Tag: nevin manimala

BMJ Open. 2023 Sep 21;13(9):e073817. doi: 10.1136/bmjopen-2023-073817.

ABSTRACT

INTRODUCTION: Patient-reported outcomes (PRO) are currently collected from trial participants using paper questionnaires by the Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU). Streamlining PRO collection using electronic questionnaires (ePRO) may improve data collection and patient experience. Here, we outline our protocol for a Study within a trial of electronic versus paper-based Patient-Reported oUtcomes CollEction (SPRUCE), which investigates the acceptability of ePRO in oncology clinical trials.

METHODS AND ANALYSIS: SPRUCE was developed alongside patient and public contributors. SPRUCE runs in multiple host trials with a partially randomised patient preference design, allowing participants to be randomised or choose their preference of electronic or paper questionnaires. Questionnaires are scheduled in accordance with host trial follow-up. The primary objective will assess differences in return rates (compliance) between ePRO and paper PROs at the first timepoint post-host trial intervention in the randomised group. Paper PRO compliance is expected to be 90%. 244 randomised participants are required to exclude ≤80% compliance rates with ePRO (10% non-inferiority margin, with 80% power and one-sided alpha=0.05). SPRUCE aims to assess acceptability of ePRO in oncology clinical trials, establish whether ePRO is acceptable to ICR-CTSU trial participants and can capture complete PRO data, consistent with paper PROs.

ETHICS AND DISSEMINATION: The SPRUCE protocol (ICR-CTSU/2021/10074) was approved by the Coventry and Warwick Central Research Ethics Committee (21/WM/0223) on 21 October 2021. Results will be disseminated via presentations, publications and lay summaries. No participant identifiable data will be included.

TRIAL REGISTRATION: SWAT169.

PMID:37734892 | DOI:10.1136/bmjopen-2023-073817

Lancet Glob Health. 2023 Oct;11(10):e1629-e1639. doi: 10.1016/S2214-109X(23)00330-3.

ABSTRACT

BACKGROUND: The COVID-19 pandemic disrupted health systems in 2020, but it is unclear how financial hardship due to out-of-pocket (OOP) health-care costs was affected. We analysed catastrophic health expenditure (CHE) in 2020 in five countries with available household expenditure data: Belarus, Mexico, Peru, Russia, and Viet Nam. In Mexico and Peru, we also conducted an analysis of drivers of change in CHE in 2020 using publicly available data.

METHODS: In this time-series analysis, we defined CHE as when OOP health-care spending exceeds 10% of consumption expenditure. Data for 2004-20 were obtained from individual and household level survey microdata (available for Mexico and Peru only), and tabulated data from the National Statistical Committee of Belarus and the World Bank Health Equity and Financial Protection Indicator database (for Viet Nam and Russia). We compared 2020 CHE with the CHE predicted from historical trends using an ensemble model. This method was also used to assess drivers of CHE: insurance coverage, OOP expenditure, and consumption expenditure. Interrupted time-series analysis was used to investigate the role of stay-at-home orders in March, 2020 in changes in health-care use and sector (ie, private vs public).

FINDINGS: In Mexico, CHE increased to 5·6% (95% uncertainty interval [UI] 5·1-6·2) in 2020, higher than predicted (3·2%, 2·5-4·0). In Belarus, CHE was 13·5% (11·8-15·2) in 2020, also higher than predicted (9·7%, 7·7-11·3). CHE was not different than predicted by past trends in Russia, Peru, and Viet Nam. Between March and April, 2020, health-care visits dropped by 4·6 (2·6-6·5) percentage points in Mexico and by 48·3 (40·6-56·0) percentage points in Peru, and the private share of health-care visits increased by 7·3 (4·3-10·3) percentage points in Mexico and by 20·7 (17·3-24·0) percentage points in Peru.

INTERPRETATION: In three of the five countries studied, health systems either did not protect people from the financial risks of health care or did not maintain health-care access in 2020, an indication of health systems failing to maintain basic functions. If the 2020 response to the COVID-19 pandemic accelerated shifts to private health-care use, policies to cover costs in that sector or motivate patients to return to the public sector are needed to maintain financial risk protection.

FUNDING: The Bill & Melinda Gates Foundation.

PMID:37734805 | DOI:10.1016/S2214-109X(23)00330-3

Lancet Glob Health. 2023 Oct;11(10):e1519-e1530. doi: 10.1016/S2214-109X(23)00376-5.

ABSTRACT

BACKGROUND: Differences in mortality exist between sexes because of biological, genetic, and social factors. Sex differentials are well documented in children younger than 5 years but have not been systematically examined for ages 5-24 years. We aimed to estimate the sex ratio of mortality from birth to age 24 years and reconstruct trends in sex-specific mortality between 1990 and 2021 for 200 countries, major regions, and the world.

METHODS: We compiled comprehensive databases on the mortality sex ratio (ratio of male to female mortality rates) for individuals aged 0-4 years, 5-14 years, and 15-24 years. The databases contain mortality rates from death registration systems, full birth and sibling histories from surveys, and reports on household deaths in censuses. We modelled the sex ratio of age-specific mortality as a function of the mortality in both sexes using Bayesian hierarchical time-series models. We report the levels and trends of sex ratios and estimate the expected female mortality and excess female mortality rates (the difference between the estimated female mortality and the expected female mortality) to identify countries with outlying sex ratios.

FINDINGS: Globally, the mortality sex ratio was 1·13 (ie, boys were more likely to die than girls of the same age) for ages 0-4 years (90% uncertainty interval 1·11 to 1·15) in 2021. This ratio increased with age to 1·16 (1·12 to 1·20) for 5-14 years, reaching 1·65 for 15-24 years (1·52 to 1·75). In all age groups, the global sex ratio of mortality increased between 1990 and 2021, driven by faster declines in female mortality. In 2021, the probability of a newborn male reaching age 25 years was 94·1% (93·7 to 94·4), compared with 95·1% for a newborn female (94·7 to 95·3). We found a disadvantage of females versus males (compared with countries with similar total mortality) in 2021 in five countries for ages 0-4 years (Algeria, Bangladesh, Egypt, India, and Iran), one country (Suriname) for ages 5-14 years, and 13 countries for ages 15-24 years (including Bangladesh and India). We found the reverse pattern (disadvantage of males vs females compared with countries of similar total mortality) in one country in ages 0-4 years (Vietnam) and eight countries in ages 15-24 years (including Brazil and Mexico). Globally, the number of excess female deaths from birth to age 24 years was 86 563 (-6059 to 164 000) in 2021, down from 544 636 (453 982 to 633 265) in 1990.

INTERPRETATION: The global sex ratio of mortality for all age groups in the first 25 years of life increased between 1990 and 2021. Targeted interventions should focus on countries with outlying sex ratios of mortality to reduce disparities due to discrimination in health care, nutrition, and violence.

FUNDING: The Bill & Melinda Gates Foundation, US Agency for International Development, and King Abdullah University of Science and Technology.

PMID:37734797 | DOI:10.1016/S2214-109X(23)00376-5

Br J Ophthalmol. 2023 Sep 21:bjo-2023-323181. doi: 10.1136/bjo-2023-323181. Online ahead of print.

ABSTRACT

BACKGROUND: Pigmentation could be a relevant prognostic factor in uveal melanoma (UM) development. Microphthalmia-associated transcription factor (MITF) regulates melanin synthesis by activating tyrosinase-related protein 2 (TYRP2) and silver protein (SILV) that induce the melanogenesis pathway. Although their oncogenic potential has been observed in various malignancies but has not been investigated in UM Asian population. Our aim is to study the ultrastructure of melanosomes and the prognostic significance of pigmentation markers such as TYRP2, MITF and SILV in UM.

METHODS: Transmission electron microscopy was performed to compare the ultrastructure of melanosomes in the normal choroid and UM cases. Immunoexpression of TYRP2, SILV and MITF was analysed in 82 UM samples. The mRNA expression level of all genes was measured in 70 UM cases. A statistical correlation was performed to determine the prognostic significance of all markers.

RESULTS: Premelanosomes and mature melanosomes undergoing dedifferentiation were observed in high-pigmented UM cases as compared with low-pigmented UM cases. Seventy per cent of UM cases showed high SILV expression while TYRP2 and MITF expression was present in 58% and 56% of cases, respectively. At the mRNA level, upregulation of TYRP2, SILV and MITF markers was seen in around 50% of UM cases, which was statistically significant with high pigmentation. Reduced metastatic-free survival was statistically significant with the MITF protein expression.

CONCLUSION: Our results demonstrated that ultrastructural changes in melanosomes and high expression of TYRP2, MITF and SILV could dysregulate the melanogenesis pathway and might be responsible for the aggressive behaviour of UM.

PMID:37734767 | DOI:10.1136/bjo-2023-323181

Open Heart. 2023 Sep;10(2):e002228. doi: 10.1136/openhrt-2022-002228.

ABSTRACT

BACKGROUND: Computer-assisted interpretation of single-lead ECG is the preliminary method for clinicians to flag and further evaluate an arrhythmia of clinical importance for acutely ill patients. Critical scrutiny of novel detection algorithms is lacking, particularly in external real-world data sets. This study’s objective was to evaluate a hybrid machine learning model’s ability to classify eight arrhythmias from a single-lead ECG signal from acutely ill patients.

METHODS: This cross-sectional external retrospective evaluation of a previously trained hybrid machine learning model against an ECG reading team in the setting of home hospital care (acute care delivered at home substituting for traditional hospital care) draws from patients admitted at two hospitals in Boston, Massachusetts, USA between 12 June 2017 and 23 November 2019. We calculated classifier statistics for each arrhythmia, all arrhythmias and strips where the model identified normal sinus rhythm.

RESULTS: The model analysed 2 680 162 min of single-lead ECG data from 423 patients and identified 691 478 arrhythmias. Patients had a mean age of 70 years (SD, 18), 60% were female and 45% were white. For any arrhythmia, the model had a sensitivity of 98%, a specificity of 100%, an accuracy of 98%, a positive predictive value of 100%, a negative predictive value of 93% and an F₁ Score of 99%. Performance was best for pause (F₁ Score, 99%) and worst for paroxysmal supraventricular tachycardia (F₁ Score, 92%). The model’s false positive rate for any arrhythmia was 0.2%, ranging from 0.4% for pause to 7.2% for paroxysmal supraventricular tachycardia. The false negative rate for any arrhythmia was 1.9%.

CONCLUSIONS: A hybrid machine learning model was effective at classifying common cardiac arrhythmias from a single-lead ECG in real-world data.

PMID:37734747 | DOI:10.1136/openhrt-2022-002228

Multisens Res. 2023 Sep 21:1-101. doi: 10.1163/22134808-bja10107. Online ahead of print.

ABSTRACT

This is the first systematic review that focuses on the influence of product-intrinsic and extrinsic sounds on the chemical senses involving both food and aroma stimuli. This review has a particular focus on all methodological details (stimuli, experimental design, dependent variables, and data analysis techniques) of 95 experiments, published in 83 publications from 2012 to 2023. 329 distinct crossmodal auditory-chemosensory associations were uncovered across this analysis. What is more, instead of relying solely on static figures and tables, we created a first-of-its-kind comprehensive Power BI dashboard (interactive data visualization tool by Microsoft) on methodologies and significant findings, incorporating various filters and visualizations allowing readers to explore statistics for specific subsets of experiments. We believe that this review can be helpful for researchers and practitioners working in the food and beverage industry and beyond these scopes (e.g., cosmetics). Theoretical and practical implications discussed in this article point to computational approaches that facilitate decision-making regarding multisensory experimental methodology design.

PMID:37734735 | DOI:10.1163/22134808-bja10107

Child Care Health Dev. 2023 Sep 21. doi: 10.1111/cch.13174. Online ahead of print.

ABSTRACT

BACKGROUND: Although current treatments are effective in dealing with congenital heart disease (CHD), non-cardiac comorbidities such as attention-deficit hyperactivity disorder (ADHD) have received widespread attention. The purpose of this systematic review and meta-analysis is to assess the risk of ADHD associated with CHD.

METHODS: The literature search was carried out systematically through eight different databases by the end of September 2022. Either a fixed- or a random-effects model was used to calculate the overall combined risk estimates. The heterogeneity of the studies was assessed by the Cochran Q test and the I² statistic. Subgroup and sensitivity analyses were used to explore the potential sources of heterogeneity.

RESULTS: Eleven studies were included in this study, which involved a total of 296 741 participants. Our study showed that the children with CHD were at a significantly increased risk of ADHD compared with the reference group (OR = 2.98, 95% CI: 2.18-4.08). The results were moderately heterogeneous. These factors including study design, geographic region and study quality were identified as the first three of the most relevant heterogeneity moderators by subgroup analyses. Sensitivity analysis yielded consistent results. There was no evidence of publication bias.

CONCLUSIONS: The present study suggests that CHD children have a significantly higher risk of ADHD when compared with those without CHD. Early identification and intervention of ADHD is important to reduce its symptoms and adverse effects; therefore, clinicians should increase screening for ADHD in children with CHD and intervene promptly to reduce its effects whenever possible.

PMID:37734724 | DOI:10.1111/cch.13174

J Am Vet Med Assoc. 2023 Sep 21:1-4. doi: 10.2460/javma.23.07.0406. Online ahead of print.

ABSTRACT

OBJECTIVE: Alfaxalone is a commonly used anesthetic agent in small animals. In cats, alfaxalone can be administered as an IM agent to achieve clinically useful sedation or anesthesia, negating the need for IV injection in difficult patients. The molecular structure of alfaxalone is similar to the hormone progesterone (P4). It is hypothesized that alfaxalone would cross-react with the assay measuring progesterone causing a false elevation.

ANIMALS: 8 healthy neutered male, domestic shorthair cats that were privately owned were enrolled in the study.

METHODS: Male neutered cats were administered 3 mg/kg of alfaxalone IM. Blood samples were collected at set time points (baseline, 30 minutes, 60 minutes, 3 hours, 6 hours, and 10 hours after administration), and serum concentrations of progesterone immunoreactivity (IR) were determined using the Siemens Immulite 1000 automated immunoassay system. Statistical analysis was performed with repeated measures ANOVA and a Tukey-Cramer multiple comparisons test. A P value of < .05 was used for significance.

RESULTS: Serum progesterone IR was significantly elevated at 30 minutes, 1 hour, and 3 hours (P < .05) when compared to baseline progesterone immunoreactivity. Progesterone immunoreactivity had returned to baseline by 6 hours.

CLINICAL RELEVANCE: This study suggests that alfaxalone administered IM in cats may interfere with immunoassay measurement of serum progesterone for up to 6 hours. Caution should be used when interpreting serum progesterone immunoreactivity results in cats within 4 hours of alfaxalone.

PMID:37734719 | DOI:10.2460/javma.23.07.0406

J Theor Biol. 2023 Sep 19:111622. doi: 10.1016/j.jtbi.2023.111622. Online ahead of print.

ABSTRACT

The newly emerging pandemic disease often poses unexpected troubles and hazards to the global health system, particularly in low and middle-income countries like Nepal. In this study, we developed mathematical models to estimate the risk of infection and the risk of hospitalization during a pandemic which are critical for allocating resources and planning health policies. We used our models in Nepal’s unique data set to explore national and provincial-level risks of infection and risk of hospitalization during the Delta and Omicron surges. Furthermore, we used our model to identify the effectiveness of non-pharmaceutical interventions (NPIs) to mitigate COVID-19 in various groups of people in Nepal. Our analysis shows no significant difference in reproduction numbers in provinces between the Delta and Omicron surge periods, but noticeable inter-provincial disparities in the risk of infection (for example, during Delta (Omicron) surges, the risk of infection of Bagmati province is: ∼ 98.94 (89.62); Madhesh province: ∼ 12.16 (5.1); Karnali province ∼31.16 (3) per hundred thousands). Our estimates show a significantly low level of hospitalization risk during the Omicron surge compared to the Delta surge (hospitalization risk is: ∼10% in Delta and ∼2.5% in Omicron). We also found significant inter-provincial disparities in the hospitalization rate (for example, ∼ 6% in Madhesh province and ∼ 21% in Sudur Paschim) during the Delta surge. Moreover, our results show that closing only schools, colleges, and workplaces reduces the risk of infection by one-third, while a complete lockdown reduces the infections by two-thirds. Our study provides a framework for the computation of the risk of infection and the risk of hospitalization and offers helpful information for controlling the pandemic.

PMID:37734704 | DOI:10.1016/j.jtbi.2023.111622

Am J Kidney Dis. 2023 Sep 19:S0272-6386(23)00807-7. doi: 10.1053/j.ajkd.2023.07.015. Online ahead of print.

ABSTRACT

RATIONALE & OBJECTIVE: Survivors of acute kidney injury (AKI) are at high risk of adverse outcomes. Monitoring of kidney function, screening for proteinuria, use of statins and renin-angiotensin-aldosterone system inhibitors (RAASi), and nephrology follow-up among survivors have not been fully characterized. We sought to examine these processes of care after discharge in survivors of hospitalized AKI.

DESIGN: Population-based retrospective cohort study.

SETTING AND PARTICIPANTS: Adults in Alberta, Canada admitted to hospital between 2009 and 2017. Study participants were followed from their discharge date until 2019, with a median follow up of 2.7 years.

EXPOSURE: Hospital-acquired AKI diagnostically conforming to Kidney Disease Improving Global Outcomes (KDIGO) serum creatinine criteria for stage 2 or stage 3 disease, or the need for acute dialysis.

OUTCOMES: Outcomes following hospital discharge included the proportion of participants who had evaluation of kidney function, were seen by a specialist or general practitioner, and received prescriptions for recommended medications for chronic kidney disease (CKD) post-discharge.

ANALYTICAL APPROACH: Cumulative incidence curves were used to characterize the proportion of participants who received each process of care outcome within the first 90 days and subsequent 1-year follow-up period after hospital discharge. To avoid risks associated with multiple hypothesis testing, differences were not statistically compared across groups.

RESULTS: The cohort (n = 23,921) included 50.2% men (n = 12,015) with a median [IQR] age of 68.1 years [56.9, 78.8]. Within 90 days post-discharge, 21.2% and 8.6% of patients with and without pre-existing CKD, respectively, were seen by a nephrologist. 60.1% of AKI survivors had at least one serum creatinine measured but only 25.5% had an assessment for albuminuria within 90 days after discharge. 52.7% of AKI survivors with pre-existing CKD, and 51.6% with de novo CKD were prescribed a RAASi within 4-15 months after discharge from hospital.

LIMITATIONS: Retrospective data were collected as part of routine clinical care.

CONCLUSION: The proportion of patients receiving optimal care after an episode of AKI in Alberta was low and may represent a target for improving long-term outcomes for this population.

PMID:37734688 | DOI:10.1053/j.ajkd.2023.07.015