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Nevin Manimala Statistics

Is accurate routine cancer prognostication psychologically harmful? 5-year outcomes of life expectancy prognostication in uveal melanoma survivors

J Cancer Surviv. 2021 Apr 19. doi: 10.1007/s11764-021-01036-4. Online ahead of print.

ABSTRACT

PURPOSE: Prognostication in cancer is growing in importance as increasingly accurate tools are developed. Prognostic accuracy intensifies ethical concerns that a poor prognosis could be psychologically harmful to survivors. Uveal melanoma (UM) prognostication allows survivors to be reliably told that life expectancy is either normal (good prognosis) or severely curtailed because of metastatic disease (poor prognosis). Treatment cannot change life expectancy. To identify whether prognosis is associated with psychological harm, we compared harm in UM survivors with good and poor prognoses and those who declined testing and compared these outcomes to general population norms.

METHODS: Non-randomized 5-year study of a consecutive series of 708 UM survivors (51.6% male, mean age 69.03, SD=12.12) with observations at 6, 12, 24, 36, 48 and 60 months. We operationalized psychological harm as anxiety and depression symptoms, worry about cancer recurrence (WREC) and poor quality of life (QoL).

RESULTS: Compared to other groups, survivors with poor prognoses showed initially elevated anxiety and depression and consistently elevated worry about local or distant recurrence over 5 years. Good prognoses were not associated with outcomes. Generally, no prognostic groups reported anxiety, depression and WREC or QoL scores that exceeded general population norms.

CONCLUSIONS: Using a large sample, we found that harm accruing from a poor prognosis was statistically significant over 5 years, but did not exceed general non-cancer population norms.

IMPLICATIONS FOR CANCER SURVIVORS: Survivors desire prognostic information. At a population level, we do not believe that our findings show sufficiently strong links between prognostication outcome and psychological harm to deny patients the option of knowing their prognosis. Nonetheless, it is important that patients are informed of potential adverse psychological consequences of a poor prognosis.

PMID:33871760 | DOI:10.1007/s11764-021-01036-4

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Nevin Manimala Statistics

Geochemical characterization and health risk assessment in two diversified environmental settings (Southern Italy)

Environ Geochem Health. 2021 Apr 19. doi: 10.1007/s10653-021-00930-1. Online ahead of print.

ABSTRACT

An integrated approach using chemical and microbial indicators has been tested in two different sites of the Campania Plain (Southern Italy) with different land use covering and different hydrogeological features in order: (1) to define the water-rock interaction processes, (2) to differentiate sources of pollution in a detailed way (3) to evaluate the degree of water quality in the studied alluvial aquifer and (4) to identify the most worrying elements for human’s health. Groundwater have showed a HCO3-Ca signature for both investigated sites, and a progressive enrichment in alkali ions has been highlighted moving from the boundary of the plain toward the coastal areas, due to groundwater interaction with volcanic rocks along the flow path. The application of the Factor Analysis allowed to identify different sources of pollution, which were attributed to (a) leaks in the sewer system for the Agro-Aversano Area and also the spreading of manure as fertilizers in agricultural activities for the Caiazzo Plain. Furthermore, it has been highlighted that the use of major elements, trace elements and microbiological indicators, allows to accurately differentiate contamination processes in progress. In fact, from the results of the Factor Analysis applied in the Agro-Aversano area, no significant statistically relationships between major elements and microbiological indicators of fecal contamination were highlighted, unlike the Caiazzo plain where statistically significant correlations have been found between major and trace elements and microbiological indicators. The use of a Groundwater Quality Index has shown general poor water quality for the majority of analyzed samples due to the high amount of Nitrate and Fecal indicators. The use of a Health Risk Assessment highlighted that Nitrate coupled with Fluoride represent the most important concern for human health compared to the all investigated parameters in both sites.

PMID:33871745 | DOI:10.1007/s10653-021-00930-1

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Nevin Manimala Statistics

Intrathecal baclofen, selective dorsal rhizotomy, and extracorporeal shockwave therapy for the treatment of spasticity in cerebral palsy: a systematic review

Neurosurg Rev. 2021 Apr 19. doi: 10.1007/s10143-021-01550-0. Online ahead of print.

ABSTRACT

Cerebral palsy (CP) is a chronic congenital disorder as the result of abnormal brain development. Children suffering from CP often battle debilitating chronic spasticity, which has been the focus of recent academic literature. In this systematic review, the authors aim to update the current neuromodulation procedures for the treatment of spasticity associated with CP in all age groups. A systematic review following was conducted using PubMed from inception to 2020. After initial title and abstract screening, 489 articles were identified, and 48 studies met the inclusion criteria for this review. In total, a majority of the published articles of treatments for CP were reporting the use of selective dorsal rhizotomy (SDR) (54%), and the remainder were of intrathecal baclofen (ITB) pumps (29%) and extracorporeal shockwave therapy (ESWT) (17%). Each method was found to have improvement of spasticity at a rate that achieved statistical significance. ITB pump therapy is an all-encompassing method of treating spasticity in children from CP, as it allows for a less invasive treatment that can be titrated to individual patient needs; however, its disadvantages include its long-term maintenance requirements. SDR appears to be an effective method for permanent spasticity relief in young patients. ESWT is a more recent and innovative technique for offering relief of spasticity while being minimally invasiveness. Further studies are needed to establish optimal frequencies and sites of application for ESWT.

PMID:33871733 | DOI:10.1007/s10143-021-01550-0

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Nevin Manimala Statistics

Circulating TNFrII levels predict incidence of ischemic heart disease and total mortality, independently of intima media thickness and pulse wave velocity in male with type 2 diabetes

Heart Vessels. 2021 Apr 19. doi: 10.1007/s00380-021-01857-4. Online ahead of print.

ABSTRACT

New and clinically useful markers of cardiovascular risk are of great importance in patients with type 2 diabetes since cardiovascular disease is a major cause of death in these patients. We analyzed inflammatory markers and other risk factors for heart disease in 761 patients who participated in the CARDIPP-study, Cardiovascular Risk factors in Patients with Diabetes-a Prospective study in Primary care. All participants had type 2 diabetes and were 55-66 years old at recruitment during the years 2005-2008. Patients were followed for incidence of stroke, myocardial infarction, or death from cardiovascular disease until the end of the year 2018 using the national Swedish Cause of Death and Hospitalization Registries. Besides traditional risk-markers for vascular disease, we also measured carotid-femoral pulse-wave velocity and intima-media thickness of carotid arteries. During a median period of 13 years, 165 men and 65 women died or were hospitalized for ischemic heart disease and stroke. TNFrII showed statistically significance as a risk factor for stroke, ischemic heart disease, and total mortality in male patients with diabetes type 2, independently of age, diabetes duration, BMI, Hba1c, systolic blood pressure, triglycerides, IMT and PWV (p = 0.002, HR 2.70, CI 1.42:5.13, p = 0.002). Circulating TNFrII levels failed to present a similar correlation in women (p = 0.48, CI 0.48:4.84). TNFrII stayed significant in males when HDL/LDL-ratio, CRP and smoking were added to the statistical analysis. Our data support the use of serum TNFrII in male type 2 diabetes patients to add independent prognostic information in terms of mortality and heart disease independently of other strong and well-established risk markers including cholesterol, inflammatory cytokines, PWV and IMT.Trial registration: ClinicalTrials.gov NCT01049737.

PMID:33871700 | DOI:10.1007/s00380-021-01857-4

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Early and mid-term results of transcatheter aortic valve implantation and valve durability assessment

Heart Vessels. 2021 Apr 19. doi: 10.1007/s00380-021-01842-x. Online ahead of print.

ABSTRACT

This study aimed to evaluate the early and mid-term outcomes of transcatheter aortic valve implantation (TAVI) and to assess valve durability. A total of 146 consecutive patients who underwent TAVI for severe aortic stenosis between October 2013 and August 2018 were retrospectively reviewed. All patients (mean age, 84 ± 6 years; age range 53-98 years; 42 males [28.7%]) had multiple comorbidities, with a mean logistic EuroSCORE of 30.9 ± 17.4%. Eighteen patients (12.3%) were aged 90 years or over. Five in-hospital deaths (3.4%) occurred, and 36 patients (24.7%) experienced major TAVI-related complications. With the transfemoral approach, 10 patients had major vascular complications, which mostly occurred with first-generation devices (n = 9) but less commonly with new-generation low-profile devices (P = 0.0078). During a follow-up period of 580 ± 450 (11-1738) days, 29 late deaths occurred. The survival rate was 86.0%, 78.0%, and 61.7% at 1, 2, and 3 years, respectively. Multivariate Cox hazard regression analysis revealed that more-than-moderate tricuspid regurgitation was the only independent risk factor for late deaths due to any cause (hazard ratio, 3.145; 95% confidence interval, 1.129-8.762; P = 0.0283). No statistically significant differences between post-TAVI before discharge from the hospital and at 4 years after TAVI were observed with respect to aortic valve area (1.76 ± 0.49 cm2 vs. 1.64 ± 0.38 cm2; P = 0.1871) and mean pressure gradient (10.0 ± 4.6 mmHg vs. 7.9 ± 3.3 mmHg; P = 0.5032). TAVI was a feasible method with acceptable early and mid-term outcomes and valve durability for at least 4 years in poor-risk patients. Further close follow-up is essential to evaluate late outcomes and valve durability.

PMID:33871699 | DOI:10.1007/s00380-021-01842-x

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Nevin Manimala Statistics

Accuracy of Transurethral Resection of the Bladder in Detecting Variant Histology of Bladder Cancer Compared with Radical Cystectomy

Eur Urol Focus. 2021 Apr 15:S2405-4569(21)00111-5. doi: 10.1016/j.euf.2021.04.005. Online ahead of print.

ABSTRACT

BACKGROUND: Correct identification of variant histologies (VHs) of bladder cancer (BCa) at transurethral resection of the bladder (TURB) could drive the subsequent treatment.

OBJECTIVE: To evaluate the concordance in detecting VHs between TURB and radical cystectomy (RC) specimens in BCa patients.

DESIGN, SETTING, AND PARTICIPANTS: We retrospectively analyzed 1881 BCa patients who underwent TURB and subsequent RC at seven tertiary care centers between 1980 and 2018. VHs were classified as sarcomatoid, lymphoepithelioma-like, neuroendocrine, squamous, micropapillary, glandular, adenocarcinoma, nested, and other variants.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Concordance between TURB and RC was defined as the ability to achieve histological subtypes at TURB confirmed at RC specimen, and was expressed according to Cohen’s kappa coefficient.

RESULTS AND LIMITATIONS: Of the patients, 14.6% and 21% were diagnosed with VH at TURB and RC specimens, respectively. The most common VHs at TURB were squamous, neuroendocrine, and micropapillary carcinoma (5.2%, 1.5%, and 1.5%, respectively). At RC, the most frequent VHs were squamous, micropapillary, and sarcomatoid carcinoma (7.2%, 3.0%, and 2.7%, respectively). The overall concordance in detecting VH was defined as slight concordance (coefficient: 0.18). Moderate concordance was found for neuroendocrine, adenocarcinoma, and squamous carcinoma (coefficient: 0.49, 0.47, and 0.41, respectively). Micropapillary, glandular, and other variants showed slight concordance (coefficient: 0.05, 0.17, and 0.12, respectively), while nested and sarcomatoid carcinoma showed fair concordance (coefficient: 0.32 and 0.26, respectively). Results may be limited by the absence of centralized pathological analysis.

CONCLUSIONS: A non-negligible percentage of patients were diagnosed with VH at both TURB and RC. TURB showed relatively low accuracy, ranging from poor to moderate, in detecting VHs. Our study underlines the need of additional diagnostic tools in order to identify VHs properly at precystectomy time and to improve patient survival outcomes.

PATIENT SUMMARY: In this report, we underlined the low accuracy of transurethral resection of the bladder in detecting variant histologies and the need for additional diagnostic tools.

PMID:33867307 | DOI:10.1016/j.euf.2021.04.005

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Nevin Manimala Statistics

Neurophysiological correlates of alcohol-specific inhibition in alcohol use disorder and its association with craving and relapse

Clin Neurophysiol. 2021 Mar 26:S1388-2457(21)00464-8. doi: 10.1016/j.clinph.2021.02.389. Online ahead of print.

ABSTRACT

OBJECTIVE: This study investigates neurophysiological correlates of general and alcohol-specific inhibitory control in patients with Alcohol Use Disorder (AUD), focusing on its association with individual craving levels and with relapse at three-month follow-up.

METHODS: 59 abstinent AUD patients and 20 healthy controls performed a Go/NoGo task incorporating alcohol-related and neutral stimuli during 64-channel electroencephalography (EEG) recording, yielding four event-related potentials (ERP) per participant (NoGo-Alcohol, Go-Alcohol, NoGo-Neutral, Go-Neutral). Whole-scalp randomization-based statistics assessed effects of the factors group (patients/controls or relapsers/abstainers), craving level, response type (NoGo/Go) and picture type (alcohol/neutral) on topography and signal strength of the ERP components N2 and P3.

RESULTS: No differences on group level were observed between patients and controls. However, analyses incorporating individual craving indicated that the topographic difference between alcohol-related and neutral NoGo-N2 components increased with craving. Moreover, topographic differences in the alcohol-related and neutral NoGo-P3 component allowed for differentiation between relapsers and abstainers.

CONCLUSIONS: In alcohol-related contexts, the response inhibition conflict reflected in the NoGo-N2 seems enhanced in patients with high craving. The inhibition-sensitive NoGo-P3 varies in relapsers but not in abstainers between neutral and alcohol-related contexts.

SIGNIFICANCE: In AUD patients, neurophysiological correlates of inhibition vary with alcohol-related contexts and craving, and might be indicative of relapse risk.

PMID:33867254 | DOI:10.1016/j.clinph.2021.02.389

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Nevin Manimala Statistics

Perioperative Peripheral Nerve Block Safety Education: A Quality Improvement Project

J Perianesth Nurs. 2021 Apr 15:S1089-9472(20)30306-3. doi: 10.1016/j.jopan.2020.08.017. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of the quality improvement (QI) project was to improve patient safety by increasing the consistency of monitor application and oxygen administration during the placement of peripheral nerve blocks (PNBs), advance the knowledge of perianesthesia staff about PNB safety, and develop a PNB hospital policy.

DESIGN: QI project using the focus, analyze, develop, and execute model.

METHODS: The project had two parts, an educational component that was deployed in the three hospitals (hospital A, hospital B, hospital C) and an observation component that was conducted in only one of the hospitals (hospital A). Baseline observation of monitor and oxygen application was recorded at hospital A for 3 months. Assessment of perioperative personnel’s baseline knowledge regarding PNB safety was attained using a knowledge assessment tool in the three hospitals. Learners in the three hospitals were given a pretest and post-test to measure the change in knowledge level after a PNB safety presentation was given. Monitor and oxygen application during nerve block placements were observed and recorded after the PNB safety presentation at hospital A. Statistical analysis was completed to determine if significant differences in knowledge levels in the three hospitals and monitor and oxygen application at hospital A existed after an educational intervention was delivered to the perioperative teams.

FINDINGS: Participants’ knowledge level increased 13% overall with post-test scores greater than 90% after the educational intervention. Monitor application and administration of oxygen during PNB placement improved from 2% to 100% in a preliminary 3-week postintervention review. Systematic changes were implemented to facilitate adherence to best practice measures.

CONCLUSIONS: PNB safety presentations significantly improved staff’s knowledge regarding PNB procedures and potential problems. A multidisciplinary team approach was used to facilitate changes to improve electrocardiogram, blood pressure, pulse oximetry, and oxygen use in this patient population. A proposed PNB policy was accepted as a protocol. Patients are safer with increased monitoring.

PMID:33867246 | DOI:10.1016/j.jopan.2020.08.017

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Nevin Manimala Statistics

Cephalometric evaluation of intrusion of maxillary posterior teeth by miniscrews in the treatment of open bite

Am J Orthod Dentofacial Orthop. 2021 Apr 16:S0889-5406(21)00101-3. doi: 10.1016/j.ajodo.2020.11.033. Online ahead of print.

ABSTRACT

INTRODUCTION: The objective of this research was to investigate the effectiveness of orthodontic miniscrews for skeletal anchorage during anterior open bite treatment using cephalometric radiographs.

METHODS: This study sample included 20 patients (mean age, 14.71; standard deviation, 1.77) with an anterior open bite. A total of 250 g of force was applied using elastic chains with anchorage from palatal miniscrew to an occlusal splint covering the posterior maxillary teeth. Cephalograms were obtained at the beginning of the treatment when the appliance was first applied and at the 8-month visit when treatment was completed. Paired t tests were used to identify statistically significant differences between initial and final measurements of skeletal and dental parameters.

RESULTS: A decrease of 2.72 ± 1.90° in the SN-GoGn angle and 3.63 ± 1.87 mm in the anterior height (N-Me) parameter in the cephalometric evaluations indicated a significant improvement of vertically increased facial dimensions, with the intrusion of the maxillary posterior teeth (P <0.05). Anterior rotation of the mandible was determined by a 1.76 ± 1.09° increase in the SNB angle and a 1.86 ± 0.90° decrease in the ANB angle (P <0.05). Reductions in the open bite amount by 5.8 ± 0.90 mm, Mx6-SN by 4.00 ± 1.01 mm, and Mx6-PP by 4.01 ± 1.00 mm were indicative of significant intrusion in the maxillary posterior teeth (P <0.05).

CONCLUSIONS: The present study confirmed that palatal miniscrew and maxillary occlusal splint caused intrusion of the maxillary posterior teeth, a decrease in the anterior open bite, and mandibular advancement, with anterior rotation after the maxillary posterior intrusion. We concluded that the treatment method in our study was appropriate for patients with Class I and mild Class II malocclusions and open bite anomalies.

PMID:33867217 | DOI:10.1016/j.ajodo.2020.11.033

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Using the power law model to predict the long-term persistence and duration of detectable hepatitis A antibody after receipt of hepatitis A vaccine (VAQTA™)

Vaccine. 2021 Apr 15:S0264-410X(21)00345-5. doi: 10.1016/j.vaccine.2021.03.052. Online ahead of print.

ABSTRACT

VAQTA™ (Hepatitis A Vaccine, inactivated [HAVi]; Merck & Co., Inc., Kenilworth, NJ, USA) is currently licensed for prevention of disease caused by hepatitis A virus in persons ≥12 months of age. This report summarizes statistical models developed to evaluate the long-term persistence and duration of detectable hepatitis A antibody (total antibody levels with no distinction on class) after receipt of HAVi in healthy children and adolescents (V251-023 and V251-035) and in healthy adults (V251-034). The statistical models presented, conducted separately for each of the three studies, are based on models that have been used in the literature to estimate the duration of antibody to protect against human papillomavirus (HPV) disease. In the absence of observed study data on hepatitis A antibody persistence for vaccine recipients over several decades, an extrapolation from a kinetic model of antibody decay was used to estimate the duration of detectable antibody. Extrapolation of observed antibody titers from postvaccination, Year 2.5-3.5, Year 5-6, and Year 10 in 165 children and adolescents who received HAVi at Day 0 and Week 24 in V251-023 suggests that detectable levels of antibody may persist after the second dose for many years. This model suggests that 25 to 50 years Postdose 1 in a two-dose series of HAVi, 99.4% of the study population will have detectable levels of hepatitis A antibody.

PMID:33867215 | DOI:10.1016/j.vaccine.2021.03.052