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Nevin Manimala Statistics

Blood Nicotine Predicts the Behavioral Economic Abuse Liability of Reduced-Nicotine Cigarettes

Nicotine Tob Res. 2021 Dec 3:ntab227. doi: 10.1093/ntr/ntab227. Online ahead of print.

ABSTRACT

BACKGROUND: Cigarette smoking continues to be a major health concern and remains the leading preventable cause of death in the U.S. Recent efforts have been made to determine the potential health and policy benefits of reducing nicotine in combustible cigarettes. The degree to which changes in blood nicotine relate to measures of the abuse liability of reduced-nicotine cigarettes is unknown. The current study examined the relation between blood nicotine and behavioral economic demand measures of cigarettes differing in nicotine content.

METHODS: Using a within-subject design, participants smoked a single cigarette during each experimental session. Cigarettes included the participant’s usual-brand cigarette and SPECTRUM investigational cigarette differing in nicotine level (mg of nicotine to g of tobacco; 15.8mg/g, 5.2mg/g, 2.4mg/g, 1.3mg/g, and 0.4mg/g). During each session, blood was collected at multiple timepoints and behavioral economic demand was assessed. Nonlinear mixed-effects models were used to estimate differences derived intensity (Q0) and change in elasticity (α).

RESULTS: Measures related to blood nicotine decreased in an orderly fashion related to nicotine level and significantly predicted change in elasticity (α), but not derived intensity. No differences in demand parameters between the usual brand and 15.8mg/g cigarettes were observed. However, αwas significantly higher (lower valuation) for 0.4mg/g than 15.8mg/g cigarettes.

CONCLUSIONS: The lowest nicotine level (0.4mg/g) corresponded with the lowest abuse liability (α) compared to the full-strength control (15.8mg/g), with the 1.3mg/g level also resulting in low abuse liability.

IMPLICATIONS: This is the first study examining the relative contributions of nicotine content in cigarettes and blood nicotine levels on the behavioral economic demand abuse liability of cigarettes ranging in nicotine content. Our results suggest blood nicotine and nicotine content both predict behavioral economic demand abuse liability. In addition, our results suggest a nicotine content of 1.3mg/g or lower may be effective at reducing cigarette uptake among first-time (naïve) smokers. Our results largely conform to previous findings suggesting a very low nicotine content cigarette maintains lower abuse liability than full-strength cigarettes.

PMID:34865118 | DOI:10.1093/ntr/ntab227

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Non-Operative Shoulder Dysfunction in the United States Military

Mil Med. 2021 Dec 4:usab468. doi: 10.1093/milmed/usab468. Online ahead of print.

ABSTRACT

INTRODUCTION: Recent epidemiological evidence shows that shoulder and upper-arm complaints impose a substantial burden on the armed forces of the United States and create significant challenges for all components of the physical fitness domain of total force fitness. Clinicians, epidemiologists, and health-services researchers interested in shoulder and upper-arm injuries and their functional limitations rarely have objective, validated criteria for rigorously evaluating diagnostic practices, prescribed treatments, or the outcomes of alternative approaches. We sought to establish and quantify patient volume, types of care, and costs within the Military Health System (MHS) in assessing and managing active duty members with nonoperative shoulder and upper-arm dysfunction.

MATERIALS AND METHODS: We performed a retrospective cohort study using data from the MHS Data Repository and MHS MART (M2) from fiscal year 2014 to identify active duty individuals with a diagnosis of shoulder and upper-arm injury or impairment defined by one of the International Classification of Disease Ninth Edition diagnosis codes that were selected to reflect nonoperative conditions such as fractures or infections. Statistical analyses include descriptive statistics on patient demographics and clinical visits, such as the range and frequency of diagnoses, number and types of appointments, and clinical procedure information following the diagnosis. We also examined treatment costs related to shoulder dysfunction and calculated the total cost to include medications, radiological, procedural, and laboratory test costs for all shoulder dysfunction visits in 2014 and the average cost for each visit. We further examined the category of each medication prescribed.

RESULTS: A total of 55,643 individuals met study criteria and accrued 193,455 shoulder-dysfunction-related clinical visits in fiscal year 2014. This cohort represents approximately 4.8% of the 1,155,183 active duty service members assigned to the United States and its territories during FY 2014. Most patients were male (85.32%), younger (85.25% were under 40 years old), and Caucasian/White (71.12%). The most common diagnosis code was 719.41 (pain in joint, shoulder region; 42.48%). The majority of the patients 42,750 (76.8%) had four or fewer medical visits during the study period and 12,893 (23.2%) had more than four visits. A total of 4,733 patients (8.5%) underwent arthrocentesis aspiration or injection. The total cost for all visits was $65,066,767.89. The average and median cost for each visit were $336.34 (standard deviation was $1,493.87) and $163.11 (range was from 0 to $84,183.88), respectively. Three out of four patients (75.3%) underwent radiological examinations, and 74.2% of these individuals had more than one radiological examination. Medications were prescribed to 50,610 (91.0%) patients with the three most common being IBUPROFEN (12.21%), NAPROXEN (8.51%), and OXYCODONE-ACETAMINOPHEN (5.04%), respectively.

CONCLUSIONS: Nearly 1 in 20 active duty military service members presented for nonoperative care of shoulder and/or upper-arm dysfunction during FY2014. Further examinations of the etiology and potential impact of shoulder/upper-arm dysfunction on force readiness are clearly warranted, as are additional studies directed at identifying best practices for preventing injury-related dysfunction and determining best practices for the treatment of shoulder dysfunction to optimize service member fitness and force readiness.

PMID:34865115 | DOI:10.1093/milmed/usab468

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Nevin Manimala Statistics

Short-Term Evaluation of Prosthetic Rehabilitation of Thin Wiry Ridge by Ridge Splitting and Simultaneous Implants Placement: Non-randomized Control Trial

Eur J Dent. 2021 Dec 4. doi: 10.1055/s-0041-1736292. Online ahead of print.

ABSTRACT

OBJECTIVE: This article evaluates the success of prosthetic rehabilitation of thin wiry ridge and implants placed simultaneously in splitted ridge both clinically and radiographically.

MATERIALS AND METHODS: Twenty-one participants were enrolled of which 13 patients (8 females and 5 males) were suffering from maxillary ridge atrophy and 8 patients (5 females and 3 males) had mandibular ridge atrophy; a total of 42 implants were performed using the ridge expansion technique. The expansion was performed using the conventional disk technique, piezoelectric corticotomy, and self-threading expanders. Implants were placed and loaded with fixed partial denture after 4 months for the mandible and 6 months for the maxilla. Implant stability quotient (ISQ) was measured at T0 (implant placement) and TL (loading). Crestal bone levels were measured at different times: T0, TL, and T12 (12 months). Evaluation of prosthetic and surgical complications was carried out. Data were analyzed and compared using analysis of variance and paired t-tests at a significance level of 5%.

RESULTS: All implants met the criteria for success. All implants showed a higher mean bone loss from T0 to TL (1.259 ± 0.3020) than from TL to T12 (0.505 ± 0.163) with a statistically significant difference (p < 0.0001). ISQ values sharply increased at the time of loading (72.52 ± 2.734) than at implant insertion (44.5 ± 4.062) with a significant difference (p < 0.0001). Minor prosthetic and surgical complications were reported.

CONCLUSION: The results from this study support the efficacy of prosthetic rehabilitation of thin wiry ridge using split ridge technique and the success of implants placed simultaneously in splitted ridge.

PMID:34863083 | DOI:10.1055/s-0041-1736292

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Fracture Incidence of Kedo-S Square Pediatric Rotary Files: A Prospective Clinical Study

Eur J Dent. 2021 Dec 4. doi: 10.1055/s-0041-1735935. Online ahead of print.

ABSTRACT

OBJECTIVE: The primary focus of this clinical study was to analyze the probability of occurrence of instrument fracture after root canal preparation of primary molars with the help of Kedo-S Square pediatric rotary file.

MATERIALS AND METHODS: Three experienced specialists treated 100 primary maxillary and mandibular molars (335 root canals) using a standardized protocol over 2 months. Biomechanical preparations were carried out using Kedo-S Square file, as per the suggestions given by the manufacturer. Every instrument in Group A helped handle three clinical cases, while for groups B, C and D, they helped in handling 5, 9, and 12 cases, respectively. Making use of an operational microscope, the rotary files, after being pulled out from the canal, were observed. The values were tabulated, and descriptive statistics were performed.

RESULTS: There were two fractures (2%), of which 1 occurred in group C in the apical 1/3rd of distobuccal canal of maxillary molar, and the other occurred in group D in the apical 1/3rd of mesiobuccal canal of maxillary molar.

CONCLUSIONS: The fracture rate of Kedo-S Square rotary file is quite low. It is primarily in the buccal canals of the maxillary molars and the apical third of the root canal that the instrument has a greater probability of separation.

PMID:34863082 | DOI:10.1055/s-0041-1735935

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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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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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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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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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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