Tag: statistics

Parasit Vectors. 2021 Sep 15;14(1):476. doi: 10.1186/s13071-021-04985-y.

ABSTRACT

BACKGROUND: In a countrywide study aiming to update the knowledge on diversity of sand fly species in Romania, a sand fly population was observed in an isolated system of cave microhabitats. The caves are located in the protected area of Canaraua Fetii, Dobrogea region, southeastern Romania. The highest sand fly diversity was recorded in this area between 1968 and 1970. This work presents a study conducted to estimate the seasonal variation of the sand fly species in correlation with the particular environmental factors of the isolated system of cave microhabitats.

METHODS: Sand flies were collected between May and October 2020 from one trapping site of interest in Canaraua Fetii. The trapping site consisted of a cave entrance. CDC miniature light traps and sticky traps were used to collect insects from the exterior walls of the cave entrance. Species identification of collected sand flies was done using morphological keys. Statistical analysis of the trapping and climatic data was performed.

RESULTS: From all collected sand flies, 99.7% (818/822) were Phlebotomus neglectus, 0.1% (1/822) Ph. balcanicus and 0.2% (2/822) Sergentomyia minuta. Sand fly activity was first observed on 2 July and last on 24 September. A monomodal abundance trend was present, with the peak activity between 16 and 17 July. The analysis of the climatic data showed correlations between the total number of captured sand flies and both average temperature and average relative humidity. The total number of collected specimens was statistically higher when CDC miniature light traps were used compared to sticky traps. The number of females on the sticky traps was significantly higher than the number of males on the same trap type. Compared with the sticky traps, significantly more males were collected by CDC miniature light traps. This is the first record of Se. minuta in Romania after 50 years of no records (despite the trapping effort of the last 5 years in the country). Also, Ph. sergenti, previously present in this location, was not found.

CONCLUSIONS: In the investigated natural habitat, the diversity of the sand fly species appears to have changed, with the predominance of Ph. neglectus instead of Ph. balcanicus and Se. minuta (recorded as the two predominant species in 1968-1970). A monomodal abundance trend was observed as in other regions of the country. The sand fly activity in this particular cave microhabitat appears to be longer than in other regions in Romania. Longer sand fly activity increases the zoonotic risk of various pathogenic species’ transmission, with an impact on public health, as sand flies are important insect vectors.

PMID:34526131 | DOI:10.1186/s13071-021-04985-y

Ital J Pediatr. 2021 Sep 15;47(1):186. doi: 10.1186/s13052-021-01139-9.

ABSTRACT

BACKGROUND: Neonatal mortality is a major global public health problem. Ethiopia is among seven countries that comprise 50 % of global neonatal mortality. Evidence on neonatal mortality in referred neonates is essential for intervention however, there is no enough information in the study area. Neonates who required referral frequently became unstable and were at a high risk of death. Therefore, this study aimed to assess the incidence and predictors of mortality among referred neonates.

METHOD: A prospective follow-up study was conducted among 436 referred neonates at comprehensive specialized hospitals in the Amhara regional state, North Ethiopia 2020. All neonates admitted to the selected hospitals that fulfilled the inclusion criteria were included. Face-to-face interviews, observations, and document reviews were used to collect data using a semi-structured questionnaire and checklists. Epi-data™ version 4.2 software for data entry and STATA™ 14 version for data cleaning and analysis were used. Variables with a p-value < 0.25 in the bi-variable logistic regression model were selected for multivariable analysis. Multivariable analyses with a 95% confidence level were performed. Variables with P < 0.05 were considered statistically significant.

RESULT: Over all incidence of death in this study was 30.6% with 95% confidence interval of (26.34-35.16) per 2 months observation. About 23 (17.83%) deaths were due to sepsis, 32 (24.80%) premature, 40 (31%) perinatal asphyxia, 3(2.33%) congenital malformation and 31(24.03%) deaths were due to other causes. Home delivery [AOR = 2.5, 95% CI (1.63-4.1)], admission weight < 1500 g [AOR =3.2, 95% CI (1.68-6.09)], travel distance ≥120 min [AOR = 3.8, 95% CI (1.65-9.14)], hypothermia [AOR = 2.7, 95% CI (1.44-5.13)], hypoglycemia [AOR = 1.8, 95% CI (1.11-3.00)], oxygen saturation < 90% [AOR = 1.9, 95% (1.34-3.53)] at admission time and neonate age ≤ 1 day at admission [AOR = 3.4, 95% CI (1.23-9.84) were predictors of neonatal death.

CONCLUSION: The incidence of death was high in this study. The acute complications arising during the transfer of referral neonates lead to an increased risk of deterioration of the newborn’s health and outcome. Preventing and managing complications during the transportation process is recommended to increase the survival of neonates.

PMID:34526106 | DOI:10.1186/s13052-021-01139-9

Trials. 2021 Sep 15;22(1):627. doi: 10.1186/s13063-021-05594-x.

ABSTRACT

BACKGROUND: Controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Although both pharmacological and/or surgical treatment are effective in PDA closure, this has not resulted in an improved neonatal outcome. In most preterm infants, a PDA will eventually close spontaneously, hence PDA treatment potentially increases the risk of iatrogenic adverse effects. Therefore, expectant management is gaining interest, even in the absence of convincing evidence to support this strategy.

METHODS/DESIGN: The BeNeDuctus trial is a multicentre, randomised, non-inferiority trial assessing early pharmacological treatment (24-72 h postnatal age) with ibuprofen versus expectant management of PDA in preterm infants in Europe. Preterm infants with a gestational age of less than 28 weeks and an echocardiographic-confirmed PDA with a transductal diameter of > 1.5 mm are randomly allocated to early pharmacological treatment with ibuprofen or expectant management after parental informed consent. The primary outcome measure is the composite outcome of mortality, and/or necrotizing enterocolitis Bell stage ≥ IIa, and/or bronchopulmonary dysplasia, all established at a postmenstrual age of 36 weeks. Secondary short-term outcomes are comorbidity and adverse events assessed during hospitalization and long-term neurodevelopmental outcome assessed at a corrected age of 2 years. This statistical analysis plan focusses on the short-term outcome and is written and submitted without knowledge of the data.

TRIAL REGISTRATION: ClinicalTrials.gov NTR5479. Registered on October 19, 2015, with the Dutch Trial Registry, sponsored by the United States National Library of Medicine Clinicaltrials.gov NCT02884219 (registered May 2016) and the European Clinical Trials Database EudraCT 2017-001376-28.

PMID:34526095 | DOI:10.1186/s13063-021-05594-x

Trials. 2021 Sep 15;22(1):623. doi: 10.1186/s13063-021-05583-0.

ABSTRACT

INTRODUCTION: Despite several ongoing efforts in biomedicine and traditional medicine, there are no drugs or vaccines for coronavirus disease 2019 (COVID-19) as of May 2020; Kabasura Kudineer (KSK), a polyherbal formulation from India’s Siddha system of medicine, has been traditionally used for clinical presentations similar to that of COVID-19. We explored the efficacy of KSK in reducing viral load and preventing the disease progression in asymptomatic, COVID-19 cases.

METHODS: A prospective, single-center, open-labeled, randomized, controlled trial was conducted in a COVID Care Centre in Chennai, India. We recruited reverse-transcription polymerase chain reaction (RT-PCR)-confirmed COVID-19 of 18 to 55 years of age, without clinical symptoms and co-morbidities. They were randomized (1:1 ratio) to KSK (60 mL twice daily for 7 days) or standard of care (7 days supplementation of vitamin C 60,000 IU morning daily and zinc 100 mg evening daily) groups. The primary outcomes were reduction in the SARS-CoV-2 load [as measured by cyclic threshold (CT) value of RT-PCR], prevention of progression of asymptomatic to symptomatic state, and changes in the immunity markers including interleukins (IL-6, IL-10, IL-2), interferon gamma (IFNγ), and tumor necrosis factor (TNF α). Siddha clinical assessment and the occurrence of adverse effects were documented as secondary outcomes. Paired t-test was used in statistical analysis.

RESULTS: Viral load in terms of the CT value (RdRp: 95% CI = 1.89 to 5.74) declined significantly on the seventh day in the KSK group and that of the control group, more pronounced in the study group. None progressed to the symptomatic state. There was no significant difference in the biochemical parameters. We did not observe any changes in the Siddha-based clinical examination and adverse events in both groups.

CONCLUSION: KSK significantly reduced SARS-CoV-2 viral load among asymptomatic COVID-19 cases and did not record any adverse effect, indicating the use of KSK in the strategy against COVID-19. Larger, multi-centric trials can strengthen the current findings.

TRIAL REGISTRATION: Clinical Trial Registry of India CTRI2020/05/025215 . Registered on 16 May 2020.

PMID:34526104 | DOI:10.1186/s13063-021-05583-0

Orphanet J Rare Dis. 2021 Sep 15;16(1):389. doi: 10.1186/s13023-021-02016-8.

ABSTRACT

AIMS: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and life-threatening intravascular hematologic disorder with significant morbidity and premature mortality. Clinical trials (NCT02946463 and NCT03056040) comparing ravulizumab with eculizumab for PNH have supported the non-inferiority of the former and similar safety and tolerability. This secondary analysis compared PNH trial participants after 26 weeks on either treatment (n = 438) to a general-population sample (GenPop) (n = 15,386) and investigated response-shift effects.

METHODS: Multivariate analysis of covariance (MANCOVA) investigated function and symptom scores on the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 of people with PNH as compared to GenPop, after covariate adjustment. Risk-factor groups were created based on clinical indicators known to be associated with worse PNH outcomes, and separate MANCOVAs were computed for lower- and higher-risk-factor groups. Differential item functioning (DIF) analyses examined whether item response varied systematically (1) by treatment, (2) compared to GenPop, and (3) over time, the latter two suggesting and reflecting response-shift effects, respectively. DIF analyses examined 24 items from scales with at least two items. Recalibration response shift was operationalized as uniform DIF over time, reflecting the idea that, for a given group, the difficulty of endorsing an item changes over time, after adjusting for the total subscale score. Reprioritization response shift was operationalized as non-uniform DIF over time, i.e., the relative difficulty of endorsing an item over time changes across the total domain score.

RESULTS: Across PNH risk-factor levels, people who had been on either treatment for 26 weeks reported better-than-expected functioning and lower symptom burden compared to GenPop. Ravulizumab generally showed larger effect sizes. Results were similar for lower and higher PNH risk factors, with slightly stronger effects in the former. DIF analyses revealed no treatment DIF, but did uncover group DIF (9 items with uniform DIF, and 11 with non-uniform) and DIF over time (7 items with uniform DIF, and 3 with non-uniform).

CONCLUSIONS: This study revealed that people with PNH on ravulizumab or eculizumab for 26 weeks reported QOL levels better than those of the general population. Significant effects of DIF by group and DIF over time support recalibration and reprioritization response-shift effects. These findings suggest that the treatments enabled adaptive changes.

PMID:34526067 | DOI:10.1186/s13023-021-02016-8

Trials. 2021 Sep 15;22(1):626. doi: 10.1186/s13063-021-05590-1.

ABSTRACT

BACKGROUND AND AIM: Some parallel-group cluster-randomized trials use covariate-constrained rather than simple randomization. This is done to increase the chance of balancing the groups on cluster- and patient-level baseline characteristics. This study assessed how well two covariate-constrained randomization methods balanced baseline characteristics compared with simple randomization.

METHODS: We conducted a mock 3-year cluster-randomized trial, with no active intervention, that started April 1, 2014, and ended March 31, 2017. We included a total of 11,832 patients from 72 hemodialysis centers (clusters) in Ontario, Canada. We randomly allocated the 72 clusters into two groups in a 1:1 ratio on a single date using individual- and cluster-level data available until April 1, 2013. Initially, we generated 1000 allocation schemes using simple randomization. Then, as an alternative, we performed covariate-constrained randomization based on historical data from these centers. In one analysis, we restricted on a set of 11 individual-level prognostic variables; in the other, we restricted on principal components generated using 29 baseline historical variables. We created 300,000 different allocations for the covariate-constrained randomizations, and we restricted our analysis to the 30,000 best allocations based on the smallest sum of the penalized standardized differences. We then randomly sampled 1000 schemes from the 30,000 best allocations. We summarized our results with each randomization approach as the median (25th and 75th percentile) number of balanced baseline characteristics. There were 156 baseline characteristics, and a variable was balanced when the between-group standardized difference was ≤ 10%.

RESULTS: The three randomization techniques had at least 125 of 156 balanced baseline characteristics in 90% of sampled allocations. The median number of balanced baseline characteristics using simple randomization was 147 (142, 150). The corresponding value for covariate-constrained randomization using 11 prognostic characteristics was 149 (146, 151), while for principal components, the value was 150 (147, 151).

CONCLUSION: In this setting with 72 clusters, constraining the randomization using historical information achieved better balance on baseline characteristics compared with simple randomization; however, the magnitude of benefit was modest.

PMID:34526092 | DOI:10.1186/s13063-021-05590-1

Reprod Health. 2021 Sep 15;18(1):183. doi: 10.1186/s12978-021-01228-2.

ABSTRACT

BACKGROUND: Obstetric fistula occurs in all developing countries but it is confined to the “fistula belt” across the northern half of Sub-Saharan Africa from Mauritania to Eritrea and in the developing countries of the Middle East and Asia. Ending obstetric fistula is critical to achieving Sustainable Development by 2030. So creating awareness on obstetrics fistula among women in the reproductive age group have a crucial role in reducing morbidity, mortality, and social stigma.

OBJECTIVE: To assess awareness on obstetric fistula and its associated factors among reproductive-age women attending governmental hospitals in southwest Ethiopia, 2021.

METHODS: An Institutional based cross-sectional study design was conducted among 413 women. The sample size was estimated by using a single population proportion formula. The collected data were coded and entered into EPI-data version 3.1 then exported to SPSS version 24 for descriptive and inferential analysis. Adjusted odds ratio (AOR) along with 95% confidence level was estimated to assess the strength of the association and variables with a p-value < 0.05 were considered to declare the statistical significance in the multivariable analysis in this study.

RESULTS: In this study, a total of 400 clients have participated in the study. The mean ages of participants were 30.26 (SD ± 8.525) years old. Education of women who cannot read and write are 85% less likely to have good awareness than women who are above the secondary level of education [AOR = 0.162; 95% CI (0.081-0.364)]. While Women who have primary education level are 83% less likely to have good awareness than women who are above the secondary level of education [AOR = 0.170; 95% CI (0.085-0.446)]. In addition, This study shows women who have not heard about obstetric complications are 54% less likely to have awareness of obstetric fistula than those who heard about obstetric complications [AOR = 0.458; 95% CI (0.368-0.643)].

CONCLUSION: This study identifies that the educational level of women, history of pregnancy, distance to the nearby health institution, and awareness of obstetrics complications were the factors associated with awareness of reproductive age women on obstetrics fistula. Hence, increasing awareness on obstetric fistula plays a key role in averting this problem.

PMID:34526056 | DOI:10.1186/s12978-021-01228-2

J Neuroinflammation. 2021 Sep 15;18(1):200. doi: 10.1186/s12974-021-02245-5.

ABSTRACT

BACKGROUND: Treatment-resistant depression (TRD) and pain frequently coexist clinically. Ketamine has analgesic and antidepressant effects, but few studies have evaluated individual differences in antidepressant outcomes to repeated ketamine in TRD patients with comorbid pain. Our aims were to determine the difference in ketamine’s antidepressant effects in TRD patients with or without pain and then to examine whether inflammatory cytokines might contribute to ketamine’s effect.

METHODS: Sixty-six patients with TRD received six infusions of ketamine. Plasma levels of 19 inflammatory cytokines were assessed at baseline and post-infusion (day 13 and day 26) using the Luminex assay. Plasma inflammatory cytokines of sixty healthy controls (HCs) were also examined.

RESULTS: TRD patients with pain had a higher antidepressant response rate (χ² = 4.062, P = 0.044) and remission rate (χ² = 4.062, P = 0.044) than patients without pain. Before ketamine treatment, GM-CSF and IL-6 levels were higher in the pain group than in the non-pain and HC groups. In the pain group, levels of TNF-α and IL-6 at day 13 and GM-CSF, fractalkine, IFN-γ, IL-10, MIP-3α, IL-12P70, IL-17α, IL-1β, IL-2, IL-4, IL-23, IL-5, IL-6, IL-7, MIP-1β, and TNF-α at day 26 were lower than those at baseline; in the non-pain group, TNF-α levels at day 13 and day 26 were lower than those at baseline. In the pain group, the changes of IL-6 were associated with improvement in pain intensity (β = 0.333, P = 0.001) and depressive symptoms (β = 0.478, P = 0.005) at day 13. Path analysis showed the direct (β = 2.995, P = 0.028) and indirect (β = 0.867, P = 0.042) effects of changes of IL-6 on improvement in depressive symptoms both were statistically significant.

CONCLUSION: This study suggested that an elevated inflammatory response plays a critical role in individual differences in TRD patients with or without pain. Ketamine showed great antidepressant and analgesic effects in TRD patients with pain, which may be related to its effects on modulating inflammation.

TRIAL REGISTRATION: ChiCTR , ChiCTR-OOC-17012239. Registered on 26 May 2017.

PMID:34526064 | DOI:10.1186/s12974-021-02245-5

J Orthop Surg Res. 2021 Sep 15;16(1):558. doi: 10.1186/s13018-021-02695-w.

ABSTRACT

PURPOSE: The aim of this study was to investigate the effect of clozapine use on bone tissue by applying computerized tomography, dual-energy X-ray absorptiometry, and histological and biomechanical analyses in an experimental rat model.

METHODS: Sixteen female Wistar Albino rats were included in this study. These animals were divided into two groups: the control group and the clozapine group. The animals in the clozapine group received 10 mg/kg clozapine, and the animals in the control group received tap water by oral gavage daily for 28 days. After sacrification, the femurs of the rats were used for radiologic, histologic, dual-energy X-ray absorptiometry, and biomechanical evaluations.

RESULTS: Although the mean values of the clozapine group were higher in terms of histological, bone mineral density, and biomechanical evaluations, the statistical analyses were not significantly different.

CONCLUSION: Clozapine use did not affect bone density in the rats. Clozapine can be the preferred treatment for patients with schizophrenia to avoid osteoporosis. It will be necessary to conduct further long-term follow-up and controlled studies in animals and humans to confirm these findings.

PMID:34526046 | DOI:10.1186/s13018-021-02695-w

Head Face Med. 2021 Sep 15;17(1):41. doi: 10.1186/s13005-021-00290-2.

ABSTRACT

BACKGROUND: Orbital decompression surgery is frequently the last therapeutic measure in the surgical treatment of endocrine orbitopathy (EO). Additional rehabilitative and corrective surgical treatments are often used to improve the resulting eyelid stigmata, such as an increased lid aperture and scleral show. The aim of the study was to evaluate the effect of adjunctive surgical procedures after orbital decompression surgery in patients with EO.

METHODS: A total of 120 orbitae from 65 patients with EO from 2010 to 2020 at a tertiary care center in Germany were retrospectively evaluated. Ocular surface area (OSA) and vertical palpebral fissures were three-dimensionally analyzed at the following stages: presurgical decompression, postsurgical decompression, and post-adjunctive surgical procedures. For the analysis of vertical palpebral fissures, predefined vertical line distances were measured on the upper and lower lids in the central, medial, and lateral pupillary regions.

RESULTS: The initial OSA was 2,98 ± 0.85 cm², and it decreased significantly after decompression surgery to 2.52 ± 0.62 cm². After adjunct surgical procedures, OSA further decreased to 2,31 ± 0,55 cm². Furthermore, a statistically significant reduction in all pupillary parameters was noted after each treatment step. More lid-lengthening procedures were performed on the lower lid than on the upper lid. Canthoplasty (n = 13) was the most frequently performed procedure during rehabilitation.

CONCLUSION: Surgical decompression surgery improves OSA and leads to a significant reduction in lid aperture. Adjunctive surgical procedures, addressing the upper and lower lid, have a significant influence on the ongoing clinical course and contribute to a reduction in OSA.

PMID:34526052 | DOI:10.1186/s13005-021-00290-2