Tag: statistics

J Bone Joint Surg Am. 2022 Sep 28. doi: 10.2106/JBJS.21.01556. Online ahead of print.

ABSTRACT

BACKGROUND: The aim of the present study was to evaluate the complications associated with conventional methods of cast removal and to compare them with the complications associated with a novel method involving the use of externally guided aids for skin protection.

METHODS: Two hundred and eight cooperative patients ≥5 years of age who had no experience with cast removal were included in the study. Patients were selected arbitrarily and were divided into 2 groups. In Group 1 (106 patients [115 casts]; 60% male; average age, 20 years), conventional protection methods were used. In Group 2 (102 patients [108 casts]; 62% male; average age, 26 years), tong-shaped, externally guided, steel plate aids were used for skin protection. After the insertion of the protective part between the skin and the cast materials, the outer portion of the aid guided the operator to stay in a safe cutting line. The cast removal procedures in each group were documented, and skin injuries, burns, patient anxiety, operator anxiety, and processing time were noted.

RESULTS: In Group 1, the skin mark/scratch rate was 18%, the full-thickness skin laceration rate was 0.9%, the burn sensation rate was 22%, and the rate of first/second-degree burns was 2.5%. Anxiety was classified as moderate by 57% of the patients and as severe by 8%. Moderate anxiety was reported by 20% of the cast operators. In Group 2, only 6% of the patients experienced moderate anxiety and the removal time was reduced by >25%. When the groups were compared with regard to severe complications such as skin laceration (resulting in bleeding), visible burn, and severe anxiety, the former 2 complications were eliminated in Group 2 but the difference between the groups was statistically significant in the last category only (p = 0.325, p = 0.247, p = 0.007, respectively).

CONCLUSIONS: Eliminating saw blade-to-skin contact with a tong-like, externally guided flexible steel aid provides a high level of safety, decreases removal time by 5 to 10 minutes (depending on cast length), and makes cast removal a better experience for both patients and operators.

LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

PMID:36413353 | DOI:10.2106/JBJS.21.01556

Cannabis Cannabinoid Res. 2022 Nov 22. doi: 10.1089/can.2022.0136. Online ahead of print.

ABSTRACT

Context: Retrospective study of 36 individuals with sickle cell disease (SCD) certified for medical cannabis. Objective: We sought to examine whether medical cannabis certification was associated with a change in utilization of acute care medical services for patients with SCD. Methods: We identified patients with SCD certified for medical cannabis use between July 2014 and December 2021 using the New York State Prescription Monitoring Program (NYS PMP) and cross-matching to our electronic medical record. We estimated the mean incidences of Emergency Department (ED) visits, hospital admissions, inpatient days, and total acute encounters for SCD-related pain per month pre- and post-medical cannabis certification and used paired t-tests to assess the statistical significance of changes in hospital use. We stratified incidence based on whether patients had received a bone marrow transplant (BMT) at any point before or during the research period, since BMT is potentially an important covariate. Recertification rates and patients’ reasons for choosing to recertify were qualitatively investigated through retrospective chart review. Results: The incidence of ED visits, hospital admissions, and total acute encounters per month for SCD-related pain decreased pre- to post-certification (p=0.02; p=0.02; p=0.01). These decreases lost statistical significance after stratifying patients based on BMT history. There was no statistically significant change in the number of days per month patients spent hospitalized in either the primary analysis or after stratification by BMT status. Forty-four percent of patients chose to be recertified. Thirty-six percent of patients cited concerns regarding the cost of medical cannabis. Conclusion: Our study did not show a statistically significant relationship between certification for medical cannabis and hospital use after addressing BMT history as a potentially important covariate. However, we were likely underpowered to detect any existing difference after patient data were stratified due to our small sample size. Regardless, 44% of patients chose to be recertified, indicating a perceived benefit and utility in further investigation of medical cannabis for this population with a larger analytic sample. Patient-reported benefits were improvement of pain and other symptoms, decreased opiate requirements, and decreased side effects compared to opiates.

PMID:36413342 | DOI:10.1089/can.2022.0136

Methods Mol Biol. 2023;2581:149-176. doi: 10.1007/978-1-0716-2784-6_12.

ABSTRACT

Isothermal titration calorimetry (ITC) is the gold standard for providing quantitative and thermodynamic understanding of the interaction mechanisms between core autophagy machinery, autophagy receptors, and ATG8. Here, we used two model peptides and Arabidopsis thaliana ATG8A to characterize ATG8-peptide interactions. We employed ITC using three different methods (direct ligand titration, displacement, and competition assays) to characterize, directly and indirectly, the interaction of the peptides with ATG8. We then analyzed the ITC data by global and statistical methods and discussed advantages, drawbacks, and negative controls for each approach. We finally provide a thorough description of all the steps, including data analysis and presentation, preparation of recombinant ATG8A from E. coli, and troubleshooting notes for technical problems that can be encountered. Although we used ATG8-peptide interactions here, these assays can be applied to any other one-to-one protein-protein and ligand-protein interactions and competitive binders.

PMID:36413317 | DOI:10.1007/978-1-0716-2784-6_12

Phlebology. 2022 Nov 22:2683555221141818. doi: 10.1177/02683555221141818. Online ahead of print.

ABSTRACT

OBJECTIVE: The study aimed to examine whether alpha-1-antitrypsin (AAT), an inhibitor of leukocyte esterase(LE), which damages the venous vessel wall, has a protective effect against chronic venous disease(CVD), and to examine the relationship between AAT levels and disease severity.

METHODS: Patients admitted with varicose vein disease and having reflux flow lasting longer than 0.5 s as determined by Doppler ultrasound were included. The informed consents were taken, and blood samples were obtained for complete blood count, C-reactive protein (CRP) level, and AAT level following anamnesis and physical examination. Clinical Etiologic Anatomic Pathologic (CEAP) classification was used to assess disease severity, and patients were divided into CEAP 1-5 groups accordingly.

RESULTS: A total of 87 patients were included in the study. There was no statistically significant difference between the groups in body weight, red blood cell counts, platelet counts, or neutrophil counts (p = 0.117, p = 0.932, p = 0.177, and p = 0.177, respectively).CRP and AAT levels were higher in patients with a CEAP clinical score of 5 compared to the other groups (p = 0.018, and p = 0.020, respectively). AAT levels were similar in the CEAP 1-3 group and decreased in the CEAP-4 group but increased again in the CEAP-5 group. The AAT level was 1.62 ± 0.3 g/L in the CEAP-1 group, 1.61 ± 0.21 g/L in the CEAP-2 group, 1.61 ± 0.27 g/L in the CEAP-3 group, 1.48 ± 0.28 g/L in the CEAP-4 group, and 1.94 ± 0.39 g/L in the CEAP-5 group. CRP levels and platelet counts were observed to affect AAT levels (p = 0.10, p = 0.017, respectively).

CONCLUSION: We believe that our hypothesis that low AAT levels play a role in the etiopathogenesis of CVD has been partially validated, at least in the CEAP-4 group. However, we believe that increased AAT levels in the CEAP-5 group may be a reactive increase in increased LE levels due to higher CRP levels of this group.

PMID:36413267 | DOI:10.1177/02683555221141818

J Gambl Stud. 2022 Nov 21. doi: 10.1007/s10899-022-10166-y. Online ahead of print.

ABSTRACT

This research empirically tests the relationship between gambling-related cognitive distortions and the development of gambling problems. In two separate studies using methodologies designed to support non-experimental causal inference, we demonstrate that holding false beliefs about gambling experiences is related to current and future risk of developing problems with gambling. In our first study, we use an instrumental variable estimation strategy on an internet sample (n = 184) and observe a statistically significant relationship between Gamblers’ Belief Questionnaire scores and measures of loss chasing, overspending, and gambling problems. These findings were robust to linear and ordinal estimation strategies and multiple model specifications. In our second study, we examine five-year prospective longitudinal data (n = 1,431) to validate our initial findings and test whether irrational thoughts are also related to future problems with gambling. While controlling for current fallacies, we find that past Gambling Fallacies Measure scores are related to present gambling problems across two survey waves. The effect size of each of the past fallacy levels is roughly half of the effect size of present levels, suggesting meaningful impacts. Our findings support the Pathways Model of Problem and Pathological Gambling.

PMID:36413263 | DOI:10.1007/s10899-022-10166-y

Cancer Chemother Pharmacol. 2022 Nov 21. doi: 10.1007/s00280-022-04489-1. Online ahead of print.

ABSTRACT

PURPOSE: Pemetrexed is a chemotherapeutic drug in the treatment of non-small cell lung cancer and mesothelioma. Optimized dosing of pemetrexed based on renal function instead of body surface area (BSA) is hypothesized to reduce pharmacokinetic variability in systemic exposure and could therefore improve treatment outcomes. The aim of this study is to compare optimized dosing to standard BSA-based dosing.

METHODS: A multicenter randomized (1:1) controlled trial was performed to assess superiority of optimized dosing versus BSA-based dosing in patients who were eligible for pemetrexed-based chemotherapy. The individual exposure to pemetrexed in terms of area under the concentration-time curve (AUC) was determined. The fraction of patients attaining to a predefined typical target AUC (164 mg × h/L ± 25%) was calculated.

RESULTS: A total of 81 patients were included. Target attainment was not statistically significant different between both arms (89% vs. 84% (p = 0.505)). The AUC of pemetrexed was similar between the optimized dosing arm (n = 37) and the standard of care arm (n = 44) (155 mg × h/L vs 160 mg × h/L (p = 0.436).

CONCLUSION: We could not show superiority of optimized dosing of pemetrexed in patients with an adequate renal function does not show added value on the attainment of a pharmacokinetic endpoint, safety, nor QoL compared to standard of care dosing.

CLINICAL TRIAL NUMBER: Clinicaltrials.gov identifier: NCT03655821.

PMID:36413252 | DOI:10.1007/s00280-022-04489-1

Sleep. 2022 Nov 22:zsac278. doi: 10.1093/sleep/zsac278. Online ahead of print.

ABSTRACT

STUDY OBJECTIVES: International guidelines recommend using benzodiazepine receptor agonists (BZRA) for maximally four weeks. Nevertheless, long-term use for chronic insomnia disorder remains a common practice. This study aimed to test the effectiveness of blended care for discontinuing long-term BZRA use in general practice.

METHODS: A pragmatic cluster randomized controlled superiority trial compared blended care to usual care through urine toxicology screening. In the intervention, care by the general practitioner (GP) was complemented by an interactive e-learning program, based on cognitive behavioral therapy for insomnia. Adults using BZRA daily for minimally six months were eligible. Participants were clustered at the level of the GP surgery for allocation (1:1). Effectiveness was measured as the proportion of patients who had discontinued at one-year follow-up. Data analysis followed intention-to-treat principles.

RESULTS: In total, 916 patients in 86 clusters, represented by 99 GPs, were randomized. Primary outcome data was obtained from 727 patients (79%). At one-year follow-up, 82 patients (18%) in blended care, compared to 91 patients (20%) in usual care, had discontinued. There was no statistically significant effect for the intervention (OR: 0·924; 95% CI: 0·60, 1·43). No adverse events were reported to the research team.

CONCLUSIONS: The findings did not support the superiority of blended care over usual care. Both strategies showed clinical effectiveness, with an average of 19% of patients having discontinued at one-year follow-up. Further research is important to study the effect of structurally implementing digital interventions in general practice.

PMID:36413221 | DOI:10.1093/sleep/zsac278

Eur J Transl Myol. 2022 Nov 22. doi: 10.4081/ejtm.2022.10847. Online ahead of print.

ABSTRACT

Mutations in tumor suppressor p53 protein can occur at different phases of malignant transformation and affect the patient’s prognosis. This study aimed to evaluate the expression of mutant p53 protein in Iranian patients with the primary and recurrence oral squamous cell carcinoma (OSCC). This retrospective cross-sectional study conducted on a group of patients with the primary OSCC (n=122) and the control subjects with oral noncancerous reactive lesions (n=80). Immunohistochemistry was performed with the DO-7 monoclonal antibody against p53 protein, and samples with ≥10% immunostaining were considered positive. Statistical analyses were carried out using SPSS. Positive staining for p53 was observed in none of the control subjects and 57.4% (70 of 122) of the primary OSCC patients (p<0.0001, OR=107.69, 95%CI=6.49-179.0). The p53 immunopositivity had no significant differences between males and females (54.2% vs. 62%, p=0.390), but significantly different between those aged below and over 50 years (p<0.0001, OR=4.52, 95%CI=1.07-12.05). During follow-up, OSCC recurrence occurred in 104 patients, but the phenotype of the mutant p53 protein in patients who relapsed was the same as in matched primary tumors (p=0.763). Risk of recurrence had no significant differences between p53-positive and p53-negative cases (p=0.953), males and females (p=0.263), and age below and over 50 years (p=0.223). Despite its confirmed diagnostic value, the immunoexpression of the p53 mutant protein in OSCC in cancer recurrence was the same as in the primary tumor. However, further studies with a larger sample size and longer follow-up are needed to confirm or change our conclusions.

PMID:36413207 | DOI:10.4081/ejtm.2022.10847

AANA J. 2022 Dec;90(6):439-445.

ABSTRACT

Patients undergoing one-lung ventilation (OLV) are at risk for lung injury leading to postoperative pulmonary complications (PPCs). Lung protective ventilation (LPV) challenges traditional anesthetic management by using lower tidal volumes, individualized positive end-expiratory pressure (PEEP), and recruitment maneuvers (RMs). LPV reduces driving pressure when properly applied, which reduces the incidence of PPCs. An LPV protocol was developed and implemented for this study for patients undergoing one-lung ventilation. Knowledge and confidence were measured prior to, immediately following, and 12 weeks after an educational offering and distribution of cognitive aids. Clinical data were collected 12 weeks prior to implementation, immediately after implementation, and again at 12 weeks post-implementation. There was a significant increase in provider knowledge regarding LPV (P = .015). A significant adherence to monitoring driving pressures (P < .05) was observed at 12 weeks post-implementation. There were increases in adherence to each component (tidal volume, PEEP, RM, and FiO₂) as well as overall adherence (P = .356). Implementation of the protocol resulted in increased adherence to lung protective strategies, including a statistically significant decrease (P < 0.05) in driving pressure which has been shown to reduce complications in patients having thoracic surgery with OLV.

PMID:36413189

Transplantation. 2022 Oct 27. doi: 10.1097/TP.0000000000004372. Online ahead of print.

ABSTRACT

BACKGROUND: Transcriptome analysis could be an additional diagnostic parameter in diagnosing kidney transplant (KTx) rejection. Here, we assessed feasibility and potential of NanoString nCounter analysis of KTx biopsies to aid the classification of rejection in clinical practice using both the Banff-Human Organ Transplant (B-HOT) panel and a customized antibody-mediated rejection (AMR)-specific NanoString nCounter Elements (Elements) panel. Additionally, we explored the potential for the classification of KTx rejection building and testing a classifier within our dataset.

METHODS: Ninety-six formalin-fixed paraffin-embedded KTx biopsies were retrieved from the archives of the ErasmusMC Rotterdam and the University Hospital Cologne. Biopsies with AMR, borderline or T cell-mediated rejections (BLorTCMR), and no rejection were compared using the B-HOT and Elements panels.

RESULTS: High correlation between gene expression levels was found when comparing the 2 chemistries pairwise (r = 0.76-0.88). Differential gene expression (false discovery rate; P < 0.05) was identified in biopsies diagnosed with AMR (B-HOT: 294; Elements: 76) and BLorTCMR (B-HOT: 353; Elements: 57) compared with no rejection. Using the most predictive genes from the B-HOT analysis and the Element analysis, 2 least absolute shrinkage and selection operators-based regression models to classify biopsies as AMR versus no AMR (BLorTCMR or no rejection) were developed achieving an receiver-operating-characteristic curve of 0.994 and 0.894, sensitivity of 0.821 and 0.480, and specificity of 1.00 and 0.979, respectively, during cross-validation.

CONCLUSIONS: Transcriptomic analysis is feasible on KTx biopsies previously used for diagnostic purposes. The B-HOT panel has the potential to differentiate AMR from BLorTCMR or no rejection and could prove valuable in aiding kidney transplant rejection classification.

PMID:36413151 | DOI:10.1097/TP.0000000000004372