Nevin Manimala

Am J Hematol. 2021 Sep 24. doi: 10.1002/ajh.26361. Online ahead of print.

ABSTRACT

Preclinical studies demonstrated activity of the oral proteasome inhibitor (PI) ixazomib (IXA) in bortezomib-resistant multiple myeloma (MM) and synergy with immunomodulatory drugs. We therefore conducted a phase I/II study to establish the safety and preliminary efficacy of IXA with pomalidomide (POM) and dexamethasone (DEX) in lenalidomide (LEN)/PI-refractory MM. Dose escalation established a 4 mg dose of POM and IXA and 20/40 mg dose of DEX as the maximum tolerated dose. The phase II portion of the trial was redesigned and started anew after 6 patients had been randomized to IXA-POM-DEX due to a rapidly changing treatment landscape. Among the 29 evaluable LEN/PI-refractory patients treated with IXA-POM-DEX in phase I / II, the overall response rate (partial response or better) was 51.7% with a median duration of response of 16.8 months (range 56 days – 4.1 years), median progression-free survival 4.4 months (95% confidence interval [CI]: 3.0 – 18.4) and median overall survival 34.3 months (95% CI: 19.2 – not reached). Hematologic, gastrointestinal, and constitutional adverse events were common and consistent with the side effect profiles of the individual agents. Our results support further evaluation of this all-oral regimen in relapsed/refractory MM. This article is protected by copyright. All rights reserved.

PMID:34559902 | DOI:10.1002/ajh.26361

Int J Gynaecol Obstet. 2021 Sep 24. doi: 10.1002/ijgo.13947. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare clinical vignettes (CV) and objective structured clinical examination (OSCE) as methods for assessing quality of intrapartum care among skilled providers in rural primary level health facilities of Tanzania.

METHODS: Cross sectional study conducted at six health facilities in Simiyu region of Tanzania. Providers were assessed using OSCE and CV in spontaneous delivery, neonatal resuscitation, and management of postpartum hemorrhage. Trained researchers used a structured clinical checklist. Frequency of items are presented as percentages and the agreement of the methods of assessment were reported using Kappa statistics (high: Kappa >0.80, moderate: 0.60-0.80, low: <0.60).

RESULTS: Most health care providers were female (60.7%), registered nurses by training (29.0%), and worked in a dispensary (56.1%) with an average age of 33 years and an average of 7.4 years of experience in their respective profession. Five items had high agreement between OSCE and CV: postpartum vital signs every 15 minutes, oxytocin within one minute of birth, diagnosis of postpartum hemorrhage, elevating legs of the mother, and deciding on manual compression of the uterus.

CONCLUSION: OSCE and CV should be viewed as complimentary to one another in assessment of provider knowledge and skill with priority given to OSCE, particularly in intrapartum care.

PMID:34559888 | DOI:10.1002/ijgo.13947

PLoS One. 2021 Sep 24;16(9):e0257881. doi: 10.1371/journal.pone.0257881. eCollection 2021.

ABSTRACT

Various factors associated with Acute Respiratory Infections (ARI) in toddlers have been widely observed, but there are no studies using data from the Sleman Health and Demographic Surveillance System (HDSS). This study aimed to determine the factors associated with ARI in children under five in Sleman, Yogyakarta, Indonesia. This research was an observational analytic study with a cross-sectional design, using secondary data from the Sleman HDSS. Data of 463 children under five who met the inclusion and exclusion criteria were used in this study. Inclusion criteria were toddlers who have complete observed variable data. The variables observed were the characteristics of children under five, the attributes of the mother, the physical condition of the house, the use of mosquito coils, sanitation facilities, and sources of drinking water. The exclusion criteria were toddlers with pulmonary tuberculosis in the past year. Data analysis used chi-squared tests for bivariate analysis and multivariate logistic regression analysis. The results showed that working mothers had a greater risk of ARI under five children with OR 1.46 (95% CI = 1.01-2.11), and groundwater as a water source was a protective factor against the occurrence of ARI in toddlers with OR 0.46 (95% CI = 0.26-0.81). After a logistic regression analysis was performed, only the drinking water source variable had a statistically significant relationship with the incidence of ARI in children under five with OR = 0.47 (95% CI = 0.268-0.827). Research on the relationship between water quality and the incidence of ARI in children under five is needed to follow up on these findings.

PMID:34559864 | DOI:10.1371/journal.pone.0257881

PLoS One. 2021 Sep 24;16(9):e0257758. doi: 10.1371/journal.pone.0257758. eCollection 2021.

ABSTRACT

BACKGROUND: Inappropriate infant and young child feeding (IYCF) practice is the leading cause of malnutrition in children. Data is needed to identify children at risk of poor feeding practice and to target interventions to improve IYCF practices. Therefore, this study aimed to assess IYCF practice and associated factors among mothers of children age 6 to 23 months in Debrelibanos district, north Showa zone, Oromia region, Ethiopia.

METHOD: A community-based cross-sectional study design was conducted among 380 mothers of children age 6 to 23 months from March 1 to April 5, 2019. A simple random sampling technique was used to select the respondents. Data was collected using a structured interviewer-administered questionnaire that had been pretested. The data was entered into Epi-Data 3.1 and then transferred to SPSS 21 for analysis. Descriptive statistical analysis was done, and an association between an outcome variable and independent variables was examined in logistic regression models.

RESULT: Overall, 65.8% of mothers practiced appropriate IYCF practice. The study revealed that 70.5% of children started breastfeeding within one hour of birth, and 61.6% were breastfed exclusively for six months. Among studied mothers, 79.5% continued to breastfeed their children until 2 years, and 69.2% of the participants started complementary feeding timely at six months. Minimum dietary diversity was observed in 19.2% of children, while minimum meal frequency was found in 79.2%. The majority of mothers (77.6%) fed their babies with bottles. Mother’s educational status of primary school [AOR = 4.50, 95% CI: (1.38,14.61)], husband’s occupation being merchant [AOR = 6.45, 95% CI: (1.51, 27.59)]; antenatal care follows up [AOR = 3.15, % CI: (1.22, 8.12)], radio/television ownership [AOR = 7.41, 95% CI: (2.86, 19.20)], child’s sex being female [AOR = 4.78, 95% CI: (2.26, 10.064) and sufficient knowledge on child feeding [AOR = 2.82, 95% CI: (1.27, 26.26)] were independent predictors for appropriate IYCF practice.

CONCLUSION: The prevalence of appropriate infant and young child feeding practice indicators was found to be rather high among the mothers in this study. The use of a bottle to feed babies, in particular is very common among the mothers who were studied. To address child malnutrition, it is critical to educate families about proper IYCF practices. This study suggests that mothers be properly educated about IYCF recommendations at health care facilities during their visits, as well as the promotion of appropriate IYCF through various media.

PMID:34559861 | DOI:10.1371/journal.pone.0257758

PLoS One. 2021 Sep 24;16(9):e0257095. doi: 10.1371/journal.pone.0257095. eCollection 2021.

ABSTRACT

BACKGROUND: If a COVID-19 patient develops a so-called severe course, he or she must be taken to hospital as soon as possible. This proves difficult in domestic isolation, as patients are not continuously monitored. The aim of our study was to establish a telemonitoring system in this setting.

METHODS: Oxygen saturation, respiratory rate, heart rate and temperature were measured every 15 minutes using an in-ear device. The data was transmitted to the Telecovid Centre via mobile network or internet and monitored 24/7 by a trained team. The data were supplemented by daily telephone calls. The patients´ individual risk was assessed using a modified National Early Warning Score. In case of a deterioration, a physician initiated the appropriate measures. Covid-19 Patients were included if they were older than 60 years or fulfilled at least one of the following conditions: pre-existing disease (cardiovascular, pulmonary, immunologic), obesity (BMI >35), diabetes mellitus, hypertension, active malignancy, or pregnancy.

FINDINGS: 153 patients (median age 59 years, 77 female) were included. Patients were monitored for 9 days (median, IQR 6-13 days) with a daily monitoring time of 13.3 hours (median, IQR 9.4-17.0 hours). 20 patients were referred to the clinic by the Telecovid team. 3 of these required intensive care without invasive ventilation, 4 with invasive ventilation, 1 of the latter died. All patients agreed that the device was easy to use. About 90% of hospitalised patients indicated that they would have delayed hospitalisation further if they had not been part of the study.

INTERPRETATION: Our study demonstrates the successful implementation of a remote monitoring system in a pandemic situation. All clinically necessary information was obtained and adequate measures were derived from it without delay.

PMID:34559832 | DOI:10.1371/journal.pone.0257095

PLoS One. 2021 Sep 24;16(9):e0252039. doi: 10.1371/journal.pone.0252039. eCollection 2021.

ABSTRACT

BACKGROUND: Needle stick and sharp injuries (NSSIs) are a common problem among healthcare workers (HCWs). Although the factors related to NSSIs for HCWs are well documented by several studies in Ethiopia, no evidence has been reported about the magnitude of and factors related to NSSIs in hospitals in northwestern Ethiopia.

METHODS: An institution-based cross-sectional study was carried out from January to March 2019 among 318 HCWs in three randomly-selected hospitals of the eight hospitals found in South Gondar Zone. Sample sizes were proportionally allocated to professional categories. Study participants were selected by systematic random sampling methods using the monthly salary payroll for each profession as the sampling frame. Data were collected using a self-administered questionnaire. The outcome of this study was the presence (injured) or absence of NSSIs during the 12 months prior to data collection. A binary logistic regression model with 95% confidence interval (CI) was used for data analysis. Variables from the bi-variable analysis with a p-value ≤ 0.25 were retained into the multivariable analysis. From the multivariable analysis, variables with a p-value less than 0.05 was declared as factors significantly associated with NSSIs.

MAIN FINDINGS: The prevalence of NSSIs was 29.5% (95% CI: 24.2-35.5%) during the 12 months prior to the survey. Of these, 46.0% reported that their injuries were moderate, superficial (33.3%) or severe (20.7%). About 41.4% of the injuries were caused by a suture needle. Factors significantly associated with NSSIs were occupation as a nurse (adjusted odds ratio [AOR] = 2.65, 95% CI: 1.18-4.26), disposal of sharp materials in places other than in safety boxes (AOR = 3.93, 95% CI: 2.10-5.35), recapping of needles (AOR = 2.27, 95% CI: 1.13-4.56), and feeling sleepy at work (AOR = 2.24, 95% CI: 1.14-4.41).

CONCLUSION: This study showed that almost one-third of HCWs had sustained NSSIs, a proportion that is high. Factors significantly associated with NSSIs were occupation as a nurse, habit of needle recapping, disposal of sharp materials in places other than in safety boxes and feeling sleepy at work. Observing proper and regular universal precautions for nurses during daily clinical activities and providing safety boxes for the disposal of sharp materials, practicing mechanical needle recapping and preventing sleepiness by reducing work overload among HCWs may reduce the incidence of NSSIs.

PMID:34559802 | DOI:10.1371/journal.pone.0252039

PLoS One. 2021 Sep 24;16(9):e0250197. doi: 10.1371/journal.pone.0250197. eCollection 2021.

ABSTRACT

The MORDOR study, a masked, community-level randomized clinical trial conducted in Niger, Malawi and Tanzania (2015 to 2017), showed that biannual administration of single-dose azithromycin to preschool children reduced all-cause mortality. We sought to evaluate its impact on causes of death in children aged 1-59 months in Tanzania. A random sampling of 614 communities was conducted in Kilosa District, Tanzania, with simple random assignment of communities to receive either azithromycin or placebo. In these communities, a census was carried out every 6 months and children aged 1-59 months received biannual (every 6 months), single-dose azithromycin (~20mg/kg) or placebo depending on community assignment, over a 2-year period. Mortality was determined at the time of the biannual census. For child deaths, a verbal autopsy was performed to ascertain the cause using a standardized diagnostic classification. A total of 190- (0.58 /100 person-years) and 200 deaths (0.59/100 person-years) were reported in the azithromycin and placebo arms, respectively. Malaria, pneumonia and diarrhea, accounted for 71% and 68% of deaths in the respective arms. Overall, the mortality was not different by treatment arm, nor were the distribution of causes of death after adjusting for community clustering. The cause-specific mortality for diarrhea/pneumonia was no different over time. In children aged 1-5 months, 32 deaths occurred in the placebo arm and 25 deaths occurred in the azithromycin arm; 20 (62.5%) deaths in the placebo- and 10 (40%) in the azithromycin arm were attributed to diarrhea or pneumonia. Neither differences in the number of deaths nor the diarrhea/pneumonia attribution was statistically significant after adjusting for community clustering. In conclusion, azithromycin was not associated with a significant decline in deaths by specific causes compared to placebo. The non-significant lower rates of diarrhea or pneumonia in children <6 months who received azithromycin merit further investigation in high-mortality settings. Trial registration: NCT02048007.

PMID:34559801 | DOI:10.1371/journal.pone.0250197

Psychiatr Danub. 2021 Sep;33(Suppl 9):158-163.

ABSTRACT

BACKGROUND: Suicidality is a widespread phenomenon with a dramatic burden worldwide. The Coronavirus disease 2019 (Covid-19) pandemic determined a relevant impact on mental health, due to the infection itself and its socio-economic consequences. The present study is aimed at analyzing the prevalence of suicidality during the Covid-19 pandemic among subjects requiring a psychiatric consultation in an emergency setting.

SUBJECTS AND METHODS: Socio-demographic and clinical information was collected at the emergency department of the General Hospital of Perugia from June 1^st, 2020 to January 31^st, 2021. Data was entered into an electronic datasheet and retrospectively analysed. Pearson’s bivariate correlation was performed in order to assess significant associations between suicide-related variables and specific socio-demographic and clinical features (p<0.05).

RESULTS: Among 447 subjects included in the analysis, 109 (24.4%) showed suicidality-related phenomena, particularly suicide attempts (SA) (n=44, 9.8%), suicidal ideation (SI) (n=41, 9.2%), non suicidal self-injury (NSSI) (n=31, 6.9%), that in some cases co-occurred. A statistically significant association was detected between NSSI and living with marital family (p=0.024) and between suicidality-related phenomena and adjustment disorders (p=0.018). None of the examined subjects reported a previous positivity for Covid-19 and neither did their relatives.

CONCLUSIONS: The present study confirms the impact of the Covid-19 pandemic on suicide-related phenomena. Consultation psychiatry fulfills a key role in the early detection and clinical management of these conditions, that require targeted intervention strategies.

PMID:34559796

Psychiatr Danub. 2021 Sep;33(Suppl 9):119-129.

ABSTRACT

BACKGROUND: The COVID-19 pandemic has substantially contributed to increased anxiety rates among the general population worldwide. Pandemic-related health anxiety and worries about getting COVID-19 can lead to generalized anxiety and anxiety somatization, which, together with insalubrious daily life habits, are risk factors of worsening somatic health in people with SARS-Cov-2 infection.

SUBJECTS AND METHODS: The current study is a part of the COMET-G project (40 countries, n=55589; approved by the Ethics Committee of the Aristotle University of Thessaloniki), which represents an intermediate analysis of data collected anonymously via online links from a national sample of the Russian general population (n=9936, 31.09±12.16 y.o., 58.7% females) to estimate anxiety using STAI-S and self-reported changes in anxiety and life habits (physical activity, nutrition and weight, internet use, sleep) during the lockdown. All statistical calculations (descriptive statistics, between group comparisons using chi-square test, MANOVA, ANOVA, significant at p<0.05) were performed with IBM SPSS 27.

RESULTS: Overall STAI-S scores were 29±5.4, a subjective feeling of anxiety increase was reported in 40.3% of respondents (43.9% significantly > in females), worsening to clinical anxiety in 2.1% (2.4% > in females). 54.2% of respondents reported decreased physical activity, 33.1% gained weight, 72% used internet more often, 52.6% experienced worries related to the information about COVID-19 (56.8% > in females). 88% experienced worsened sleep quality, 69.2% stayed up until late, 23.2% took sleeping pills, and 31% had nightmares in which they felt trapped. To ANOVA, such life habits as reduced physical activity during the lockdown, increased time spent online, internet browsing about COVID-19, tendency to stay up late, use of sleeping pills and disturbing dreams with scenario of being trapped were significantly related to worsening of clinical anxiety. However, eating behaviour, weight changes, and social media use did not contribute to the clinical anxiety increase.

CONCLUSIONS: Factors of decreased physical activity and sleep disturbances related to the lockdown, as well as excessive internet browsing for information about COVID-19, emerged as risk factors for increased anxiety, more notably in women than in men. Preventive measures should be targeted against relevant factors imparting anxiety in the vulnerable population.

PMID:34559790

Psychiatr Danub. 2021 Sep;33(Suppl 9):47-54.

ABSTRACT

BACKGROUND: Antidepressants (AD) are widely used in the treatment of mood disorders and administered for mental disorders coded across other diagnostic categories. However, inaccuracy in AD prescription may lead to unresponsive cases, decreased compliance, and treatment discontinuation. Following a one-way cross-sectional study design, we aimed to analyze the AD prescription patterns in routine clinical practice in Moscow, as compared to clinical guidelines, taking the capital as representative of the Russian national experience.

SUBJECTS AND METHODS: We studied 537 medical case records of inpatients and outpatients who had received treatments on an arbitrarily chosen day, focusing on classes, doses, drug combinations, and switching patterns for AD prescription. All statistical calculations (descriptive statistics, between group comparisons using Fisher exact, binominal and Pearson chi-square tests, significant at two-tailed p<0.05) were performed with the IBM SPSS 27.

RESULTS: 15% of inpatients and 52% of outpatients with mental disorders received ADs. ADs were prescribed for major depressive disorder and other diagnoses, including the majority of schizophrenia spectrum disorders and non-organic conditions. Selective serotonin reuptake inhibitors, particularly fluvoxamine, were used most often for outpatient and inpatient settings, but at lower average dose rather than recommended, while tricyclic ADs were more likely to be correctly administered for severe depression. ADs were often prescribed within combined treatment rather than monotherapy, but clinical recommendations were not strictly followed in relation to the drug choice, combination with antipsychotic agents and switching strategies.

CONCLUSIONS: The clinical reality of AD prescriptions in the studied psychiatric setting differed from the clinical guidelines, insofar as the choice of AD medication did not always follow evidence-based recommendations. Choice and dosage of ADs should properly follow duration and severity of the illness, and the clinical profile of disorders.

PMID:34559778