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Nevin Manimala Statistics

Application of a six sigma model to evaluate the analytical performance of urinary biochemical analytes and design a risk-based statistical quality control strategy for these assays: A multicenter study

J Clin Lab Anal. 2021 Oct 15:e24059. doi: 10.1002/jcla.24059. Online ahead of print.

ABSTRACT

BACKGROUND: The six sigma model has been widely used in clinical laboratory quality management. In this study, we first applied the six sigma model to (a) evaluate the analytical performance of urinary biochemical analytes across five laboratories, (b) design risk-based statistical quality control (SQC) strategies, and (c) formulate improvement measures for each of the analytes when needed.

METHODS: Internal quality control (IQC) and external quality assessment (EQA) data for urinary biochemical analytes were collected from five laboratories, and the sigma value of each analyte was calculated based on coefficients of variation, bias, and total allowable error (TEa). Normalized sigma method decision charts for these urinary biochemical analytes were then generated. Risk-based SQC strategies and improvement measures were formulated for each laboratory according to the flowchart of Westgard sigma rules, including run sizes and the quality goal index (QGI).

RESULTS: Sigma values of urinary biochemical analytes were significantly different at different quality control levels. Although identical detection platforms with matching reagents were used, differences in these analytes were also observed between laboratories. Risk-based SQC strategies for urinary biochemical analytes were formulated based on the flowchart of Westgard sigma rules, including run size and analytical performance. Appropriate improvement measures were implemented for urinary biochemical analytes with analytical performance lower than six sigma according to the QGI calculation.

CONCLUSIONS: In multilocation laboratory systems, a six sigma model is an excellent quality management tool and can quantitatively evaluate analytical performance and guide risk-based SQC strategy development and improvement measure implementation.

PMID:34652033 | DOI:10.1002/jcla.24059

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Nevin Manimala Statistics

The Battalion Aid Station-The Forgotten Frontier of the Army Health System During the Global War on Terrorism

Mil Med. 2021 Oct 15:usab401. doi: 10.1093/milmed/usab401. Online ahead of print.

ABSTRACT

BACKGROUND: The battalion aid station (BAS) has historically served as the first stop during which combat casualties would receive care beyond a combat medic. Since the conflicts in Iraq and Afghanistan, many combat casualties have bypassed the BAS for treatment facilities capable of surgery. We describe the care provided at these treatment facilities during 2007-2020.

METHODS: This is a secondary analysis of previously described data from the Department of Defense Trauma Registry. We included encounters with the documentation of an assessment or intervention at a BAS or forward operating base from January 1, 2007 to March 17, 2020. We utilized descriptive statistics to characterize these encounters.

RESULTS: There were 28,950 encounters in our original dataset, of which 3.1% (884) had the documentation of a prehospital visit to a BAS. The BAS cohort was older (25 vs. 24, P < .001) The non-BAS cohort saw a larger portion of pediatric (<18 years) patients (10.7% vs. 5.7%, P < .001). A higher proportion of BAS patients had nonbattle injuries (40% vs. 20.7%, P < .001). The mean injury severity score was higher in the non-BAS cohort (9 vs. 5, P < .001). A higher proportion of the non-BAS cohort had more serious extremity injuries (25.1% vs. 18.4%, P < .001), although the non-BAS cohort had a trend toward serious injuries to the abdomen (P = .051) and thorax (P = .069). There was no difference in survival.

CONCLUSIONS: The BAS was once a critical point in casualty evacuation and treatment. Within our dataset, the overall number of encounters that involved a stop at a BAS facility was low. For both the asymmetric battlefield and multidomain operations/large-scale combat operations, the current model would benefit from a more robust capability to include storage of blood, ventilators, and monitoring and hold patients for an undetermined amount of time.

PMID:34651651 | DOI:10.1093/milmed/usab401

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Nevin Manimala Statistics

Estimating cell type-specific differential expression using deconvolution

Brief Bioinform. 2021 Oct 14:bbab433. doi: 10.1093/bib/bbab433. Online ahead of print.

NO ABSTRACT

PMID:34651640 | DOI:10.1093/bib/bbab433

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Nevin Manimala Statistics

Updating of the official statistics of deaths causes: “Let’s get stronger after the COVID-19 pandemic”.

Rev Esp Salud Publica. 2021 Apr 19;95:perspectivas17_cirera_zurriaga.

ABSTRACT

The National Spanish Institute of Statistics (INE) website is the main means of communication for official statistics in Spain. The INE publishes the annual statistics of deaths according to the cause of death. This vital statistic has improved a lot in recent years; also, thanks to the collaboration from the Autonomous Communities. There are certain areas that could optimize its usefulness. Indicator improvements could include provisional case-counts by causes of death, besides the age-standardization of specified causes of death and the Potential Years of Life Lost by cause of death, for territorial comparison. Meanwhile, the usefulness of social indicators applied to the statistics of death causes could be enhanced, as is the case of education. By updating the databases, it would be possible to maintain the registries of deceased and their causes of death without an annual closure before the statistical publication. Moreover, we could link the databases of demographic records of the population to their health files, to obtain individually the people at risk of sickness or death, and to enable their respective vital, social, health trajectories for statistics. In this way, the INE would increase its leadership and reference on mortality statistics in Spain and EuroStat, as well. Furthermore, the State, Autonomous and municipal administrations could redefine their publication offer into a more specified or innovative statistics of death causes.

PMID:34651616

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Nevin Manimala Statistics

Unintended pregnancy in users of nomegestrol acetate and 17β-oestradiol (NOMAC-E2) compared with levonorgestrel-containing combined oral contraceptives: final results from the PRO-E2 study

Eur J Contracept Reprod Health Care. 2021 Oct 15:1-7. doi: 10.1080/13625187.2021.1988923. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess and compare the risk of unintended pregnancy in NOMAC-E2 users with levonorgestrel-containing COC (COCLNG) users in clinical practice.

STUDY DESIGN: In this observational study, new users1 of NOMAC-E2 and COCLNG were recruited in Europe, Australia, and Latin America and followed for up to 2 years. Unintended pregnancy was expressed by the Pearl Index (contraceptive failures per 100 women-years [WY]), crude hazard ratios (HRcrude) and adjusted hazard ratios (HRadj).

RESULTS: Overall, 44,559 and 46,754 users were recruited to the NOMAC-E2 and COCLNG user cohorts, respectively. There were 64 unintended pregnancies in NOMAC-E2 users (0.15 per 100 WY; 95% CI, 0.11-0.19) and 200 in COCLNG users (0.41 per 100 WY; 95% CI, 0.35-0.47). The unintended pregnancy risk was statistically significantly lower in the NOMAC-E2 cohort (p<.0001) compared to the COCLNG user cohort. The HRadj of NOMAC-E2 vs COCLNG was 0.45 (95% CI, 0.34-0.60; adjusted for age, body mass index, gravidity, COC user status, education level).

CONCLUSIONS: NOMAC-E2 demonstrated superior contraceptive effectiveness compared to COCLNG, likely due to the comparatively short hormone-free interval and possibly reinforced by the long half-life of NOMAC.

PMID:34651535 | DOI:10.1080/13625187.2021.1988923

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Nevin Manimala Statistics

Relationship between passion and psychological well-being of Taekwondo athletes: testing the mediating effects of social behavior

J Sports Med Phys Fitness. 2021 Oct 15. doi: 10.23736/S0022-4707.21.12924-X. Online ahead of print.

ABSTRACT

OBJECTIVE: The study uses PROCESS Macro statistical model and examines the causal relationship of passion, social behavior, and psychological well-being of Taekwondo athletes.

METHODS: Passion, social behavior, and psychological well-being were measured among 261 registered athletes at Korea Taekwondo Association in 2021 in South Korea. The collected data was analyzed using SPSS 24.0, PROCESS Macro, Amos 24.0.

RESULTS: Harmonious passion had a significant indirect effect through prosocial behavior on the feelings of self-realization, confidence, and flow and through antisocial behavior on the feeling of flow. Obsessive passion had a significant indirect effect through prosocial behavior on the feelings of self-realization, confidence, and flow and through antisocial behavior on feeling of flow, hedonic enjoyment.

CONCLUSIONS: The results of the study suggest that the level of perceiving psychological wellbeing differs based on the level of Taekwondo athletes’ dualistic passion. social behavior, the study is expected to serve as a model study that enables applying psychological well-being.

PMID:34651615 | DOI:10.23736/S0022-4707.21.12924-X

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Nevin Manimala Statistics

Comparative analysis of the quantitative parameter method and elasticity color mode method for real-time shear wave elastography in the diagnosis of benign and malignant solid breast lesions

Tumori. 2021 Oct 15:3008916211048239. doi: 10.1177/03008916211048239. Online ahead of print.

ABSTRACT

OBJECTIVE: To examine the performance of real-time shear wave elastography (RT-SWE) in routine clinical practice.

METHODS: This was a prospective study of 500 patients. The elasticity color mode method was judged by a four-mode system. The quantitative parameter method was used to measure the modulus of elasticity of the lesions. Pathologic reports were used as a gold standard to comparatively analyze the diagnostic performance of the two methods.

RESULTS: A total of 553 tumors were detected. The average mode value and the modulus of elasticity (Emax) of the benign breast masses was lower than that of malignant masses (p < 0.05). With Emax = 67.4 as the diagnostic threshold value, the sensitivity, specificity, accuracy, negative predictive value, and positive predictive value of the two methods were not statistically significant different (p > 0.05).

CONCLUSIONS: The shear wave quantitative parameter method and the elasticity color mode method showed similar performances in the diagnosis of benign and malignant breast masses. The elasticity color mode method is convenient and intuitive, whereas the quantitative parameter method can be used to objectively assess the lesions when it is difficult to score the elasticity of an image, but could not be relied on alone.

PMID:34651522 | DOI:10.1177/03008916211048239

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Nevin Manimala Statistics

Communication and swallowing management in childhood brain tumour or leukaemia: A survey of health professionals and consumers

Int J Speech Lang Pathol. 2021 Oct 15:1-12. doi: 10.1080/17549507.2021.1987520. Online ahead of print.

ABSTRACT

Purpose: Brain tumour and leukaemia represent the most common childhood cancers and can result in communication and swallowing difficulties. The purpose of this study was to survey health professionals and consumers regarding the management of communication and swallowing difficulties in children with brain tumour or leukaemia (CBTL).Method: In this study participants completed a survey focussing on (1) communication and swallowing assessment and intervention, (2) multidisciplinary team (MDT) practices and (3) risk factors. Quantitative data were reported using descriptive statistics. Qualitative data were analysed using NVivo12 Qualitative Data Analysis Software.Result: Twenty-four participants were included (22 health professionals; two consumers). Most participants (≥80%) agreed that comprehensive and regular communication and swallowing assessments improved outcomes. Communication and swallowing interventions were reported to improve outcomes by 96% of participants. MDT care was considered essential in improving outcomes. Speech-language pathologists were the primary health professional identified in communication management; additional multidisciplinary health professionals were highlighted in swallowing management. Risk factors were identified across three categories: cancer-related, treatment-related and child-factors.Conclusion: This study collates the expertise and experience of multidisciplinary health professionals and consumers which can be used to guide assessment and intervention for communication and swallowing in CBTL. It also provides perspectives on MDT care and consideration of patient values and risk factors.

PMID:34651529 | DOI:10.1080/17549507.2021.1987520

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Nevin Manimala Statistics

Generating, Presenting, and Interpreting Cost-Effectiveness Results in the Context of Uncertainty: A Tutorial for Deeper Knowledge and Better Practice

Med Decis Making. 2021 Oct 15:272989X211045070. doi: 10.1177/0272989X211045070. Online ahead of print.

ABSTRACT

This tutorial aims to help make the best available methods for generating and presenting cost-effectiveness results with uncertainty common practice. We believe there is a need for such type of tutorial because some erroneous practices persist (e.g., identifying the cost-effective intervention as the one with the highest probability to be cost-effective), while some of the more advanced methods are hardly used (e.g., the net loss statistic ‘NL’, expected net loss curves and frontier). The tutorial explains with simple examples the pros and cons of using ICER, incremental net benefit and NL to identify the cost-effective intervention, both with and without uncertainty accounted for probabilistically. A flowchart provides practical guidance on when and how to use ICER, incremental net benefit or NL. Different ways to express and present uncertainty in the results are described, including confidence and credible intervals, the probability that a strategy is cost-effective (as usually shown with cost-effectiveness acceptability curves (CEACs)) and the expected value of perfect information (EVPI). The tutorial clarifies and illustrates why EVPI is the only measure accounting fully for decision uncertainty, and why NL curves and the NL frontier may be preferred over CEACs and other plots for presenting cost-effectiveness results in the context of uncertainty. The easy calculations and a worked-out real-life example will help users to thoroughly understand and correctly interpret key cost-effectiveness results. Examples with mathematical calculations, interpretation, plots and R code are provided.

PMID:34651515 | DOI:10.1177/0272989X211045070

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Nevin Manimala Statistics

Effect of Exercise Training on 1,25(OH)2D Levels: The FIT-AGEING Randomized Controlled Trial

Sports Health. 2021 Oct 15:19417381211050033. doi: 10.1177/19417381211050033. Online ahead of print.

ABSTRACT

BACKGROUND: Vitamin D deficiency is currently endemic worldwide and is considered as an important factor in the development of several chronic conditions. Physical exercise has been postulated as an auspicious strategy to counteract age-related disorders preventing premature mortality. However, the effects of chronic exercise training on 1,25-dihydroxyvitamin D [1,25(OH)2D] is unclear. This 12-week randomized controlled trial aimed to investigate the effects of different training modalities on 1,25(OH)2D in healthy sedentary adults.

HYPOTHESIS: Exercise training will increase 1,25(OH)2D in the study cohort.

STUDY DESIGN: Randomized controlled clinical trial.

LEVEL OF EVIDENCE: Level 1.

METHODS: A total of 89 healthy sedentary adults (53% women; 53.5 ± 4.9 years old) were enrolled in the FIT-AGEING study. The participants were randomized to (1) a control group (no exercise), (2) physical activity recommendation from the World Health Organization (PAR group), (3) high-intensity interval training (HIIT group), and (4) HIIT adding whole-body electromyostimulation training (HIIT + EMS). 1,25(OH)2D plasma levels were measured using a DiaSorin Liaison immunochemiluminometric analyzer.

RESULTS: Compared with the control group, 1,25(OH)2D increased in PAR (Δ = 10.99 ± 3.44 pg/mL; P = 0.01), HIIT (Δ = 11.63 ± 3.51 pg/mL; P = 0.009), and HIIT + EMS groups (Δ = 14.01 ± 3.59 pg/mL; P = 0.001) without statistical differences between them (all Ps > 0.1).

CONCLUSION: In summary, the results show that a 12-week exercise intervention produced an increment of 1,25(OH)2D independently of age, sex, and exercise modality in healthy sedentary adults.

CLINICAL RELEVANCE: The implementation of physical exercise could be considered a strategy not only aiming to reverse the seasonal decrease of 1,25(OH)2D in winter explained by low sunlight exposure but also for obtaining subsequent increases of this hormone even in these a priori adverse conditions.

PMID:34651517 | DOI:10.1177/19417381211050033