Tag: pubmed

JMIR Form Res. 2024 Apr 25;8:e52189. doi: 10.2196/52189.

ABSTRACT

BACKGROUND: The eHealth Literacy Scale (eHEALS) is a widely used instrument for measuring eHealth literacy (eHL). However, little is known so far about whether the instrument is valid for the assessment of eHL in persons who are affected by the post-COVID-19 condition. This is particularly important as people with the post-COVID-19 condition are frequently affected by false information from the internet.

OBJECTIVE: The objective of our study was to evaluate the validity and reliability of the German Revised eHealth Literacy Scale (GR-eHEALS) in individuals with the post-COVID-19 condition.

METHODS: A cross-sectional study was conducted from January to May 2022. The self-assessment survey consisted of the GR-eHEALS, health status- and internet use-related variables, sociodemographic data, and (post)-COVID-19-related medical data. Confirmatory factor analysis (CFA), correlational analyses, and tests of measurement invariance were deployed.

RESULTS: In total, 330 participants were included in the statistical analyses. CFA revealed that the 2-factor model reached an excellent model fit (comparative fit index=1.00, Tucker-Lewis index=0.99, root mean square error of approximation=0.036, standardized root mean square residual=0.038). Convergent validity was confirmed by significant positive correlations between eHL and knowledge of internet-based health promotion programs, experience in using these programs, and the duration of private internet use. In addition, a significantly negative relationship of eHL with internet anxiety supported convergent validity. Further, significant relationships of eHL with mental health status and internal health locus of control confirmed the criterion validity of the instrument. However, relationships of eHL with physical health status and quality of life could not be confirmed. The 2-factor model was fully measurement invariant regarding gender. Regarding age and educational level, partial measurement invariance was confirmed. The subscales as well as the overall GR-eHEALS reached good-to-excellent reliability (Cronbach α≥.86).

CONCLUSIONS: The GR-eHEALS is a reliable and largely valid instrument for assessing eHL in individuals with the post-COVID-19 condition. Measurement invariance regarding gender was fully confirmed and allows the interpretation of group differences. Regarding age and educational level, group differences should be interpreted with caution. Given the high likelihood that individuals with the post-COVID-19 condition will be confronted with misinformation on the Internet, eHL is a core competency that is highly relevant in this context, in both research and clinical practice. Therefore, future research should also explore alternative instruments to capture eHL to overcome shortcomings in the validity of the GR-eHEALS.

PMID:38662429 | DOI:10.2196/52189

Diabetes Technol Ther. 2024 Apr 25. doi: 10.1089/dia.2023.0595. Online ahead of print.

ABSTRACT

BACKGROUND: Computer simulators of human metabolism are powerful tools to design and validate new diabetes treatments. However, these platforms are often limited in the diversity of behaviors and glycemic conditions they can reproduce. Replay methodologies leverage field-collected data to create ad-hoc simulation environments representative of real-life conditions. After formal validations of our method in prior publications, we demonstrate its capacity to reproduce a recent clinical trial.

METHODS: Using the replay methodology, an ensemble of replay simulators was generated using data from a randomized crossover clinical trial comparing hybrid closed loop (HCL) and fully closed loop (FCL) control modalities in automated insulin delivery (AID), creating 64 subject/modality pairs. Each virtual subject was exposed to the alternate AID modality to compare the simulated vs observed glycemic outcomes. Equivalence tests were performed for time in, below, and above range (TIR, TBR, TAR) and glucose indexes (LBGI, HBGI) considering equivalence margins corresponding to clinical significance.

RESULTS: TIR, TAR, LBGI, and HBGI showed statistical and clinical equivalence between the original and the simulated data, TBR failed the equivalence test. For example, in HCL mode, simulated TIR was 84.89% vs. an observed 84.31% (p=0.0170, CI [-3.96,2.79]), and for FCL mode, TIR was 76.58% versus 77.41% (p=0.0222, CI [-2.54,4.20]).

CONCLUSION: Clinical trial data confirms the prior in-silico validation of the UVA replay method in predicting the glycemic impact of modified insulin treatments. This in-vivo demonstration justifies the application of the replay method to the personalization and adaptation of treatment strategies in people with T1D.

PMID:38662426 | DOI:10.1089/dia.2023.0595

J Anal Toxicol. 2024 Apr 24:bkae033. doi: 10.1093/jat/bkae033. Online ahead of print.

ABSTRACT

Total Blood Carbon Monoxide (TBCO) showed promising results in improving accuracy of CO determinations in blood and presenting better stability to different storage conditions. Therefore, it was proposed as alternative biomarker to carboxyhemoglobin (COHb) for CO poisoning diagnosis. However, given that current interpretation reference values exist for COHb only, it is difficult to implement TBCO analysis in routine. Therefore, we aimed at determining TBCO reference values for postmortem CO poisoning cases. A previously validated method for TBCO analysis via gas chromatography-mass spectrometry was applied to cardiac, peripheral, cranial and spleen blood samples collected from 92 autopsies. Autopsy cases included 21 non-CO related and 71 CO-related cases with varying postmortem intervals (PMI). Statistical analyses were performed using statistical software R Studio. When comparing lower to higher PMI for non-CO related cases, no significant differences were found, which suggests that CO formation or degradation at low PMIs does not occur. Spleen blood showed potential as alternative matrix for CO determinations in cases with sample availability issues, but needs to be evaluated for CO positive cases. Results for cardiac blood in CO-related autopsies showed a positive correlation between COHb and TBCO values (R = 0.78). This value is lower than what is found in the literature, suggesting that even though COHb and TBCO are correlated, a potential underestimation of the true CO exposure might occur if only COHb values are taken into consideration. Samples were divided into CO exposure groups based on COHb concentrations and with the data obtained, classification into following TBCO concentration groups are proposed: no significant CO exposure case <6 µmol/mL, medium CO exposure case 6-20 µmol/mL, high CO exposure case >20µmol/mL. Even if a higher number of samples in each group would enable to increase the confidence, these results are very promising and highlight the importance of TBCO measurement.

PMID:38662395 | DOI:10.1093/jat/bkae033

Invest Ophthalmol Vis Sci. 2024 Apr 1;65(4):39. doi: 10.1167/iovs.65.4.39.

ABSTRACT

PURPOSE: Little is known regarding differences in childhood growth between somatic and heritable retinoblastoma (Rb) populations. We aimed to compare childhood growth parameters between somatic and heritable Rb cohorts at birth and at time of diagnosis with Rb.

METHODS: A multinational, longitudinal cohort study was conducted with patients from 11 centers in 10 countries who presented with treatment naïve Rb from January to December 2019. Variables of interest included age, sex, and size characteristics at birth and at time of presentation, as well as germline mutation status. After Bonferroni correction, results were statistically significant if the P value was less than 0.005.

RESULTS: We enrolled 696 patients, with 253 analyzed after exclusion criteria applied. Between somatic (n = 39) and heritable (n = 214) Rb cohorts, with males and females analyzed separately, there was no significant difference in birth weight percentile, weight percentile at time of diagnosis, length percentile at time of diagnosis, weight-for-length percentile at time of diagnosis, or change of weight percentile from birth to time of diagnosis. Patients with heritable Rb had a smaller mean weight percentile at birth and smaller mean weight and length percentiles at time of diagnosis with Rb, although this difference was not statistically significant. All cohorts experienced a slight negative change of weight percentile from birth to time of diagnosis. No cohort mean percentiles met criteria for failure to thrive, defined as less than the 5th percentile.

CONCLUSIONS: Children with Rb seem to have normal birth and childhood growth patterns. There is no definitive evidence that somatic or heritable Rb has a biological or environmental impact on childhood growth parameters.

PMID:38662390 | DOI:10.1167/iovs.65.4.39

JAMA Netw Open. 2024 Apr 1;7(4):e247581. doi: 10.1001/jamanetworkopen.2024.7581.

NO ABSTRACT

PMID:38662376 | DOI:10.1001/jamanetworkopen.2024.7581

JAMA Netw Open. 2024 Apr 1;7(4):e248487. doi: 10.1001/jamanetworkopen.2024.8487.

NO ABSTRACT

PMID:38662374 | DOI:10.1001/jamanetworkopen.2024.8487

JAMA Netw Open. 2024 Apr 1;7(4):e247604. doi: 10.1001/jamanetworkopen.2024.7604.

ABSTRACT

IMPORTANCE: Antipsychotics, such as quetiapine, are frequently prescribed to people with dementia to address behavioral symptoms but can also cause harm in this population.

OBJECTIVE: To determine whether warning letters to high prescribers of quetiapine can successfully reduce its use among patients with dementia and to investigate the impacts on patients’ health outcomes.

DESIGN, SETTING, AND PARTICIPANTS: This is a secondary analysis of a randomized clinical trial of overprescribing letters that began in April 2015 and included the highest-volume primary care physician (PCP) prescribers of quetiapine in original Medicare. Outcomes of patients with dementia were analyzed in repeated 90-day cross-sections through December 2018. Analyses were conducted from September 2021 to February 2024.

INTERVENTIONS: PCPs were randomized to a placebo letter or 3 overprescribing warning letters stating that their prescribing of quetiapine was high and under review by Medicare.

MAIN OUTCOMES AND MEASURES: The primary outcome of this analysis was patients’ total quetiapine use in days per 90-day period (the original trial primary outcome was total quetiapine prescribing by study PCPs). Prespecified secondary outcomes included measures of cognitive function and behavioral symptoms from nursing home assessments, indicators of depression from screening questionnaires in assessments and diagnoses in claims, metabolic diagnoses derived from assessments and claims, indicators of use of the hospital and other health care services, and death. Outcomes were analyzed separately for patients living in nursing homes and in the community.

RESULTS: Of the 5055 study PCPs, 2528 were randomized to the placebo letter, and 2527 were randomized to the 3 warning letters. A total of 84 881 patients with dementia living in nursing homes and 261 288 community-dwelling patients with dementia were attributed to these PCPs. There were 92 874 baseline patients (mean [SD] age, 81.5 [10.5] years; 64 242 female [69.2%]). The intervention reduced quetiapine use among both nursing home patients (adjusted difference, -0.7 days; 95% CI, -1.3 to -0.1 days; P = .02) and community-dwelling patients (adjusted difference, -1.5 days; 95% CI, -1.8 to -1.1 days; P < .001). There were no detected adverse effects on cognitive function (cognitive function scale adjusted difference, 0.01; 95% CI, -0.01 to 0.03; P = .19), behavioral symptoms (agitated or reactive behavior adjusted difference, -0.2%; 95% CI -1.2% to 0.8% percentage points; P = .72), depression, metabolic diagnoses, or more severe outcomes, including hospitalization and death.

CONCLUSIONS AND RELEVANCE: This study found that overprescribing warning letters to PCPs safely reduced quetiapine prescribing to their patients with dementia. This intervention and others like it may be useful for future efforts to promote guideline-concordant care.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05172687.

PMID:38662373 | DOI:10.1001/jamanetworkopen.2024.7604

JAMA Netw Open. 2024 Apr 1;7(4):e247615. doi: 10.1001/jamanetworkopen.2024.7615.

ABSTRACT

IMPORTANCE: The pharmacokinetics of abatacept and the association between abatacept exposure and outcomes in patients with severe COVID-19 are unknown.

OBJECTIVE: To characterize abatacept pharmacokinetics, relate drug exposure with clinical outcomes, and evaluate the need for dosage adjustments.

DESIGN, SETTING, AND PARTICIPANTS: This study is a secondary analysis of data from the ACTIV-1 (Accelerating COVID-19 Therapeutic Interventions and Vaccines) Immune Modulator (IM) randomized clinical trial conducted between October 16, 2020, and December 31, 2021. The trial included hospitalized adults who received abatacept in addition to standard of care for treatment of COVID-19 pneumonia. Data analysis was performed between September 2022 and February 2024.

EXPOSURE: Single intravenous infusion of abatacept (10 mg/kg with a maximum dose of 1000 mg).

MAIN OUTCOMES AND MEASURES: Mortality at day 28 was the primary outcome of interest, and time to recovery at day 28 was the secondary outcome. Drug exposure was assessed using the projected area under the serum concentration time curve over 28 days (AUC0-28). Logistic regression modeling was used to analyze the association between drug exposure and 28-day mortality, adjusted for age, sex, and disease severity. The association between time to recovery and abatacept exposure was examined using Fine-Gray modeling with death as a competing risk, and was adjusted for age, sex, and disease severity.

RESULTS: Of the 509 patients who received abatacept, 395 patients with 848 serum samples were included in the population pharmacokinetic analysis. Their median age was 55 (range, 19-89) years and most (250 [63.3%]) were men. Abatacept clearance increased with body weight and more severe disease activity at baseline. Drug exposure was higher in patients who survived vs those who died, with a median AUC0-28 of 21 428 (range, 8462-43 378) mg × h/L vs 18 262 (range, 9628-27 507) mg × h/L (P < .001). Controlling for age, sex, and disease severity, an increase of 5000 units in AUC0-28 was associated with lower odds of mortality at day 28 (OR, 0.52 [95% CI, 0.35-0.79]; P = .002). For an AUC0-28 of 19 400 mg × h/L or less, there was a higher probability of recovery at day 28 (hazard ratio, 2.63 [95% CI, 1.70-4.08] for every 5000-unit increase; P < .001). Controlling for age, sex, and disease severity, every 5000-unit increase in AUC0-28 was also associated with lower odds of a composite safety event at 28 days (OR, 0.46 [95% CI, 0.33-0.63]; P < .001). Using the dosing regimen studied in the ACTIV-1 IM trial, 121 of the 395 patients (30.6%) would not achieve an abatacept exposure of at least 19 400 mg × h/L, particularly at the extremes of body weight. Using a modified, higher-dose regimen, only 12 patients (3.0%) would not achieve the hypothesized target abatacept exposure.

CONCLUSIONS AND RELEVANCE: In this study, patients who were hospitalized with severe COVID-19 and achieved higher projected abatacept exposure had reduced mortality and a higher probability of recovery with fewer safety events. However, abatacept clearance was high in this population, and the current abatacept dosing (10 mg/kg intravenously with a maximum of 1000 mg) may not achieve optimal exposure in all patients.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04593940.

PMID:38662372 | DOI:10.1001/jamanetworkopen.2024.7615

JAMA Netw Open. 2024 Apr 1;7(4):e247629. doi: 10.1001/jamanetworkopen.2024.7629.

ABSTRACT

IMPORTANCE: Many veterans who served in Afghanistan and Iraq during Operations Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) were deployed to military bases with open burn pits and exposed to their emissions, with limited understanding of the long-term health consequences.

OBJECTIVE: To determine the association between deployment to military bases where open burn pits were used for waste disposal and the subsequent risk of developing respiratory and cardiovascular diseases.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective observational cohort study used Veterans Health Administration medical records and declassified deployment records from the Department of Defense to assess Army and Air Force veterans who were deployed between 2001 and 2011 and subsequently received health care from the Veterans Health Administration, with follow-up through December 2020. Data were analyzed from January 2023 through February 2024.

EXPOSURE: Duration of deployment to military bases with open burn pits.

MAIN OUTCOMES AND MEASURES: Diagnosis of asthma, chronic obstructive pulmonary disease, interstitial lung disease, hypertension, myocardial infarction, congestive heart failure, ischemic stroke, and hemorrhagic stroke.

RESULTS: The study population included 459 381 OEF and OIF veterans (mean [SD] age, 31.6 [8.7] years; 399 754 [87.0%] male). Median (IQR) follow-up from end of deployment was 10.9 (9.4-12.7) years. For every 100 days of deployment to bases with burn pits, veterans experienced increased adjusted odds for asthma (adjusted odds ratio [aOR], 1.01; 95% CI, 1.01-1.02), chronic obstructive pulmonary disease (aOR, 1.04; 95% CI, 1.02-1.07), hypertension (aOR, 1.02; 95% CI, 1.02-1.03), and ischemic stroke (aOR, 1.06; 95% CI, 0.97-1.14). Odds of interstitial lung disease, myocardial infarction, congestive heart failure, or hemorrhagic stroke were not increased. Results based on tertiles of duration of burn pit exposures were consistent with those from the continuous exposure measures.

CONCLUSIONS AND RELEVANCE: In this cohort study, prolonged deployment to military bases with open burn pits was associated with increased risk of developing asthma, COPD, and hypertension. The results also point to a possible increased risk in ischemic stroke. The novel ability to use integrated data on deployment and health outcomes provides a model for additional studies of the health impact of environmental exposures during military service.

PMID:38662371 | DOI:10.1001/jamanetworkopen.2024.7629

JAMA Netw Open. 2024 Apr 1;7(4):e248481. doi: 10.1001/jamanetworkopen.2024.8481.

ABSTRACT

IMPORTANCE: Psychiatric symptoms are reportedly common among adults with post-COVID-19 condition (PCC). However, nationally representative data regarding symptom prevalence, treatment uptake, and barriers to care are needed to inform the development of care models.

OBJECTIVES: To evaluate the prevalence of psychiatric symptoms in US adults with PCC compared with those without PCC and assess treatment uptake and cost-related barriers to treatment.

DESIGN, SETTING, AND PARTICIPANTS: Data from the 2022 National Health Interview Survey (NHIS), a nationally representative US cross-sectional survey, were analyzed between October 2023 and February 2024.

EXPOSURE: Current PCC, defined as new symptoms following SARS-CoV-2 infection lasting more than 3 months and ongoing at the time of interview.

MAIN OUTCOMES AND MEASURES: Depression symptoms were evaluated by the Patient Health Questionnaire-8 and anxiety symptoms were assessed using the General Anxiety Disorder-7 instrument. Participants were classified as having received treatment if they received mental health counseling or therapy or medications for mental health. Sleep difficulties, cognitive difficulties, disabling fatigue, and cost-related barriers were assessed from additional NHIS questions.

RESULTS: Of the 25 122 participants representing approximately 231 million US adults (median [IQR] age, 46 [32-61] years; 49.8% male and 50.2% female participants), a weighted prevalence (wPr) of 3.4% (95% CI, 3.1%-3.6%) had current PCC. Compared with other US adults, participants with current PCC were more likely to have depression symptoms (wPr, 16.8% vs 7.1%; adjusted odds ratio [AOR], 1.96; 95% CI, 1.51-2.55), anxiety symptoms (wPr, 16.7% vs 6.3%; AOR, 2.21; 95% CI, 1.53-3.19), sleep difficulties (wPr, 41.5% vs 22.7%; AOR 1.95; 95% CI, 1.65-2.29), cognitive difficulties (wPr, 35.0% vs 19.5%; AOR, 2.04; 95% CI, 1.66-2.50), and disabling fatigue (wPr, 4.0% vs 1.6%; AOR, 1.85; 95% CI, 1.20-2.86). Among participants who had depression or anxiety symptoms, those with PCC had a similar likelihood of not having received treatment (wPr, 28.2% vs 34.9%; AOR, 1.02; 95% CI, 0.66-1.57). However, participants with current PCC were more likely to report a cost-related barrier to accessing mental health counseling or therapy (wPr, 37.2% vs 23.3%; AOR, 2.05; 95% CI, 1.40-2.98).

CONCLUSIONS AND RELEVANCE: The findings of this study suggest that people with PCC have a higher prevalence of psychiatric symptoms than other adults but are more likely to experience cost-related barriers to accessing therapy. Care pathways for PCC should consider prioritizing mental health screening and affordable treatment.

PMID:38662370 | DOI:10.1001/jamanetworkopen.2024.8481