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Nevin Manimala Statistics

The Effects of the 11+ Dance Neuromuscular Program on Jump Height and Lower Extremity Biomechanics in Female Adolescent Dancers: A Non-Randomized Controlled Pilot Trial

J Dance Med Sci. 2023 Jun 6:1089313X231178096. doi: 10.1177/1089313X231178096. Online ahead of print.

ABSTRACT

INTRODUCTION: Neuromuscular warm-up programs, such as FIFA 11+ were developed as early as 2006. These programs have been effective in reducing the risk of injury in female athletes by decreasing the moments surrounding the knee and improving neuromuscular control during static and dynamic movements such as jumping and landing. In addition, they have been effective for improving jump height in soccer, volleyball, and basketball.

METHODS: The effects of the 11+ Dance, a dance-specific neuromuscular warm-up program, was examined on jump height and lower extremity biomechanics during bilateral and single leg countermovement jumps in recreational dancers. Twenty female adolescents from 2 dance schools participated in this 2-centered 8-week controlled non-randomized trial. The intervention group (IG) performed the 11+ Dance program 3×/week for 8-weeks during the first 30-minute of their regularly scheduled dance classes. The control group (CG) continued with their regular dance classes routine. Ground reaction force and motion capture data were used to assess jump height and lower extremity biomechanics pre and post intervention.

RESULTS: Both groups statistically increased their jump height (CG: Z = 1.89-2.45, P ≤ .0167; IG: Z = 2.18-2.76, P ≤ .0167). However, no statistical between group differences were observed (Z = 0.38-1.22, P > .05). During takeoff, the IG statistically reduced peak knee extension moments (t(18) = -3.04 to -3.77, P ≤ .0167) while increasing peak hip extension moments (t(18) = 2.16-2.79, P ≤ .05) and peak hip flexion angles (t(18) = 2.68-3.72, P ≤ .0167) compared to the CG. The IG also increased the hip flexion angles compared to the CG during landing (t(18) = 2.78-5.13, P ≤ .0167) while no systematic differences were observed in all other variables of lower extremity biomechanics.

CONCLUSION: The reduced joint load at the knee observed during takeoff needs further investigation. Neuromuscular training, such as the 11+ Dance, is supported by numerous quality research. Due to its simplicity, the 11+ Dance may be feasible and beneficial to complement regular warm-ups in recreational dance practice.

PMID:37278196 | DOI:10.1177/1089313X231178096

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Nevin Manimala Statistics

Estimating transformationsfor evaluating diagnostic testswith covariate adjustment

Stat Methods Med Res. 2023 Jun 6:9622802231176030. doi: 10.1177/09622802231176030. Online ahead of print.

ABSTRACT

Receiver operating characteristic analysis is one of the most popular approaches for evaluating and comparing the accuracy of medical diagnostic tests. Although various methodologies have been developed for estimating receiver operating characteristic curves and their associated summary indices, there is no consensus on a single framework that can provide consistent statistical inference while handling the complexities associated with medical data. Such complexities might include non-normal data, covariates that influence the diagnostic potential of a test, ordinal biomarkers or censored data due to instrument detection limits. We propose a regression model for the transformed test results which exploits the invariance of receiver operating characteristic curves to monotonic transformations and accommodates these features. Simulation studies show that the estimates based on transformation models are unbiased and yield coverage at nominal levels. The methodology is applied to a cross-sectional study of metabolic syndrome where we investigate the covariate-specific performance of weight-to-height ratio as a non-invasive diagnostic test. Software implementations for all the methods described in the article are provided in the tram add-on package to the R system for statistical computing and graphics.

PMID:37278185 | DOI:10.1177/09622802231176030

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Nevin Manimala Statistics

qTPI: A quasi-toxicity probability interval design for phase I trials with multiple-grade toxicities

Stat Methods Med Res. 2023 Jun 6:9622802231176034. doi: 10.1177/09622802231176034. Online ahead of print.

ABSTRACT

The common terminology criteria for adverse events by the National Cancer Institute has greatly facilitated the revolution of drug development and an increasing number of Phase I trials have started to collect multiple-grade toxicity endpoints. Appropriate and yet transparent Phase I statistical designs for multiple-grade toxicities are therefore in great needs. In this article, we propose a quasi-toxicity probability interval (qTPI) design that incorporates a quasi-continuous measure of the toxicity probability (qTP) into the Bayesian theoretic framework of the interval based designs. Multiple-grade toxicity outcomes of each patient are mapped to qTP according to a severity weight matrix. Dose-toxicity curve underlying the dosing decisions in the qTPI design is continuously updated using accumulating trial data. Numerical simulations investigating the operating characteristics of qTPI show that qTPI achieved better safety, accuracy and reliability compared to designs that rely on binary toxicity data. Furthermore, parameter elicitation in qTPI is simple and does not involve multiple hypothetical cohorts specification. Finally, a hypothetical soft tissue sarcoma trial with six toxicity types and grade 0 to grade 4 severity grades is illustrated with patient-by-patient dose allocation under the qTPI design.

PMID:37278183 | DOI:10.1177/09622802231176034

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Nevin Manimala Statistics

Matching ratio and sample size for optimal sequential testing with binomial data

Stat Methods Med Res. 2023 Jun 6:9622802231176031. doi: 10.1177/09622802231176031. Online ahead of print.

ABSTRACT

Statistical sequential analysis of binary data is an important tool in clinical trials such as placebo-controlled trials, where a total of K individuals are randomly allocated into two groups, one of size κ1 receiving the treatment/drug, and the other of size κ2 for placebo. The ratio z=κ2/κ1, namely “matching ratio,” determines the expected proportion of adverse events from the treatment group among the κ1+κ2 individuals. Bernoulli-based designs are used for monitoring the safety of post-licensed drugs and vaccines as well. For instance, in a self-control design, z is the ratio between the risk and the control time windows. Irrespective of the type of application, the choice of z is a critical design criterion as it determines the sample size, the statistical power, the expected sample size, and the expected time to signal the sequential procedure. In this paper, we run exact calculations to offer a statistical rule of thumb for the choice of z. All the calculations and examples are performed using the R Sequential package.

PMID:37278182 | DOI:10.1177/09622802231176031

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Nevin Manimala Statistics

Comprehensive clinical evaluation of bedaquiline in the treatment of multidrug-resistant tuberculosis

Zhonghua Jie He He Hu Xi Za Zhi. 2023 Jun 12;46(6):572-579. doi: 10.3760/cma.j.cn112147-20221031-00859.

ABSTRACT

Objective: To assess the clinical value of bedaquiline in five dimensions: effectiveness, safety, economics, appropriateness, and social benefits, to provide a reference for medical and health insurance-related decisions. Methods: A total of 792 patients with multidrug-resistant tuberculosis who were hospitalized at Wuhan Pulmonary Hospital, Ganzhou Fifth People’s Hospital and Jiangxi Chest Hospital between January 2018 and December 2020 were included in the study. Based on a retrospective survey of case data, and each evaluation dimension of bedaquiline was statistically analyzed by causal analysis or chi-square test, using linezolid as the reference drug. Results: In terms of effectiveness, bedaquiline significantly increased treatment success by 23.9% (95%CI:4.8%-43.0%) and shortened treatment duration by 64 days(95%CI:18-109 days). In terms of safety, the incidence of adverse reactions to bedaquiline and the discontinuation rate of adverse reactions (5.11%,4.55%) were significantly lower than those for linezolid (22.49%,15.24%), with statistically significant differences (χ2=27.50,P<0.001;χ2=14.09,P<0.001). In terms of economics, patients treated with bedaquiline had a significantly higher anti-TB drug course cost of RMB 48 209.4 Yuan(95%CI: 28 336.0-68 082.8 Yuan). In terms of appropriateness, the proportion of bedaquiline in patients’ initial treatment regimens was lower than that of linezolid (16.7% vs. 86.5%) in the 2020 observation sample, with a statistically significant difference (χ2=238.96,P<0.001). In terms of social benefits, the infection control rate was significantly increased by 27.8% (95%CI:8.2%-47.5%) in patients using bedaquiline. Conclusions: Bedaquiline performed well in terms of efficacy, safety, and social benefits. However, it was less economical and the actual use rate of bedaquiline in clinical practice was lower than that of its counterpart drug, linezolid. Price reductions might be needed to increase the clinical use and performance of bedaquiline in the future.

PMID:37278171 | DOI:10.3760/cma.j.cn112147-20221031-00859

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Nevin Manimala Statistics

Validation of Hospital Anxiety and Depression Scale in an Indonesian population: a scale adaptation study

Fam Med Community Health. 2023 Jun;11(2):e001775. doi: 10.1136/fmch-2022-001775.

ABSTRACT

OBJECTIVE: This study aims to adapt the English-language Hospital Anxiety and Depression Scale (HADS) to the Indonesian language and evaluate the validity and reliability of the adapted version (ie, HADS-Indonesia).

DESIGN: A cross-sectional study was conducted between June and November 2018. First, a translation and back-translation process was conducted by a committee consisting of the researchers, a psychiatrist, a methodology consultant and two translators. Face and convergent validity and test-retest reliability evaluations were conducted. Next, structural validity and internal consistency analyses were performed. An intraclass correlation coefficient (ICC) test evaluated the scale’s test-retest reliability. A Spearman’s rank correlation coefficient was calculated to evaluate the correlation between HADS-Indonesia and Zung’s Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) for convergent validity evidence. Next, a structural validity analysis using exploratory factor analysis (EFA) and an internal consistency evaluation based on Cronbach’s alpha was conducted.

SETTING: This study was conducted in three villages in Jatinangor subdistrict, Sumedang Regency, West Java province, Indonesia; the villages were chosen based on their profiles.

PARTICIPANTS: A total of 200 participants (male: n=91, 45.50% and female: n=109, 54.50%), with a mean age of 42.41 (14.25) years, were enrolled in this study using a convenience sampling method. The inclusion criteria were age ≥18 years old with basic Indonesian language literacy.

RESULTS: The overall HADS-Indonesia’s ICC value was 0.98. There was a significant positive correlation between HADS-Indonesia’s anxiety subscale and Zung’s SAS (rs=0.45, p=0.030) and between the depression subscale of HADS-Indonesia and Zung’s SDS (rs=0.58, p<0.001). The Kaiser-Meyer-Olkin statistics (KMO) (KMO=0.89) and Bartlett’s test of sphericity (χ2(91, N=200)=1052.38, p<0.001)) indicated an adequate number of samples for EFA. All items’ commonality was >0.40 and the average inter-item correlation was 0.36. EFA yielded a 2-factor solution explaining 50.80% (40.40%+10.40%) of the total variance. All items from the original HADS were retained, including its original subscales. The adapted HADS-Anxiety subscale consisted of seven items (alpha=0.85), and the HADS-Depression subscale consisted of seven items (alpha=0.80).

CONCLUSIONS: HADS-Indonesia is a valid and reliable instrument for use in the general population of Indonesia. However, further studies are warranted to provide more sophisticated validity and reliability evidence.

PMID:37277187 | DOI:10.1136/fmch-2022-001775

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Nevin Manimala Statistics

Cross-Cultural Adaptation of the Hospital Ethical Climate Survey to Brazil

J Nurs Meas. 2022 Jun 3:JNM-2021-0036.R1. doi: 10.1891/JNM-2021-0036. Online ahead of print.

ABSTRACT

Background and Purpose: Adapting cross-culturally the Hospital Ethical Climate Survey to Brazilian nurses. Methods: A methodological study comprising translation, back translation, multidisciplinary committee, expert panel, pilot test and validation of the instrument. The validation was carried out with 269 nurses of a university hospital in the South of Brazil. Results: In the validation step, the quadratic weighted Kappa test-retest and the correlation coefficient ranged from 0.15 to 0.74. All factor loadings were higher than 0.4, ranging from 0.445 to 0.859. The Portuguese version of the instrument had a 0.93 Cronbach’s alpha and the confirmatory analysis demonstrated the model’s suitability with five factors and 26 items validated. Conclusions: The version of the instrument adapted to Brazilian Portuguese was considered valid and reliable in this sample.

PMID:37277157 | DOI:10.1891/JNM-2021-0036

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Nevin Manimala Statistics

Brazilian Version of the Nursing Professional Values Scale: Validity and Reliability Assessment

J Nurs Meas. 2022 Jun 3:JNM-2021-0032.R1. doi: 10.1891/JNM-2021-0032. Online ahead of print.

ABSTRACT

Background and Purpose: The Nurses Professional Values Scale-3 (NPVS-3) is an instrument designed to measure nurses professional values. This study aimed to assess the cultural reliability and validity of the NPVS-3 for use in Brazil. Methods: Translation followed the steps: translation, back-translation, Internal consistency was verified using Cronbach’s alpha coefficient and construct validity, by confirmatory factor analysis for the NPVS-3 three-domain model. Results: NPVS-3 applied to 169 nursing students. The culturally and semantically equivalent to the original English version was appropriate. The internal consistency values of each factor represented by Cronbach’s alpha were adequate: Care (0.790), Activism (0.898), and Professionalism (0.763). Conclusion: The analyses showed that the Brazilian version of NPVS-3 has high validity and reliability, being effective in assessing professional nursing values for Brazil.

PMID:37277153 | DOI:10.1891/JNM-2021-0032

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Nevin Manimala Statistics

Occurrence of adverse events after magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) therapy in symptomatic uterine fibroids-a retrospective case-control study

Int J Hyperthermia. 2023;40(1):2219436. doi: 10.1080/02656736.2023.2219436.

ABSTRACT

OBJECTIVES: Our study aims at the comprehensive analysis of adverse events (AEs) in patients with symptomatic uterine fibroids (UFs) who underwent magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) in the last 6 years in one of the major Polish centers performing this type of therapy.

METHODS: The presented retrospective case-control study was conducted in the Department of Obstetrics and Gynecology, Pro-Familia Hospital, Rzeszów in cooperation with the Second Department of Obstetrics and Gynecology, Center of Postgraduate Medical Education, Warsaw. The study enrolled 372 women with symptomatic UFs who underwent MR-HIFU and reported AEs during or after the procedure. The occurrence of particular AEs was analyzed. Statistical comparison of two cohorts (patients with and without AEs) was conducted based on epidemiological factors, UF characteristics, fat layer thickness, the presence of abdominal scars and technical parameters of the procedure.

RESULTS: The overall mean occurrence rate of AEs was 8.9% (n = 33). No major AEs were reported. The only statistically significant risk factor of AEs was the treatment of type II UFs according to Funaki (OR 2.12, CI 95%, p = 0.043). Other investigated factors did not have a statistically significant influence on AE occurrence. Abdominal pain was the most common AE.

CONCLUSION: Our data showed that MR-HIFU seemed to be a safe procedure. The AE rate after the treatment is relatively low. According to the obtained data it seems that the occurrence of AEs does not depend on the technical parameters of the procedure and the volume, position and location of UFs. Further prospective, randomized studies and with long follow-up are necessary to confirm the final conclusions.

PMID:37277102 | DOI:10.1080/02656736.2023.2219436

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Nevin Manimala Statistics

Comparative Efficacy of Granisetron and Droperidol After Orthognathic Surgery for Prophylaxis of Postoperative Nausea and Vomiting: A Retrospective Study

J Oral Maxillofac Surg. 2023 May 26:S0278-2391(23)00471-8. doi: 10.1016/j.joms.2023.05.010. Online ahead of print.

ABSTRACT

BACKGROUND: In the fall of 2021, granisetron was approved for postoperative nausea and vomiting (PONV) management in Japan. However, the comparative efficacy of droperidol and granisetron in the field of orthognathic surgery has not been determined.

PURPOSE: We compare the efficacy of droperidol and granisetron for PONV prophylaxis following orthognathic surgery.

STUDY DESIGN, SETTING, SAMPLE: We performed a retrospective cohort study of patients who underwent orthognathic surgery at a single institution from September 2020 to December 2022. Patients who had undergone Le Fort I osteotomy with sagittal split ramus osteotomy or isolated sagittal split ramus osteotomy were included. Patients were divided into three groups; the isolated droperidol (D), isolated granisetron (G), and droperidol with granisetron (DG) groups. General anesthesia was performed using total intravenous anesthesia for all patients; however, droperidol and granisetron were administered at the anesthesiologist’s discretion.

PREDICTOR VARIABLE: PONV prophylactic therapy included isolated droperidol, isolated granisetron, and droperidol with granisetron administration.

OUTCOME VARIABLES: Postoperative nausea (PON) and postoperative vomiting (POV) were determined through medical examination within 48 hours following surgery. Secondary outcomes included complications due to droperidol and/or granisetron administration.

COVARIATES: Age, sex, body mass index, Apfel’s score, duration of surgery, duration of anesthesia, intraoperative blood loss, and type of surgery.

ANALYSES: Statistical analysis was conducted using Fisher exact test, Mann-Whitney U test with Bonferroni correction for univariate comparison, and modified Poisson regression for comparison of PON and POV efficacy for multivariate analyses. P values <.05 were considered statistically significant.

RESULTS: Our study included 218 participants. There were no significant differences in covariates between groups D (n = 111), G (n = 52), and DG (n = 55). No significant difference in PON incidence was observed between groups. However, POV incidence was significantly lower in group DG than group D (relative risk, 0.21; 95% confidence interval, 0.05 to 0.86; P = .03). No significant difference in complication incidence was observed between groups.

CONCLUSIONS AND RELEVANCE: Granisetron was as effective as droperidol for PONV management, while droperidol combined with granisetron was more effective than isolated droperidol for POV management. As compared to the use of each drug separately, their combination was considered safe, with no increase in complication rates.

PMID:37277099 | DOI:10.1016/j.joms.2023.05.010