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Underlying Tremor Improvement with Consistent Use of Transcutaneous Afferent Patterned Stimulation in Patients with Essential Tremor.
No full textBACKGROUND: Transcutaneous afferent patterned stimulation (TAPS) is a non-invasive, wrist-worn neurostimulation therapy that has demonstrated acute and short-term lasting tremor reduction in patients with essential tremor (ET). However, the longer-term improvement in underlying tremor severity from consistent use of TAPS has not been fully explored.
METHODS: We conducted a retrospective analysis of the multicenter PROSPECT trial, which evaluated twice-daily TAPS use over three months in patients with ET. Underlying tremor improvement was assessed by comparing pre-stimulation tremor severity at baseline with pre-stimulation tremor severity at 1- and 3-month follow-up visits. Tremor severity was measured using the Bain & Findley Activities of Daily Living (BF-ADL) scale and the Tremor Research Group\u27s Essential Tremor Rating Assessment Scale (TETRAS). Responders were defined as patients demonstrating at least a 1-point improvement on any qualifying task.
RESULTS: Among 192 patients with available data, pre-stimulation BF-ADL scores improved significantly by 2.0 points at 1 month and 2.7 points at 3 months compared with baseline (p \u3c 0.001). Pre-stimulation TETRAS scores also showed significant improvements at both time points (p \u3c 0.001). Measurements at 1 and 3 months were made an average of 16.2 hours after the prior stimulation session. Over 80% of patients met responder criteria for underlying tremor improvement on BF-ADL and TETRAS at both follow-up visits. Improvements were observed even among patients using TAPS approximately once daily.
CONCLUSIONS: Consistent use of TAPS was associated with significant improvement in underlying tremor severity in patients with essential tremor. These findings suggest that regular TAPS use may confer sustained therapeutic benefit
Validation of a Serum-Based Biomarker Signature for Detection of Early-Stage Pancreatic Ductal Adenocarcinoma.
No full textBackground & aims: This study\u27s goal was to clinically validate the performance of PancreaSure (Immunovia, Inc), a serum biomarker signature composed of tissue inhibitor of metalloproteinase 1, intercellular adhesion molecule 1, cathepsin D, thrombospondin 1, and carbohydrate antigen 19-9 for detection of early-stage pancreatic ductal adenocarcinoma (PDAC) in an independent cohort.
Methods: Signature analytes were retrospectively measured in serum samples from a blinded cohort of stage I and stage II PDAC cases and genetic and/or familial high-risk controls. A predictive signal for PDAC was generated from a predefined cutoff established in a previous model development study optimized at 98% specificity. Diagnostic sensitivity and specificity were evaluated on the full cohort. McNemar or 2-proportion z tests were used to compare test performance between stage I and stage II cases, and between controls with and without a germline mutation and/or familial susceptibility to PDAC. Diagnostic certainty of test results was evaluated using a Monte Carlo simulation.
Results: PancreaSure distinguished early-stage PDAC (n = 202) from high-risk controls (n = 864) with 78.5% sensitivity (95% CI, 72.5%-83.9%) and 93.5% specificity (95% CI, 91.9%-95.2%), significantly outperforming carbohydrate antigen 19-9 alone (P \u3c .001). The test performed consistently between stage I and II PDAC and between controls with and without genetic or familial susceptibility. In addition, 93.7% of all samples were classified as PDAC-positive or PDAC-negative with 100% certainty. Only 1.8% of all samples were classified with \u3c 80% certainty.
Conclusions: These findings indicate that PancreaSure is a high-performing biomarker test to aid in the detection of early-stage PDAC. Overall, this work represents an important step toward improving early-stage diagnostic success
When are Short Fusions Successful in Cervical Deformity Surgery?
No full textStudy design: Retrospective review of a prospective cervical deformity (CD) database.
Objective: Determining when shorter fusions can be successful in CD surgery to reduce the extent of the surgical procedure while mitigating complications.
Summary of background data: Multicenter outcomes database of CD patients.
Methods: CD patients were stratified as short fusions (SF: ≤4 levels fused, cervical LIV) or long fusions (LF: \u3e4 levels fused, LIV caudal to C7). Groups were compared in terms of demographics, baseline and 1-year alignment, patient-reported outcome measures (PROMs), and surgical parameters. The data were then reanalyzed after controlling for baseline cervical Sagittal Vertical Axis (cSVA) using propensity score matching. Decision trees were used to identify baseline factors associated with postop alignment failure (1-year cSVA\u3e4 mm or C2S\u3e20°) among SF patients.
Results: 127 patients were analyzed with 100 LF and 27 SF patients. SF had significantly less EBL (131 vs. 1001 mL) and shorter operative time (223min vs. 435 min). At baseline, LF had worse cervical alignment (cSVA=42.6 vs. 23.0 mm) and were more disabled by Neck Disability Index (NDI, 50 vs. 38). After matching by cSVA, the mean baseline cSVA decreased from 42.6 mm to 27.6 mm in the LF group and increased from 23.0 mm to 27.2 mm in the SF group. 71% (n=15) of SF achieved the MCID for NDI vs. 52% (n=11) of LF pts. SF patients with a BL C2S\u3e26° (n=13) were 12.4 times as likely as SF patients with C2S≤26° (n=13) to have post-operative alignment failure (85% vs. 31%, P\u3c .01) and 5.1 times as likely to have a post-operative complication (69% vs. 31%, P\u3c .05).
Conclusions: Although short fusions can result in excellent outcomes with less extensive surgeries, those with more severe deformities may require longer fusions. SF should be avoided in patients with a BL C2S\u3e26° due to the increased risk of complications and realignment failure
The Impact of Atherectomy in Severely Calcified Lesions in Impella-Supported High-Risk Percutaneous Coronary Intervention.
No full textSevere coronary artery calcification (CAC) complicates high-risk percutaneous coronary intervention (HRPCI), particularly in patients with impaired left ventricular function. Atherectomy may facilitate lesion preparation, but its use in high-risk settings is limited. We therefore aimed to assess the impact of CAC severity and atherectomy on outcomes in Impella-supported HRPCI. In the PROTECT III study (NCT04136392), 1,015 of 1,237 patients had data on CAC severity and atherectomy. Patients were grouped as severe CAC without atherectomy (n = 298), severe CAC with atherectomy (n = 326), and no severe CAC (n = 400). The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE: all-cause death, myocardial infarction, stroke/TIA, or repeat revascularization) at 30- and 90-days. Secondary endpoints included 1-year mortality, PCI-related complications, and hemodynamic instability. Patients with severe CAC had higher baseline SYNTAX scores and more left main disease. Atherectomy was associated with slightly longer procedural times, but not increased periprocedural complications or hemodynamic instability. At 90 days, MACCE was highest in the untreated severe CAC group (16.1% vs 12.6% vs 9.2%; overall log-rank p = 0.048). One-year mortality was also highest in this group (23.7%; p = 0.02). However, CAC severity and atherectomy use were not independent predictors of outcomes. Sensitivity analysis excluding patients with atherectomy but no severe CAC showed higher mortality risk in untreated severe CAC cases (adjHR: 0.59; overall p = 0.026). In conclusion, Severe CAC is common in patients undergoing Impella-supported HRPCI and is associated with worse outcomes. Atherectomy was safe but its benefit remains uncertain. These findings highlight the prognostic relevance of CAC and the potential role of calcium modification in HRPCI
Male or female sex stratified by age does not impact survival in patients with metastatic melanoma receiving immunotherapy.
No full textBACKGROUND: Increasing age and male sex are associated with worse prognosis in melanoma. Here, we evaluated outcomes in stage IV melanoma patients who received immunotherapy, stratified by sex and age.
METHODS: The National Cancer Database (NCDB) was queried to identify patients with stage IV melanoma (n = 20023) with or without first-course immunotherapy from 2012 to 2019.
RESULTS: 67.7 % of patients were male, and 44.2 % received immunotherapy. On multivariable analysis, when compared to males, female patients had improved survival without immunotherapy (HR 0.90, p \u3c 0.001), but survival was equivalent with immunotherapy (HR 0.95, p = 0.106). The benefit of immunotherapy was smaller in females compared to males overall (HR 1.08, p = 0.039), and greater in patients aged 45-60 years (HR 0.82, p = 0.006) or \u3e60 years (HR 0.84, p = 0.008), relative to 18-44-year-olds.
CONCLUSIONS: Survival outcomes between male and female metastatic melanoma patients were equivalent when receiving immunotherapy. The benefit of immunotherapy was greatest in those aged \u3e45 years, regardless of sex
Nurse Practitioners and Physician Assistants in Spondyloarthritis: A Narrative Review and Expert Commentary.
No full textPsoriatic arthritis and axial spondyloarthritis belong to a group of related inflammatory conditions known as spondyloarthritis (SpA), each with several musculoskeletal and extramusculoskeletal manifestations. Disease onset can be insidious, and symptoms affect patient quality of life in subtle but impactful ways, requiring careful discernment to ensure proper diagnosis and management. Heterogeneity of disease manifestations often leads to underrecognition and delayed diagnosis, resulting in suboptimal disease management and clinical outcomes. In the United States, advanced practice providers (APPs), including nurse practitioners and physician assistants, have opportunities to contribute meaningfully to the management of patients with SpA. The role of APPs in SpA management is multifaceted and includes performing patient examinations, ordering and interpreting diagnostic tests, providing differential diagnoses, determining and executing treatment plans with patient input, and evaluating treatment efficacy and safety outcomes. Further, APPs enhance care by decreasing time to clinical visits and by educating patients on disease awareness and available treatments. Having more time than rheumatologists to spend with patients is a key benefit for APPs in managing patients with SpA and ultimately results in a deeper emotional connection and understanding of the individual burdens and disease manifestations faced by these patients. The goals of this narrative review are to provide a brief overview of SpA, highlight the value of APPs in rheumatology practice in the US by reviewing recent literature, and offer expert commentary from the perspectives of both the rheumatologist and the APP on the importance of these practitioners in meeting the unique needs of patients with SpA
Quantifying Disease Activity Despite Treatment with Tumor Necrosis Factor Inhibitors Among Patients with Psoriatic Arthritis and Axial Spondyloarthritis: Real-World Results from the PPD CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry.
No full textINTRODUCTION: Although tumor necrosis factor inhibitors (TNFis) have improved management of psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA); many patients experience suboptimal disease control. We quantified achievement of varying degrees of disease activity in patients with PsA and axSpA who initiated and maintained TNFi treatment for 12 months.
METHODS: Patients with PsA or axSpA enrolled in the PPD™ CorEvitas™ PsA/Spondyloarthritis Registry were included in the study. Varying degrees of disease control were quantified based on minimal disease activity (MDA) status for PsA and BASDAI50 (≥ 50% improvement in Bath Ankylosing Spondylitis Disease Activity Index) status for axSpA at 6 and 12 months. Patients were categorized into four groups: sustained (MDA/BASDAI50 at 6 and 12 months), improved (MDA/BASDAI50 at 12 months only), worsened (MDA/BASDAI50 at 6 months only), and never achieved (no MDA/BASDAI50 at 6 or 12 months).
RESULTS: For PsA, 338 patients initiated and persisted on TNFis. At 6 months, the majority (65%, n = 221) did not achieve MDA status; of these, 86% (n = 189) still did not achieve MDA at 12 months. For axSpA, 152 patients initiated and persisted on TNFis. At 6 months, 80% (n = 121) did not achieve BASDAI50; among these patients, 91% (n = 110) still did not achieve BASDAI50 status at 12 months. For both PsA and axSpA initiators, the risk of not achieving clinical or quality of life outcomes was two- to threefold lower in patients who never achieved versus patients who achieved and sustained MDA/BASDAI50.
CONCLUSION: More than 80% of patients with PsA or axSpA who did not achieve low disease activity at 6 months still did not achieve low disease activity by 12 months even though they persisted on TNFi treatment. These findings underscore the importance for physicians to consider modifying therapy if treatment targets with TNFi have not been achieved in the first 6 months
