Tag: nevin manimala

Ann Neurol. 2023 May 28. doi: 10.1002/ana.26714. Online ahead of print.

ABSTRACT

Platform trials allow efficient evaluation of multiple interventions for a specific disease. The HEALEY ALS Platform Trial is testing multiple investigational products in parallel and sequentially in persons with ALS with the goal of rapidly identifying novel treatments to slow disease progression. Platform trials have considerable operational and statistical efficiencies compared to typical randomized controlled trials due to their use of shared infrastructure and shared control data. We describe the statistical approaches required to achieve the objectives of a platform trial in the context of ALS. This includes following regulatory guidance for the disease area of interest and accounting for potential differences in outcomes of participants within the shared control (potentially due to differences in time of randomization, mode of administration and eligibility criteria). Within the HEALEY ALS Platform Trial, the complex statistical objectives are met using a Bayesian shared parameter analysis of function and survival. This analysis serves to provide a common integrated estimate of treatment benefit, overall slowing in disease progression, as measured by function and survival while accounting for potential differences in the shared control group using Bayesian hierarchical modeling. Clinical trial simulation is used to provide a better understanding of this novel analysis method and complex design. This article is protected by copyright. All rights reserved.

PMID:37245090 | DOI:10.1002/ana.26714

J Clin Nurs. 2023 May 27. doi: 10.1111/jocn.16769. Online ahead of print.

ABSTRACT

BACKGROUND: Qualified individualised nursing care should be provided to all communities and ethnic groups with free of ethnocentrism.

AIMS: To evaluate nurses’ individualised care behaviours and ethnocentric attitudes and predict the relationship between their individualised care behaviours and ethnocentric attitudes.

DESIGN: A descriptive and exploratory study.

METHODS: This study was conducted with 250 nurses working in a public and two private hospitals in a city, an area with many refugees. Data were collected using the Ethnocentrism Scale and Individualised Care Behaviours Scale. Structural equation model analysis to test hypothetical model and descriptive statistics were used.

RESULTS: Nurses working in the private hospitals had a higher individualised care decision control mean score. Those nurses who enjoyed spending time with people from different cultures had lower mean ethnocentrism scale scores, higher individualised care clinical status, personal life and decision control status subscales mean scores compared to other nurses. Mean scores of the individualised care personal life and decision control status subscales of the nurses who followed the literature on transcultural nursing was higher. A significant relationship between the ethnocentrism levels and individualised care behaviours was identified. Accordingly, the ethnocentric attitudes of the nurses negatively affected their individualised care behaviours, and the model established between the two concepts is statistically appropriate.

CONCLUSIONS: Nurses who work in private hospitals, receive intercultural nursing education and enjoy spending time with different cultures have higher individualised care behaviours and lower ethnocentrism levels. Ethnocentric attitudes of the nurses negatively affected their individualised care behaviours. Care strategies should be developed that consider the factors that will maximize individualised care practices that minimize ethnocentric behaviours among nurses.

IMPLICATIONS FOR THE PROFESSION: Increasing awareness on individualised care behaviours, ethnocentric attitudes and effected factors will contribute to improve of nursing care quality of nurses while giving care to individuals from different cultures.

PMID:37245069 | DOI:10.1111/jocn.16769

BMC Cancer. 2023 May 27;23(1):481. doi: 10.1186/s12885-023-10931-1.

ABSTRACT

BACKGROUND: This study aims to evaluate the clinical efficacy and side effects of setting up a high-risk clinical target volume (CTV-hr) alongside simultaneous integrated boost intensity-modulated radiotherapy (IMRT-SIB) in patients diagnosed with stage IIB-IVA cervical cancer.

METHODS: This study retrospectively analysed patients with stage IIB-IVA cervical cancer who received radical radiotherapy at the Affiliated Hospital of Qingdao University between November 2014 and September 2019. The patients were divided into experimental and control groups based on whether CTV-hr was set. All patients received a combined treatment of radiotherapy and chemotherapy. The dosage for paclitaxel was 135 mg/m², while for cisplatin it was 75 mg/m² or for carboplatin it was AUC 4-6, given in a cycle of 21 days. Radiotherapy (RT) included external beam radiation therapy (EBRT) and intracavitary brachytherapy (ICBT). In the control group, positive lymph nodes (GTV-n) were treated at a dose of 58-62 Gy/26-28 fractions(f), while clinical target volumes (CTV) were treated with a dose of 46-48 Gy/26-28f. The experimental group received a simultaneous integrated boost (SIB) to CTV-hr at a dose of 54-56 Gy/26-28f, with the same CTV and GTV-n as the control group. Both groups were combined with brachytherapy with a total dose (EQD2, the equivalent dose in 2 Gy/f) of 80-90 Gy. The study measured objective remission rate (ORR), 3-year progression-free survival (PFS) rate, 3-year overall survival (OS) rate, recurrence rate, and side effects as endpoints.

RESULTS: The study enrolled 217 patients, with 119 in the experimental group and 98 in the control group. Results showed that the experimental group had a higher 3-year OS rate (87.4% vs. 71.4%, p = 0.001) and 3-year PFS rate (72.3% vs. 51.0%, p = 0.000) compared to the control group. Additionally, the experimental group had significantly lower rates of overall recurrence (26.1% vs. 50.0%, p = 0.003), in-field recurrence (15.1% vs. 36.7%, p = 0.000), and out-field recurrence(13.4% vs. 35.7%, p = 0.000) compared to the control group. All observed differences were found to be statistically significant. However, the experimental and control groups had no statistically significant difference in ORR and radiological side effects, such as radiation cystitis and enteritis (p > 0.05).

CONCLUSIONS: Setting CTV-hr and performing IMRT-SIB on patients with stage IIB-IVA cervical cancer effectively increased the 3-year OS rate, 3-year PFS rate and reduced recurrence rate, with no significant differences in side effects.

PMID:37245053 | DOI:10.1186/s12885-023-10931-1

Syst Rev. 2023 May 27;12(1):88. doi: 10.1186/s13643-023-02250-0.

ABSTRACT

BACKGROUND: Ongoing symptoms or the development of new symptoms following a SARS-CoV-2 diagnosis has caused a complex clinical problem known as “long COVID” (LC). This has introduced further pressure on global healthcare systems as there appears to be a need for ongoing clinical management of these patients. LC personifies heterogeneous symptoms at varying frequencies. The most complex symptoms appear to be driven by the neurology and neuropsychiatry spheres.

METHODS: A systematic protocol was developed, peer reviewed, and published in PROSPERO. The systematic review included publications from the 1st of December 2019-30th June 2021 published in English. Multiple electronic databases were used. The dataset has been analyzed using a random-effects model and a subgroup analysis based on geographical location. Prevalence and 95% confidence intervals (CIs) were established based on the data identified.

RESULTS: Of the 302 studies, 49 met the inclusion criteria, although 36 studies were included in the meta-analysis. The 36 studies had a collective sample size of 11,598 LC patients. 18 of the 36 studies were designed as cohorts and the remainder were cross-sectional. Symptoms of mental health, gastrointestinal, cardiopulmonary, neurological, and pain were reported.

CONCLUSIONS: The quality that differentiates this meta-analysis is that they are cohort and cross-sectional studies with follow-up. It is evident that there is limited knowledge available of LC and current clinical management strategies may be suboptimal as a result. Clinical practice improvements will require more comprehensive clinical research, enabling effective evidence-based approaches to better support patients.

PMID:37245047 | DOI:10.1186/s13643-023-02250-0

BMC Med Educ. 2023 May 27;23(1):390. doi: 10.1186/s12909-023-04375-1.

ABSTRACT

BACKGROUND: Snakebite is a global health problem that predominantly occurs in rural areas. In Sri Lanka, the majority of snakebite patients first present to smaller rural primary hospitals. Improving care delivered at rural hospitals has the potential to reduce morbidity and mortality from snakebites.

OBJECTIVE: In this study, we evaluated whether an educational intervention would increase compliance with national snakebite treatment guidelines in primary hospitals.

METHODS: The hospitals were randomized into educational intervention (n = 24) and control groups (n = 20). The intervention hospitals received a brief educational intervention based on Sri Lankan Medical Association (SLMA) guidelines on the management of snakebites. Control hospitals had free access to the guidelines but no additional promotion. Four outcomes were assessed: pre- and post-test knowledge at the completion of a one-day workshop of educational intervention (intervention group only); improvement in the quality of the patient’s medical records; appropriateness of transfers to higher hospitals; and quality of overall management graded by a blinded expert. The data was collected over a period of 12 months.

RESULTS: All case notes of snakebite hospital admissions were reviewed. There were 1021 cases in the intervention group hospitals and 1165 cases in the control hospitals. Four hospitals in the intervention group and three hospitals in the control group did not have snakebite admissions and were excluded from the cluster analysis. The absolute quality of care was high in both groups. Post-test knowledge was improved (p < 0.0001) following the intervention group’s educational workshop. There was no statistical difference between the two groups in terms of clinical data documentation in hospital notes (scores, p = 0.58) or transfer appropriateness (p = 0.68)-both of which were significantly different from the guidelines.

CONCLUSION: Education of primary hospital staff improved the immediate knowledge gained but did not improve record-keeping or the appropriateness of inter-hospital patient transfer.

TRIAL REGISTRATION: The study was registered with Sri Lanka Medical Associations’ clinical trial registry. Reg. No SLCTR -2013-023. Registered: 30/07/2013.

PMID:37245040 | DOI:10.1186/s12909-023-04375-1

BMC Musculoskelet Disord. 2023 May 27;24(1):427. doi: 10.1186/s12891-023-06405-x.

ABSTRACT

OBJECTIVE: Nano-hydroxyapatite and its composites(nHA) have been widely used as grafts in inter-vertebral fusion. However, the safety and efficacy of the graft in inter-vertebral fusion is controversial. This meta-analysis aimed at evaluating the safety and efficacy of nHA and non-hydroxyapatite grafts (noHA) (autologous bone, etc.) in inter-body fusion.

MATERIALS AND METHODS: A comprehensive search was performed in electronic database as follows: PubMed, EMBASE, the Cochrane Library, Web of Science, and China National Knowledge Internet (CNKI) from inception until October 2022. Clinical studies on the effect of nHA and noHA in spinal fusion were collected. Analysis of outcome indicators using RevMan 5.4 statistical software.

RESULTS: The meta-analysis showed that the operation time of patients who underwent inter-body fusion with nHA grafts was less than that of patients who underwent noHA (p < 0.05). Compared with the noHA group, the nHA group can achieve similar clinical effects in the fusion rate(OR = 1.29,95%CI: 0.88 to 1.88,p = 0.19),Subsidence rate(OR = 1.2,95%CI:0.44 to 3.28,p = 0.72), inter-vertebral space height(SMD = 0.04,95%CI:-0.08 to 0.15,p = 0.54),Cobb angle(SMD = 0.21,95%CI: 0.18 to 0.6,p = 0.21),Blood loss(SMD = -36.58,95%CI: -81.45 to 8.29,p = 0.11),operative time in 12 months(SMD = -5.82,95%CI: -9.98 to -1.67,p = 0.006) and in the final follow-up(SMD = -0.38,95%CI: -0.51 to -0.26,p < 0.00001),ODI(SMD = 0.68,95%CI: -0.84 to 2.19,p = 0.38), VAS(SMD = 0.17,95%CI: -0.13 to 0.48,p = 0.27) and adverse events(OR = 0.98,95%CI: 0.66 to 1.45,p = 0.92), and the differences are not statistically significant.

CONCLUSION: This meta-analysis suggests that nHA matrix grafts are similar to noHA grafts in the safety and efficacy of spinal reconstruction, and are an ideal material for inter-vertebral bone grafting.

PMID:37245034 | DOI:10.1186/s12891-023-06405-x

Infect Agent Cancer. 2023 May 27;18(1):34. doi: 10.1186/s13027-023-00515-w.

ABSTRACT

OBJECTIVE: to evaluate the efficacy of US, both qualitatively and semi-quantitatively, in the selection of treatment for the Covid-19 patient, using patient triage as the gold standard.

METHODS: Patients admitted to the Covid-19 clinic to be treated with monoclonal antibodies (mAb) or retroviral treatment and undergoing lung ultrasound (US) were selected from the radiological data set between December 2021 and May 2022 according to the following inclusion criteria: patients with proven Omicron variant and Delta Covid-19 infection; patients with known Covid-19 vaccination with at least two doses. Lung US (LUS) was performed by experienced radiologists. The presence, location, and distribution of abnormalities, such as B-lines, thickening or ruptures of the pleural line, consolidations, and air bronchograms, were evaluated. The anomalous findings in each scan were classified according to the LUS scoring system. Nonparametric statistical tests were performed.

RESULTS: The LUS score median value in the patients with Omicron variant was 1.5 (1-20) while the LUS score median value in the patients with Delta variant was 7 (3-24). A difference statistically significant was observed for LUS score values among the patients with Delta variant between the two US examinations (p value = 0.045 at Kruskal Wallis test). There was a difference in median LUS score values between hospitalized and non-hospitalized patients for both the Omicron and Delta groups (p value = 0.02 on the Kruskal Wallis test). For Delta patients groups the sensitivity, specificity, positive and negative predictive values, considering a value of 14 for LUS score for the hospitalization, were of 85.29%, 44.44%, 85.29% and 76.74% respectively.

CONCLUSIONS: LUS is an interesting diagnostic tool in the context of Covid-19, it could allow to identify the typical pattern of diffuse interstitial pulmonary syndrome and could guide the correct management of patients.

PMID:37245026 | DOI:10.1186/s13027-023-00515-w

Environ Microbiome. 2023 May 27;18(1):43. doi: 10.1186/s40793-023-00502-z.

ABSTRACT

BACKGROUND: The root-associated microbiome has been of keen research interest especially in the last decade due to the large potential for increasing overall plant performance in agricultural systems. Knowledge about the impact of above ground plant disturbances on the root-associated microbiome remains limited. We addressed this by focusing on two potential impacts, foliar pathogen infection alone and in combination with the application of a plant health protecting product. We hypothesized that these lead to plant-mediated responses in the rhizosphere microbiota.

RESULTS: The effects of an infection of greenhouse grown apple saplings with either Venturia inaequalis or Podosphaera leucotricha as foliar pathogen, as well as the combined effect of P. leucotricha infection and foliar application of the synthetic plant health protecting product Aliette (active ingredient: fosetyl-aluminum), were studied on the root-associated microbiota. The bacterial community structure of rhizospheric soil and endospheric root material was characterized post-infection, using 16S rRNA gene amplicon sequencing. With increasing disease severity both pathogens led to changes in the rhizosphere and endosphere bacterial communities in comparison to uninfected plants (explained variance up to 17.7%). While the preventive application of Aliette on healthy plants two weeks prior inoculation did not induce changes in the root-associated microbiota, a second later application on the diseased plants decreased disease severity and resulted in differences of the rhizosphere bacterial community between infected and several of the cured plants, though differences were overall not statistically significant.

CONCLUSIONS: Foliar pathogen infections can induce plant-mediated changes in the root-associated microbiota, indicating that above ground disturbances are reflected in the below-ground microbiome, even though these become evident only upon severe leaf infection. The application of the fungicide Aliette on healthy plants itself did not induce any changes, but the application to diseased plants helped the plant to regain the microbiota of a healthy plant. These findings indicate that above ground agronomic management practices have implications for the root-associated microbiome, which should be considered in the context of microbiome management strategies.

PMID:37245023 | DOI:10.1186/s40793-023-00502-z

BMC Pregnancy Childbirth. 2023 May 27;23(1):391. doi: 10.1186/s12884-023-05718-y.

ABSTRACT

INTRODUCTION: The composite coverage index (CCI) is the weighted average coverage of eight preventive and curative interventions received along the maternal and childcare continuum. This study aimed to analyse maternal and child health indicators using CCI.

METHODS: We performed a secondary analysis of demographic and health surveys (DHS) focused on women aged 15 to 49 and their children aged 1 to 4. This study took place in Guinea. The CCI (meeting the need for planning, childbirth assisted by qualified healthcare workers, antenatal care assisted by qualified healthcare workers, vaccination against diphtheria, pertussis, tetanus, measles and Bacillus Calmette-Guérin, taking oral rehydration salts during diarrhoea and seeking care for pneumonia) is optimal if the weighted proportion of interventions is > 50%; otherwise, it is partial. We identified the factors associated with CCI using the descriptive association tests, the spatial autocorrelation statistic and multivariate logistic regression.

RESULTS: The analyses involved two DHS surveys, with 3034 included in 2012 and 4212 in 2018. The optimal coverage of the CCI has increased from 43% in 2012 to 61% in 2018. In multivariate analysis, in 2012: the poor had a lower probability of having an optimal CCI than the richest; OR = 0.11 [95% CI; 0.07, 0.18]. Those who had done four antenatal care visits (ANC) were 2.78 times more likely to have an optimal CCI than those with less OR = 2.78 [95% CI;2.24, 3.45]. In 2018: the poor had a lower probability of having an optimal CCI than the richest OR = 0.27 [95% CI; 0.19, 0.38]. Women who planned their pregnancies were 28% more likely to have an optimal CCI than those who had not planned OR = 1.28 [95% CI;1.05, 1.56]. Finally, women with more than 4 ANC were 2.43 times more likely to have an optimal CCI than those with the least OR = 2.43 [95% CI; 2.03, 2.90]. The spatial analysis reveals significant disparities with an aggregation of high partial CCI in Labé between 2012 and 2018.

CONCLUSION: This study showed an increase in CCI between 2012 and 2018. Policies should improve access to care and information for poor women. Besides, strengthening ANC visits and reducing regional inequalities increases optimal CCI.

PMID:37245008 | DOI:10.1186/s12884-023-05718-y

BMC Infect Dis. 2023 May 27;23(1):361. doi: 10.1186/s12879-023-08338-1.

ABSTRACT

BACKGROUND: Viral hepatitis (VH) is a leading contributor to morbidity and mortality worldwide, constituting a public health problem associated with the level of human development. In recent years, Venezuela has experienced a political, social, and economic crisis and has been impacted by natural disasters that have led to the deterioration of sanitary and health infrastructures modifying the determinants of VH. Despite epidemiological studies conducted in specific regions of the country or populations, the national epidemiological behaviour of VH remains unclear.

METHODS: This is a time series study involving records of morbidity and mortality by VH in Venezuela reported during the period from 1990 to 2016. The Venezuelan population was taken as the denominator of the morbidity and mortality rates, according to the Venezuelan National Institute of Statistics and the 2016 population projections from the latest census published on the website of the responsible Venezuelan agency.

RESULTS: During the study period, 630,502 cases and 4,679 deaths from VH in Venezuela were analysed. Most of the cases (n = 457,278; 72.6%) were classified as unspecific VH (UVH). The deaths were mainly attributed to VHB (n = 1,532; 32.7%), UVH (n = 1,287; 27.5%), and sequelae of VH (n = 977; 20.8%). The mean rates of cases and deaths from VH in the country were 95 ± 40.4 cases per 100,000 inhabitants and 0.7 ± 0.1 deaths per 100,000 inhabitants, respectively, showing a large dispersion that is evident from the calculation of the coefficients of variation. There was document a strong correlation between UVH and VHA cases (0.78, p < 0.01) morbidity rates. VHB mortality rate was very strongly correlated with sequelae of VH (-0.9, p < 0.01).

CONCLUSIONS: VH is a major burden of morbidity and mortality in Venezuela with an endemic-epidemic trend and an intermediate prevalence for VHA, VHB, and VHC. Epidemiological information is not published in a timely manner and diagnostic tests are insufficient in primary health services. There is an urgent need to resume epidemiological surveillance of VH and to optimise the classification system for a better understanding of UVH cases and deaths due to sequelae of VHB and VHC.

PMID:37245003 | DOI:10.1186/s12879-023-08338-1