Tag: statistics

Med J Malaysia. 2025 Mar;80(2):118-126.

ABSTRACT

INTRODUCTION: Cirrhosis is common in Malaysia, but no questionnaire in the local language (Malay) has been developed to assess patients’ knowledge of this disease. This study aimed to adapt and validate the Malay Adult cirrhosiS Knowledge Questionnaire (ASK-QM).

MATERIALS AND METHODS: ASK-QM was translated from English to Malay according to international guidelines. It was validated among cirrhotic patient who understand Malay language from two major liver centers in Klang Valley, Malaysia (University of Malaya and Hospital Selayang) from January 2021 to March 2022, at week 0 and 2. Patients with hepatic encephalopathy were excluded.

RESULTS: 121 out of 132 patients with cirrhosis agreed to participate (response rate=91.7%). The overall median score of the ASK-QM was 54.5 [38.6-68.2] and the difficulty factor was 0.5 (range: 0.1-0.8 for each domain). Confirmatory factor analysis showed a good model fit with results of Comparative fit index (CFI) ranging from 0.836 to 1.000, whilst, the Tucker-Lewis index (TLI) ranged from 0.690 to 1.004 across all four domains. The root mean square error of approximation (RMSEA) value was reported from 0.000 to 0.100. For standardized root mean squared residual (SRMR) was from 0.008 to 0.015. Patients with tertiary education scored higher compared to those without (63.6 [45.5-77.3] vs 52.3 [36.4-63.6], p<0.05). The overall Kuder-Richardson (KR) coefficient was 0.761 indicating adequate internal consistency. Test-retest among 82 out of 121 patients (response rate=67.7%) demonstrated adequate reliability with eighteen out of 22 items having Wilcoxon signed-rank test values that were statistically not significant, p>0.005.

CONCLUSION: The ASK-QM was found to be a valid and reliable questionnaire for evaluating knowledge of liver cirrhosis amongst Malay-speaking adults.

PMID:40145151

Clin J Pain. 2025 Mar 27. doi: 10.1097/AJP.0000000000001290. Online ahead of print.

ABSTRACT

OBJECTIVES: The assessment of the spatial characteristics of pain, such as location and extent, is essential in the clinical evaluation of pain syndromes, especially when managing patient’s with chronic musculoskeletal pain. This study evaluated the convergent validity of pain drawings (PDs) and anatomical checklists (ACLs) in measuring pain location (PL) and pain extent (PE) in individuals with chronic musculoskeletal pain.

METHODS: Twenty volunteers participated, each completing a PD and an ACL in a randomized order following standardized training. PDs were digitized and analyzed using a custom algorithm on a web platform. PL was categorized across 45 anatomical areas. PE was assessed using a region-weighted approach by means of the Margolis rating scale and a pixel-based method. Statistical analyses included Spearman’s rho and the Jaccard Index to compare the obtained PD metrics.

RESULTS: A strong correlation was found between a PDs and ACLs for PE (Spearman’s rho=0.823), suggesting similar capabilities in quantifying the spatial distribution of pain. However, a significant discrepancy in PL measurements, with a mean Jaccard Index of 0.54, indicated poor agreement between methods.

DISCUSSION: These results highlight the non-interchangeability of these instruments for PL identification and underscore the importance of each tool’s unique advantages and limitations. The study also highlighted the potential benefits of incorporating innovative pain metrics into current health questionnaires to enhance their clinimetric properties. These findings advocate for continued research with larger and more diverse patient cohorts to further validate PDs and ACLs and to explore additional psychometric properties for pain assessment.

PMID:40145148 | DOI:10.1097/AJP.0000000000001290

Front Immunol. 2025 Mar 12;16:1526318. doi: 10.3389/fimmu.2025.1526318. eCollection 2025.

ABSTRACT

BACKGROUND: Relevant studies have demonstrated the poor treatment outcomes and prognosis for double-expressor diffuse large B cell lymphoma (DE-DLBCL) in the rituximab era. Zanubrutinib plus R-CHOP (rituximab, cyclophosphamide, doxorubicin/liposomal doxorubicin, vincristine, prednisone; ZR-CHOP) has shown efficacy in untreated non-GCB DLBCL patients with extranodal involvement. However, its efficacy in newly diagnosed DE-DLBCL remains uncertain.

OBJECTIVE: This retrospective study sought to assess the efficacy and safety of ZR-CHOP in comparison to R-CHOP in treatment-naïve patients with DE-DLBCL.

METHOD: This study assessed 78 patients with newly diagnosed DE-DLBCL who were admitted between June 2017 and January 2024. Among them, 55 patients received the R-CHOP regimen, while 23 patients were treated with the ZR-CHOP regimen. The clinical characteristics were well balanced between the two groups.

RESULTS: The complete response rates (CRR) were higher in the ZR-CHOP group than the R-CHOP group, regardless of whether patients completed 4 or 6 treatment cycles (P= 0.019; P= 0.025). ORR in the ZR-CHOP group showed a higher trend than that in the R-CHOP group (P= 0.624; P= 0.219). The median follow-up period was 23.3 months, and the predicted median progression free survival (PFS) in the R-CHOP group was 22.8 months, whereas the median PFS in the ZR-CHOP group was not reached. The 1-, 2-, and 3-year PFS rates in the ZR-CHOP group showed a beneficial trend compared with the R-CHOP group, but there was no statistical difference (P= 0.072). However, the PFS of the ZR-CHOP group was longer than that of the R-CHOP group in patients with Ki67 index >75% (P= 0.034) and p53 expression >50% (P= 0.0033). The predicted median overall survival (OS) in the ZR-CHOP and R-CHOP groups were not reached. The 1-, 2- and 3-year OS rates were not significantly different between the two groups (P= 0.29). The most common adverse event in both groups was hematotoxicity, but there was no significant difference in the incidence of all adverse events between the two groups.

CONCLUSION: First-line treatment with the ZR-CHOP regimen improved CRR in the untreated patients with DE-DLBCL and prolonged PFS in the Ki67 index >75% subgroup and the p53 expression >50% subgroup.

PMID:40145086 | PMC:PMC11936942 | DOI:10.3389/fimmu.2025.1526318

N Am Spine Soc J. 2025 Feb 13;21:100594. doi: 10.1016/j.xnsj.2025.100594. eCollection 2025 Mar.

ABSTRACT

BACKGROUND: Adjacent segment disease (ASD) is one of the most common complications after spinal fusion. There are several risk factors for ASD, but recently the quality of the paraspinal musculature has been implicated as a potential risk factor. The purpose of this study is to examine the association between paraspinal muscle degeneration and risk of surgery for ASD.

METHODS: We conducted a retrospective review of spinal fusion patients at our institution from 2009 to 2022 who underwent subsequent surgery for ASD. Inclusion criteria included patients aged 18 and older at time of index operation. Control cohort included patients who did not undergo subsequent surgery for adjacent segment disease with a minimum one year follow up. Patients were matched based on age, gender, and BMI. We measured paraspinal fat percentage and circumferential surface area (CSA) at L3 and at the proximal end of their future construct. Paraspinal fat percentage and CSA were measured using ImageJ (National Institutes of Health, Bethesda, Maryland, USA). Student T-test was used to evaluate for statistically significant differences with p-value ≤ .05.

RESULTS: A total of 154 patients were reviewed with 77 patients in each cohort. The average age and BMI in the control group was 61.3 and 30.0 versus 61.2 and 29.6 in patients who underwent subsequent surgery. Overall, patients who underwent surgery for adjacent segment disease had 24% higher paraspinal fat percentage at L3 (13.8 ± 7.7% vs. 11.1 ± 6.5%, p-value = .02) and 22% higher paraspinal fat percentage at the top end of their construct (16.0 ± 9.0% vs. 13.1 ± 7.1%, p-value = .03).

CONCLUSIONS: Our study found that patients who undergo surgery for adjacent segment disease have 24% higher fat percentage in their paraspinal musculature at L3 and 22% higher fat percentage at the proximal end of their fusion construct.

PMID:40145066 | PMC:PMC11938154 | DOI:10.1016/j.xnsj.2025.100594

JHLT Open. 2024 Aug 12;6:100147. doi: 10.1016/j.jhlto.2024.100147. eCollection 2024 Nov.

ABSTRACT

BACKGROUND: Combined heart-liver transplantation (CHLT) is a complex procedure with rising demand and is subject to ongoing assessment. Here, we provide an update on indications, patient outcomes, and risk factors.

METHODS: This retrospective study utilized CHLT data from the United Network for Organ Sharing registry between 1990 and 2023. Recipient and donor characteristics, and risk factors for mortality were analyzed using Cox regression hazard models. Recipient and graft survival at 30 days, 1 year, and 5 years were analyzed using the Kaplan-Meier method.

RESULTS: This cohort included 532 patients with median survival of 16.9 years (SD: 1.09). The most common indications for CHLT were congenital heart disease (36%) and dilated cardiomyopathy (31%). Patient survival at 30 days, 1 year, and 5 years were 94%, 85%, and 77%, respectively. Combined heart-liver graft survival was 93%, 85%, and 77%, respectively. Diabetes (hazard ratio [HR]: 1.74; p = 0.04) was associated with multigraft failure and mortality in multivariate analysis. Compared to congenital heart disease, dilated (HR: 0.55; p = 0.03) and restrictive myopathies (HR: 0.5; p = 0.03) were associated with improved graft and overall survival. Higher donor left ventricular ejection fraction (EF) was also associated with improved graft and overall survival (HR: 0.96; p = 0.008).

CONCLUSIONS: CHLTs are being performed at increasingly higher rates with comparable survival to single-organ transplants. Diabetes was associated with increased mortality. Recipient dilated or restrictive myopathies and higher donor EF were correlated with improved survival compared to congenital heart disease. Further studies are needed to better understand these observations.

PMID:40145062 | PMC:PMC11935517 | DOI:10.1016/j.jhlto.2024.100147

JHLT Open. 2024 Sep 5;6:100154. doi: 10.1016/j.jhlto.2024.100154. eCollection 2024 Nov.

ABSTRACT

BACKGROUND: Heart transplantation is the gold standard treatment for end-stage heart failure patients. However, the shortage of donor hearts limits its applicability. This study aims to evaluate the risk factors associated with survival within 1-year after heart transplantation.

METHODS: A single-center retrospective cohort study evaluated 299 adult patients who underwent transplantation at the Heart Institute (Incor) between January 2013 and December 2019. Univariate and multivariate Cox regression analyses were conducted to identify independent predictors of 1-year survival among well-established prognostic clinical characteristics described in the literature. Patients were followed until death or the last observation on October 12, 2022. A Simple Risk Index was created based on the hazard ratio of each factor.

RESULTS: Chagas disease was the most common cause of cardiomyopathy (36%). Most patients were male (65%) with a median age of 50 (39-58) years. Four variables observed during the last clinical assessment in the intensive care unit before surgery were found to be statistically significant: maximum Sequential Organ Failure Assessment (SOFA) score, creatinine clearance in 3 quartile categories, C-reactive protein in 3 categories, and white blood cell count in 3 categories. The model demonstrated good discrimination (C-index = 0.74) and calibration. The group at high risk (>20 points) exhibited significantly higher mortality rates at 1 year (p < 0.001).

CONCLUSIONS: The study introduces a risk prediction score for 1-year post-transplant mortality in a reference center in Brazil. The score is based on four variables: maximum SOFA score, creatinine clearance, C-reactive protein, and white blood cell count.

PMID:40145057 | PMC:PMC11935338 | DOI:10.1016/j.jhlto.2024.100154

JHLT Open. 2024 Aug 28;6:100155. doi: 10.1016/j.jhlto.2024.100155. eCollection 2024 Nov.

ABSTRACT

BACKGROUND: Donor-derived cell-free DNA (dd-cfDNA) is a nonspecific plasma biomarker for tissue injury that has been validated for monitoring acute rejection (AR) after lung transplantation (LT). However, no studies to date have focused specifically on single lung transplantation (SLT). Herein, we report the performance of dd-cfDNA in detecting AR in SLT from 6 academic centers that implemented this biomarker surveillance in their standard of practice (SOP).

METHODS: dd-cfDNA test results were corrected for SLT by an algorithm in the Clinical Laboratory Improvement Amendments (CLIA) laboratory to permit comparison against the same 1.0% threshold used in double-lung transplant. Investigators reviewed patient SOP electronic medical record clinical data to assign test results into cohorts based on clinical allograft health status. To avoid ambiguity in interpretation, samples drawn after a prior AR or infection event or without histopathologic confirmation of AR were excluded from further analysis. Diagnostic cohorts included AR (N=25 samples), healthy (STABLE, N=137), allograft infection (INFXN, N=41), chronic lung allograft dysfunction (CLAD, N=7), and “OTHER” types of graft injury (N=12).

RESULTS: The study included a total of 257 dd-cfDNA results from 103 SLT patients with one patient excluded due to active cancer. Samples were drawn a median of 233 days (interquartile range: 96-489) after SLT. Laterality for SLT (R vs L) and median dd-cfDNA fraction in AR and STABLE cohort were not statistically different. The median dd-cfDNA fraction was elevated with AR (1.8%) and INFXN (1.1%) vs STABLE (0.46%; p < 0.0001). dd-cfDNA with CLAD was also significantly higher than STABLE cohort (p = 0.0155). The area under receiver operator characteristics curve was 0.850 (95% confidence interval: 0.72-0.95, p < 0.0001) for AR vs STABLE cohort. Applying the dd-cfDNA threshold ≥1.0% for detection of AR yielded a sensitivity = 77.8%, specificity = 84.6%, positive predictive value = 38.31%, and negative predictive value = 96.83%.

CONCLUSIONS: These multicenter data, incorporating real-world experiences, support the clinical validity and utility of dd-cfDNA monitoring of SLT recipients. Additional studies of the impact of biomarker surveillance on clinically meaningful outcomes should be forthcoming from robust, prospective, and clinical trials already in progress.

PMID:40145054 | PMC:PMC11935494 | DOI:10.1016/j.jhlto.2024.100155

JHLT Open. 2024 Sep 26;6:100159. doi: 10.1016/j.jhlto.2024.100159. eCollection 2024 Nov.

ABSTRACT

BACKGROUND: This study investigated oxygen handling of human hearts donated after circulatory death (DCD) on normothermic ex-situ heart perfusion (ESHP) and evaluated oxygen handling markers as adjuncts to cardiac viability assessment.

METHODS: This single-center retrospective study included human DCD heart transplantation procedures using ESHP. Lactate concentrations, blood gas, myocardial oxygen consumption (MVO₂), delivery (MDO₂), and extraction (MEO₂), coronary blood flow (CBF), coronary vascular resistance (CVR), and adenosine infusion were reported over time. Correlation between parameters was assessed, and statistical testing compared patients who did and did not require extracorporeal membrane oxygenation (ECMO) support after transplantation.

RESULTS: Lactate concentrations decreased during ESHP in all transplanted hearts (n = 25) and increased in 1 rejected heart. Arterial partial pressure of oxygen (PO₂) was 75.2 ± 2.9 kPa, with an arteriovenous ΔPO₂ of 44.8 ± 10.4 kPa. Oxygen saturation was 100% in most arterial and venous samples. Average MVO₂ was 2.7 ± 0.6 ml/min/100 g myocardium, MDO₂ 98.5 ± 20.4 ml/min, and MEO₂ 8.6 ± 1.8%. Average CVR was 0.025 ± 0.006 mm Hg min/ml/100 g and increased over time. ΔPO₂ correlated strongly with MVO₂ (R = 0.797, p < 0.001) and lactate trend (R = 0.799, p < 0.001) in transplanted hearts, without differences compared to the rejected heart with increasing lactate. Adenosine infusion on ESHP was significantly higher in patients requiring ECMO post-transplantation vs non-ECMO cases (11.7 (4.5-21.0) vs 2.2 (1.5-6.7) ml/h, p = 0.039).

CONCLUSIONS: Hearts on normothermic ESHP receive excessive MDO₂, due to high PO₂ and CBF, while the MVO₂ is relatively low. Thus, CBF and PO₂ can potentially be lowered. Furthermore, ΔPO₂ could serve as additional marker of metabolic function under these hyperoxic circumstances. The adenosine infusion rate might predict post-transplantation ECMO requirement.

PMID:40145048 | PMC:PMC11935508 | DOI:10.1016/j.jhlto.2024.100159

Med Sci (Basel). 2025 Mar 12;13(1):29. doi: 10.3390/medsci13010029.

ABSTRACT

BACKGROUND: Synthetic 2D mammography was developed to decrease radiation exposure, but to our knowledge there have been no studies evaluating the impact of implementation of full field synthetic mammography/digital breast tomosynthesis (FFSM/DBT) on indications for stereotactic biopsy.

OBJECTIVE: To compare indications and biopsy outcomes for stereotactic biopsy for full field digital mammography (FFDM/DBT) to those of FFSM/DBT.

METHODS: Retrospective chart review of stereotactic biopsies performed from July 2014 to September 2018. Reports were reviewed and indication for biopsy, lesion size, and final pathology were recorded. Comparison between the two groups following transition to FFSM/DBT in 2016 was performed.

RESULTS: 66 of 361 stereotactic biopsies performed in the FFDM/DBT group were malignant (PPV 18.3%), compared to 60 of the 391 biopsies performed in the FFSM/DBT group (PPV 15.4%) with no significant difference in PPV (p = 0.281). There were statistically significant changes in indications for biopsies after transitioning to FFSM/DBT: with a decrease in calcifications referred for biopsy (68.03% vs. 89.75%; p < 0.001), and a statistically significant increase in referral of masses (10.74% vs. 4.43%; p < 0.001), asymmetries (15.60% vs. 5.26%; p < 0.001), and architectural distortion (5.63% vs. 0.55%; p < 0.001). PPV across all indications (21.8% in FFSM/DBT vs. 20.3% in FFDM; p = 0.213), and invasive cancer yield (5.63% vs. 3.32%; p = 0.129) remained comparable following transition to FFSM/DBT without statistically significant differences.

CONCLUSIONS: Following transition to FFSM/DBT, statistically significant shifts in indications for biopsies were observed with a decrease in referral of calcifications and an increase for masses, asymmetries and architectural distortions. PPV for stereotactic biopsy was not significantly different and cancer yield across all indications remained similar, with an increase in invasive cancer diagnosis.

PMID:40137449 | DOI:10.3390/medsci13010029

Med Sci (Basel). 2025 Mar 1;13(1):25. doi: 10.3390/medsci13010025.

ABSTRACT

Background/Objectives: Stress urinary incontinence (SUI) is a common and often under-reported condition that significantly impacts quality of life. SUI is more than just a physical issue; it can also affect social interactions, mental health, and emotional well-being due to the embarrassment and limitations it can cause. SUI is often acquired during pregnancy and childbirth as a result of pelvic floor muscle weakness. The aim of this study was to evaluate the effectiveness of an innovative dual-wavelength laser system (CO₂ + 1540 nm) in SUI management. Methods: A total of 56 women affected by SUI were enrolled in this study. Half of the patients were treated with CO₂ alone, while the other half were treated with the combination of CO₂ + 1540 nm wavelengths. The patients were split into four groups based on the type of treatment they received and their menopausal status. Data were acquired at baseline and at various follow-ups (T1, T2, and T3, respectively, after the first, second, and third treatment). The Visual Analog Scale (VAS) (score 0-10) was used. Cystoscopic images were acquired before and at the end of the laser treatment cycle. Results: At the end of the treatment, the patients in each group were very satisfied, on average. In each group, the treatment led to a statistically significant improvement in the SUI VAS score between baseline and follow-up after the first treatment; in both groups 3 and 4, the treatment led to a significant change in the dryness score, both from baseline to T1 (p < 0.05) and also for T2 and T3 compared to baseline. Finally, cystoscopic photos showed an evident increase in mucosa epithelial thickness after the laser treatment cycle. Conclusions: The use of a dual-wavelength laser system (CO₂ + 1540 nm) was proven to be well tolerated and safe, with promising outcomes in reducing SUI symptoms, especially in non-menopausal patients.

PMID:40137445 | DOI:10.3390/medsci13010025