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Nevin Manimala Statistics

Characteristics of COVID-19 Patients Admitted to a Tertiary Care Hospital in Pune, India and Predictors of Requirement for Intensive Care Treatment

J Assoc Physicians India. 2021 Jul;69(7):11-12.

ABSTRACT

OBJECTIVES: 1. To study associations of severity of COVID-19 disease with clinical features and laboratory markers. 2. To develop a model to predict the need for ICU treatment.

METHODS: This is an analysis of clinical course in 800 consecutive patients from a dedicated COVID-19 tertiary care hospital in Pune, India (8th April to 15th June 2020). We obtained clinical and laboratory information, severity grading and progress from hospital records. We studied associations of these characteristics with need for ICU management. We developed a predictive model of need for ICU treatment among first 500 patients and tested its sensitivity and specificity in the following 300 patients.

RESULTS: Average age was 41 years, 16% were 20 years of age, 55% were male, 50% were asymptomatic and 16% had at least one comorbidity. Using MoHFW India severity guidelines, 73% patients had mild, 6% moderate and 20% severe disease. Severity was associated with higher age, symptomatic presentation, elevated neutrophil and reduced lymphocyte counts and elevated inflammatory markers. Seventy-seven patients needed ICU treatment: they were older (56 years), more symptomatic and had lower SpO2 and abnormal chest X-ray and deranged hematology and biochemistry at admission. A model trained on the first 500 patients, using above variables predicted need for ICU treatment with sensitivity 80%, specificity 88% in subsequent 300 patients; exclusion of expensive laboratory tests (Ferritin, C- Reactive Protein) did not affect accuracy.

CONCLUSION: In the early phase of COVID- 19 pendemic, a significant proportion of hospitalized patients were young and asymptomatic. Need for ICU treatment was predicted by simple measures including higher age, symptomatic onset, low SpO2 and abnormal chest X-ray. We propose a simple model for referring patients for treatment at specialized COVID-19 hospitals.

PMID:34431267

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Nevin Manimala Statistics

A Retrospective Analysis of Fixed Combination of Empagliflozin and Linagliptin in Addition to the Existing Treatment for its Clinical Effectiveness in Adults with Type 2 Diabetes: A Real-World Clinical Experience

J Assoc Physicians India. 2021 Jul;69(7):11-12.

ABSTRACT

BACKGROUND: The efficacy and safety of empagliflozin and linagliptin (Empa/Lina), is demonstrated in adults with T2DM in the various trials. The study was planned to investigate the clinical effectiveness and safety of Empa/Lina in a more representative population of the Indian outpatient setting.

METHODS: The study was conducted in poorly controlled T2DM patients being treated with Empa/Lina once daily (25/5mg) as an add on in a tertiary care institute in Jammu, India. Various efficacy and safety parameters were assessed prior to the initiation of Empa/Lina and thereafter at periodic intervals until week 12. Appropriate statistical tests were applied.

RESULTS: In a total of 347 eligible patients, the mean age (SD) was 57.84 ±7.3 years, Males were 49%, average body weight was 79.81±9.72 kg. The median duration of diabetes was 6.42±2.05 years. Empa/Lina as an add on therapy to other glucose-lowering treatment was associated with a significant lowering in HbA1c (-1.1 ±0.64 mg/dl), FPG level -47.11(±20.42) mg/dl, PPG level (-71.32± 26.56), body weight -2.64 (±1.97) kg and blood pressure parameters (systolic BP -7.68 ±5.2 and Diastolic BP -3.16±1.7) from baseline at 12 weeks. A total of 47.55 percent of patients responded to Empa/Lina (25/5mg) added in conjunction with other antidiabetes agents. There was no significant difference in glycemic parameters of various subgroups assessed based on concurrent antidiabetes drugs. However, a significant reduction in body weight of subjects on insulin therapy was noticed. There was an improvement in eGFR level which was maintained across the study period. Genital mycotic infection was reported in 8.6% of patients. Empa/Lina (25/5 mg) as an add-on therapy was well tolerated with less hypoglycemic events.

DISCUSSION AND CONCLUSION: Thus, the combination of empagliflozin and linagliptin (25/5 mg) significantly improved the glycemic and non-glycemic measures in combination with one or more commonly prescribed antidiabetic drugs in inadequately controlled diabetes patients and is well tolerated.

PMID:34431269

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Nevin Manimala Statistics

Comparisons of survival outcomes between bevacizumab and olaparib in BRCA-mutated, platinum-sensitive relapsed ovarian cancer: a Korean Gynecologic Oncology Group study (KGOG 3052)

J Gynecol Oncol. 2021 Aug 5. doi: 10.3802/jgo.2021.32.e90. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare survival outcomes between bevacizumab (BEV) and olaparib (OLA) maintenance therapy in BRCA-mutated, platinum-sensitive relapsed (PSR) high-grade serous ovarian carcinoma (HGSOC).

METHODS: From 10 institutions, we identified HGSOC patients with germline and/or somatic BRCA1/2 mutations, who experienced platinum-sensitive recurrence between 2013 and 2019, and received second-line platinum-based chemotherapy. Patients were divided into BEV (n=29), OLA (n=83), and non-BEV/non-OLA users (n=36). The OLA and non-BEV/non-OLA users were grouped as the OLA intent group. We conducted 1:2 nearest neighbor-matching between the BEV and OLA intent groups, setting the proportion of OLA users in the OLA intent group from 65% to 100% at 5% intervals, and compared survival outcomes among the matched groups.

RESULTS: Overall, OLA users showed significantly better progression-free survival (PFS) than BEV users (median, 23.8 vs. 17.4 months; p=0.004). Before matching, PFS improved in the OLA intent group but marginal statistical significance (p=0.057). After matching, multivariate analyses adjusting confounders identified intention-to-treat OLA as an independent favorable prognostic factor for PFS in the OLA 65P (adjusted hazard ratio [aHR]=0.505; 95% confidence interval [CI]=0.280-0.911; p=0.023) to OLA 100P (aHR=0.348; 95% CI=0.184-0.658; p=0.001) datasets. The aHR of intention-to-treat OLA for recurrence decreased with increasing proportions of OLA users. No differences in overall survival were observed between the BEV and OLA intent groups, and between the BEV and OLA users.

CONCLUSION: Compared to BEV, intention-to-treat OLA and actual use of OLA maintenance therapy were significantly associated with decreased disease recurrence risk in patients with BRCA-mutated, PSR HGSOC.

PMID:34431258 | DOI:10.3802/jgo.2021.32.e90

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Effect of Angiotensin Converting Enzyme Inhibitors/Angiotensin Receptor Blockers on COVID-19 outcome: A Record Based Observational Study in West Bengal

J Assoc Physicians India. 2021 Jul;69(7):11-12.

ABSTRACT

BACKGROUND: Since its first identification in December 2019, in WUHAN (CHINA), SARS-COV-2, causative agent of Corona virus pandemic, has affected millions of people worldwide, causing thousands of death. There is much speculation about the interplay between ACEI/ARB and Corona virus infection, as for internalization into host cell SARS-COV-2 binds through S spike protein to ACE-2, aided TMPRSS2.

METHODS: A record based observational study has been conducted (data obtained from the clinics of fourteen physicians) in two worst affected districts of West Bengal, to find out the association of ACEI/ARB on patients, suffering from Corona virus infection. The study-protocol has already been approved by Clinical Research Ethics Committee of Calcutta School of Tropical Medicine. (IEC Ref. No: CREC-STM/2020-AS-37) Results: Increasing age, male sex and presence of co-morbidities (viz. Diabetes, COPD) are significantly associated with the occurrence of moderate and severe disease. Drugs (viz. ACEI/ARB), though are associated with less severe disease, have not achieved statistical significance, in the present study.

CONCLUSION: Drugs, like ACEI/ARB, should be continued in patients suffering from COVID-19 infection, (if they are already on these drugs).

PMID:34431266

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Nevin Manimala Statistics

Brachytherapy utilization rate and effect on survival in cervical cancer patients in Korea

J Gynecol Oncol. 2021 Jul 16. doi: 10.3802/jgo.2021.32.e85. Online ahead of print.

ABSTRACT

OBJECTIVE: External beam radiation therapy (EBRT) with concurrent chemotherapy followed by intracavitary brachytherapy is the standard treatment in locally advanced cervical cancer. This study examined the brachytherapy utilization rate and evaluated the effect of brachytherapy on survival in cervical cancer patients in Korea.

METHODS: In this study, data from the Korea Central Cancer Registry and Korean National Health Insurance Service and data on mortality from Statistics Korea were linked and used. Patients with other cancers, distant metastasis at diagnosis, or unknown stage or who underwent hysterectomy were excluded. A total of 12,721 cervical cancer patients were analyzed in this study.

RESULTS: The brachytherapy utilization rate (%) was calculated as the proportion of patients who received brachytherapy among those who received curative EBRT. The brachytherapy utilization rate decreased from 84% in 2005 to 78% in 2013 (p<0.001). Brachytherapy utilization rates varied by region, ranging from 72% to 100% except for in Jeju Island, where the rate was 56%. The brachytherapy utilization rate was lower in patients older than 80 years; patients with localized disease, non-squamous cell carcinoma, or Charlson comorbidity index 3 or more; patients diagnosed after 2010; patients from certain regions; patients receiving medical aid; and patients who underwent gynecologic procedures. Multivariable Cox regression analysis showed that brachytherapy when added to curative EBRT was independently associated with better cancer-specific survival (CSS) and overall survival (OS) than curative EBRT only.

CONCLUSION: The brachytherapy utilization rate decreased from 2005 to 2013 and varied by region in Korea. Brachytherapy use is independently associated with significantly higher CSS and OS in cervical cancer.

PMID:34431256 | DOI:10.3802/jgo.2021.32.e85

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Nevin Manimala Statistics

Financial toxicity in patients with gynecologic malignancies: a cross sectional study

J Gynecol Oncol. 2021 Jul 23. doi: 10.3802/jgo.2021.32.e87. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate financial toxicity and assess its risk factors among patients with gynecologic cancers.

METHODS: This is a cross sectional study that included 2 survey tools, as well as patient demographics, disease characteristics, and treatment regimen. Financial toxicity is measured by validated Comprehensive Score for Financial Toxicity (COST) tool. Participants were also asked to complete a 55-question-survey on attitudes and perspectives surrounding cost of care. Descriptive statistics was used to report patient demographics. Spearman’s rank correlation was calculated to assess the relation between financial toxicity and patient/disease related variables. Graphpad Prism Software Version 8.0 was used for analyses.

RESULTS: A total of 50 patients with various gynecologic malignancies were enrolled. Median COST score was 20.5 (range, 1-33). Sixty-five percent of the patients reported being in debt due to their cancer care and 4% filed bankruptcy. Correlation analysis showed that COST score was correlated with age (r=-0.3, p=0.028), malignancy type (r=0.3, p=0.039) and income (r=0.3, p=0.047). Ovarian cancer patients had significantly less financial toxicity (median COST score=23) when compared to patients with other gynecologic malignancies (median COST score=17, p=0.043). When scores were dichotomized into low (score ≥22) and high toxicity (score <22), 58% (29/50) of the patients were noted to have high financial toxicity. Enrollment to a clinical trial did not significantly alleviate financial burden.

CONCLUSION: Financial toxicity is a significant burden even among highly insured gynecologic oncology patients. Age, malignancy type and income were correlated with high financial burden.

PMID:34431257 | DOI:10.3802/jgo.2021.32.e87

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Nevin Manimala Statistics

Placental DNA methylation signatures of maternal smoking during pregnancy and potential impacts on fetal growth

Nat Commun. 2021 Aug 24;12(1):5095. doi: 10.1038/s41467-021-24558-y.

ABSTRACT

Maternal smoking during pregnancy (MSDP) contributes to poor birth outcomes, in part through disrupted placental functions, which may be reflected in the placental epigenome. Here we present a meta-analysis of the associations between MSDP and placental DNA methylation (DNAm) and between DNAm and birth outcomes within the Pregnancy And Childhood Epigenetics (PACE) consortium (N = 1700, 344 with MSDP). We identify 443 CpGs that are associated with MSDP, of which 142 associated with birth outcomes, 40 associated with gene expression, and 13 CpGs are associated with all three. Only two CpGs have consistent associations from a prior meta-analysis of cord blood DNAm, demonstrating substantial tissue-specific responses to MSDP. The placental MSDP-associated CpGs are enriched for environmental response genes, growth-factor signaling, and inflammation, which play important roles in placental function. We demonstrate links between placental DNAm, MSDP and poor birth outcomes, which may better inform the mechanisms through which MSDP impacts placental function and fetal growth.

PMID:34429407 | DOI:10.1038/s41467-021-24558-y

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Nevin Manimala Statistics

Inertial and viscous flywheel sensing of nanoparticles

Nat Commun. 2021 Aug 24;12(1):5099. doi: 10.1038/s41467-021-25266-3.

ABSTRACT

Rotational dynamics often challenge physical intuition while enabling unique realizations, from the rotor of a gyroscope that maintains its orientation regardless of the outer gimbals, to a tennis racket that rotates around its handle when tossed face-up in the air. In the context of inertial sensing, which can measure mass with atomic precision, rotational dynamics are normally considered a complication hindering measurement interpretation. Here, we exploit the rotational dynamics of a microfluidic device to develop a modality in inertial sensing. Combining theory with experiments, we show that this modality measures the volume of a rigid particle while normally being insensitive to its density. Paradoxically, particle density only emerges when fluid viscosity becomes dominant over inertia. We explain this paradox via a viscosity-driven, hydrodynamic coupling between the fluid and the particle that activates the rotational inertia of the particle, converting it into a ‘viscous flywheel’. This modality now enables the simultaneous measurement of particle volume and mass in fluid, using a single, high-throughput measurement.

PMID:34429420 | DOI:10.1038/s41467-021-25266-3

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Nevin Manimala Statistics

Undecidability in quantum thermalization

Nat Commun. 2021 Aug 24;12(1):5084. doi: 10.1038/s41467-021-25053-0.

ABSTRACT

The investigation of thermalization in isolated quantum many-body systems has a long history, dating back to the time of developing statistical mechanics. Most quantum many-body systems in nature are considered to thermalize, while some never achieve thermal equilibrium. The central problem is to clarify whether a given system thermalizes, which has been addressed previously, but not resolved. Here, we show that this problem is undecidable. The resulting undecidability even applies when the system is restricted to one-dimensional shift-invariant systems with nearest-neighbour interaction, and the initial state is a fixed product state. We construct a family of Hamiltonians encoding dynamics of a reversible universal Turing machine, where the fate of a relaxation process changes considerably depending on whether the Turing machine halts. Our result indicates that there is no general theorem, algorithm, or systematic procedure determining the presence or absence of thermalization in any given Hamiltonian.

PMID:34429406 | DOI:10.1038/s41467-021-25053-0

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Nevin Manimala Statistics

Hospital Quality of Care and Racial and Ethnic Disparities in Unexpected Newborn Complications

Pediatrics. 2021 Aug 24:e2020024091. doi: 10.1542/peds.2020-024091. Online ahead of print.

ABSTRACT

OBJECTIVES: To investigate racial and ethnic differences in unexpected, term newborn morbidity and the influence of hospital quality on disparities.

METHODS: We used 2010-2014 birth certificate and discharge abstract data from 40 New York City hospitals in a retrospective cohort study of 483 834 low-risk (term, singleton, birth weight ≥2500 g, without preexisting fetal conditions) neonates. We classified morbidity according to The Joint Commission’s unexpected newborn complications metric and used multivariable logistic regression to compare morbidity risk among racial and ethnic groups. We generated risk-standardized complication rates for each hospital using mixed-effects logistic regression to evaluate quality, ranked hospitals on this measure, and assessed differences in the racial and ethnic distribution of births across facilities.

RESULTS: The unexpected complications rate was 48.0 per 1000 births. Adjusted for patient characteristics, morbidity risk was higher among Black and Hispanic infants compared with white infants (odds ratio: 1.5 [95% confidence interval 1.3-1.9]; odds ratio: 1.2 [95% confidence interval 1.1-1.4], respectively). Among the 40 hospitals, risk-standardized complications ranged from 25.3 to 162.8 per 1000 births. One-third of Black and Hispanic women gave birth in hospitals ranking in the highest-morbidity tertile, compared with 10% of white and Asian American women (P < .001).

CONCLUSIONS: Black and Hispanic women were more likely to deliver in hospitals with high complication rates than were white or Asian American women. Findings implicate hospital quality in contributing to preventable newborn health disparities among low-risk, term births. Quality improvement targeting routine obstetric and neonatal care is critical for equity in perinatal outcomes.

PMID:34429339 | DOI:10.1542/peds.2020-024091