Category: Statistics

Exp Clin Transplant. 2021 Dec;19(12):1334-1340. doi: 10.6002/ect.2021.0402.

ABSTRACT

OBJECTIVES: Vaccination against SARS-CoV-2 may reduce COVID-19 mortality and complications in solidorgan transplant recipients, and we evaluated the associated antibody responses and adverse effects in this high-risk population.

MATERIALS AND METHODS: This prospective observational study (April-June 2021) included 10 liver and 38 kidney transplant recipients who received 2 vaccine doses (Sinovac, n = 31; or BioNTech, n = 17) and 56 healthy adults (Sinovac), all of whom provided 3 blood samples (prevaccination, 4 weeks after first dose, and 4-6 weeks after second dose) for quantitative tests (Abbott Quant assay forimmunoglobulin G antibodies against SARS-CoV-2 spike protein). Type I error was α = .05 in all statistical analyses (SPSS, version 25).

RESULTS: We analyzed demographic data, antibody responses, and adverse events after 2 doses of SARSCoV-2 vaccine, comparedimmune responses from solidorgan transplant recipients (median age, 36.5 years) versus healthy patients (median age, 37.5 years), and observed significantly higher seropositivity in healthy versus transplant patients after Sinovac vaccination (100% vs 67.5%; P = .001). However, we observed no significant seropositive differences for Sinovac versus BioNTech second doses in transplantrecipients. Median SARS-CoV-2 immunoglobulin G level after second dose was significantly higher in BioNTech (1388.6 AU/mL) versus Sinovac patients (136.6 AU/mL) (P = .012). The seropositivity difference between the 2 vaccines was significant in participants 24 to 44 years old (P = .040). The rate of at least 1 side effect was 82.4% (n = 14) for BioNTech vaccine and 32.3% (n = 10) for Sinovac vaccine, and the difference was statistically significant.The most common side effect was arm pain (significantly higher in BioNTech group).

CONCLUSIONS: Solid-organ transplant recipients demonstrated inadequate vaccine responses (higher risk of complications and mortality) versus healthy patients. Furthermore, immune responses may differ between vaccines. Therefore, additional vaccine doses and strict control measures remain crucial.

PMID:34951350 | DOI:10.6002/ect.2021.0402

Stat Methods Med Res. 2021 Dec 24:9622802211064996. doi: 10.1177/09622802211064996. Online ahead of print.

ABSTRACT

Many clinical trials incorporate stopping rules to terminate early if the clinical question under study can be answered with a high degree of confidence. While common in later-stage trials, these rules are rarely implemented in dose escalation studies, due in part to the relatively smaller sample size of these designs. However, even with a small sample size, this paper shows that easily implementable stopping rules can terminate dose-escalation early with minimal loss to the accuracy of maximum tolerated dose estimation. These stopping rules are developed when the goal is to identify one or two dose levels, as the maximum tolerated dose and co-maximum tolerated dose. In oncology, this latter goal is frequently considered when the study includes dose-expansion cohorts, which are used to further estimate and compare the safety and efficacy of one or two dose levels. As study protocols do not typically halt accrual between escalation and expansion, early termination is of clinical importance as it either allows for additional patients to be treated as part of the dose expansion cohort to obtain more precise estimates of the study endpoints or allows for an overall reduction in the total sample size.

PMID:34951338 | DOI:10.1177/09622802211064996

Clin Exp Hypertens. 2021 Dec 24:1-8. doi: 10.1080/10641963.2021.2018599. Online ahead of print.

ABSTRACT

INTRODUCTION: Left ventricular (LV) diastolic dysfunction and structural abnormalities are common cardiac changes in hypertension (HTN), and several factors other than high blood pressure (BP) may play a role in these changes. The aim of this study was to reveal the relationship between triglyceride glucose (TyG) index, a novel parameter for insulin resistance (IR), with LV diastolic function and structure in hypertensive patients.

MATERIAL AND METHOD: A total of 119 newly diagnosed, untrated hypertensive patients free of diabetes and/or cardiovascular complications were included in this study. IR was estimated with the TyG index calculated from ln [fasting TG (mg/dL) × fasting blood glucose (mg/dL)/2]. Two-dimensional and Doppler echocardiographic examinations were performed to assess LV diastolic functions and structure.

RESULTS: Based on median TyG index, 51 patients was assigned as group I (<8.7) and 68 patients as group II (>8.7). In patients with high TyG index, left atrial volume index (LAVi) (p < .001) LV mass index (LVMI) (p = .016), E/e‘ ratio (p < .001) increased, and e’ velocity (p < .001) and E/A ratio (p = .028) decreased. There was a statistically significant correlation between TyG index and these parameters (all p > .05). Stepwise multiple regression analysis demonstrated that the relationship of TyG index with LV diastolic function and structure was independent of potential confounders (all p < .001).

CONCLUSION: This study suggest that a high TyG index is related to LV diastolic functional impairment and structure abnormality in newly diagnosed hypertensive patients in the absence of diabetes or CVD.

PMID:34951339 | DOI:10.1080/10641963.2021.2018599

Ann Clin Biochem. 2021 Dec 24:45632211063142. doi: 10.1177/00045632211063142. Online ahead of print.

ABSTRACT

OBJECTIVE: A series of physiological changes in thyroid function occur during pregnancy and differ from those non-pregnant women. This study aimed to establish the pregnancy-specific reference intervals of TSH and FT4 using an indirect method based on the healthy pregnant women from southwest China population.

METHODS: Thyroid function test results which available on the Laboratory Information System (LIS) were collected from the pregnancies who visited the Obstetric Clinic or the Department of Gynecology between 1 January 2015, and 30 December 2020. We grouped the data by trimesters to establish the reference intervals (RIs) based on the clinical consensus of different levels of TSH and FT4 at different weeks of gestation. All arrangements were referenced to the document CLSI EP28-A3C.

RESULTS: A total of 33,040 thyroid function test results of pregnant women, aged 31 (28,33) years were statistical analyzed. Estimated RIs for TSH and FT4 in the first, second and third trimesters corresponding to the 2.5^th and 97.5^th percentiles in TPOAb negative were 0.02-5.23, 0.03-5.24, 0.37-5.68 mIU/L, 11.66-20.69, 10.1-18.59, 9.85-16.86pmol/L, respectively.

CONCLUSION: This study provides trimester-specific RIs for TSH and FT4 among healthy pregnant women in southwest China which guides clinicians to diagnosis and screen for thyroid disorders in this region.

PMID:34951326 | DOI:10.1177/00045632211063142

J Obstet Gynaecol. 2021 Dec 24:1-7. doi: 10.1080/01443615.2021.1999910. Online ahead of print.

ABSTRACT

Maternal mortality and morbidity can be minimised if adequate timely emergency obstetric life-saving care is provided especially at the primary health level. We conducted a descriptive cross-sectional study among 167 community health workers to investigate the pattern of performance of implementation of emergency obstetric life-saving skills (EmOLSS) in health facilities in Nsukka Local Government Area (LGA) of Enugu State. A pre-tested, paper-based questionnaire was utilised and data was analysed using descriptive and Chi-square statistics. Almost all were female (99.4%) and mean age was 39.5 ± 8.17 years. The pattern of core EmOLSS showed that 8.4% always use partograph and 60.8% use oxytocin for active management of third stage of labour. Only 15% had high level of confidence to carry out intrapartum and postpartum EmOLSS activities. Increased workload (66.3%), lack of supportive supervision (91.0%) and lack of infrastructure to work with (81.3%) influenced the pattern of implementation while poor basic knowledge of EmOLSS and lack of time influenced the level of confidence of the health workers. Health workers displayed poor pattern of EmOLSS implementation and low level of confidence. Regular training with supervision and provision of infrastructure will be beneficial to ensure improvement in the quality of care and reduction in maternal mortality.IMPACT STATEMENTWhat is already known on this subject? Emergency obstetric life-saving care is a key interventional strategy in the reduction of maternal mortality and morbidity. Reports showed that effective coordination and implementation of this care especially at the primary care level could reduce birth complications. Yet, there are gaps in the implementation of this essential care in the low and middle income countries.What do the results of this study add? This study revealed poor pattern of implementation of emergency obstetric life-saving care and low level of confidence among frontline health workers in public primary healthcare facilities in Nsukka Local Government Area of Enugu State, Nigeria. While there are efforts geared towards training of these health workers, the pattern of implementation of emergency obstetric life-saving care was affected by other health workers’ intrapersonal, client-related and institutional factors.What are the implications of these findings for clinical practice and/or further research? Information from this study is useful to the government and other maternal health stakeholders to formulate policies, and design ecological programs that target the clients, health workers and institutions.

PMID:34951332 | DOI:10.1080/01443615.2021.1999910

J Geriatr Psychiatry Neurol. 2021 Dec 24:8919887211063810. doi: 10.1177/08919887211063810. Online ahead of print.

ABSTRACT

BACKGROUND: One of the non-motor features of idiopathic Parkinson’s disease (IPD) is sexual dysfunction (SD) which is under-recognized and, consequently, undertreated. This study aimed to evaluate SD in patients with IPD.

PATIENTS AND METHODS: The study was conducted on 67 IPD patients; 30 healthy subjects with age and gender matching with the patients served as the control group. All participants were subjected to sexual function assessment using the Arabic version of Arizona Sexual Experience Scale (ASEX), Mini-Mental State Examination (MMSE), and Beck Depression Inventory (BDI), while the severity of IPD was assessed using the modified Hoehn and Yahr scoring scale and MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).

RESULTS: There were no statistically significant differences between patients with IPD and the control group regarding MMSE, hypertension, diabetes mellitus, or dyslipidemia. However, BDI scores were significantly higher in patients with IPD. The rate of SD among our patients was 64% compared to 30% in the control group. The total score and subscales of ASEX were significantly higher in IPD patients than in controls. SD showed a significant correlation with the severity of the IPD irrespective of other variables, including patient age, sex, disease duration, hypertension, diabetes, dyslipidemia, smoking, and dose of L-dopa.

CONCLUSION: SD is a commonly underrated feature in patients with IPD; it should be investigated carefully as it is an important non-motor symptom that correlates with disease severity.

PMID:34951322 | DOI:10.1177/08919887211063810

Zhongguo Zhong Yao Za Zhi. 2021 Dec;46(23):6105-6113. doi: 10.19540/j.cnki.cjcmm.20210930.505.

ABSTRACT

Clinical comprehensive evaluation was conducted in &quot;6+1&quot; dimensions(safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine) to reflect the advantages and characteristics of Diemai-ling~® Kudiezi Injection in the treatment of cerebral infarction. This study adopted a combination of qualitative and quantitative evaluation methods. Based on the methodologies of evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, pharmacoeconomics, mathematical statistics, and health technology assessment(HTA), experts gave weight to the criterion layer and index layer, and multi-criteria decision analysis(MCDA) model and CSC v2.0 were used for calculations to evaluate the clinical value of Diemailing~® Kudiezi Injection. The existing evidence showed that active monitoring and a number of randomized controlled trials(RCTs) have been carried out after the listing of Diemailing~® Kudiezi Injection. Since the total incidence of adverse reactions is 0.099% and the incidence of adverse drug reactions(ADR) is rare, the safety evaluation is grade A. The evidence value of effectiveness demonstrated that Diemailing~® Kudiezi Injection combined with conventional western medicine improves the total effective rate of neurological deficit score and quality of daily life in the acute stage of cerebral infarction, which is superior to that in the conventional western medicine treatment group, and the level of evidence is high. Therefore, its efficacy is assessed as grade A. According to the results of economic research, when Diemailing~® Kudiezi Injection combined with conventional western medicine treatment is compared with conventional western medicine treatment, the Diemailing~® Kudiezi Injection group has a greater incremental effect, but the cost is affordable. Given the overall quality evaluation results of economic report is clear, it is evaluated as grade B. The innovation is grade A. The drug is favorable for clinical operation by medical staff and can be accepted by patients due to easy usage without special technical and management requirements. Since the drug exhibits good suitability for clinicians, nurses, pharmacists, and patients, it is evaluated as grade B. Considering its moderate price among similar drugs and good affordability and availability, it is evaluated as grade B. Diemailing~® Kudiezi Injection can evidently improve the clinical symptoms and neurological deficits of fire toxin syndrome of acute cerebral infarction, and this medicine belongs to ethnic medicine. Large-sample active monitoring research has been conducted with rich experience in human use. Therefore, the characteristics of traditional Chinese medicine are evaluated as grade A. The comprehensive clinical evaluation of Diemailing~® Kudiezi Injection is class A. We suggest that it can be directly transformed into relevant policy results of basic clinical medication management by procedure.

PMID:34951238 | DOI:10.19540/j.cnki.cjcmm.20210930.505

J Phys Chem B. 2021 Dec 24. doi: 10.1021/acs.jpcb.1c08655. Online ahead of print.

ABSTRACT

Building on the observation that chromatin compaction can be locally modulated by activity, we propose a model of in vivo chromatin as an active polymer and study its large scale conformations. In particular, we study an active mechanochemical model of chromosomal folding based on the interplay among polymer elasticity, confinement, topological constraints, and fluctuating active stresses arising from the ATP-dependent action of a variety of chromatin-associated protein machines and chromatin-remodeling proteins and their stochastic turnover. We find that activity drives the chromatin to a nonequilibrium steady state; the statistics of conformations in this nonequilibrium steady state are consistent with recent measurements on intrachromosomal contact probabilities and chromosomal compaction. The contact exponents at steady state show a systematic variation with changes in the nature of activity and the rates of turnover. The steady state configuration of the active chromatin in two dimensions resembles a space-filling Peano curve, which might have implications for the optimization of genome information storage.

PMID:34951303 | DOI:10.1021/acs.jpcb.1c08655

Zhongguo Zhong Yao Za Zhi. 2021 Nov;46(22):6004-6010. doi: 10.19540/j.cnki.cjcmm.20210702.601.

ABSTRACT

To learn the current situation and strengthen the management of national standards for Chinese medicinal materials, we sorted out the relevant national standards. According to incomplete statistics, there are 1 185 kinds of Chinese medicinal materials, including 1 024 kinds of plant medicines, 106 kinds of animal medicines, and 54 kinds of mineral medicines, in addition to ethnic medicinal materials with different functions. The relevant standards include 819 Pharmacopoeia standards, 342 standards issued by the Ministry of Health or National Medicinal Products Administration, 7 standards for new medicinal materials, and 17 standards for imported medicinal materials. In this paper, the sources of standards as well as the distribution of families and genera and the distribution of medicinal parts of medicinal materials are analyzed. The suggestions are as follows:(1)to improve the coordination among different national standards of Chinese medicinal materials;(2)to improve the standardization and controllability of relevant standards;(3)to revise the issued standards for Chinese medicinal materials(including Tibetan, Uygur, and Mongolian medicinal materials).

PMID:34951193 | DOI:10.19540/j.cnki.cjcmm.20210702.601

Zhongguo Zhong Yao Za Zhi. 2021 Dec;46(23):6096-6104. doi: 10.19540/j.cnki.cjcmm.20210930.506.

ABSTRACT

This study systematically reviewed the existing research on Danhong Injection in the treatment of stroke with blood stasis syndrome. The methods of evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, drug economics, mathematical statistics, and health technology assessment(HTA) were employed to qualitatively and quantitatively evaluate the &quot;6+1&quot; dimensions(safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine) of Danhong Injection through questionnaire survey, public information, real world data, and secondary evaluation of literature. With the weights given by experts, the multi-criteria decision analysis(MCDA) model was employed to measure each dimension and highlight the clinical value of Danhong Injection. Multi-source safety evidence showed that Danhong Injection had been fully monitored and studied. The severity of adverse reactions was mostly moderate or mild, and the prognosis was good. So it was rated as grade A for safety. Compared with Ligustrazine Injection, Fufang Danshen Injection and conventional treatment of western medicine, Danhong Injection had obvious advantages in clinical response rate and NIHSS score improvement in the treatment of stroke with blood stasis syndrome. So it was rated as grade A for effectiveness. Compared with Ligustrazine Injection and Yinxing Damo Injection, Danhong Injection had a cost-effectiveness advantage in the treatment of stroke with blood stasis syndrome, and the economic results were good. According to the existing evidence, the Danhong Injection was rated as grade B for economy. Danhong Injection had won a number of national patents, which was rated as grade A for its good innovation in guaranteeing supply measures, scalability of production capacity, and production process. It had good suitability for clinicians, nurses, pharmacists, and patients using the drug, and met the needs of clinical medication, so it was rated as grade B for suitability. Danhong Injection is rich in medicinal materials, stable in price, and sustainable. However, its availability needed to be further improved due to the limitation of prescription use, so it was rated as grade B for accessibility. Danhong Injection can promote blood circulation, resolve blood stasis, warm vessels, and smooth collaterals. It had accumulated more than 30 000 pieces of empirical evidence for human use in the real world. It had prominent characteristics of traditional Chinese medicine and was rated as grade B. CSC v2.0 was used for calculation, and the clinical value of Danhong Injection was comprehensively evaluated as class A, which could be directly translated into relevant policy results of basic clinical medication management according to the Guidelines for the Management Clinical Comprehensive Evaluation of Drugs(trial version 2021).

PMID:34951237 | DOI:10.19540/j.cnki.cjcmm.20210930.506