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Nevin Manimala Statistics

AHA STEROID TRIAL, Dexamethasone in Acute High-risk Abdominal surgery, protocol for a randomized controlled trial

Acta Anaesthesiol Scand. 2022 Feb 6. doi: 10.1111/aas.14040. Online ahead of print.

ABSTRACT

INTRODUCTION: Existing multimodal pathways for patients undergoing acute high-risk abdominal surgery for intestinal obstruction (IO) and perforated viscus (PV) has focused on rescue in the immediate perioperative period. However, there is little focus on the peri-operative pathophysiology of recovery in this patient group, as done to develop enhanced recovery pathways in elective care. Acute inflammation is a main driver of the perioperative pathophysiology leading to adverse outcomes. Pre-operative high-dose glucocorticoids provide reduction in the inflammatory response after surgery, effective pain relief in several major surgical procedures, as well as reducing fatigue and improving endothelial dysfunction.

AIM: To evaluate the effect of high-dose glucocorticoid on inflammatory response, fluid distribution and recovery after acute high-risk abdominal surgery in patients with IO and PV.

METHODS: AHA STEROID trial is a sponsor-initiated single center, randomized, double-blind placebo-controlled trial, assessing preoperative high-dose Dexamethasone (1mg/kg) versus placebo (normal saline) in patients undergoing emergency high-risk abdominal surgery. We plan to enroll 120 patients. Primary outcome is reduction in C-reactive protein on postoperative day one as a marker of successful attenuation of acute stress response. Secondary outcomes include perioperative change in endothelial and other inflammatory markers, fluid distribution, pulmonary function, pain, fatigue, and mobilization. The statistical plan is outlined in the protocol.

DISCUSSION: The AHA STEROID trial will provide important evidence to guide the potential use of high-dose glucocorticoids in emergency high-risk abdominal surgery, with respect to different pathophysiologies.

PMID:35124808 | DOI:10.1111/aas.14040

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Nevin Manimala Statistics

Intermodality differences in statistical learning: phylogenetic and ontogenetic influences

Ann N Y Acad Sci. 2022 Feb 5. doi: 10.1111/nyas.14749. Online ahead of print.

ABSTRACT

In Basque-Spanish bilinguals, statistical learning (SL) in the visual modality was more efficient on nonlinguistic than linguistic input; in the auditory modality, we found the reverse pattern of results. We hypothesize that SL was shaped for processing nonlinguistic environmental stimuli and only later, as the language faculty emerged, recycled for speech processing. This led to further adaptive changes in the neurocognitive mechanisms underlying speech processing, including SL. By contrast, as a recent cultural innovation, written language has not yet led to adaptations. The current study investigated whether such phylogenetic influences on SL can be modulated by ontogenetic influences on a shorter timescale, over the course of individual development. We explored how SL is modulated by the ambient linguistic environment. We found that SL in the auditory modality can be further modulated by exposure to a bilingual environment, in which speakers need to process a wider range of diverse speech cues. This effect was observed only on linguistic, not nonlinguistic, material. We conclude that ontogenetic factors modulate the efficiency of already existing SL ability, honing it for specific types of input, by providing new targets for selection via exposure to different cues in the sensory input.

PMID:35124815 | DOI:10.1111/nyas.14749

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Nevin Manimala Statistics

Effect of sleep hygiene training given to elderly individuals on daytime sleepiness and fatigue: A randomized controlled trial

Perspect Psychiatr Care. 2022 Feb 5. doi: 10.1111/ppc.13043. Online ahead of print.

ABSTRACT

PURPOSE: This study was conducted to determine the effect of sleep hygiene training given to elderly individuals on daytime sleepiness and fatigue.

DESIGN AND METHODS: The sample size was calculated by G. Power and determined as 134 elderly individuals. The experimental group was trained in sleep, two sessions a week for a total of 2 weeks.

FINDINGS: The difference between Epworth Sleepiness Scale and Fatigue Severity Scale posttest mean scores of the elderly individuals in the experimental and control groups were found to be statistically significant (p < 0.05).

PRACTICE IMPLICATIONS: Sleep hygiene training reduced daytime sleepiness and fatigue in older adults.

PMID:35124807 | DOI:10.1111/ppc.13043

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Nevin Manimala Statistics

Estimation of the Under-Reporting of Suspected Serious Adverse Drug Reactions in Japan Using An Interrupted Time Series Analysis

Ther Innov Regul Sci. 2022 Feb 5. doi: 10.1007/s43441-022-00379-z. Online ahead of print.

ABSTRACT

OBJECTIVE: Spontaneous reports of adverse drug reactions (ADRs) are an essential data source for pharmacovigilance activities. However, spontaneous reporting is affected by under-reporting, which can lead to bias in statistical signal detection and failure to identify potential drug-associated risks. This study aimed to estimate the degree of under-reporting of suspected serious ADRs (sADRs) in spontaneous reports in Japan.

METHODS: The new active ingredients approved in Japan between 2010 and 2016 for which all-case surveillance was conducted were selected for this study. Data of sADR reports were extracted from the Japanese Adverse Drug Event Report database (JADER). An interrupted time series (ITS) analysis was conducted to compare the number of sADR reports (sADR cases) obtained in the all-case surveillance period with that obtained in the spontaneous report period (after all-case surveillance had been completed).

RESULTS: The ITS analysis of all sADR cases revealed that 24 (68.6%) of the 35 investigated drugs showed a statistically significant decrease in the intercept (level) in the spontaneous reporting period compared with that in the all-case surveillance period. The median of the reduction rate of the level was 60.1%. The number of drugs with a statistically significant decrease in the level of cases with sADRs in the Important Medical Event list and in that leading to death was 19/35(54.3%) and 6/35 (17.1%), respectively.

CONCLUSION: This study demonstrated the existence of sADR under-reporting in spontaneous reports in Japan quantitatively. Meanwhile, it was suggested that information on sADRs was reported appropriately according to their level of severity.

PMID:35124790 | DOI:10.1007/s43441-022-00379-z

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Nevin Manimala Statistics

Interdependencies of cellular and humoral immune responses in heterologous and homologous SARS-CoV-2 vaccination

Allergy. 2022 Feb 6. doi: 10.1111/all.15247. Online ahead of print.

ABSTRACT

BACKGROUND: Homologous and heterologous SARS-CoV-2 vaccinations yield different spike protein-directed humoral and cellular immune responses. This study aimed to explore their currently unknown interdependencies.

METHODS: COV-ADAPT is a prospective, observational cohort study of 417 healthcare workers who received vaccination with homologous ChAdOx1 nCoV-19, homologous BNT162b2 or with heterologous ChAdOx1 nCoV-19/BNT162b2. We assessed humoral (anti-spike-RBD-IgG, neutralizing antibodies, avidity) and cellular (spike-induced T cell interferon-γ release) immune responses in blood samples up to 2 weeks before (T1) and 2 to 12 weeks following secondary immunization (T2).

RESULTS: Initial vaccination with ChAdOx1 nCoV-19 resulted in lower anti-spike-RBD-IgG compared to BNT162b2 (70±114 vs. 226±279 BAU/ml, p<0.01) at T1. Booster vaccination with BNT162b2 proved superior to ChAdOx1 nCoV-19 at T2 (anti-spike-RBD-IgG: ChAdOx1 nCoV-19/BNT162b2 2387±1627 and homologous BNT162b2 3202±2184 vs. homologous ChAdOx1 nCoV-19 413±461 BAU/ml, both p<0.001; spike-induced T cell interferon-γ release: ChAdOx1 nCoV-19/BNT162b2 5069±6733 and homologous BNT162b2 4880±7570 vs. homologous ChAdOx1 nCoV-19 1152±2243 mIU/ml, both p<0.001). No significant differences were detected between BNT162b2-boostered groups at T2. For ChAdOx1 nCoV-19, no booster effect on T cell activation could be observed. We found associations between anti-spike-RBD-IgG levels (ChAdOx1 nCoV-19/BNT162b2 and homologous BNT162b2) and T cell responses (homologous ChAdOx1 nCoV-19 and ChAdOx1 nCoV-19/BNT162b2) from T1 to T2. Additionally, anti-spike-RBD-IgG and T cell response were linked at both time points (all groups combined). All regimes yielded neutralizing antibodies and increased antibody avidity at T2.

CONCLUSIONS: Interdependencies between humoral and cellular immune responses differ between common SARS-CoV-2 vaccination regimes. T cell activation is unlikely to compensate for poor humoral responses.

PMID:35124800 | DOI:10.1111/all.15247

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Nevin Manimala Statistics

Evaluation of the Fall Protection of Type I Industrial Helmets

Ann Biomed Eng. 2022 Feb 5. doi: 10.1007/s10439-022-02922-3. Online ahead of print.

ABSTRACT

The performance of Type I industrial helmets for fall protection is not required to be tested in standardized tests. The current study analyzed the fall protection performance of Type I industrial helmets and evaluated if the use of a chin strap and the suspension system tightness have any effect on protection performance. Head impact tests were performed using an instrumented manikin. There were 12 combinations of test conditions: with or without chin strap usage, three levels of suspension system tightness, and two impact surfaces. Four representative helmet models (two basic and two advanced models) were selected for the study. Impact tests without a helmet under all other applicable test conditions were used as a control group. There were four replicates for each test condition-a total of 192 impact tests with helmets and eight impact tests for the control group. The peak acceleration and the calculated head impact criteria (HIC) were used to evaluate shock absorption performance of the helmets. The results showed that all four helmet models demonstrated excellent performance for fall protection compared to the barehead control group. The fall protection performance of the advanced helmet models was substantially better than the basic helmet models. However, the effects of the use of chin straps and suspension system tightness on the helmets’ fall protection performance were statistically not significant.

PMID:35124769 | DOI:10.1007/s10439-022-02922-3

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Nevin Manimala Statistics

No-cutting remodelling intra-pharyngeal surgery can avoid CPAP in selected OSA patients: myth or reality?

Eur Arch Otorhinolaryngol. 2022 Feb 6. doi: 10.1007/s00405-022-07261-6. Online ahead of print.

ABSTRACT

INTRODUCTION: Oropharyngeal surgery for Obstructive Sleep Apnea (OSA) has evolved from a radical excision of “redundant” soft tissue for the enlargment of the airway to a minimally invasive reconstruction to fulfill both preservation of pharyngeal function and improvement of sleep apnea. Recently, Alianza surgical technique has been successfully introduced as a new, non-resective procedure aimed to treat concentric pharyngeal collapse at the velum using Barbed Sutures. The aim of this study was to show the effectiveness and safety of Alianza technique as standalone surgical treatment in selected patients with moderate-severe OSA and concentric pharyngeal collapse that refused or did not tolerate Continuous Positive Airway Pressure therapy.

MATERIALS AND METHODS: Effectiveness of the surgical procedure was assessed by means of the Epworth Sleepiness Scale (ESS), Home Sleep Test, and a 0-10 snoring VAS.

RESULTS: At the end of our selection process, 26 patients were enrolled, with a mean age of 52.7 ± 9.2 years, that undergone Alianza tecnique. There was a statistically significant reduction in mean post-operative apnea-hypopnea indexes (34.1 ± 11.5-16.3 ± 10.3; p <0.01), mean oxygen desaturation index (29.0 ± 14.5-13.1 ± 9.2; p < 0.01), and mean ESS scores (12.1 ± 5.8 and 5.8 ± 4.4; p < 0.01).There was also a significant decrease in mean post-operative snoring VAS scores (7.85 ± 1.23 vs 3.2 ± 1.7, p < 0.01). There were no major complications.

CONCLUSIONS: Our preliminary results suggest that Alianza technique is a safe and repeatable surgery. Further studies on a larger scale are needed to confirm these encouraging data supporting the role of Alianza alone or in OSA multilevel surgery in selected OSA patients.

PMID:35124744 | DOI:10.1007/s00405-022-07261-6

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Nevin Manimala Statistics

Differential impact of telehealth extended-care programs for weight-loss maintenance in African American versus white adults

J Behav Med. 2022 Feb 5. doi: 10.1007/s10865-022-00291-9. Online ahead of print.

ABSTRACT

Extended-care interventions have been demonstrated to improve maintenance of weight loss after the end of initial obesity treatment; however, it is unclear whether these programs are similarly effective for African American versus White participants. The current study examined differences in effectiveness of individual versus group telephone-based extended-care on weight regain, compared to educational control, in 410 African American (n = 82) and White (n = 328) adults with obesity (mean ± SD age = 55.6 ± 10.3 years, BMI = 36.4 ± 3.7 kg/m2). After controlling for initial weight loss, multivariate linear models demonstrated a significant interaction between treatment condition and race, p = .048. Randomization to the individual telephone condition produced the least amount of weight regain in White participants, while the group condition produced the least amount of weight regain in African American participants. Future research should investigate the role of social support in regain for African American versus White participants and examine whether tailoring delivery format by race may improve long-term outcomes.

PMID:35124742 | DOI:10.1007/s10865-022-00291-9

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Nevin Manimala Statistics

Age-stratified outcomes after radical prostatectomy in a randomized setting (LAP-01): do younger patients have more to lose?

World J Urol. 2022 Feb 6. doi: 10.1007/s00345-022-03945-0. Online ahead of print.

ABSTRACT

OBJECTIVE: Age is known to have an impact on outcomes after radical prostatectomy (RP). However, age differences can be investigated from a cross-sectional as well as from a longitudinal perspective. This study combines both perspectives.

MATERIALS AND METHODS: LAP-01 is the first multicenter randomized patient blinded trial comparing outcomes after robotic-assisted and laparoscopic RP. This study stratified the entire population that received nerve-sparing surgery and was potent at baseline by the following ages: ≤ 60 years, 61-65 years, and > 65 years. Potency was assessed using the IIEF-5. The EORTC QLQ-C30 was used for global health perception and the EORTC QLQ-PR25 for urinary symptoms. Continence was assessed by the number of pads used. Longitudinal change was assessed using either validated anchor-based criteria or the 1 or 0.5-standard-deviation criterion. Worsening of continence was measured by increasing numbers of pads.

RESULTS: 310 patients were included into this study. Older patients had a significantly higher risk for worsening of continence at 3 and 6 months (OR 2.21, 95% CI [1.22, 4.02], p = 0.009 and OR 2.00, 95% CI [1.16, 3.46], p = 0.013, respectively); at 12 months, the odds of worsening did not differ significantly between age groups. Potency scores were better in younger patients from a cross-sectional perspective, but longitudinal change did not differ between the age groups. In contrast, global health perception was better in older patients from a cross-sectional perspective and longitudinal decreases were significantly more common among the youngest patients, at 12 months (36.9% vs. 24.4%, p = 0.038).

CONCLUSION: From a cross-sectional perspective, function scores were better in younger patients, but from a longitudinal perspective, age differences were found in continence only. In contrast, global health scores were better in older patients from a cross-sectional and longitudinal perspective.

TRIAL REGISTRATION: The LAP-01 trial was registered with the U.S. National Library of Medicine clinical trial registry (clinicaltrials.gov), NCT number: NCT03682146, and with the German Clinical Trial registry (Deutsches Register Klinischer Studien), DRKS ID number: DRKS00007138.

PMID:35124734 | DOI:10.1007/s00345-022-03945-0

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Nevin Manimala Statistics

Does voluntary health insurance improve health and longevity? Evidence from European OECD countries

Eur J Health Econ. 2022 Feb 6. doi: 10.1007/s10198-022-01439-9. Online ahead of print.

ABSTRACT

The financing structure of the healthcare system and, particularly, the voluntary health insurance (VHI) constituent, has been a vital pillar in improving the overall quality of life. Consequently, this study aims to shed light on the effect of VHI on the population’s health and longevity in a sample of 26 European OECD countries. The methodology employed covers both hierarchical clustering and the novel dynamic panel threshold technique. First, the descriptive cluster analysis unveils a delimitation of the countries into four main groups with respect to a broad set of health status indicators. Second, the estimates show that VHI is a significant determinant of health and longevity. More specifically, we find that the relationship between variables is characterized by a threshold effect, whose estimated value is roughly 6.3% of the total healthcare financing. Also, the heterogeneity analysis unveils consistent differences regarding the impact of VHI on health and longevity for the supplementary and complementary types of VHI. Overall, results are strongly robust, the signs and the significance of the coefficients being preserved in the presence of several additional control factors. From a policy perspective, the study’s findings can be used nationwide to stimulate regulatory policies to encourage the achievement of a satisfactory level of private health insurance.

PMID:35124741 | DOI:10.1007/s10198-022-01439-9