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Nevin Manimala Statistics

How to Prevent Vaccines Falling Victim to Their Own Success: Intertemporal Dependency of Incidence Levels on Indirect Effects in Economic Reevaluations

Value Health. 2021 Oct;24(10):1391-1399. doi: 10.1016/j.jval.2021.03.022. Epub 2021 Jul 30.

ABSTRACT

OBJECTIVES: Incremental cost-effectiveness analyses may inform the optimal choice of healthcare interventions. Nevertheless, for many vaccines, benefits fluctuate with incidence levels over time. Reevaluating a vaccine after it has successfully decreased incidences may eventually cause a disease resurgence if switching to a vaccine with lower indirect benefits. Decisions may successively alternate between vaccines alongside repeated rises and falls in incidence and when indirect effects from historic use are ignored. Our suggested proposal aims to prevent suboptimal decision making.

METHODS: We used a conceptual model of demand to illustrate alternating decisions between vaccines because of time-varying levels of indirect effects. Similar to the concept of subsidies, we propose internalizing the indirect effects achievable with vaccines. In a case study over 60 years, we simulated a hypothetical 10-year reevaluation of 2 oncogenic human papillomavirus vaccines, of which only 1 protects additionally against anogenital warts.

RESULTS: Our case study showed that the vaccine with additional warts protection is initially valued higher than the vaccine without additional warts protection. After 10 years, this differential decreases because of declines in warts incidence, which supports switching to the nonwarts vaccine that causes a warts resurgence eventually. Instead, pricing the indirect effects separately supports continuing with the warts vaccine.

CONCLUSIONS: Ignoring how the observed incidences depend on the indirect effects achieved with a particular vaccine may lead to repeated changes in vaccines at successive reevaluations, with unintended resurgences, economic inefficiencies, and eroding vaccine confidence. We propose internalizing indirect effects to prevent vaccines falling victim to their own success.

PMID:34593161 | DOI:10.1016/j.jval.2021.03.022

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Nevin Manimala Statistics

A Systematic Review of Demand-Side Methods of Estimating the Societal Monetary Value of Health Gain

Value Health. 2021 Oct;24(10):1423-1434. doi: 10.1016/j.jval.2021.05.018. Epub 2021 Aug 6.

ABSTRACT

OBJECTIVES: Although many reviews of the literature on cost-effectiveness thresholds (CETs) exist, the availability of new studies and the absence of a fully comprehensive analysis warrant a new review. This study systematically reviews demand-side methods for estimating the societal monetary value of health gain.

METHODS: Several electronic databases were searched from inception to October 2019. To be included, a study had to be an original article in any language, with a clearly described method for estimating the societal monetary values of health gain and with all estimated values reported. Estimates were converted to US dollars ($), using purchasing power parity (PPP) exchange rates and the gross domestic product (GDP) per capita (2019).

RESULTS: We included 53 studies; 45 used direct approach and 8 used indirect approach. Median estimates from the direct approach were PPP$ 24 942 (range 554-1 301 912) per quality-adjusted life-year (QALY), which were typically 0.53 (range 0.02-24.08) GDP per capita. Median estimates using the indirect approach were PPP$ 310 051 (range 36 402-7 574 870) per QALY, which accounted for 7.87 (range 0.68-116.95) GDP per capita.

CONCLUSIONS: Our review found that the societal values of health gain or CETs were less than GDP per capita. The great variety in methods and estimates suggests that a more standardized and internationally agreed methodology for estimating CET is warranted. Multiple CETs may have a role when QALYs are not equally valued from a societal perspective (eg, QALYs accruing to people near death compared with equivalent QALYs to others).

PMID:34593165 | DOI:10.1016/j.jval.2021.05.018

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Nevin Manimala Statistics

Knee Ablation Approaches

Phys Med Rehabil Clin N Am. 2021 Nov;32(4):779-790. doi: 10.1016/j.pmr.2021.05.012. Epub 2021 Jul 14.

ABSTRACT

Genicular nerve radiofrequency ablation has quickly become one of the most promising interventions for chronic knee pain secondary to osteoarthritis, with consistent improvements in pain and function. Although there are multiple techniques using slightly variable lesion locations, cannulas, lesion types, and imaging modalities, the clinical effectiveness targeting the anterior branches of the superior medial, superolateral, and inferior medial has reproducibly demonstrated clinically and statistically significant improvements up to 24 months after the procedure with minimal adverse events. This article summarizes the current knowledge of the sensory innervation of the knee joint, the principles of radiofrequency ablation, and the current literature on clinical outcomes.

PMID:34593143 | DOI:10.1016/j.pmr.2021.05.012

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Nevin Manimala Statistics

Cardiovascular status of breast cancer patients before and after receiving anthracycline chemotherapy regimen

Nurs Open. 2021 Sep 30. doi: 10.1002/nop2.1059. Online ahead of print.

ABSTRACT

AIM: To explore the effect of TEC chemotherapy regimen (Docetaxel + Epirubicin + Cyclophosphamide) on traditional cardiovascular risk factors, atherosclerotic cardiovascular disease and cardiac electrical activity.

DESIGN: 243 patients with first initially diagnosed breast cancer were collected who receiving TEC chemotherapy.

METHODS: Univariate analysis, multivariate analysis, binary logistic regression analysis and statistical description were used to analyse the data.

RESULTS: Among the first diagnosed patients, prevalence of hypertension and overweight/obesity in postmenopausal patients were significantly higher than premenopausal group. Compared with initially diagnosed state, incidence of hyperlipidaemia increased significantly after TEC chemotherapy, blood glucose level was remarkably increased, and prevalence of hyperuricaemia was significantly increased, changes of blood pressure level and prevalence rate of hypertension were not significant, and there was no statistical difference. Different menopause status showed the same trend. Atherosclerotic cardiovascular disease risk stratification showed after chemotherapy low-risk patients decrease, medium-risk and high-risk people increased. Grouped by menstrual status, after chemotherapy, both groups showed the same trend. The independent influencing factors of increased heart rate after chemotherapy were postmenopausal status. Postmenopausal patients had more cardiovascular risk factors than premenopausal patients. After receiving chemotherapy, levels of cardiovascular risk factors in both groups mostly changed to the direction of disease. Chemotherapy drugs increase the risk of atherosclerotic cardiovascular disease in breast cancer patients. It is necessary to strengthen interdisciplinary cooperation to dynamic assess the cardiovascular health of patients of breast cancer patients.

PMID:34592784 | DOI:10.1002/nop2.1059

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Nevin Manimala Statistics

Is fetal nuchal cord associated with autism spectrum disorder? A meta-analysis

Clin Exp Pediatr. 2021 Sep 24. doi: 10.3345/cep.2021.00514. Online ahead of print.

ABSTRACT

PURPOSE: There is inconsistent evidence about the association between fetal nuchal cord and the risk of autism spectrum disorder (ASD). We performed a meta-analysis to investigate whether fetal nuchal cord is associated with an increased risk of ASD in offspring.

METHODS: Three main English databases were searched until January 2021. The Newcastle-Ottawa Scale was used to assess study quality. Study heterogeneity was determined using the I2 statistic, while publication bias was assessed using Begg’s and Egger’s tests. Results are presented as odds ratios (ORs) and relative ratios with 95% confidence intervals (CI) and were determined by a random-effects model.

RESULTS: Five articles (one cohort, four case-control; 3088 total children) were included in the present meta-analysis. Fetal nuchal cord was not a risk factor for ASD (OR=1.11; 95% CI, 0.66-1.57). There was homogeneity among studies that reported a risk of ASD (I2=0.0%).

CONCLUSION: Our results showed that fetal nuchal cord is not a risk factor for ASD. Future large cohort studies should confirm this finding.

PMID:34592803 | DOI:10.3345/cep.2021.00514

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Nevin Manimala Statistics

Clinical and Molecular Study of the NOG Gene in Families with Mandibular Micrognathism

Eur J Dent. 2021 Sep 30. doi: 10.1055/s-0041-1726162. Online ahead of print.

ABSTRACT

OBJECTIVES: Previous studies showed that noggin gene (NOG) sequence alterations, as well as epigenetic factors, could influence mandibular development. The aim of this study was to analyze clinical characteristics, NOG gene sequences, and promoter methylation sites in patients with mandibular micrognathism.

MATERIALS AND METHODS: A total of 35 individuals of five Colombian families were subject to clinical and cephalometric analysis for mandibular micrognathism. One nonaffected individual of each family was included as a control. DNA was isolated from whole blood sample from all individuals by salting out method. Nine NOG gene fragments were amplified by polymerase chain reaction (PCR) and sequenced. Identification of CpG islands for methylation analysis at the NOG gene promoter was performed by MSP-PCR kit (Qiagen R).

STATISTICAL ANALYSIS: A descriptive statistical analysis was carried out evaluating the presence or absence of genetics variants and the methylation sites in the NOG gene.

RESULTS: NOG sequence results of affected individuals with mandibular micrognathism for one of the families studied demonstrated that they were heterozygous for 672 C/A (new mutation). For a second family, individuals were heterozygous for 567 G/C (single nucleotide polymorphism [SNP] RS116716909). For DNA analyzed from all patients studied, no methylations were observed at the NOG gene promoter region.

CONCLUSION: Our results suggest that 672 C/A and 567 G/C variants could be involved in the presence of mandibular micrognathism. Moreover, lack of methylation sites at the NOG gene promoter region of all individuals studied suggests possibly other epigenetic factors could modulate mandibular growth. The search of genetic variants related with mandibular micrognathism will allow to predict in an integral way the development patterns of the patients and therefore establish a better clinical treatment.

PMID:34592770 | DOI:10.1055/s-0041-1726162

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Nevin Manimala Statistics

Acquired autoimmune Haemophilia following SARS-CoV-2 vaccines: Dual drug effects on blood coagulation and the Scylla and Charybdis phenomenon

Thromb Haemost. 2021 Sep 30. doi: 10.1055/a-1658-4852. Online ahead of print.

ABSTRACT

Vaccination against the SARS-CoV-2 may lead to immunologic reactions activating the haemostatic system and resulting in both venous and arterial thromboembolism. Aquired autoimmune Haemophilia following SARS-CoV-2 vaccines were now reported 15 to 19 days (or later) after vaccination and resolution of symptoms by adequate treatment of the immunologic reaction. From patients’ point of view, anticoagulants and SARS-CoV-2 vaccines share their capacity to induce thrombosis as well as bleeding and clinicians are subjected to Scylla and Charybdis when they treat patients not only with anticoagulants but also with SARS-CoV-2 vaccines. Careful analysis of coincidence and causality requires attention when reporting on acquired coagulation inhibitors regarding severity, treatments, duration and statistical risk.

PMID:34592779 | DOI:10.1055/a-1658-4852

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Nevin Manimala Statistics

Concomitant opioid and benzodiazepine use and risk of suicide attempt and intentional self-harm: Pharmacoepidemiologic study

Drug Alcohol Depend. 2021 Sep 20;228:109046. doi: 10.1016/j.drugalcdep.2021.109046. Online ahead of print.

ABSTRACT

BACKGROUND: Overdose due to concomitant use of opioids and benzodiazepines has been raised as a major public health concern, although little research has examined whether this risk extends to intentional overdose or other self-harm. This study examined whether prescription opioids and benzodiazepines interact to increase the rate of suicide attempt and intentional self-harm.

METHODS: The study analyzed 4762,438 users of opioids, benzodiazepines, both drugs concomitantly, or neither drug from the MarketScan Commercial Claims and Encounters databases (2014-2016). The four groups were matched using inverse probability of treatment weighting and a difference in difference design was used to examine associations with risk of suicide attempt, intentional self-harm and drug overdose, including suicide death resulting in a medical claim.

RESULTS: There was a small association for opioids (HR=1.23; 95% CI 1.06-1.43) but a larger association for benzodiazepines (HR=2.55; 95% CI 2.12-3.05) with suicide attempt, intentional self-harm, and drug overdose. The medication interaction was opposite to the expected direction (HR=0.70; 95% CI 0.55-0.89), indicating that risk associated with concomitant use was lower than would be expected on an additive basis. Sensitivity analyses found no evidence of increased risk due to interaction between the two drug classes.

CONCLUSIONS: Increased risk of suicide attempt, intentional self-harm and drug overdose for concomitant use of opioids and benzodiazepines is in large part attributable to benzodiazepine use alone. In typically prescribed quantities, opioids and benzodiazepines may not represent a drug interaction in terms of yielding increased risk of suicide attempt and intentional self-harm resulting in medical care.

PMID:34592702 | DOI:10.1016/j.drugalcdep.2021.109046

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Nevin Manimala Statistics

Can intubation be improved with endotracheal tubes marked with a color scale? Randomized controlled study

Am J Perinatol. 2021 Sep 30. doi: 10.1055/a-1659-0422. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess if a color scale in the endotracheal tube (ETT) helps operators to correctly select the size and depth of placement of the ETT and decrease the time required, compared with the usual numeric ETT scale, in a mannequin model.

DESIGN/METHODS: The study was conducted in 8 centers. Each size of the ETT was identified with different color by size. All experimental ETT had two painted zones: the mouthpiece and an area of 1 cm marked with the same color (to identify where the ETT should be taped above the lip). The operators were trained as part of the protocol using a video. Four clinical scenarios requiring endotracheal intubation were designed and randomly assigned. Each operator had to select the size and depth of ETT based on the BW, and then had to perform 4 intubation procedures.

RESULTS: 108 operators performed 432 intubations. No difference were found in the correct placement and selection of the ETT. Median time (in seconds) required for intubation using numeric vs. experimental tube was: for ETT Ø 2.5, 11.5 vs. 8 (p<0.001), ETTØ3,12 vs. 10 (p<0.001), ETT Ø 3.5, 15.5 vs.12 (p 0.003), ETT Ø4 12 vs.11 (p 0.019).

CONCLUSIONS: No significant difference was observed in the selection and correct placement of the ETT. However, the intubation time was significantly shorter using the experimental ETT. This device could improve the effectiveness of intubation by reducing the time needed to properly place the ETT at mid trachea.

PMID:34592768 | DOI:10.1055/a-1659-0422

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Nevin Manimala Statistics

Weight average approaches for predicting dynamical properties of biomolecules

Curr Opin Struct Biol. 2021 Sep 27;72:88-94. doi: 10.1016/j.sbi.2021.08.008. Online ahead of print.

ABSTRACT

Recent advances in atomistic molecular dynamics (MD) simulations of biomolecules allow us to explore their conformational spaces widely, observing large-scale conformational fluctuations or transitions between distinct structures. To reproduce or refine experimental data using MD simulations, structure ensembles, which are characterized by multiple structures and their statistical weights on the rugged free-energy landscapes, are often used. Here, we summarize weight average approaches for various experimental measurements. Weight average approaches are now applied to hybrid quantum mechanics/molecular mechanics MD simulations to predict fast vibrational motions in a protein with a high accuracy for better understanding of molecular functions from atomic structures.

PMID:34592697 | DOI:10.1016/j.sbi.2021.08.008