Category: Statistics

Stroke. 2024 Nov 27. doi: 10.1161/STROKEAHA.124.045607. Online ahead of print.

ABSTRACT

BACKGROUND: Lack of a dedicated thrombectomy device for cerebral venous thrombosis hinders the recanalization ability of endovascular treatment (EVT). Novel NiTi-braided stent retriever (Venous-TD) is a dedicated venous sinus thrombectomy device. This study aims to demonstrate the safety and efficacy of Venous-TD.

METHODS: In this pilot, prospective, randomized, single-blind, parallel-group control, single-center clinical study, patients with cerebral venous thrombosis from Beijing Xuanwu Hospital were included. Randomization was performed to EVT with either the Venous-TD or Angioguard with Sterling balloon (control group). The primary efficacy outcome was the proportion of immediate complete recanalization during EVT. Secondary outcomes included the proportion of functional independence and moderate to severe residential headache at 180 days after EVT. Safety outcomes included peri-procedural complications, all-cause mortality, and symptomatic intracranial hemorrhage after EVT.

RESULTS: A total of 61 patients were enrolled and randomized. Thirty-one patients were randomized to the Venous-TD group, and 30 were randomized to the control group. The median (interquartile range) age was 28 (21-45) in the Venous-TD group and 34 (24-43) in the control group. The proportion of patients with a National Institutes of Health Stroke Scale score >8 on admission was 8 (25.8%) in the Venous-TD group and 11 (36.7%) in the control group. During EVT, Venous-TD significantly improved the proportion of complete recanalization compared with Angioguard (23 [76.7%] versus 6 [20.0%]; relative risk, 3.833 [95% CI, 1.825-8.054]). The proportions of long-term functional independence at 180 days in the Venous-TD group and the control group were not significantly different. The proportion of patients with severe residual headache at 180 days in the Venous-TD group was significantly lower than that in the control group (3 [9.7%] versus 10 [35.7%]; relative risk, 0.271 [95% CI, 0.083-0.886]). Safety outcomes showed no statistically significant difference between the 2 groups.

CONCLUSIONS: This trial indicated that Venous-TD did not increase complications in EVT of cerebral venous thrombosis and can significantly increase the proportion of complete recanalization. A multicenter phase III randomized control trial assessing efficacy and safety of Venous-TD is warranted.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05291585.

PMID:39601121 | DOI:10.1161/STROKEAHA.124.045607

Headache. 2024 Nov 27. doi: 10.1111/head.14874. Online ahead of print.

ABSTRACT

BACKGROUND: The Migraine-Specific Quality-of-Life Questionnaire version 2.1 (MSQ 2.1) is one of the most frequently used tools in assessing the impact of migraine in clinical practice and in migraine research. This work aimed to examine the reliability and validity of the Arabic version of the MSQ 2.1 in Arabic-speaking patients with migraine and to assess its ability to detect subtle changes in quality of life after receiving prophylactic migraine medications.

METHODS: This multicenter prospective observational study was conducted with 140 patients experiencing migraine and indicated for prophylactic medications. Headache assessment was done at baseline and 3 months after receiving prophylactic medications using the Arabic version of MSQ 2.1, Headache Impact Test (HIT-6), and visual analog scale (VAS). The MSQ 2.1 was repeated 1 week after the first visit to a group of patients (n = 70) to assess test-retest reliability.

RESULTS: Cronbach’s alpha for the MSQ 2.1 was 0.973, indicating excellent internal consistency. The intraclass correlation coefficient (average measure) was 0.99, indicating excellent test-retest reliability. There were statistically significant correlations between the MSQ 2.1 total score and monthly migraine days, VAS, and HIT-6 scores before and 3 months after prophylactic medications. The receiver operating characteristic curve revealed that an increase of 8.5 in the total score of the MSQ 2.1 represents the minimally important change that means significant improvement (area under the curve = 0.785, sensitivity = 0.861, specificity = 0.656, p < 0.001).

CONCLUSION: The Arabic version of the MSQ 2.1 is a valid, reliable, and sensitive tool that can precisely assess the impact of migraine on quality of life.

PMID:39601107 | DOI:10.1111/head.14874

Laryngoscope. 2024 Nov 27. doi: 10.1002/lary.31933. Online ahead of print.

ABSTRACT

OBJECTIVE: Patients with obstructive sleep apnea (OSA) are at an increased risk for perioperative cardiopulmonary complications. Our objective was to assess the postoperative effects of hypoglossal nerve stimulation implantation (HGNS) and expansion pharyngoplasty (EP) on longitudinal sleep apnea measures as a surrogate for respiratory complications.

STUDY DESIGN: Prospective longitudinal cohort study of patients with OSA undergoing HGNS or EP.

METHODS: Sleep studies were performed with the NightOwl Mini peripheral arterial tonometry (PAT) device. Changes in apnea-hypopnea index (AHI) and oximetry time below 90% (T90) were assessed between two baseline PAT studies prior to surgery and nightly PAT studies for the first postoperative nights (PON) 1-7, 10, and 14.

RESULTS: Thirty patients were enrolled (19 HGNS, 11 EP). The mean age was 52.6 years, 76.7% were male, and the mean clinical baseline AHI was 29.8/h. There were no significant changes in the AHI or T90 following HGNS implantation. Following EP, there was a statistically significant mean increase in AHI of +19.2/h on PON1, +24.9/h on PON2, and + 20/h on PON3 compared to baseline. T90 was also elevated after EP on PON1, 4, and 5. The mean increase in T90 was +7.4% (95% CI 2.9, 11.9) on PON1 compared to baseline.

CONCLUSIONS: In the immediate postoperative period, there were no significant changes in AHI or hypoxemia after HGNS, suggesting that there is no need for routine overnight observation after HGNS. There were significant increases in AHI and hypoxemia after EP suggesting that postoperative disposition should be considered on a case-by-case basis.

LEVEL OF EVIDENCE: III Laryngoscope, 2024.

PMID:39601102 | DOI:10.1002/lary.31933

Headache. 2024 Nov 27. doi: 10.1111/head.14860. Online ahead of print.

ABSTRACT

BACKGROUND: The Trial of External trigeminal nerve stimulation (eTNS) for the Acute treatment of Migraine (TEAM) study demonstrated that eTNS use during active migraine resulted in significantly higher rates of resolution of migraine-associated most bothersome symptom (MBS) compared to sham. However, no previous studies have examined the association between pretreatment MBS subtype and efficacy of eTNS treatment for active migraine.

OBJECTIVE: We conducted a post hoc analysis examining efficacy of eTNS for different pretreatment MBS subtypes using TEAM study data.

METHODS: Pretreatment MBS subtypes included photophobia (n = 345), nausea (n = 109), phonophobia (n = 73), and vomiting (n = 11). We examined MBS sub-group × treatment group (verum n = 259; sham n = 279) interaction for each post-treatment outcome to explore differential effects conditional on the total sample. We further explored direct, between treatment group comparisons for each MBS subtype, as well as compared treatment outcomes among all MBS subtypes within the sham, verum, and total sample. Finally, clinical heterogeneity of treatment effect (HTE) was assessed using a 1% absolute treatment effect difference as the clinically important threshold.

RESULTS: Significant sub-group × treatment interactions were found for resolution of MBS at 2 h (p = 0.008), pain relief at 2 h (p = 0.001), rescue medication between 2 and 24 h (p = 0.012), sustained pain freedom at 24 h (p = 0.033), and sustained pain relief at 24 h (p = 0.003). Significant sub-group × treatment interactions were not found for pain freedom at 2 h (p = 0.054) or absence of all symptoms at 2 h (p = 0.265). Between treatment group comparisons indicated that pain freedom after 2 h of eTNS was not significantly different between the verum and sham groups for any pretreatment MBS. The verum group had a significantly greater proportion of participants who had resolution of nausea MBS after 2 h of treatment compared to sham (37/55 [67.3%] vs. 25/54 [46.3%], respectively; p = 0.028) and resolution of photophobia MBS compared to sham (85/162 [52.5] vs. 71/183 [38.8%], respectively; p = 0.011). There were no significant differences between treatment groups for phonophobia or vomiting. Pain freedom after 2 h of eTNS was not significantly different among pretreatment MBS groups. Within the sham group and total sample, a greater proportion of participants who had vomiting MBS had resolution of their MBS compared to any other pretreatment MBS (p < 0.05 after Bonferroni adjustment). A greater proportion of participants with nausea MBS used rescue medications between 2 and 24 h after eTNS compared to participants with photophobia or phonophobia MBS within the verum and total sample (p < 0.05 after Bonferroni adjustment). No statistical differences were found among MBS groups for any other treatment outcomes. Clinically important HTE was present in vomiting MBS for resolution of MBS and present in nausea MBS for pain freedom and pain relief after 2 h, need for rescue medication, and sustained pain freedom at 24 h post-treatment. There was no clinically relevant HTE in the nausea MBS group for resolution of MBS at 2 h, absence of all migraine-associated symptoms and sustained pain relief at 24 h, or for any endpoint for other MBS subtypes.

CONCLUSION: Our results suggest the presence of both statistically significant HTE as well as clinically meaningful HTE. Statistical differences were primarily found for photophobia MBS, while clinically meaningful HTE was primarily found for nausea MBS. These findings may be clinically relevant for patients and clinicians when developing a treatment plan for acute treatment of migraine. Further studies are needed to elucidate the underlying pathophysiological differences between MBS subtypes and treatment optimization, particularly for patients with nausea MBS subtypes.

PMID:39601100 | DOI:10.1111/head.14860

J Magn Reson Imaging. 2024 Nov 27. doi: 10.1002/jmri.29668. Online ahead of print.

ABSTRACT

BACKGROUND: The long-term prevalence of clinically significant prostate cancer (csPCa) in patients with initial negative prostate biopsy is unknown.

PURPOSE: To investigate the rate of csPCa of men with initial negative biopsy.

STUDY TYPE: Retrospective analysis of prospectively collected data.

POPULATION: A total of 197 men (mean age 63 years [SD ±6.98, range 29-79]) without csPCa on initial biopsy and available baseline biparametric prostate MRI (bpMRI).

FIELD STRENGTH/SEQUENCE: 3.0 T, turbo spin-echo T2-weighted (axial and sagittal) and three sets of diffusion-weighted imaging using single-shot spin-echo planar imaging (5 b-values 0-500 seconds/mm²; 2 b-values 0 and 1500 seconds/mm², and 2 b-values 0 and 2000 seconds/mm²).

ASSESSMENT: BpMRI was read using Prostate Imaging Reporting Data System (PI-RADS) v2.1. Systematic or targeted biopsy results served as reference standard.

STATISTICAL TESTS: Continuous variables were compared using Kruskal-Wallis rank sum test. Categorical variables were compared using either Fisher’s exact test or Pearson’s chi-square test. Uni- and multivariate regression odds ratios (95% confidence interval) were used to study factors affecting csPCa being diagnosed during follow-up. Time to diagnosis of csPCa is calculated using the Kaplan-Meier method.

RESULTS: Of 197 men, 74 (38%), 57 (29%), and 66 (34%) presented with PI-RADS 1-2, 3, and 4-5 findings in the baseline bpMRI. During the median follow-up of 52 months, 8.1%, 5.3%, and 18.2% of these men were diagnosed with csPCa, respectively. Baseline PI-RADS finding was the only factor that associated with csPCa found during the follow-up.

DATA CONCLUSION: Baseline bpMRI with PI-RADS scores 1-3 and initial biopsies negative of csPCa had low rate of csPCa during follow-up, which supports more conservative follow-up for them but further research with longer follow-up is warranted.

LEVEL OF EVIDENCE: 3 TECHNICAL EFFICACY: Stage 2.

PMID:39601084 | DOI:10.1002/jmri.29668

Belitung Nurs J. 2024 Nov 24;10(6):654-661. doi: 10.33546/bnj.3565. eCollection 2024.

ABSTRACT

BACKGROUND: In China, the incidence of hypertension rises significantly with age, resulting in a markedly reduced quality of life (QoL) among older patients compared to the general population. Therefore, it is essential for healthcare providers, particularly nurses, to identify the predictive factors that influence QoL in this demographic.

OBJECTIVE: This study aimed to describe the QoL levels and investigate the predictive power of perceived health status, self-care behavior, and social support on QoL among older patients with hypertension in Wenzhou, China.

METHODS: A cross-sectional study was conducted with 131 patients with hypertension aged 60 and above, visiting the Cardiovascular Outpatient Department of The Second Affiliated Hospital of Wenzhou Medical University. Data were collected using validated instruments between November and December 2022 and analyzed using descriptive statistics and stepwise multiple regression.

RESULTS: The overall QoL was moderate (Mean = 75.52, SD = 5.86). Self-care behavior (β = 0.421, p <0.001), social support (β = 0.416, p <0.001), and perceived health status (β = -0.170, p <0.001) were significant predictors of QoL, collectively explaining 82.7% of the variance.

CONCLUSIONS: The findings highlight the importance of self-care behavior, social support, and perceived health status as critical factors influencing QoL among older patients with hypertension. Nurses and other healthcare providers should focus on enhancing these areas through targeted education and support initiatives to improve the overall well-being of this vulnerable population.

PMID:39601033 | PMC:PMC11586613 | DOI:10.33546/bnj.3565

Belitung Nurs J. 2024 Nov 24;10(6):662-669. doi: 10.33546/bnj.3590. eCollection 2024.

ABSTRACT

BACKGROUND: Early pregnancy ultrasound provides a more accurate estimate of the estimated delivery date (EDD) than the last menstrual period (LMP). However, LMP-based EDD calculation remains common in resource-limited settings. Inaccurate EDDs can contribute to adverse birth outcomes. However, research examining the accuracy of LMP-based EDDs and their association with delivery-related adverse events is limited.

OBJECTIVE: This study aimed to evaluate the accuracy of self-reported LMP in predicting EDD and its association with adverse events during delivery.

METHODS: Data were analyzed from 171 pregnant women participating in the Indonesian Birth Cohort Study based in Makassar, Indonesia. This study utilized a prospective cohort design, employing descriptive statistics and Poisson regression analysis in Stata. Adverse events were defined as any unexpected negative occurrence during delivery, including issues related to healthcare access, birth attendance, and the medical condition of the mother and newborn.

RESULTS: Mode of delivery and categorized differences between actual delivery date and estimated delivery date (ADD-EDD) were significantly associated with adverse events during delivery. Cesarean delivery was associated with a higher risk of adverse events compared to vaginal birth (Adjusted Risk Ratio [ARR] 1.11, 95% CI: 1.02-1.22, p <0.001). Additionally, ADD-EDD differences of ≤-15 days (ARR 1.49, 95% CI: 1.35-1.65), -14 to -8 days (ARR 1.33, 95% CI: 1.19-1.49), and ≥15 days (ARR 1.37, 95% CI: 1.20-1.58) showed an increased risk (all p <0.001). An ADD-EDD difference of 8 to 14 days was marginally significant (ARR 1.20, 95% CI: 1.00-1.44, p = 0.046). The ADD-EDD distribution showed notable gaps, with ADD deviations occurring as early as 109 days before and as late as 45 days after the EDD. On average, the ADD occurred approximately one week earlier (-7.15 days) than the EDD.

CONCLUSION: Lower accuracy of LMP-based EDDs and delivery mode is associated with increased adverse events during delivery. Transitioning from LMP-based EDDs to more accurate methods is necessary to improve maternal and neonatal care outcomes. Integrating routine early ultrasound for EDD calculation can better equip healthcare providers and nurses to plan deliveries, reduce risks, and improve patient outcomes in resource-limited settings.

PMID:39601031 | PMC:PMC11586618 | DOI:10.33546/bnj.3590

Belitung Nurs J. 2024 Nov 24;10(6):635-643. doi: 10.33546/bnj.3519. eCollection 2024.

ABSTRACT

BACKGROUND: Chronic kidney disease (CKD) is a leading cause of death, with a rising incidence worldwide. Effective disease management requires health literacy (HL) interventions to optimize patients’ self-management. However, difficulties in communication between patients and healthcare providers often impede improvements in HL. While HL interventions should prioritize enhancing communication quality, current evidence supporting this approach remains limited.

OBJECTIVE: This study aimed to investigate the effectiveness of a Health Literacy Enhancement (HLE) program on CKD knowledge, self-management behaviors, and clinical outcomes in people with CKD.

METHODS: A quasi-experimental study using a two-group pretest-posttest design was conducted from December 2022 to March 2023. Fifty-two participants with stage 3 to 4 CKD, recruited from outpatient CKD clinics in two district hospitals in Central Thailand, were divided into two groups. Participants in the experimental group (n = 25) received the HLE Program based on Baker’s HL concept, while the control group (n = 27) received usual care for 12 weeks. Data were collected twice before and after the 12-week program using a demographic form, CKD knowledge, CKD self-management behaviors (SMBs), and clinical outcomes, including blood pressure (BP), hemoglobin A1c (HbA1c), estimated glomerular rate (eGFR), body mass index (BMI), and waist circumference (WC). Data were analyzed using descriptive statistics, Chi-square, Paired t-test, and Independent t-test.

RESULTS: Following the HLE Program, the experimental group had a significantly higher score in CKD knowledge (t = 8.79, p <0.001) and self-management behaviors (SMBs) (t = 7.70, p <0.001). They also achieved a better average estimated glomerular filtration rate (eGFR) (t = 3.14, p <0.01) and had lower systolic blood pressure (SBP) (t = -2.54, p <0.05) and diastolic blood pressure (DBP) (t = -2.05, p <0.05) compared to the control group and their baseline measures. The effect sizes (Cohen’s d) were substantial, indicating large effects for CKD knowledge (2.44), self-management behaviors (2.14), and eGFR (0.87), while SBP (-0.71) and DBP (-0.55) indicated medium effects. However, no significant differences were observed in HbA1c, BMI, and WC.

CONCLUSION: The HLE program can enhance effective patient-provider communication using plain language, leading to significant improvements in CKD knowledge and SMBs, as well as clinical outcomes, including eGFR and BP. Nurses should implement this program to enhance HL in people with CKD, leading to effective self-management and helping slow the progression of the disease.

TRIAL REGISTRY NUMBER: Thai Clinical Trials Registry (TCTR20240920001).

PMID:39601028 | PMC:PMC11586617 | DOI:10.33546/bnj.3519

Belitung Nurs J. 2024 Nov 24;10(6):680-694. doi: 10.33546/bnj.3560. eCollection 2024.

ABSTRACT

BACKGROUND: Clinical judgment is crucial for nurses in complex healthcare settings. In the Philippines, nursing students must develop critical thinking and decision-making skills to handle resource-limited environments and challenging patient care. However, existing educational methods often fail to engage students and fully promote diverse perspectives.

OBJECTIVE: This study aimed to examine the effect of integrating the Philips 66 technique into Case-Based Learning (CBL) on enhancing clinical judgment competence among Filipino nursing students.

METHODS: This study utilized an explanatory sequential mixed methods design. The quantitative phase involved a true experimental pre-test/post-test design with 60 senior nursing students randomly assigned to intervention (n = 30) and control (n = 30) groups. The intervention group participated in the Philips 66 technique with CBL, while the control group followed standard CBL. Clinical judgment competence was assessed using the Lasater Clinical Judgment Rubric (LCJR) and a researcher-designed/validated questionnaire to measure confidence. Focus group discussions (FGDs) with a subset of the intervention group explored their experiences with the Philips 66 technique. Data were analyzed using descriptive statistics and non-parametric tests for the quantitative component, while thematic analysis was applied to qualitative data.

RESULTS: The intervention group significantly outperformed the control group in both self-reported confidence and overall clinical judgment abilities. The Philips 66-CBL group showed significant improvements (p <0.005, r (effect size) = 0.66 – 0.71) in all areas, while the control group demonstrated significant improvements in information seeking, evaluation/self-analysis, and commitment to improvement (p <0.001, Cohen’s d = 0.54 – 0.617). Qualitative data from FGDs highlighted the value of Philips 66 in fostering teamwork, rapid knowledge sharing, and increased efficiency in addressing clinical scenarios, which are essential skills for nursing practice.

CONCLUSION: The combination of the Philips 66 technique with CBL significantly improves the clinical judgment abilities of Filipino nursing students in a shorter timeframe compared to conventional approaches. Insights from qualitative data highlight its effectiveness in fostering collaborative learning and preparing students for the challenges of dynamic clinical settings. Further research with larger, more diverse samples across different contexts is essential to confirm these findings and explore the long-term influence of Philips 66-CBL on nursing students’ clinical judgment development worldwide.

TRIAL REGISTRY NUMBER: NCT06646068 [clinicaltrias.gov].

PHILIPPINE HEALTH RESEARCH REGISTRY: PHRR241010-007605 [registry.healthresearch.ph].

PMID:39601025 | PMC:PMC11586615 | DOI:10.33546/bnj.3560

Lang Learn Dev. 2024;20(4):364-379. doi: 10.1080/15475441.2024.2342873. Epub 2024 Apr 20.

ABSTRACT

Natural languages contain systematic relationships between verb meaning and verb argument structure. Artificial language learning studies typically remove those relationships and instead pair verb meanings randomly with structures. Adult participants in such studies can detect statistical regularities associated with words in these languages and their use of novel words will adhere to those statistical regularities. However, word use in natural languages is associated with more than distributional statistics. Using an artificial language learning paradigm, we asked how a relationship between verb meaning and sentence structure affected learning and structure generalization. Twenty-four English-speaking adults watched videos described in an artificial language with two possible sentence structures. Half of the participants (statistics-only condition) learned a language with no relationship between verb meaning and sentence structure. The other half (semantics condition) learned a language in which verb meaning predicted which structures a verb occurred in. Although all learners were able to comprehend the learned structures with novel verbs, participants in the semantics conditions made grammaticality judgments and productions with novel verbs that were more consistent with the target language than participants in the statistics-only condition. The availability of semantic cues to verb subcategory supports artificial language learning.

PMID:39601021 | PMC:PMC11588301 | DOI:10.1080/15475441.2024.2342873