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Nevin Manimala Statistics

Authors’ response: Bias in the vaccine effectiveness estimates of one-dose post-exposure prophylaxis against mpox

Euro Surveill. 2023 Aug;28(34). doi: 10.2807/1560-7917.ES.2023.28.34.2300442.

NO ABSTRACT

PMID:37616117 | DOI:10.2807/1560-7917.ES.2023.28.34.2300442

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Nevin Manimala Statistics

Which information locations in covered entities under HIPAA must be secured first? A multi-criteria decision-making approach

J Healthc Risk Manag. 2023 Aug 24. doi: 10.1002/jhrm.21555. Online ahead of print.

ABSTRACT

Creating adequate safeguards for physical and online locations (e.g., desktop computers, network servers) where protected health information (PHI) may be breached is critical for management within entities compliant with the Health Information Portability and Accountability Act (HIPAA). With the increasing complexity of cyber breaches and budgetary issues, prioritizing which locations require the most immediate attention by top management through a data-driven model is more important than ever. Using CORAS threat modeling and five methods for multi-criteria decision-making, these locations were ranked from greatest to least risk of data breaches. Statistical methods were subsequently used for consistency and robustness checks. The findings illustrate that each type of covered entity under HIPAA must prioritize a different set of locations to safeguard first: health care providers must focus on the security of network servers, other portable electronic devices, and category of others (i.e., miscellaneous locations); health plans must focus on the security of paper and films, network servers, and others; and business associates must focus on the security of category of others, network servers, and other portable electronic devices. Combined with data on the source of the breaches (external vs. internal) and type of threats (e.g., hacking, theft), these findings provide recommendations for risk identification for privacy officers across health care.

PMID:37616038 | DOI:10.1002/jhrm.21555

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Effects of a Nonwearable Digital Therapeutic Intervention on Preschoolers With Autism Spectrum Disorder in China: Open-Label Randomized Controlled Trial

J Med Internet Res. 2023 Aug 24;25:e45836. doi: 10.2196/45836.

ABSTRACT

BACKGROUND: Autism spectrum disorder (ASD) is a neurodevelopmental disorder that can cause difficulty with communication and social interactions as well as complicated family dynamics. Digital health interventions can reduce treatment costs and promote healthy lifestyle changes. These therapies can be adjunctive or replace traditional treatments. However, issues with cooperation and compliance prevent preschool patients with ASD from applying these tools. In this open-label, randomized controlled trial, we developed a nonwearable digital therapy called virtual reality-incorporated cognitive behavioral therapy (VR-CBT).

OBJECTIVE: The aim of this study was to assess the adjunctive function of VR-CBT by comparing the effects of VR-CBT plus learning style profile (LSP) intervention with those of LSP-only intervention in preschool children with ASD.

METHODS: This trial was performed in China on 78 preschool children (age 3-6 years, IQ>70) diagnosed with ASD who were randomized to receive a 20-week VR-CBT plus LSP intervention (intervention group, 39/78, 50%) or LSP intervention only (control group, 39/78, 50%). The primary outcome was the change of scores from baseline to week 20, assessed by using the parent-rated Autism Behavior Checklist (ABC). Secondary outcomes included the Childhood Autism Rating Scale (CARS), Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV), and behavioral performance data (accuracy and reaction time) in go/no-go tasks. All primary and secondary outcomes were analyzed in the intention-to-treat population.

RESULTS: After the intervention, there was an intervention effect on total ABC (β=-5.528; P<.001) and CARS scores (β=-1.365; P=.02). A similar trend was observed in the ABC subscales: sensory (β=-1.133; P=.047), relating (β=-1.512; P=.03), body and object use (β=-1.211; P=.03), and social and self-help (β=-1.593; P=.03). The intervention also showed statistically significant effects in improving behavioral performance (go/no-go task, accuracy, β=2.923; P=.04). Moreover, a significant improvement of ADHD hyperactivity-impulsivity symptoms was observed in 53 children with comorbid ADHD based on ADHD-RS-IV (β=-1.269; P=.02). No statistically significant intervention effect was detected in the language subscale of ABC (β=-.080; P=.83). Intervention group girls had larger improvements in ABC subscales, that is, sensory and body and object use and in the CARS score and accuracy of go/no-go task (all P<.05) than the control group girls. Statistically significant intervention effects could be observed in hyperactivity-impulsivity symptoms in the intervention group boys with comorbid ADHD compared with those in the control group boys (β=-1.333; P=.03).

CONCLUSIONS: We found potentially positive effects of nonwearable digital therapy plus LSP on core symptoms associated with ASD, leading to a modest improvement in the function of sensory, motor, and response inhibition, while reducing impulsivity and hyperactivity in preschoolers with both ASD and ADHD. VR-CBT was found to be an effective and feasible adjunctive digital tool.

TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100053165; http://www.chictr.org.cn/showproj.aspx?proj=137016.

PMID:37616029 | DOI:10.2196/45836

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Nevin Manimala Statistics

Demographic Comparison of Information Security Behavior Toward Health Information System Protection: Survey Study

JMIR Form Res. 2023 Aug 24;7:e49439. doi: 10.2196/49439.

ABSTRACT

BACKGROUND: The health information system (HIS) functions are getting wider with more diverse users. Information security in the health industry is crucial because it involves comprehensive and strategic information that might harm human life. The human factor is one of the biggest security threats to HIS.

OBJECTIVE: This study aims to investigate the information security behavior (ISB) of HIS users using a comprehensive assessment scale suited to the information security concerns in health care. Patients are increasingly being asked to submit their own data into HIS systems. As a result, this study examines the security behavior of health workers and patients, as well as their demographic variables.

METHODS: We used a quantitative approach using surveys of health workers and patients. We created a research instrument from 4 existing measurement scales to measure prosecurity and antisecurity behavior. We analyzed statistical differences to test the hypotheses, that is, the Kruskal-Wallis test and the Mann-Whitney test. The descriptive analysis was used to determine whether the group exhibited exemplary behavior when processing the survey results. A correlational test using the Spearman correlation coefficient was performed to establish the significance of the relationship between ISB and age as well as level of education.

RESULTS: We analyzed 421 responses from the survey. According to demographic factors, the hypotheses tested for full and partial security behavior reveal substantial differences. Education levels most significantly affect security behavior differences, followed by user type, gender, and age. The health workers’ ISB is higher than that of the patients. Women are more likely than men to engage in prosecurity actions while avoiding antisecurity behaviors. The older the HIS user, the more likely it is that they will participate in prosecurity behavior and the less probable it is that they will engage in antisecurity behavior. According to this study, differences in prosecurity behavior are mostly impacted by education level. Higher education, on the other hand, does not guarantee improved ISB for HIS users. All demographic characteristics, particularly concerning user type, show discrepancies that are caused mainly by antisecurity behavior rather than prosecurity behavior.

CONCLUSIONS: Since patients engage in antisecurity behavior more frequently than health workers and may pose security risks, health care facilities should start to consider information security education for patients. More comprehensive research on ISB in health care facilities is required to better understand the patient’s perspective, which is currently understudied.

PMID:37616025 | DOI:10.2196/49439

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Adolescent alcohol and cannabis use as risk factors for head trauma in the Northern Finland Birth Cohort study 1986

Eur J Public Health. 2023 Aug 23:ckad151. doi: 10.1093/eurpub/ckad151. Online ahead of print.

ABSTRACT

BACKGROUND: The aim of this study was to assess the associations between cannabis use and frequency of alcohol intoxication in adolescence with the risk of traumatic brain injury and craniofacial fractures in early adulthood. Hypothesis was that using alcohol and cannabis in adolescence could increase the risk for head traumas.

METHODS: Data from the Northern Finland Birth Cohort 1986 (n = 9432 individuals) were used to investigate the prospective association between the self-reported frequency of alcohol intoxication (n = 6472) and cannabis use (n = 6586) in mid-adolescence and register-based, head trauma diagnoses by ages 32-33 years. To test the robustness of these associations, the statistical models were adjusted for a range of other confounders such as illicit drug use, previous head trauma and self-reported mental health problems.

RESULTS: In multivariate analyses, cannabis use was statistically significantly associated with a greater risk of traumatic brain injury among females [hazard ratio (HR) 1.9, 95% confidence interval (CI) 1.1-3.2, P = 0.024). Frequent alcohol intoxication was a statistically significant independent risk factor for both traumatic brain injury (HR 2.6, 95% CI 1.7-3.9, P < 0.001) and craniofacial fractures (HR 2.7, 95% CI 1.6-4.8, P < 0.001) among males.

CONCLUSIONS: Cannabis use in adolescence appears to associate independently with elevated risk for traumatic brain injury among females, and frequent alcohol intoxication in adolescence seems to associate with elevated risk of both traumatic brain injury and craniofacial fractures among males.

PMID:37616019 | DOI:10.1093/eurpub/ckad151

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Time to Benefit of Sodium-Glucose Cotransporter-2 Inhibitors Among Patients With Heart Failure

JAMA Netw Open. 2023 Aug 1;6(8):e2330754. doi: 10.1001/jamanetworkopen.2023.30754.

ABSTRACT

IMPORTANCE: Emerging evidence has consistently demonstrated that sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of heart failure (HF) hospitalization and cardiovascular (CV) death among patients with HF. However, it remains unclear how long a patient needs to live to potentially benefit from SGLT2 inhibitors in this population.

OBJECTIVES: To estimate the time to benefit from SGLT2 inhibitors among patients with HF.

DESIGN, SETTING, AND PARTICIPANTS: This comparative effectiveness study systematically searched PubMed for completed randomized clinical trials about SGLT2 inhibitors and patients with HF published until September 5, 2022; 5 trials with the year of publication ranging from 2019 to 2022 were eventually included. Statistical analysis was performed from April to October 2022.

INTERVENTION: Addition of SGLT2 inhibitors or placebo to guideline-recommended therapy.

MAIN OUTCOMES AND MEASURES: The primary outcome was the time to first event of CV death or worsening HF, which was broadly comparable across the included trials.

RESULTS: Five trials consisting of 21 947 patients with HF (7837 [35.7%] were female; mean or median age older than 65 years within each trial) were included. SGLT2 inhibitors significantly reduced the risk of worsening HF or CV death (hazard ratio [HR], 0.77 [95% CI, 0.73-0.82]). Time to first nominal statistical significance (P < .05) was 26 days (0.86 months), and statistical significance was sustained from day 118 (3.93 months) onwards. A mean of 0.19 (95% CI, 0.12-0.35) months were needed to prevent 1 worsening HF or CV death per 500 patients with SGLT2 inhibitors (absolute risk reduction [ARR], 0.002). Likewise, 0.66 (95% CI, 0.43-1.13) months was estimated to avoid 1 event per 200 patients with SGLT2 inhibitors (ARR, 0.005), 1.74 (95% CI, 1.07-2.61) months to avoid 1 event per 100 patients (ARR, 0.010), and 4.96 (95% CI, 3.18-7.26) months to avoid 1 event per 50 patients (ARR, 0.020). Further analyses indicated a shorter time to benefit for HF hospitalization and among patients with diabetes or HF with reduced ejection fraction.

CONCLUSIONS AND RELEVANCE: In this comparative effectiveness research study of estimating the time to benefit from SGLT2 inhibitors among patients with HF, a rapid clinical benefit in reducing CV death or worsening HF was found, suggesting that their use may be beneficial for most individuals with HF.

PMID:37615988 | DOI:10.1001/jamanetworkopen.2023.30754

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Clinical Outcomes Associated With Overestimation of Oxygen Saturation by Pulse Oximetry in Patients Hospitalized With COVID-19

JAMA Netw Open. 2023 Aug 1;6(8):e2330856. doi: 10.1001/jamanetworkopen.2023.30856.

ABSTRACT

IMPORTANCE: Many pulse oximeters have been shown to overestimate oxygen saturation in persons of color, and this phenomenon has potential clinical implications. The relationship between overestimation of oxygen saturation with timing of COVID-19 medication delivery and clinical outcomes remains unknown.

OBJECTIVE: To investigate the association between overestimation of oxygen saturation by pulse oximetry and delay in administration of COVID-19 therapy, hospital length of stay, risk of hospital readmission, and in-hospital mortality.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study included patients hospitalized for COVID-19 at 186 acute care facilities in the US with at least 1 functional arterial oxygen saturation (SaO2) measurement between March 2020 and October 2021. A subset of patients were admitted after July 1, 2020, without immediate need for COVID-19 therapy based on pulse oximeter saturation (SpO2 levels of 94% or higher without supplemental oxygen).

EXPOSURES: Self-reported race and ethnicity, difference between concurrent SaO2 and pulse oximeter saturation (SpO2) within 10 minutes, and initially unrecognized need for COVID-19 therapy (first SaO2 reading below 94% despite SpO2 levels of 94% or above).

MAIN OUTCOME AND MEASURES: The association of race and ethnicity with degree of pulse oximeter measurement error (SpO2 – SaO2) and odds of unrecognized need for COVID-19 therapy were determined using linear mixed-effects models. Associations of initially unrecognized need for treatment with time to receipt of therapy (remdesivir or dexamethasone), in-hospital mortality, 30-day hospital readmission, and length of stay were evaluated using mixed-effects models. All models accounted for demographics, clinical characteristics, and hospital site. Effect modification by race and ethnicity was evaluated using interaction terms.

RESULTS: Among 24 504 patients with concurrent SpO2 and SaO2 measurements (mean [SD] age, 63.9 [15.8] years; 10 263 female [41.9%]; 3922 Black [16.0%], 7895 Hispanic [32.2%], 2554 Asian, Native American or Alaskan Native, Hawaiian or Pacific Islander, or another race or ethnicity [10.4%], and 10 133 White [41.4%]), pulse oximetry overestimated SaO2 for Black (adjusted mean difference, 0.93 [95% CI, 0.74-1.12] percentage points), Hispanic (0.49 [95% CI, 0.34-0.63] percentage points), and other (0.53 [95% CI, 0.35-0.72] percentage points) patients compared with White patients. In a subset of 8635 patients with a concurrent SpO2 – SaO2 pair without immediate need for COVID-19 therapy, Black patients were significantly more likely to have pulse oximetry values that masked an indication for COVID-19 therapy compared with White patients (adjusted odds ratio [aOR], 1.65; 95% CI, 1.33-2.03). Patients with an unrecognized need for COVID-19 therapy were 10% less likely to receive COVID-19 therapy (adjusted hazard ratio, 0.90; 95% CI, 0.83-0.97) and higher odds of readmission (aOR, 2.41; 95% CI, 1.39-4.18) regardless of race (P for interaction = .45 and P = .14, respectively). There was no association of unrecognized need for COVID-19 therapy with in-hospital mortality (aOR, 0.84; 95% CI, 0.71-1.01) or length of stay (mean difference, -1.4 days; 95% CI, -3.1 to 0.2 days).

CONCLUSIONS AND RELEVANCE: In this cohort study, overestimation of oxygen saturation by pulse oximetry led to delayed delivery of COVID-19 therapy and higher probability of readmission regardless of race. Black patients were more likely to have unrecognized need for therapy with potential implications for population-level health disparities.

PMID:37615985 | DOI:10.1001/jamanetworkopen.2023.30856

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A pilot test of an infographic-based health communication intervention to enhance patient education among Latino persons with HIV

J Am Med Inform Assoc. 2023 Aug 23:ocad157. doi: 10.1093/jamia/ocad157. Online ahead of print.

ABSTRACT

OBJECTIVE: To pilot test an infographic-based health communication intervention that our team rigorously designed and explore whether its implementation leads to better health outcomes among Latino persons with HIV (PWH).

MATERIALS AND METHODS: Latino PWH (N = 30) living in New York City received the intervention during health education sessions at 3 study visits that occurred approximately 3 months apart. At each visit, participants completed baseline or follow-up assessments and laboratory data were extracted from patient charts. We assessed 6 outcomes (HIV-related knowledge, self-efficacy to manage HIV, adherence to antiretroviral therapy, CD4 count, viral load, and current and overall health status) selected according to a conceptual model that describes pathways through which communication influences health outcomes. We assessed changes in outcomes over time using quantile and generalized linear regression models controlling for the coronavirus disease 2019 (COVID-19) research pause and new patient status (new/established) at the time of enrollment.

RESULTS: Most participants were male (60%) and Spanish-speaking (60%); 40% of participants identified as Mixed Race/Mestizo, 13.3% as Black, 13.3% as White, and 33.3% as “other” race. Outcome measures generally improved after the second intervention exposure. Following the third intervention exposure (after the COVID-19 research pause), only the improvements in HIV-related knowledge and current health status were statistically significant.

DISCUSSION AND CONCLUSION: Our infographic-based health communication intervention may lead to better health outcomes among Latino PWH, but larger trials are needed to establish efficacy. From this work, we contribute suggestions for effective infographic use for patient-provider communication to enhance patient education in clinical settings.

PMID:37615971 | DOI:10.1093/jamia/ocad157

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Comparison of two COVID-19 mortality measures used during the pandemic response in England

Int J Epidemiol. 2023 Aug 23:dyad116. doi: 10.1093/ije/dyad116. Online ahead of print.

NO ABSTRACT

PMID:37615969 | DOI:10.1093/ije/dyad116

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Intracellular bacterial eradication using a novel peptide in vitro

Int Endod J. 2023 Aug 24. doi: 10.1111/iej.13965. Online ahead of print.

ABSTRACT

AIM: To determine the effect of a novel antimicrobial peptide (AMP; OP145) and cell-penetrating peptide (Octa-arginine/R8) conjugate on the killing of intracellular Enterococcus faecalis, compared to OP145 and an antibiotic combination recommended for regenerative endodontic procedures.

METHODOLOGY: The biocompatible concentrations of OP145 and OP145-R8 were determined by assessing their cytotoxicity against human macrophages and red blood cells. Spatiotemporal internalization of the peptides into macrophages was investigated qualitatively and quantitatively by confocal laser scanning microscopy and flow cytometry respectively. Killing of extracellular and intracellular E. faecalis OG1RF by the peptides was determined by counting the colony-forming units (CFU). Intracellular antibacterial activity of the peptides was compared to a double antibiotic combination. Confocal microscopy was used to confirm the intracellular bacterial eradication. Significant differences between the different test groups were analysed using one-way analysis of variance. p < .05 was considered to be statistically significant.

RESULTS: Peptides at a concentration of 7.5 μmol/L were chosen for subsequent experiments based on the results of the alamarBlue™ cell viability assay and haemolytic assay. OP145-R8 selectively internalized into lysosomal compartments and the cytosol of macrophages. Conjugation with R8 improved the internalization of OP145 into macrophages in a temporal manner (70.53% at 1 h to 77.13% at 2 h), while no temporal increase was observed for OP145 alone (60.53% at 1 h with no increase at 2 h). OP145-R8 demonstrated significantly greater extracellular and intracellular antibacterial activity compared to OP145 at all investigated time-points and concentrations (p < .05). OP145-R8 at 7.5 μmol/L eradicated intracellular E. faecalis after 2 h (3.5 log reduction compared to the control; p < .05), while the antibiotics could not reduce more than 0.5 log CFU compared to the control (p > .05). Confocal microscopy showed complete absence of E. faecalis within the OP145-R8 treated macrophages.

CONCLUSIONS: The results of this study demonstrated that the conjugation of an AMP OP145 to a cell-penetrating peptide R8 eradicated extracellular and intracellular E. faecalis OG1RF without toxic effects on the host cells.

PMID:37615967 | DOI:10.1111/iej.13965