Nevin Manimala

BMC Cancer. 2021 May 7;21(1):512. doi: 10.1186/s12885-021-08026-w.

ABSTRACT

BACKGROUND: Definitive radiation therapy (dRT) is an effective initial treatment of intermediate-risk (IR) and high-risk (HR) prostate cancer (PCa). PSMA PET/CT is superior to standard of care imaging (CT, MRI, bone scan) for detecting regional and distant metastatic PCa. PSMA PET/CT thus has the potential to guide patient selection and the planning for dRT and improve patient outcomes.

METHODS: This is a multicenter randomized phase 3 trial (NCT04457245). We will randomize 312 patients to proceed with standard dRT (control Arm, n = 150), or undergo a PSMA PET/CT scan at the study site (both 18F-DCFPyL and 68Ga-PSMA-11 can be used) prior to dRT planning (intervention arm, n = 162). dRT will be performed at the treating radiation oncologist facility. In the control arm, dRT will be performed as routinely planned. In the intervention arm, the treating radiation oncologist can incorporate PSMA PET/CT findings into the RT planning. Androgen deprivation therapy (ADT) is administered per discretion of the treating radiation oncologist and may be modified as a result of the PSMA PET/CT results. We assume that approximately 8% of subjects randomized to the PSMA PET arm will be found to have M1 disease and thus will be more appropriate candidates for long-term systemic or multimodal therapy, rather than curative intent dRT. PET M1 patients will thus not be included in the primary endpoint analysis. The primary endpoint is the success rate of patients with unfavorable IR and HR PCa after standard dRT versus PSMA PET-based dRT. Secondary Endpoints (whole cohort) include progression free survival (PFS), metastasis-free survival after initiation of RT, overall survival (OS), % of change in initial treatment intent and Safety.

DISCUSSION: This is the first randomized phase 3 prospective trial designed to determine whether PSMA PET/CT molecular imaging can improve outcomes in patients with PCa who receive dRT. In this trial the incorporation of PSMA PET/CT may improve the success rate of curative intent radiotherapy in two ways: to optimize patient selection as a biomarker and to personalizes the radiotherapy plan.

CLINICAL TRIAL REGISTRATION: UCLA IND#147591 ○ Submission: 02.27.2020 ○ Safe-to-proceed letter issued by FDA: 04.01.2020 UCLA IRB #20-000378 ClinicalTrials.gov Identifier NCT04457245 . Date of Registry: 07.07.2020. Essen EudraCT 2020-003526-23.

PMID:33962579 | DOI:10.1186/s12885-021-08026-w

BMC Infect Dis. 2021 May 7;21(1):429. doi: 10.1186/s12879-021-06127-2.

ABSTRACT

BACKGROUND: Hydatidosis is a zoonotic disease and has a great general and economic health importance in both developed and developing countries. Therefore, this systematic and meta-analytic study was conducted to determine the prevalence of cystic echinococcosis in slaughtered livestock in Iran.

METHODS: The present study was conducted as a systematic review and meta-analysis. The SID & Magiran, MEDLINE (PubMed), ScienceDirect, Scopus, and Google Scholar databases were searched with a view to selecting relevant research works. As a result, 31 articles published from April 1970 to April 2020 were selected. The heterogeneity of the studies was assessed using the I² index. Data analysis was conducted within the Comprehensive Meta-Analysis software (CMA) v.3.0 (Biostat, Englewood, NJ, USA) and Arc map (ArcGIS 10.3) software.

RESULTS: The heterogeneity of the studies was evaluated using the I² test which value was 99% showing a high heterogeneity in the studies. The results of publication bias in studies were evaluated by the Egger test, which were not statistically significant (P = 0.144). The overall prevalence of cystic echinococcosis in slaughtered livestock in Iran is 13.9% (95%CI: 10.7-17.7%). The results of the meta-regression analysis indicate the increasing trend of the hydatid cyst prevalence with the increase of sample size and publication year (P < 0.05).

CONCLUSION: According to the results of this study and the relatively high prevalence of cystic echinococcosis in slaughtered livestock in Iran, health policy makers should make effective decisions in this regard, and implement careful inspections and interventions by experts and health authorities.

PMID:33962578 | DOI:10.1186/s12879-021-06127-2

BMC Infect Dis. 2021 May 7;21(1):428. doi: 10.1186/s12879-021-06128-1.

ABSTRACT

BACKGROUND: Since December 2019, the coronavirus disease 2019 (COVID-19) has spread quickly among the population and brought a severe global impact. However, considerable geographical disparities in the distribution of COVID-19 incidence existed among different cities. In this study, we aimed to explore the effect of sociodemographic factors on COVID-19 incidence of 342 cities in China from a geographic perspective.

METHODS: Official surveillance data about the COVID-19 and sociodemographic information in China’s 342 cities were collected. Local geographically weighted Poisson regression (GWPR) model and traditional generalized linear models (GLM) Poisson regression model were compared for optimal analysis.

RESULTS: Compared to that of the GLM Poisson regression model, a significantly lower corrected Akaike Information Criteria (AICc) was reported in the GWPR model (61953.0 in GLM vs. 43218.9 in GWPR). Spatial auto-correlation of residuals was not found in the GWPR model (global Moran’s I = – 0.005, p = 0.468), inferring the capture of the spatial auto-correlation by the GWPR model. Cities with a higher gross domestic product (GDP), limited health resources, and shorter distance to Wuhan, were at a higher risk for COVID-19. Furthermore, with the exception of some southeastern cities, as population density increased, the incidence of COVID-19 decreased.

CONCLUSIONS: There are potential effects of the sociodemographic factors on the COVID-19 incidence. Moreover, our findings and methodology could guide other countries by helping them understand the local transmission of COVID-19 and developing a tailored country-specific intervention strategy.

PMID:33962576 | DOI:10.1186/s12879-021-06128-1

BMC Anesthesiol. 2021 May 7;21(1):139. doi: 10.1186/s12871-021-01360-3.

ABSTRACT

PURPOSE: To investigate the effect of dexmedetomidine on intraoperative blood glucose hemostasis in elderly patients undergoing non-cardiac major surgery.

METHODS: This was secondary analysis of a randomized controlled trial. Patients in dexmedetomidine group received a loading dose dexmedetomidine (0.6 μg/kg in 10 min before anaesthesia induction) followed by a continuous infusion (0.5 μg/kg/hr) till 1 h before the end of surgery. Patients in control group received volume-matched normal saline at the same time interval. Primary outcome was the incidence of intraoperative hyperglycemia (blood glucose higher than 10 mmol/L).

RESULTS: 303 patients in dexmedetomidine group and 306 patients in control group were analysed. The incidence of intraoperative hyperglycemia showed no statistical significance between dexmedetomidine group and control group (27.4% vs. 22.5%, RR = 1.22, 95%CI 0.92-1.60, P = 0.167). Median value of glycemic variation in dexmedetomidine group (2.5, IQR 1.4-3.7, mmol) was slightly lower than that in control group (2.6, IQR 1.5-4.0, mmol), P = 0.034. In multivariable logistic analysis, history of diabetes (OR 3.007, 95%CI 1.826-4.950, P < 0.001), higher baseline blood glucose (OR 1.353, 95%CI 1.174-1.560, P < 0.001) and prolonged surgery time (OR 1.197, 95%CI 1.083-1.324, P < 0.001) were independent risk factors of hyperglycaemia.

CONCLUSIONS: Dexmedetomidine presented no effect on intraoperative hyperglycemia in elderly patients undergoing major non-cardiac surgery.

TRIAL REGISTRATION: Present study was registered at Chinese Clinical Trial Registry on December 1, 2015 ( www.chictr.org.cn , registration number ChiCTR-IPR-15007654).

PMID:33962565 | DOI:10.1186/s12871-021-01360-3

BMC Cancer. 2021 May 7;21(1):517. doi: 10.1186/s12885-021-08204-w.

ABSTRACT

BACKGROUND: CA19-9 is one of the most widely used tumor markers in biliary-pancreatic diseases. The measured value may not factually reflect the genuine CA19-9 level secreted by tumor, which affected by biliary obstruction. There is an urgent need of developing a correction formula of CA19-9 in biliary obstructive patients to guide clinical practice and avoid making improper clinical decision.

METHODS: Clinical characteristics were collected among patients undergoing biliary drainage in our hospital between January 2014 and January 2019. By comparing the malignant and benign patients statistically, dynamic change trend of CA19-9 levels after biliary drainage was obtained. The correction formulas of CA19-9 were generated by means of linear regression.

RESULTS: 121 patients, including 102 malignant and 19 benign patients, were enrolled in this study. The baseline CA19-9 level of malignant patients is much higher than that of benign patients. Total bilirubin (TB) level was found to be not related with CA19-9 value (p = 0.109). The drop proportion of the average CA19-9 level in the malignant patients (39.2%, IQR -18.4-78.6%) was much lower than that in the benign patients (75.7%, IQR 58.1-86.6%) (p = 0.014). The correction formula, CA19-9_True = 0.63 × CA19-9_Measured – 20.3 (R² = 0.693, p<0.001), was generated based on the linear relation between CA19-9 after drainage and CA19-9 before drainage in malignant patients, which had similar diagnostic value with true CA19-9 value.

CONCLUSIONS: Quantitative correction formulas of CA19-9 considering the effect of biliary decompression was first proposed in this study, aiming to provide a more accurate CA19-9 level to make more accurate clinical decision and avoid making improper therapeutic schedule.

PMID:33962560 | DOI:10.1186/s12885-021-08204-w

BMC Infect Dis. 2021 May 7;21(1):430. doi: 10.1186/s12879-021-06033-7.

ABSTRACT

BACKGROUND: The upsurge in HIV infections among students is a matter of particular concern. However, few studies have explored the epidemiological characteristics including the risky sexual networking of HIV-infected students in Zhejiang province, China.

METHODS: Using the provincial surveillance data of HIV-infected students, we conducted a retrospective epidemiology study to describe the epidemiological characteristics of 628 newly diagnosed cases from 2011 to 2016 and detailed information of 124 cases from 2015 to 2016. Spatial analyses were conducted using ArcGIS software, and statistical analyses were performed using SPSS software.

RESULTS: A total of 628 cases of HIV/AIDS were diagnosed among students in Zhejiang Province, China between 2011 and 2016. The cases showed an overall increasing trend over time, while the proportions of students with HIV disease status, cases diagnosed by HIV voluntary counseling and testing (VCT), and cases of homosexual transmission remained stable over time. Significant spatial heterogeneity in the cases was seen at the county level. Detailed data on 124 HIV-positive individuals collected from the local Center for Disease Control and Prevention (CDC) from 2015 and 2016, showed that the majority of them (85.5%,) engaged in homosexual behavior, and 93.4% had sex with casual partners. These partners included not only social members, but also other students. Online dating applications represented the most common means of seeking and communicating with homosexual partners. The level of awareness regarding the risk of HIV infection, and the amount coverage of face-to-face education towards students were both low.

CONCLUSIONS: HIV infections among students were characterized by increasing trend and spatial clustering in Zhejiang Province between 2011 and 2016, with homosexual sexual activity being the main mode of infection. Interventions are urgently required to prevent HIV infection in this population by increasing awareness of the disease. HIV testing programs and information regarding disease prevention specifically through online dating applications are needed.

PMID:33962557 | DOI:10.1186/s12879-021-06033-7

J Osteopath Med. 2021 May 7. doi: 10.1515/jom-2020-0040. Online ahead of print.

ABSTRACT

CONTEXT: Asthma is a leading cause of pediatric chronic illness, and poor disease control can lead to decreased quality of life and impaired academic performance. Although osteopathic manipulative treatment (OMT) has been shown to have positive effects on pulmonary function in adult patient populations, less is known about its impact in children.

OBJECTIVES: To evaluate changes in pulmonary function testing (PFT) in pediatric patients on the same day they received OMT compared with PFT in those who received usual care.

METHODS: We recruited patients between the ages of 7-18 years with a diagnosis of asthma who were receiving routine care at a primary care asthma clinic and had undergone baseline spirometry. Patients were excluded if they met any of the following criteria: clinical indication for pre- and postbronchodilator spirometry on the day of their visit, albuterol use in the last 8 hours, oral steroid use in the previous 2 weeks, or diagnosis of asthma exacerbation in the previous 4 weeks. Eligible patients were then randomized to either an OMT or a control group. Patients in the OMT group were treated with rib raising and suboccipital release in addition to standard asthma care, while control group patients received standard care only. A second PFT was performed for patients in both groups at the end of the visit. OMT was performed by multiple osteopathic pediatric residents specifically trained for this study. Change in spirometry results (forced vital capacity [FVC], forced expiration volume in 1 second [FEV1], FVC/FEV1, and forced expiratory flow 25-75%) were then compared.

RESULTS: The study population included 58 patients: 31 (53.4%) were assigned to the OMT group and 27 (46.6%) were assigned to the standard of care group. Patients who received OMT had greater improvement in all spirometry values compared to the usual group; however, these changes were not statistically significant.

CONCLUSIONS: The benefits of OMT on short term spirometry results in pediatric asthma patients remain unclear.

PMID:33962511 | DOI:10.1515/jom-2020-0040

J Complement Integr Med. 2021 May 7. doi: 10.1515/jcim-2020-0377. Online ahead of print.

ABSTRACT

OBJECTIVES: A healthy lifestyle is one, where the individual adapts it aiming at prevention from ailments. Unhealthy lifestyle is a behavioral risk factor for non-communicable diseases (NCDs). Arogya Raksha Panchatantra (five principles of healthy living), is a Naturopathy and Yoga lifestyle practice proposed by an eminent Indian Naturopath Dr. B. Venkat Rao, observed to modify the behavioral risk factors. The main objective of this study is to observe the changes in Hematological parameters and Anthropometric measures by practicing this Naturopathic lifestyle.

METHODS: The study adapted one group Pretest – Posttest quasi experimental design, with a total of nine healthy student volunteers between age group 18-20 years. Hematological parameters such as total blood cells count, hemoglobin concentration, MCV, MCH, PCV, and anthropometric measurements such as weight, body circumferences (waist, hip) and changes in blood pressure were measured at baseline and after practice at 25th day.

RESULTS: There was a statistically significant difference observed in weight, waist and hip circumference, hematological indices except with MCV and MCH, and blood pressure (p<0.05), with no significant changes in waist-hip ratio and blood counts.

CONCLUSIONS: The findings of the study indicate that adapting Naturopathy and Yoga lifestyle based on proposed lifestyle practices may be beneficial in reducing the risk factors for non-communicable diseases. The study does not attribute the effects observed to any particular lifestyle practiced in this study; rather it is combination of healthy practices as observed in the study and it needs further longitudinal observations whether the beneficial effect of Naturopathy lifestyle practices is sustained for longer period of time.

PMID:33962498 | DOI:10.1515/jcim-2020-0377

Immunohematology. 2021 Mar;37(1):25-32. doi: 10.21307/immunohematology-2021-006.

ABSTRACT

Determination of accurate anti-A/-B titers is important for treatment selection in ABO-incompatible stem cell and solid-organ transplants. The standard method for ABO antibody titration is the conventional tube test (CTT). Dithiothreitol (DTT) is commonly used to inactivate the IgM antibody component. The aim of this study was to compare six different methods for ABO antibody titration and to observe the effectiveness of DTT on antibody estimation. A total of 90 healthy voluntary blood donors were enrolled in this study, including 30 each for blood groups A, B, and O. Antibody titrations were performed and tested using the CTT-immediate spin (IS), CTT-antihuman globulin (AHG) with and without DTT, column agglutination technology (CAT)-IS, and CAT-AHG with and without DTT methods. Bead-CAT was used, and the positive cutoff value was set to 1+ for each method to determine the endpoint of the titer. The median values of anti-A/-B titers by IS were found to be higher than those values by AHG in CTT and CAT among group B and A individuals, whereas no statistically significant differences were observed in values from group O individuals for IS and AHG anti-A/-B titers, estimated by each method. Although there was positive correlation between the anti-A/-B titer results obtained using the CTT and CAT in all blood groups, testing using AHG showed poor agreement with and without DTT pretreatment (kappa value of 0.11 and 0.20, respectively). Moderate agreement was observed between CTT-IS and CAT-IS (kappa value of 0.46). Median anti-A/-B AHG titers were reduced by the use of DTT in all blood group samples. Significant differences in the interpretability of anti-A/-B titers were observed among different methods. A uniform approach for selecting the method for ABO antibody titration is highly recommended, and DTT pretreatment of plasma to neutralize IgM activity should be considered to obtain precise values of IgG anti-A/-B titers. Immunohematology 2021;37:25-32 .

Determination of accurate anti-A/-B titers is important for treatment selection in ABO-incompatible stem cell and solid-organ transplants. The standard method for ABO antibody titration is the conventional tube test (CTT). Dithiothreitol (DTT) is commonly used to inactivate the IgM antibody component. The aim of this study was to compare six different methods for ABO antibody titration and to observe the effectiveness of DTT on antibody estimation. A total of 90 healthy voluntary blood donors were enrolled in this study, including 30 each for blood groups A, B, and O. Antibody titrations were performed and tested using the CTT-immediate spin (IS), CTT-antihuman globulin (AHG) with and without DTT, column agglutination technology (CAT)-IS, and CAT-AHG with and without DTT methods. Bead-CAT was used, and the positive cutoff value was set to 1+ for each method to determine the endpoint of the titer. The median values of anti-A/-B titers by IS were found to be higher than those values by AHG in CTT and CAT among group B and A individuals, whereas no statistically significant differences were observed in values from group O individuals for IS and AHG anti-A/-B titers, estimated by each method. Although there was positive correlation between the anti-A/-B titer results obtained using the CTT and CAT in all blood groups, testing using AHG showed poor agreement with and without DTT pretreatment (kappa value of 0.11 and 0.20, respectively). Moderate agreement was observed between CTT-IS and CAT-IS (kappa value of 0.46). Median anti-A/-B AHG titers were reduced by the use of DTT in all blood group samples. Significant differences in the interpretability of anti-A/-B titers were observed among different methods. A uniform approach for selecting the method for ABO antibody titration is highly recommended, and DTT pretreatment of plasma to neutralize IgM activity should be considered to obtain precise values of IgG anti-A/-B titers. Immunohematology 2021;37:25–32 .

PMID:33962486 | DOI:10.21307/immunohematology-2021-006

Cochrane Database Syst Rev. 2021 May 7;5:CD010876. doi: 10.1002/14651858.CD010876.pub3.

ABSTRACT

BACKGROUND: The impact of exercise-based cardiac rehabilitation (CR) following heart valve surgery is uncertain. We conducted an update of this systematic review and a meta-analysis to assess randomised controlled trial evidence for the use of exercise-based CR following heart valve surgery.

OBJECTIVES: To assess the benefits and harms of exercise-based CR compared with no exercise training in adults following heart valve surgery or repair, including both percutaneous and surgical procedures. We considered CR programmes consisting of exercise training with or without another intervention (such as an intervention with a psycho-educational component).

SEARCH METHODS: We searched the Cochrane Central Register of Clinical Trials (CENTRAL), in the Cochrane Library; MEDLINE (Ovid); Embase (Ovid); the Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO); PsycINFO (Ovid); Latin American Caribbean Health Sciences Literature (LILACS; Bireme); and Conference Proceedings Citation Index-Science (CPCI-S) on the Web of Science (Clarivate Analytics) on 10 January 2020. We searched for ongoing trials from ClinicalTrials.gov, Clinical-trials.com, and the World Health Organization International Clinical Trials Registry Platform on 15 May 2020.

SELECTION CRITERIA: We included randomised controlled trials that compared exercise-based CR interventions with no exercise training. Trial participants comprised adults aged 18 years or older who had undergone heart valve surgery for heart valve disease (from any cause) and had received heart valve replacement or heart valve repair. Both percutaneous and surgical procedures were included.

DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data. We assessed the risk of systematic errors (‘bias’) by evaluating risk domains using the ‘Risk of bias’ (RoB2) tool. We assessed clinical and statistical heterogeneity. We performed meta-analyses using both fixed-effect and random-effects models. We used the GRADE approach to assess the quality of evidence for primary outcomes (all-cause mortality, all-cause hospitalisation, and health-related quality of life).

MAIN RESULTS: We included six trials with a total of 364 participants who have had open or percutaneous heart valve surgery. For this updated review, we identified four additional trials (216 participants). One trial had an overall low risk of bias, and we classified the remaining five trials as having some concerns. Follow-up ranged across included trials from 3 to 24 months. Based on data at longest follow-up, a total of nine participants died: 4 CR versus 5 control (relative risk (RR) 0.83, 95% confidence interval (CI) 0.26 to 2.68; 2 trials, 131 participants; GRADE quality of evidence very low). No trials reported on cardiovascular mortality. One trial reported one cardiac-related hospitalisation in the CR group and none in the control group (RR 2.72, 95% CI 0.11 to 65.56; 1 trial, 122 participants; GRADE quality of evidence very low). We are uncertain about health-related quality of life at completion of the intervention in CR compared to control (Short Form (SF)-12/36 mental component: mean difference (MD) 1.28, 95% CI -1.60 to 4.16; 2 trials, 150 participants; GRADE quality of evidence very low; and SF-12/36 physical component: MD 2.99, 95% CI -5.24 to 11.21; 2 trials, 150 participants; GRADE quality of evidence very low), or at longest follow-up (SF-12/36 mental component: MD -1.45, 95% CI -4.70 to 1.80; 2 trials, 139 participants; GRADE quality of evidence very low; and SF-12/36 physical component: MD -0.87, 95% CI -3.57 to 1.83; 2 trials, 139 participants; GRADE quality of evidence very low). AUTHORS’ CONCLUSIONS: Due to lack of evidence and the very low quality of available evidence, this updated review is uncertain about the impact of exercise-CR in this population in terms of mortality, hospitalisation, and health-related quality of life. High-quality (low risk of bias) evidence on the impact of CR is needed to inform clinical guidelines and routine practice.

PMID:33962483 | DOI:10.1002/14651858.CD010876.pub3