Categories
Nevin Manimala Statistics

Statistical analysis plan for the multicenter, open, randomized controlled clinical trial to assess the efficacy and safety of intravenous tirofiban vs aspirin in acute ischemic stroke due to tandem lesion, undergoing recanalization therapy by endovascular treatment (ATILA trial)

Trials. 2024 Jan 9;25(1):35. doi: 10.1186/s13063-023-07817-9.

ABSTRACT

RATIONALE: In-stent reocclusion after endovascular therapy has a negative impact on outcomes in acute ischemic stroke (AIS) due to tandem lesions (TL). Optimal antiplatelet therapy approach in these patients to avoid in-stent reocclusion is yet to be elucidated.

AIMS: To assess efficacy and safety of intravenous tirofiban versus intravenous aspirin in patients undergoing MT plus carotid stenting in the setting of AIS due to TL.

SAMPLE SIZE ESTIMATES: Two hundred forty patients will be enrolled, 120 in every treatment arm.

METHODS AND DESIGN: A multicenter, prospective, randomized, controlled (aspirin group), assessor-blinded clinical trial will be conducted. Patients fulfilling the inclusion criteria will be randomized at MT onset to the experimental or control group (1:1). Intravenous aspirin will be administered at a 500-mg single dose and tirofiban at a 500-mcg bolus followed by a 200-mcg/h infusion during the first 24 h. All patients will be followed for up to 3 months.

STUDY OUTCOMES: Primary efficacy outcome will be the proportion of patients with carotid in-stent thrombosis within the first 24 h after MT. Primary safety outcome will be the rate of symptomatic intracranial hemorrhage.

DISCUSSION: This will be the first clinical trial to assess the best antiplatelet therapy to avoid in-stent thrombosis after MT in patients with TL.

TRIAL REGISTRATION: The trial is registered as NCT05225961. February, 7th, 2022.

PMID:38195586 | DOI:10.1186/s13063-023-07817-9

Categories
Nevin Manimala Statistics

Substantial variability exists in the interpretation of survey radiographs among equine veterinarians

Equine Vet J. 2024 Jan 9. doi: 10.1111/evj.14045. Online ahead of print.

ABSTRACT

BACKGROUND: Radiographs are a common diagnostic tool utilised during pre-purchase examinations, yet differences surround their interpretation among equine veterinarians.

OBJECTIVES: (1) To determine veterinarians’ subjective impressions of a spectrum of radiographic abnormalities regarding suitability for purchase; (2) To determine how veterinarians’ years in practice, primary discipline or board certification status influence their subjective impression of radiographic abnormalities, and (3) To determine how horses’ discipline, current level of work (working at intended level vs. future prospect) and buyer intent (sell vs. retain ownership) influence veterinarians’ subsequent recommendation.

STUDY DESIGN: Worldwide electronic survey of veterinary professionals.

METHODS: Four radiographic series of navicular bones, tarsi, and stifles, representing varying degrees of pathological change (normal, mild, moderate and marked) were presented. Respondents (n = 211) graded their level of concern from 1 (no concern) to 10 (very concerned) based on the radiographs and case scenarios presented.

RESULTS: Overall, as the grade of pathological change increased for each anatomical location, so did the level of veterinarian concern, but a wide range of answers were submitted for all grades of pathology. Board certified practitioners had a higher level of concern over marked radiographic changes of the navicular bone for both western performance and English sport horses as well as prospect horses (mean = 7.2 vs. 6.1; P = 0.009; 95% CI for difference = [0.3, 2.0]). Board certified respondents had a lower level of concern over marked radiographic changes of the tarsus regardless of the performance status of the horse (mean = 7.1 vs. 8.0; P = 0.008; 95% CI for difference = [-1.5, -0.2]). Western performance horse practitioners had a lower level of concern over mild radiographic changes of the tarsus regardless of the performance status of the horse (mean = 3.3 vs. 4.2; P = 0.009; 95% CI for difference = [-1.6, -0.2]).

MAIN LIMITATIONS: Only one example of each pathological grade per anatomical region was presented.

CONCLUSIONS: On survey radiographs, the perceived clinical relevance of radiographic abnormalities among equine practitioners differs widely, making purchase recommendations highly variable.

PMID:38194693 | DOI:10.1111/evj.14045

Categories
Nevin Manimala Statistics

Prediction of outcomes for high-count monoclonal B lymphocytosis using an epigenetic and immunogenetic signature

Blood. 2024 Jan 9:blood.2023022180. doi: 10.1182/blood.2023022180. Online ahead of print.

ABSTRACT

Monoclonal B cell lymphocytosis (MBL) progresses to chronic lymphocytic leukemia (CLL) requiring therapy at 1-5%/year. Improved prediction of progression would greatly benefit individuals with MBL. CLL patients separate into three distinct epigenetic subtypes (epitypes) with high prognostic significance, and recently the intermediate epitype has been shown to be enriched for high-risk IGLV3-21 rearrangements, impacting outcomes for these patients. Here we employed this combined strategy to generate the epigenetic and light chain immunoglobulin (ELCLV3-21) signature to classify 219 individuals with MBL. The ELCLV3-21 high-risk signature distinguished MBL individuals with a high probability of progression (39.9% and 71.1% at 5 and 10 years, respectively). ELCLV3-21 improved the accuracy of predicting time to therapy for MBL individuals compared to other established prognostic indicators, including the CLL international prognostic index (c-statistic 0.767 versus 0.668, respectively). Comparing ELCLV3-21 risk groups in MBL versus a cohort of 226 CLL patients revealed ELCLV3-21 high-risk MBL individuals had significantly shorter time to therapy (P=0.003) and reduced OS (P=0.03) compared to ELCLV3-21 low-risk CLL. These results highlight the power of the ELCLV3-21 approach to identify individuals with a higher likelihood of adverse clinical outcome and may provide a more accurate approach to classify individuals with small B-cell clones.

PMID:38194687 | DOI:10.1182/blood.2023022180

Categories
Nevin Manimala Statistics

Association of Designated Pediatric Trauma Center and Outcomes of Severely Injured Children Who Were Mechanically Ventilated and Underwent Tracheostomy: A Propensity-Matched Analysis

Pediatr Emerg Care. 2024 Jan 10. doi: 10.1097/PEC.0000000000003054. Online ahead of print.

ABSTRACT

OBJECTIVES: The purpose of the study is to examine the outcomes of care delivered at the pediatric trauma center (PTC) in severely injured children who were intubated, mechanically ventilated, and underwent tracheostomy.

METHODS: The study data were obtained from the Trauma Quality Improvement Program database for the calendar years 2017 to 2019. All children aged ≤17 years who sustained severe injury, required intubation and mechanical ventilation for more than 96 hours, and underwent tracheostomy were included in the study. Patients’ characteristics, injury severity, and outcomes were compared between the care provided at the PTCs (level I or level II) and nonpediatric trauma centers (NPTCs). The propensity score matching methodology was used to perform the analysis. All P values are 2-sided, and a P value of <0.0.5 is considered statistically significant.

RESULTS: Of 2164 patients who were qualified for the study, 1288 (59%) of the patients were treated at PTCs, and 876 (40.5%) of the patients were treated at NPTCs. Propensity matching created 876 pairs of patients. There were no significant differences found between the 2 groups on patients’ characteristics except for age. Patients who were treated at PTCs had a median age of 14 (10-16) versus 15 (11-17) years (P < 0.001) when compared with care provided at NPTCs. A longer hospital stay was found in the PTC group when compared with the NPTC group (24 [23, 25] vs 22 [21, 24], P = 0.008). Patients who were treated at PTC were found to have significantly less sepsis occurrence (0.9% vs 2.2%), and a higher proportion of patients were discharged home without needing additional support (26.2% vs 18.5%).

CONCLUSIONS: Care at the PTC was associated with a lower occurrence of sepsis complications. A higher number of patients were discharged home without additional services when the care was provided at PTC.

PMID:38194684 | DOI:10.1097/PEC.0000000000003054

Categories
Nevin Manimala Statistics

The effect of internal limiting membrane peeling on the inner retinal layers in patients without macular pathology

Retina. 2024 Jan 8. doi: 10.1097/IAE.0000000000004042. Online ahead of print.

ABSTRACT

BACKGROUND: To examine the effect of internal limiting membrane (ILM) peeling on the inner retinal layers in patients without macular pathology.

METHODS: A prospective nonrandomized trial of patients undergoing pars plana vitrectomy with ILM peeling for pathology outside of the macula was performed. Optical coherence tomography (OCT) including macular ganglion cell layer (GCL), inner plexiform layer (IPL) and peripapillary retinal nerve fiber layer imaging was performed prior to surgery, 1,3 and 6 months post-operatively and at the end of follow up (ranges between 4-17 months). Patients with any macular pathology on OCT prior to surgery were excluded. The main outcome measure was change in thickness of the GCL and IPL.

RESULTS: Ten patients who underwent pars plana vitrectomy with ILM peeling for macula-on retinal detachment were included in the analysis. The mean age was 55 years and the mean follow up was 10.8 months. All patients completed at least 2 post-operative follow up visits that included an OCT as per the protocol (range 2-6 months). There was an immediate reduction in the global (G), infero-temporal (IT), supero-temporal (ST) and superior (S) GCL thickness at the first follow up as compared to the pre-operative state (P=0.028, P=0.027, P=0.026 and P=0.027 respectively). From the first follow up visit onward until the final follow up the thinning persisted, though there was no further statistically significant thinning.

CONCLUSION: Peeling of the ILM causes significant GCL thinning in maculae without pathology prior to surgery. At up to 17 months of follow up, this effect seems to be immediate and non-progressive.

PMID:38194675 | DOI:10.1097/IAE.0000000000004042

Categories
Nevin Manimala Statistics

Mental Health Effects on the Minimal Clinically Important Difference in Total Joint Arthroplasty

J Am Acad Orthop Surg. 2024 Jan 9. doi: 10.5435/JAAOS-D-23-00538. Online ahead of print.

ABSTRACT

INTRODUCTION: The effect of mental health on patient-reported outcome measures is not fully understood in total joint arthroplasty (TJA). Thus, we investigated the relationship between mental health diagnoses (MHDs) and the Minimal Clinically Important Difference for Improvement (MCID-I) and Worsening (MCID-W) in primary TJA and revision TJA (rTJA).

METHODS: Retrospective data were collected using relevant Current Procedural Terminology and MHDs International Classification of Diseases, 10th Revision, codes with completed Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form, Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form, Patient-reported Outcomes Measurement Information System (PROMIS)-Physical Function Short Form 10a, PROMIS Global-Mental, or PROMIS Global-Physical questionnaires. Logistic regressions and statistical analyses were used to determine the effect of a MHD on MCID-I/MCID-W rates.

RESULTS: Data included 4,562 patients (4,190 primary TJAs/372 rTJAs). In primary total hip arthroplasty (pTHA), MHD-affected outcomes for Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form (MCID-I: 81% versus 86%, P = 0.007; MCID-W: 6.0% versus 3.2%, P = 0.008), Physical Function Short Form 10a (MCID-I: 68% versus 77%, P < 0.001), PROMIS Global-Mental (MCID-I: 38% versus 44%, P = 0.009), and PROMIS Global-Physical (MCID-I: 61% versus 73%, P < 0.001; MCID-W: 14% versus 7.9%, P < 0.001) versus pTHA patients without MHD. A MHD led to lower rates of MCID-I for PROMIS Global-Physical (MCID-I: 56% versus 63%, P = 0.003) in primary total knee arthroplasty patients. No effects from a MHD were observed in rTJA patients.

DISCUSSION: The presence of a MHD had a prominent negative influence on pTHA patients. Patients who underwent rTJA had lower MCID-I rates, higher MCID-W rates, and lower patient-reported outcome measure scores despite less influence from a MHD.

LEVEL OF EVIDENCE: Level III, retrospective comparative study.

PMID:38194673 | DOI:10.5435/JAAOS-D-23-00538

Categories
Nevin Manimala Statistics

The role of Intravitreal Methotrexate as an Adjunct to Local or Systemic Corticosteroids in Vitrectomy for Rhegmatogenous Retinal Detachment and Choroidal Detachment: A Pilot Study

Retina. 2024 Jan 8. doi: 10.1097/IAE.0000000000004046. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the role of repeated intravitreal Methotrexate (IMTX) as an adjunct to pars plana vitrectomy (PPV) in the management of rhegmatogenous retinal detachment with choroidal detachment (RRDCD).

METHOD: We compared anatomical and visual outcomes of RRDCD eyes that underwent PPV with (group B) or without repeated IMTX (group A).

RESULTS: The study included 25 eyes of 25 patients, 16 eyes in group A and nine in Group B. Both groups had similar baseline characteristics. In Group A, successful retinal attachment was achieved in 50% as compared to 89% in Group B, however the difference was not statistically significant (p=0.08). Also, Group B had a significantly greater change in visual acuity from baseline to the last follow-up visit (1.6+1.5 logMAR units) compared to Group A (1.18+1logMAR units) (p=0.05). There were no significant safety concerns with the use of IMTX.

CONCLUSION: Repeated IMTX after vitrectomy for RRDCD improves outcomes without posing major safety concerns. Nonetheless, further investigation is necessary to establish the optimal IMTX dosage and duration to prevent recurrence effectively.

PMID:38194672 | DOI:10.1097/IAE.0000000000004046

Categories
Nevin Manimala Statistics

Are We Moving in the Right Direction? Demographic and Outcome Trends in Same-day Total Hip Arthroplasty From 2015 to 2020

J Am Acad Orthop Surg. 2024 Jan 9. doi: 10.5435/JAAOS-D-23-00762. Online ahead of print.

ABSTRACT

INTRODUCTION: Understanding the trends among patients undergoing same-day discharge (SDD) total hip arthroplasty (THA) is imperative to highlight the progression of outpatient surgery and the criteria used for enrollment. The purpose of this study was to identify trends in demographic characteristics and outcomes among patients who participated in an academic hospital SDD THA program over 6 years.

METHODS: We retrospectively reviewed all patients who enrolled in our institution’s SDD THA program from January 2015 to October 2020. Patient demographics, failure-to-launch rate, as well as readmission and revision rates were evaluated. Trends for continuous variables were analyzed using analysis of variance, and categorical variables were analyzed using chi-square tests.

RESULTS: In total, 1,334 patients participated in our SDD THA program between 2015 and 2020. Age (54.82 to 57.94 years; P < 0.001) and mean Charlson Comorbidity Index (2.15 to 2.90; P < 0.001) significantly differed over the 6-year period. More African Americans (4.3 to 12.3%; P = 0.003) and American Society of Anesthesiology class III (3.2% to 5.8%; P < 0.001) patients enrolled in the program over time. Sex (P = 0.069), BMI (P = 0.081), marital status (P = 0.069), and smoking status (P = 0.186) did not statistically differ. Although the failure-to-launch rate (0.0% to 12.0%; P < 0.001) increased over time, the 90-day readmissions (P = 0.204) and 90-day revisions (P = 0.110) did not statistically differ.

CONCLUSION: More African Americans, older aged individuals, and patients with higher preexisting comorbidity burden enrolled in the program over this period. Our findings are a reflection of a more inclusive selection criterion for participation in the SDD THA program. These results highlight the potential increase in the number of patients and surgeons interested in SDD THA, which is paramount in the current incentivized and value-based healthcare environment.

LEVEL EVIDENCE: III, Retrospective Review.

PMID:38194641 | DOI:10.5435/JAAOS-D-23-00762

Categories
Nevin Manimala Statistics

Electrographic Seizure Characteristics and Electrographic Status Epilepticus Prediction

J Clin Neurophysiol. 2024 Jan 9. doi: 10.1097/WNP.0000000000001068. Online ahead of print.

ABSTRACT

PURPOSE: We aimed to characterize electrographic seizures (ES) and electrographic status epilepticus (ESE) and determine whether a model predicting ESE exclusively could effectively guide continuous EEG monitoring (CEEG) utilization in critically ill children.

METHODS: This was a prospective observational study of consecutive critically ill children with encephalopathy who underwent CEEG. We used descriptive statistics to characterize ES and ESE, and we developed a model for ESE prediction.

RESULTS: ES occurred in 25% of 1,399 subjects. Among subjects with ES, 23% had ESE, including 37% with continuous seizures lasting >30 minutes and 63% with recurrent seizures totaling 30 minutes within a 1-hour epoch. The median onset of ES and ESE occurred 1.8 and 0.18 hours after CEEG initiation, respectively. The optimal model for ESE prediction yielded an area under the receiver operating characteristic curves of 0.81. A cutoff selected to emphasize sensitivity (91%) yielded specificity of 56%. Given the 6% ESE incidence, positive predictive value was 11% and negative predictive value was 99%. If the model were applied to our cohort, then 53% of patients would not undergo CEEG and 8% of patients experiencing ESE would not be identified.

CONCLUSIONS: ESE was common, but most patients with ESE had recurrent brief seizures rather than long individual seizures. A model predicting ESE might only slightly improve CEEG utilization over models aiming to identify patients at risk for ES but would fail to identify some patients with ESE. Models identifying ES might be more advantageous for preventing ES from evolving into ESE.

PMID:38194638 | DOI:10.1097/WNP.0000000000001068

Categories
Nevin Manimala Statistics

Impact of Centers for Medicare and Medicaid Services Final Rule on Organ Procurement Organization Metrics and Procedural Trends in the Procurement of Pancreata for Research

Pancreas. 2024 Jan 4. doi: 10.1097/MPA.0000000000002284. Online ahead of print.

ABSTRACT

OBJECTIVE: Pancreata recovered for research are included as a success (or positive) in the Centers for Medicare and Medicaid Services’ (CMS) donation and organ transplantation rate metrics for recertification of organ procurement organizations (OPOs).

MATERIALS AND METHODS: Given these metrics directly incentivize recovery of pancreata for research, this study tracks trends in recovery of pancreata for research across the implementation of the CMS metrics.

RESULTS: In the 26 months before the December 2, 2020, publication of the CMS metrics, research pancreata as a percent of organs transplanted, including research pancreata, was 1.7% nationally, including as much as 10.8% of organs transplanted within any OPO. In the 26 months after the CMS metrics were published, research pancreata increased to 5.1% of organs counted as transplants nationally, including as much as 20.3% within any OPO. If research pancreata were excluded from the CMS metrics, 6 OPOs would change their CMS evaluation status for recertification purposes: 2 would move up a tier and 4 would move down a tier.

CONCLUSIONS: Procurement of research pancreata has increased since the publication of the CMS performance metrics, OPOs vary in their recovery of pancreata for research, and recovery of pancreata for research can affect recertification of OPOs.

PMID:38194634 | DOI:10.1097/MPA.0000000000002284