Tag: statistics

Hepatol Commun. 2021 Dec 27. doi: 10.1002/hep4.1886. Online ahead of print.

ABSTRACT

The host genetic background for hepatocellular carcinoma (HCC) is incompletely understood. We aimed to determine if four germline genetic polymorphisms, rs429358 in apolipoprotein E (APOE), rs2642438 in mitochondrial amidoxime reducing component 1 (MARC1), rs2792751 in glycerol-3-phosphate acyltransferase (GPAM), and rs187429064 in transmembrane 6 superfamily member 2 (TM6SF2), previously associated with progressive alcohol-related and nonalcoholic fatty liver disease, are also associated with HCC. Four HCC case-control data sets were constructed, including two mixed etiology data sets (UK Biobank and FinnGen); one hepatitis C virus (HCV) cohort (STOP-HCV), and one alcohol-related HCC cohort (Dresden HCC). The frequency of each variant was compared between HCC cases and cirrhosis controls (i.e., patients with cirrhosis without HCC). Population controls were also considered. Odds ratios (ORs) associations were calculated using logistic regression, adjusting for age, sex, and principal components of genetic ancestry. Fixed-effect meta-analysis was used to determine the pooled effect size across all data sets. Across four case-control data sets, 2,070 HCC cases, 4,121 cirrhosis controls, and 525,779 population controls were included. The rs429358:C allele (APOE) was significantly less frequent in HCC cases versus cirrhosis controls (OR, 0.71; 95% confidence interval [CI], 0.61-0.84; P = 2.9 × 10^-5 ). Rs187429064:G (TM6SF2) was significantly more common in HCC cases versus cirrhosis controls and exhibited the strongest effect size (OR, 2.03; 95% CI, 1.45-2.86; P = 3.1 × 10^-6 ). In contrast, rs2792751:T (GPAM) was not associated with HCC (OR, 1.01; 95% CI, 0.90-1.13; P = 0.89), whereas rs2642438:A (MARC1) narrowly missed statistical significance (OR, 0.91; 95% CI, 0.84-1.00; P = 0.043). Conclusion: This study associates carriage of rs429358:C (APOE) with a reduced risk of HCC in patients with cirrhosis. Conversely, carriage of rs187429064:G in TM6SF2 is associated with an increased risk of HCC in patients with cirrhosis.

PMID:34958182 | DOI:10.1002/hep4.1886

J Perinat Med. 2021 Dec 24. doi: 10.1515/jpm-2021-0519. Online ahead of print.

ABSTRACT

OBJECTIVES: Chlamydia trachomatis is one of the most common sexually transmitted diseases in the world, but there are limited data on its impact on perinatal outcomes. Our objective was to investigate the association between chlamydia infections and adverse perinatal outcomes.

METHODS: This is a retrospective analysis of the United States Centers for Disease Control and Prevention natality live birth database for the years 2016-2019. The rates of adverse perinatal outcomes were compared between patients with a chlamydia infection during pregnancy and patients without such infection, using Pearson’s chi-square test with the Bonferroni adjustment. A multivariate logistic regression was then used to adjust outcomes for potential confounders.

RESULTS: Chlamydia infections were associated with small, but statistically significant, increased odds of preterm birth (<37 weeks), early preterm birth (<32 weeks), low birthweight (<2,500 g), congenital anomalies, low 5-min Apgar score (<7), neonatal intensive care unit admission, immediate neonatal ventilation, prolonged (>6 h) neonatal ventilation, and neonatal antibiotic treatment for suspected sepsis.

CONCLUSIONS: Chlamydia infections during pregnancy are associated with adverse perinatal outcomes. These results call for increased education regarding the potential risks of pregnancies with a chlamydia infection, as well as for increased antenatal surveillance and post-natal pediatric assessment in these pregnancies.

PMID:34958185 | DOI:10.1515/jpm-2021-0519

J Nurs Scholarsh. 2021 Dec 27. doi: 10.1111/jnu.12762. Online ahead of print.

ABSTRACT

BACKGROUND: Postoperative pain has adverse effects on children after urology treatment, including sleep disturbance, incision dehiscence, bleeding, and delayed recovery. Parents, as the most direct caregivers of children, can make accurate assessments of children´s personal behaviors and responses, which is very important for the management of postoperative pain in children.

PURPOSE: The purpose of the current study was to develop a Parent Participation in Postoperative Pain Management Program for children in a urology ward and to evaluate its effects on children’s postoperative pain scores and other outcome indicators.

DESIGN: This research comprised two phases. The first phase was the development of a Parent Participation in Postoperative Pain Management Program. The second phase was a randomized controlled trial between two groups, and was carried out in a 45-bed inpatient urology ward of a tertiary children’s hospital in China. In the trial, 211 children and their parents were randomly selected as a control group between July 1 and August 15, 2019, and 202 children and their parents were randomly selected as an intervention group between August 16 and September 15, 2019.

METHODS: Following the framework and methods of the Evidence-based Continuous Quality Improvement Model developed at Fudan University Evidence-Based Nursing Center, we systematically gathered evidence regarding parental involvement in postoperative pain management in children to construct the program. To evaluate the program’s effectiveness, the control group performed routine postoperative pain management, while the intervention group underwent the Parent Participation in Postoperative Pain Management Program. The management period was during hospitalization, and generally ranged 3-7 days. The Statistical Table of Pain Assessment for Children after Urology was employed by researchers.

FINDINGS: The results revealed no significant differences in demographic characteristics between the two groups of children and their parents. Children’s pain scores during dressing removal (Z = -3.108, p = 0.002), at discharge (Z = -2.185, p = 0.029) and during catheter removal (Z = -6.553, p = 0.000) were significantly lower in the intervention group compared with the control group.

CONCLUSIONS AND CLINICAL RELEVANCE: The Parent Participation in Postoperative Pain Management Program was found to be effective for alleviating postoperative pain scores among children, and provided useful information regarding postoperative pain management in children involving four aspects of parental involvement: cognition, guidance, documentation and support.

PMID:34958176 | DOI:10.1111/jnu.12762

J Magn Reson Imaging. 2021 Dec 27. doi: 10.1002/jmri.28028. Online ahead of print.

ABSTRACT

BACKGROUND: Absolute quantification of metabolites in MR spectroscopic imaging (MRSI) requires a stable reference signal of known concentration. The Electronic REference To access In vivo Concentrations (ERETIC) has shown great promise but has not been applied in patients and 3D MRSI. ERETIC hardware has not been integrated with receive arrays due to technical challenges, such as coil combination and unwanted coupling between multiple ERETIC and receive channels, for which we developed mitigation strategies.

PURPOSE: To develop absolute quantification for whole-brain MRSI in glioma patients.

STUDY TYPE: Prospective.

POPULATION: Five healthy volunteers and three patients with isocitrate dehydrogenase mutant glioma (27% female). Calibration and coil loading phantoms.

FIELD STRENGTH/SEQUENCE: A 3 T; Adiabatic spin-echo spiral 3D MRSI with real-time motion correction, Fluid Attenuated Inversion Recovery (FLAIR), Gradient Recalled Echo (GRE), Multi-echo Magnetization Prepared Rapid Acquisition of Gradient Echo (MEMPRAGE).

ASSESSMENT: Absolute quantification was performed for five brain metabolites (total N-acetyl-aspartate [NAA]/creatine/choline, glutamine + glutamate, myo-inositol) and the oncometabolite 2-hydroxyglutarate using a custom-built 4x-ERETIC/8x-receive array coil. Metabolite quantification was performed with both EREIC and internal water reference methods. ERETIC signal was transmitted via optical link and used to correct coil loading. Inductive and radiative coupling between ERETIC and receive channels were measured.

STATISTICAL TESTS: ERETIC and internal water methods for metabolite quantification were compared using Bland-Altman (BA) analysis and the nonparametric Mann-Whitney test. P < 0.05 was considered statistically significant.

RESULTS: ERETIC could be integrated in receive arrays and inductive coupling dominated (5-886 times) radiative coupling. Phantoms show proportional scaling of the ERETIC signal with coil loading. The BA analysis demonstrated very good agreement (3.3% ± 1.6%) in healthy volunteers, while there was a large difference (36.1% ± 3.8%) in glioma tumors between metabolite concentrations by ERETIC and internal water quantification.

CONCLUSION: Our results indicate that ERETIC integrated with receive arrays and whole-brain MRSI is feasible for brain metabolites quantification. Further validation is required to probe that ERETIC provides more accurate metabolite concentration in glioma patients.

EVIDENCE LEVEL: 2 TECHNICAL EFFICACY: Stage 1.

PMID:34958166 | DOI:10.1002/jmri.28028

Asian J Endosc Surg. 2021 Dec 27. doi: 10.1111/ases.13023. Online ahead of print.

ABSTRACT

BACKGROUND: In parastomal hernia (PH) repair, laparoscopic Sugarbaker technique (LS) is considered the best practice; however, meshes specific for LS repairs ceased to be available.

PURPOSE: The aim of the study was to evaluate feasibility of using a physician-modified mesh (tailored mesh: TM) in LS.

METHODS: Thirty-three patients who underwent LS for PH between June 2012 and September 2021 were examined to compare surgical outcomes between LS with TM (n = 11) and with a ready-made specific mesh (SM, n = 22). All meshes were coated plastic meshes. Statistical analysis was performed with the Mann-Whitney U test and Fisher’s exact test. P < .05 was considered to be statistically significant.

RESULTS: We compared the outcomes of TM with SM in LS for similar hernia types during median follow-up periods of 23 (range, 2-29) and 74 (range, 36-110) months (P < .0001), respectively. The median operation times were 146 (range, 45-423) for TM and 193 (range, 65-386) minutes for SM (P = .2301). Perioperative complications were observed in one TM patient (9%) and two SM patients (9%) (P = 1.0000). The lengths of postoperative stay were similar. Recurrence was observed in two cases in the SM group (9%) within 1 year after the operation.

CONCLUSION: In LS, TM seems to be a feasible mesh comparable to SM within short- and mid-term follow-up.

PMID:34958170 | DOI:10.1111/ases.13023

Australas J Dermatol. 2021 Dec 27. doi: 10.1111/ajd.13780. Online ahead of print.

ABSTRACT

Anecdotal evidence suggests that selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) cause cutaneous adverse drug reactions (CADRs). However, there is limited information on the factors associated with these occurrences. In this study, we aimed to describe the demographic, clinical and pharmacological characteristics associated with CADRs encountered by patients administered SSRIs and/or SNRIs for psychiatric diagnoses and to compare the differences in these factors between severe and non-severe CADRs. A protocol was developed a priori (PROSPERO: CRD42020204830) in line with the PRISMA guidelines. We searched PubMed/Medline, PsycINFO and SCOPUS from inception to October 2020 to identify case reports and/or case series of SSRI and SNRI associated CADRs. Additional cases were obtained from the retrieved articles’ bibliography. A total of 141 articles were included in the study, documenting 173 CADRs. Females accounted for 128 (74.0%) of the analysed CADRs. The median age of the cases was 42 IQR (27; 53) with no statistically significant differences in age between males and females (P = 0.542). A total of 157 (90.8%) of the reported CADRs were associated with SSRIs, particularly fluoxetine 68 (39.5%), sertraline 30 (17.4%) and paroxetine 25 (14.5%). Non-severe CADRs and severe CADRs accounted for 23 (13.4%) and 149 (86.6%) reports respectively. No statistically significant differences were observed for gender (P = 0.616), age at onset (P = 0.493) and time to onset (P = 0.105) between non-severe CADRs and SCARs. In conclusion, CADRs following SSRIs and SNRIs disproportionately affect females in the reproductive age group compared to males and are mostly associated with SSRIs.

PMID:34958129 | DOI:10.1111/ajd.13780

Am J Hypertens. 2021 Dec 27:hpab195. doi: 10.1093/ajh/hpab195. Online ahead of print.

ABSTRACT

BACKGROUND: Targeted treatment of primary aldosteronism (PA) is informed by adrenal vein sampling (AVS), which remains limited to specialized centers. Clinical prediction models have been developed to help select patients who would most likely benefit from AVS. Our aim was to assess the performance of these models for PA subtyping.

METHODS: This external validation study evaluated consecutive patients referred for PA who underwent AVS at a tertiary care referral center in Alberta, Canada during 2006-2018. In alignment with the original study designs and intended uses of the clinical prediction models, the primary outcome was the presence of lateralization on AVS. Model discrimination was evaluated using the C-statistic. Model calibration was assessed by comparing the observed vs. predicted probability of lateralization in the external validation cohort.

RESULTS: The validation cohort included 342 PA patients who underwent AVS (mean age, 52.1 years [SD, 11.5]; 201 [58.8%] male; 186 [54.4%] with lateralization). Six published models were assessed. All models demonstrated low-to-moderate discrimination in the validation set (C-statistics; range, 0.60-0.72), representing a marked decrease compared to the derivation sets (range, 0.80-0.87). Comparison of observed and predicted probabilities of unilateral PA revealed significant miscalibration. Calibration-in-the-large for every model was >0 (range, 0.35-1.67), signifying systematic underprediction of lateralizing disease. Calibration slopes were consistently <1 (range, 0.35-0.87), indicating poor performance at the extremes of risk.

CONCLUSIONS: Overall, clinical prediction models did not accurately predict AVS lateralization in this large cohort. These models cannot be reliably used to inform the decision to pursue AVS for most patients.

PMID:34958097 | DOI:10.1093/ajh/hpab195

Eur J Clin Invest. 2021 Dec 26:e13735. doi: 10.1111/eci.13735. Online ahead of print.

ABSTRACT

BACKGROUND: It is uncertain whether higher doses of anticoagulants than recommended for thromboprophylaxis are necessary in COVID-19 patients hospitalized in general wards METHODS: This is a multicentre, open-label, randomized trial performed in 9 Italian centres, comparing 40 mg b.i.d. versus 40 mg o.d. enoxaparin in COVID-19 patients, between April 30 2020 and April 25 2021. Primary efficacy outcome was in-hospital incidence of venous thromboembolism (VTE): asymptomatic or symptomatic proximal deep vein thrombosis (DVT) diagnosed by serial compression ultrasonography (CUS), and/or symptomatic pulmonary embolism (PE) diagnosed by computed tomography angiography (CTA). Secondary endpoints included each individual component of the primary efficacy outcome and a composite of death, VTE, mechanical ventilation, stroke, myocardial infarction, admission to ICU. Safety outcomes included major bleeding.

RESULTS: The study was interrupted prematurely due to slow recruitment. We included 183 (96%) of the 189 enrolled patients in the primary analysis (91 in b.i.d., 92 in o.d.). Primary efficacy outcome occurred in 6 patients (6.5%, 0 DVT, 6 PE) in the o.d. group and 0 in the b.id. group (ARR 6.5, 95% CI: 1.5-11.6). The absence of concomitant DVT and imaging characteristics suggests that most pulmonary artery occlusions were actually caused by local thrombi rather than PE. Statistically nonsignificant differences in secondary and safety endpoints were observed, with two major bleeding events in each arm.

CONCLUSIONS: No DVT developed in COVID-19 patients hospitalized in general wards, independently of enoxaparin dosing used for thromboprophylaxis. Pulmonary artery occlusions developed only in the o.d. group. Our trial is underpowered and with few events.

PMID:34958123 | DOI:10.1111/eci.13735

Biostatistics. 2021 Dec 27:kxab042. doi: 10.1093/biostatistics/kxab042. Online ahead of print.

ABSTRACT

Univariate spatio-temporal models for areal count data have received great attention in recent years for estimating risks. However, models for studying multivariate responses are less commonly used mainly due to the computational burden. In this article, multivariate spatio-temporal P-spline models are proposed to study different forms of violence against women. Modeling distinct crimes jointly improves the precision of estimates over univariate models and allows to compute correlations among them. The correlation between the spatial and the temporal patterns may suggest connections among the different crimes that will certainly benefit a thorough comprehension of this problem that affects millions of women around the world. The models are fitted using integrated nested Laplace approximations and are used to analyze four distinct crimes against women at district level in the Indian state of Maharashtra during the period 2001-2013.

PMID:34958093 | DOI:10.1093/biostatistics/kxab042

Malays J Pathol. 2021 Dec;43(3):425-434.

ABSTRACT

INTRODUCTION: In line with the association of prostaglandin-endoperoxide synthase 2 (PTGS2) and defensin beta 1 (DEFB1) single nucleotide polymorphisms (SNPs) with periodontitis among the Chinese and European populations, the current study was aimed to assess the same association among the Malays in Malaysia.

METHODS: Blood samples of individuals with periodontitis (PD) (n=72) and periodontally healthy (PH) (n=62) donors were obtained from Malaysian Periodontal Database and Biobanking system (MPDBS). Genomic DNA samples were analyzed for three PTGS2 SNPs (rs5275, rs20417, rs689466,) and one DEFB1 SNP (rs1047031) using Taqman SNP genotyping assays. Notably, rs20417 and rs689466 were located in the promoter region while rs5275 and rs1047031 were located in the 3′ untranslated region of the transcript. Association between the SNPs and PD were then analyzed using genotypic association analysis (additive, dominant and recessive models).

RESULTS: The allelic frequency for the rs689466-G was higher in PD group (35.2%) compared that in PH group (29.0%). However, the association of rs689466-G and other SNPs with PD was not statistically significant (at 95% CI). No associations were observed for genotypic associations between the PTGS2 and DEFB1 SNPs with PD susceptibility.

CONCLUSIONS: PTGS2 (rs5275, rs20417, and rs689466) and DEFB1 (rs1047031) polymorphism was not associated with PD in Malays, unlike the Chinese, Taiwanese & European population. This suggests that other causal variants might be involved in the development and progression of PD among Malays.

PMID:34958064