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Nevin Manimala Statistics

Effect of photobiomodulation after non-surgical mechanical debridement on cortisol levels in the peri-implant sulcular fluid among patients with peri-implant mucositis

Photodermatol Photoimmunol Photomed. 2022 Jan 21. doi: 10.1111/phpp.12774. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim was to compare the efficacy of photobiomodulation after non-surgical mechanical debridement (MD) on cortisol levels (CL) in periimplant sulcular fluid (PISF) among patients with peri-implant mucositis.

METHODS: Patients with peri-implant mucositis were encompassed. All patients underwent non-surgical MD with (test-group) and without (control-group) a single application of photobiomodulation. Demographic data was collected and PISF was collected. Peri-implant modified plaque-index (mPI), modified gingival-index (mGI), probing depth and crestal bone loss were measured and CL in PISF were recorded. All clinical parameters and PISF CL were re-assessed at 4-months of follow-up. P<0.05 showed statistical significance.

RESULTS: Seventeen (14males and 3females) and 17 (15males and 2females) patients with peri-implant mucositis were recruited in test- and control-groups. The mean age of patients in the test and control-groups were 46.1 ± 6.5 and 50.2 ± 2.7 years, respectively. At baseline, mPI, mGI, PD and PISF volume and CL in control and test-groups were similar. At follow-up, there was a significant reduction in mPI(P<0.001), mGI(P<0.001), PD(P<0.001) and PISF volume(P<0.001) and CL(P<0.001) in both groups compared with baseline. There was no difference in mPI, mGI, PD and PISF volume and CL in test- and control-groups at follow-up.

CONCLUSION: In short-term, non-surgical MD with photobiomodulation does not offer additional benefits in terms of reducing soft-tissue inflammatory parameters and PISF CL in patients with peri-implant mucositis.

PMID:35064588 | DOI:10.1111/phpp.12774

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Nevin Manimala Statistics

Multiple imputation for longitudinal data using Bayesian lasso imputation model

Stat Med. 2022 Jan 21. doi: 10.1002/sim.9315. Online ahead of print.

ABSTRACT

Multiple imputation is a promising approach to handle missing data and is widely used in analysis of longitudinal clinical studies. A key consideration in the implementation of multiple imputation is to obtain accurate imputed values by specifying an imputation model that incorporates auxiliary variables potentially associated with missing variables. The use of informative auxiliary variables is known to be beneficial to make the missing at random assumption more plausible and help to reduce uncertainty of the imputations; however, it is not straightforward to pre-specify them in many cases. We propose a data-driven specification of the imputation model using Bayesian lasso in the context of longitudinal clinical study, and develop a built-in function of the Bayesian lasso imputation model which is performed within the framework of multiple imputation using chained equations. A simulation study suggested that the Bayesian lasso imputation model worked well in a variety of longitudinal study settings, providing unbiased treatment effect estimates with well-controlled type I error rates and coverage probabilities of the confidence interval; in contrast, ignorance of the informative auxiliary variables led to serious bias and inflation of type I error rate. Moreover, the Bayesian lasso imputation model offered higher statistical powers compared with conventional imputation methods. In our simulation study, the gains in statistical power were remarkable when the sample size was small relative to the number of auxiliary variables. An illustration through a real example also suggested that the Bayesian lasso imputation model could give smaller standard errors of the treatment effect estimate.

PMID:35064581 | DOI:10.1002/sim.9315

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Nevin Manimala Statistics

Consumption of caffeinated and decaffeinated coffee enriched with cocoa and fructo-oligosaccharides among non-diabetic persons: Double blind randomized clinical trial

J Food Biochem. 2022 Jan 21:e14081. doi: 10.1111/jfbc.14081. Online ahead of print.

ABSTRACT

Food industry has been investing in bringing to the market coffee-based drinks enriched in compounds that promise weight loss, which consequently influences diabetes risk. However, there are no clinical trials showing the effects of brewed coffee (with or without caffeine) enriched with bioactive compounds on body fat and glycemic control in healthy individuals. Therefore, we have evaluated the effect of consuming two coffee formulas enriched with cocoa and fructo-oligosaccharides (FOS) on glycemic and anthropometric biomarkers and blood pressure in non-diabetic adults for 10 weeks. In general, we observed that the values of fasting plasma glucose (FPG) (p = .006) and fasting capillary blood glucose (FCBG) (p < .001) had lower values with a tendency to decrease in FCG (p = .003) and FBG (p < .005) in both formulas. We observed statistically significant reductions in waist circumference (WC) (p = .012), arm circumference (AC) (p = .015), and percentage of fat (<0.0001) for all participants. However, we noticed a greater reduction in the caffeinated formula group (-2.92%, p = .005) compared to the decaffeinated formula (-1.62%, p = .008). Consumers of both cocoa and FOS-enriched coffee formulas benefited from reduced FBG, FCG, WC, and body fat percentage. The consumption of caffeinated formula was more effective in reducing the percentage of fat, while the decaffeinated formula was more effective in reducing diastolic blood pressure. PRACTICAL APPLICATIONS: This study provides robust evidence that effects of fortified coffee on non-diabetic people is positive for reduction in blood glucose, body fat and diastolic blood pressure. This study proposes a practical and safe coffee formulation for the consumption of caffeinated and decaffeinated coffee for non-diabetic people.

PMID:35064574 | DOI:10.1111/jfbc.14081

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Nevin Manimala Statistics

Predictors of 1-year drug-related admissions in older multimorbid hospitalized adults

J Am Geriatr Soc. 2022 Jan 22. doi: 10.1111/jgs.17667. Online ahead of print.

ABSTRACT

BACKGROUND: Identifying patients at high risk of drug-related hospital admission (DRA) may help to efficiently target preventive interventions. We developed a score to predict DRAs in older patients with multimorbidity and polypharmacy.

METHODS: We used participants from the multicenter European OPERAM trial (“Optimising PharmacothERapy in the Mutlimorbid Elderly”). We assessed the association between easily identifiable predictors and 1-year DRAs by univariable logistic regression. Variables with p-value< 0.20 were taken forward to backward regression. We retained all variables with p < 0.05 in the model. We assessed the C-statistic, calibration (observed/predicted proportions), and overall accuracy (scaled Brier score, <0.25 indicating a useful model) of the score, and internally validated it by tenfold cross-validation.

RESULTS: Within 1 year, 435/1879 (23.2%) patients (mean age 79.4 years) had a DRA. The score included seven variables: previous hospitalizations, non-elective admission, hypertension, cirrhosis with portal hypertension, chronic kidney disease, diuretic, oral corticosteroid. The C-statistic was 0.64 (95% CI 0.61-0.67). Patients with <1 point had a 12.4% predicted and observed risk of DRA, while those with >3 points had a 40.4% predicted and 38.9% observed risk of DRA. The scaled Brier score was 0.05. Calibration showed an adequate match between predicted and observed proportions.

CONCLUSION: Comorbidities related to drug metabolism, specific medications, non-elective admission, and a history of hospitalization, were associated with a higher risk of DRA. Awareness of these associations and the score we developed may help identify patients most likely to benefit from preventive interventions.

PMID:35064571 | DOI:10.1111/jgs.17667

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Nevin Manimala Statistics

Impact of COVID-19 on hip fracture care in Ireland: findings from the Irish Hip Fracture Database

Eur Geriatr Med. 2022 Jan 22. doi: 10.1007/s41999-021-00600-6. Online ahead of print.

ABSTRACT

PURPOSE: To describe the impact of COVID-19 on hip fracture care during the first 6 months of the pandemic.

METHODS: A secondary analysis of 4385 cases in the Irish Hip Fracture Database from 1st June 2019 to 31st August 2020 was conducted.

RESULTS: Hip fracture admissions decreased by 15% during the study period (p < 0.001). Patient characteristics were largely unchanged as the majority of cases occurred in females over 80 years admitted from home. Adherence to many of the Irish Hip Fracture Standards (IHFS) changed following the COVID-19 pandemic. There was an increase in patients admitted to an orthopaedic ward from Emergency Department (ED) within 4 h from 27 to 36% (p < 0.001). However, the proportion of patients reviewed by a geriatrician reduced from 85% pre-COVID to 80% (p < 0.001). Fewer patients received a bone health assessment [90% from 95% (p < 0.001)] and specialist falls assessment [(82% from 88% (p < 0.001)]. No change was seen in time to surgery or incidence of pressure injuries. There was a significant decrease in length of stay from 18 to 14 days (p < 0.001). There was an increase in patients discharged home during the COVID-19 period and a decrease in patients discharged to rehabilitation, convalescence or nursing home care. There was no statistically significant change in mortality.

CONCLUSION: Healthcare services were widely restructured during the pandemic, which had implications for hip fracture patients. There was a notable change in compliance with the IHFS. Multidisciplinary teams involved in hip fracture care should be preserved throughout any subsequent waves of the pandemic.

PMID:35064562 | DOI:10.1007/s41999-021-00600-6

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Nevin Manimala Statistics

Zero-Inflated Binomial Model for Meta-Analysis and Safety-Signal Detection

Ther Innov Regul Sci. 2022 Jan 22. doi: 10.1007/s43441-021-00353-1. Online ahead of print.

ABSTRACT

BACKGROUND: Meta-analysis of related trials can provide an overall measure of safety-signal accounting for variability across studies. In addition to an overall measure, researchers may often be interested in study-specific measures to assess safety of the product. Likelihood ratio tests (LRT) methods serve this purpose by identifying studies that appear to show a safety concern. In this paper, we present a Bayesian approach. Despite having good statistical properties, the LRT methods may not be suitable for the meta-analysis of randomized controlled trials (RCTs) when there are several studies with zero events in at least one arm.

METHODS: In this article, we describe a Bayesian framework using a Zero-inflated binomial model with spike-and-slab parameterization for the treatment effects. In addition to providing an overall meta-analytic estimate, this method provides posterior probability of a safety-signal for each study.

RESULTS: We illustrate the approach using two published data sets comprising several randomized controlled trials (RCTs) each and compare the model performance for different choices of priors for treatment effect.

DISCUSSION: The proposed Bayesian methodological framework is useful to identify potential signal for single adverse event and to determine overall meta-analytic estimate of the magnitude of the signal. Practitioners may consider this approach as an alternative to the frequentist’s LRT approach discussed in Jung et al. (J Biopharm Stat 31:47-54, 2020) when there are zero events in either the treatment arm or the control arm. In the future, this approach can be further extended to accommodate multiple adverse events.

PMID:35064554 | DOI:10.1007/s43441-021-00353-1

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Nevin Manimala Statistics

Assessing Interpersonal Relationships in Medical Education: the Connection Index

Acad Psychiatry. 2022 Jan 22. doi: 10.1007/s40596-021-01574-0. Online ahead of print.

ABSTRACT

OBJECTIVE: The relationship between a resident physician and his/her supervising attending is foundational to graduate medical education and may impact the clinical learning environment and resident well-being. This paper focuses on how to measure connection between a resident and their clinical supervisor. Connection includes the subdomains of psychological safety, empathy, educational alliance, and feedback.

METHODS: After reviewing the literature, the authors designed the 12-item, 7-point Connection Index (CI12) to quantitatively measure connections between a resident and his/her supervisor during a 6-month period (supervision dyad), and based on educational alliance, empathy, psychological safety, and effective feedback. A 9-criteria evaluation framework was applied to assess its reliability and validity on a sample of psychiatry residents at a residency program, July 2016 through June 2018.

RESULTS: Out of a total possible number of 50 residents, 100% participated to rate 41 supervisors over 201 supervision dyads; the CI12 satisfied all eight of the eight testable criteria, including high scalability (H = 0.78), consistency (alpha = 0.98), test-retest validity (ICC = 0.95), and construct validity where CI12 was found to have statistically significant correlations with outcomes measures (greater connection was associated with less negative emotional experiences, less mistreatment or bias, less burnout, and higher attendance to supervision sessions).

CONCLUSION: The authors showed the CI12 can be a valid and reliable instrument to quantify whether a resident and his/her supervisor connects during a 6-month supervision with respect to empathy, psychological safety, educational alliance, and feedback. We recommend assessing connections as part of the overall evaluation of a resident’s experience with the clinical learning environment.

PMID:35064549 | DOI:10.1007/s40596-021-01574-0

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Nevin Manimala Statistics

Effect of Cliothosa aurivilli on Paclitaxel-induced Peripheral Neuropathy in Experimental Animals

Mol Neurobiol. 2022 Jan 22. doi: 10.1007/s12035-021-02685-3. Online ahead of print.

ABSTRACT

Chemotherapy-induced peripheral neuropathy (CIPN) is a serious complication leading to painful episodes of parasthesia and numbness in hands and feet. The present drugs that have been used for symptomatic treatment yield inconclusive results in trials and assorted side effects. Thus, there is a pressing demand for development of therapeutically efficacious strategy to combat CIPN. The present study investigates about the effect of a marine sponge; Cliothosa aurivilli (CA) on paclitaxel (PT)-induced peripheral neuropathy in mice. Peripheral neuropathy was induced by intoxication with chemotherapeutic drug PT (2 mg/kg; i.p.) for 5 days consequently. Subsequent treatment with aqueous extract of CA (100 and 200 mg/kg) and standard drug methylcobalamin (MCA) (5 mg/kg) was done and results compared statistically. Neuropathic pain sensations were assessed using various behavioural and locomotory models and evaluated on 0th, 7th and 14th days. Kinovea software was used for video path-tracking of animals and total distance travelled calculated. The results indicated clear signs of improvement post 10 days of PT intoxication in CA-treated groups when compared PT challenged group. A significant reduction in pain behaviours in mechanical allodynia, cold chemical allodynia and thermal hyperalgesia models, improvement in sensory motor coordination, locomotor activity, and distance travelled in closed field model reveals that CA possesses potential ameliorating effect against PT-induced neuropathic pain symptoms. The extract notably improved the movement of the PT challenged animals which was shown by the video path-tracking software and total distance travelled by those animals.

PMID:35064539 | DOI:10.1007/s12035-021-02685-3

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Nevin Manimala Statistics

A systematic review of magnetic versus conventional ureteric stents for short term ureteric stenting

Ir J Med Sci. 2022 Jan 22. doi: 10.1007/s11845-022-02920-3. Online ahead of print.

ABSTRACT

Ureteric stents play an essential role in urology. However, patients can suffer a range of stent-related symptoms with stent in situ and during removal. Conventional ureteric stents are removed using a flexible cystoscopy, whereas magnetic stents may be rapidly removed with a smaller catheter-like retrieval device. The primary aim of this systematic review was to compare the morbidity including pain associated with conventional versus magnetic ureteric stents. The secondary aim was cost comparison. Searches were performed across databases, including Medline, Scopus, Embase and Cochrane. This review was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The search from the 5 databases returned a total of 358 articles. After duplicates were removed as well as the inclusion and exclusion criteria applied, a total of 6 studies were included in the final review. Ureteric Stent Symptoms Questionnaire (USSQ) and Visual Analogue Score (VAS) were used in most of the studies. All the studies reported that magnetic ureteric stents resulted in a reduction in the pain on the removal of magnetic ureteric stents, and no statistically significant difference with indwelling ureteric stents. Furthermore, majority of the studies reported a reduction in the cost associated with magnetic ureteric stents. There is no significant difference in pain from indwelling ureteric stents. There is a reduction in pain with the removal of magnetic ureteric stents compared to conventional removal via cystoscopy and an associated reduction in cost.

PMID:35064536 | DOI:10.1007/s11845-022-02920-3

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Nevin Manimala Statistics

Application of Parametric Shared Frailty Models to Analyze Time-to-Death of Gastric Cancer Patients

J Gastrointest Cancer. 2022 Jan 22. doi: 10.1007/s12029-021-00775-y. Online ahead of print.

ABSTRACT

BACKGROUND: Despite its declining incidence, gastric cancer (GC) is one of the world’s leading malignancies and a major global health concern due to its high prevalence and fatality rate. Furthermore, it is the world’s fourth most common cancer and the second leading cause of cancer death. Studying the determinants of time to death of gastric cancer patients will give clinicians more information to develop specific treatment plans, forecast prognosis, and track the progress of death cases. The application of the frailty model can help account for random variation in survival that may exist due to unobserved factors, as well as show the impact of latent factors on death risk. As a result, the purpose of this study was to assess the determinants of time to death of GC patients’ by applying the parametric shared frailty models.

METHODS: The data for this study were obtained from gastric cancer patients admitted to the Tikur Anbesa Specialized Hospital, Addis Ababa, from January 1, 2015, to February 29, 2020. With the aim of coming up with an appropriate survival model that determines factors that affect the time to death of gastric cancer patients, various parametric shared frailty models were compared. In all of the frailty models, patient regions were used as a clustering variable. The current study implemented exponential, Weibull, log-logistic, and lognormal distributions for baseline hazard functions with gamma and inverse Gaussian’s frailty distributions. The performance of all models was compared using the AIC and BIC criteria. R statistical software was used to conduct the analysis.

RESULTS: A retrospective study was undertaken on a total of 407 gastric cancer patients under follow-up at Tikur Anbesa Specialized Hospital. Of all 407 GC patients, 56.3% died while the remaining 43.7% were censored. The patients’ median time to death was 21.9 months, with a maximum survival time of 49.6 months. In the current study, the clustering effect was significant in modeling the time to death from gastric cancer. The Weibull model with inverse Gaussian frailty has the minimum AIC and BIC value among the candidate models compared. The dependency within the clusters for the Weibull-inverse Gaussian frailty model was [Formula: see text] (13.4%). According to the results of our best model (Weibull-inverse Gaussian), the sex of the patient, the smoking status, the tumor size, the treatment taken, the vascular invasion, and the disease stage was found to be statistically significant at an alpha = 0.05 significance level.

CONCLUSION: Time to death of GC patient’s data set was well described by the Weibull-inverse Gaussian shared frailty. Furthermore, Weibull baseline distribution best fits the GC data set as it enables proportional hazard and accelerated failure time model, for time to failure data. There is unobserved heterogeneity between clusters (patient regions), indicating the need to account for this clustering effect. In this study, survival time to death among GC patients was discovered to be small. Covariates like older age, being male, having higher (advanced) stage of GC disease (stage three and stage four), advanced tumor size, being smoker, infected by Helicobacter pylori, and existence of vascular invasion significantly accelerate the time to death of GC patients. In contrast, talking combination of more treatments prolongs the time to death of patients. To improve the health of patients, interventions should be taken based on significant prognostic factors, with special attention dedicated to patients with such factors to prevent GC death.

PMID:35064523 | DOI:10.1007/s12029-021-00775-y