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Nevin Manimala Statistics

Determinants of hemoglobin level and time to default from Highly Active Antiretroviral Therapy (HAART) for adult clients living with HIV under treatment; a retrospective cohort study design

Sci Rep. 2024 Jun 28;14(1):14929. doi: 10.1038/s41598-024-62952-w.

ABSTRACT

HIV/AIDS is one of the most devastating infectious diseases affecting humankind all over the world and its impact goes beyond public health problems. This study was conducted to investigate the joint predictors of hemoglobin level and time to default from treatment for adult clients living with HIV/AIDS under HAART at the University of Gondar Comprehensive and Specialized Hospital, North-west Ethiopia. The study was conducted using a retrospective cohort design from the medical records of 403 randomly selected adult clients living with HIV whose follow-ups were from September 2015 to March 2022. Hemoglobin level was projected using Sahli’s acid-hematin method. Hence, the hemoglobin tube was filled with N/10 hydrochloric acid up to 2 g % marking and the graduated tube was placed in Sahli’s hemoglobin meter. The blood samples were collected using the finger-pick method, considering 22 G disposable needles. The health staff did this. From a total of 403 adult patients living with HIV/AIDS included in the current study, about 44.2% defaulted from therapy. The overall mean and median estimated survival time of adult clients under study were 44.3 and 42 months respectively. The patient’s lymphocyte count (AHR = 0.7498, 95% CI: (0.7411: 0.7587), p-value < 0.01), The weight of adult patients living with HIV/AIDS (AHR = 0.9741, 95% CI: (0.9736: 0.9747), p-value = 0.012), sex of adult clients (AHR = 0.6019, 95% CI: (0.5979, 0.6059), p-value < 0.01), WHO stages III compared to Stage I (AHR = 1.4073, 95% CI: (1.3262, 1.5078), p-value < 0.01), poor adherence level (AHR = 0.2796, 95% CI: (0.2082, 0.3705) and p-value < 0.01), bedridden patients (AHR = 1.5346, 95% CI: (1.4199, 1.6495), p-value = 0.008), and opportunistic infections (AHR = 0.2237, 95% CI: (0.0248, 0.4740), p-value = 0.004) had significant effect on both hemoglobin level and time to default from treatment. Similarly, other co-morbidity conditions, disclosure status of the HIV disease, and tobacco and alcohol addiction had a significant effect on the variables of interest. The estimate of the association parameter in the slope value of Hgb level and time default was negative, indicating that the Hgb level increased as the hazard of defaulting from treatment decreased. A patient with abnormal BMI like underweight, overweight, or obese was negatively associated with the risk of anemia (lower hemoglobin level). As a recommendation, more attention should be given to those patients with abnormal BMI, patients with other co-morbidity conditions, patients with opportunistic infections, and low lymphocytes, and bedridden and ambulatory patients. Health-related education should be given to adult clients living with HIV/AIDS to be good adherents for medical treatment.

PMID:38942753 | DOI:10.1038/s41598-024-62952-w

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Nevin Manimala Statistics

Real-world severe COVID-19 outcomes associated with use of antivirals and neutralising monoclonal antibodies in Scotland

NPJ Prim Care Respir Med. 2024 Jun 28;34(1):17. doi: 10.1038/s41533-024-00374-x.

ABSTRACT

We sought to investigate the incidence of severe COVID-19 outcomes after treatment with antivirals and neutralising monoclonal antibodies, and estimate the comparative effectiveness of treatments in community-based individuals. We conducted a retrospective cohort study investigating clinical outcomes of hospitalisation, intensive care unit admission and death, in those treated with antivirals and monoclonal antibodies for COVID-19 in Scotland between December 2021 and September 2022. We compared the effect of various treatments on the risk of severe COVID-19 outcomes, stratified by most prevalent sub-lineage at that time, and controlling for comorbidities and other patient characteristics. We identified 14,365 individuals treated for COVID-19 during our study period, some of whom were treated for multiple infections. The incidence of severe COVID-19 outcomes (inpatient admission or death) in community-treated patients (81% of all treatment episodes) was 1.2% (n = 137/11894, 95% CI 1.0-1.4), compared to 32.8% in those treated in hospital for acute COVID-19 (re-admissions or death; n = 40/122, 95% CI 25.1-41.5). For community-treated patients, there was a lower risk of severe outcomes (inpatient admission or death) in younger patients, and in those who had received three or more COVID-19 vaccinations. During the period in which BA.2 was the most prevalent sub-lineage in the UK, sotrovimab was associated with a reduced treatment effect compared to nirmaltrelvir + ritonavir. However, since BA.5 has been the most prevalent sub-lineage in the UK, both sotrovimab and nirmaltrelvir + ritonavir were associated with similarly lower incidence of severe outcomes than molnupiravir. Around 1% of those treated for COVID-19 with antivirals or neutralising monoclonal antibodies required hospital admission. During the period in which BA.5 was the prevalent sub-lineages in the UK, molnupiravir was associated with the highest incidence of severe outcomes in community-treated patients.

PMID:38942748 | DOI:10.1038/s41533-024-00374-x

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Nevin Manimala Statistics

Confirmatory validation of the Mesothelioma Psychological Distress Tool-Patients: A brief patient-reported outcome measure assessing psychological distress in malignant mesothelioma patients

Psychooncology. 2024 Jul;33(7):e6371. doi: 10.1002/pon.6371.

ABSTRACT

OBJECTIVE: Psychological suffering in patients with Malignant Mesothelioma (MM) is different from the one experienced by patients with other cancers due to its occupational or environmental etiology and its peculiar symptomatology and prognosis (i.e., poor prognosis, reduced effectiveness of the therapies, poor quality of residual life, and advanced age at the time of diagnosis). Therefore, the Mesothelioma Psychological Distress Tool-Patients (MPDT-P) has been developed to evaluate the specific profile of psychological suffering in this population. This paper describes the item selection, factor analysis, and psychometric evaluation of the revised MPDT-P.

METHODS: The analyses of the current work aimed to confirm the factorial structure found in the first version of the MPDT-P. In the case of nonfit, it aimed to find an alternative structure and causes of nonfit in the model. The search for the fit of the factorial model was conducted using a Bayesian approach.

RESULTS: The two-factor model reported in the first version of the instrument did not fit the data. Confirmatory Bayesian analyses showed adequate fit for the three-factor solution. Based on the content of the items, we labeled the factors as dysfunctional emotions, claims for justice, and anxieties about the future.

CONCLUSIONS: Integrating the MPDT-P into clinical practice could help clinicians gain insight into the specific suffering related to MM and investigate potential differences related to different occupational and environmental exposure contexts.

PMID:38942736 | DOI:10.1002/pon.6371

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Nevin Manimala Statistics

The Safety of Aztreonam Versus Ceftazidime in Patients Labeled With Penicillin Allergy: A Cohort Study

Clin Ther. 2024 Jun 27:S0149-2918(24)00114-0. doi: 10.1016/j.clinthera.2024.05.007. Online ahead of print.

ABSTRACT

PURPOSE: Penicillin allergy is the most common drug allergy among hospitalized patients. Traditionally, aztreonam is recommended for patients labeled with penicillin allergy (PLWPA) in our institutional empirical antibiotic guidelines. Due to a global aztreonam shortage in December 2022, the antimicrobial stewardship unit recommended ceftazidime as a substitute. There is a paucity of real-world data on the safety profile of ceftazidime in PLWPA. Hence, we evaluated tolerability outcomes of ceftazidime use in PLWPA.

METHODS: This retrospective cohort study compared PLWPA in Singapore General Hospital who received aztreonam (October 2022-December 2022) or ceftazidime (December 2022-February 2023). Patients were stratified according to their risk of allergic reaction (AR) based on history of penicillin allergy. The severity of AR was based on the Delphi study grading system. The primary outcome was development of AR after initiation of aztreonam or ceftazidime. The secondary tolerability outcomes include hepatotoxicity and neurotoxicity.

FINDINGS: There were 168 patients in the study; 69 were men (41.1%) and the median age was 69 years (interquartile range: 59-76 years). Incidence of AR was statistically similar in both arms: 1 of 102 patients (0.98%) in the aztreonam arm vs 2 of 66 patients (3.03%) in the ceftazidime arm (P = 0.33). The patient in the aztreonam arm was deemed at medium risk of having an AR and developed localized rashes (grade 1). Both patients in the ceftazidime arm were deemed at high risk of AR and developed localized skin reaction (grade 1). Hepatotoxicity was observed in 1 patient prescribed aztreonam. No patients in the ceftazidime arm developed adverse events.

IMPLICATIONS: Ceftazidime appears to be better tolerated and cheaper compared with aztreonam in PLWPA, and serves as an antimicrobial stewardship strategy to conserve broader-spectrum antibiotics use.

PMID:38942719 | DOI:10.1016/j.clinthera.2024.05.007

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Restoration of teeth lacking complete ferrules using cast precious metal alloy post-and-cores and knife-edged crowns: A retrospective clinical study

J Prosthet Dent. 2024 Jun 27:S0022-3913(24)00367-6. doi: 10.1016/j.prosdent.2024.05.015. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: While the presence of a ferrule has been reported to be essential for post-and-core restorations, many extensively damaged teeth lack complete ferrules. The outcome of post-and-core restorations for these teeth remains uncertain.

PURPOSE: The purpose of this retrospective clinical study was to assess the outcome of cast alloy post-and-cores and knife-edged crowns for the restoration of teeth lacking complete ferrules.

MATERIAL AND METHODS: A total of 106 participants with endodontically treated teeth with 2 or fewer walls with ferrules who had received cast precious metal alloy post-and-cores along with knife-edged crowns between 2013 and 2022 were recalled for a clinical examination. The minimum follow-up time was 5 months after restoration, and restoration failure and the periodontal status difference between restored teeth and reference teeth were determined. Kaplan-Meier analysis was performed to obtain success curves. The influence of age, sex, jaw position, tooth type, and antagonistic dentition upon the success function was analyzed with the log-rank or Breslow test (α=.05).

RESULTS: A total of 100 participants with 130 restorations were studied. The success rate of the restorations was 93.85% in a mean ±standard deviation period of 48.3 ±26.1 months. The estimated 5-year cumulative success probability was 91.61%. No significant effect on the success of restorations was found regarding age, sex, jaw position, tooth type, or antagonistic dentition (P>.05). The main failure types were post debonding, root fracture, and apical periodontitis. No statistical difference in tooth mobility (Z=-1.265, P=.206) was found between the restored and the reference teeth, but the plaque index and calculus index of the restored teeth were significantly lower than of the reference teeth (Z=-7.216, P<.001; Z=-7.044, P<.001). Teeth that had received cast post-and-cores and knife-edged crowns were found to have no significant correlation with periodontal disease (χ²=1.131, P=.288) or bleeding on probing (χ²=3.436, P=.064).

CONCLUSIONS: The clinical outcomes for the restoration of teeth with 2 or fewer walls with ferrules using cast precious metal alloy post-and-cores and knife-edged crowns were favorable, exhibiting a high 5-year cumulative success probability and no increased periodontal health risk.

PMID:38942716 | DOI:10.1016/j.prosdent.2024.05.015

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Nevin Manimala Statistics

Diagnostic performance of contrast-enhanced ultrasound (CEUS) combined with Ovarian-Adnexal Reporting and Data System (O-RADS) ultrasound risk stratification for adnexal masses: a systematic review and meta-analysis

Clin Radiol. 2024 Jun 7:S0009-9260(24)00294-0. doi: 10.1016/j.crad.2024.05.021. Online ahead of print.

ABSTRACT

AIM: A number of studies have reported that contrast-enhanced ultrasound (CEUS) imaging might be used for the early diagnosis of adnexal masses. A meta-analysis was performed to evaluate the diagnostic accuracy of CEUS combined with Ovarian-Adnexal Reporting and Data System (O-RADS) ultrasound risk stratification for adnexal masses.

MATERIALS AND METHODS: Related articles were retrieved from PubMed, Web of Science, Embase, and the Cochrane Library in strict accordance with established standards, and data (including true positive, false positive, false negative, and true negative values) was extracted from the original articles. The Quality Assessment of Diagnostic Accuracy Studies 2 was used to evaluate the quality of articles and the possibility of bias. STATA 12.0 software was used to perform statistical analysis.

RESULTS: Five articles that included 598 patients were analyzed in this meta-analysis. The pooled sensitivity and specificity of CEUS combined with O-RADS for the diagnosis of adnexal masses were 0.95 (95% confidence interval [CI]: 0.91-0.98) and 0.86 (95% CI: 0.79-0.91). Moreover, the positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio (DOR), and area under the curve (AUC) were 6.81 (95% CI: 4.61-10.08), 0.05 (95% CI: 0.03-0.11), 111.30 (95% CI: 65.32-189.65), and 0.97 (95% CI: 0.95-0.98), respectively. The pooled AUC and DOR for the detection of CEUS combined with O-RADS were superior to O-RADS US.

CONCLUSION: Our findings revealed that O-RADS combined with CEUS can improve the diagnostic accuracy of ovarian adnexal masses.

PMID:38942707 | DOI:10.1016/j.crad.2024.05.021

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Nevin Manimala Statistics

Comparison of the predictive validity of the Braden, Munro and 3S scales in surgical patients

J Tissue Viability. 2024 Jun 25:S0965-206X(24)00086-X. doi: 10.1016/j.jtv.2024.06.011. Online ahead of print.

ABSTRACT

AIM OF THE STUDY: This research is a descriptive and cross-sectional study aimed at examining the use of three different scales to assess the risk of pressure injury (PI) in surgical patients.

MATERIALS AND METHODS: This study was conducted between February 1 and July 1, 2022. The study included patients who had planned surgery in general surgery clinic. The sample size was 388 patients. Patients who agreed to participate in the study were asked to fill out the ” Introductory Information Form ” and perform a risk assessment using the Braden, Munro and 3S Scales. The statistics program IBM SPSS Statistics 25.0 packaged software was used in the analyses of data.

RESULTS: It is evident that the relationship between the scales and the diagnosis of PI, as well as the strength of this relationship, are statistically significant (p < 0.05). The Munro Scale exhibited the highest value of Phi value and validity coefficient c, indicating a stronger association with the diagnosis of PI, thus suggesting its greater effectiveness in discrimination. According to the validity coefficients found, it can be stated that the correct classification percentages for Munro, Braden, and 3S Scales were 91 %, 71 %, and 66 %, respectively.

CONCLUSION: The findings of this study indicate that both the Braden, Munro, and 3S Scales can be used for PI risk assessment in surgical patients, but the Munro Scale exhibits superior predictive validity compared to the Braden and 3S Scales in terms of overall sensitivity and specificity.

PMID:38942648 | DOI:10.1016/j.jtv.2024.06.011

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Nevin Manimala Statistics

Nipocalimab, an anti-FcRn monoclonal antibody, in participants with moderate to severe active rheumatoid arthritis and inadequate response or intolerance to anti-TNF therapy: results from the phase 2a IRIS-RA study

RMD Open. 2024 Jun 28;10(2):e004278. doi: 10.1136/rmdopen-2024-004278.

ABSTRACT

OBJECTIVES: To investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of nipocalimab in participants with moderate to severe active rheumatoid arthritis (RA) and inadequate response or intolerance to ≥1 antitumour necrosis factor agent.

METHODS: In this phase 2a study, participants with RA seropositive for anticitrullinated protein antibodies (ACPA) or rheumatoid factors were randomised 3:2 to nipocalimab (15 mg/kg intravenously every 2 weeks) or placebo from Weeks 0 to 10. Efficacy endpoints (primary endpoint: change from baseline in Disease Activity Score 28 using C reactive protein (DAS28-CRP) at Week 12) and patient-reported outcomes (PROs) were assessed through Week 12. Safety, pharmacokinetics and pharmacodynamics were assessed through Week 18.

RESULTS: 53 participants were enrolled (nipocalimab/placebo, n=33/20). Although the primary endpoint did not reach statistical significance for nipocalimab versus placebo, a numerically higher change from baseline in DAS28-CRP at Week 12 was observed (least squares mean (95% CI): -1.03 (-1.66 to -0.40) vs -0.58 (-1.24 to 0.07)), with numerically higher improvements in all secondary efficacy outcomes and PROs. Serious adverse events were reported in three participants (burn infection, infusion-related reaction and deep vein thrombosis). Nipocalimab significantly and reversibly reduced serum immunoglobulin G, ACPA and circulating immune complex levels but not serum inflammatory markers, including CRP. ACPA reduction was associated with DAS28-CRP remission and 50% response rate in American College of Rheumatology (ACR) criteria; participants with a higher baseline ACPA had greater clinical improvement.

CONCLUSIONS: Despite not achieving statistical significance in the primary endpoint, nipocalimab showed consistent, numerical efficacy benefits in participants with moderate to severe active RA, with greater benefit observed for participants with a higher baseline ACPA.

TRIAL REGISTRATION NUMBER: NCT04991753.

PMID:38942592 | DOI:10.1136/rmdopen-2024-004278

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Children with medical complexity receiving home healthcare devices in Japan: a retrospective cohort study

BMJ Paediatr Open. 2024 Jun 28;8(1):e002685. doi: 10.1136/bmjpo-2024-002685.

ABSTRACT

BACKGROUND: Limited evidence exists regarding children receiving home healthcare devices (HHDs). This study aimed to describe the range and type of HHD use by children with chronic medical conditions in Japan and explore factors leading to increased use of these devices.

METHODS: This retrospective cohort study was conducted using data from the National Database of Health Insurance Claims and Specific Health Checkups of Japan. Children receiving HHD aged ≤18 years between April 2011 and March 2019 were included. Children newly administered HHD between 2011 and 2013 were followed up for 5 years, and logistic regression analysis was performed to assess the relationship between increased HHD use and each selected risk factor (comorbidity or types of HHD). The models were adjusted for age category at home device introduction, sex and region.

RESULTS: Overall, 52 375 children receiving HHD were identified. The number (proportion) of children receiving HHD increased during the study period (11 556 [0.05%] in 2010 and 25 593 [0.13%] in 2018). The most commonly administered HHD was oxygen (51.0% in 2018). Among the 12 205 children receiving HHD followed up for 5 years, 70.4% and 68.3% who used oxygen or continuous positive airway pressure, respectively, were released from the devices, while only 25.8% who used mechanical ventilation were released from the device. The following diagnosis/comorbidities were associated with increased HHD use: other neurological diseases (OR): 2.85, 95% CI): 2.54-3.19), cerebral palsy (OR: 2.16, 95% CI: 1.87 to 2.49), congenital malformations of the nervous system (OR: 1.70, 95% CI: 1.34 to 2.13) and low birth weight (OR: 1.68, 95% CI: 1.41 to 2.00).

CONCLUSIONS: This study provides nationwide population-based empirical data to clarify the detailed information regarding children receiving HHD in Japan. This information could assist healthcare professionals in improving the quality of life of these children and their families and help health policymakers consider measures.

PMID:38942589 | DOI:10.1136/bmjpo-2024-002685

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Prevalence and risk factors of scabies among children living in Madrasahs (Islamic religious boarding schools) of Bangladesh: a cross-sectional study

BMJ Paediatr Open. 2024 Jun 28;8(1):e002421. doi: 10.1136/bmjpo-2023-002421.

ABSTRACT

INTRODUCTION: To determine the prevalence and associated factors of scabies among the children living in the Madrasahs (Islamic religious educational institution) of Bangladesh was the objective of the study.

METHODS: This cross-sectional study was conducted in eight selected Madrasahs from May to October 2023 among male and female children aged between 3 and 18 years. Children were screened for scabies according to criteria developed by the International Alliance for the Control of Scabies.

RESULTS: It was found that overall prevalence of scabies among the children living in Madrasahs was almost 34% (mild 73.5%, moderate 24.9% and severe 1.6%). Prevalence of scabies among male was higher than female (39.4% vs 28.4%). Male gender (aOR 2.09, 95% CI 1.27 to 3.47, p=0.004) and age (aOR 0.95, 95% CI 0.91 to 0.99, p=0.017) were two significant predictors of scabies among children. Besides, living in Madrasahs having more boarders (aOR 1.37, 95% CI 1.06 to 1.69, p=0.025), shared bedding, clothes or toilet stuffs with other children (aOR 1.46, 95% CI 1.03 to 2.09, p=0.036) and history of pruritus in the close entourage (aOR 4.19, 95% CI 3.07 to 5.73, p<0.001) were associated with a higher chance of being infected by scabies.

CONCLUSION: Almost one-third of the children living in the Islamic boarding schools in Bangladesh are suffering from scabies, more prevalence in male and younger children. Accommodation of higher number of boarders, sharing personal staffs and pruritus in close contacts increase the risk of scabies in these children.

PMID:38942588 | DOI:10.1136/bmjpo-2023-002421