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Nevin Manimala Statistics

Evaluating sensitivity and specificity of the Biomeme Franklin™ three9 real-time PCR device and SARS-CoV-2 go-strips assay using clinical samples

J Clin Virol. 2021 Nov 25;146:105046. doi: 10.1016/j.jcv.2021.105046. Online ahead of print.

ABSTRACT

We evaluated the sensitivity and specificity of the Biomeme Franklin™ three9 Real-Time PCR Thermocycler and Biomeme SARS-CoV-2 Go-Strips in the detection of SARS-CoV-2. The Biomeme Franklin™ three9 platform is a portable, battery-operated system that could be used in remote settings. We assessed performance of the Biomeme SARS-CoV-2 detection system at a wide range of viral concentrations, examined cross-reactivity of the SARS-CoV-2 Go-Strips against several near-neighbor respiratory pathogens, and evaluated agreement against the BioFire® Respiratory Panel 2.1 in four clinical sample types. Our data indicate the Biomeme Go-Strips can reliably detect SARS-CoV-2 at a concentration of 4.2 × 103 copies/mL. No cross reactivity of the Go-Strips targets was detected against any of the tested near-neighbor respiratory pathogens. Cohen’s kappa statistics ranged from 0.68 to 0.92 between results from the Biomeme SARS-CoV-2 Go-Strips and the BioFire® Respiratory Panel 2.1 in all the different sample types. Compared to the BioFire® Respiratory Panel 2.1, the Biomeme SARS-CoV-2 Go-Strips demonstrated statistically significantly lower sensitivity in 3 out of 5 sample types. Overall, our study demonstrates the Biomeme Franklin™ three9 used with the SARS-CoV-2 Go-Strips is an effective system for the detection of SARS-CoV-2 that could potentially be used in a remote or austere environment.

PMID:34863057 | DOI:10.1016/j.jcv.2021.105046

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Remote transmission monitoring for postoperative perineural analgesia after major orthopedic surgery: A multicenter, randomized, parallel-group, controlled trial

J Clin Anesth. 2021 Dec 1;77:110618. doi: 10.1016/j.jclinane.2021.110618. Online ahead of print.

ABSTRACT

STUDY OBJECTIVE: After surgery, patients reported the delay in receiving help as the primary factor for poorly controlled pain. This study aimed to compare the effectiveness of patient management through two communication modalities: remote transmission (RT) versus bedside control (BC). We hypothesized that using remote technology for pump programming may provide the best postoperative infusion regimen for the patient’s self-assessment of pain and adverse events.

DESIGN: A multicenter, randomized, parallel-group, controlled trial.

SETTING: Anesthesiology department and orthopedic surgery ward at three university hospitals.

PATIENTS: Eighty patients undergoing orthopedic surgery with postoperative perineural patient-controlled analgesia were included.

INTERVENTIONS: Two groups (n = 40 for each group) were formed by randomization. In the postoperative period, perineural analgesia was followed up via an RT system or BC for 72 h.

MEASUREMENTS: A nurse assessed daily pain, sensory and motor blocks and adverse events. Patients completed a questionnaire three times a day and alerted for any problem according to the group (RT system or nurses’ follow-up). On the third postoperative day, the nurse removed the catheter, completed the final assessment, and collected the historical data from the pump. A physician’s shorter response time to change the patient control analgesia (PCA) program was the primary endpoint.

RESULTS: Of the 80 patients, 71 were analyzed (34 were randomized to the RT group and 37 to the BC group). Fifty-eight pump setting changes were noted. Analysis of repeated evaluations shows that mean time (SD) to change the PCA pump settings was significantly lower in the RT group (20 min (22.3 min)) than in the BC group (55.9 min (71.1 min)); mean difference [95% CI], -35.9 min [-74.3 to 2.4]); β estimation [95% CI], -34 [-63 to -6], p = 0.011). Pain relief, sensory and motor blocks did not differ between the groups: β estimation [95% CI], 0.1 [-0.4 to 0.6], p = 0.753; 0.5 [-0.4 to 1.4], p = 0.255; 0.9 [-0.04 to 1.8], p = 0.687, respectively. β = -34 [-63 to -6], p = 0.011). The consumption of ropivacaine, nurse workload and the cost of the analgesia regimen decreased in the RT group. No differences were noted in satisfaction scores or complication rates.

CONCLUSIONS: The response time for the physician to change the PCA program when necessary was shorter for patients using RT and alerts to the physician were more frequent compared with spot checks by nurses. RT helps to decrease nurses’ workload, ropivacaine consumption, and costs but did not affect postoperative pain relief, complication rate, or patient-reported satisfaction score.

IRB CONTACT INFORMATION: Comité de Protection des Personnes, Sud Méditerranée III, Montpellier-Nîmes, France, registration number EudraCT A01698-35.

CLINICAL TRIAL NUMBER: ClinicalTrials.gov ID:NCT02018068 PROTOCOL: The full trial protocol can be accessed at Department of Anesthesiology and Critical Care Medicine, Medical Research and Statistics Unit, Lapeyronie University Hospital, Avenue Doten G Giraud, Montpellier, France. s-bringuierbranchereau@chu-montpellier.fr.

PMID:34863052 | DOI:10.1016/j.jclinane.2021.110618

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Nevin Manimala Statistics

Relationships of social support and attitudes towards death: A mediator role of depression in older patients on haemodialysis

Nurs Open. 2021 Dec 4. doi: 10.1002/nop2.1135. Online ahead of print.

ABSTRACT

AIM: To explore the mediating role of depression in older people receiving haemodialysis on social support and the attitude of participants towards death.

DESIGN: A cross-sectional questionnaire survey.

METHODS: Data were collected from older people undergoing dialysis (N = 209) at two regional hospitals in the north of Taiwan. Confirmatory factor analysis with structural equation model was used to clarify the strength of relationships and intermediary effects of three scales in which with 5,000 bootstrap samples using LISREL 9.31.

RESULTS: The final model provided a good fit for the data. Social support and depression have statistically significant effects on dialysis older person’ negative death attitudes. The direct effect of social support on depression was the strongest (p<.001). Overall, depression completely mediates social support and positive death attitudes. Depression partially mediates social support and negative death attitude.

PMID:34863049 | DOI:10.1002/nop2.1135

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A 3D Mirroring and Colormap Asymmetry Study of Class II Subdivision Patients

Orthod Craniofac Res. 2021 Dec 4. doi: 10.1111/ocr.12553. Online ahead of print.

ABSTRACT

INTRODUCTION: Patients with Class II subdivision malocclusion present skeletal and dental asymmetries. The purpose of this study is to assess those asymmetries by 3D mirroring and colormap quantification.

METHODS: This study analyzed 50 initial CBCTs divided in two groups: Class I (control group) and Class II subdivision (study group) malocclusion patients. CBCTs were oriented and full skull was segmented generating a 3D model. The right side of the 3D models was mirrored, using a midsagittal plane as reference, resulting in a perfectly symmetric skull based on two right sides. Original and mirrored models were superimposed on the unchanged right half, and differences were quantified using a colormap. Eight regions of interest were assessed: gonion, mandibular front, maxillary front, zygomatic process, maxillary and mandibular canine and molar areas.

RESULTS: Statistically significant differences using the Mann Whitney test were found in six of the eight evaluated areas when comparing the control to the study group. The maxillary areas did not show any difference between the groups.

CONCLUSIONS: Patients with Class II subdivision malocclusion show true skeletal and dental asymmetries when comparing right and left sides. The maxilla showed no significant skeletal asymmetry, but the maxillary teeth were positioned more mesially on the Class II side. The maxillary canine on the Class II side was also more bucally positioned. The mandible showed significant asymmetries with both skeletal and dental areas in the Class II side more distally and bucally positioned.

PMID:34863033 | DOI:10.1111/ocr.12553

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Psychomotor development in infants and young children with Down syndrome-A prospective, repeated measure, post-hoc analysis

Am J Med Genet A. 2021 Dec 4. doi: 10.1002/ajmg.a.62587. Online ahead of print.

ABSTRACT

Children with Down syndrome (DS) show delayed acquisition of cognitive and functional skills compared to typically developing children. The objective of this study was to accurately describe early development of infants and young children (children hereafter) with DS based on a large recent sample. We carried out repeated measure analysis of the global development quotient (GDQ) and developmental age using data from the Assessment of Systematic Treatment with Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children (ACTHYF) study (NCT01576705). Because there was no statistically significant difference in the primary endpoint between active treatment and placebo, data from all treatment groups were pooled for post-hoc analysis. Data of 141 children with DS aged 6-18 months at inclusion were analyzed. Mean GDQ decreased over the study period, especially in the youngest age classes ([6-9] and [9-12] months), indicating that acquisition of skills occurred at a slower pace compared to typically developing children. Strongest deficits were observed for motor and hearing and language skills. Only GDQ at baseline correlated significantly with evolution of GDQ. Future studies should aim at elucidating the mechanisms underlying motor and language development. Early pharmacological interventions together with early childhood therapies might be necessary to improve the developmental trajectory of children with DS.

PMID:34863019 | DOI:10.1002/ajmg.a.62587

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Incidence and remission rates of self-reported hidradenitis suppurativa – A prospective cohort study conducted in Danish blood donors

J Eur Acad Dermatol Venereol. 2021 Dec 4. doi: 10.1111/jdv.17857. Online ahead of print.

ABSTRACT

BACKGROUND: A large discrepancy between physician-diagnosed and self-reported HS exists. Knowledge regarding incidence and remission rates of self-reported HS is missing, but may help bridge the gap in understanding between these two phenotypes.

OBJECTIVES: To determine the incidence and remission rates of self-reported HS, and to what degree these are affected by sex, smoking and BMI.

METHODS: A prospective cohort of 23,930 Danish blood donors. Information on self-reported HS, symptom-localization, sex, age, BMI and smoking status was collected at baseline and study termination. Self-reported HS fulfilled clinical obligatory diagnostic criteria. Cox proportional hazards regression analyses were conducted for both incidence and remission rates providing a hazard ratio (HR) of risk for each variable in the regression.

RESULTS: incidence rate of self-reported HS was 10.8/1,000 person-years (95% CI: 9.9-11.7), decreasing as a function of numbers of areas affected. Female BMI points above 25 (HR=1.11, 95% CI: 1.09-1.13), male BMI points above 25 (HR=1.07, 95% CI: 1.04-1.11) , active smoking (HR=1.72, 95% CI: 1.15-2.57), male sex (HR=0.55, 95% CI: 0.45-0.67) and years of age above 25 (HR=0.97, 95% CI: 0.96-0.97) were all statistically associated with the development of self-reported HS. Remission rate of self-reported HS was 256.7/1,000 person-years (95% CI: 223.9-292.6), decreasing as a function of numbers of affected areas. Symptoms in ≥3 areas (HR=0.54, 95% CI: 0.34-0.85), active smoking (HR=0.49, 95% CI: 0.32-0.76) and female weight loss (every percentage drop in BMI: HR=1.07, 95%CI: 1.05-1.11) all significantly affected the remission rate.

CONCLUSIONS: Both incidence and remission rates of self-reported HS are high, indicating that many with self-reported HS are unlikely to be diagnosed, as they to a higher degree experience mild transient HS symptoms.

PMID:34862994 | DOI:10.1111/jdv.17857

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Improving trial generalizability using observational studies

Biometrics. 2021 Dec 4. doi: 10.1111/biom.13609. Online ahead of print.

ABSTRACT

Complementary features of randomized controlled trials (RCTs) and observational studies (OSs) can be used jointly to estimate the average treatment effect of a target population. We propose a calibration weighting estimator that enforces the covariate balance between the RCT and OS, therefore improving the trial-based estimator’s generalizability. Exploiting semiparametric efficiency theory, we propose a doubly robust augmented calibration weighting estimator that achieves the efficiency bound derived under the identification assumptions. A nonparametric sieve method is provided as an alternative to the parametric approach, which enables the robust approximation of the nuisance functions and data-adaptive selection of outcome predictors for calibration. We establish asymptotic results and confirm the finite sample performances of the proposed estimators by simulation experiments and an application on the estimation of the treatment effect of adjuvant chemotherapy for early-stage non-small cell lung patients after surgery. This article is protected by copyright. All rights reserved.

PMID:34862966 | DOI:10.1111/biom.13609

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Impact of precipitous labor on the onset of transient tachypnea in vaginal deliveries at term

Int J Gynaecol Obstet. 2021 Dec 4. doi: 10.1002/ijgo.14060. Online ahead of print.

ABSTRACT

OBJECTIVE: To study the association between precipitous labor (less than 3 hours) and the onset of transient tachypnea in singleton fetuses in cephalic presentation with term vaginal deliveries.

METHODS: This cohort study included women delivered from 2013 through 2017 in our French tertiary university hospital maternity unit. Inclusion criteria were vaginal delivery of liveborn singleton fetus in cephalic presentation and at term. We compared women with precipitous labor and those with longer labor. The principal endpoint was the rate of transient tachypnea of the newborn (TTN). We investigated risk factors for TTN besides duration of labor.

RESULTS: Comparison of 2644 women with precipitous labor and 7571 with longer labor showed a lower TTN rate in the precipitous labor group (1.6 vs 2.7%; P=0.003). The association was no longer significant after adjustment for the risk factors identified in the univariate analysis (adjusted OR 0.99, 95% CI 0.64-1.54). Risk factors identified for TTN were non-clear amniotic fluid, shoulder dystocia, umbilical cord encirclement, birth weight less than 2500 g, use of cervical ripening and operative vaginal delivery.

CONCLUSION: Precipitous labor, lasting less than 3 hours, is not associated with a higher risk of transient tachypnea in term newborns after vaginal delivery.

PMID:34862963 | DOI:10.1002/ijgo.14060

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Comparison of Long-Term Effects After Modified CO2 Laser-Assisted Deep Sclerectomy and Conventional Trabeculectomy in Chinese Primary Open-Angle Glaucoma

Ophthalmol Ther. 2021 Dec 4. doi: 10.1007/s40123-021-00413-7. Online ahead of print.

ABSTRACT

INTRODUCTION: To compare the long-term effect after modified CO2 laser-assisted sclerectomy surgery (MCLASS) and conventional trabeculectomy (TRAB) in medically uncontrolled Chinese primary open-angle glaucoma (POAG) patients. This was a retrospective comparative study.

METHODS: A total of 87 patients were reviewed, including 45 in the MCLASS group and 42 in the TRAB group. Intraocular pressure (IOP), best-corrected visual acuity (BCVA), and use of supplemental medical therapy were retrospectively compared at baseline, and until 36 months postoperatively.

RESULTS: Patients in both groups achieved a significant IOP decrease from baseline (P < 0.001); postoperative IOP in the MCLASS group was significantly lower than that in the TRAB group at 24 and 36 months. The reduced use of medication was statistically significant in both groups, and the number of postoperative medications was significantly more in TRAB group at 24 and 36 months. At 24 and 36 months, the complete success rate was 60% and 53.3% for MCLASS versus 66.7% and 59.5% for TRAB, and the qualified success rate was 91.1% and 88.9% for MCLASS versus 83.3% and 80.9% for TRAB, respectively. BCVA deterioration post TRAB was clinically more serious than that post MCLASS at 24 and 36 months, although the difference was not statically significant at any time point postoperatively. Compared with MCLASS, more complications occurred postoperatively in the TRAB group.

CONCLUSIONS: MCLASS is an effective surgical option for Chinese POAG patients. Compared to TRAB, eyes undergoing MCLASS experience a comparable success rate, a greater IOP reduction, fewer medications, and a lower risk of complications up to 36 months.

PMID:34862960 | DOI:10.1007/s40123-021-00413-7

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Introduction of ultrasound-based living anatomy into the medical curriculum: a survey on medical students’ perceptions

Ultrasound J. 2021 Dec 4;13(1):47. doi: 10.1186/s13089-021-00247-1.

ABSTRACT

BACKGROUND: Traditional anatomy teaching methods are based on the models and cadaveric dissections, providing fixed views of the anatomical structures. However, in the last few years, the emerging concept of ultrasound-based teaching in anatomy has started to gain ground among medical curricula. This study aims to evaluate the integration of ultrasound as an adjunct tool to traditional anatomy teaching methods and explore students’ perceptions of whether ultrasound-based teaching enhances their interest and knowledge of anatomy. A cross-sectional study was carried out among the students of the 6-year undergraduate entry (MD) and 4-year graduate entry (MBBS) program of the University of Nicosia. A questionnaire was distributed to them after the delivery of several twenty minutes ultrasound sessions by an expert in the field during anatomy practicals. The data were analyzed utilizing SPSS software, and the statistical significance was determined as p value < 0.05.

RESULTS: 107 MD and 42 MBBS students completed the questionnaire. Both groups agreed that their ultrasound-based learning experience was good or excellent (79.4% MD students; 92.9% MBBS students), that it enhanced their knowledge of anatomy (68.2% MD students; 90.5% MBBS students) and boosted their confidence regarding their examination skills practice (69.2% MD students; 85.7% MBBS students). Although most students desired more time allocated to the ultrasound station (72% MD students; 85.7% MBBS students), they believed that ultrasound-based teaching is a necessary adjunct to the traditional teaching methods of anatomy (89.7% MD students; 92.9% MBBS students).

CONCLUSIONS: Overall, MBBS students were more confident about the benefits of ultrasound-based teaching. Most of the students agreed that cross-sectional sessions of traditional teaching and ultrasound-based teaching strengthened their knowledge of anatomy and enhanced their confidence concerning their clinical examination skills. Medical schools should embrace the advantages that ultrasound-based teaching offers in order future doctors to be qualified to utilize ultrasound for procedural and diagnostical purposes.

PMID:34862937 | DOI:10.1186/s13089-021-00247-1