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Nevin Manimala Statistics

Statistical considerations for some issues in clinical bridging studies evaluating companion diagnostic devices

J Biopharm Stat. 2023 Jun 18:1-12. doi: 10.1080/10543406.2023.2220398. Online ahead of print.

ABSTRACT

An in vitro diagnostic device (IVD) that is essential for the safe and effective use of a corresponding therapeutic product is commonly referred to as companion diagnostic device. Clinical trials using companion diagnostic devices (tests) together with therapies can yield the information necessary to address whether both products are safe and effective. A clinical trial ideally assesses safety and effectiveness of a therapy, where the clinical trial enrolls subjects based on the final market ready companion diagnostic test (CDx). However, such a requirement may be difficult to accomplish or impractical to achieve at the time of the clinical trial enrollment, due to unavailability of the CDx. Instead, clinical trial assay(s) (CTA), which are not the final marketable product, are often used in enrollment of patients in a clinical trial. When CTA is used for subject enrollment, a clinical bridging study provides a mechanism to bridge the clinical efficacy of the therapeutic product from CTA to CDx. This manuscript reviews some issues and challenges commonly associated with clinical bridging studies, including missing data, use of local tests for enrollment, prescreening before enrollment, and evaluation of CDx for low positive rate biomarkers, with particular focus on clinical trials using a binary endpoint and provide alternative statistical methodologies to assess effectiveness of CDx.

PMID:37330676 | DOI:10.1080/10543406.2023.2220398

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Nevin Manimala Statistics

The impact of smartphone app-based interventions on adolescents’ dietary intake: a systematic review and evaluation of equity factor reporting in intervention studies

Nutr Rev. 2023 Jun 18:nuad058. doi: 10.1093/nutrit/nuad058. Online ahead of print.

ABSTRACT

CONTEXT: Adolescence is a critical stage for improving nutrition. The popularity of smartphones makes them an ideal platform for administering interventions to adolescents. A systematic review has yet to assess the impact of smartphone app-based interventions exclusively on adolescents’ dietary intake. Furthermore, despite the impact of equity factors on dietary intake and the claim for mobile health of increased accessibility, there is minimal research on the reporting of equity factors in the evaluation of smartphone app-based nutrition-intervention research.

OBJECTIVES: This systematic review examines the effectiveness of smartphone app-based interventions on adolescents’ dietary intake and the frequency with which equity factors and statistical analyses specific to equity factors are reported in these intervention studies.

DATA SOURCES: Databases (ie, Scopus, CINAHL, EMBASE, MEDLINE, PsycINFO, ERIC, and Cochrane Central Register for Randomized Control Trials) were searched for studies published from January 2008 to October 2022. Smartphone app-based intervention studies that were nutrition focused, evaluated at least 1 dietary intake variable, and included participants with a mean age between 10 and 19 years were included. All geographic locations were included.

DATA EXTRACTION AND ANALYSIS: Study characteristics, intervention results, and reported equity factors were extracted. Because of the heterogeneity of dietary outcomes, findings were reported as a narrative synthesis.

CONCLUSION: In total, 3087 studies were retrieved, 14 of which met the inclusion criteria. Eleven studies reported a statistically significant improvement in at least 1 dietary outcome because of the intervention. Reporting of at least 1 equity factor across articles’ Introduction, Methods, Results, and Discussion sections was minimal (n = 5), and statistical analyses specific to equity factors were rare, occurring in only 4 of the 14 included studies. Future interventions should include a measurement of intervention adherence and report the impact of equity factors on the effectiveness and applicability of interventions for equity-deserving groups.

PMID:37330675 | DOI:10.1093/nutrit/nuad058

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Nevin Manimala Statistics

Evaluation of grafting for management of southern blight in processing tomatoes in California

Plant Dis. 2023 Jun 17. doi: 10.1094/PDIS-10-22-2445-RE. Online ahead of print.

ABSTRACT

Options for managing southern blight of processing tomato (caused by Athelia rolfsii) in California are limited. The objectives of this study were to: (i) evaluate grafting with the resistant rootstock Maxifort for southern blight management in processing tomato; and (ii) evaluate increasing the height of the graft union to further reduce incidence of southern blight in grafted plants. We evaluated two cultivars (Heinz 5608 or Heinz 8504) and a grafting factor with three levels (grafted to Maxifort rootstock with standard scion height, grafted to Maxifort rootstock at a tall height, and non-grafted) in a field study with natural inoculum or in inoculated greenhouse experiments. Southern blight severity was low in both greenhouse experiments in 2018 and 2019 and no consistent trends were observed. In field experiments in 2018 and 2019, mean incidence in non-grafted plots was 6.2 to 17.0 times higher when compared to either the standard or tall grafted treatments. Southern blight was numerically lower in tall grafted plots compared to standard, but the magnitude was small and not statistically significant. Based on our studies, grafting can reduce losses of processing tomato in California to southern blight but increasing the height of the graft union does not offer a tangible benefit.

PMID:37330632 | DOI:10.1094/PDIS-10-22-2445-RE

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Nevin Manimala Statistics

The value of Medicare coverage on depressive symptoms among older immigrants

Gerontologist. 2023 Jun 18:gnad070. doi: 10.1093/geront/gnad070. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: The immigrant population, the primary driver of U.S. population growth, is aging and many immigrants remain uninsured. Lack of health insurance limits access to care, aggravating the already high level of depression for older immigrants. However, there is scarce evidence on how health insurance, particularly Medicare, affects their mental health. Using the Health and Retirement Study, this study examines the effect of Medicare coverage on depressive symptoms of older immigrants in the U.S.

RESEARCH DESIGN AND METHODS: Exploiting the fact that many immigrants are not covered by Medicare after passing age 65, we use a difference-in-difference model with propensity score weighting to compare differences in depressive symptoms pre- and post-age-65. We further stratify the sample by socioeconomic status and by race/ethnicity.

RESULTS: Medicare coverage was significantly associated with a reduction in the probability of reporting depressive symptoms for immigrants with low socioeconomic status, especially for those below median wealth levels. The beneficial effect of Medicare coverage was also statistically significant for non-White immigrants – Black, Hispanic, and Asian/Pacific Islander – even when holding socioeconomic status constant.

DISCUSSION AND IMPLICATIONS: Our findings imply that immigration policies that expand healthcare protection to older immigrants can lead to further health benefits and reduce existing disparities for the aging population. Policy reforms such as providing limited Medicare access to immigrants who paid sufficient taxes but are still awaiting permanent residency status could increase coverage for the uninsured and improve participation of immigrants in the payroll system.

PMID:37330627 | DOI:10.1093/geront/gnad070

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Nevin Manimala Statistics

Executive function predicts older adults’ lure discrimination difficulties on the Mnemonic Similarity Task

J Gerontol B Psychol Sci Soc Sci. 2023 Jun 18:gbad091. doi: 10.1093/geronb/gbad091. Online ahead of print.

ABSTRACT

OBJECTIVES: Older adults often have difficulty remembering the details of recently encountered objects. We (Davidson et al., 2019) found this with the Mnemonic Similarity Task (MST). Surprisingly, the older adults’ MST lure discrimination index (LDI) was significantly correlated with visual acuity but not with memory or executive function. Here we ran a replication with new, larger samples of young (N=45) and older adults (N=70). We then combined the original and replication older adult samples (N=108) to critically examine the relative contributions of visual acuity, memory, and executive function composite scores to LDI performance using dominance analysis. This provided, to our knowledge, the first direct statistical comparison of all three of these factors and their interactions on LDI.

METHOD: Participants completed the MST and a battery assessing visual acuity, memory, and executive function. We examined age group differences on MST performance in the new (i.e., replication) young and older adult samples and performed multiple regression and dominance analysis on the combined older adult sample.

RESULTS: Consistent with previous findings, the older adults showed significantly poorer LDI but preserved item recognition. LDI was significantly correlated with both memory and executive function but not with visual acuity. In the combined older adult sample, all three composites predicted LDI, but dominance analysis indicated that executive function was the most important predictor.

DISCUSSION: Older adults’ MST LDI difficulty may be predicted by their executive function and visual acuity. These factors should be considered when interpreting older adults’ MST performance.

PMID:37330622 | DOI:10.1093/geronb/gbad091

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Nevin Manimala Statistics

Prescription of Panoramic Radiographs in Children Using Age-based Prevalence of Dental Anomalies and Pathologies

Int J Paediatr Dent. 2023 Jun 17. doi: 10.1111/ipd.13095. Online ahead of print.

ABSTRACT

BACKGROUND: Panoramic radiographs (PRs) are used in the detection and diagnosis of developmental dental anomalies and pathologies (DDAP) in children.

AIM: The primary objective of this observational cohort study was to evaluate the age-based prevalence of DDAP on PRs while the secondary objective was to determine a threshold age for detection of DDAP to provide supportive evidence for prescription of PR in pediatric dental practice.

DESIGN: The study examined diagnostic PRs from 581 subjects from ages 6-19 years. All PRs were reviewed by experienced, calibrated, masked examiners for identification or presence of anomalies of size, shape, position, structure, and other developmental anomalies and pathologies (ODAP) of face-neck region in a standardized condition. The data was statistically analyzed for interpretation.

RESULTS: Overall, 74% (n=411) of the cohort had at least one anomaly (shape anomaly: 12%, number anomaly: 17%, positional anomaly: 28%, structural anomaly: 0%, and ODAP: 63%). The optimal Youden index cutoff for any anomaly was 9 years. Twelve and 15 years also showed predictive ability.

CONCLUSIONS: The results suggest that PRs should be prescribed at ages 9, 12, and 15 years for the diagnosis of DDAP.

PMID:37330621 | DOI:10.1111/ipd.13095

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Nevin Manimala Statistics

Carbon stocks of particle board and fiberboard in Japan

Sci Rep. 2023 Jun 17;13(1):9846. doi: 10.1038/s41598-023-37132-x.

ABSTRACT

The carbon stock function of harvested wood products (HWPs) is attracting attention among climate change countermeasures. Among HWPs, particle board (PB) and fiberboard (FB) mainly use recycled materials. This study estimated carbon stocks of PB and FB and their annual changes over the past 70 years in Japan using three methods of the Intergovernmental Panel on Climate Change guidelines: Tiers 1-3. Tier 1 uses first order decay (FOD), a 25-year half-life, and the Food and Agriculture Organization of the United Nations database. Tier 2 uses FOD, a 25-year half-life, and Japan-specific statistics. Tier 3 uses a log-normal distribution for the decay function and a 38-63-year half-life of building PB/FB. Japan’s PB and FB carbon stocks have increased for the past 70 years. The latest carbon stock in early 2022 and the annual change in carbon stock in 2021 was 21.83 million t-C and 0.42 million t-C/year, respectively for Tier 3. Tier 3 has the highest estimation accuracy by using decay functions and half-lives that match the actual conditions of building PB and FB, whereas Tiers 1 and 2 were underestimates. Approximately 40% of the carbon stock is derived from waste wood, which extends its utilization.

PMID:37330597 | DOI:10.1038/s41598-023-37132-x

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Nevin Manimala Statistics

Magnitude of central obesity and associated factors among adult patients attending public health facilities in Adama town, Oromia region, Ethiopia, 2022

J Health Popul Nutr. 2023 Jun 17;42(1):57. doi: 10.1186/s41043-023-00397-z.

ABSTRACT

BACKGROUND: Central obesity is excessive accumulation of fat around the abdomen, which is associated with the risk of coronary heart and cerebrovascular diseases. This study determined the magnitude of central obesity among adult patients using the waist-to-hip ratio, which has a superior capacity to measure the risk of developing non-communicable diseases compared to the body mass index used in previous studies in Ethiopia.

METHODS: Institutional-based cross-sectional study was conducted among a sample of 480 adults from April 1 to May 30, 2022. A systematic random sampling technique was used to select the study participants. Data were collected by using interviewer-administered structured questionnaires and anthropometric measurements. The data were entered into EPI INFO version 7 and analyzed by Statistical Software for Social Science Version 25. The associations between independent and dependent variables were checked using bivariate and multivariate logistic regression analyses. Adjusted odds ratio and 95% confidence interval were used to measure the strengths of the association. Statistical significance was declared at a P value of less than 0.05.

RESULTS: The magnitude of central obesity in this study was 40% (51.2% and 27.4% among females and males, respectively (95% CI 36-44%)). Being a female (AOR = 9.5, 95% CI 5.22-17.9), age range 35-44 (AOR = 7.0, 95% CI 2.9-16.7), 45-64 years (AOR = 10.1, 95% CI4.0-15.2), married (AOR = 2.5, 95% CI 1.3-4.7), high monthly income (AOR = 3.3, 95% CI 1.5-7.3), high consumption of milk and milk products (AOR = 0.3, 95% CI 0.1-0.6), family history of obesity (AOR = 1.8, 95% CI 1.1-3.2) were significantly associated with central obesity among the study participants.

CONCLUSION: The magnitude of central obesity was higher in the study area. Sex, age, marital status, monthly income, consumption of milk and milk products, and family history of obesity were independent determinants of central obesity. Therefore, it is important to raise awareness about central obesity through behavior change communication that targets the high-risk population.

PMID:37330577 | DOI:10.1186/s41043-023-00397-z

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Nevin Manimala Statistics

Machine-learning-based diagnosis of thyroid fine-needle aspiration biopsy synergistically by Papanicolaou staining and refractive index distribution

Sci Rep. 2023 Jun 17;13(1):9847. doi: 10.1038/s41598-023-36951-2.

ABSTRACT

We developed a machine learning algorithm (MLA) that can classify human thyroid cell clusters by exploiting both Papanicolaou staining and intrinsic refractive index (RI) as correlative imaging contrasts and evaluated the effects of this combination on diagnostic performance. Thyroid fine-needle aspiration biopsy (FNAB) specimens were analyzed using correlative optical diffraction tomography, which can simultaneously measure both, the color brightfield of Papanicolaou staining and three-dimensional RI distribution. The MLA was designed to classify benign and malignant cell clusters using color images, RI images, or both. We included 1535 thyroid cell clusters (benign: malignancy = 1128:407) from 124 patients. Accuracies of MLA classifiers using color images, RI images, and both were 98.0%, 98.0%, and 100%, respectively. As information for classification, the nucleus size was mainly used in the color image; however, detailed morphological information of the nucleus was also used in the RI image. We demonstrate that the present MLA and correlative FNAB imaging approach has the potential for diagnosing thyroid cancer, and complementary information from color and RI images can improve the performance of the MLA.

PMID:37330568 | DOI:10.1038/s41598-023-36951-2

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Nevin Manimala Statistics

The role of asymmetric dimethylarginine (ADMA) in COVID-19: association with respiratory failure and predictive role for outcome

Sci Rep. 2023 Jun 17;13(1):9811. doi: 10.1038/s41598-023-36954-z.

ABSTRACT

We aimed to assess the potential role of Asymmetric dimethylarginine (ADMA) in conditioning respiratory function and pulmonary vasoregulation during Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2) infection. Within 72 h from admission, samples from 90 COVID-19 patients were assessed for ADMA, SDMA, L-arginine concentrations. In addition to classical statistics, patients were also clustered by a machine learning approach according to similar features. Multivariable analysis showed that C-reactive protein (OR 1.012), serum ADMA (OR 4.652), white blood cells (OR = 1.118) and SOFA (OR = 1.495) were significantly associated with negative outcomes. Machine learning-based clustering showed three distinct clusters: (1) patients with low severity not requiring invasive mechanical ventilation (IMV), (2) patients with moderate severity and respiratory failure whilst not requiring IMV, and (3) patients with highest severity requiring IMV. Serum ADMA concentration was significantly associated with disease severity and need for IMV although less pulmonary vasodilation was observed by CT scan. High serum levels of ADMA are indicative of high disease severity and requirement of mechanical ventilation. Serum ADMA at the time of hospital admission may therefore help to identify COVID-19 patients at high risk of deterioration and negative outcome.

PMID:37330534 | DOI:10.1038/s41598-023-36954-z