Nevin Manimala

Trials. 2023 Apr 21;24(1):286. doi: 10.1186/s13063-023-07262-8.

ABSTRACT

INTRODUCTION: Randomised controlled trials (RCTs) aim to assess the effect of one (or more) unproven health interventions relative to other reference interventions. RCTs sometimes use an ordinal outcome, which is an endpoint that comprises of multiple, monotonically ordered categories that are not necessarily separated by a quantifiable distance. Ordinal outcomes are appealing in clinical settings as specific disease states can represent meaningful categories that may be of clinical importance to researchers. Ordinal outcomes can also retain information and increase statistical power compared to dichotomised outcomes and can allow multiple clinical outcomes to be comprised in a single endpoint. Target parameters for ordinal outcomes in RCTs may vary depending on the nature of the research question, the modelling assumptions and the expertise of the data analyst. The aim of this scoping review is to systematically describe the use of ordinal outcomes in contemporary RCTs. Specifically, we aim to: [Formula: see text] Identify which target parameters are of interest in trials that use an ordinal outcome, and whether these parameters are explicitly defined. [Formula: see text] Describe how ordinal outcomes are analysed in RCTs to estimate a treatment effect. [Formula: see text] Describe whether RCTs that use an ordinal outcome adequately report key methodological aspects specific to the analysis of the ordinal outcome. Results from this review will outline the current state of practice of the use of ordinal outcomes in RCTs. Ways to improve the analysis and reporting of ordinal outcomes in RCTs will be discussed.

METHODS AND ANALYSIS: We will review RCTs that are published in the top four medical journals (British Medical Journal, New England Journal of Medicine, The Lancet and the Journal of the American Medical Association) between 1 January 2012 and 31 July 2022 that use an ordinal outcome as either a primary or a secondary outcome. The review will identify articles through a PubMed-specific search strategy. Our review will adhere to guidelines for scoping reviews as described in the PRISMA-ScR checklist. The study characteristics and details of the study design and analysis, including the target parameter(s) and statistical methods used to analyse the ordinal outcome, will be extracted from eligible studies. The screening, review and data extraction will be conducted using Covidence, a web-based tool for managing systematic reviews. The data will be summarised using descriptive statistics.

PMID:37085929 | DOI:10.1186/s13063-023-07262-8

Genome Biol. 2023 Apr 21;24(1):84. doi: 10.1186/s13059-023-02940-x.

NO ABSTRACT

PMID:37085916 | DOI:10.1186/s13059-023-02940-x

Antimicrob Resist Infect Control. 2023 Apr 21;12(1):39. doi: 10.1186/s13756-023-01240-0.

ABSTRACT

BACKGROUND: Hospital-acquired infections (HAIs) are a global public health problem and put patients at risk of complications, including death. HAIs increase treatment costs, but their financial impact on Serbia’s healthcare system is unknown. Our goal was to assess incremental costs of HAIs in a tertiary care adult intensive care unit (ICU) that managed COVID-19 patients.

METHODS: A retrospective study from March 6th to December 31st, 2020 included patients with microbiologically confirmed COVID-19 (positive rapid antigen test or real-time polymerase chain reaction) treated in the ICU of the Teaching Hospital for Infectious and Tropical Diseases, University Clinical Centre of Serbia. Demographic and HAI-specific data acquired in our ICU were collected, including total and stratified medical costs (services, materials, laboratory testing, medicines, occupancy costs). Median total and stratified costs were compared in relation to HAI acquisition. Linear regression modelling was used to assess incremental costs of HAIs, adjusted for age, biological sex, prior hospitalisation, Charlson Comorbidity Index (CCI), and Glasgow Coma Scale (GCS) on admission. Outcome variables were length of stay (LOS) in days and mortality.

RESULTS: During the study period, 299 patients were treated for COVID-19, of which 214 were included. HAIs were diagnosed in 56 (26.2%) patients. Acinetobacter spp. was the main pathogen in respiratory (38, 45.8%) and bloodstream infections (35, 42.2%), the two main HAI types. Median total costs were significantly greater in patients with HAIs (€1650.4 vs. €4203.2, p < 0.001). Longer LOS (10.0 vs. 18.5 days, p < 0.001) and higher ICU mortality (51.3% vs. 89.3%, p < 0.001) were seen if HAIs were acquired. Patients with ≥ 2 HAIs had the highest median total costs compared to those without HAIs or with a single HAI (€1650.4 vs. €3343.4 vs. €7336.9, p < 0.001). Incremental costs in patients with 1 and ≥ 2 HAIs were €1837.8 (95% CI 1257.8-2417.7, p < 0.001) and €5142.5 (95% CI 4262.3-6022.7, p < 0.001), respectively.

CONCLUSIONS: This is the first economic evaluation of HAIs in Serbia, showing significant additional costs to our healthcare system. HAIs prolong LOS and influence ICU mortality rates. Larger economic assessments are needed to enhance infection control practices.

PMID:37085906 | DOI:10.1186/s13756-023-01240-0

BMC Med Inform Decis Mak. 2023 Apr 21;23(1):76. doi: 10.1186/s12911-023-02164-w.

ABSTRACT

OBJECTIVE: Tinnitus is a highly prevalent hearing disorder, and the burden of tinnitus diagnosis and treatment is very heavy, especially in China. In order to better benefit the majority of tinnitus patients, we developed a new mobile app based on our patented invention – named the Fudan Tinnitus Relieving System (FTRS) – for tinnitus management. The FTRS app aims to alleviate patients’ tinnitus symptoms using customized sound therapy, to evaluate the treatment effect, to provide a doctor-patient communication platform, and to support tinnitus rehabilitation and auditory health.

METHODS: In this study, we introduced the major functions of the FTRS app, analyzed the geographical distribution of users around China, and performed an analysis on the demographic and clinical characteristics of patients with tinnitus, including age and tinnitus position, duration, frequency, and severity in both men and women based on the user information collected by the FTRS. The data for 22,867 participants (males: 13,715; females: 9,152) were included in the statistical analysis.

RESULTS: The FTRS app has been popular with tinnitus patients since its launch in May 2018 with its integrated pitch-matching test, individualized sound therapy, follow-up assessment, and provision of easy-to-understand science and education for tinnitus. The users were located throughout Mainland China but primarily concentrated in Shanghai, Jiangsu, Zhejiang, Guangdong, and Shandong provinces. We observed gender differences regarding age and tinnitus frequency, severity, and position among the app’s users. The FTRS has not only facilitated patients’ access to treatment at times and places that are convenient for them, but also provides a large amount of data based on user feedback in order to support clinical tinnitus research.

CONCLUSIONS: Compared with traditional face-to-face medical treatment, the FTRS greatly reduced medical costs and enabled patients with tinnitus to arrange their own treatment times. At the same time, the FTRS has provided standardized tinnitus data that have laid a foundation for clinical research on tinnitus. However, because of differences in the popularity and utilization of smart devices, FTRS user data might only reflect the situation of tinnitus patients who can effectively use smart devices. Therefore, the findings of this study need to be interpreted with caution.

PMID:37085904 | DOI:10.1186/s12911-023-02164-w

J Transl Med. 2023 Apr 21;21(1):272. doi: 10.1186/s12967-023-04107-5.

ABSTRACT

BACKGROUND: Irritable bowel syndrome (IBS) is a chronic disorder of gut-brain interaction frequently accompanied by mental conditions, including depression and anxiety. Despite showing substantial heritability and being partly determined by a genetic component, the genetic underpinnings explaining the high rates of comorbidity remain largely unclear and there are no conclusive data on the temporal relationship between them. Exploring the overlapping genetic architecture between IBS and mental conditions may help to identify novel genetic loci and biological mechanisms underlying IBS and causal relationships between them.

METHODS: We quantified the genetic overlap between IBS, neuroticism, depression and anxiety, conducted a multi-trait genome-wide association study (GWAS) considering these traits and investigated causal relationships between them by using the largest GWAS to date.

RESULTS: IBS showed to be a highly polygenic disorder with extensive genetic sharing with mental conditions. Multi-trait analysis of IBS and neuroticism, depression and anxiety identified 42 genome-wide significant variants for IBS, of which 38 are novel. Fine-mapping risk loci highlighted 289 genes enriched in genes upregulated during early embryonic brain development and gene-sets related with psychiatric, digestive and autoimmune disorders. IBS-associated genes were enriched for target genes of anti-inflammatory and antirheumatic drugs, anesthetics and opioid dependence pharmacological treatment. Mendelian-randomization analysis accounting for correlated pleiotropy identified bidirectional causal effects between IBS and neuroticism and depression and causal effects of the genetic liability of IBS on anxiety.

CONCLUSIONS: These findings provide evidence of the polygenic architecture of IBS, identify novel genome-wide significant variants for IBS and extend previous knowledge on the genetic overlap and relationship between gastrointestinal and mental disorders.

PMID:37085903 | DOI:10.1186/s12967-023-04107-5

Infect Dis Poverty. 2023 Apr 21;12(1):41. doi: 10.1186/s40249-023-01063-6.

ABSTRACT

BACKGROUND: Yersinia enterocolitica has been sporadically recovered from animals, foods, and human clinical samples in various regions of Ningxia, China. However, the ecological and molecular characteristics of Y. enterocolitica, as well as public health concerns about infection in the Ningxia Hui Autonomous Region, remain unclear. This study aims to analyze the ecological and molecular epidemiological characteristics of Y. enterocolitis in order to inform the public health intervention strategies for the contains of related diseases.

METHODS: A total of 270 samples were collected for isolation [animals (n = 208), food (n = 49), and patients (n = 13)], then suspect colonies were isolated and identified by the API20E biochemical identification system, serological tests, biotyping tests, and 16S rRNA-PCR. Then, we used an ecological epidemiological approach combined with machine learning algorithms (general linear model, random forest model, and eXtreme Gradient Boosting) to explore the associations between ecological factors and the pathogenicity of Y. enterocolitis. Furthermore, average nucleotide identity (ANI) estimation, single nucleotide polymorphism (SNP), and core gene multilocus sequence typing (cgMLST) were applied to characterize the molecular profile of isolates based on whole genome sequencing. The statistical test used single-factor analysis, Chi-square tests, t-tests/ANOVA-tests, Wilcoxon rank-sum tests, and Kruskal-Wallis tests.

RESULTS: A total of 270 isolates of Yersinia were identified from poultry and livestock (n = 191), food (n = 49), diarrhoea patients (n = 13), rats (n = 15), and hamsters (n = 2). The detection rates of samples from different hosts were statistically different (χ² = 22.636, P < 0.001). According to the relatedness clustering results, 270 isolates were divided into 12 species, and Y. enterocolitica (n = 187) is a predominated species. Pathogenic isolates made up 52.4% (98/187), while non-pathogenic isolates made up 47.6% (89/187). Temperature and precipitation were strongly associated with the pathogenicity of the isolates (P < 0.001). The random forest (RF) prediction model showed the best performance. The prediction result shows a high risk of pathogenicity Y. enterocolitica was located in the northern, northwestern, and southern of the Ningxia Hui Autonomous Region. The Y. enterocolitica isolates were classified into 54 sequence types (STs) and 125 cgMLST types (CTs), with 4/O:3 being the dominant bioserotype in Ningxia. The dominant STs and dominant CTs of pathogenic isolates in Ningxia were ST429 and HC100_2571, respectively.

CONCLUSIONS: The data indicated geographical variations in the distribution of STs and CTs of Y. enterocolitica isolates in Ningxia. Our work offered the first evidence that the pathogenicity of isolates was directly related to fluctuations in temperature and precipitation of the environment. CgMLST typing strategies showed that the isolates were transmitted to the population via pigs and food. Therefore, strengthening health surveillance on pig farms in high-risk areas and focusing on testing food of pig origin are optional strategies to prevent disease outbreaks.

PMID:37085902 | DOI:10.1186/s40249-023-01063-6

BMC Palliat Care. 2023 Apr 21;22(1):47. doi: 10.1186/s12904-023-01169-6.

ABSTRACT

BACKGROUND: The need to spread the culture of palliative care and to train health care professionals from undergraduate courses is recognised internationally. The article presents the outcomes of a project devoted to palliative care training in university courses in four countries.

AIMS: This article considered the outcomes of a course designed for university students who had the potential to work in a palliative care team. The main aim was to check the efficacy of the course and the motivation to work in palliative care settings, considering the impact of fear and representations of death.

METHODS: The project presented the essential contents related to palliative care, using psychodramatic and photo-voice techniques. Longitudinal measurements were taken using a quantitative method design to detect changes among the students involved. The project involved 341 students at the first administration of the survey consisted of a protocol composed of standardized questionnaires in five countries (Austria, Israel, Italy, Poland and Romania), of whom 276 completed the pre- and post-surveys-165 of them in the experimental group and 111, in the control group.

RESULTS: The experience showed that it is possible to address death-related issues seriously and competently without necessarily causing discomfort and despondency in students. The results of the changes over time in the experimental and control groups highlight how the view of death as annihilation is correlated with the fear of death and the need for avoidance of thoughts concerning dying. The main result is that competence in palliative care facilitates familiarisation with issues of death and dying, as well as the ability to work in this area, thereby enhancing interpersonal skills.

CONCLUSION: The project showed that it is possible to implement death education on palliative care topics in undergraduate courses to increase motivation to work in this field.

PMID:37085886 | DOI:10.1186/s12904-023-01169-6

Trials. 2023 Apr 21;24(1):289. doi: 10.1186/s13063-023-07290-4.

ABSTRACT

Data Monitoring Committees (DMCs) have the important task to protect the safety of current and future patients during the conduct of a clinical study. Unfortunately, their work is often made difficult by voluminous DMC reports that are poorly structured and difficult to digest. In this article, we suggest improved solutions. Starting from a principled approach and building upon previous proposals, we offer concrete and easily understood displays, including related computer code. While leveraging modern tools, the most important is that these displays support the DMC’s workflow in answering the relevant questions of interest. We hope that the adoption of these proposals can ease the task of DMCs, and importantly, lead to better decision-making for the benefit of patients.

PMID:37085883 | DOI:10.1186/s13063-023-07290-4

Arch Public Health. 2023 Apr 21;81(1):63. doi: 10.1186/s13690-023-01092-5.

ABSTRACT

BACKGROUND: Under-five mortality remains a global public health concern, particularly in East African countries. Short birth interval is highly associated with under-five mortality, and birth spacing has a significant effect on a child’s likelihood of survival. The association between short birth intervals and under-five mortality was demonstrated by numerous observational studies. However, the effect of short birth intervals on under-five mortality has not been investigated yet. Therefore, this study aimed to investigate the impact of short birth intervals on under-five mortality in East Africa using Propensity Matched Analysis.

METHODS: A secondary data analysis was conducted based on the most recent Demographic and Health Survey (DHS) data of 12 East African countries. A total weighted sample of 105,662 live births was considered for this study. A PSM analysis was carried out to evaluate the effect of short birth intervals on under-five mortality. Under-five mortality was the outcome variable, while the short birth interval was considered a treatment variable. To determine the Average Treatment Effect on the population (ATE), Average Treatment Effect on the treated (ATT), and Average Treatment Effect on the untreated (ATU), we performed PSM analysis with a logit-based model using the psmatch2 ate STATA function. The quality of matching was assessed statistically and graphically. The common support assumption was checked and fulfilled. We have employed Mantel-Haenszel bounds to examine whether the result would be free from hidden bias or not.

RESULTS: The prevalence of short birth intervals in East Africa was 44%. The under-five mortality rate among mothers who had optimal birth intervals was 39.9 (95% CI: 38.3, 41.5) per 1000 live births while it was 60.6 (95% CI: 58.5, 62.8) per 1000 live births among mothers who had a short birth intervals. Propensity score matching split births from mothers into treatment and control groups based on the preceding birth interval. In the PSM analysis, the ATT values in the treated and control groups were 6.09% and 3.97%, respectively, showed under-five mortality among births to mothers with short birth intervals was 2.17% higher than births to mothers who had an optimal birth interval. The ATU values in the intervention and control groups were 3.90% and 6.06%, respectively, indicating that for births from women who had an optimal birth interval, the chance of dying within five years would increase by 2.17% if they were born to mother with short birth interval. The final ATE estimate was 2.14% among the population. After matching, there was no significant difference in baseline characteristics between the treated and control groups (p-value > 0.05), which indicates the quality of matching was good.

CONCLUSIONS: We conclude that enhancing mothers to have optimal birth spacing is likely to be an effective approach to reducing the incidence of under-five mortality. Our findings suggest that births to mothers with short birth intervals have an increased risk of death in the first five years of life than births to mothers who had an optimal birth interval. Therefore, public health programs should enhance interventions targeting improving birth spacing to reduce the incidence of under-five mortality in low-and middle-income countries like East African countries. Moreover, to achieve a significant reduction in the under-five mortality rate, interventions that encourage birth spacing should be considered. This will improve child survival and help in attaining Sustainable Development Goal targets in East African countries.

PMID:37085879 | DOI:10.1186/s13690-023-01092-5

Biomed Eng Online. 2023 Apr 21;22(1):37. doi: 10.1186/s12938-023-01098-8.

ABSTRACT

BACKGROUND: Although titanium plates/screws are effective fixation methods (FM) after L-shaped osteotomy reduction malarplasty (LORM), the ideal FM remains controversial. This first finite element analysis (FEA) aimed to study the effect of various zygomatic body/zygomatic arch FM combinations and their placement vectors on the zygoma complex stability after virtual LORM under the effect of both average (150 N/mm²) and maximum (750 N/mm²) forces and three-dimensional (3D) mapping of stress and strain parameters distribution over the zygomatic bone, fixation methods, and total model.

RESULTS: The fixation methods about the short-arm of the L-shaped osteotomy showed lower stress, strain, and displacement values than those across the long-arm osteotomy site. Combined with any zygomatic arch fixation methods (ZAFm), the two bicortical screws group (2LS) on the zygomatic body osteotomy site resulted in smaller displacements and the lowest zygoma bone stress and displacement when combined with Mortice-Tenon structure (MT) as zygomatic arch fixation method. Applied forces caused statistically significant differences in zygomatic bone stress (P < 0.001 and P = 0.001) and displacement (P = 0.001 and P = 0.002).

CONCLUSION: All FMs both on the zygomatic body and zygomatic arch provide adequate zygomatic complex stability after LORM. The 2LS group showed better resistance than rectangular plate (RP) and square plate (SP) with lower stress concentrations. The L-shaped plate with short-wing on the maxilla (LPwM) is more stable than having the short-wing on the zygoma bone (LPwZ). Future prospective clinical studies are required to validate the current findings.

PMID:37085878 | DOI:10.1186/s12938-023-01098-8