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Nevin Manimala Statistics

Factorization of person response profiles to identify summative profiles carrying central response patterns

Psychol Methods. 2023 Mar 27. doi: 10.1037/met0000568. Online ahead of print.

ABSTRACT

A data matrix, where rows represent persons and columns represent measured subtests, can be viewed as a stack of person profiles, as rows are actually person profiles of observed responses on column subtests. Profile analysis seeks to identify a small number of latent profiles from a large number of person response profiles to identify central response patterns, which are useful for assessing the strengths and weaknesses of individuals across multiple dimensions in domains of interest. Moreover, the latent profiles are mathematically proven to be summative profiles that linearly combine all person response profiles. Since person response profiles are confounded with profile level and response pattern, the level effect must be controlled when they are factorized to identify a latent (or summative) profile that carries the response pattern effect. However, when the level effect is dominant but uncontrolled, only a summative profile carrying the level effect would be considered statistically meaningful according to a traditional metric (e.g., eigenvalue ≥ 1) or parallel analysis results. Nevertheless, the response pattern effect among individuals can provide assessment-relevant insights that are overlooked by conventional analysis; to achieve this, the level effect must be controlled. Consequently, the purpose of this study is to demonstrate how to correctly identify summative profiles containing central response patterns regardless of the centering techniques used on data sets. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

PMID:36972078 | DOI:10.1037/met0000568

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Nevin Manimala Statistics

Family Conferences to Facilitate Deprescribing in Older Outpatients With Frailty and With Polypharmacy: The COFRAIL Cluster Randomized Trial

JAMA Netw Open. 2023 Mar 1;6(3):e234723. doi: 10.1001/jamanetworkopen.2023.4723.

ABSTRACT

IMPORTANCE: For older adults with frailty syndrome, reducing polypharmacy may have utility as a safety-promoting treatment option.

OBJECTIVE: To investigate the effects of family conferences on medication and clinical outcomes in community-dwelling older adults with frailty receiving polypharmacy.

DESIGN, SETTING, AND PARTICIPANTS: This cluster randomized clinical trial was conducted from April 30, 2019, to June 30, 221, at 110 primary care practices in Germany. The study included community-dwelling adults aged 70 years or older with frailty syndrome, daily use of at least 5 different medications, a life expectancy of at least 6 months, and no moderate or severe dementia.

INTERVENTIONS: General practitioners (GPs) in the intervention group received 3 training sessions on family conferences, a deprescribing guideline, and a toolkit with relevant nonpharmacologic interventions. Three GP-led family conferences for shared decision-making involving the participants and family caregivers and/or nursing services were subsequently held per patient at home over a period of 9 months. Patients in the control group received care as usual.

MAIN OUTCOMES AND MEASURES: The primary outcome was the number of hospitalizations within 12 months, as assessed by nurses during home visits or telephone interviews. Secondary outcomes included the number of medications, the number of European Union list of the number of potentially inappropriate medication (EU[7]-PIM) for older people, and geriatric assessment parameters. Both per-protocol and intention-to-treat analyses were conducted.

RESULTS: The baseline assessment included 521 individuals (356 women [68.3%]; mean [SD] age, 83.5 [6.17] years). The intention-to-treat analysis with 510 patients showed no significant difference in the adjusted mean (SD) number of hospitalizations between the intervention group (0.98 [1.72]) and the control group (0.99 [1.53]). In the per-protocol analysis including 385 individuals, the mean (SD) number of medications decreased from 8.98 (3.56) to 8.11 (3.21) at 6 months and to 8.49 (3.63) at 12 months in the intervention group and from 9.24 (3.44) to 9.32 (3.59) at 6 months and to 9.16 (3.42) at 12 months in the control group, with a statistically significant difference at 6 months in the mixed-effect Poisson regression model (P = .001). After 6 months, the mean (SD) number of EU(7)-PIMs was significantly lower in the intervention group (1.30 [1.05]) than in the control group (1.71 [1.25]; P = .04). There was no significant difference in the mean number of EU(7)-PIMs after 12 months.

CONCLUSIONS AND RELEVANCE: In this cluster randomized clinical trial with older adults taking 5 or more medications, the intervention consisting of GP-led family conferences did not achieve sustainable effects in reducing the number of hospitalizations or the number of medications and EU(7)-PIMs after 12 months.

TRIAL REGISTRATION: German Clinical Trials Register: DRKS00015055.

PMID:36972052 | DOI:10.1001/jamanetworkopen.2023.4723

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Nevin Manimala Statistics

Association of Electronic Cigarette Use by US Adolescents With Subsequent Persistent Cigarette Smoking

JAMA Netw Open. 2023 Mar 1;6(3):e234885. doi: 10.1001/jamanetworkopen.2023.4885.

ABSTRACT

IMPORTANCE: Many studies have reported a positive association of youth electronic cigarette (e-cigarette) use with subsequent cigarette smoking initiation, but it remains unclear whether e-cigarette use is associated with continued cigarette smoking after initiation.

OBJECTIVE: To assess the association of youth baseline e-cigarette use with their continued cigarette smoking 2 years after initiation.

DESIGN, SETTING, AND PARTICIPANTS: The Population Assessment of Tobacco and Health (PATH) Study is a national longitudinal cohort study. This sample consisted of youth who participated in waves 3, 4, and 5 of the study (wave 3 was from October 2015 to October 2016, wave 4 was from December 2016 to January 2018, and wave 5 was from December 2018 to November 2019) and had never used cigarettes (cigarette-naive) by wave 3. The current analysis used multivariable logistic regressions in August 2022 to assess the association between e-cigarette use among cigarette-naive adolescents aged 12 to 17 years in 2015 and 2016 and subsequent continued cigarette smoking. PATH uses audio computer-assisted self-interviewing and computer-assisted personal interviewing to collect data.

EXPOSURES: Ever and current (past 30-day) use of e-cigarettes in wave 3.

MAIN OUTCOMES AND MEASURES: Continued cigarette smoking in wave 5 after initiating smoking in wave 4.

RESULTS: The current sample included 8671 adolescents who were cigarette naive in wave 3 and also participated in waves 4 and 5; 4823 of the participants (55.4%) were aged 12 to 14 years, 4454 (51.1%) were male, and 3763 (51.0%) were non-Hispanic White. Overall, regardless of e-cigarette use, few adolescents (362 adolescents [4.1%]) initiated cigarette smoking at wave 4, and even fewer (218 participants [2.5%]) continued smoking at wave 5. Controlling for multiple covariates, the adjusted odds ratio of baseline ever e-cigarette use, compared with never e-cigarette use, was 1.81 (95% CI, 1.03 to 3.18) for continued smoking measured as past 30-day smoking at wave 5. However, the adjusted risk difference (aRD) was small and not significant. The aRD was 0.88 percentage point (95% CI, -0.13 to 1.89 percentage points) for continued smoking, with the absolute risk being 1.19% (95% CI, 0.79% to 1.59%) for never e-cigarette users and 2.07% (95% CI, 1.01% to 3.13%) for ever e-cigarette users. Similar results were found using an alternative measure of continued smoking (lifetime ≥100 cigarettes and current smoking at wave 5) and using baseline current e-cigarette use as the exposure measure.

CONCLUSIONS AND RELEVANCE: In this cohort study, absolute and relative measures of risks yielded findings suggesting very different interpretations of the association. Although there were statistically significant odds ratios of continued smoking comparing baseline e-cigarette users with nonusers, the minor risk differences between them, along with the small absolute risks, suggest that few adolescents are likely to continue smoking after initiation regardless of baseline e-cigarette use.

PMID:36972048 | DOI:10.1001/jamanetworkopen.2023.4885

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Nevin Manimala Statistics

Value Placed on Comfort vs Life Prolongation Among Patients Treated With Maintenance Dialysis

JAMA Intern Med. 2023 Mar 27. doi: 10.1001/jamainternmed.2023.0265. Online ahead of print.

ABSTRACT

IMPORTANCE: Patients receiving maintenance dialysis experience intensive patterns of end-of-life care that might not be consistent with their values.

OBJECTIVE: To evaluate the association of patients’ health care values with engagement in advance care planning and end-of-life care.

DESIGN, SETTING, AND PARTICIPANTS: Survey study of patients who received maintenance dialysis between 2015 and 2018 at dialysis centers in the greater metropolitan areas of Seattle, Washington, and Nashville, Tennessee, with longitudinal follow-up of decedents. Logistic regression models were used to estimate probabilities. Data analysis was conducted between May and October 2022.

EXPOSURES: A survey question about the value that the participant would place on longevity-focused vs comfort-focused care if they were to become seriously ill.

MAIN OUTCOMES AND MEASURES: Self-reported engagement in advance care planning and care received near the end of life through 2020 using linked kidney registry data and Medicare claims.

RESULTS: Of 933 patients (mean [SD] age, 62.6 [14.0] years; 525 male patients [56.3%]; 254 [27.2%] identified as Black) who responded to the question about values and could be linked to registry data (65.2% response rate [933 of 1431 eligible patients]), 452 (48.4%) indicated that they would value comfort-focused care, 179 (19.2%) that they would value longevity-focused care, and 302 (32.4%) that they were unsure about the intensity of care they would value. Many had not completed an advance directive (estimated probability, 47.5% [95% CI, 42.9%-52.1%] of those who would value comfort-focused care vs 28.1% [95% CI, 24.0%-32.3%] of those who would value longevity-focused care or were unsure; P < .001), had not discussed hospice (estimated probability, 28.6% [95% CI, 24.6%-32.9%] comfort focused vs 18.2% [95% CI, 14.7%-21.7%] longevity focused or unsure; P < .001), or had not discussed stopping dialysis (estimated probability, 33.3% [95% CI, 29.0%-37.7%] comfort focused vs 21.9% [95% CI, 18.2%-25.8%] longevity focused or unsure; P < .001). Most respondents wanted to receive cardiopulmonary resuscitation (estimated probability, 78.0% [95% CI, 74.2%-81.7%] comfort focused vs 93.9% [95% CI, 91.4%-96.1%] longevity focused or unsure; P < .001) and mechanical ventilation (estimated probability, 52.0% [95% CI, 47.4%-56.6%] comfort focused vs 77.9% [95% CI, 74.0%-81.7%] longevity focused or unsure; P < .001). Among decedents, the percentages of participants who received an intensive procedure during the final month of life (estimated probability, 23.5% [95% CI, 16.5%-31.0%] comfort focused vs 26.1% [95% CI, 18.0%-34.5%] longevity focused or unsure; P = .64), discontinued dialysis (estimated probability, 38.3% [95% CI, 32.0%-44.8%] comfort focused vs 30.2% [95% CI, 23.0%-37.8%] longevity focused or unsure; P = .09), and enrolled in hospice (estimated probability, 32.2% [95% CI, 25.7%-38.7%] comfort focused vs 23.3% [95% CI, 16.4%-30.5%] longevity focused or unsure; P = .07) were not statistically different.

CONCLUSIONS AND RELEVANCE: This survey study found that there appeared to be a disconnect between patients’ expressed values, which were largely comfort focused, and their engagement in advance care planning and end-of-life care, which reflected a focus on longevity. These findings suggest important opportunities to improve the quality of care for patients receiving dialysis.

PMID:36972031 | DOI:10.1001/jamainternmed.2023.0265

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Nevin Manimala Statistics

Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters

Ther Innov Regul Sci. 2023 Mar 27. doi: 10.1007/s43441-023-00504-6. Online ahead of print.

ABSTRACT

Since the release of ICH E6(R2), multiple efforts have been made to interpret the requirements and suggest ways of implementing quality tolerance limits (QTLs) alongside existing risk-based quality management methodologies. While these efforts have contributed positively to developing a common understanding of QTLs, some uncertainty remains regarding implementable approaches. In this article, we review the approaches taken by some leading biopharmaceutical companies, offering recommendations for how to make QTLs most effective, what makes them ineffective, and several case studies to illustrate these concepts. This includes how best to choose QTL parameters and thresholds for a given study, how to differentiate QTLs from key risk indicators, and how QTLs relate to critical-to-quality factors and the statistical design of the trials.

PMID:36972010 | DOI:10.1007/s43441-023-00504-6

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Nevin Manimala Statistics

Non-Gaussian model-based diffusion-weighted imaging of oral squamous cell carcinoma: associations with Ki-67 proliferation status

Oral Radiol. 2023 Mar 27. doi: 10.1007/s11282-023-00682-x. Online ahead of print.

ABSTRACT

OBJECTIVES: To investigate possible associations between diffusion-weighted imaging (DWI) parameters derived from a non-Gaussian model fitting and Ki-67 status in patients with oral squamous cell carcinoma (OSCC).

METHODS: Twenty-four patients with newly diagnosed OSCC were prospectively recruited. DWI was performed using six b-values (0-2500). The diffusion-related parameters of kurtosis value (K), kurtosis-corrected diffusion coefficient (DK), diffusion heterogeneity (α), distributed diffusion coefficient (DDC), slow diffusion coefficient (Dslow), and apparent diffusion coefficient (ADC) were calculated from four diffusion fitting models. Ki-67 status was categorized as low (Ki-67 percentage score < 20%), middle (20-50%), or high (> 50%). Kruskal-Wallis tests were performed between each non-Gaussian diffusion model parameters and Ki-67 grade.

RESULTS: The Kruskal-Wallis tests revealed that multiple parameters (K, ADC, Dk, DDC and Dslow) showed statistically significant differences between the three levels of Ki-67 status (K: p = 0.020, ADC: p = 0.012, Dk: p = 0.027, DDC: p = 0.007 and Dslow: p = 0.026).

CONCLUSIONS: Several non-Gaussian diffusion model parameters and ADC values were significantly associated with Ki-67 status and have potential as promising prognostic biomarkers in patients with OSCC.

PMID:36971988 | DOI:10.1007/s11282-023-00682-x

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Nevin Manimala Statistics

Reply to: “The Feasibility of Breast-Conserving Surgery for Multiple Ipsilateral Breast Cancer: An Initial Report from ACOSOG Z11102 (Alliance) Trial: A Comment” by Alser, Osaid

Ann Surg Oncol. 2023 Mar 27. doi: 10.1245/s10434-023-13375-w. Online ahead of print.

NO ABSTRACT

PMID:36971986 | DOI:10.1245/s10434-023-13375-w

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Nevin Manimala Statistics

Role of intra-operative traction in deformity correction in neuromuscular scoliosis: a systematic review and meta-analysis

Spine Deform. 2023 Mar 27. doi: 10.1007/s43390-023-00682-1. Online ahead of print.

ABSTRACT

PURPOSE: Intra-operative traction (IOT) has emerged as new modality for improving correction rates in scoliosis since it has the potential to reduce operative time and blood loss in neuromuscular scoliosis (NMS). The aim of this study is to describe the effects of IOT in deformity correction in NMS.

METHODS: The search was conducted in online electronic databases following the PRISMA guidelines. This review included studies on NMS which have described usage of IOT in deformity correction.

RESULTS: Eight studies were included in analysis and review. There was low-to-moderate heterogeneity across the studies (I2 – 42.4 to 93.9%). All the studies used cranio-femoral traction for IOT. The final Cobb’s angle in coronal plane was significantly lower in the traction group as compared to the non-traction group (SMD – 0.36 95% CI – 0.71 to 0). There was a trend towards better outcomes in final obliquity (SMD – 0.78 95% CI – 1.64 to 0.09), operative time (SMD – 1.09 95% CI – 2.25 to 0.08) and blood loss (SMD – 0.86 95% CI significantly lower in the traction group as 2.15 to 0.44) but did not reach statistical significance.

CONCLUSION: IOT helped to achieve significant scoliotic curve correction in NMS compared to non-traction group. Despite the overall tendency of improved pelvic obliquity correction, reduced operative time and reduced blood loss as compared to a surgery without the use of IOT, it did not achieve statistical significance. Further studies which are prospective with a larger sample size and focussing on a particular etiology may be conducted which would validate the results.

LEVEL OF EVIDENCE: IV.

PMID:36971963 | DOI:10.1007/s43390-023-00682-1

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Nevin Manimala Statistics

Toxicity of methylparaben and its chlorinated derivatives to Allium cepa L. and Eisenia fetida Sav

Environ Sci Pollut Res Int. 2023 Mar 27. doi: 10.1007/s11356-023-26539-8. Online ahead of print.

ABSTRACT

Methylparaben, chloro-methylparaben, and dichloro-methylparaben were evaluated in Allium cepa at 5, 10, 50, and 100 μg/L and in Eisenia fetida at 10 and 100 μg/L. In A. cepa roots, 100 μg/L methylparaben and 50 and 100 μg/L chlorinated methylparabens reduced cell proliferation, caused cellular changes, and reduced cell viability in meristems, which caused a reduction in root growth. Furthermore, they caused drastic inhibition of catalase, ascorbate peroxidase, and superoxide dismutase; activated guaiacol peroxidase and promoted lipid peroxidation in meristematic root cells. In earthworms, after 14 days exposure to the three compounds, there were no deaths, and catalase, ascorbate peroxidase, and superoxide dismutase were not inhibited. However, guaiacol peroxidase activity and lipid peroxidation were observed in animals exposed to dichloro-methylparaben. Soils with dichloro-methylparaben also caused the escape of earthworms. It is inferred that the recurrent contamination of soils with these methylparabens, with emphasis on chlorinated derivatives, can negatively impact different species that depend directly or indirectly on soil to survive.

PMID:36971943 | DOI:10.1007/s11356-023-26539-8

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Nevin Manimala Statistics

Spatiotemporal analysis of the surface urban heat island (SUHI), air pollution and disease pattern: an applied study on the city of Granada (Spain)

Environ Sci Pollut Res Int. 2023 Mar 27. doi: 10.1007/s11356-023-26564-7. Online ahead of print.

ABSTRACT

There is worldwide concern about how climate change -which involves rising temperatures- may increase the risk of contracting and developing diseases, reducing the quality of life. This study provides new research that takes into account parameters such as land surface temperature (LST), surface urban heat island (SUHI), urban hotspot (UHS), air pollution (SO2, NO2, CO, O3 and aerosols), the normalized difference vegetation index (NDVI), the normalized difference building index (NDBI) and the proportion of vegetation (PV) that allows evaluating environmental quality and establishes mitigation measures in future urban developments that could improve the quality of life of a given population. With the help of Sentinel 3 and 5P satellite images, we studied these variables in the context of Granada (Spain) during the year 2021 to assess how they may affect the risk of developing diseases (stomach, colorectal, lung, prostate and bladder cancer, dementia, cerebrovascular disease, liver disease and suicide). The results, corroborated by the statistical analysis using the Data Panel technique, indicate that the variables LST, SUHI and daytime UHS, NO2, SO2 and NDBI have important positive correlations above 99% (p value: 0.000) with an excess risk of developing these diseases. Hence, the importance of this study for the formulation of healthy policies in cities and future research that minimizes the excess risk of diseases.

PMID:36971934 | DOI:10.1007/s11356-023-26564-7