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Nevin Manimala Statistics

Pairs or Paradoxes: Questioning Assumptions in Tuberculosis Transmission Research

Am J Respir Crit Care Med. 2024 Jul 17. doi: 10.1164/rccm.202405-0958LE. Online ahead of print.

NO ABSTRACT

PMID:39018563 | DOI:10.1164/rccm.202405-0958LE

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The Impact of COVID-19 Health Measures on Adults With Multiple Chemical Sensitivity: Cross-Sectional Study

JMIR Form Res. 2024 Jul 17;8:e48434. doi: 10.2196/48434.

ABSTRACT

BACKGROUND: Multiple chemical sensitivity (MCS) develops in response to repeated small-level chemical exposures or a major exposure in a subset of people, who then experience symptoms that can range from mild to debilitating when exposed to chemicals. The arrival of the COVID-19 pandemic and the stringent health measures put in place may have increased the burden for those living with MCS, as it became more challenging to avoid chemicals that trigger their condition.

OBJECTIVE: This study aimed to better understand the lived experience of Canadians living with MCS during the first year of the COVID-19 pandemic.

METHODS: An online questionnaire was created to ask participants to compare daily living during the pandemic to before March 11, 2020. Data were collected in January and February 2021. Three areas were investigated: (1) environmental exposures to chemical triggers from ambient air (pollution from industry, farming, and traffic) and indoor air (the smell of cleaning products, cooking odors, and smoke); (2) access to, and satisfaction with, health care visits; and (3) how people experiencing MCS rated contact with their social network.

RESULTS: In all, 119 Canadians who had lived with MCS for more than a year completed the questionnaire. The participant sample was mostly female (86.6%, n=103) and highly educated, with 57.1% (n=68) having a university degree. Slightly more than half (57.1%, n=68) were older than 55 years. McNemar chi-square and Wilcoxon signed rank tests were used to evaluate if there were statistically significant changes before (“prepandemic period”) and after (“postpandemic period”) March 11, 2020. Perceived exposure to pollution from a highway or a road was significantly decreased from the prepandemic to postpandemic period (z=-3.347; P<.001). Analysis of industry or power plants also suggested a significant decrease in the perceived exposure from the prepandemic to postpandemic period (z=-2.152; P=.04). Participants reported an increase in exposure to odors from disinfectants or sanitizers that entered their living environment (P<.001). There was a significant decrease between prepandemic and postpandemic levels of satisfaction when attending in-person meetings with a physician (z=-2.048; P=.04), yet there were no significant differences between prepandemic and postpandemic levels of satisfaction for online or telephone meetings with a physician. Although people with MCS experienced increased social isolation (P<.001), they also reported an increase in understanding from family (P=.03) and a decrease in stigma for wearing personal protective equipment (P<.001).

CONCLUSIONS: During the first year of the COVID-19 pandemic, people with MCS were impacted by inaccessibility, loss of social support, and barriers to accessing health care. This study highlights unique challenges and possible benefits associated with the COVID-19 pandemic public health measures for individuals living with MCS. These findings can guide decision makers to improve policies on accessibility through appropriate accommodation measures.

PMID:39018551 | DOI:10.2196/48434

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Mental health among women and girls of diverse backgrounds in Canada before and during the COVID-19 pandemic: An intersectional analysis

Health Rep. 2024 Jul 17;35(7):14-27. doi: 10.25318/82-003-x202400700002-eng.

ABSTRACT

BACKGROUND: Mental health disparity is associated with diverse characteristics, such as gender, socioeconomic status, Indigenous identity, immigrant status, race, disability, and sexual orientation. However, intersectional studies on women’s mental health have been rare, particularly during the COVID-19 pandemic period.

METHODS: Using data from two cycles of the Canadian Community Health Survey (2019 annual data and data from September to December 2020), self-reported mental health outcomes before the COVID-19 pandemic (sample size was 64,880) and during the second wave of the pandemic in the fall of 2020 (sample size of 27,246) were analyzed.

RESULTS: After sociodemographic factors were controlled for, women and girls had higher odds of poorer self-perceived mental health and worsened mental health compared with before the COVID-19 pandemic than men and boys. Compared with 2019, the gender gap in negative self-perceived mental health increased during the pandemic. The number and type of intersections of specific socioeconomic characteristics also had an impact on mental health outcomes. During the pandemic, women and girls with the following characteristics were more likely to report low self-perceived mental health, compared with women and girls with no intersections: those with a disability (7.8 times); or who are lesbian, gay, or bisexual or have another sexual orientation than heterosexual (5.6); or who are Indigenous (3.6).

INTERPRETATION: The intersections of gender and other sociodemographic characteristics increased the odds of negative self-perceived mental health.

PMID:39018524 | DOI:10.25318/82-003-x202400700002-eng

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The association between rurality, places of care and the location of death of long-term care home residents with dementia: A population-based study

Health Rep. 2024 Jul 17;35(7):3-13. doi: 10.25318/82-003-x202400700001-eng.

ABSTRACT

BACKGROUND: Most individuals prefer to spend their final moments of life outside a hospital setting. This study compares the places of care and death of long-term care (LTC) home residents in Ontario in the last 90 days of life, according to LTC home rurality.

DATA AND METHODS: This retrospective cohort study was conducted using health administrative data from ICES (formerly known as the Institute for Clinical Evaluative Sciences). The study population, which was identified through algorithms, included all Ontario LTC home residents with a dementia diagnosis who died between April 1, 2014, and March 31, 2019. The location of death was categorized as in an acute care hospital, an LTC home, a subacute care facility, or the community. Places of care included emergency department visits and hospitalizations in the last 90 days of life. Statistical tests were used to evaluate differences in location of death and places of care by rurality.

RESULTS: Of the 65,375 LTC home residents with dementia, 49,432 (75.6%) died in an LTC home. Residents of LTC homes in the most urban areas were less likely to die in an LTC home than those in more rural homes (adjusted relative risk: 0.84; 95% confidence interval: 0.83 to 0.85). A higher proportion of residents of the most urban LTC homes had at least one hospitalization in the last 90 days of life compared with rural residents (23.7% versus 9.9% palliative hospitalizations and 28.3% versus 15.9% non-palliative hospitalizations [p ⟨ 0.001]).

INTERPRETATION: Individuals with dementia residing in urban LTC homes are more likely to receive care in the hospital and to die outside a LTC home than their counterparts living in rural LTC homes. The findings of this work will inform efforts to improve end-of-life care for older adults with dementia living in LTC homes.

PMID:39018523 | DOI:10.25318/82-003-x202400700001-eng

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Tailored Dose-Dense Versus Standard Adjuvant Chemotherapy for High-Risk Early Breast Cancer: End-of-Study Results of the Randomized PANTHER Trial

J Clin Oncol. 2024 Jul 17:JCO2400178. doi: 10.1200/JCO.24.00178. Online ahead of print.

ABSTRACT

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.Although dose-dense adjuvant chemotherapy administered once every 2 weeks leads to superior outcomes compared with standard regimens once every 3 weeks, the observed improvement is largely limited to studies using the suboptimal paclitaxel schedule once every 3 weeks as control. PANTHER is an international phase III trial which compared sequential epirubicin/cyclophosphamide and docetaxel administered either once every 2 or once every 3 weeks, with tailored dosing at the dose-dense schedule according to hematologic toxicity. In this end-of-study analysis, the median follow-up was 10.3 years. Compared with standard adjuvant chemotherapy, dose-dense treatment improved breast cancer recurrence-free survival (hazard ratio [HR], 0.80 [95% CI, 0.65 to 0.98]; P = .030), event-free survival (HR, 0.78 [95% CI, 0.65 to 0.94]; P = .009), and distant disease-free survival (HR, 0.79 [95% CI, 0.64 to 0.98]; P = .030) while the improvement in overall survival was not statistically significant (HR, 0.82 [95% CI, 0.65 to 1.04]; P = .109). To our knowledge, this is the first trial that confirms the benefit of a dose-dense regimen over a control regimen containing docetaxel once every 3 weeks.

PMID:39018515 | DOI:10.1200/JCO.24.00178

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Predicting Benefit From FOLFOXIRI Plus Bevacizumab in Patients With Metastatic Colorectal Cancer

JCO Clin Cancer Inform. 2024 Jul;8:e2400037. doi: 10.1200/CCI.24.00037.

ABSTRACT

PURPOSE: Patient outcomes may differ from randomized trial averages. We aimed to predict benefit from FOLFOXIRI versus infusional fluorouracil, leucovorin, and oxaliplatin/fluorouracil, leucovorin, and irinotecan (FOLFOX/FOLFIRI), both plus bevacizumab, in patients with metastatic colorectal cancer (mCRC).

METHODS: A Cox model with prespecified clinical, molecular, and laboratory variables was developed in 639 patients from the TRIBE2 trial for predicting 2-year mortality. Data from the CHARTA (n = 232), TRIBE1 (n = 504), and CAIRO5 (liver-only mCRC, n = 287) trials were used for external validation and heterogeneity of treatment effects (HTE) analysis. This involves categorizing patients into risk groups and assessing treatment effects across these groups. Performance was assessed by the C-index and calibration plots. The C-for-benefit was calculated to assess evidence for HTE. The c-for-benefit is specifically designed for HTE analysis. Like the commonly known c-statistic, it summarizes the discrimination of a model. Values over 0.5 indicate evidence for HTE.

RESULTS: In TRIBE2, the overoptimism-corrected C-index was 0.66 (95% CI, 0.63 to 0.69). At external validation, the C-index was 0.69 (95% CI, 0.64 to 0.75), 0.68 (95% CI, 0.64 to 0.72), and 0.65 (95% CI, 0.65 to 0.66), in CHARTA, TRIBE1, and CAIRO5, respectively. Calibration plots indicated slight underestimation of mortality. The c-for-benefit indicated evidence for HTE in CHARTA (0.56, 95% CI, 0.48 to 0.65), but not in TRIBE1 (0.49, 95% CI, 0.44 to 0.55) and CAIRO5 (0.40, 95% CI, 0.32 to 0.48).

CONCLUSION: Although 2-year mortality could be reasonably estimated, the HTE analysis showed that clinically available variables did not reliably identify which patients with mCRC benefit from FOLFOXIRI versus FOLFOX/FOLFIRI, both plus bevacizumab, across the three studies.

PMID:39018510 | DOI:10.1200/CCI.24.00037

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The incremental design of a machine learning framework for medical records processing

J Am Med Inform Assoc. 2024 Jul 17:ocae194. doi: 10.1093/jamia/ocae194. Online ahead of print.

ABSTRACT

OBJECTIVES: This work presents the development and evaluation of coordn8, a web-based application that streamlines fax processing in outpatient clinics using a “human-in-the-loop” machine learning framework. We demonstrate the effectiveness of the platform at reducing fax processing time and producing accurate machine learning inferences across the tasks of patient identification, document classification, spam classification, and duplicate document detection.

METHODS: We deployed coordn8 in 11 outpatient clinics and conducted a time savings analysis by observing users and measuring fax processing event logs. We used statistical methods to evaluate the machine learning components across different datasets to show generalizability. We conducted a time series analysis to show variations in model performance as new clinics were onboarded and to demonstrate our approach to mitigating model drift.

RESULTS: Our observation analysis showed a mean reduction in individual fax processing time by 147.5 s, while our event log analysis of over 7000 faxes reinforced this finding. Document classification produced an accuracy of 81.6%, patient identification produced an accuracy of 83.7%, spam classification produced an accuracy of 98.4%, and duplicate document detection produced a precision of 81.0%. Retraining document classification increased accuracy by 10.2%.

DISCUSSION: coordn8 significantly decreased fax-processing time and produced accurate machine learning inferences. Our human-in-the-loop framework facilitated the collection of high-quality data necessary for model training. Expanding to new clinics correlated with performance decline, which was mitigated through model retraining.

CONCLUSION: Our framework for automating clinical tasks with machine learning offers a template for health systems looking to implement similar technologies.

PMID:39018499 | DOI:10.1093/jamia/ocae194

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The Relationship between TNF-α, IL-1, IL-12, IL-17, IL-23, IL-36 Expression and Treatment Response in Psoriasis Histopathologically and Immunohistochemically

Cutan Ocul Toxicol. 2024 Jul 17:1-10. doi: 10.1080/15569527.2024.2380310. Online ahead of print.

ABSTRACT

AIM: There is no marker that can predict whether there is resistance to treatment in patients with psoriasis. In this study, we investigated the relationship between the staining rates of TNF-α, IL-1, IL-12, IL-17, IL-23, and IL-36 markers immunohistochemically from cutaneous biopsy and the treatment success.

METHODS: The patients who were followed up in the dermatology clinic with the diagnosis of plaque-type psoriasis vulgaris and received biological treatment and previously had cutaneous biopsy were included in the study. The cutaneous biopsies of the cases that met the conditions were re-sectioned and subjected to immunohistochemical examination for TNF-α, IL-1, IL-12, IL-17, IL-23, and IL-36.

RESULTS: Comparing the staining scores with psoriasis area severity index (PASI); A statistically significant positive correlation was found between PASI and TNF-α staining score(p = 0.034). A statistically significant positive correlation was found between PASI and IL-17 staining score(p = 0.004).When the staining scores and PASI response rates of psoriasis treatment were evaluated in terms of correlation; there was a positive correlation between TNF-α, IL-17, and IL-23 immunohistochemical staining rates and PASI response rates.

CONCLUSIONS: In line with the data obtained from our study, we think that making immunohistochemical scoring before the biological treatment decision in psoriasis patients will be beneficial in treatment selection. In this respect, our study may open a new era in the selection of biological treatments for psoriasis.

PMID:39018470 | DOI:10.1080/15569527.2024.2380310

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A Prediction Model for Pelvic Floor Recovery After Vaginal Birth With Risk Factors

Urogynecology (Phila). 2024 Jul 16. doi: 10.1097/SPV.0000000000001556. Online ahead of print.

ABSTRACT

IMPORTANCE: Although parturients report few postpartum symptoms, birth is clearly associated with future symptom development. The ability to identify asymptomatic at-risk women would facilitate prevention.

OBJECTIVE: The aim of the study was to develop a model predicting abnormal recovery in women at risk for childbirth-associated pelvic floor injury.

STUDY DESIGN: Women undergoing first vaginal birth at high risk of pelvic floor injury underwent examinations and ultrasound imaging and completed 6-week and 6-month postpartum questionnaires. We defined “abnormal” recovery as having ≥1 of the following 3 findings: (1) levator ani injury, (2) decreased objective pelvic floor strength, and (3) Pelvic Organ Prolapse Quantification point Bp ≥0. Descriptive statistics and bivariate analyses compared “normal” and “abnormal” recovery. Birth characteristics, 6-week examinations, and questionnaires potentially predicted abnormal recovery at 6 months. Significant variables were included as candidates in the multivariable logistic regression predicting “abnormal” recovery after birth.

RESULTS: Fifty-four women (63.5%) had normal and 31 (36.5%) had abnormal recovery at 6 months. At 6 weeks, women with abnormal recovery had decreased pelvic floor strength by Oxford scores (3 [2-5], 6 [2-8]; P = 0.002), lower point Bp (-1 [-3 to 0], -2 [-3 to -1]; P = 0.02), larger genital hiatus (4 [3 to 4], 3 [3 to 3.5]; P = 0.02), and higher levator ani injury rate (76.7%, 22.4%; P < 0.001). Between-group questionnaire differences were not clinically significant. Our final model included postpartum examination findings or birth characteristics: Oxford Scale, 6-week Pelvic Organ Prolapse Quantification GH strain, infant head circumference, and second stage ≥120 minutes. The area under the curve for predicting abnormal recovery at 6 months was 0.84, indicating a good sensitivity and specificity balance.

CONCLUSION: The model identifies women at risk for an abnormal recovery trajectory.

PMID:39018453 | DOI:10.1097/SPV.0000000000001556

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Predicting the Intravenous Pharmacokinetics of Covalent Drugs in Animals and Humans

J Med Chem. 2024 Jul 17. doi: 10.1021/acs.jmedchem.4c00776. Online ahead of print.

ABSTRACT

30 covalent drugs were used to assess clearance (CL) prediction reliability in animals and humans. In animals, marked CL underprediction was observed using cryopreserved hepatocytes or liver microsomes (LMs) supplemented for cytochrome P450 activity. Improved quantitative performance was observed by combining metabolic stability data from LMs and liver S9 fractions, the latter supplemented with reduced glutathione for glutathione transferase activity. While human LMs provided reliable human CL predictions, prediction statistics were improved further by incorporating S9 stability data. CL predictions with allometric scaling were less robust compared to in vitro drug metabolism methods; the best results were obtained using the fu-corrected intercept model. Human volume of distribution (Vd) was well predicted using allometric scaling of animal pharmacokinetic data; the most reliable results were achieved using simple allometric scaling of unbound Vd values. These results provide a quantitative framework to guide appropriate method selection for human PK prediction with covalent drugs.

PMID:39018425 | DOI:10.1021/acs.jmedchem.4c00776