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Nevin Manimala Statistics

SLESIS-R: an improved score for prediction of serious infection in patients with systemic lupus erythematosus based on the RELESSER prospective cohort

Lupus Sci Med. 2024 Apr 8;11(1):e001096. doi: 10.1136/lupus-2023-001096.

ABSTRACT

OBJECTIVE: To develop an improved score for prediction of severe infection in patients with systemic lupus erythematosus (SLE), namely, the SLE Severe Infection Score-Revised (SLESIS-R) and to validate it in a large multicentre lupus cohort.

METHODS: We used data from the prospective phase of RELESSER (RELESSER-PROS), the SLE register of the Spanish Society of Rheumatology. A multivariable logistic model was constructed taking into account the variables already forming the SLESIS score, plus all other potential predictors identified in a literature review. Performance was analysed using the C-statistic and the area under the receiver operating characteristic curve (AUROC). Internal validation was carried out using a 100-sample bootstrapping procedure. ORs were transformed into score items, and the AUROC was used to determine performance.

RESULTS: A total of 1459 patients who had completed 1 year of follow-up were included in the development cohort (mean age, 49±13 years; 90% women). Twenty-five (1.7%) had experienced ≥1 severe infection. According to the adjusted multivariate model, severe infection could be predicted from four variables: age (years) ≥60, previous SLE-related hospitalisation, previous serious infection and glucocorticoid dose. A score was built from the best model, taking values from 0 to 17. The AUROC was 0.861 (0.777-0.946). The cut-off chosen was ≥6, which exhibited an accuracy of 85.9% and a positive likelihood ratio of 5.48.

CONCLUSIONS: SLESIS-R is an accurate and feasible instrument for predicting infections in patients with SLE. SLESIS-R could help to make informed decisions on the use of immunosuppressants and the implementation of preventive measures.

PMID:38589223 | DOI:10.1136/lupus-2023-001096

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School performance and educational achievement in children exposed to maternal cancer in utero

J Epidemiol Community Health. 2024 Apr 8:jech-2023-221753. doi: 10.1136/jech-2023-221753. Online ahead of print.

ABSTRACT

BACKGROUND: In utero exposure to maternal cancer and cancer treatment might influence the child’s cognitive development. This study investigated if exposure to maternal cancer during fetal life impacted school performance and educational achievement as adults.

METHODS: This nationwide retrospective cohort study identified all live-born children in Denmark between January 1978 and December 2013. Exposure was defined as maternal cancer diagnosis during pregnancy. Four partly overlapping birth cohorts were constructed depending on the outcome of interest: (1) receiving special educational support for birth years 2001-2013; (2) grade point average (GPA) at the final exams after 10th grade for 1986-2003; (3) educational achievement at 20 years for 1978-1998; and (4) education at 30 years for 1978-1988. Logistic and linear models were adjusted for birth year, maternal age, maternal education and maternal death.

RESULTS: The estimated probability of receiving special educational support was similar in the exposed group and the reference (adjusted OR 0.96; 95% CI 0.46 to 1.77, non-significant). The GPA did not statistically differ (0.13 grade points; 95% CI -0.18 to 0.45, non-significant). The achieved educational levels were similar for the exposed group and the reference at 20 years, with an adjusted OR of 1.07 (95% CI 0.82 to 1.40) for low versus medium educational level, and at 30 years with an adjusted OR of 0.73 (95% CI 0.35 to 1.50) for low versus high educational level and of 1.07 (95% CI 0.66 to 1.72) for medium versus high educational level.

CONCLUSION: Our findings did not indicate poorer performance in compulsory school nor impairment of adult educational achievement after exposure to maternal cancer in utero.

PMID:38589221 | DOI:10.1136/jech-2023-221753

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Importance of using the correct statistics

Arch Dis Child Fetal Neonatal Ed. 2024 Apr 8:fetalneonatal-2024-326963. doi: 10.1136/archdischild-2024-326963. Online ahead of print.

NO ABSTRACT

PMID:38589207 | DOI:10.1136/archdischild-2024-326963

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Diagnostic accuracy of tests for tuberculous pericarditis: A network meta-analysis

Indian J Tuberc. 2024 Apr;71(2):185-194. doi: 10.1016/j.ijtb.2023.05.013. Epub 2023 May 16.

ABSTRACT

Tuberculous pericarditis (TBP) is a relatively uncommon but potentially fatal extrapulmonary manifestation of tuberculosis. Despite its severity, there is no universally accepted gold standard diagnostic test for TBP currently. The objective of this study is to compare the diagnostic accuracy of the most commonly used tests in terms of specificity, sensitivity, negative predictive value (NPV), and positive predictive value (PPV), and provide a summary of their diagnostic accuracies. A comprehensive literature review was performed using Scopus, MEDLINE, and Cochrane central register of controlled trials, encompassing studies published from start to April 2022. Studies that compared Interferon Gamma Release Assay (IGRA), Xpert MTB/RIF, Adenosine Deaminase levels (ADA), and Smear Microscopy (SM) were included in the analysis. Bayesian random-effects model was used for statistical analysis and mean and standard deviation (SD) with 95% confidence intervals were calculated using the absolute risk (AR) and odds ratio (OR). Rank probability and heterogeneity were determined using risk difference and Cochran Q test, respectively. Sensitivity and specificity were evaluated using true negative, true positive, false positive, and false negative rates. Area under the receiver operating characteristic (AUROC) was calculated for mean and standard error. A total of seven studies comprising 16 arms and 618 patients were included in the analysis. IGRA exhibited the highest mean (SD) sensitivity of 0.934 (0.049), with a high rank probability of 87.5% for being the best diagnostic test, and the AUROC was found to be 94.8 (0.36). On the other hand, SM demonstrated the highest mean (SD) specificity of 0.999 (0.011), with a rank probability of 99.5%, but a leave-one-out analysis excluding SM studies revealed that Xpert MTB/RIF ranked highest for specificity, with a mean (SD) of 0.962 (0.064). The diagnostic tests compared in our study exhibited similar high NPV, while ADA was found to have the lowest PPV among the evaluated methods. Further research, including comparative studies, should be conducted using a standardized cutoff value for both ADA levels and IGRA to mitigate the risk of threshold effect and minimize bias and heterogeneity in data analysis.

PMID:38589123 | DOI:10.1016/j.ijtb.2023.05.013

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Effect of adjunct Vitamin D treatment in vitamin D deficient pulmonary tuberculosis patients: A randomized, double blind, active controlled clinical trial

Indian J Tuberc. 2024 Apr;71(2):170-178. doi: 10.1016/j.ijtb.2023.04.026. Epub 2023 Apr 29.

ABSTRACT

BACKGROUND: Since, Vitamin D [1α,25(OH)2D)] enhances antimicrobial activity of Innate immunity and modulate Adaptive immune responses, simultaneously, so it play a potential role for balanced immune activity against Mycobacterium tuberculosis and restricting tissue injuries within the TB patients.(Chun et al., 2011) 9 We aimed to determine the role of adjunct Vitamin D treatment on the outcome of pulmonary tuberculosis patients and evaluated the effect of Vitamin D administration on Differential Leucocyte Count, Erythrocyte Sedimentation Rate, serum Adenosine deaminase, serum C- reactive protein, Oxygen saturation (SpO2) and Body Weight in Vitamin D deficient pulmonary tuberculosis patients.

METHODS: We conducted a prospective, interventional, randomized, double blind, parallel group, active controlled clinical trial. Newly diagnosed Vitamin D deficient pulmonary tuberculosis patients were randomly assigned to intervention group (received standard anti-tubercular treatment with adjunct Vitamin D3) and control group (received standard anti-tubercular treatment without adjunct Vitamin D3). Total four doses [each dose of 2.5 mg (100000 IU)] of Vitamin D3 were given, orally. First dose was given within 7 days of starting anti-tubercular treatment and second, third, fourth dose were given at 2, 4 and 6 weeks respectively. At the time of enrollment, we measured all baseline characteristics. During follow-up, we measured the study variables and monitored adverse events at 2, 4, 6, 8 and 12 weeks. Our safety parameter was serum corrected calcium level to assess the risk of hypercalcemia.

RESULTS: Total 130 pulmonary TB patients, 65 patients in each group, were analyzed. Our study results showed that decrease in Neutrophil count was statistically significant with small effect sizes at every time point of measurement and increase in Lymphocyte count was statistically significant with small and moderate effect sizes at 4, 6 and 8 week for intervention group than for control group. Decrease in erythrocyte sedimentation rate was statistically significant with small effect sizes at 6 and 8 week, decrease in serum adenosine deaminase and serum C- reactive protein was statistically significant with moderate effect sizes at 4, 6 and 8 week for intervention group than for control group. Increase in Oxygen saturation was statistically significant at 4 week with small effect size and increase in body weight was statistically significant with small effect sizes for intervention group than for control group. No case of hypercalcemia was reported.

CONCLUSION: Our findings suggest a potential role of adjunctive Vitamin D3 to accelerate resolution of inflammatory responses and improvement in clinical outcomes of pulmonary TB patients.

TRIAL REGISTRATION: This trial is registered with Clinical Trials Registry – INDIA (http://ctri.nic.in) with CTRI Number – CTRI/2021/11/037914.

PLACE OF STUDY: Room Number 27, first floor out-patients department (OPD) and inpatient Wards, fourth floor, Department of Respiratory Medicine, Uttar Pradesh University of Medical Sciences, Saifai, Etawah (U.P.), INDIA.

PMID:38589121 | DOI:10.1016/j.ijtb.2023.04.026

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Evaluation of clinical profiles, imaging findings and antituberculosis treatment outcome in granulomatous mastitis: An Indian scenario

Indian J Tuberc. 2024 Apr;71(2):163-169. doi: 10.1016/j.ijtb.2023.04.025. Epub 2023 Apr 29.

ABSTRACT

BACKGROUND: The management of choice for granulomatous mastitis (GM) has yet to be determined but few studies have demonstrated that anti-tubercular treatment (ATT) could be an effective alternative therapeutic option. Hence, the objective of the current study is to determine the clinical feature, radiological imaging findings, and histopathological examination results exhibited by GM and tuberculosis (TB)-proven GM as well as to evaluate the ATT clinical outcome in GM patients.

METHODS: The study was performed on 68 GM patients who were referred to the department of pulmonology by the breast clinic (from January 2018 to August 2021). Study populations were categorized into two groups GM and TB-proven GM patients and all were prescribed with standard ATT regimen and were continuously followed up. SPSS version 25 was employed for statistical assessment.

RESULTS: Our study showed that 6 patients from GM and 4 patients from the TB-proven GM group got relapsed. For patients who displayed partial remission, ATT treatment was started after assessing the side effects potential. 14.6% (n = 6) and 7.4% (n = 2) patients who initially demonstrated partial remission were also completely cured. ATT treatment curable rate was determined to be 90% (n = 37) and 81.5% (n = 22) for GM and TB-proven GM patients correspondingly. Therefore, the current study demonstrated nil significant differences between groups.

CONCLUSION: The current study warrants that ATT therapy could be an effective and better treatment of choice for GM patients irrespective of their clinical condition.

PMID:38589120 | DOI:10.1016/j.ijtb.2023.04.025

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Correlation between serum isoniazid concentration and therapeutic response in patients of pulmonary tuberculosis in Central India: A prospective observational study

Indian J Tuberc. 2024 Apr;71(2):153-162. doi: 10.1016/j.ijtb.2023.04.022. Epub 2023 Apr 27.

ABSTRACT

BACKGROUND: Tuberculosis (TB), an infectious disease caused by Mycobacterium tuberculosis is one of the top ten causes of death worldwide. Isoniazid (INH) is an important component of anti-tuberculosis therapy (ATT). Low isoniazid levels can serve as a risk factor for the development of treatment failure, relapse of disease and acquired secondary resistance. Hence, serum level of isoniazid becomes a critical factor in determining the treatment outcome of patients on ATT. This study aimed to evaluate the correlation between serum isoniazid concentration and therapeutic response in patients of pulmonary tuberculosis in Central India.

METHODS: This was a prospective single cohort observational study conducted at a tertiary care hospital. Therapeutic response in newly diagnosed patients of pulmonary TB was determined based the microbiological, clinical and radiological parameters. Serum INH levels were estimated based on a spectrophotometric method using nano-spectrophotometer.

RESULTS: In this study, patients had a significant improvement in treatment outcome as evident by a significant decrease in the TB score I at end of IP (p = 0.001) and a significant decline in the Timika score at end of CP (p = 0.001). Although all patients converted to sputum negative at end of CP, 20% remained positive at end of IP. Lower INH levels were seen in 13.3% of the study population. Higher INH levels were observed in sputum converters, patients with low TB score I and low Timika score, although no statistically significant difference was noted (p > 0.05).

CONCLUSION: In this study, we could not find any statistically significant association between serum INH levels and therapeutic outcome of the patients. Further studies on a larger population could provide better understanding about the prevalence of low serum isoniazid levels among the Indian population and establish its relationship with therapeutic outcome. Also, the usage of a comparatively less expensive spectrophotometric method of analysis makes this feasible in almost every district hospital without the need of high-performance liquid chromatography which is costlier and needs more expertise.

PMID:38589119 | DOI:10.1016/j.ijtb.2023.04.022

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Comparison of Image Quality and Radiation Dose in Pediatric Temporal Bone CT using Photon Counting Detectors CT and Energy Integrating Detectors CT

AJNR Am J Neuroradiol. 2024 Apr 8:ajnr.A8276. doi: 10.3174/ajnr.A8276. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: To compare the image quality and radiation dose of temporal bone CT scans in pediatric patients acquired with photon counting detectors (PCD) CT and energy integrating detectors (EID) CT.

MATERIALS AND METHODS: The retrospective study included a total of 110 pediatric temporal bone CT scans (PCD-CT, n=52; EIDCT, n=58). Two independent readers evaluated the spatial resolution of 4 anatomical structures (tympanic membrane, incudostapedial joint, stapedial crura, and cochlear modiolus) and overall image quality using a 4-point scale. Inter-reader agreement was assessed. Dose length product (DLP) for each CT was compared, and subgroup analyses were performed based on age (under 3 years, 3-5 years, 6-11 years, and 12 years and above).

RESULTS: PCD-CT demonstrated statistically significantly higher scores than EID-CT for all items (tympanic membrane, 2.9 vs. 2.4; incudostapedial joint, 3.6 vs. 2.6, stapedial crura, 3.2 vs. 2.4; cochlear modiolus, 3.4 vs. 2.8; overall image quality, 3.6 vs. 2.8; p<0.05). Inter-reader agreement ranged from good to excellent (ICCs, 0.6-0.81). PCD-CT exhibited a 43% dose reduction compared to EID-CT, with a particularly substantial reduction of over 70% in the subgroups of children under 6 years.

CONCLUSIONS: PCD temporal bone CT achieves significantly superior imaging quality at a lower radiation dose compared to EID-CT.

ABBREVIATIONS: PCD-CT = photon counting detectors CT; EID-CT = energy integrating detectors CT; DLP = dose length product; AEC = automatic exposure control; ICC = interclass correlation coefficient.

PMID:38589057 | DOI:10.3174/ajnr.A8276

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Call me Ishmael: addressing the white whale of team communication in the operating room with labelled surgical caps at an academic medical centre

BMJ Open Qual. 2024 Apr 8;13(2):e002453. doi: 10.1136/bmjoq-2023-002453.

ABSTRACT

INTRODUCTION: Effective communication in the operating room (OR) is crucial. Addressing a colleague by their name is respectful, humanising, entrusting and associated with improved clinical outcomes. We aimed to enhance team communication in the perioperative environment by offering personalised surgical caps labelled with name and provider role to all OR team members at a large academic medical centre.

MATERIALS AND METHODS: This was a quasi-experimental, uncontrolled, before-and-after quality improvement study. A survey regarding perceptions of team communication, knowledge of names and roles, communication barriers, and culture was administered before and after cap delivery. Survey results were measured on a 5-point Likert Scale; descriptive statistics and mean scores were compared. All cause National Surgical Quality Improvement Project (NSQIP) morbidity and mortality outcomes for surgical specialties were examined.

RESULTS: 1420 caps were delivered across the institution. Mean survey scores increased for knowing the names and roles of providers around the OR, feeling that people know my name and feeling comfortable communicating without barriers across disciplines. The mean score for team communication around the OR is excellent was unchanged. The highest score both before and after was knowing the name of an interdisciplinary team member is important for patient care. A total of 383 and 212 providers participated in the study before and after cap delivery, respectively. Participants agreed or strongly agreed that labelled surgical caps made it easier to talk to colleagues (64.9%) while improving communication (66.0%), team culture (60.5%) and patient care (56.8%). No significant differences were noted in NSQIP outcomes.

CONCLUSIONS: Personalised labelled surgical caps are a simple, inexpensive tool that demonstrates promise in improving perioperative team communication. Creating highly reliable surgical teams with optimal communication channels requires a multifaceted approach with engaged leadership, empowered front-line providers and an institutional commitment to continuous process improvement.

PMID:38589054 | DOI:10.1136/bmjoq-2023-002453

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Cotton plants overexpressing the Bacillus thuringiensis Cry23Aa and Cry37Aa binary-like toxins exhibit high resistance to the cotton boll weevil (Anthonomus grandis)

Plant Sci. 2024 Apr 6:112079. doi: 10.1016/j.plantsci.2024.112079. Online ahead of print.

ABSTRACT

The cotton boll weevil (CBW, Anthonomus grandis) stands as one of the most significant threats to cotton crops (Gossypium hirsutum). Despite substantial efforts, the development of a commercially viable transgenic cotton event for effective open-field control of CBW has remained elusive. This study describes a detailed characterization of the insecticidal toxins Cry23Aa and Cry37Aa against CBW. Our findings reveal that CBW larvae fed exclusively on artificial diets supplemented with Cry37Aa alone displayed no statistical difference compared to the control. Conversely, when exposed solely to Cry23Aa, larval survival decreased by roughly 69%. However, the combined provision of both Cry23Aa and Cry37Aa in the artificial diet led to mortality rates approaching 100% among CBW larvae (LC50 equal to 0.26 PPM). Additionally, we engineered transgenic cotton plants by introducing cry23Aa and cry37Aa genes under the regulation of the flower bud-specific pGhFS4 and pGhFS1 promoters, respectively. After confirming forty-five transgenic cotton events, we selected the top seven events that exhibited elevated expression levels of Cry23Aa and Cry37Aa toxins in flower buds, 70%, for greenhouse bioassays. The mortality rate of CBW larvae feeding on both T0 and T1 generation transgenic cotton plants ranged from 75 to 100%. Our computational analyses unveiled that Cry23Aa possesses all the hallmark characteristics of a β-pore-forming toxin (β-PFT), specifically binding to sugar components in glycoproteins. Intriguingly, our studies also discovered a distinctive zinc-binding site within Cry23Aa, which appears to be involved in protein-protein interactions. Ultimately, our discussion centers on the crucial structural attributes of Cry23Aa that likely play a role in the toxin’s mechanism of action. With the observed low LC50 for CBW and the significant accumulation of these toxins in the flower buds of both T0 and T1 plants, we anticipate that across successive generations of these transgenic lines, cotton plants engineered to overexpress cry23Aa and cry37Aa hold promise for effectively managing CBW infestations in cotton crops.

PMID:38588981 | DOI:10.1016/j.plantsci.2024.112079