Tag: statistics

Int Immunopharmacol. 2021 Mar 12;95:107524. doi: 10.1016/j.intimp.2021.107524. Online ahead of print.

ABSTRACT

OBJECTIVE: Rituximab (RTX) is widely used in the treatment of connective tissue disease (CTD) because it can target and eliminate pathogenic B cells. Interstitial lung disease (ILD) is one of the common complications of CTD; however, the clinical benefits of RTX in connective tissue disease-associated interstitial lung disease (CTD-ILD) are still controversial. This meta-analysis was performed to systematically evaluate the efficacy and safety of RTX in CTD-ILD patients.

METHODS: We performed a systematic online query in PubMed, Cochrane, and Embase up to February 2020. Randomized controlled trials and observational studies on the use of RTX and conventional treatment in CTD-ILD patients were comprehensively reviewed and investigated.

RESULTS: In total, 6 studies, including 242 participants, were analysed. The pooled results showed that RTX is superior to conventional treatment methods in improving forced vital capacity and modified Rodnan skin scores (MRSS) in patients with systemic sclerosis (P＜0. 05), but there was no statistically significant difference between RTX and conventional treatment method in the improvement of lung diffusion function. The risk of adverse effects declined in the RTX therapy groups compared with the conventional therapy groups in terms of infection and the blood system.

CONCLUSION: The pooled results of this meta-analysis indicated that RTX is well tolerated, and RTX is able to improve or stabilize pulmonary function in CTD-ILD patients.

PMID:33721757 | DOI:10.1016/j.intimp.2021.107524

Psychiatry Res. 2021 Feb 24;299:113837. doi: 10.1016/j.psychres.2021.113837. Online ahead of print.

ABSTRACT

ABO blood types and their corresponding antigens have long been assumed to be related to different human diseases. So far, smaller studies on the relationship between mental disorders and blood types yielded contradicting results. In this study we analyzed the association between ABO blood types and lifetime major depressive disorder (MDD). We performed a pooled analysis with data from 26 cohorts that are part of the MDD working group of the Psychiatric Genomics Consortium (PGC). The dataset included 37,208 individuals of largely European ancestry of which 41.6% were diagnosed with lifetime MDD. ABO blood types were identified using three single nucleotide polymorphisms in the ABO gene: rs505922, rs8176746 and rs8176747. Regression analyses were performed to assess associations between the individual ABO blood types and MDD diagnosis as well as putative interaction effects with sex. The models were adjusted for sex, cohort and the first ten genetic principal components. The percentage of blood type A was slightly lower in cases than controls while blood type O was more prominent in cases. However, these differences were not statistically significant. Our analyses found no evidence of an association between ABO blood types and major depressive disorder.

PMID:33721783 | DOI:10.1016/j.psychres.2021.113837

Arch Oral Biol. 2021 Mar 4;125:105103. doi: 10.1016/j.archoralbio.2021.105103. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine nickel levels and their impact on protein carbonylation in gum samples from patients with gingival overgrowth by orthodontic treatment.

DESIGN: A retrospective observational study with 33 patients divided into three groups. Group 1 patients with gingival overgrowth by orthodontic appliances; group 2 patients without gingival overgrowth but with a history of orthodontic treatment; group 3 patients without overgrowth and history of orthodontic appliances. Nickel level in gingiva samples was measured by atomic absorption while protein carbonylation was determined by Western Blot. Furthermore, three proteins were identified in carbonylated protein bands by mass spectrometry.

RESULTS: Statistically significant differences (p < 0,05) in tissue nickel levels among groups were established (nickel levels group 1: 1.33 ± 1.52; group 2: 0.33 ± 0.44; group 3: 0.20 ± 0.22 μg Ni/g tissue). Protein carbonylation was higher in patients with gingival enlargement (group 1) and history of appliance use (group 2) than controls (group 3). It was observed that band A of the Western blots presented the highest intensity (Rf 0.23) with an average intensity of 4.133.830 ± 1.958.569 for group 1; 4.420.146 ± 1.594.679 for group 2 and 2.110. 727 ± 1.640.721 for group 3. Also, the proteins Teneurin-4, Bromodomain adjacent to zinc finger domain protein 2B, Lysine-specific demethylase 5B, and Serum albumin, were identified from oxidized bands.

CONCLUSIONS: The gum of patients with gingival overgrowth by orthodontic appliances contains higher nickel residues and carbonylation of its proteins.

PMID:33721694 | DOI:10.1016/j.archoralbio.2021.105103

Respir Med. 2021 Mar 6;180:106355. doi: 10.1016/j.rmed.2021.106355. Online ahead of print.

ABSTRACT

Non-pharmacological interventions and tracing-testing strategy proved insufficient to reduce SARS-CoV-2 spreading worldwide. Several vaccines with different mechanisms of action are currently under development. This review describes the potential target antigens evaluated for SARS-CoV-2 vaccine in the context of both conventional and next-generation platforms. We reported experimental data from phase-3 trials with a focus on different definitions of efficacy as well as factors affecting real-life effectiveness of SARS-CoV-2 vaccination, including logistical issues associated to vaccine availability, delivery, and immunization strategies. On this background, new variants of SARS-CoV-2 are discussed. We also provided a critical view on vaccination in special populations at higher risk of infection or severe disease as elderly people, pregnant women and immunocompromised patients. A final paragraph addresses safety on the light of the unprecedented reduction of length of the vaccine development process and faster authorization.

PMID:33721697 | DOI:10.1016/j.rmed.2021.106355

Epilepsy Res. 2021 Mar 5;172:106600. doi: 10.1016/j.eplepsyres.2021.106600. Online ahead of print.

ABSTRACT

BACKGROUND: Seizures are a frequent complication after intracerebral hemorrhage (ICH). The CAVE score was developed in Europeans to predict late seizures after ICH. Given the higher incidence of ICH in Asians, we aimed to develop and validate a clinical scoring tool for predicting post-ICH late seizures in Chinese.

METHODS: We retrospectively included patients admitted with ICH to a major stroke center in Shandong province, China, in the derivation cohort, who were followed up for occurrence of late seizures (more than seven days after ICH). We applied Cox regression model to identify significant clinical factors which were used to derive a predictive scoring model. The performance of this model was compared with CAVE, and validated in a separate cohort of patients with ICH admitted to another stroke center.

RESULTS: In the derivation cohort (n = 602; median age 65 years; 57 % male；median follow up 24 months), 47 (7.8 %) patients had late seizures during follow up. Four significant risk factors were identified and selected to derive the LANE score (Lobar hemorrhage, Age <65 years, NIHSS score ≥15, Early seizures). The total possible points ranged from 0 to 6, corresponding to positive predictive values of 10.1%-100%, and negative predictive values of 96.8%-92.2%, respectively. The c-statistics of the LANE score in the derivation cohort and validation cohort (n = 521) were 0.83 and 0.78, respectively, while those of the CAVE score were 0.81 and 0.74, respectively.

CONCLUSION: We have developed and validated a clinical scoring tool for predicting late seizures after ICH in Chinese. This tool may be used to identify high risk patients for closer monitoring and clinical trials of therapies to prevent post-ICH epilepsy in the future.

PMID:33721707 | DOI:10.1016/j.eplepsyres.2021.106600

Eur J Obstet Gynecol Reprod Biol. 2021 Feb 19;260:42-47. doi: 10.1016/j.ejogrb.2021.02.017. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare efficacy of myoinositol as an adjuvant to dietary modification for treatment of gestational diabetes mellitus in Asian Indian women compared to controls.

STUDY DESIGN: Setting: This pilot randomized open label trial was conducted in a single antenatal clinic in India.

SUBJECTS: One hundred women with singleton pregnancy and gestational diabetes diagnosed between 14-28 weeks’ gestation were included. Overt diabetes, twin pregnancy, pre-existing renal disease, heart disease and other chronic medical disorders were exclusions.

INTERVENTION: Participants were randomized in two groups (1:1 ratio) by opaque envelope method. Individualized nutrition counseling with dietary modification and routine antenatal care was provided to all. Fifty women received myoinositol 1000 mg twice daily; 50 controls did not receive myoinositol. Fasting and postprandial glucose levels were assessed after two weeks. Women not achieving glycemic targets (fasting glucose <95 and postprandial glucose <120 mg/dL) were given pharmacologic therapy. Contributory factors in women requiring additional pharmacologic therapy, maternal and fetal outcomes were noted.

STATISTICAL ANALYSIS: Between group comparisons reported relative risk and mean difference. To assess predictive factors for need for pharmacologic therapy, univariate and multivariable logistic regression analysis were used.

RESULTS: Baseline characteristics were comparable in both groups. Except one woman in the myoinositol group, all women provided glycaemia data throughout their pregnancy. Glycemic control was achieved in 44/ 49 (89.8 %) women in myoinositol group which was significantly higher than 34/50 (68 %) in the controls ((relative risk 0.31, 95 % confidence interval 0.13 to 0.80, p = 0.008). Mean duration of myoinositol treatment was 17.6 weeks (standard deviation 5.3). Additional treatment with metformin/insulin was needed in all women failing to achieve glycaemic control. The mean (range) dose of insulin was 25.3 units in myoinositol group compared to 14.27 units in controls (p = 0.058). Secondary outcomes were similar in two groups except baby weight which was higher in controls (p = 0.018).

CONCLUSIONS: Oral supplementation with myoinositol in dose of 1 gm twice-daily, when started soon after the diagnosis of GDM, is effective in achieving glycemic control and decreasing the need for additional pharmacological therapy in Asian Indian women.

PMID:33721623 | DOI:10.1016/j.ejogrb.2021.02.017

Prev Vet Med. 2021 Feb 22;189:105306. doi: 10.1016/j.prevetmed.2021.105306. Online ahead of print.

ABSTRACT

Inadequate transfer of passive immunity (TPI) is associated with increased risk for calfhood disease and increased risk of mortality and morbidity. Accurately diagnosing calves and herds with inadequate TPI is of primary importance and brix (BRIX) or classical refractometer (REF) devices are more practical for this purpose than measuring the serum immunoglobulin G concentration in neonatal calves. We previously reported a systematic review and meta-analysis for quantifying the pooled accuracy of BRIX and REF for detecting calves with serum IgG < 10 g/L noting that sparse data were available especially because studies did not report the same thresholds. We updated the previous systematic review using different methods that accounted for the test results distribution in calves with or without inadequate TPI. With this approach, all reported cut-offs for a specific study are used in that Bayesian approach that quantifies how accuracy varied among all reported thresholds. Five new manuscripts were included, which represented 4 new studies since the initial study was performed. A total of 11 REF and 9 BRIX studies were available. The meta-analytic methods allowed reporting variation of the true and false positive rate across and among all reported cut-offs. Pooled points estimates (95 % Bayesian credible intervals) for sensitivity (Se) and specificity (Sp) of REF < 5.5 g/L were 86.1 % (68.5-97.9%) and 76.2 % (65.9-88.4%) whereas BRIX < 8.4 % was associated with Se of 91.6 % (77.2-99.5%) and Sp of 88.2 % (65.4-99.8%). Interestingly, the accuracy (Se + Sp-1) was generally higher for BRIX than for REF at the reported cut-offs. Besides the benefit of providing pooled estimates for all reported and unreported BRIX and REF thresholds, the general framework used in this study could potentially be used in many veterinary diagnostic tests studies that reported multiple thresholds accounting for potentially different tests distributions in population with and without the target condition.

PMID:33721672 | DOI:10.1016/j.prevetmed.2021.105306

Leuk Lymphoma. 2021 Mar 10:1-9. doi: 10.1080/10428194.2021.1889539. Online ahead of print.

ABSTRACT

The Swedish national guidelines for treatment of acute myeloid leukemia (AML) recommend analysis of measurable residual disease (MRD) by multiparameter flow cytometry (MFC) in bone marrow in the routine clinical setting. The Swedish AML registry contains such MRD data in AML patients diagnosed 2011-2019. Of 327 patients with AML (non-APL) with MRD-results reported in complete remission after two courses of intensive chemotherapy 229 were MRD-negative (70%), as defined by <0.1% cells with leukemia-associated immunophenotype in the bone marrow. MRD-results were reported to clinicians in real time. Multivariate statistical analysis adjusted for known established risk factors did not indicate an association between MFC-MRD and overall survival (HR: 1.00 [95% CI 0.61, 1.63]) with a median follow-up of 2.7 years. Knowledge of the importance of MRD status by clinicians and individualized decisions could have ameliorated the effects of MRD as an independent prognostic factor of overall survival.

PMID:33719843 | DOI:10.1080/10428194.2021.1889539

Clin Exp Optom. 2021 Mar 15:1-4. doi: 10.1080/08164622.2021.1896335. Online ahead of print.

ABSTRACT

CLINICAL RELEVANCE: The relationship between the cornea and systemic autoimmune diseases has been demonstrated in prior studies. Corneal Visualisation Scheimpflug Technology (Corvis ST) provides a specific and detailed assessment of corneal biomechanical features, such as stiffness and elasticity.

BACKGROUND: This study aims to evaluate corneal biomechanical changes in patients with systemic autoimmune diseases using Corvis ST.

METHODS: This prospective study included 36 patients with ankylosing spondylitis (AS), 38 patients with rheumatoid arthritis (RA), and 36 age- and sex-matched healthy subjects. After ophthalmologic examinations Pentacam HR and Corvis ST was performed on all eyes. The mean keratometric and pachymetric data, corneal biomechanical parameters, biomechanical intraocular pressure (bIOP) were analysed.

RESULTS: There was no statistically significant differences among the groups regarding age, gender, refraction, visual acuity, IOP, pachymetry and keratometry. Compared to healthy controls, the mean velocity values of applanation 1 (A1V) and 2 (A2V), deformation amplitude (DA), and corvis biomechanical index (CBI) were statistically significantly higher and stiffness parameter at first applanation (SPA1) was statistically significantly lower in AS and RA patients (all p < 0.05). In both AS and RA groups, disease duration was found to be negatively correlated with SPA1 (p = 0.043, 0.027, respectively) and positively correlated with CBI (p = 0.022, 0.020, respectively).

CONCLUSION: AS and RA patients have a decreased corneal stiffness compared to healthy subjects. Disease duration seems to be correlated with these changes.

PMID:33719873 | DOI:10.1080/08164622.2021.1896335

Leuk Lymphoma. 2021 Mar 10:1-6. doi: 10.1080/10428194.2021.1885663. Online ahead of print.

ABSTRACT

Among acute myeloid leukemia (AML) patients treated with 7 + 3 induction, we evaluate the association between complete morphologic remission (CR) and long-term overall survival (OS) over four decades. We analyzed 1247 patients age ≤65 randomized to 7 + 3 arms from five SWOG studies. OS has improved over the four decades. Hazards for death in the two most recent studies fell after year 2. In multivariable models, decade of therapy was the most important variable with respect to long-term survival and CR by day 100 the second most important variable. Protocol/decade, which captures many factors not included in our multivariable model, was the most important predictor of being alive at year 2 or 3. The next most important factor was achievement of first CR by day 100.

PMID:33719833 | DOI:10.1080/10428194.2021.1885663