease-modifying antirheumatic drugs (bDMARDs) improve disease activity and cardiovascular disease outcomes. We explored whether bDMARDs influence the impact of disease...

CLEAR Thrombectomy Score: An Index to Estimate the Probability of Good Functional Outcome With or Without Endovascular Treatment in the Late Window for Anterior Circulation Occlusion.

With the expanding eligibility for endovascular therapy (EVT) of patients presenting in the late window (6-24 hours after last known well), we aimed to derive a score to predict favorable outcomes associated with EVT versus best medical management. A multinational observational cohort of patients from the CLEAR (Computed Tomography for Late Endovascular Reperfusion) study with proximal intracranial occlusion (2014-2022) was queried (n=58 sites). Logistic regression analyses were used to derive a 9-point score for predicting good functional outcome (modified Rankin Scale score 0-2 or return to premorbid modified Rankin Scale score) at 90 days, with sensitivity analyses for prespecified subgroups conducted using bootstrapped random forest regressions. Secondary outcomes included 90-day functional independence (modified Rankin Scale score 0-2), poor outcome (modified Rankin Scale score 5-6), and 90-day survival. The score was externally validated with a single-center cohort (2014-2023). Of the 3231 included patients (n=2499 EVT), a 9-point score included age, early computed tomography ischemic changes, and stroke severity, with higher points indicating a higher probability of a good functional outcome. The areas under the curve for the primary outcome among EVT and best medical management subgroups were 0.72 (95% CI, 0.70-0.74) and 0.87 (95% CI, 0.84-0.90), respectively, with similar performance in the external validation cohort (area under the curve, 0.71 [95% CI, 0.66-0.76]). There was a significant interaction between the score and EVT for good functional outcome, functional independence, and poor outcome (all Pinteraction<0.001), with greater benefit favoring patients with lower and midrange scores. This score is a pragmatic tool that can estimate the probability of a good outcome with EVT in the late window. URL: https://www.Clinicaltrials.gov; Unique identifier: NCT04096248.

Development and validation of a machine learning-based model for post-sepsis frailty.

The development of post-sepsis frailty is a common and significant problem, but it is a challenge to predict. Data for deep learning were extracted from a national multicentre prospective observational cohort of patients with sepsis in Korea between September 2019 and December 2021. The primary outcome was frailty at survival discharge, defined as a clinical frailty score on the Clinical Frailty Scale ≥5. We developed a deep learning model for predicting frailty after sepsis by 10 variables routinely collected at the recognition of sepsis. With cross-validation, we trained and tuned six machine learning models, including four conventional and two neural network models. Moreover, we computed the importance of each predictor variable in the model. We measured the performance of these models using a temporal validation data set. A total of 8518 patients were included in the analysis; 5463 (64.1%) were frail, and 3055 (35.9%) were non-frail at discharge. The Extreme Gradient Boosting (XGB) achieved the highest area under the receiver operating characteristic curve (AUC) (0.8175) and accuracy (0.7414). To confirm the generalisation performance of artificial intelligence in predicting frailty at discharge, we conducted external validation with the COVID-19 data set. The XGB still showed a good performance with an AUC of 0.7668. The machine learning model could predict frailty despite the disparity in data distribution. The machine learning-based model developed for predicting frailty after sepsis achieved high performance with limited baseline clinical parameters.

Patients with stage IV colorectal carcinoma selected for palliative primary tumor resection and systemic therapy survive longer compared with systemic therapy alone - A retrospective comparative cohort study.

To compare the survival of palliative stage IV colorectal cancer patients selected for primary tumor resection and systemic treatment (PTR+SYST) to patients with systemic treatment only (SYST). About 20-25% of all colorectal cancer patients are diagnosed with stage IV disease. The benefit of primary tumor resection in the palliative situation is therefore of high concern. However, empirical evidence from randomized and observational studies is inconsistent. Mortality after PTR and systemic treatment was compared to systemic treatment alone in a retrospective observational cohort of patients diagnosed 2012-2020 from the cancer registry in the federal state of Brandenburg (Germany), excluding patients with rectal cancer of the lower two-thirds, emergency procedures, unknown ECOG status, ECOG >2, unknown metastatic status or unclear grading. Of 480 patients, 416 died during an average follow-up of 23 months in mean. 12-months survival was 75% after PTR+SYST compared with 49% after SYST (HR=0.39, 95% CI 0.29-0.53, P<0.001). The difference persisted to 36 months (28% vs. 13%, HR=0.53, 95% CI 0.43-0.66, P<0.001). Results were similar after multivariate adjustment, propensity score matching and delayed entry. Patients with stage IV colorectal carcinoma who are selected for primary tumor resection in combination with systemic therapy and who receive such treatment survive longer compared with patients who receive only systemic treatment. Whether the difference is due to selection of patients or PTR remains unclear. At present, current practice of selecting patients for PTR appears to do no harm.

Transcriptomic responses of peripheral blood leukocytes to cardiac surgery after acute inflammation, and three months recovery

Traumatic perioperative conditions may trigger early systemic responses, activate leukocytes and reprogram the immune system. We hypothesize that leukocyte activation may not revert to pre-surgical states, and that protracted activation may emerge with increased risks of comorbidities. We tested this concept by examining the transcriptomes of monocytes and T cells in a representative observational cohort of patients (n = 13) admitted for elective cardiac surgery. Transcriptomes in T cells and monocytes were compared from before surgery (t0), and monocytes were analyzed longitudinally after acute (t24hr), and convalescent (t3m) time points. Monocytes and T cells expressed distinct transcriptomes, reflected by statistically significant differential expression of 558 T cell related genes. Monocytes expressed genes related to protein degradation and presented atypical activation of surface markers and cytoplasmic functions over time. Additionally, monocytes exhibited limited transcriptomic heterogeneity prior to surgery, and long-term patterns of gene expression associated with atherosclerosis showed three temporally distinct signatures. These data establish that post-cardiac surgery transcriptomes of monocytes differ even at three months compared to baselines, which may reflect latent (‘smoldering’) inflammation and persistent progression of tissue degenerative processes that should inform clinical care.

5-year multicenter analysis of clinical trial participation and total cost of care for older adults with cancer.

11013 Background: Clinical trial access particularly for older adults aged 65 years and above with cancer is impacted by multilevel barriers, including cost concerns to payers in the usual models of cancer care delivery. Alternative models recently studied include the Centers for Medicare and Medicaid Innovation’s Oncology Care Model (OCM), a value-based care pilot to enhance quality &amp; reduce costs. Here, we investigated the association between clinical trial participation (CTP) and the total cost of care (TCOC) within this non-traditional model. Methods: We identified prospective longitudinal observational cohort of patients cared for in 11 states within 323 clinics in 14 multi-site community practices participating in OCM, in The US Oncology Network and extracted data (episode claims, medical records, episodes) from OCM performance periods (PP) 3-11 between 7/1/17 and 6/30/22. Propensity score matching by PP, age, gender, date of death, cancer type identified the analysis cohort of matched episodes, then stratified by trial participation (CTP vs usual care) to compare TCOC and drug expenditures. Results: Over 5 years, 121,717 unique patients (94% of whom were aged 65y+) received 282,604 episodes of cancer care in the community, most common cancers being breast, lung, multiple myeloma. Propensity score matching identified 13,260 matched episodes (6630 usual care, 6630 CTP). The actual expenditure differed by $2,341 per episode between CTP &amp; usual care (CTP $43,890 vs usual care $41,548; p &lt; 0.0001), while trial participation had significant savings against the OCM CTP benchmark ($4816 saved per CTP episode), compared to usual care vs its benchmark ($826 saved per usual care episode, p &lt; 0.0001). Drug costs per episode did not differ between the two groups (CTP $29,516 vs usual care $30,553; p 0.54). Further breakdown shows that drug spending on anticancer agents (CTP $28,008 vs usual care $29,139) and other drugs including supportive care meds (CTP $1,511 vs usual care $1,414) did not differ significantly. Conclusions: Clinical trial participation saw relative cost savings against the benchmark compared to usual care, owing largely to the higher benchmark prices for CTP episodes in OCM’s risk-adjusted price prediction model, rather than an absolute cost savings to payers. Drug expenditures remain the largest contributor to total cost of care in this alternative model. The contributors to both drug expenditures as well as the absence of absolute cost savings between the two cohorts represent key areas for further investigation. CMMI Disclaimer: The statements contained in this document are solely those of the authors and do not necessarily reflect the views or policies of CMS. The authors assume responsibility for the accuracy and completeness of the information contained in this document.

Patient-Reported Outcomes Following Periprosthetic Joint Infection of the Hip and Knee: A Longitudinal, Prospective Observational Study.

The role of patient-reported outcome measures (PROMs) as tools for monitoring the impact and outcomes of periprosthetic joint infection (PJI) is not well described. This study analyzed the Oxford Hip Score (OHS) or Oxford Knee Score (OKS) in a prospective observational cohort of patients with hip or knee PJI. The PIANO (Prosthetic joint Infection in Australia and New Zealand, Observational study) cohort prospectively enrolled patients with newly diagnosed PJI from multiple centers. The OHS and OKS were evaluated at PJI diagnosis (baseline) and at 3, 12, and 24 months. Scores and score changes were examined according to PJI type, patient characteristics, and management. A successful functional outcome at 12 months was defined as an OHS of >38 or OHS of >36 and/or an improvement from baseline of >12 or >9, respectively. Of the 741 participants, PROMs were available at 12 months for 233 with hip and 342 with knee PJI. Significant improvements (p < 0.0001) were seen at 12 months for both the OHS (24.5 to 36) and OKS (25 to 34), with no further improvement at 24 months. Patients with late-acute PJI had a higher median baseline OHS (35; interquartile range [22 to 46]) and OKS (30 [18 to 41]) than those with early PJI (OHS: 19 [15 to 29]; OKS: 22 [16 to 29.5]) or chronic PJI (OHS: 23 [14 to 34]; OKS 22 [14 to 28]). Logistic regression showed that a clinical cure (adjusted odds ratio [aOR] = 1.88, 95% confidence interval [CI] = 1.28 to 2.76, p = 0.001) and early PJI (aOR = 2.56, 95% CI = 1.64 to 4.07, p < 0.0001) independently predicted a successful functional outcome. Chronic renal impairment (aOR = 0.31, 95% CI = 0.13 to 0.71, p = 0.007), congestive cardiac failure (aOR = 0.41, 95% CI = 0.17 to 0.95, p = 0.04), and clinical signs of inflammation (aOR = 0.53, 95% CI = 0.33 to 0.85, p = 0.009) at diagnosis independently predicted failure to achieve a successful functional outcome. The OHS and OKS varied significantly at baseline and 12 months according to PJI type, emphasizing the need to consider the PJI type when evaluating treatment success. This study highlights superior functional outcomes associated with early PJI and with achievement of a clinical cure. Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence.

Response- and Progression-Based End Points in Trial and Observational Cohorts of Patients With NSCLC

Response Evaluation Criteria in Solid Tumors (RECIST) are commonly used to assess therapeutic response in clinical trials but not in routine care; thus, RECIST-based end points are difficult to include in observational studies. Clinician-anchored approaches for measuring clinical response have been validated but not widely compared with clinical trial data, limiting their use as evidence for clinical decision-making. To compare response- and progression-based end points in clinical trial and observational cohorts of patients with non-small cell lung cancer (NSCLC). This retrospective cohort study used patient-level data from the IMpower132 trial (conducted April 7, 2016, to May 31, 2017) and a nationwide electronic health record (EHR)-derived deidentified database (data collected January 1, 2011, to March 31, 2022). Patients in the observational cohort were selected according to the inclusion and exclusion criteria of the IMpower132 trial. All patients in the observational cohort had stage IV NSCLC. All patients were randomized to or received first-line carboplatin or cisplatin plus pemetrexed. End points included response rates, duration of response, and progression-free survival, compared between the trial and observational cohorts before and after weighting. Response rates for the observational cohort were derived from the EHR. A total of 769 patients met inclusion criteria, 494 in the observational cohort (median [IQR] age, 67 [60-74] years; 228 [46.2%] female; 45 [9.1%] Black or African American; 352 [71.3%] White; 53 [10.7%] American Indian or Alaska Native, Asian, Hawaiian or Pacific Islander, or multiracial) and 275 in the trial cohort (median [IQR] age, 63 [56-68] years; 90 [32.7%] female; 4 [1.5%] Black or African American; 194 [70.5%] White; 65 [23.6%] American Indian or Alaska Native, Asian, Hawaiian or Pacific Islander, or multiracial). All 3 end points were comparable between the study cohorts. Trial patients had a higher number of response assessments compared with patients in the weighted observational cohort. The EHR-derived response rate was numerically higher than the objective response rate after weighting (100.3 of 249.3 [40.2%] vs 105 of 275 [38.2%]) due to higher rates of observed partial response than RECIST-based partial response. Among patients with at least 1 response assessment, the EHR-derived response rate remained higher than the objective response rate (100.3 of 193.4 [51.9%] vs 105 of 256 [41.0%]) due to a higher proportion of patients in the observational cohort with no response assessment. In this study, response- and progression-based end points were similar between clinical trial and weighted observational cohorts, which increases confidence in the reliability of observational end points and can inform their interpretation in relation to trial end points. Additionally, the difference observed in response rates (including vs excluding patients with no response assessment) highlights the importance of future research adopting this 2-way approach when evaluating the relationship of EHR-derived and objective response rates.

Low incidence of invasive fungal infection and risk factors in a large observational cohort of patients initiating tumor necrosis factor-alpha inhibitors for dermatologic conditions

Low incidence of invasive fungal infection and risk factors in a large observational cohort of patients initiating tumor necrosis factor-alpha inhibitors for dermatologic conditions

P158 Cutaneous vasculitis in systemic lupus erythematosus: trends of incidence and risk factors

Abstract Background/Aims Cutaneous vasculitis (CV) is the most common form of vasculitis observed in patients with SLE; however, the precise epidemiological trends and underlying risk factors remain uncertain. The aim of this study was to define the incidence, prevalence, and risk factors of CV in systemic lupus erythematosus (SLE) patients over a period of 20 years. Methods The Birmingham Lupus Cohort is a longitudinal observational cohort of patients with SLE. All patients fulfilled the 1997 ACR Updated Classification Criteria for SLE. Inception patients were recruited within three years of their fourth ACR criterion. Disease activity was assessed using the classic BILAG index and laboratory results recorded. The BILAG vascular domain was used to determine the incidence rate, which refers to the rate at which new cases of minor and major CV attributed to active SLE occur. Cox proportional hazards frailty models were developed to identify clinical and laboratory variables associated with development of CV. Results We analysed 392 patients, of whom 375 (92.5%) were females. There were 213 (55.0%) White, 72 (18.6%) African-Caribbean, 82 (21.1%) South Asian, 9 (2.3%) East Asian, and 11 (2.8%) other ethnicities. The median (IQR) age at enrolment was 33 (26 - 44) years and the median duration of follow up was 9.2 (5.1 - 14.7) years. The incidence rates of minor and major CV were reported in Table 1. In Cox proportional hazards models, there was a positive association between CV and discoid rash (hazard ratio [HR] 2.16 [95% CI: 1.01, 4.61]), Raynaud’s phenomenon (HR 5.67 [95% CI: 4.11, 7.81]), livedo reticularis (HR = 4.69 [95% CI: 1.83, 12.0]), arthritis (HR 3.02 [95% CI: 2.20, 4.15]), renal involvement (OR 2.40 [95% CI: 1.55, 3.71]), haematological involvement (HR = 2.46 [95% CI: 1.80, 3.36]), and Afro-Caribbean descent (HR 1.96 [95% CI: 1.03, 3.74]). In addition, CV was positively associated with anti-dsDNA (HR = 2.33 [95% CI: 1.67, 3.27]), low C3 or C4 (HR 2.29 [95% CI: 2.18, 4.10]), and history of anti-Ro or anti-La (HR = 1.92 [95% CI: 1.15, 3.21]). Conclusion The incidence rates of CV decrease over the duration of follow-up and are associated with defined clinical and serological features. Disclosure A. Saleh: Grants/research support; A.S. is a sponsored PhD student by the Egyptian ministry of higher education represented by The Egyptian Bureau for Cultural &amp; Educational Affairs in London. C. Gordon: None. J. Reynolds: None.

Implementation of Opioid Safety Efforts: Influence of Academic Detailing on Adverse Outcomes Among Patients in the Veterans Health Administration.

The Veterans Health Administration (VA) implemented academic detailing (AD) to support safer opioid prescribing and overdose prevention initiatives. Patient-level data were extracted monthly from VA's electronic health record to evaluate whether AD implementation was associated with changes in all-cause mortality, opioid poisoning inpatient admissions, and opioid poisoning emergency department (ED) visits in an observational cohort of patients with long-term opioid prescriptions (≥45-day supply of opioids 6 months prior to a given month with ≤15 days between prescriptions). A single-group interrupted time series analysis using segmented logistic regression for mortality and Poisson regression for counts of inpatient admissions and ED visits was used to identify whether the level and slope of these outcomes changed in response to AD implementation. Among 955 376 unique patients (19 431 241 person-months), there were 53 369 deaths (29 025 pre-AD; 24 344 post-AD), 1927 opioid poisoning inpatient admissions (610 pre-AD; 1317 post-AD), and 408 opioid poisoning ED visits (207 pre-AD; 201 post-AD). Immediately after AD implementation, there was a 5.8% reduction in the odds of all-cause mortality (95% confidence interval [CI]: 0.897, 0.990). However, patients had a significantly increased incidence rate of inpatient admissions for opioid poisoning immediately after AD implementation (incidence rate ratio = 1.523; 95% CI: 1.118, 2.077). No significant differences in ED visits for opioid poisoning were observed. AD was associated with decreased all-cause mortality but increased inpatient hospitalization for opioid poisoning among patients prescribed long-term opioids. Mechanisms via which AD's efforts influenced opioid-related outcomes should be explored.

Preoperative expectations of patients with degenerative cervical myelopathy: an observational study from the Canadian Spine Outcomes and Research Network

BACKGROUNDDespite an abundance of literature on degenerative cervical myelopathy (DCM), little is known about preoperative expectations of these patients. PURPOSEThe primary objective was to describe patient preoperative expectations. Secondary objectives included identifying patient characteristics associated with high preoperative expectations and to determine if expectations varied depending on myelopathy severity. STUDY DESIGNThis was a retrospective study of a prospective multicenter, observational cohort of patients with DCM. PATIENT SAMPLEPatients who consented to undergo surgical treatment between January 2019 and September 2022 were included. OUTCOMES MEASURESAn 11-domain expectation questionnaire was completed preoperatively whereby patients quantified the expected change in each domain. METHODSThe most important expected change was captured. A standardized expectation score was calculated as the sum of each expectation divided by the maximal possible score. The high expectation group was defined by patients who had an expectation score above the 75th percentile. Predictors of patients with high expectations were determined using multivariable logistic regression models. RESULTSThere were 262 patients included. The most important patient expectation was preventing neurological worsening (40.8%) followed by improving balance when standing or walking (14.5%), improving independence in everyday activities (10.3%), and relieving arm tingling, burning and numbness (10%). Patients with mild myelopathy were more likely to select no worsening as the most important expected change compared to patients with severe myelopathy (p<.01). Predictors of high patient expectations were: having fewer comorbidities (OR -0.30 for every added comorbidity, 95% CI -0.59 to -0.10, p=.01), a shorter duration of symptoms (OR 0.92, 95% CI 0.35–1.19, p=.02), no contribution from “failure of other treatments” on the decision to undergo surgery (OR 1.49, 95% CI 0.56–2.71, p=.02) and more severe neck pain (OR 0.19 for 1 point increase, 95% CI 0.05–0.37, p=.01). CONCLUSIONSMost patients undergoing surgery for DCM expect prevention of neurological decline, better functional status, and improvement in their myelopathic symptoms. Stopping neurological deterioration is the most important expected outcomes by patients.

Low incidence of invasive fungal infections in a large observational cohort of patients initiating IL-17 or IL-23 inhibitor therapy, United States, 2016-2022

Low incidence of invasive fungal infections in a large observational cohort of patients initiating IL-17 or IL-23 inhibitor therapy, United States, 2016-2022