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Nevin Manimala Statistics

Approaches to Evaluating Digital Health Technologies: Scoping Review

J Med Internet Res. 2024 Aug 28;26:e50251. doi: 10.2196/50251.

ABSTRACT

BACKGROUND: Profound scientific evaluation of novel digital health technologies (DHTs) is key to enhance successful development and implementation. As such, we previously developed the eHealth evaluation cycle. The eHealth evaluation cycle contains 5 consecutive study phases: conceptual, development, feasibility, effectiveness, and implementation.

OBJECTIVE: The aim of this study is to develop a better understanding of the daily practice of the eHealth evaluation cycle. Therefore, the objectives are to conduct a structured analysis of literature data to analyze the practice of the evaluation study phases and to determine which evaluation approaches are used in which study phase of the eHealth evaluation cycle.

METHODS: We conducted a systematic literature search in PubMed including the MeSH term “telemedicine” in combination with a wide variety of evaluation approaches. Original peer-reviewed studies published in the year 2019 (pre-COVID-19 cohort) were included. Nonpatient-focused studies were excluded. Data on the following variables were extracted and systematically analyzed: journal, country, publication date, medical specialty, primary user, functionality, evaluation study phases, and evaluation approach. RStudio software was used to summarize the descriptive data and to perform statistical analyses.

RESULTS: We included 824 studies after 1583 titles and abstracts were screened. The majority of the evaluation studies focused on the effectiveness (impact; 304/824, 36.9%) study phase, whereas uptake (implementation; 70/824, 8.5%) received the least focus. Randomized controlled trials (RCTs; 170/899, 18.9%) were the most commonly used DHT evaluation method. Within the effectiveness (impact) study phase, RCTs were used in one-half of the studies. In the conceptual and planning phases, survey research (27/78, 35%) and interview studies (27/78, 35%) were most frequently used. The United States published the largest amount of DHT evaluation studies (304/824, 36.9%). Psychiatry and mental health (89/840, 10.6%) and cardiology (75/840, 8.9%) had the majority of studies published within the field.

CONCLUSIONS: We composed the first comprehensive overview of the actual practice of implementing consecutive DHT evaluation study phases. We found that the study phases of the eHealth evaluation cycle are unequally studied and most attention is paid to the effectiveness study phase. In addition, the majority of the studies used an RCT design. However, in order to successfully develop and implement novel DHTs, stimulating equal evaluation of the sequential study phases of DHTs and selecting the right evaluation approach that fits the iterative nature of technology might be of the utmost importance.

PMID:39196643 | DOI:10.2196/50251

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Nevin Manimala Statistics

Outcomes of Patients With Traumatic Brain Injury Transferred to Trauma Centers

JAMA Surg. 2024 Aug 28. doi: 10.1001/jamasurg.2024.3254. Online ahead of print.

ABSTRACT

IMPORTANCE: Wide variations exist in traumatic brain injury (TBI) management strategies and transfer guidelines across the country.

OBJECTIVE: To assess the outcomes of patients with TBI transferred to the American College of Surgeons (ACS) level I (LI) or level II (LII) trauma centers (TCs) on a nationwide scale.

DESIGN, SETTING, AND PARTICIPANTS: In this secondary analysis of the ACS Trauma Quality Improvement Program database (2017 to 2020), adult patients with isolated TBI (nonhead abbreviated injury scale = 0) with intracranial hemorrhage (ICH) who were transferred to LI/LII TCs we re included. Data were analyzed from January 1, 2017, through December 31, 2020.

MAIN OUTCOMES AND MEASURES: Outcomes were rates of head computed tomography scans, neurosurgical interventions (cerebral monitors, craniotomy/craniectomy), hospital length of stay, and mortality. Descriptive statistics and hierarchical mixed-model regression analyses were performed.

RESULTS: Of 117 651 patients with TBI with ICH managed at LI/LII TCs 53 108; (45.1%; 95% CI, 44.8%-45.4%) transferred from other centers were identified. The mean (SD) age was 61 (22) years and 30 692 were male (58%). The median (IQR) Glasgow Coma Scale score on arrival was 15 (14-15); 5272 patients had a Glasgow Coma Scale score of 8 or less on arrival at the receiving trauma center (10%). A total of 30 973 patients underwent head CT scans (58%) and 2144 underwent repeat head CT scans at the receiving TC (4%). There were 2124 patients who received cerebral monitors (4%), 6862 underwent craniotomy/craniectomy (13%), and 7487 received mechanical ventilation (14%). The median (IQR) hospital length of stay was 2 (1-5) days and the mortality rate was 6.5%. There were 9005 patients (17%) who were discharged within 24 hours and 19 421 (37%) who were discharged within 48 hours of admission without undergoing any neurosurgical intervention. Wide variations between and within trauma centers in terms of outcomes were observed in mixed-model analysis.

CONCLUSIONS: In this study, nearly half of the patients with TBI managed at LI/LII TCs were transferred from lower-level hospitals. Over one-third of these transferred patients were discharged within 48 hours without any interventions. These findings indicate the need for systemwide guidelines to improve health care resource use and guide triage of patients with TBI.

PMID:39196585 | DOI:10.1001/jamasurg.2024.3254

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Nevin Manimala Statistics

Cost and Cost-Effectiveness of the Management Strategies of Chronic Urticaria: A Systematic Review

JAMA Dermatol. 2024 Aug 28. doi: 10.1001/jamadermatol.2024.2863. Online ahead of print.

ABSTRACT

IMPORTANCE: Although treatment for chronic urticaria (CU) has improved over the past decades, evidence regarding costs and net benefits associated with these treatment strategies have yet to be comprehensively characterized and synthesized.

OBJECTIVE: To summarize the cost and cost-effectiveness of CU management strategies.

EVIDENCE REVIEW: An extensive systematic literature search of 6 databases (MEDLINE, Embase, PubMed Cochrane, Scopus, and CINAHL) and gray literature sources, without language restriction, was conducted and updated to March 23, 2024. Articles that performed cost analysis or full economic evaluation among patients with CU were included. Two reviewers independently extracted data, such as annual costs of health care services or incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY). All monetary values were converted and inflated to 2023 US dollars. Evidence-based synthesis for health benefit was judged using the Evidence Rating Matrix by the Institute for Clinical and Economic Review.

FINDINGS: Seventeen unique studies (11 cost analysis studies and 6 full economic evaluations) were included. With the wide variation in health care resources, services that included biologic omalizumab utilization had higher annual health care cost estimations for CU management than services that did not include omalizumab prescription (median [IQR] cost, $6933 [$5988-$8717] vs $5621 [$2488-$8754]). The biologic omalizumab, 300 mg, for H1 antihistamine-refractory chronic spontaneous urticaria (CSU) (3 studies) was found to have a median (IQR) ICER of $89 005 ($36 058-$145 694) per QALY (evidence rating as incremental or better; moderate certainty with substantial net health benefit). Routine laboratory testing among patients with CSU with otherwise normal histories and physical examination findings (1 study) had ICERs ranging from $1 427 928 to $1 950 524 per QALY (evidence rating as comparable or inferior; moderate certainty that the net health benefit is inferior).

CONCLUSIONS AND RELEVANCE: With limited evidence of cost-effectiveness, biologic omalizumab, 300 mg, for H1 antihistamine-refractory CSU was found to be cost-effective in US health care services at the willingness to pay threshold of $150 000 per QALY. Meanwhile, routine laboratory testing among patients with CSU without compelling indication was not cost-effective. Future studies in more diverse CU populations and resource settings are needed to fill evidence gaps.

PMID:39196583 | DOI:10.1001/jamadermatol.2024.2863

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Nevin Manimala Statistics

Prevalence, Cardiac Phenotype, and Outcomes of Transthyretin Variants in the UK Biobank Population

JAMA Cardiol. 2024 Aug 28. doi: 10.1001/jamacardio.2024.2190. Online ahead of print.

ABSTRACT

IMPORTANCE: The population prevalence of cardiac transthyretin amyloidosis (ATTR) caused by pathogenic variation in the TTR gene (vATTR) is unknown.

OBJECTIVE: To estimate the population prevalence of disease-causing TTR variants and evaluate associated phenotypes and outcomes.

DESIGN, SETTING, AND PARTICIPANTS: This population-based cohort study analyzed UK Biobank (UKB) participants with whole-exome sequencing, electrocardiogram, and cardiovascular magnetic resonance data. Participants were enrolled from 2006 to 2010, with a median follow-up of 12 (IQR, 11-13) years (cutoff date for the analysis, March 12, 2024). Sixty-two candidate TTR variants were extracted based on rarity (minor allele frequency ≤0.0001) and/or previously described associations with amyloidosis if more frequent.

EXPOSURE: Carrier status for TTR variants.

MAIN OUTCOMES AND MEASURES: Associations of TTR carrier status with vATTR prevalence and cardiovascular imaging and electrocardiogram traits were explored using descriptive statistics. Associations between TTR carrier status and atrial fibrillation, conduction disease, heart failure, and all-cause mortality were evaluated using adjusted Cox proportional hazards models. Genotypic and diagnostic concordance was examined using International Statistical Classification of Diseases, Tenth Revision codes from the hospital record.

RESULTS: The overall cohort included 469 789 UKB participants (mean [SD] age, 56.5 [8.1] years; 54.2% female and 45.8% male). A likely pathogenic/pathogenic (LP/P) TTR variant was detected in 473 (0.1%) participants, with Val142Ile being the most prevalent (367 [77.6%]); 91 individuals (0.02%) were carriers of a variant of unknown significance . The overall prevalence of LP/P variants was 0.02% (105 of 444 243) in participants with European ancestry and 4.3% (321 of 7533) in participants with African ancestry. The LP/P variants were associated with higher left ventricular mass indexed to body surface area (β = 4.66; 95% CI, 1.87-7.44), and Val142Ile was associated with a longer PR interval (β = 18.34; 95% CI, 5.41-31.27). The LP/P carrier status was associated with a higher risk of heart failure (hazard ratio [HR], 2.68; 95% CI, 1.75-4.12) and conduction disease (HR, 1.88; 95% CI, 1.25-2.83). Higher all-cause mortality risk was observed for non-Val142Ile LP/P variants (HR, 1.98; 95% CI, 1.06-3.67). Thirteen participants (2.8%) with LP/P variants had diagnostic codes compatible with cardiac or neurologic amyloidosis. Variants of unknown significance were not associated with outcomes.

CONCLUSIONS AND RELEVANCE: This study found that approximately 1 in 1000 UKB participants were LP/P TTR variant carriers, exceeding previously reported prevalence. The findings emphasize the need for clinical vigilance in identifying individuals at risk of developing vATTR and associated poor outcomes.

PMID:39196575 | DOI:10.1001/jamacardio.2024.2190

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Nevin Manimala Statistics

Psychiatric Symptoms, Cognition, and Symptom Severity in Children

JAMA Psychiatry. 2024 Aug 28. doi: 10.1001/jamapsychiatry.2024.2399. Online ahead of print.

ABSTRACT

IMPORTANCE: Mental illnesses are a leading cause of disability globally, and functional disability is often in part caused by cognitive impairments across psychiatric disorders. However, studies have consistently reported seemingly opposite findings regarding the association between cognition and psychiatric symptoms.

OBJECTIVE: To determine if the association between general cognition and mental health symptoms diverges at different symptom severities in children.

DESIGN, SETTING, AND PARTICIPANTS: A total of 5175 children with complete data at 2 time points assessed 2 years apart (aged 9 to 11 years at the first assessment) from the ongoing Adolescent Brain and Cognitive Development (ABCD) study were evaluated for a general cognition factor and mental health symptoms from September 2016 to August 2020 at 21 sites across the US. Polynomial and generalized additive models afforded derivation of continuous associations between cognition and psychiatric symptoms across different ranges of symptom severity. Data were analyzed from December 2022 to April 2024.

MAIN OUTCOMES AND MEASURES: Aggregate cognitive test scores (general cognition) were primarily evaluated in relation to total and subscale-specific symptoms reported from the Child Behavioral Checklist.

RESULTS: The sample included 5175 children (2713 male [52.4%] and 2462 female [47.6%]; mean [SD] age, 10.9 [1.18] years). Previously reported mixed findings regarding the association between general cognition and symptoms may consist of several underlying, opposed associations that depend on the class and severity of symptoms. Linear models recovered differing associations between general cognition and mental health symptoms, depending on the range of symptom severities queried. Nonlinear models confirm that internalizing symptoms were significantly positively associated with cognition at low symptom burdens higher cognition = more symptoms) and significantly negatively associated with cognition at high symptom burdens.

CONCLUSIONS AND RELEVANCE: The association between mental health symptoms and general cognition in this study was nonlinear. Internalizing symptoms were both positively and negatively associated with general cognition at a significant level, depending on the range of symptom severities queried in the analysis sample. These results appear to reconcile mixed findings in prior studies, which implicitly assume that symptom severity tracks linearly with cognitive ability across the entire spectrum of mental health. As the association between cognition and symptoms may be opposite in low vs high symptom severity samples, these results reveal the necessity of clinical enrichment in studies of cognitive impairment.

PMID:39196567 | DOI:10.1001/jamapsychiatry.2024.2399

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Nevin Manimala Statistics

Intersection of Poverty and Rurality for Early-Onset Colorectal Cancer Survival

JAMA Netw Open. 2024 Aug 1;7(8):e2430615. doi: 10.1001/jamanetworkopen.2024.30615.

NO ABSTRACT

PMID:39196562 | DOI:10.1001/jamanetworkopen.2024.30615

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Nevin Manimala Statistics

Influenza and COVID-19 Vaccination Rates Among Children Receiving Long-Term Ventilation

JAMA Netw Open. 2024 Aug 1;7(8):e2430989. doi: 10.1001/jamanetworkopen.2024.30989.

NO ABSTRACT

PMID:39196561 | DOI:10.1001/jamanetworkopen.2024.30989

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Nevin Manimala Statistics

First-Generation Antihistamines and Seizures in Young Children

JAMA Netw Open. 2024 Aug 1;7(8):e2429654. doi: 10.1001/jamanetworkopen.2024.29654.

ABSTRACT

IMPORTANCE: The widespread use of antihistamines in children for treatment of common cold symptoms and their central nervous system effects, like drowsiness, underscore the importance of being aware of the associated risks.

OBJECTIVE: To assess associations between prescriptions of first-generation antihistamines and seizures in children using a comprehensive and nationwide dataset.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study used a self-controlled case-crossover design. Data were obtained from the National Health Insurance Service database in Korea. Children born between January 1, 2002, and December 31, 2005, who visited the emergency department for seizure events (International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, codes R56.8, G40, and G41) during the follow-up period were included. Follow-up was completed on December 31, 2019, and data were analyzed from June 3, 2023, to January 30, 2024.

EXPOSURE: First-generation antihistamine prescription.

MAIN OUTCOMES AND MEASURES: Primary outcome consisted of an index seizure event. Odds ratios (ORs) for seizure events were estimated using a conditional logistic regression model, comparing first-generation antihistamine prescription 1 to 15 days before seizure (hazard period) against control period 1 (31-45 days before the event) and control period 2 (61-75 days before the event) using the same period windows. Stratified analyses were conducted to examine the association with individual participant characteristics.

RESULTS: Of 11 729 children who had a seizure event, 3178 (1776 [55.9%] boys) were identified as having been prescribed antihistamines during the hazard or the control period, but not both. Seizure events were predominantly observed in children aged 6 to 24 months (985 [31.0%]) and 25 months to 6 years (1445 [45.5%]). During the hazard period, 1476 first-generation antihistamine prescriptions were recorded, in contrast to 1239 and 1278 prescriptions during control periods 1 and 2, respectively. After multiple confounder adjustments, first-generation antihistamine prescription was associated with an increased seizure event risk during the hazard period (adjusted OR [AOR], 1.22 [95% CI, 1.13-1.31]). Stratified subgroup analyses showed consistent results, particularly in children aged 6 to 24 months who were prescribed first-generation antihistamines having a higher risk (AOR, 1.49 [95% CI, 1.31-1.70]) than children aged 25 months to 6 years (AOR, 1.11 [95% CI, 1.00-1.24]; P = .04 for interaction). Furthermore, sensitivity analyses, including adjustment for exposure window periods, evaluation of new first-generation antihistamine prescriptions, comparison of control points from the same period 1 year prior, and exclusion of individuals using combination drugs, confirmed a similarly high risk.

CONCLUSIONS AND RELEVANCE: In this cohort study, prescriptions for first-generation antihistamines were associated with a 22.0% higher seizure risk in children, especially in those aged 6 to 24 months. These findings emphasize the need for careful and judicious prescription of first-generation antihistamines in young children and underline the need for further research to elucidate associations between antihistamine prescriptions and seizure risk.

PMID:39196558 | DOI:10.1001/jamanetworkopen.2024.29654

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Nevin Manimala Statistics

Consumption of Total and Specific Alcoholic Beverages and Long-Term Risk of Gout Among Men and Women

JAMA Netw Open. 2024 Aug 1;7(8):e2430700. doi: 10.1001/jamanetworkopen.2024.30700.

ABSTRACT

IMPORTANCE: Previous studies on alcohol consumption and incident gout have mostly included men or combined both sexes, and the sex-specific associations between alcohol consumption and gout are poorly understood.

OBJECTIVE: To evaluate the consumption of total and specific alcoholic beverages in association with incident gout in men and women.

DESIGN, SETTING, AND PARTICIPANTS: This prospective cohort study included 401 128 participants in the UK Biobank aged 37 to 73 years who were free of gout at baseline (2006-2010). Participants were followed up through December 31, 2021, and data were analyzed between August 2023 and June 2024.

EXPOSURE: Questionnaire-based consumption of total alcohol and specific alcoholic beverages.

MAIN OUTCOMES AND MEASURES: The outcome was incident gout, identified using hospital records. Multivariable Cox proportional hazards regression models were used to estimate sex-specific hazard ratios (HRs) and 95% CIs of incident gout associated with alcohol consumption, with a particular consideration of reverse causation bias.

RESULTS: The main analysis included 179 828 men (mean [SD] age, 56.0 [8.2] years) and 221 300 women (mean [SD] age, 56.0 [8.0] years). Current drinkers showed a higher risk of gout than never drinkers among men (HR, 1.69; 95% CI, 1.30-2.18) but not among women (HR, 0.83; 95% CI, 0.67-1.03). Among current drinkers, higher total alcohol consumption was associated with a higher risk of gout among both sexes and more strongly among men than women (men: HR, 2.05 [95% CI, 1.84-2.30]; women: HR, 1.34 [95% CI, 1.12-1.61]). The most evident sex difference in the consumption of specific alcoholic beverages was observed for beer or cider (men: mean [SD], 4.2 [4.8] pints per week; women: mean [SD], 0.4 [1.1] pints per week). Consumption of champagne or white wine, beer or cider, and spirits each was associated with a higher risk of gout among both sexes, with beer or cider showing the strongest association per 1 pint per day (men: HR, 1.60 [95% CI, 1.53-1.67]; women: HR, 1.62 [95% CI, 1.02-2.57]). Some inverse associations between light to moderate consumption of specific alcoholic beverages and gout were eliminated after adjusting for other alcoholic beverages and excluding individuals who had reduced alcohol consumption for health reasons, self-reported poor health, or had cardiovascular disease, cancer, or kidney failure at baseline, or developed gout within the first 2 years of follow-up.

CONCLUSIONS AND RELEVANCE: In this cohort study, higher consumption of several specific alcoholic beverages was associated with a higher risk of gout among both sexes. The sex-specific associations for total alcohol consumption may be associated with differences between men and women in the types of alcohol consumed.

PMID:39196557 | DOI:10.1001/jamanetworkopen.2024.30700

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Nevin Manimala Statistics

Latent Profiles of Childhood Adversity, Adolescent Mental Health, and Neural Network Connectivity

JAMA Netw Open. 2024 Aug 1;7(8):e2430711. doi: 10.1001/jamanetworkopen.2024.30711.

ABSTRACT

IMPORTANCE: Adverse childhood experiences are pervasive and heterogeneous, with potential lifelong consequences for psychiatric morbidity and brain health. Existing research does not capture the complex interplay of multiple adversities, resulting in a lack of precision in understanding their associations with neural function and mental health.

OBJECTIVES: To identify distinct childhood adversity profiles and examine their associations with adolescent mental health and brain connectivity.

DESIGN, SETTING, AND PARTICIPANTS: This population-based birth cohort used data for children who were born in 20 large US cities between 1998 and 2000 and participated in the Future Families and Child Well-Being Study. Families were interviewed when children were born and at ages 1, 3, 5, 9, and 15 years. At age 15 years, neuroimaging data were collected from a subset of these youths. Data were collected from February 1998 to April 2017. Analyses were conducted from March to December 2023.

EXPOSURES: Latent profiles of childhood adversity, defined by family and neighborhood risks across ages 0 to 9 years.

MAIN OUTCOMES AND MEASURES: Internalizing and externalizing symptoms at age 15 years using parent- and youth-reported measures. Profile-specific functional magnetic resonance imaging connectivity across the default mode network (DMN), salience network (SN), and frontoparietal network (FPN).

RESULTS: Data from 4210 individuals (2211 [52.5%] male; 1959 [46.5%] Black, 1169 [27.7%] Hispanic, and 786 [18.7%] White) revealed 4 childhood adversity profiles: low-adversity (1230 individuals [29.2%]), medium-adversity (1973 [46.9%]), high-adversity (457 [10.9%]), and high maternal depression (MD; 550 [13.1%]). High-adversity, followed by MD, profiles had the highest symptoms. Notably, internalizing symptoms did not differ between these 2 profiles (mean difference, 0.11; 95% CI, -0.03 to 0.26), despite the MD profile showing adversity levels most similar to the medium-adversity profile. In the neuroimaging subsample of 167 individuals (91 [54.5%] female; 128 [76.6%] Black, 11 [6.6%] Hispanic, and 20 [12.0%] White; mean [SD] age, 15.9 [0.5] years), high-adversity and MD profiles had the highest DMN density relative to other profiles (F(3,163) = 11.14; P < .001). The high-adversity profile had lower SN density relative to the low-adversity profile (mean difference, -0.02; 95% CI, -0.04 to -0.003) and the highest FPN density among all profiles (F(3,163) = 18.96; P < .001). These differences were specific to brain connectivity during an emotion task, but not at rest.

CONCLUSIONS AND RELEVANCE: In this cohort study, children who experienced multiple adversities, or only elevated MD, had worse mental health and different neural connectivity in adolescence. Interventions targeting multiple risk factors, with a focus on maternal mental health, could produce the greatest benefits.

PMID:39196556 | DOI:10.1001/jamanetworkopen.2024.30711