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Prevalence and patterns of adverse events following childhood immunization and the responses of mothers in Ile-Ife, South West Nigeria: a facility-based cross-sectional survey

Osong Public Health Res Perspect. 2023 Aug;14(4):291-299. doi: 10.24171/j.phrp.2023.0071. Epub 2023 Jul 27.

ABSTRACT

BACKGROUND: This study aimed to examine the prevalence and pattern of adverse events following childhood immunization and the responses of mothers in Ile-Ife, South West Nigeria.

METHODS: This descriptive cross-sectional study was conducted among 422 mothers of children aged 0 to 24 months attending any of the 3 leading immunization clinics in Ile-Ife, Nigeria. The respondents were selected using the multi-stage sampling technique. Data were collected using a pretested structured interviewer-administered questionnaire and analyzed using IBM SPSS ver. 26.0. The chi-square test was used to test associations, while binary logistic regression was used to determine the predictors of mothers’ responses to adverse events following immunization (AEFIs). A p-value of <0.05 was considered statistically significant.

RESULTS: The mean age of the respondents was 29.99±5.74 years. About 38% of the children had experienced an AEFI. Most mothers believed that the pentavalent vaccine was the most common cause of AEFIs (67.5%). Fever (88.0%) and pain and swelling (76.0%) were the most common AEFIs. More than half of the mothers (53.7%) administered home treatment following an AEFI. Younger mothers (odds ratio [OR], 2.43; 95% confidence interval [CI], 1.20-5.01), mothers who delivered their children at a healthcare facility (OR, 3.24; 95% CI, 1.08-9.69), and mothers who were knowledgeable about reporting AEFIs (OR, 2.53; 95% CI, 1.04-7.70) were most likely to respond appropriately to AEFIs.

CONCLUSION: The proportion of mothers who responded poorly to AEFIs experienced by their children was significant. Therefore, strategies should be implemented to improve mothers’ knowledge about AEFIs to improve their responses.

PMID:37652684 | DOI:10.24171/j.phrp.2023.0071

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Risk factors for transmission in a COVID-19 cluster infection in a high school in the Republic of Korea

Osong Public Health Res Perspect. 2023 Aug;14(4):252-262. doi: 10.24171/j.phrp.2023.0125. Epub 2023 Jul 27.

ABSTRACT

BACKGROUND: This study aimed to examine the scale, characteristics, risk factors, and modes of transmission in a coronavirus disease 2019 (COVID-19) outbreak at a high school in Seoul, Republic of Korea.

METHODS: An epidemiological survey was conducted of 1,118 confirmed cases and close contacts from a COVID-19 outbreak at an educational facility starting on May 31, 2021. In-depth interviews, online questionnaires, flow evaluations, and CCTV analyses were used to devise infection prevention measures. Behavioral and spatial risk factors were identified, and statistical significance was tested.

RESULTS: Among 3rd-year students, there were 33 confirmed COVID-19 cases (9.6%). Students who used a study room in the annex building showed a statistically significant 4.3-fold elevation in their relative risk for infection compared to those who did not use the study room. Moreover, CCTV facial recognition analysis confirmed that 17.8% of 3rd-year students did not wear masks and had the lowest percentage of mask-wearers by grade. The air epidemiological survey conducted in the study room in the annex, which met the 3 criteria for a closed space, confirmed that there was only 10% natural ventilation due to the poor ventilation system.

CONCLUSION: To prevent and manage the spread of COVID-19 in educational facilities, advance measures that consider the size, operation, and resources of each school are crucial. In addition, various survey methodologies should be used in future studies to quickly analyze a wider range of data that can inform an evidence-based quarantine response.

PMID:37652680 | DOI:10.24171/j.phrp.2023.0125

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Endoluminal radiofrequency ablation in patients with malignant biliary obstruction: a randomised trial

Gut. 2023 Aug 31:gutjnl-2023-329700. doi: 10.1136/gutjnl-2023-329700. Online ahead of print.

ABSTRACT

BACKGROUND: Endoluminal radiofrequency ablation (RFA) has been promoted as palliative treatment for patients with cholangiocarcinoma (CCA) and pancreatic ductal adenocarcinoma (PDAC) in order to improve biliary drainage and eventually prolong survival. No high level evidence is, however, available on this technique.

DESIGN: In this randomised controlled study, we compared endoluminal RFA plus stenting with stenting alone (control group) in patients with malignant biliary obstruction; metal stents were primarily placed. Primary outcome was overall survival; secondary outcomes were stent patency, quality of life and adverse events. In a superiority design, survival was assumed to be doubled by RFA as compared with 6.4 months in the control group (n=280).

RESULTS: A total of 161 patients (male:female 90:71, mean age 71±9 years) were randomised before recruitment was terminated for futility after an interim analysis. Eighty-five patients had CCA (73 hilar, 12 distal) and 76 had pancreatic cancer. There was no difference in survival in both subgroups: for patients with CCA, median survival was 10.5 months (95% CI 6.7 to 18.3) in the RFA group vs 10.6 months (95% CI 9.0 to 24.8), p=0.58)) in the control group. In the subgroup with pancreatic cancer, median survival was 6.4 months (95% CI 4.3 to 9.7) for the RFA vs 7.7 months (95% CI 5.6 to 11.3), p=0.73) for the control group. No benefit was seen in the RFA group with regard to stent patency (at 12 months 40% vs 36% in CCA and 66% vs 65% in PDAC), and quality of life was unchanged by either treatment and comparable between the groups. Adverse events occurred in seven patients in each groups.

CONCLUSION: A combination of endoluminal RFA and stenting was not superior to stenting alone in prolonging survival or improving stent patency in patients with malignant biliary obstruction.

TRIAL REGISTRATION NUMBER: NCT03166436.

PMID:37652677 | DOI:10.1136/gutjnl-2023-329700

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Oxidative stress and early mortality in acute ischemic stroke: A prospective cohort study

Neurol Res. 2023 Aug 31:1-8. doi: 10.1080/01616412.2023.2252284. Online ahead of print.

ABSTRACT

BACKGROUND: Malondialdehyde (MDA) is an oxidative stress biomarker, which represents a unifying mechanism of brain injury that occurs throughout the ischemic stroke cascade. The current study aimed to examine whether or not acute ischemic stroke (AIS) patients who had elevated serum MDA levels at admission had an increased risk of mortality and a worse functional outcome three months later.

METHODS: An observational, prospective cohort study that enrolled 90 patients with AIS. The patients were examined in the first 24 hours and then followed up for three months to assess mortality, short-term neurological functional outcome, and neurological disability by the Modified Rankin Scale (MRS).

RESULTS: The mean of serum MDA level among AIS patients was 6.3 ± 3.7 nmol/ml. Non-survivor cases were associated with statistically significantly higher serum MDA levels compared to survivors (9.7 ± 4.3 vs. 5.3 ± 2.8, p < 0.001), respectively. Patients with severe stroke, according to NIHSS score, were associated with significantly (p < 0.05) higher MDA levels compared to moderate and mild cases (7.4 ± 4.3 vs. 5.4 ± 2.6 vs. 3.3 ± .6). At a cutoff point of ≥ 6.7 nmol/ml, the area under the curve (AUC) for serum MDA levels as a predictor of mortality was 0.8 (0.69-0.91; p < 0.05). The sensitivity, specificity, positive predictive value, and negative predictive value were 77%, 80%, 89.5%, and 48.5%, respectively. Multivariate regression demonstrated that MDA level was a significant independent predictor of mortality among patients with AIS (OR = 1.29, 95% CI: 1.01 to 1.65; p = 0.041).

CONCLUSION: MDA serum level was significantly higher in non-survivors than in survivors patients, so MDA could be used as a predictor for early mortality and short-term outcome of cases with AIS.

PMID:37652662 | DOI:10.1080/01616412.2023.2252284

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Developing a supportive and palliative care intervention for patients with allogeneic stem cell transplantation: protocol of a multicentre mixed-methods study (allo-PaS)

BMJ Open. 2023 Aug 31;13(8):e066948. doi: 10.1136/bmjopen-2022-066948.

ABSTRACT

INTRODUCTION: Although allogeneic stem cell transplantation (allo-SCT) is a curative treatment for many haematological malignancies, it is often associated with a high morbidity and mortality. Yet, little is known about the needs for supportive and palliative care among allo-SCT recipients. Moreover, targeted interventions that reduce symptom burden and suffering are still lacking. The present study aims to inform a supportive-palliative care intervention for patients with allo-SCT and their informal carers by exploring their experience and assessing their needs, especially their existential concerns, regarding four research topics: symptom burden and quality of life; coexistence of a chance for cure and a relevant risk of dying; change in goals of care; dying phase.

METHODS AND ANALYSIS: This is a descriptive mixed-methods study in progress with a convergent parallel design. Data on the four research topics will be collected and analysed separately in three steps: (1) qualitative semi-structured interviews among 20 patients, 20 informal carers and 12 healthcare providers (HCPs) and focus groups among 12-24 HCPs; (2) a quantitative cross-sectional survey with validated questionnaires and self-developed questions among 100 patients, 100 informal carers and 50 HCPs; (3) a retrospective case analysis of all deceased patients who underwent an allo-SCT between 2010 and 2019, with collection of quantitative and qualitative data. The qualitative and quantitative data sets will be finally merged for comparison and interpretation. Results will serve to develop a supportive-palliative care intervention.

ETHICS AND DISSEMINATION: The Ethics Commission of the Faculty of Medicine of the University of Cologne approved this study (20-1370_2). The study results will be published in peer-review journals, be presented at congresses and will be translated into clinical practice through the development of the palliative-supportive care intervention.

TRIAL REGISTRATION NUMBER: DRKS00027290 (German Clinical Trials Register).

PMID:37652589 | DOI:10.1136/bmjopen-2022-066948

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Impact of the COVID-19 pandemic on mortality trends in Japan: a reversal in 2021? A descriptive analysis of national mortality data, 1995-2021

BMJ Open. 2023 Aug 31;13(8):e071785. doi: 10.1136/bmjopen-2023-071785.

ABSTRACT

OBJECTIVE: The COVID-19 pandemic led to an increase in mortality in most countries in 2020, deviating from prior decreasing trends. In Japan, however, mortality was suggested to decrease in 2020. This study investigated long-term mortality trends and cause-specific contributions, focusing on the period of the COVID-19 pandemic in Japan.

DESIGN: We analysed Japanese age-standardised mortality rates (ASMRs) from 1995 to 2021 using vital statistics.

MAIN OUTCOME MEASURES: The cause-specific annual ASMR changes were calculated in comparison with the previous year over the abovementioned period.

RESULTS: There was a general downward trend in overall ASMR for both sexes until 2020 followed by a small increase in 2021. In men, the all-cause ASMR (per 100 000 persons) decreased from 1352.3 to 1328.8 in 2020 (-1.74% from 2019), and increased to 1356.3 in 2021 in men (+2.07% from 2020). In women, the all-cause ASMR decreased from 746.0 to 722.1 in 2020 (-3.20% from 2019), and increased to 737.9 (+2.19% from 2020) in 2021. ASMRs from malignant neoplasms, pneumonia, accidents and suicide (men only) continued to decrease during the COVID-19 pandemic while the trend of cardiovascular mortality increased in 2021. Analysis of ASMR changes revealed that COVID-19, senility, cardiovascular disease and ‘other causes not classified as major causes’ contributed to the all-cause mortality increase in 2021.

CONCLUSIONS: In Japan, the decreasing trend in overall mortality continued in 2020 despite the COVID-19 pandemic. However, approximately 2% mortality increase was observed in 2021, which was attributable to COVID-19, senility, cardiovascular disease and ‘other causes’. The year 2021 was a turning point of mortality trends in Japan, although continued monitoring is warranted.

PMID:37652585 | DOI:10.1136/bmjopen-2023-071785

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Procedural education for cancer-related pain in Pain Medicine fellowships: a national program survey

Reg Anesth Pain Med. 2023 Aug 31:rapm-2023-104630. doi: 10.1136/rapm-2023-104630. Online ahead of print.

ABSTRACT

INTRODUCTION: Cancer-related pain is ubiquitous. Targeted procedural interventions may be an important and underutilized method for improving cancer-related pain and quality of life. The goal of this study was to determine the baseline educational experience and perceived post-graduation comfort of Pain Medicine fellows in performing procedures that can be used for cancer-related pain.

METHODS: Using Qualtrics, a 16-question survey was distributed to graduating fellows at accredited Pain Medicine Fellowship programs in the USA in June 2022. The fellows’ experience and comfort level performing eight procedures was analyzed using summary descriptive statistics and contingency table analysis with statistical significance determined by Pearson’s χ2 test.

RESULTS: Survey respondents represented 30% of fellows among 44% of Pain Medicine programs during the 2021-2022 academic year. The majority of respondents reported no experience performing 7 of the 8 procedures for cancer-related pain (56.1%-90.6%). Graduating fellows reported overall comfort performing sympathetic neurolysis (65.7%), spinal cord stimulator trials (85.7%) and implantations (66.0%), but not intrathecal pump trials (36.9%) and implantations (31.3%), peripheral nerve stimulator implantations (41.7%), vertebral augmentations (31.3%), and vertebral body radiofrequency ablations (16.7%).

CONCLUSIONS: Experience performing 10 or more of the surveyed procedures, personal interest in treating cancer-related pain, and attendance of cancer-related pain lectures were found to significantly increase comfortability in performing cancer-related pain procedures post graduation, whereas cadaver-based learning did not. This study highlights the need for more robust procedural education for cancer-related pain and identifies procedural experience in non-cancer patients and lectures on cancer-related pain as ways to bridge this educational gap.

PMID:37652574 | DOI:10.1136/rapm-2023-104630

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Developing evidence-based patient-focused learning materials to support health behaviour change for people living with psoriatic arthritis

RMD Open. 2023 Aug;9(3):e003190. doi: 10.1136/rmdopen-2023-003190.

ABSTRACT

OBJECTIVES: In psoriatic arthritis (PsA), self-management is important for patient function and quality of life. Behaviour change can be difficult, patients could benefit from high-quality support to initiate change. Our aim was to codesign the project as theory-informed, evidence-based, patient-focused, materials supporting healthy lifestyle changes for patients diagnosed with PsA.

METHODS: Development of the materials was overseen by a steering group of patients with PsA, psychologists, rheumatologists, a design team and researchers. First, a literature review was performed to establish the evidence base for behaviours and potential interventions in PsA, including diet, weight, alcohol, smoking, exercise, anxiety, depression and stress. An initial roundtable of patients with PsA prioritised areas and content ideas. Draft materials including a website and downloadable materials were produced. A second roundtable of patients with PsA collected feedback on the draft content and design. A third roundtable was held with patients with PsA and a fourth with clinicians to refine the materials and ensuring that they were evidence based, accessible, interesting, and helpful to initiate and maintain change. A final evaluation survey was performed to review the draft website before launching the final materials.

RESULTS: 15 candidate topics were prioritised. A website and set of postcards summarising the topics were developed by the design team and refined following feedback from the roundtable groups.

CONCLUSION: This project created patient-focused resources to support behaviour change. It addresses common concerns of patients with PsA about how they may optimise their health by providing practical and brief interventions to challenge and support them to make changes.

PMID:37652555 | DOI:10.1136/rmdopen-2023-003190

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Phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel-group study of ustekinumab in Japanese patients with active polymyositis and dermatomyositis who have not adequately responded to one or more standard-of-care treatments

RMD Open. 2023 Aug;9(3):e003268. doi: 10.1136/rmdopen-2023-003268.

ABSTRACT

OBJECTIVES: To evaluate the efficacy and safety of ustekinumab (UST) in a multicentre, randomised, double-blind, placebo-controlled trial in adult Japanese patients with active polymyositis (PM) and dermatomyositis (DM).

METHODS: Fifty-one Japanese adults diagnosed with active PM/DM who did not respond adequately to one or more standard-of-care treatments were randomised 1:1 to receive UST (n=25) or placebo (n=26). Participants received body weight-range based intravenous administration of UST (6 mg/kg) or placebo at week 0 followed by 90 mg subcutaneous (SC) administration of UST or placebo every 8 weeks from week 8 to week 24. At week 24, placebo group crossed over to receive body weight-range based intravenous administration of UST, and thereafter, all participants received/were to receive SC administration of UST 90 mg every 8 weeks (week 32 through to week 72). The primary efficacy endpoint was the proportion of participants who achieved minimal improvement (≥20) in the International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) at week 24.

RESULTS: No statistically significant difference was seen in the proportion of participants who achieved minimal improvement (≥20) in IMACS TIS at week 24 between the treatment groups (UST 64.0% vs placebo 61.5%, p=0.94) based on the primary estimand of the primary endpoint analysis.

CONCLUSIONS: UST was safe and well tolerated but did not meet the primary efficacy endpoint in adult Japanese participants with active PM/DM based on the primary analysis at week 24 in the study.

TRIAL REGISTRATION NUMBER: NCT03981744.

PMID:37652554 | DOI:10.1136/rmdopen-2023-003268

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Predictive IDH Genotyping Based on the Evaluation of Spatial Metabolic Heterogeneity by Compartmental Uptake Characteristics in Preoperative Glioma Using 18F-FET PET

J Nucl Med. 2023 Aug 31:jnumed.123.265642. doi: 10.2967/jnumed.123.265642. Online ahead of print.

ABSTRACT

Molecular markers are of increasing importance for classifying, treating, and determining the prognosis for central nervous system tumors. Isocitrate dehydrogenase (IDH) is a critical regulator of glucose and amino acid metabolism. Our objective was to investigate metabolic reprogramming of glioma using compartmental uptake (CU) characteristics in O-(2-18F-fluoroethyl)-l-tyrosine (FET) PET and to evaluate its diagnostic potential for IDH genotyping. Methods: Between 2017 and 2022, patients with confirmed glioma were preoperatively investigated using static 18F-FET PET. Metabolic tumor volume (MTV), MTV for 60%-100% uptake (MTV60), and T2-weighted and contrast-enhancing lesion volumes were automatically segmented using U-Net neural architecture and isocontouring. Volume intersections were determined using the Dice coefficient. Uptake characteristics were determined for metabolically defined compartments (central [80%-100%] and peripheral [60%-75%] areas of 18F-FET uptake). CU ratio was defined as the fraction between the peripheral and central compartments. Mean target-to-background ratio was calculated. Comparisons were performed using parametric and nonparametric tests. Receiver-operating-characteristic curves, regression, and correlation were used for statistical analysis. Results: In total, 52 participants (male, 27, female, 25; mean age ± SD, 51 ± 16 y) were evaluated. MTV60 was greater and distinct from contrast-enhancing lesion volume (P = 0.046). IDH-mutated tumors presented a greater volumetric CU ratio and SUV CU ratio than IDH wild-type tumors (P < 0.05). Volumetric CU ratio determined IDH genotype with excellent diagnostic performance (area under the curve [AUC], 0.88; P < 0.001) at more than 5.49 (sensitivity, 86%, specificity, 90%), because IDH-mutated tumors presented a greater peripheral metabolic compartment than IDH wild-type tumors (P = 0.045). MTV60 and MTV were not suitable for IDH classification (P > 0.05). SUV CU ratio (AUC, 0.72; P = 0.005) and target-to-background ratio (AUC, 0.68; P = 0.016) achieved modest diagnostic performance-inferior to the volumetric CU ratio. Furthermore, the classification of loss of heterozygosity of chromosomes 1p and 19q (AUC, 0.75; P = 0.019), MGMT promoter methylation (AUC, 0.70; P = 0.011), and ATRX loss (AUC, 0.73; P = 0.004) by amino acid PET was evaluated. Conclusion: We proposed parametric 18F-FET PET as a noninvasive metabolic biomarker for the evaluation of CU characteristics, which differentiated IDH genotype with excellent diagnostic performance, establishing a critical association between spatial metabolic heterogeneity, mitochondrial tricarboxylic acid cycle, and genomic features with critical implications for clinical management and the diagnostic workup of patients with central nervous system cancer.

PMID:37652542 | DOI:10.2967/jnumed.123.265642