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Nevin Manimala Statistics

Quality and fragility of meta-analyses assessing the efficacy and safety of Ginkgo biloba preparation: protocol for a methodological study

Ann Palliat Med. 2022 Oct 8:apm-22-795. doi: 10.21037/apm-22-795. Online ahead of print.

ABSTRACT

BACKGROUND: Ginkgo biloba L. (GB) is an ancient plant with high medicinal value. GB preparations are widely used to treat diseases such as angina pectoris, ischemic stroke, and dementia. Many meta-analyses of GB preparations for these diseases have recently been published. However, the methodological and reporting quality of relevant meta-analyses have not been systematically evaluated and reported to date. Therefore, the present methodological study was designed to fill this knowledge gap.

METHODS: PubMed, Embase, CNKI, WanFang, and the Chinese Biomedical Literature Database will be comprehensively searched from inception to June 2022. Meta-analyses on the efficacy and safety of GB preparations for humans with health conditions will be included. Two researchers will independently screen the literature, extract the data, and evaluate the methodological and reporting quality through AMSTAR-2 and PRISMA 2020. Spearman correlation coefficient will be used to evaluate the correlation between methodological and reporting quality. Five factors potentially affecting the methodological quality will be evaluated through univariate and multivariate linear analyses. The fragility index of statistically significant binary outcomes will be calculated to assess the robustness of pooled results. Stata 16.0 and Excel 2016 will be utilized to conduct the statistical analysis, and P<0.05 will be considered statistically significant.

DISCUSSION: This is the first research to thoroughly investigate the methodological and reporting quality of GB preparations for health conditions. The results of this investigation will improve the quality of future studies and clinical decision-making.

PMID:36226650 | DOI:10.21037/apm-22-795

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Nevin Manimala Statistics

Performance of mid-upper arm circumference and other prognostic indices based on inflammation and nutrition in oncology outpatients: a tertiary cancer center study

Ann Palliat Med. 2022 Oct 9:apm-22-481. doi: 10.21037/apm-22-481. Online ahead of print.

ABSTRACT

BACKGROUND: We aimed to compare the performance of established inflammation and nutrition-based prognostic indices with a relatively novel index ‘mid-upper arm circumference (MUAC)’ in outpatients with advanced cancer.

METHODS: This study was a secondary analysis of a prospective cohort study that enrolled 200 outpatients with advanced cancer visiting a medical oncology clinic at a tertiary hospital. All patients were followed until death, and the Glasgow Prognostic Score (GPS), modified GPS (mGPS), Prognostic Nutritional Index (PNI), neutrophil/lymphocyte ratio (NLR), C-reactive protein/albumin ratio (CAR), and MUAC were compared by calculating the area under the receiver operating characteristic curves (AUROCs).

RESULTS: The mean age of the patients was 64.4 years, 64.0% were male, and the median overall survival was 32.4 weeks [95% confidence interval (CI): 5.6-142.7]. Overall, all indices showed similarly high AUROCs for estimating 12-week (0.68 to 0.75) and 24-week survival (0.67 to 0.74). When confined to the GPS, mGPS, and MUAC, the AUROCs for 12-week survival were 0.75 (95% CI: 0.66-0.82), 0.74 (95% CI: 0.65-0.82), and 0.72 (95% CI: 0.64-0.79), respectively. For 24-week survival, the AUROCs were 0.70 (95% CI: 0.62-0.76), 0.67 (95% CI: 0.60-0.74), and 0.72 (95% CI: 0.64-0.79), respectively. MUAC had the highest specificity for estimating 12-week survival (86.0%), while GPS showed the highest sensitivity for estimating 12-week survival (81.1%).

CONCLUSIONS: Inflammation and nutrition-based prognostic indices showed similar acceptable accuracies in estimating the 12- and 24-week survival of oncology outpatients. Notably, a simple and non-invasive index MUAC, showed comparable performance with established indices including GPS and mGPS.

PMID:36226642 | DOI:10.21037/apm-22-481

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Nevin Manimala Statistics

Increase in NREM sleep slow waves following injections of sodium oxybate in the mouse cerebral cortex and the role of somatostatin-positive interneurons

Eur J Neurosci. 2022 Oct 13. doi: 10.1111/ejn.15846. Online ahead of print.

ABSTRACT

The systemic administration of sodium oxybate (SXB), the sodium salt of gamma-hydroxybutyric acid, promotes slow wave activity (SWA, 0.5-4 Hz EEG power) and increases non-rapid eye movement (NREM) sleep. These effects are mediated by the widely expressed GABAb receptors, and thus the brain areas targeted by SXB remain unclear. Because slow waves are mainly a cortical phenomenon, we tested here whether systemic SXB promotes SWA by acting directly on the cortex. Moreover, because somatostatin (SOM)+ cortical interneurons play a key role in SWA generation, we also assessed their contribution to the effects of SXB. In adult SOM-Cre mice the injection of SXB in left secondary motor cortex increased SWA during NREM sleep in the first 30 min post-injection (11 mice: either sex). SWA, the amplitude and frequency of the slow waves, and the frequency of the OFF periods increased ipsilaterally and contralaterally to the SXB injection in frontal and parietal cortex. All these changes disappeared when the intracortical injection of SXB was preceded by the chemogenetic inhibition of the SOM+ cells. Thus, SXB may promote the slow waves of NREM sleep, at least in part, by acting directly on the cortex, and this effect involves GABAergic SOM+ interneurons. Our working hypothesis is that SXB potentiates the ability of these cells to inhibit all other cortical cell types via a GABAb mechanism, thus promoting the transition from ON to OFF periods during NREM sleep.

PMID:36226638 | DOI:10.1111/ejn.15846

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Nevin Manimala Statistics

Rostrum abnormalities in the endangered Indian Ocean humpback dolphin (Sousa plumbea) in South Africa

Integr Zool. 2022 Oct 13. doi: 10.1111/1749-4877.12685. Online ahead of print.

ABSTRACT

Morphological abnormalities in wild animals can be indicators of the underlying health of a population and may be determined through routine photographic surveys. Here we assess unusual rostrum conditions in Indian Ocean humpback dolphins (Sousa plumbea) inhabiting South African coastal waters to understand the rate of prevalence of abnormal rostrums and formulate hypotheses on potential causes. Photographic data were collated from systematic boat surveys and opportunistic sightings, obtained between April 1998 and March 2021 in various regions along the South African coast. Overall, 31 unique individuals were found with abnormal rostrum conditions, varying from slight misalignments to severe wounds and/or aberrant morphologies. In most cases, injuries were likely caused by natural events during the animal’s life history such as interactions with sharks and/or reef-associated hunting strategies. Mark-recapture data indicated that individuals had survived with these injuries for up to ten years. This study reports the highest incidence of rostrum abnormalities in the species. As numbers reflect only those that have survived their injuries, they are considered a minimum estimate. Better understanding of the cause(s) of these injuries is important given the endangered status of this species. This article is protected by copyright. All rights reserved.

PMID:36226602 | DOI:10.1111/1749-4877.12685

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Nevin Manimala Statistics

Is this a good questionnaire? Dimensionality and category functioning of questionnaires used in nursing research

Nurse Res. 2022 Oct 13. doi: 10.7748/nr.2022.e1842. Online ahead of print.

ABSTRACT

BACKGROUND: Questionnaires are perhaps the most widely used measuring tools in nursing research, as many studies conducted by nurses focus on understanding the underlying complex factors that are amenable to questionnaires. However, most questionnaires used in nursing research continue to display inadequate evidence of validity under the traditional methods while ignoring the modern Rasch techniques with better proofs of objective measurement.

AIM: To draw researchers’ attention to the recurrent limitations of the classical approach to questionnaire design and to suggest advanced psychometric analysis exemplified in Rasch methodology as a more appropriate alternative.

DISCUSSION: For questionnaire data to be suitable for statistical analysis, transparent demonstration of mathematical assumptions embodied in the questionnaire is compulsory. The failure to engage contemporary measurement models in designing good questionnaires raises concerns about researchers’ awareness of the application and usefulness of the evidence generated by the modern approach. This paper illustrates with examples the problems inherent in the traditional or classical test theory and advanced dimensionality and category functioning as requisite psychometric properties of a questionnaire. It also outlines several diagnostic parameters that proponents of Rasch techniques recommend for testing.

CONCLUSION: Traditional methods of assessing and analysing a questionnaire’s psychometric properties are no longer tenable because the modern Rasch approach offers exemplary proofs of questionnaire validity rooted in objective measurement theories.

IMPLICATIONS FOR PRACTICE: Nurse researchers using questionnaires for clinical decisions and education purposes should apply the fundamental principles of objective measurements demonstrated in Rasch theory.

PMID:36226577 | DOI:10.7748/nr.2022.e1842

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Nevin Manimala Statistics

Post COVID-19 sequelae of the respiratory system. A single center experience reporting the compromise of the airway, alveolar and vascular components

Monaldi Arch Chest Dis. 2022 Oct 11. doi: 10.4081/monaldi.2022.2412. Online ahead of print.

ABSTRACT

The long-term sequelae of COVID-19 have now become more common and appreciable. The SARS-CoV-2 virus can cause a variety of infectious and non-infectious pulmonary complications. The purpose of this study is to raise awareness about post-COVID-19 pulmonary sequelae, both infectious and non-infectious, in this geographical area. A retrospective study was conducted from July 1st 2020 to December 20th 2020. A total of 1200 patients were evaluated, with 83 suffering from post-COVID-19 pulmonary complications. The patients’ mean age was 62 years (IQR 55-69), with 63 (75.9%) being male. The most common co-morbid illnesses were hypertension (49, 59%) and diabetes (45, 54.2%). The majority of them (37, 44.6%) had severe COVID-19, followed by critical COVID-19 (33, 39.8%). There was no statistically significant difference in recurrence of respiratory symptoms or duration of current illness between non-severe, severe, and critical COVID-19 patients. Non-infectious complications were observed in the majority of patients (n=76, 91.5%), including organizing pneumonia/ground glass opacities in 71 (88%) patients, fibrosis in 44 (55%), pulmonary embolism in 10 (12.5%), pneumomediastinum in 6 (7.4%) and pneumothorax in 7 (8.6%). Infective complications (25, 30.1%) included aspergillus infection in 10 (12.0%) and bacterial infection in 5 (8.47%), with more gram-negative infections and one patient developing Mycobacterium tuberculosis. Post COVID-19 mortality was 11 (13.3%). The long-term pulmonary sequelae of COVID-19 are not rare. Cryptogenic organizing pneumonia, ground glass opacities, and fibrosis were common post-COVID-19 sequelae in our patients. This necessitates frequent close monitoring of these patients in order to initiate early appropriate management and prevent further morbidity and eventual mortality.

PMID:36226558 | DOI:10.4081/monaldi.2022.2412

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Nevin Manimala Statistics

Evaluation of the diagnostic accuracy of the cervical biopsy under colposcopic vision

Eur J Transl Myol. 2022 Oct 12. doi: 10.4081/ejtm.2022.10670. Online ahead of print.

ABSTRACT

This study was conducted to evaluate the diagnostic accuracy of the cervical biopsy under colposcopic vision. This retrospective study was performed on 190 women, who were selected from a total of 412 cases referring for colposcopy in one year. All patients underwent colposcopy and loop electrosurgical excision procedure (LEEP). After the investigation of demographic characteristics and data confirmation, colposcopic characteristics were examined. Then, the diagnostic indicators and diagnostic accuracy of the cervical biopsy under colposcopic vision were determined. The mean age of patients was 35.51± 5.91 years. In smokers, the percentage of cancer and CIN3 cases was higher than in normal individuals, and this difference was statistically significant in terms of the frequency of cancerous lesions (P = 0.2). A comparison of colposcopic biopsy with LEEP has shown that the frequency of advanced cases in LEEP has been detected more, and the correlation coefficient (kappa) indicated the weak agreement between the findings of colposcopically directed biopsy (CDB) and LEEP methods. (k = 0.23). The diagnostic accuracy of the cervical biopsy under colposcopic vision for cervical cancer is effectively high. It is recommended that this procedure be performed to diagnose cancerous lesions; however, contrary to what is seen in colposcopy, malignant cases may be spreading and follow-up of patients can affect therapeutic performance.

PMID:36226527 | DOI:10.4081/ejtm.2022.10670

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Nevin Manimala Statistics

Comparison of Inflammatory Markers Changes in Patients Who Used Postoperative Prophylactic Antibiotics within 24 Hours after Spine Surgery and 5 Days after Spine Surgery

J Korean Neurosurg Soc. 2022 Oct 14. doi: 10.3340/jkns.2022.0126. Online ahead of print.

ABSTRACT

OBJECTIVE: C-reactive protein (CRP) level, erythrocyte sedimentation rate (ESR), and white blood cell (WBC) count are inflammatory markers used to evaluate postoperative infections. Although these markers are non-specific, understanding their normal kinetics after surgery may be helpful in the early detection of postoperative infections. To compliment the recent trend of reducing the duration of antibiotic use, this retrospective study investigated the inflammatory markers of patients who had received antibiotics within 24 hours after surgery according to the Health Insurance Review & Assessment Service guidelines and compared them with those of patients who had received antibiotics for 5 days, which was proven to be non-infectious.

METHODS: We enrolled 74 patients, divided into two groups. Patients underwent posterior lumbar interbody fusion (PLIF) at a single institution between 2019 and 2020. Group A included 37 patients who received antibiotics within 24 hours after the PLIF procedure, and group B comprised 37 patients who had used antibiotics for 5 days. A 1 : 1 nearest-neighbor propensity-matched analysis was used. The clinical variables included age, sex, medical history, body mass index, estimated blood loss, and operation time. Laboratory data included CRP, ESR, and WBC, which were measured preoperatively and on postoperative days (POD) 1, 3, 5, and 7.

RESULTS: CRP dynamics tended to decrease after peaking on POD 3, with a similar trend in both groups. The average CRP level in group B was slightly higher than that in group A; however, the difference was not statistically significant. Multiple linear regression analysis revealed operation time, number of fused levels, and estimated blood loss as significant predictors of a greater CRP peak value (r²=0.473, p<0.001) in patients. No trend (a tendency to decrease from the peak value) could be determined for ESR and WBC count on POD 7.

CONCLUSION: Although slight differences were observed in numerical values and kinetics, sequential changes in inflammatory markers according to the duration of antibiotic administration showed similar patterns. Knowledge of CRP kinetics allows the assessment of the degree of difference between the clinical and expected values.

PMID:36226528 | DOI:10.3340/jkns.2022.0126

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Nevin Manimala Statistics

Cell administration routes for heart failure: a comparative re-evaluation of the REGENERATE-DCM and REGENERATE-IHD trials

Regen Med. 2022 Oct 13. doi: 10.2217/rme-2022-0138. Online ahead of print.

ABSTRACT

Aims: Given the logistical issues surrounding intramyocardial cell delivery, we sought to address the efficacy of the simpler, more accessible intracoronary route by re-evaluating REGENERATE-DCM and REGENERATE-IHD (autologous cell therapy trials for heart failure; n = 150). Methods: A retrospective statistical analysis was performed on the trials’ combined data. The following end points were evaluated: left ventricular ejection fraction (LVEF), N-terminal pro brain natriuretic peptide concentration (NT-proBNP), New York Heart Association class (NYHA) and quality of life. Results: This demonstrated a new efficacy signal for intracoronary delivery, with significant benefits to: LVEF (3.7%; p = 0.01), NT-proBNP (median -76 pg/ml; p = 0.04), NYHA class (48% patients; p = 0.01) and quality of life (12 ± 19; p = 0.006). The improvements in LVEF, NYHA and quality of life scores remained significant compared to the control group. Conclusion: The efficacy and logistical simplicity of intracoronary delivery should be taken into consideration for future trials.

PMID:36226504 | DOI:10.2217/rme-2022-0138

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Nevin Manimala Statistics

Variation and impact of polygenic hematological traits in monogenic sickle cell disease

Haematologica. 2022 Oct 13. doi: 10.3324/haematol.2022.281180. Online ahead of print.

ABSTRACT

Several complications observed in sickle cell disease (SCD) are influenced by variation in hematological traits (HT), such as fetal hemoglobin (HbF) level and neutrophil count. Previous large-scale genome-wide association studies carried out in largely healthy individuals have identified 1000s of variants associated with HT, which have then been used to develop multiancestry polygenic trait scores (PTS). Here, we tested if these PTS associate with HT in SCD patients and can improve statistical models associated with SCD-related complications. In 2,056 SCD patients, we found that the PTS predicted less HT variance than in non-SCD Africanancestry individuals. This was particularly striking at the Duffy/DARC locus, where we observed an epistatic interaction between the SCD genotype and the Duffy null variant (rs2814778) that led to a two-fold weaker effect on neutrophil count. PTS for these routinely measured HT were not associated with complications in SCD. In contrast, we found that a simple PTS for HbF that includes only six variants explained a large fraction of the phenotypic variation (20.5-27.1%), associated with acute chest syndrome and stroke risk, and improved the statistical modeling of vaso-occlusive crisis rate. Using Mendelian randomization, we found that increasing HbF by 4.8% reduces stroke risk by 39% (P = 0.0006). Taken together, our results highlight the importance of validating PTS in large diseased populations before proposing their implementation in the context of precision medicine initiatives.

PMID:36226494 | DOI:10.3324/haematol.2022.281180