Tag: statistics

BMJ Evid Based Med. 2021 Mar 30:bmjebm-2020-111641. doi: 10.1136/bmjebm-2020-111641. Online ahead of print.

ABSTRACT

OBJECTIVES: Depression affects an estimated 7% of the adult population at an estimated cost of over US$200 billion/year in the USA. Complete, transparent reporting of clinical trial data facilitates valid estimates of treatment efficacy. In the USA, ClinicalTrials.gov increases transparency through mandatory prospective trial registration and outcome reporting. We examined characteristics of the transparent reporting of depression treatment studies registered in ClinicalTrials.gov.

DESIGN: Cross sectional.

SETTING AND PARTICIPANTS: US-based studies identified in a search of ClinicalTrials.gov with depression as the condition, enrolling ages 18 and older, and completed between 1 January 2008 and 1 May 2019.

INTERVENTIONS: All interventions were included.

MAIN OUTCOMES AND MEASURES: The main outcome was whether any results were reported prior to 1 May 2020. Data were extracted regarding inclusion and exclusion criteria, publications related to the study and specification of hypotheses.

RESULTS: 725 studies involving 156 634 patients met inclusion criteria. 416 (57.4%) of the studies posted some results. However, statistical test results were not included in 230 studies (55.3%). Most studies had data that could have been analysed and reported. Compared with studies without results, studies with any results were more likely to have hypotheses, include drug treatment conditions, and to have publications related to the study.

CONCLUSIONS: Required study registration does not always result in transparent outcome reporting. Better compliance with mandated reporting and improved reporting standards would facilitate a more comprehensive representation of depression treatment research.

PMID:33785513 | DOI:10.1136/bmjebm-2020-111641

Hosp Pediatr. 2021 Mar 30:hpeds.2020-003673. doi: 10.1542/hpeds.2020-003673. Online ahead of print.

ABSTRACT

OBJECTIVES: Maintenance intravenous fluids (IVFs) are routinely used in the care of hospitalized children. The American Academy of Pediatrics (AAP) published clinical practice guidelines in November 2018 that recommended the use of isotonic maintenance IVF. Our primary aim was to increase the proportion of hospital days pediatric inpatients were exclusively administered isotonic maintenance IVF to ≥80% by May 2020 at our institution.

METHODS: We conducted a single-center quality improvement (QI) study as part of an AAP collaborative. An interdisciplinary team led QI interventions including providing targeted education to clinicians, integrating guideline recommendations into the electronic medical record, engaging hospital leaders, and providing performance data to clinicians. Our study population included children ages 28 days to 18 years admitted to inpatient wards. Our primary outcome was the proportion of hospital days with exclusive isotonic maintenance IVF use. Balancing measures included transfers to the ICU, ordering of serum sodium laboratory tests, and adverse events. Data were analyzed by using statistical process control.

RESULTS: We analyzed 500 hospital admissions and found a significant increase in exclusive isotonic IVF use (63% to 95%) within 9 months of starting our QI intervention. We found no significant changes in balancing measures (serum sodium laboratory tests [24% to 25%], ICU transfer [0.3% to 1%], adverse events [0.3% to 1%]).

CONCLUSIONS: Our interdisciplinary QI team led interventions that were associated with significant improvements in isotonic IVF use, in accordance with AAP clinical practice guidelines. With our study, we provide detailed guidance on successful interventions for implementing this evidence-based guideline.

PMID:33785518 | DOI:10.1542/hpeds.2020-003673

J Am Acad Child Adolesc Psychiatry. 2021 Mar 22:S0890-8567(21)00155-6. doi: 10.1016/j.jaac.2021.02.022. Online ahead of print.

ABSTRACT

OBJECTIVE: Wraparound is a common method for coordinating care for children and adolescents with serious emotional disorders (SED), with nearly 100,000 youth served annually in the U.S. The current systematic review and meta-analysis estimated effects on youth outcomes (symptoms, functioning, school, juvenile justice, and residential placement) and costs.

METHOD: A literature search identified 17 peer-reviewed and grey literature studies meeting criteria, which were coded on characteristics of sample, design, implementation, and outcomes. Random effects modeling was conducted using Comprehensive Meta-Analysis Version 3.0. Effect sizes were calculated using Hedges’ g. Homogeneity of effects were assessed using Q statistics.

RESULTS: Medium-sized effects favored Wraparound-enrolled youth for costs (g =.391, CI = [.282, .500], p < .001), residential outcomes (g = .413, CI = [.176, .650], p = .001), and school functioning (g = .397, CI = [.106, .688], p = .007); small effects were found for mental health symptoms (g = .358, CI = [.030, .687], p = .033) and functioning (g = .315, CI = [.086, .545], p = .007). Larger effects were found for peer-reviewed studies, quasi-experimental designs, samples with a larger percentage of youth of color, and Wraparound conditions with higher fidelity.

CONCLUSION: Results indicate positive effects for Wraparound, especially for maintaining youth with SED in home and community. However, many studies showed methodological weaknesses and fidelity measurement was largely absent, suggesting a need for additional research. Nonetheless, the results should aid decisions around resource allocation, referral practices, and system partnerships among child psychiatrists and other behavioral health professionals.

PMID:33785404 | DOI:10.1016/j.jaac.2021.02.022

Photodiagnosis Photodyn Ther. 2021 Mar 27:102267. doi: 10.1016/j.pdpdt.2021.102267. Online ahead of print.

ABSTRACT

PURPOSE: The purpose is to evaluate macular vascular densities (VDs) using optical coherence tomography angiography (OCTA) in patients affected by coronavirus disease-2019 (COVID-19).

METHODS: The superficial (SF) and deep macular VD of 50 patients with SARS CoV2 pneumonia who had positive polymerase chain reaction (PCR) tests and who recovered after receiving treatment and 55 healthy age- and gender-matched controls were compared using OCTA. Blood inflammation parameters were also recorded.

RESULTS: There was no statistically significant difference between the two groups in terms of age and gender (p = 0.147 and p = 0.504, respectively). Nor was there a difference with respect to smokers between the two groups (p = 0.231). In COVID-19 patients, the VDs in superior hemi quadrant, superior quadrant and inferior quadrant, were significantly lower (p = 0.033, p = 0.029 and p = 0.042, respectively) in superficial plexus. It was also significantly lower in parafovea, superior hemi and superior quadrants (p = 0.026, p < 0.001 and p = 0.004, respectively) in deep plexus. In addition, white blood cell and neutrophil counts were significantly negatively correlated with the VD of the deep parafovea, deep superior quadrant and deep superior hemi quadrant (p < 0.05). There was no difference between the patient and control groups in both superficial and deep foveal avascular zone (FAZ) (p = 0.101 and p = 0.691 respectively) CONCLUSION: In COVID-19 disease, VD is low in some sectors in both SF and deep layers, but no change in FAZ. The effect of COVID 19 disease on the retina and whether it makes the retina sensitive to damage can only be understood with long-term follow-up.

PMID:33785439 | DOI:10.1016/j.pdpdt.2021.102267

Photodiagnosis Photodyn Ther. 2021 Mar 27:102268. doi: 10.1016/j.pdpdt.2021.102268. Online ahead of print.

ABSTRACT

PURPOSE: To compare the lens autofluorescence (AF) levels among patients with end-stage renal failure and undergoing hemodialysis secondary to hypertension, patients with well-controlled hypertension, and healthy controls.

METHOD: This study was a prospective, cross-sectional, comparative study conducted between February and April 2018. Two groups of patients and a group of healthy individuals were included in the study. The first group of patients included individuals with a renal insufficiency due to essential hypertension who underwent regular hemodialysis treatment (dialysis group). The second group included patients with well-controlled essential hypertension (hypertension group). Lens autofluorescence was measured via a scanning confocal lens fluorescence biomicroscope optical system for all participants. The measurement of fluorescence ratio is given as a numerical data. The AF results were compared in all groups.

RESULTS: The study included 87 individuals. There were 29 individuals (33.3%) in the dialysis group, 30 (34.5%) in the hypertension group, and 28 (32.2%) in the healthy group. The mean fluorescence ratio(FR) was 0.20 ± 0.06, 0.20 ± 0.04, and 0.17 ± 0.04 in the dialysis, hypertension, and healthy groups respectively. There was a significant difference in the mean FR measurements between the three groups (p = .004). As a result of a binary comparison, mean FR values for patients in the dialysis group were higher (0.20 ± 0.06) than for healthy individuals (0.17 ± 0.04), which was statistically significant (p = .025). Mean FR measurements of hypertensive patients were higher (0.20 ± 0.04) than healthy individuals (0.17 ± 0.04), which was also statistically significant (p = .02). However, there was no statistically significant difference among the mean FR measurements between the hypertension and dialysis groups (p = .63).

CONCLUSION: We demonstrated that lens autofluorescence increased in both patients with renal failure undergoing hemodialysis and those with well-controlled hypertension. The mean lens autofluorescence levels were significantly higher in both patient groups than the healthy control group.

PMID:33785443 | DOI:10.1016/j.pdpdt.2021.102268

J Sep Sci. 2021 Mar 30. doi: 10.1002/jssc.202001190. Online ahead of print.

ABSTRACT

Fructus Aurantii is a traditional medicated diet in East Asia. To determine the underlying chemical markers responsible for the quality and efficacy of Fructus Aurantii, a sensitive metabolomic method was applied to distinguish Fructus Aurantii in Jiangxi Province from other two geographical locations (Hunan Province and Chongqi City) in China. In the present study, multivariate analyses were adopted to compare chemical compositions in 21 batches of Fructus Aurantii samples. Among three geographical origins, 23 differential compounds were structurally identified. Serum pharmacochemistry exhibited that 22 components could be detected in rat serum. Six differential and absorbed components were selected as six potential markers. Statistical analysis of the effects of six potential markers on the quality of Fructus Aurantii revealed that the content of markers varied widely in three origins. Six differential and absorbed components were evaluated further biological activity. Neohesperidin, naringin and meranzin showed inhibitory effect on acetylcholinesterase that regulates gastrointestinal motility in vitro and in silico, suggesting that these three components may be determined as the active biomarkers of Fructus Aurantii. These findings demonstrate the potential of biomarkers for identification and quality control of Fructus Aurantii. This article is protected by copyright. All rights reserved.

PMID:33784419 | DOI:10.1002/jssc.202001190

Head Neck. 2021 Mar 30. doi: 10.1002/hed.26683. Online ahead of print.

ABSTRACT

BACKGROUND: Although nonsurgical treatment strategy is increasingly adopted in patients with locoregionally advanced laryngeal squamous cell carcinoma (LSCC), survival disparities were reported between surgical treatment modality and organ preservation protocols, highlighting the great importance for accurate patients’ selection.

METHOD: This secondary analysis used data from the Surveillance, Epidemiology, and End Results database between 2010 and 2015 with follow-up data up to 2018. We developed and validated a dynamic prognostic nomogram for overall survival (OS) in 4237 patients with LSCC and subgroup of 2087 patients with locoregionally advanced laryngeal squamous cell carcinoma (LALSCC). Based on the total risk score derived from the dynamic nomogram, two well-matched risk groups (i.e., low- and high-risk) were created via X-tile software and 1-to-1 propensity score matching (PSM); surgical treatment modality was compared with nonsurgical one in each risk group.

RESULTS: A more accurate and convenient dynamic prognostic nomogram based on age, marital status, T category, N category, M category, tumor size, and tumor differentiation was developed and validated, of which the predictive performance was superior to that of TNM staging system. For high-risk LALSCC selected by the dynamic nomogram, after 1-to-1 PSM, significantly improved OS was observed in patients with receiving surgical treatment compared to those receipt of nonsurgical management (restricted mean survival time at 36-month: 26.6 vs 22.7, p < 0.001; restricted mean survival time at 60-month: 36.7 vs 31.0, p = 0.003).

CONCLUSION: We establish and validate a more accurate and convenient dynamic prognostic nomogram for patients with LSCC, which may predict the benefit from surgical treatment modality for patients with high-risk LALSCC.

PMID:33784432 | DOI:10.1002/hed.26683

PLoS One. 2021 Mar 30;16(3):e0249085. doi: 10.1371/journal.pone.0249085. eCollection 2021.

ABSTRACT

BACKGROUND: Ethiopia launched free access for antiretroviral therapy in 2005. The number of patients on second line antiretroviral treatment has increased with each passing year. The objectives of this study were to describe the clinical, immunological and virologic outcomes of children and adolescents receiving second line anti-retroviral therapy in two referral hospitals, Yekatit 12 and Zewditu Memorial Hospitals, in Addis Ababa, Ethiopia.

METHODS: This was a hospital based retrospective cohort study conducted among children and adolescents aged 18 years and less and receiving a second line antiretroviral drugs. Data was collected using structured questionnaires. Means and percentages were used for nominal variables. Statistical analysis was made using statistical software-SPSS 23.0. Kaplan Meier analysis, long rank test and multivariate Cox proportion model were used to identify factors affecting survival.

RESULTS: A total of 75 children and adolescents were studied with a mean age of 13.28 years (SD: 4) with a mean treatment period on second line regimens of 35.2 months (SD: 21.8 months). Forty-eight participants were experiencing successful measures (in all three parameters) for their second line anti-retroviral treatment. Ten had virologic treatment failure while seven had died. Both treatment failure and death rates were higher within the first two years of treatment. Poor treatment adherence (Adjusted hazard ratio: 5.1 (95% CI: 1.1-23.2; p-value = 0.02)) and advanced World Health Organization clinical stage at start of the second line antiretrovirals (Adjusted hazard ratio: 7.51 (95% CI: 1.35-18.02; p-value = 0.002)) correlated significantly with survival of children and adolescents receiving treatment.

CONCLUSIONS: The study describes clinical, immunological and virologic outcomes of second line antiretroviral treatment in a pediatric cohort under care in two hospitals in Addis Ababa, Ethiopia. Poor adherence and pre-treatment advanced clinical stages were predictors of survival.

PMID:33784335 | DOI:10.1371/journal.pone.0249085

PLoS One. 2021 Mar 30;16(3):e0249325. doi: 10.1371/journal.pone.0249325. eCollection 2021.

ABSTRACT

BACKGROUND: The association between prolong metformin usage and B12 deficiency has been documented. However, the prevalence estimates of metformin-induced vitamin B12 deficiency showed substantial disparity among studies due to varied study definitions of vitamin B12 deficiency. Metformin blocks the calcium dependent absorption of the vitamin B12-Intrinsic Factor complex at the terminal ileum. Lack of intrinsic factor due to the presence of auto-antibodies to parietal cells (IFA) could lead to vitamin B12 deficiency and subsequently cause peripheral neuropathy. We investigated the prevalence of vitamin B12 deficiency using more sensitive, combined markers of vitamin B12 status (4cB12) and the immuno-biochemical mediators of vitamin B12 deficiency.

METHODS: In this observational study, 200 consecutive consenting metformin-treated T2DM patients, aged 35 and above, attending the diabetic clinic at KATH were recruited. Vitamin B12 deficiency was classified based on the Fedosov age-normalized wellness quotient. Anthropometric measurement was taken as well as blood samples for immunological and biochemical mediators. Peripheral neuropathy was assessed using the Michigan Neuropathy Screening Instrument (MNSI). Statistical analysis was performed using the R Language for Statistical Computing.

RESULTS: Using the combined indicator (4cB12), the prevalence of metformin induced vitamin B12 deficiency was 40.5% whilst the prevalence of MNSI-Q and MNSI-PE diabetic neuropathy was 32.5% and 6.5% respectively. Participants with vitamin B12 deficiency had significantly higher levels of IFA, GPA, TNF-α, TC, LDL and albumin compared to those with normal vitamin B12 levels (p < 0.05). Correlation analysis revealed a statistically significant negative association between 4cB12 and the immunological markers [IFA (rs = -0.301, p<0.0001), GPA (rs = -0.244, p = 0.001), TNF-α (rs = -0.242, p = 0.001) and IL-6 (rs = -0.145, p = 0.041)]. Likewise, 4cB12 was negatively associated with TC (rs = -0.203, p = 0.004) and LDL (rs = -0.222, p = 0.002) but positively correlated with HDL (rs = 0.196, p = 0.005).

CONCLUSION: Vitamin B12 deficiency and diabetic neuropathy are very high among metformin-treated T2DM patients and it is associated with increased GPA, IFA, TNF-α and cardiometabolic risk factors (higher LDL and TC and lower HDL). Upon verification of these findings in a prospective case-control study, it may be beneficial to include periodic measurement of Vitamin B12 using the more sensitive combined indicators (4cB 12) in the management of patients with T2DM treated with metformin in Ghana.

PMID:33784336 | DOI:10.1371/journal.pone.0249325

PLoS One. 2021 Mar 30;16(3):e0249365. doi: 10.1371/journal.pone.0249365. eCollection 2021.

ABSTRACT

BACKGROUND: Hyaline membrane disease (HMD) is a leading cause of morbidity and mortality in preterm newborn babies. Though, there are studies related to Hyaline membrane disease inclusive of all neonates, studies related to the burden among preterm neonates were limited. In addition, increasing neonatal mortality in Ethiopia could be related to increase in the burden of hyaline membrane disease among preterm neonates. Therefore, this study was aimed to assess the burden of hyaline membrane disease, mortality and its associated factors among preterm neonate admitted at neonatal intensive care unit, North Central Ethiopia.

METHODOLOGY: An institution-based retrospective follow-up study was conducted among 535 preterm neonates admitted at neonatal intensive care unit from January 1, 2014-December 30, 2017. Data were entered into EPi-data 4.2.0.0 and transferred to STATA version 14 statistical software for statistical analysis. Binary logistic regression was used for the analysis. All variables with P-value < 0.25 during bi-variable analysis were considered for multivariable logistic regression. Level of statistical significance was declared at P value ≤0.05.

RESULTS: In the current study, proportion of hyaline membrane disease was 40% (95% CI; 35.8, 44.3) of which 49.5% died. Preterm neonate born with Gestational age of less than 34 weeks of age (Adjusted odd ratio (AOR = 2.64; 95 CI: 1.49, 4.66)), 5th minute Apgar score less than 7 (AOR = 2.2; 95% CI: 1.20, 4.07), and newborn with birth weight of less than 1500 gram (AOR = 2.4, 95% CI: 1.3, 4.3) were predictors of hyaline membrane disease.

CONCLUSIONS: The mean gestational age (±) was 33.46 (±2.55) weeks. The incidence of hyaline membrane disease among preterm admissions was high. Preterm neonate born with gestational age of less than 34 weeks of age, asphyxiated newborns and newborn with birth weight of less than 1500 gram were predictors of hyaline membrane disease. So, emphasis should be given on early screening, follow up and timely interventions for preterm neonate.

PMID:33784349 | DOI:10.1371/journal.pone.0249365