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Nevin Manimala Statistics

Comparison of the Newborn Infant Parasympathetic Evaluation (NIPETM ) index to changes in heart rate to detect intraoperative nociceptive stimuli in healthy and critically ill children below 2 years: An observational study

Paediatr Anaesth. 2022 Mar 24. doi: 10.1111/pan.14446. Online ahead of print.

ABSTRACT

BACKGROUND: The validity of current tools for intraoperative objective assessment of nociception/antinociception balance during anesthesia in young and very young surgery children is unknown.

AIM: Primary aim of the study was to test the hypothesis that the Newborn Infant Parasympathetic Evaluation (NIPE) index performs better in indicating nociception in anesthetized children below 2 years than changes in heart rate. Secondary aims were to evaluate associations between intraoperative changes in NIPE index values and postoperative pain and emergence delirium.

METHODS: Fifty-one children aged <2 years who underwent surgery were included in this prospective observational study. Patients were assigned to either group 1 (healthy children, n = 31) or group 2 (critically ill, ventilated premature infants and neonates, n = 20). The NIPE index and heart rate in response to three defined nociceptive stimuli were continuously recorded. Two different scales, Kindliche Unbehagens- und Schmerzskala (KUS) and Pediatric Anesthesia Emergence Delirium (PAED) as well as a Pain Questionnaire were used to assess postoperative pain levels and emergence delirium.

RESULTS: In total, 110 nociceptive events were evaluated. The analysis revealed a statistically significant association between a decrease in the NIPE index and all nociceptive stimuli, with a sensitivity of 92 % and a specificity of 96 %. The mean percentage decrease ranged from approx. 15 % to 30 % and was highly statistically significant in both groups and for each of the nociceptive events except for venous puncture (p = 0.004). In contrast, no consistent change in heart rate was demonstrated. The KUS and PAED scale scores were significantly associated with the duration of anesthesia (p = 0.04), but not with intraoperative NIPE depression.

CONCLUSION: The NIPE index was reliable for assessing intraoperative nociception in children aged <2 years and was more reproducible for detecting specific nociceptive stimuli during general anesthesia than heart rate. An effect on postoperative outcome is still elusive.

PMID:35332622 | DOI:10.1111/pan.14446

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Nevin Manimala Statistics

Endodontic pulp revitalization in traumatized necrotic immature permanent incisors: Early failures and long-term outcomes – a longitudinal cohort study

Int Endod J. 2022 Mar 25. doi: 10.1111/iej.13735. Online ahead of print.

ABSTRACT

AIM: This prospective cohort study evaluates clinical and radiographical outcomes of endodontic pulp revitalization (PR) of traumatized necrotic incisors.

METHODOLOGY: PR was performed in 75 traumatized necrotic immature incisors from 71 patients. The radiographic outcome measures were continued root formation (width and length), root resorption, apex closure, periapical index, and root development stage. The clinical outcome measures were percussion pain, palpation pain, pathological tooth mobility, swelling, sinus tract, ankylosis, crown discolouration, response to pulp sensitivity test, and subjective pain. Treatment outcomes were categorized as a success based on absence of clinical symptoms and when radiographic evidence was present for apical healing and continued root development. The performed statistical tests were repeated measures ANOVA, pairwise comparisons of interactions (t-test), McNemar’s test and linear regression model.

RESULTS: In 45 of 75 teeth (60%), PR was successful with resolution of clinical and radiographic signs and continued root development. PR failed due to absence of bleeding (n=19) and persistent infection (n=11). PR showed statistically significant increases in root length (11%), and dentinal wall thickness (30%), root maturation (pre-operative 3.38 [CI 1.88; 4.88]; post-operative 4.04, [CI 2.56; 5.52]) apical closure (71.4%), healing of pre-operative apical periodontitis (100%), and healing of pre-operative inflammatory root resorptions (100%). Three predictive variables for continued root maturation were identified – root development stage at entry (P=0.0001, β 0.649), [CI 0.431; 0.867], trauma to the soft tissues (P=0.026, β -0.012), [CI -0.0225; -0.015] and pre-operative dentinal wall thickness (P=0.009, β -0.001); [CI -0.001; 0.0001].

CONCLUSION: Our findings indicate that PR provides satisfactory clinical and radiographical outcomes in traumatized necrotic incisors. The failed cases were related to lack of bleeding and persistent infections, indicating that new techniques are needed to improve the predictability of PR.

PMID:35332566 | DOI:10.1111/iej.13735

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Nevin Manimala Statistics

A systematic review on the impact of pharmacist-provided services on patients’ health outcomes in Arab countries

J Clin Pharm Ther. 2022 Mar 24. doi: 10.1111/jcpt.13633. Online ahead of print.

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: The pharmacist’s role has evolved dramatically over the last few decades and shows considerable impact globally. The aim of this systematic review was to describe the nature and extent of studies evaluating the impact of pharmacist-provided services on clinical, humanistic and economic outcomes in different healthcare settings across the Arab world.

METHODS: A systematic literature search was conducted using the following databases from their inception until June 2020: Cochrane, Embase, MEDLINE, PubMed, ScienceDirect and Scopus. Reporting was done according to PRISMA guidelines, and the quality assessment utilized the Mixed Methods Appraisal Tool.

RESULTS AND DISCUSSION: Thirty-five eligible studies were included in this review, the majority of which were randomized controlled trials (RCT) (n = 26) conducted in hospital settings (n = 26). Most of the studies involved patients with specific medical conditions (n = 29) and pharmacist’s interventions involved mainly medication therapy management (n = 32), counselling and education (n = 29), and medication therapy recommendations (n = 12). Several studies showed a positive impact (i.e., a statistically and/or clinically significant difference in favour of pharmacist-provided care or intervention) of pharmacist-provided services on clinical (n = 28), humanistic (n = 6) and economic (n = 5) outcomes. Conversely, five studies showed neutral or mixed effect of pharmacist interventions on clinical and humanistic outcomes.

WHAT IS NEW AND CONCLUSION: The findings of this systematic review demonstrate a positive impact of pharmacist-provided services on clinical, humanistic and economic outcomes across diverse settings in the Arab world. Most of the included studies evaluated clinical outcomes and were from hospital setting. Directed approaches are needed to advance pharmacy practice across various healthcare settings in the Arab world.

PMID:35332557 | DOI:10.1111/jcpt.13633

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Nevin Manimala Statistics

Marginal, conditional, and pseudo likelihood ratio approaches for biomarker combination to predict a binary disease outcome

Stat Med. 2022 Mar 24. doi: 10.1002/sim.9371. Online ahead of print.

ABSTRACT

It is a common practice in public health research that multiple biomarkers are collected to diagnose or predict a disease outcome. A natural question is how to combine multiple biomarkers to improve the diagnostic accuracy. It has been shown by Neyman-Pearson lemma that the likelihood ratio statistic achieves the optimal AUC in theory. However, practical difficulty often lies in the estimation of the multivariate density functions. We propose three novel methods for the biomarker combination, with the idea of breaking down the joint densities to a series of univariate densities. The marginal likelihood ratio approach only assumes the marginal distribution of each biomarker. While the conditional likelihood ratio (CLR) and pseudo likelihood ratio (PLR) approaches assume the conditional distributions of a marker given others, and hence make use of the correlation structure to estimate the combination rules. The proposed methods make it much easier to assume and validate the univariate distributions of a biomarker than making multivariate distributional assumptions. Extensive simulation studies demonstrate that the CLR and the PLR approaches outperform many existing methods, and are therefore recommended for practical use. The proposed methods are motivated by and applied to a biomarker study to diagnose childhood autism/autism spectrum disorder.

PMID:35332560 | DOI:10.1002/sim.9371

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Nevin Manimala Statistics

Pharmacokinetic characteristics of danofloxacin in green sea (Chelonia mydas) and hawksbill sea (Eretmochelys imbricata) turtles

J Vet Pharmacol Ther. 2022 Mar 24. doi: 10.1111/jvp.13054. Online ahead of print.

ABSTRACT

To date, the number of green sea and hawksbill sea turtles is in decline due to environmental, anthropogenic, and pathological factors. The present study described the pharmacokinetic characteristics of danofloxacin (DNX) in green sea and hawksbill sea turtles, following single intravenous (i.v.) and intramuscular (i.m.) administrations at single dosages of 6 mg/kg body weight (b.w.). Blood samples were collected at assigned times up to 168 h. DNX in the harvested plasma was cleaned up using liquid-liquid extraction and analyzed using a validated high-performance liquid chromatography method with fluorescence detection. The pharmacokinetic analysis was performed using a non-compartmental approach. DNX was quantifiable from 5 min to 168 h after i.v. and i.m. administrations at an identical dosage in both turtle types. No statistical differences were found in the pharmacokinetic parameters between green sea and hawksbill sea turtles. The long elimination half-life value of DNX obtained in green sea (35 h) and hawksbill sea (30.21 h) turtles was consistent with the quite large volume of distribution and the slow clearance rate. The high values of absolute bioavailability (87%-94%) should be advantageous for clinical use of DNX in sea turtles. According to the pharmacokinetic-pharmacodynamic surrogate (AUC0-24 /MIC > 125), DNX is predicted to have antibacterial success for disease caused by bacteria with MIC < 0.04 µg/ml.

PMID:35332549 | DOI:10.1111/jvp.13054

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Nevin Manimala Statistics

Predictive accuracy of admission cardiotocography as a screening tool for perinatal asphyxia in high risk parturients, in Northern Nigeria

Int J Gynaecol Obstet. 2022 Mar 25. doi: 10.1002/ijgo.14191. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine the predictive accuracy of admission cardiotocography as a screening test for perinatal asphyxia in high-risk parturients.

METHODS: A prospective study was done on a group of 180 high-risk parturients in the labor ward of Aminu Kano teaching Hospital were subjected to a 30-minute admission cardiotocography. Results were categorized based on the RCOG criteria. Those with normal results were allowed to progress in labor, while those with abnormal results had their delivery expedited. Umbilical artery blood gas analysis was done at delivery. Measured variables were expressed in descriptive statistics. Tests of association for categorical variables were done using the non-parametric chi-square test (p-value of ≤ 0.05). The Binary logistic regression model was used to control potential confounders.

RESULTS: After excluding five cord blood samples, 175 samples were analyzed. The CTG was reassuring in 149 (85.1%), non-reassuring in 15 (8.6%) and abnormal in 11 (6.3%) women. Fetal distress developed in 5 (3.4%) and 7 (46.7%) of reassuring and non-reassuring respectively. The test had 91% sensitivity, specificity was 68.8%, and the predictive accuracy was 88.6% for asphyxia using base deficit.

CONCLUSION: The admission CTG is useful in detecting fetuses at risk of perinatal asphyxia in high- risk deliveries.

PMID:35332538 | DOI:10.1002/ijgo.14191

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Nevin Manimala Statistics

The effect of tele-yoga training in healthy women on menstrual symptoms, quality of life, anxiety-depression level, body awareness, and self-esteem during COVID-19 pandemic

Ir J Med Sci. 2022 Mar 24. doi: 10.1007/s11845-022-02985-0. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: This study was planned to examine the effects of tele-yoga training on menstrual symptoms, quality of life, anxiety-depression level, body awareness, and self-esteem in healthy women.

METHODS: Thirty-two healthy premenopausal women between the ages of 18 and 45 were included in the study. The women were randomly divided into two groups as tele-yoga training (n: 16) and the control group (n: 16). The tele-yoga training was performed on the Zoom software for 6 weeks, 2 times a week and 45 min a day. No intervention was made in the control group. Menstrual pain and symptoms by Menstrual Symptom Scale (MSS), quality of life by Nottingham Health Profile (NHP), depression levels by Beck Depression Scale (BDS), anxiety levels by State and Trait Anxiety Scale (STAI), body awareness by Body Awareness Questionnaire (BAQ), and self-esteem by Rosenberg Self-Esteem Scale (RSES) were determined.

RESULTS: In the tele-yoga training group, statistically significant improvements were observed in the MSS total (p = 0.001), negative effects (p = 0.003), menstrual pain symptoms (p = 0.003), coping methods (p = 0.001) sub-parameters, BDS score (p = 0.000), NHP sleep (p = 0.021), energy (p = 0.002), emotional (p = 0.000), and isolation (p = 0.039) sub-parameters. In the control group, there was statistically significant worsening in the NHP total score (p = 0.000). As regards the differences in values between the two groups, there were statistically difference in favor of the training group in sub-parameters of MSS, NHP sleep, energy, emotional, and isolation sub-parameters, and BDS and BAQ scores (p < 0.05).

CONCLUSION: It is thought that tele-yoga training may be a safe and effective method in reducing menstrual symptoms and depression, increasing quality of life, and body awareness.

PMID:35332504 | DOI:10.1007/s11845-022-02985-0

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Nevin Manimala Statistics

Developing a bi-objective resilience relief logistic considering operational and disruption risks: a post-earthquake case study in Iran

Environ Sci Pollut Res Int. 2022 Mar 25. doi: 10.1007/s11356-022-18699-w. Online ahead of print.

ABSTRACT

Today, according to the occurrence of numerous disasters in allover over the world, designing the proper and comprehensive plan for relief logistics has received a lot of attention from crisis managers and people. Besides, considering resilience capability along with operational and disruption risks leads to the robustness of the humanitarian relief chain (HRC), and this comprehensive framework ensures the essential supplies delivery to the beneficiaries and is close to real-world problems. The resilience parameters used for the second objective are obtained by a strong Best Worst Method (BWM). Another supposition of the model is the consideration of uncertainty in all stages of the proposed problem. Moreover, the multiple disasters (sub-sequent minor post disasters) which can increase the initial demand are considered. Furthermore, the proposed model is solved using three well-known metaheuristic algorithms includes non-dominated sorting genetic algorithm (NSGA-II), network reconfiguration genetic algorithm (NRGA), and multi-objective particle swarm optimization (MOPSO), and their performance is compared by several standard multi-objective measure metrics. Finally, the obtained results show the robustness of the proposed approaches, and some directions for future researches are provided.

PMID:35332457 | DOI:10.1007/s11356-022-18699-w

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Nevin Manimala Statistics

Antibody to hepatitis B virus core antigen positivity is a predictor of non-alcoholic fatty liver disease severity

Intern Emerg Med. 2022 Mar 24. doi: 10.1007/s11739-022-02971-5. Online ahead of print.

ABSTRACT

Insufficient information is available about co-factors favoring the progression of non-alcoholic fatty liver disease (NAFLD) toward cirrhosis. We aimed to evaluate the impact of a limited alcohol intake and of occult hepatitis B virus (HBV) infection (OBI) on the severity of NAFLD. Three-hundred-seventy-four alcohol non-abusers and HBV surface antigen negative NAFLD patients (223 males; mean age 55.4 years), consecutively admitted to the outpatients clinic of a referral liver unit from January 1st, 2018 to December 31st, 2019, were studied. Anti-HBV core antigen antibody [(anti-HBc), a surrogate marker of OBI] was assessed in all patients. Patients were distinguished between teetotal and moderate alcohol consumers (intake of less than 30 g and 20 g if males or females, respectively). Liver fibrosis was non-invasively assessed by FIB-4 and transient elastography. Uni- and multivariate analyses were performed to identify predictors of advanced fibrosis. Patients had a mean BMI of 28.5 kg/m2, and the majority presented metabolic and cardio-vascular comorbidities [258 patients (69%) had insulin resistance/diabetes, 249 (66.6%) dyslipidemia, 200 (53.5%) arterial hypertension]. Multivariate analysis showed that anti-HBc positivity (p = 0.046, OR 2.153) was a factor associated with advanced fibrosis at FIB-4 score testing, whereas moderate alcohol intake was not associated with severe NAFLD both at FIB-4 and transient elastography evaluations. The study showed that a moderate alcohol intake has no impact on NAFLD severity and suggested that OBI might negatively affect the NAFLD outcome.

PMID:35332431 | DOI:10.1007/s11739-022-02971-5

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Nevin Manimala Statistics

Target Trial Emulation for Transparent and Robust Estimation of Treatment Effects for Health Technology Assessment Using Real-World Data: Opportunities and Challenges

Pharmacoeconomics. 2022 Mar 25. doi: 10.1007/s40273-022-01141-x. Online ahead of print.

ABSTRACT

Evidence about the relative effects of new treatments is typically collected in randomised controlled trials (RCTs). In many instances, evidence from RCTs falls short of the needs of health technology assessment (HTA). For example, RCTs may not be able to capture longer-term treatment effects, or include all relevant comparators and outcomes required for HTA purposes. Information routinely collected about patients and the care they receive have been increasingly used to complement RCT evidence on treatment effects. However, such routine (or real-world) data are not collected for research purposes, so investigators have little control over the way patients are selected into the study or allocated to the different treatment groups, introducing biases for example due to selection or confounding. A promising approach to minimise common biases in non-randomised studies that use real-world data (RWD) is to apply design principles from RCTs. This approach, known as ‘target trial emulation’ (TTE), involves (1) developing the protocol with respect to core study design and analysis components of the hypothetical RCT that would answer the question of interest, and (2) applying this protocol to the RWD so that it mimics the data that would have been gathered for the RCT. By making the ‘target trial’ explicit, TTE helps avoid common design flaws and methodological pitfalls in the analysis of non-randomised studies, keeping each step transparent and accessible. It provides a coherent framework that embeds existing analytical methods to minimise confounding and helps identify potential limitations of RWD and the extent to which these affect the HTA decision. This paper provides a broad overview of TTE and discusses the opportunities and challenges of using this approach in HTA. We describe the basic principles of trial emulation, outline some areas where TTE using RWD can help complement RCT evidence in HTA, identify potential barriers to its adoption in the HTA setting and highlight some priorities for future work.

PMID:35332434 | DOI:10.1007/s40273-022-01141-x