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Nevin Manimala Statistics

Effectiveness of Nirmatrelvir-Ritonavir for the Prevention of COVID-19-Related Hospitalization and Mortality: A Systematic Literature Review

Am J Ther. 2024 May-Jun 01;31(3):e246-e257. doi: 10.1097/MJT.0000000000001744. Epub 2024 Apr 29.

ABSTRACT

BACKGROUND: Nirmatrelvir/ritonavir (NMV/r) is an oral antiviral drug used to treat mild-to-moderate coronavirus disease 2019 (COVID-19) in patients aged 12 years or older at high risk of progression to severe disease (eg, hospitalization and death). Despite being the preferred option for outpatient treatment in the majority of countries worldwide, NMV/r is currently underutilized in real-world clinical practice.

AREAS OF UNCERTAINTY: As numerous real-world studies have described patient outcomes following treatment with NMV/r, this systematic literature review provides a comprehensive summary of evidence on NMV/r effectiveness against hospitalization and mortality further organized by clinically meaningful categories, such as acute versus longer-term follow-up, age, underlying health conditions, and vaccination status, to help inform health care decision making.

DATA SOURCES: We searched Embase and PubMed (December 22, 2021-March 31, 2023) and congress abstracts (December 1, 2021-December 31, 2022) for reports describing NMV/r effectiveness.

THERAPEUTIC ADVANCES: In total, 18 real-world studies met final selection criteria. The evidence showed that NMV/r significantly reduced postinfection risk of all-cause and COVID-19-related hospitalization and mortality in both acute (≤30 days) (21%-92%) and longer-term (>30 days) (1%-61%) follow-up. The reduction in postinfection risk was higher when treatment was received within 5 days of symptom onset. Real-world effectiveness of NMV/r treatment was observed regardless of age, underlying high-risk conditions, and vaccination status.

CONCLUSION: The systematic literature review findings demonstrated the effectiveness of NMV/r against hospitalization and mortality during the Omicron period among individuals at high risk of progression to severe COVID-19 disease.

PMID:38691664 | DOI:10.1097/MJT.0000000000001744

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Nevin Manimala Statistics

Sex Differences in Cardiovascular Management: A Call for Better Acknowledgment-Part 1 Pharmacological Differences in Women and Men; How Relevant Are They?

Am J Ther. 2024 May-Jun 01;31(3):e237-e245. doi: 10.1097/MJT.0000000000001753.

ABSTRACT

BACKGROUND: Sex differences (SDs) in pharmacology of cardiovascular (CV) drugs have been described previously; however, paradoxically, there are scarce recommendations in therapy based on these differences. It is of utmost importance to identify whether these SDs determine a modified clinical response and the potential practical implications for this, to provide a base for personalized medicine.

AREA OF UNCERTAINTY: The aim of this article was to outline the most important pharmacological drivers of cardiovascular drugs that differ between women and men, along with their implications and challenges in clinical practice.

DATA SOURCES: A detailed assessment of English-written resources reflecting SDs impact in CV drug pharmacology was performed using PubMed and Embase databases.

RESULTS: Despite large variations in CV drug pharmacokinetics and pharmacodynamics in individuals, correcting for height, weight, surface area, and body composition compensate for most “sex-dependent” differences. In addition, individual, cultural, and social factors significantly impact disease management in women versus men. Gender-biased prescribing patterns and gender-dependent adherence to therapy also influence outcomes. The development of sex-specific guidelines requires that they should reflect the SDs implications for the management of a disease and that the evidence should be carefully evaluated as to whether there is an adequate representation of both sexes and whether sex-disaggregated data are reported.

CONCLUSIONS: Pharmacological drivers are under the influence of an impressive number of differences between women and men. However, to establish their significance in clinical practice, an adequate representation of women in studies and the reporting of distinct results is mandatory.

PMID:38691663 | DOI:10.1097/MJT.0000000000001753

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Nevin Manimala Statistics

Cognitive Outcomes in Nonacute Patients With Schizophrenia Treated With Long-Acting Injectable Antipsychotics Versus Oral Antipsychotics

Am J Ther. 2024 May-Jun 01;31(3):e219-e228. doi: 10.1097/MJT.0000000000001729.

ABSTRACT

BACKGROUND: Patients with schizophrenia often face challenges related to cognitive function, affecting their daily functioning and overall quality of life. The choice of antipsychotic treatment may play a crucial role in determining cognitive outcomes.

STUDY QUESTION: Our study aimed to investigate whether there was a difference in cognitive ability between the patients with schizophrenia receiving oral antipsychotics (OAP) versus long-acting injectable antipsychotics (LAI-APs).

STUDY DESIGN: We conducted a cross-sectional study using analytical methods between January 1, 2020, and January 1, 2022. Participants were divided into 2 groups: patients undergoing treatment with OAP and patients undergoing treatment with LAI-AP. All participants underwent version A of Brief Assessment of Cognition in Schizophrenia (BACS).

MEASURES AND OUTCOMES: The primary objective was to compare cognitive function in patients with schizophrenia treated with LAI antipsychotics versus OAP using BACS. Primary outcome measures include overall BACS score, with secondary measures focusing on specific cognitive domains. This study contributes to the understanding of the cognitive effects of different antipsychotic formulations in schizophrenia treatment.

RESULTS: Although there was a slightly higher intelligence quotient in the LAI-AP group (102.2 vs. 101.32, P = 0.5401), it was not statistically significant. Olanzapine was the most commonly prescribed antipsychotic, with 48% of patients in the LAI-AP group and 40% in the OAP group. The LAI-AP group outperformed in all BACS evaluations. The most notable difference was in the token motor task (57.78 ± 17.03 vs. 50.04 ± 18.82, P = 0.0335), while the Tower of London test showed the smallest difference (17.26 ± 2.61 vs. 15.48 ± 3.47, P = 0.0046). Regression analysis revealed no significant variance in intelligence quotient scores; however, a significant discrepancy in BACS scores was evident, favoring the LAI treatment for better cognitive outcomes.

CONCLUSIONS: The use of long-acting antipsychotic treatment in individuals with schizophrenia offers promising advantages in preserving cognitive function.

PMID:38691662 | DOI:10.1097/MJT.0000000000001729

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Nevin Manimala Statistics

Deriving Treatment Decision Support From Dutch Electronic Health Records by Exploring the Applicability of a Precision Cohort-Based Procedure for Patients With Type 2 Diabetes Mellitus: Precision Cohort Study

Online J Public Health Inform. 2024 May 1;16:e51092. doi: 10.2196/51092.

ABSTRACT

BACKGROUND: The rapidly increasing availability of medical data in electronic health records (EHRs) may contribute to the concept of learning health systems, allowing for better personalized care. Type 2 diabetes mellitus was chosen as the use case in this study.

OBJECTIVE: This study aims to explore the applicability of a recently developed patient similarity-based analytics approach based on EHRs as a candidate data analytical decision support tool.

METHODS: A previously published precision cohort analytics workflow was adapted for the Dutch primary care setting using EHR data from the Nivel Primary Care Database. The workflow consisted of extracting patient data from the Nivel Primary Care Database to retrospectively generate decision points for treatment change, training a similarity model, generating a precision cohort of the most similar patients, and analyzing treatment options. This analysis showed the treatment options that led to a better outcome for the precision cohort in terms of clinical readouts for glycemic control.

RESULTS: Data from 11,490 registered patients diagnosed with type 2 diabetes mellitus were extracted from the database. Treatment-specific filter cohorts of patient groups were generated, and the effect of past treatment choices in these cohorts was assessed separately for glycated hemoglobin and fasting glucose as clinical outcome variables. Precision cohorts were generated for several individual patients from the filter cohorts. Treatment options and outcome analyses were technically well feasible but in general had a lack of statistical power to demonstrate statistical significance for treatment options with better outcomes.

CONCLUSIONS: The precision cohort analytics workflow was successfully adapted for the Dutch primary care setting, proving its potential for use as a learning health system component. Although the approach proved technically well feasible, data size limitations need to be overcome before application for clinical decision support becomes realistically possible.

PMID:38691393 | DOI:10.2196/51092

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Nevin Manimala Statistics

Gray matter matters: Cognitive stability and flexibility in schizophrenia spectrum disorder

Psychophysiology. 2024 May 1:e14596. doi: 10.1111/psyp.14596. Online ahead of print.

ABSTRACT

Cognitive dysfunction constitutes a core characteristic of schizophrenia spectrum disorders (SZ). Specifically, deficits in updating generative models (i.e., cognitive flexibility) and shielding against distractions (i.e., cognitive stability) are considered critical contributors to cognitive impairment in these patients. Here, we examined the structural integrity of frontostriatal networks and their associations with reduced cognitive stability and flexibility in SZ patients. In a sample of 21 patients diagnosed with SZ and 22 healthy controls, we measured gray matter volume (GMV) using structural MRI. Further, cognitive stability and flexibility were assessed using a switch-drift paradigm, quantifying the successful ignoring of distracters and detection of rule switches. Compared to controls, patients showed significantly smaller GMV in the whole brain and three predefined regions of interest: the medial prefrontal cortex (mPFC), inferior frontal gyrus (IFG), and caudate nucleus (CN). Notably, GMV in these areas positively correlated with correct rule-switch detection but not with ignoring rule-compatible drifts. Further, the volumetric differences between SZ patients and controls were statistically explainable by considering the behavioral performance in the switch-drift task. Our results indicate that morphological abnormalities in frontostriatal networks are associated with deficient flexibility in SZ patients and highlight the necessity of minimizing neurodevelopmental and progressive brain atrophy in this population.

PMID:38691383 | DOI:10.1111/psyp.14596

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Prospective and Retrospective Measures of Child Maltreatment and Their Association With Psychopathology: A Systematic Review and Meta-Analysis

JAMA Psychiatry. 2024 May 1. doi: 10.1001/jamapsychiatry.2024.0818. Online ahead of print.

ABSTRACT

IMPORTANCE: Prospective and retrospective measures of childhood maltreatment identify largely different groups of individuals. However, it is unclear if these measures are differentially associated with psychopathology.

OBJECTIVE: To analyze the associations of prospective and retrospective measures of childhood maltreatment with psychopathology.

DATA SOURCES: Based on a preregistered protocol, Embase, PsycInfo, and MEDLINE were searched for peer-reviewed studies published by January 1, 2023, that measured the associations of prospective and retrospective measures of child maltreatment with psychopathology.

STUDY SELECTION: Titles and abstracts of all articles captured by the search and full texts of potentially eligible studies were independently screened by 2 authors. Observational studies with measures of the association of prospective and retrospective measures of childhood maltreatment with psychopathology were included.

DATA EXTRACTION AND SYNTHESIS: Multiple investigators independently extracted data. Multilevel random-effects meta-analyses were used to pool the results and test predictors of heterogeneity.

MAIN OUTCOME AND MEASURES: Associations between prospective or retrospective measures of child maltreatment and psychopathology, both unadjusted and adjusted (ie, the association between prospective measures of maltreatment and psychopathology adjusted for retrospective measures, and vice versa), and moderation of these associations by preselected variables.

RESULTS: The meta-analyses were based on 24 studies including 15 485 individuals (51.0% female; mean age, 21.3 years at retrospective report). Retrospective measures of childhood maltreatment showed stronger associations with psychopathology relative to prospective measures in both unadjusted analyses (retrospective measures: odds ratio [OR], 2.21; 95%, 1.94-2.42 vs prospective measures: OR, 1.56; 95% CI, 1.39-1.76) and adjusted analyses (retrospective measures: OR, 2.14; 95% CI, 1.90-2.42 vs prospective measures: OR, 1.27; 95% CI, 1.13-1.41). There was no statistically significant moderation of the unadjusted or adjusted associations between prospective measures of child maltreatment and psychopathology. The associations between retrospective measures and psychopathology were stronger when the assessment of psychopathology was based on self-reports and was focused on internalizing or emotional disorders.

CONCLUSIONS AND RELEVANCE: Psychopathology is more strongly associated with retrospective measures-which capture the first-person, subjective appraisal of childhood events reflected in memory recall-compared to prospective measures-which essentially capture third-person accounts of such events. Maltreatment-related psychopathology may be driven by subjective interpretations of experiences, distressing memories, and associated schemas, which could be targeted by cognitive interventions.

PMID:38691376 | DOI:10.1001/jamapsychiatry.2024.0818

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Nevin Manimala Statistics

Now That We Are Disaggregating Race and Ethnicity Data, We Need to Start Understanding What They Mean

JAMA Netw Open. 2024 May 1;7(5):e243674. doi: 10.1001/jamanetworkopen.2024.3674.

NO ABSTRACT

PMID:38691365 | DOI:10.1001/jamanetworkopen.2024.3674

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Nevin Manimala Statistics

Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals

JAMA Netw Open. 2024 May 1;7(5):e249233. doi: 10.1001/jamanetworkopen.2024.9233.

NO ABSTRACT

PMID:38691363 | DOI:10.1001/jamanetworkopen.2024.9233

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Nevin Manimala Statistics

COVID-19 Hospitalization in Hawai’i and Patterns of Insurance Coverage, Race and Ethnicity, and Vaccination

JAMA Netw Open. 2024 May 1;7(5):e243696. doi: 10.1001/jamanetworkopen.2024.3696.

ABSTRACT

IMPORTANCE: The people of Hawai’i have both high rates of health insurance and high levels of racial and ethnic diversity, but the degree to which insurance status and race and ethnicity contribute to health outcomes in COVID-19 remains unknown.

OBJECTIVE: To evaluate the associations of insurance coverage, race and ethnicity (using disaggregated race and ethnicity data), and vaccination with outcomes for COVID-19 hospitalization.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included hospitalized patients at a tertiary care medical center between March 2020 and March 2022. All patients hospitalized for acute COVID-19, identified based on diagnosis code or positive results on polymerase chain reaction-based assay for SARS-CoV-2, were included in analysis. Data were analyzed from May 2022 to May 2023.

EXPOSURE: COVID-19 requiring hospitalization.

MAIN OUTCOME AND MEASURES: Electronic medical record data were collected for all patients. Associations among race and ethnicity, insurance coverage, receipt of at least 1 COVID-19 vaccine, intensive care unit (ICU) transfer, in-hospital mortality, and COVID-19 variant wave (pre-Delta vs Delta and Omicron) were assessed using adjusted multivariable logistic regression.

RESULTS: A total of 1176 patients (median [IQR] age of 58 [41-71] years; 630 [54%] male) were hospitalized with COVID-19, with a median (IQR) body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 30 (25-36) and Sequential Organ Failure Assessment score of 1 (0-2). The sample included 16 American Indian or Alaska Native patients, 439 Asian (not otherwise specified) patients, 15 Black patients, 66 Chinese patients, 246 Filipino patients, 76 Hispanic patients, 107 Japanese patients, 10 Korean patients, 299 Native Hawaiian patients, 523 Pacific Islander (not otherwise specified) patients, 156 Samoan patients, 5 Vietnamese patients, and 311 White patients (patients were able to identify as >1 race or ethnicity). When adjusting for age, BMI, sex, medical comorbidities, and socioeconomic neighborhood status, there were no differences in either ICU transfer (eg, Medicare vs commercial insurance: odds ratio [OR], 0.84; 95% CI, 0.43-1.64) or in-hospital mortality (eg, Medicare vs commercial insurance: OR, 0.85; 95% CI, 0.36-2.03) as a function of insurance type. Disaggregation of race and ethnicity revealed that Filipino patients were more likely to die in the hospital (OR, 1.79; 95% CI, 1.04-3.03; P = .03). When considering variant waves, mortality among Filipino patients was highest during the pre-Delta time period (OR, 2.72; 95% CI, 1.02-7.14; P = .04), when mortality among Japanese patients was lowest (OR, 0.19; 95% CI, 0.03-0.78; P = .04); mortality among Native Hawaiian patients was lowest during the Delta and Omicron period (OR, 0.35; 95% CI, 0.13-0.79; P = .02). Patients with Medicare, compared with those with commercial insurance, were more likely to have received at least 1 COVID-19 vaccine (OR, 1.85; 95% CI, 1.07-3.21; P = .03), but all patients, regardless of insurance type, who received at least 1 COVID-19 vaccine had reduced ICU admission (OR, 0.40; 95% CI, 0.21-0.70; P = .002) and in-hospital mortality (OR, 0.42; 95% CI, 0.21-0.79; P = .01).

CONCLUSIONS AND RELEVANCE: In this cohort study of hospitalized patients with COVID-19, those with government-funded insurance coverage (Medicare or Medicaid) had similar outcomes compared with patients with commercial insurance, regardless of race or ethnicity. Disaggregation of race and ethnicity analysis revealed substantial outcome disparities and suggests opportunities for further study of the drivers underlying such disparities. Additionally, these findings illustrate that vaccination remains a critical tool to protect patients from COVID-19 mortality.

PMID:38691362 | DOI:10.1001/jamanetworkopen.2024.3696

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Nevin Manimala Statistics

Differences in Cardiovascular Health at the Intersection of Race, Ethnicity, and Sexual Identity

JAMA Netw Open. 2024 May 1;7(5):e249060. doi: 10.1001/jamanetworkopen.2024.9060.

ABSTRACT

IMPORTANCE: An understanding of the intersectional effect of sexual identity, race, and ethnicity on disparities in cardiovascular health (CVH) has been limited.

OBJECTIVE: To evaluate differences in CVH at the intersection of race, ethnicity, and sexual identity using the American Heart Association’s Life’s Essential 8 measure.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study was conducted from July 27 to September 6, 2023, using National Health and Nutrition Examination Survey data from 2007 to 2016. Participants were noninstitutionalized, nonpregnant adults (aged 18-59 years) without cardiovascular disease or stroke.

EXPOSURES: Self-reported sexual identity, categorized as heterosexual or sexual minority (SM; lesbian, gay, bisexual, or “something else”), and self-reported race and ethnicity, categorized as non-Hispanic Black (hereafter, Black), Hispanic, non-Hispanic White (hereafter, White), and other (Asian, multiracial, or any other race and ethnicity).

MAIN OUTCOME AND MEASURES: The primary outcome was overall CVH score, which is the unweighted mean of 8 CVH metrics, assessed from questionnaire, dietary, and physical examination data. Regression models stratified by sex, race, and ethnicity were developed for the overall CVH score and individual CVH metrics, adjusting for age, survey year, and socioeconomic status (SES) factors.

RESULTS: The sample included 12 180 adults (mean [SD] age, 39.6 [11.7] years; 6147 [50.5%] male, 2464 [20.2%] Black, 3288 [27.0%] Hispanic, 5122 [42.1%] White, and 1306 [10.7%] other race and ethnicity). After adjusting for age, survey year, and SES, Black (β, -3.2; 95% CI, -5.8 to -0.6), Hispanic (β, -5.9; 95% CI, -10.3 to -1.5), and White (β, -3.3; 95% CI, -6.2 to -0.4) SM female adults had lower overall CVH scores compared with their heterosexual counterparts. There were no statistically significant differences for female adults of other race and ethnicity (β, -2.8; 95% CI, -9.3 to 3.7) and for SM male adults of any race and ethnicity compared with their heterosexual counterparts (Black: β, 2.2 [95% CI, -1.2 to 5.7]; Hispanic: β, -0.9 [95% CI, -6.3 to 4.6]; White: β, 1.5 [95% CI, -2.2 to 5.2]; other race and ethnicity: β, -2.2 [95% CI, -8.2 to 3.8]).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, CVH differed across race and ethnicity categories in SM females, suggesting that different communities within the larger SM population require tailored interventions to improve CVH. Longitudinal studies are needed to identify the causes of CVH disparities, particularly in Black and Hispanic SM females and inclusive of other racial and ethnic identities.

PMID:38691360 | DOI:10.1001/jamanetworkopen.2024.9060