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Nevin Manimala Statistics

Assessing Performance and Clinical Usefulness in Prediction Models With Survival Outcomes: Practical Guidance for Cox Proportional Hazards Models

Ann Intern Med. 2022 Dec 27. doi: 10.7326/M22-0844. Online ahead of print.

ABSTRACT

Risk prediction models need thorough validation to assess their performance. Validation of models for survival outcomes poses challenges due to the censoring of observations and the varying time horizon at which predictions can be made. This article describes measures to evaluate predictions and the potential improvement in decision making from survival models based on Cox proportional hazards regression. As a motivating case study, the authors consider the prediction of the composite outcome of recurrence or death (the “event”) in patients with breast cancer after surgery. They developed a simple Cox regression model with 3 predictors, as in the Nottingham Prognostic Index, in 2982 women (1275 events over 5 years of follow-up) and externally validated this model in 686 women (285 events over 5 years). Improvement in performance was assessed after the addition of progesterone receptor as a prognostic biomarker. The model predictions can be evaluated across the full range of observed follow-up times or for the event occurring by the end of a fixed time horizon of interest. The authors first discuss recommended statistical measures that evaluate model performance in terms of discrimination, calibration, or overall performance. Further, they evaluate the potential clinical utility of the model to support clinical decision making according to a net benefit measure. They provide SAS and R code to illustrate internal and external validation. The authors recommend the proposed set of performance measures for transparent reporting of the validity of predictions from survival models.

PMID:36571841 | DOI:10.7326/M22-0844

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Nevin Manimala Statistics

Influence of scan technology on the accuracy and speed of intraoral scanning systems for the edentulous maxilla: an in vitro study

J Prosthodont. 2022 Dec 26. doi: 10.1111/jopr.13633. Online ahead of print.

ABSTRACT

PURPOSE: To compare the accuracy of three intraoral scanners (IOSs) in terms of trueness and precision relative to the scanner acquisition technology and scan capture mode. Scan speed of each scanner was also evaluated.

MATERIALS AND METHODS: An edentulous maxillary arch was digitized (reference model) and 3D-printed using an SLA-based 3D-printer (XFAB; DWS, Italy) (n = 10). Each model was scanned using three intraoral scanners, each with different scan technology: Confocal (Trios 3; 3Shape, Copenhagen, Denmark), Parallel confocal (iTero; Align Technology) and Triangulation (Medit i700). Scan time and scanning accuracy (trueness and precision) were calculated using digital subtraction technique (Geomagic Control X v2020, 3DSystems, USA). One way analysis of variance (ANOVA) test was used to detect differences in trueness, precision and scanning time between the tested groups (P < .05).

RESULTS: ANOVA results showed statistically significant differences in trueness, precision, and scan time among the tested groups. Confocal scanning technique (Trios 3) showed the highest trueness and precision (RMSE 0.094, 0.096 respectively) followed by iTero displaying parallel confocal technique (RMSE 0.113, 0.133 respectively), the difference was not significant (P = 0.849, P = 0.488). Further, Trios showed the longest scanning time (100 seconds) compared to iTero and Medit i700 (P = 0.011, 0.002 respectively). Medit i700 presenting triangulation scan technology revealed lowest trueness and precision (RMSE 0.268) (P = 0.000, P = 001) and fastest scan time (59 seconds) close to iTero (66 seconds) (P = 0.802).

CONCLUSIONS: Scanner technology had an influence on the accuracy and scan speed of the acquired intraoral scans. The Trios 3 scanner featuring the confocal acquisition technology displayed the highest trueness, precision, and longest scan time. Medit i700 IOS with triangulation acquisition concept featured the lowest trueness, precision, and fastest scan speed. There is no ideal scanner with the best combination of accuracy and scan speed. This article is protected by copyright. All rights reserved.

PMID:36571837 | DOI:10.1111/jopr.13633

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Nevin Manimala Statistics

Effects of Cold Therapy on Pain and Anxiety During Needle Removal From Implanted Ports

J Infus Nurs. 2023 Jan-Feb 01;46(1):36-42. doi: 10.1097/NAN.0000000000000495.

ABSTRACT

This study was conducted as a quasiexperimental, single-blind study to examine the effect of cold therapy on pain and anxiety during port needle removal. Patients in the experimental group received cold therapy 10 minutes before port needle removal. Patients in the control group received no intervention before port needle removal. Data were collected using the visual analog scale (VAS) and State-Trait Anxiety Inventory (STAI). After cold therapy was applied to the patients in the experimental group, the second and third VAS scores were found to be statistically significant and lower than those in the control group (P < .05). There was no statistically significant difference between the anxiety levels of the experimental group and the control group before cold therapy (P> .005). However, the STAI scores of the experimental group were found to be statistically and significantly lower than those of the control group after cold therapy (P < .05). This study determined that cold therapy before port needle removal reduces pain and anxiety. Cold therapy may be recommended as an effective nonpharmacological pain control method with ease of application to prevent pain induced by port needle removal.

PMID:36571826 | DOI:10.1097/NAN.0000000000000495

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Nevin Manimala Statistics

Excess deaths from Alzheimer’s disease and Parkinson’s disease during the COVID-19 pandemic in the USA

Age Ageing. 2022 Dec 5;51(12):afac277. doi: 10.1093/ageing/afac277.

ABSTRACT

BACKGROUND: COVID-19 pandemic has indirect impacts on patients with chronic medical conditions, which may increase mortality risks for various non-COVID-19 causes. This study updates excess death statistics for Alzheimer’s disease (AD) and Parkinson’s disease (PD) up to 2022 and evaluates their demographic and spatial disparities in the USA.

METHODS: This is an ecological time-series analysis of AD and PD mortality in the USA from January 2018 to March 2022. Poisson log-linear regressions were utilised to fit the weekly death data. Excess deaths were calculated with the difference between the observed and expected deaths under a counterfactual scenario of pandemic absence.

RESULTS: From March 2020 to March 2022, we observed 41,115 and 10,328 excess deaths for AD and PD, respectively. The largest percentage increases in excess AD and PD deaths were found in the initial pandemic wave. For people aged ≥85 years, excess mortalities of AD and PD (per million persons) were 3946.0 (95% confidence interval [CI]: 2954.3, 4892.3) and 624.3 (95% CI: 369.4, 862.5), which were about 23 and 9 times higher than those aged 55-84 years, respectively. Females had a three-time higher excess mortality of AD than males (182.6 vs. 67.7 per million persons). The non-Hispanic Black people experienced larger increases in AD or PD deaths (excess percentage: 31.8% for AD and 34.6% for PD) than the non-Hispanic White population (17.1% for AD and 14.7% for PD).

CONCLUSION: Under the continuing threats of COVID-19, efforts should be made to optimise health care capacity for patients with AD and PD.

PMID:36571781 | DOI:10.1093/ageing/afac277

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Nevin Manimala Statistics

Efficacy of a premedication with melatonin during cataract surgery under peribulbar block: a prospective randomized double-blinded study

Tunis Med. 2022 Octobre;100(10):713-718.

ABSTRACT

INTRODUCTION: Cataract is a ubiquitous pathology. Its prevalence increases with age. Nowadays, cataract surgery is increasingly performed on an outpatient basis under locoregional anesthesia. In this context, sedation-analgesia is essential but not without risks.

AIM: To evaluate the effectiveness of premedication with melatonin on intraoperative sedation-analgesia.

METHODS: This is a prospective randomized double-blind study including patients proposed for scheduled cataract surgery by phacoemulsification under peribulbar anesthetic block. The participants will be randomized into two groups: group (M) will receive 05 tablets of melatonin (10mg sublingual) and group (P) will receive 05 tablets of Sucralose sublingually. Perioperative sedation-analgesia will be evaluated by the Ramsey score, the bisectral index, the simple verbal scale (EVS) and by the perioperative consumption of midazolam and alfentanyl. Secondary endpoints will be the degree of preoperative anxiety (Amsterdam Preoperative, Anxiety and Information Scale), the perioperative tonus of the eyeball, intraoperative nicardepine consumption and patients and surgeons satisfaction. A value of p <0.05 will be considered statistically significant.

EXPECTED RESULTS: The administration of melatonin as a premedication for scheduled cataract surgery will allow a better quality of intraoperative sedationanalgesia, a reduction in the doses consumed of midazolam and alfentanyl, improves surgical conditions, leads to a decrease in ocular tone, and optimizes surgical safety conditions for the patient.

PMID:36571756

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Ultrasound guidance versus anatomical landmarks for subclavian vein catheterization: a prospective study

Tunis Med. 2022 juillet;100(7):520-524.

ABSTRACT

BACKGROUND: Several clinical practice guidelines strongly support the use of ultrasound guidance (USG) for internal jugular vein catheterization. The level of evidence concerning the use of USG for subclavian vein (SCV) cannulation remains low.

AIM: To compare the effectiveness and safety of USG and anatomical landmarks approaches for cannulation of SCV.

METHODS: This was a prospective randomized study. Patients aged over 18 years old who requiring elective central venous catheterization were included. Non-inclusion criteria were thrombosis of the vein or major coagulopathy. All catheterizations were performed by two anaesthesiology residents. Patients were randomized into two groups: ultrasound guidance group (US group) and anatomical landmarks (LM group). The main outcome was the success rate. The secondary outcomes were the first attempt success rate and the incidence of complications.

RESULTS: Seventy patients were included (35 in each group). The success rate was higher in US group compared to LM group without statistical significance (100% vs 85.7%; p=0.054). The first attempt success rate was significantly higher in the US group (82.9% vs. 40%; p <10-3). The incidence of mechanical complications was significantly lower in the US group compared to LM group (5.7% vs. 37.1%; p=0,001).

CONCLUSION: according to our study, US guidance for SCV catheterization seems to be an interesting alternative to anatomical landmarks approaches.

PMID:36571740

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Nevin Manimala Statistics

Reproductive Risk Estimation Calculator for Balanced Translocation Carriers

Curr Protoc. 2022 Dec;2(12):e633. doi: 10.1002/cpz1.633.

ABSTRACT

Balanced translocation carriers experience elevated reproductive risks, including pregnancy loss and children with anomalies due to generating chromosomally unbalanced gametes. While understanding the likelihood of producing unbalanced conceptuses is critical for individuals to make reproductive decisions, risk estimates are difficult to obtain as most balanced translocations are unique. To improve reproductive risk estimates, Drs. Trunca and Mendell created models based on a logistic regression analysis of a dataset of over 6000 individuals from over 1000 translocation families. While risk assessments using these models have been offered as a free service for years, this protocol aims to create a sustainable model for genetics professionals to obtain risk estimates for their patients directly. This protocol guides the user through collecting clinical information, using a risk-generating Java program based on the models, and interpreting the program outputs. A practice tutorial is provided to ensure competency in interpretation prior to use. © 2022 Wiley Periodicals LLC. Basic Protocol 1: Estimation of reproductive risks for balanced translocation carriers Basic Protocol 2: Practical examples of typical patient encounters with instructive interpretations.

PMID:36571718 | DOI:10.1002/cpz1.633

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Nevin Manimala Statistics

AARC score determines outcomes in patients with alcohol-associated hepatitis: a multinational study

Hepatol Int. 2022 Dec 26. doi: 10.1007/s12072-022-10463-z. Online ahead of print.

ABSTRACT

BACKGROUND AND AIM: Acute-on-chronic liver failure (ACLF) is a severe form of alcoholic hepatitis (SAH). We aimed to study the natural course, response to corticosteroids (CS), and the role of the Asian Pacific Association for the Study of Liver (APASL) research consortium (AARC) score in determining clinical outcomes in AH patients.

METHODS: Prospectively collected data from the AARC database were analyzed.

RESULTS: Of the 1249 AH patients, (aged 43.8 ± 10.6 years, 96.9% male, AARC score 9.2 ± 1.9), 38.8% died on a 90 day follow-up. Of these, 150 (12.0%) had mild-moderate AH (MAH), 65 (5.2%) had SAH and 1034 (82.8%) had ACLF. Two hundred and eleven (16.9%) patients received CS, of which 101 (47.87%) were steroid responders by day 7 of Lille’s model, which was associated with improved survival [Hazard ratio (HR) 0.15, 95% CI 0.12-0.19]. AARC-ACLF grade 3 [OR 0.28, 0.14-0.55] was an independent predictor of steroid non-response and mortality [HR 3.29, 2.63-4.11]. Complications increased with degree of liver failure [AARC grade III vs. II vs I], bacterial infections [48.6% vs. 37% vs. 34.7%; p < 0.001); extrahepatic organ failure [66.9% vs. 41.8% vs. 35.4%; p < 0.001] respectively. The AARC score better discriminated 90-day mortality. Harrell’s C-index was 0.72 compared to other scores.

CONCLUSION: Nearly 4 of 5 patients with AH present with ACLF. Such patients have a higher risk of infections, organ failures, lower response to CS, and higher mortality. Patients with AH and ACLF with AARC grade 3 should be considered for an early liver transplant.

PMID:36571711 | DOI:10.1007/s12072-022-10463-z

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Risk stratification by sex and menopausal status in the multivariable apnea prediction index

Sleep Breath. 2022 Dec 26. doi: 10.1007/s11325-022-02766-0. Online ahead of print.

ABSTRACT

STUDY OBJECTIVES: To determine the sensitivity of the Multivariable Apnea Prediction (MAP) index for obstructive sleep apnea (OSA) in pre- and post-menopausal women with the goal of developing a tailored scoring classification approach.

METHODS: Data from two studies (N = 386); the diabetes sleep treatment trial (N = 236) and EMPOWER (N = 150) were used to assess the sensitivity and specificity of the MAP index by comparing men (n = 129) to women (n = 257), and premenopausal (n = 100) to post-menopausal women (n = 136). We evaluated participants at two cut points, apnea-hypopnea index (AHI) values of ≥ 5 and ≥ 10, using 0.5 as a predicted probability cut point to establish baseline sensitivity and specificity. Contingency tables and receiver operating characteristic (ROC) analysis were conducted to evaluate the accuracy of the MAP index in predicting OSA in men versus women, and in pre-versus post-menopausal women. To select optimal predicted probabilities for classification by sex and menopausal status, Youden’s J statistic was generated from ROC coordinates.

RESULTS: The MAP index was more sensitive to women in the AHI ≥ 5 group (76%) compared to AHI ≥ 10 group (30%). Among post-menopausal women with AHI ≥ 5, sensitivity was similar to men (98%), but less than men when AHI ≥ 10 (32%). Suggested probability cut points for women with an AHI ≥ 10 are 0.24 overall; 0.15 for premenopausal, and 0.38 for postmenopausal women.

CONCLUSIONS: Because women’s risk for OSA (AHI ≥ 10) was underestimated by the MAP index, we suggest the use of tailored cut points based on sex and menopausal status or assessing for OSA risk with an AHI of ≥ 5.

PMID:36571709 | DOI:10.1007/s11325-022-02766-0

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Effect of finerenone on cardiovascular events in kidney disease and/or diabetes: a meta analysis of randomized control trials

Int Urol Nephrol. 2022 Dec 26. doi: 10.1007/s11255-022-03432-w. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the effect of finerenone on cardiovascular events in Kidney Disease and/or Diabetes.

METHODS: The ClinicalTrials.gov, Medline, EMBASE, Web of Science, Cochrane Library databases were systematically searched from the inception dates to December 20, 2021 in order to identify randomized controlled trials that evaluated the effect of finerenone on cardiovascular events in Kidney Disease and/or Diabetes, without language restriction. This meta-analysis collected data from 7 randomized clinical trials that evaluated the effect of finrrenone in 15,618 patients with kidney disease and/or diabetes. Risk of bias was assessed by Cochrane Risk of Bias Assessment Tool. Inconsistency among trial results was assessed by I2 statistic. The main endpoints included death from cardiovascular causes, death from any cause, incidence of myocardial infarction, rate of heart failure, hospitalization for any cause, rate of total advent events and study-drug-related adverse events.

RESULTS: A total of 7 randomized controlled trials involving 15,618 fulfilled the inclusion criteria. The outcomes of this meta-analysis presented that finerenone significantly reduced the death from any cause (95% CI 0.82-0.99; P = 0.031), risk of heart failure (95% CI 0.67-0.92; P = 0.002) among patients with kidney disease and/or diabetes when compared to control group. Besides, finerenone could not reduce the incidence of death from cardiovascular, myocardial infarction and hospitalization for any cause among patients with kidney disease and/or diabetes (p > 0.05). In terms of safety, finerenone shared the same risk of total advent events with placebo among patients with kidney disease and/or diabetes (p > 0.05). However, finerenone had higher risk of study-drug-related advent events than placebo among patients with kidney disease and/or diabetes (95% CI 1.27-1.48; P < 0.001).

CONCLUSIONS: In patients with kidney disease and/or diabetes, treatment with finerenone resulted in lower risk of death from any cause and heart failure than placebo. However, the study-drug-related advent events also increased significantly at the same time.

PMID:36571667 | DOI:10.1007/s11255-022-03432-w