Category: Statistics

JAMA Netw Open. 2022 Jul 1;5(7):e2223911. doi: 10.1001/jamanetworkopen.2022.23911.

ABSTRACT

IMPORTANCE: The most appropriate therapy for older adults with multimorbidity may depend on life expectancy (ie, mortality risk), and several scores have been developed to predict 1-year mortality risk. However, often, these mortality risk scores have not been externally validated in large sample sizes, and a head-to-head comparison in a prospective contemporary cohort is lacking.

OBJECTIVE: To prospectively compare the performance of 6 scores in predicting the 1-year mortality risk in hospitalized older adults with multimorbidity.

DESIGN, SETTING, AND PARTICIPANTS: This prognostic study analyzed data of participants in the OPERAM (Optimising Therapy to Prevent Avoidable Hospital Admissions in Multimorbid Older People) trial, which was conducted between December 1, 2016, and October 31, 2018, in surgical and nonsurgical departments of 4 university-based hospitals in Louvain, Belgium; Utrecht, the Netherlands; Cork, Republic of Ireland; and Bern, Switzerland. Eligible participants in the OPERAM trial had multimorbidity (≥3 coexisting chronic diseases), were aged 70 years or older, had polypharmacy (≥5 long-term medications), and were admitted to a participating ward. Data were analyzed from April 1 to September 30, 2020.

MAIN OUTCOMES AND MEASURES: The outcome of interest was any-cause death occurring in the first year of inclusion in the OPERAM trial. Overall performance, discrimination, and calibration of the following 6 scores were assessed: Burden of Illness Score for Elderly Persons, CARING (Cancer, Admissions ≥2, Residence in a nursing home, Intensive care unit admit with multiorgan failure, ≥2 Noncancer hospice guidelines) Criteria, Charlson Comorbidity Index, Gagné Index, Levine Index, and Walter Index. These scores were assessed using the following measures: Brier score (0 indicates perfect overall performance and 0.25 indicates a noninformative model); C-statistic and 95% CI; Hosmer-Lemeshow goodness-of-fit test and calibration plots; and sensitivity, specificity, and positive and negative predictive values.

RESULTS: The 1879 patients in the study had a median (IQR) age of 79 (74-84) years and 835 were women (44.4%). The median (IQR) number of chronic diseases was 11 (8-16). Within 1 year, 375 participants (20.0%) died. Brier scores ranged from 0.16 (Gagné Index) to 0.24 (Burden of Illness Score for Elderly Persons). C-statistic values ranged from 0.62 (95% CI, 0.59-0.65) for Charlson Comorbidity Index to 0.69 (95% CI, 0.66-0.72) for the Walter Index. Calibration was good for the Gagné Index and moderate for other mortality risk scores.

CONCLUSIONS AND RELEVANCE: Results of this prognostic study suggest that all 6 of the 1-year mortality risk scores examined had moderate prognostic performance, discriminatory power, and calibration in a large cohort of hospitalized older adults with multimorbidity. Overall, none of these mortality risk scores outperformed the others, and thus none could be recommended for use in daily clinical practice.

PMID:35895059 | DOI:10.1001/jamanetworkopen.2022.23911

JAMA Cardiol. 2022 Jul 27. doi: 10.1001/jamacardio.2022.2222. Online ahead of print.

ABSTRACT

IMPORTANCE: In patients with severe aortic stenosis and left ventricular ejection fraction (LVEF) less than 50%, early LVEF improvement after transcatheter aortic valve replacement (TAVR) is associated with improved 1-year mortality; however, its association with long-term clinical outcomes is not known.

OBJECTIVE: To examine the association between early LVEF improvement after TAVR and 5-year outcomes.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study analyzed patients enrolled in the Placement of Aortic Transcatheter Valves (PARTNER) 1, 2, and S3 trials and registries between July 2007 and April 2015. High- and intermediate-risk patients with baseline LVEF less than 50% who underwent transfemoral TAVR were included in the current study. Data were analyzed from August 2020 to May 2021.

EXPOSURES: Early LVEF improvement, defined as increase of 10 percentage points or more at 30 days and also as a continuous variable (ΔLVEF between baseline and 30 days).

MAIN OUTCOMES AND MEASURES: All-cause death at 5 years.

RESULTS: Among 659 included patients with LVEF less than 50%, 468 (71.0%) were male, and the mean (SD) age was 82.4 (7.7) years. LVEF improvement within 30 days following transfemoral TAVR occurred in 216 patients (32.8%) (mean [SD] ΔLVEF, 16.4 [5.7%]). Prior myocardial infarction, diabetes, cancer, higher baseline LVEF, larger left ventricular end-diastolic diameter, and larger aortic valve area were independently associated with lower likelihood of LVEF improvement. Patients with vs without early LVEF improvement after TAVR had lower 5-year all-cause death (102 [50.0%; 95% CI, 43.3-57.1] vs 246 [58.4%; 95% CI, 53.6-63.2]; P = .04) and cardiac death (52 [29.5%; 95% CI, 23.2-37.1] vs 135 [38.1%; 95% CI, 33.1-43.6]; P = .05). In multivariable analyses, early improvement in LVEF (modeled as a continuous variable) was associated with lower 5-year all-cause death (adjusted hazard ratio per 5% increase in LVEF, 0.94 [95% CI, 0.88-1.00]; P = .04) and cardiac death (adjusted hazard ratio per 5% increase in LVEF, 0.90 [95% CI, 0.82-0.98]; P = .02) after TAVR. Restricted cubic spline analysis demonstrated a visual inflection point at ΔLVEF of 10% beyond which there was a steep decline in all-cause mortality with increasing degree of LVEF improvement. There were no statistically significant differences in rehospitalization, New York Heart Association functional class, or Kansas City Cardiomyopathy Questionnaire Overall Summary score at 5 years in patients with vs without early LVEF improvement. In subgroup analysis, the association between early LVEF improvement and 5-year all-cause death was consistent regardless of the presence or absence of coronary artery disease or prior myocardial infarction.

CONCLUSIONS AND RELEVANCE: In patients with severe aortic stenosis and LVEF less than 50%, 1 in 3 experience LVEF improvement within 1 month after TAVR. Early LVEF improvement is associated with lower 5-year all-cause and cardiac death.

PMID:35895046 | DOI:10.1001/jamacardio.2022.2222

JAMA Dermatol. 2022 Jul 27. doi: 10.1001/jamadermatol.2022.2823. Online ahead of print.

ABSTRACT

IMPORTANCE: Photoaggravated atopic dermatitis (PAD) is estimated to affect 1.4% to 16% of patients with AD but remains poorly characterized with limited published data.

OBJECTIVE: To provide detailed clinical and photobiological characterization of PAD.

DESIGN, SETTING, AND PARTICIPANTS: This case series study used cross-sectional data collected from 120 consecutive patients diagnosed with PAD from January 2015 to October 2019 at a tertiary center referral unit for photobiology.

MAIN OUTCOMES AND MEASURES: Routinely collected standardized clinical and photobiological data were analyzed using descriptive statistics, and regression analysis explored associations between demographic and clinical data.

RESULTS: Of 869 patients who underwent photoinvestigation, 120 (14%) were diagnosed with PAD (69 female [58%]; median age, 45 [IQR, 31-61] years; range, 5-83 years; skin phototypes [SPTs] I-VI). Of these patients, 104 (87%) were adults. All patients had a history of AD, and most (62 of 104 [60%]) presented with sunlight-provoked or photodistributed eczema; median age at photosensitivity onset was 37 years (range, 1-72 years). Past-year Dermatology Life Quality Index score was greater than 10 for 80 of 103 adults (78%), and 82 of 119 (69%) had vitamin D (25-hydroxyvitamin D) level insufficiency or deficiency (<20 ng/mL; to convert ng/mL to nmol/L, multiply by 2.496). Broadband UV radiation provocation test results were positive for 112 patients (93%). In 28 patients (23%) with abnormal monochromator phototest findings, sensitivity occurred to UV-A, UV-B, and/or visible light, and UV-A of 350 ± 10 nm was the most prevalent wavelength. Photopatch test reactions were positive for 18 patients (15%). Patients with SPTs V to VI (31 [26%]) vs SPTs I to IV (89 [74%]) were younger at photosensitivity onset (median age, 24 years [IQR, 15-37 years] vs 40 years [IQR, 25-55 years]; P = .003), were more likely to be female (23 [74%] vs 46 [52%]; P = .03), and had a lower vitamin D status and a higher frequency of abnormal monochromator phototest findings.

CONCLUSIONS AND RELEVANCE: In this case series study, PAD affected patients with different ages and SPTs and was associated with substantially impaired quality of life. The findings suggest that confirming PAD through phototesting may provide better personalized care for patients through identification of provoking wavelengths, relevant photocontact allergies, and appropriate photoprotection advice.

PMID:35895040 | DOI:10.1001/jamadermatol.2022.2823

Clin Trials. 2022 Jul 27:17407745221111818. doi: 10.1177/17407745221111818. Online ahead of print.

ABSTRACT

Network science methods can be useful in design, monitoring, and analysis of randomized trials for control of spread of infections. Their usefulness arises from the role of statistical network models in molecular epidemiology and in study design. Computational models, such as agent-based models that propagate disease on simulated contact networks, can be used to investigate the properties of different study designs and analysis plans. Particularly valuable is the use of these methods to assess how magnitude and detectability of intervention effects depend on both individual-level and network-level characteristics of the enrolled populations. Such investigation also provides an important approach to assessing consequences of study data being incomplete or measured with error. To address these goals, we consider two statistical network models: exponential random graph models and the more flexible congruence class models. We focus first on an historical use of these methods in design and monitoring of a cluster randomized trial in Botswana to evaluate the effect of combination HIV prevention modalities compared to standard of care on HIV incidence. We then present a framework for the design of a study of booster vaccine effects on infection with, and forward transmission of, SARS-CoV-2 variants. Motivation for the study is driven in part by guidance from the United Kingdom to base approval of booster vaccines with “strain changes” that target variants on results of neutralizing antibody tests and information about safety, but without requiring evidence of clinical efficacy. Using designs informed by our agent-based network models, we show it may be feasible to conduct a trial of novel SARS-CoV-2 vaccines in a single large campus to obtain useful information regarding vaccine efficacy against susceptibility and infectiousness. If needed, the sample size could be increased by extending the study to a small number of campuses. Novel network methods may be useful in developing pragmatic SARS-CoV-2 vaccine trials that can leverage existing infrastructure to reduce costs and hasten the development of results.

PMID:35894099 | DOI:10.1177/17407745221111818

J Clin Pharm Ther. 2022 Jul 27. doi: 10.1111/jcpt.13736. Online ahead of print.

ABSTRACT

WHAT IS KNOWN AND OBJECTIVES: Potential inappropriate medications (PIMs) can increase the risk of medication-induced harm. However, there are no studies regarding PIMs in older and critically ill patients with cardiovascular diseases in China. Therefore, studies evaluating PIMs in these patients can help in the implementation of more effective interventions to reduce the risk of drug use. Our objective was to analyse the prevalence of PIMs in elderly patients admitted to the cardiac intensive care unit (CICU) comparing the 2019 Beers criteria (Beers criteria), Screening Tool of Older People’s Potentially Inappropriate Prescriptions (STOPP) criteria version 2 (STOPP criteria) and criteria of potentially inappropriate medications for older adults in China (Chinese criteria); and analyse the factors influencing the PIMs.

METHODS: This cross-sectional and retrospective study was performed with elderly patients (≥65 years) admitted to the CICU of the Beijing Tongren Hospital in China from January 2019 to June 2020. The PIMs were identified based on the Chinese, STOPP and Beers criteria at admission and discharge. The three criteria were compared using the Kappa statistic. Multiple regression analysis was used to investigate the influencing factors associated with PIMs.

RESULTS AND DISCUSSION: A total of 369 patients who met the inclusion/exclusion criteria were included in this study. According to the three criteria used to evaluate the PIMs, the prevalence was 78.3% and 72.6% at admission and discharge, respectively. The prevalence rate of PIMs determined by the Chinese criteria was 62.1% at admission versus 56.6% at discharge (p = 0.134); the Beers criteria was 53.9% at admission versus 46.9% at discharge (p = 0.056); by the STOPP criteria was 20.6% at admission versus 13.8% at discharge (p = 0.015). Moreover, 28.9% (STOPP criteria), 56.8% (Beers criteria) and 73.4% (Chinese criteria) of patients taking PIMs on admission still had the same problem at discharge. The most common PIMs screened by the Beers, STOPP and Chinese criteria were diuretics, benzodiazepines and clopidogrel, respectively. Besides, the three criteria showed poor agreement. Finally, the stronger predictor of PIMs was the increased number of medications (p < 0.05).

WHAT IS NEW AND CONCLUSION: The prevalence of PIMs in elderly patients admitted to the CICU was high. The Chinese, STOPP and Beers criteria are effective screening tools to detect PIMs, but the consistency between them was poor. The increased number of medications was a significant predictor of PIMs.

PMID:35894086 | DOI:10.1111/jcpt.13736

Palliat Support Care. 2022 Jul 27:1-7. doi: 10.1017/S1478951522000864. Online ahead of print.

ABSTRACT

CONTEXT: Knowledge, beliefs, and attitudes toward palliative care (PC) constitute barriers to its access. Few studies have focused on the intrinsic relationship between these variables, and none has examined the relationship between them and self-care self-efficacy.

OBJECTIVE: To examine the direct and indirect effects of self-care self-efficacy, knowledge, and beliefs on attitudes toward PC.

METHODS: A cross-sectional predictive study was conducted. Self-care self-efficacy, knowledge, attitudes, and beliefs about PC were analyzed using information from the Health Information National Trends Survey (HINTS 5, cycle 2, 2018). Data from 1,162 participants were considered. Structural equation modeling (SEM) was used to represent the statistical mediation model with latent and observable variables.

RESULTS: The structural model presents positive coefficients indicating that self-care self-efficacy significantly predicts knowledge (β = 0.127, p < 0.001) and beliefs (β = 0.078, p = 0.023). Similarly, knowledge is associated with attitudes (β = 0.179, p < 0.001) and beliefs (β = 0.213, p < 0.001). The beliefs measure is also significantly related to attitudes (β = 0.474, p < 0.001). In addition, this structural multiple mediation model shows optimal goodness-of-fit indices: χ²/df = 3.49, CFI = 0.983, TLI = 0.976, RMSEA = 0.046 [90% CI: 0.037-0.056], SRMR = 0.038.

CONCLUSION: Self-care self-efficacy is significantly associated with knowledge and beliefs about PC, which in turn are related to each other. Altogether, these variables predict positive attitudes toward PC. Understanding the relationship between these variables is relevant for targeting-specific populations and designing timely strategies to improve access to PC.

PMID:35894093 | DOI:10.1017/S1478951522000864

Obesity (Silver Spring). 2022 Aug;30(8):1691-1698. doi: 10.1002/oby.23482.

ABSTRACT

OBJECTIVE: This study analyzed the association between adolescent BMI and myopia severity.

METHODS: This cross-sectional study comprised 1,359,153 adolescents who were medically examined before mandatory military service. Mild-to-moderate and high myopia were defined based on right-eye refractive data. BMI was categorized based on the US age- and sex-matched percentiles. Logistic regression models were applied separately for women and men to estimate odds ratios (ORs) for myopia per BMI category.

RESULTS: A total of 318,712 adolescents had mild-to-moderate myopia and 23,569 had high myopia. Compared with low-normal BMI (reference group), adjusted ORs for mild-to-moderate and high myopia increased with increasing BMI status, reaching 1.39 (95% CI: 1.23-1.57) and 1.73 (95% CI: 1.19-2.51) for men with severe obesity, respectively, and 1.19 (95% CI: 1.12-1.27) and 1.38 (95% CI: 1.14-1.65) for women with mild obesity, respectively. ORs for mild-to-moderate and high myopia were also higher in men with underweight (OR = 1.20; 95% CI: 1.18-1.23 and OR = 1.39; 95% CI: 1.30-1.47) and women with underweight (OR = 1.06; 95% CI: 1.03-1.09 and OR = 1.12; 95% CI: 1.04-1.22). The overall size effect was greater for men than women (p_interaction < 0.001), in whom the group with severe obesity did not reach statistical significance.

CONCLUSIONS: BMI was associated with myopia in a J-shaped pattern, with the size effect being greater for adolescent men than women. This study indicates that both low BMI and high BMI are associated with mild-to-moderate and severe myopia.

PMID:35894082 | DOI:10.1002/oby.23482

Obesity (Silver Spring). 2022 Aug;30(8):1608-1620. doi: 10.1002/oby.23481.

ABSTRACT

OBJECTIVE: This study aimed to determine the effects of a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, liraglutide, and placebo subcutaneously over 16 weeks on weight and gastric functions and to evaluate associations of single-nucleotide polymorphisms in GLP1R (rs6923761) and TCF7L2 (rs7903146) with effects of liraglutide.

METHODS: The study conducted a randomized, parallel-group, placebo-controlled, 16-week trial of liraglutide, escalated to 3 mg subcutaneously daily in 136 otherwise healthy adults with obesity. Weight, gastric emptying of solids (GES), gastric volumes, satiation, and body composition measured at baseline and after treatment were compared in two treatment groups using analysis of covariance.

RESULTS: Liraglutide (n = 59) and placebo (n = 65) groups completed treatment. Relative to placebo, liraglutide increased weight loss at 5 and 16 weeks (both p < 0.05), slowed time to half GES (T_1/2 ) at 5 and 16 weeks (both p < 0.001), and increased fasting gastric volume (p = 0.01) and satiation (p < 0.01) at 16 weeks. GES T_1/2 was positively correlated with weight loss on liraglutide (both p < 0.001). After 16 weeks of liraglutide, GLP1R rs6923761 (AG/AA vs. GG) was associated with reduced percent body fat (p = 0.062), and TCF7L2 rs7903146 (CC vs. CT/TT) was associated with lower body weight (p = 0.015).

CONCLUSIONS: Liraglutide, 3 mg, induces weight loss with delay in GES T_1/2 and reduces calorie intake. Slowing GES and variations in GLP1R and TCF7L2 are associated with liraglutide effects in obesity.

PMID:35894080 | DOI:10.1002/oby.23481

Pathogens. 2022 Jul 25;11(8):830. doi: 10.3390/pathogens11080830.

ABSTRACT

Q fever, caused by the bacterium Coxiella burnetii, is an important zoonotic disease worldwide. Australia has one of the highest reported incidences and seroprevalence of Q fever, and communities in the state of Queensland are at highest risk of exposure. Despite Australia’s Q fever vaccination programs, the number of reported Q fever cases has remained stable for the last few years. The extent to which Q fever notifications cluster in circumscribed communities is not well understood. This study aimed to retrospectively explore and identify the spatiotemporal variation in Q fever household and community clusters in Queensland reported during 2002 to 2017, and quantify potential within cluster drivers. We used Q fever notification data held in the Queensland Notifiable Conditions System to explore the geographical clustering patterns of Q fever incidence, and identified and estimated community Q fever spatiotemporal clusters using SatScan, Boston, MA, USA. The association between Q fever household and community clusters, and demographic and socioeconomic characteristics was explored using the chi-squared statistical test and logistic regression analysis. From the total 2175 Q fever notifications included in our analysis, we found 356 Q fever hotspots at a mesh-block level. We identified that 8.2% of Q fever notifications belonged to a spatiotemporal cluster. Within the spatiotemporal Q fever clusters, we found 44 (61%) representing household clusters and 20 (27.8%) were statistically significant with an average cluster size of 3 km radius. Our multivariable model shows statistical differences between cases belonging to clusters in comparison with cases outside clusters based on the type of reported exposure. In conclusion, our results demonstrate that clusters of Q fever notifications are temporally stable and geographically circumscribed, indicating a persistent common exposure. Furthermore, within individuals in household and community clusters, abattoir exposure (a traditional occupational exposure) was rarely reported by individuals.

PMID:35894053 | DOI:10.3390/pathogens11080830

Polymers (Basel). 2022 Jul 27;14(15):3033. doi: 10.3390/polym14153033.

ABSTRACT

Parylene is used as encapsulating material for medical devices due to its excellent biocompatibility and insulativity. Its performance as the insulating polymer of implantable neural interfaces has been studied in electrolyte solutions and in vivo. Biological tissue in vitro, as a potential environment for characterization and application, is convenient to access in the fabrication lab of polymer and neural electrodes, but there has been little study investigating the behaviors of Parylene in the tissue in vitro. Here, we investigated the electrochemical impedance behaviors of Parylene C polymer coating both in normal saline and in a chilled pig brain in vitro by performing electrochemical impedance spectroscopy (EIS) measurements of platinum (Pt) wire neural electrodes. The electrochemical impedance at the representative frequencies is discussed, which helps to construct the equivalent circuit model. Statistical analysis of fitted parameters of the equivalent circuit model showed good reliability of Parylene C as an insulating polymer in both electrolyte models. The electrochemical impedance measured in pig brain in vitro shows marked differences from that of saline.

PMID:35893997 | DOI:10.3390/polym14153033