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Nevin Manimala Statistics

Association Between the Characteristics of mHealth Apps and User Input During Development and Testing: Secondary Analysis of App Assessment Data

JMIR Mhealth Uhealth. 2023 Nov 22;11:e46937. doi: 10.2196/46937.

ABSTRACT

BACKGROUND: User involvement is increasingly acknowledged as a central part of health care innovation. However, meaningful user involvement during the development and testing of mobile health apps is often not fully realized.

OBJECTIVE: This study aims to examine in which areas user input is most prevalent and whether there is an association between user inclusion and compliance with best practices for mobile health apps.

METHODS: A secondary analysis was conducted on an assessment data set of 1595 health apps. The data set contained information on whether the apps had been developed or tested with user input and whether they followed best practices across several domains. Background information was also available regarding the apps’ country of origin, targeted condition areas, subjective user ratings, download numbers, and risk (as per the National Institute for Health and Care Excellence Evidence Standards Framework [ESF]). Descriptive statistics, Mann-Whitney U tests, and Pearson chi-square analyses were applied to the data.

RESULTS: User involvement was reported by 8.71% (139/1595) of apps for only the development phase, by 33.67% (537/1595) of apps for only the testing phase, by 21.88% (349/1595) of apps for both phases, and by 35.74% (570/1595) of apps for neither phase. The highest percentage of health apps with reported user input during development was observed in Denmark (19/24, 79%); in the condition areas of diabetes (38/79, 48%), cardiology (15/32, 47%), pain management (20/43, 47%), and oncology (25/54, 46%); and for high app risk (ESF tier 3a; 105/263, 39.9%). The highest percentage of health apps with reported user input during testing was observed in Belgium (10/11, 91%), Sweden (29/34, 85%), and France (13/16, 81%); in the condition areas of neurodiversity (42/52, 81%), respiratory health (58/76, 76%), cardiology (23/32, 72%), and diabetes (56/79, 71%); and for high app risk (ESF tier 3a; 176/263, 66.9%). Notably, apps that reported seeking user input during testing demonstrated significantly more downloads than those that did not (P=.008), and user inclusion was associated with better compliance with best practices in clinical assurance, data privacy, risk management, and user experience.

CONCLUSIONS: The countries and condition areas in which the highest percentage of health apps with user involvement were observed tended to be those with higher digital maturity in health care and more funding availability, respectively. This suggests that there may be a trade-off between developers’ willingness or ability to involve users and the need to meet challenges arising from infrastructure limitations and financial constraints. Moreover, the finding of a positive association between user inclusion and compliance with best practices indicates that, where no other guidance is available, users may benefit from prioritizing health apps developed with user input as the latter may be a proxy for broader app quality.

PMID:37991822 | DOI:10.2196/46937

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Nevin Manimala Statistics

Subjective cognitive complaints and objective cognitive functioning in combat veterans: Effects of PTSD and deployment mild TBI

Appl Neuropsychol Adult. 2023 Nov 22:1-7. doi: 10.1080/23279095.2023.2280807. Online ahead of print.

ABSTRACT

OBJECTIVES: (1) Examine the relationship between subjective cognitive complaints and objective cognitive functioning in combat veterans; and (2) evaluate conditional effects of posttraumatic stress disorder (PTSD) and deployment-related mild traumatic brain injury (TBI) within that relationship.

METHOD: Combat veterans (N = 225, 86.22% male) completed a lifetime TBI interview, a structured interview assessing PTSD symptoms, a neuropsychological assessment battery, and a self-report measure of cognitive symptoms.

RESULTS: All correlations between subjective cognitive complaints and objective cognitive measures were not statistically significant. Hierarchical linear regression indicated that cognitive performance was not significantly related to cognitive complaints, but both PTSD diagnosis and history of deployment mild TBI explained a significant amount of unique variance in self-reported cognitive symptoms. Interactions between the studied variables were not significant.

CONCLUSIONS: PTSD and history of deployment mild TBI were uniquely related to cognitive complaints, but cognitive test performance was not. No confounding effects of PTSD or deployment mild TBI were observed in the relationship between cognitive performance and cognitive complaints. This provides support that symptom distress may be a better explanatory factor for perception of lower cognitive functioning than actual cognitive performance.

PMID:37991812 | DOI:10.1080/23279095.2023.2280807

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Rising Incidence of Syphilitic Uveitis-Related Hospitalizations in the US

JAMA Ophthalmol. 2023 Nov 22. doi: 10.1001/jamaophthalmol.2023.5386. Online ahead of print.

ABSTRACT

IMPORTANCE: The number of syphilis cases continues to increase in the US every year since 2001 with a 74% increase observed since 2017. In addition, there remains a national shortage of injectable penicillin G. Despite the increase in reported cases, to the authors’ knowledge, there has been no recent nationwide study investigating the trends in incidence of syphilitic uveitis.

OBJECTIVE: To evaluate the national and regional incidence of syphilitic uveitis-related hospitalizations in the US.

DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective, cross-sectional study. The Nationwide Inpatient Sample was queried to identify all inpatient admissions with a diagnosis of syphilitic uveitis in the US between the years 2010 and 2019. Analyses were performed to determine baseline sociodemographic characteristics and identify national and regional trends in incidence. All patients hospitalized with a diagnosis of syphilis, uveitis, and/or syphilitic uveitis were eligible for inclusion. Statistical analysis of study data took place in June 2023.

EXPOSURE: Diagnosis of syphilis, uveitis, and/or syphilitic uveitis on inpatient admissions during the years 2010 to 2019 in the Nationwide Inpatient Sample.

MAIN OUTCOME MEASURES: The primary outcome was to determine trends in the national and regional incidence of syphilitic uveitis-related hospitalizations in the US. Secondary outcome measures included sociodemographic characteristics of patients with syphilitic uveitis, incidence stratified by sex and race and ethnicity, and median charge per syphilitic uveitis hospital admission.

RESULTS: From the Nationwide Inpatient Sample, inpatient data from 444 674 patients (median [IQR] age, 53 [37-67] years; 54.8% male) were analyzed. There were an estimated 5581 syphilitic uveitis-related hospitalizations during the 10-year study period. The median (IQR) age of individuals with syphilitic uveitis was 45 (35-55) years, and 4395 patients (78.9%) were male. Syphilitic uveitis disproportionately affected African American individuals (1787 patients [32%], although they compose 13.6% of the population) and those belonging to the lowest median household income quartile (2163 [38.8%]). The national incidence was 0.15 per 100 000 population and showed an increasing trend over the years, with the lowest incidence in 2011 (0.08 per 100 000 population) and the highest incidence in 2019 (0.23 per 100 000 population; P = .04). Regional analysis showed an increase in incidence across all 4 US geographical regions. A total of 1293 patients (23.2%) had comorbid AIDS.

CONCLUSION AND RELEVANCE: Although this cross-sectional study only captured inpatient diagnosis, an increasing incidence of syphilitic uveitis-related hospitalizations was observed in the US between 2010 and 2019. Given the concomitant national shortage of injectable penicillin G, results suggest that clinicians should maintain a high index of suspicion for syphilis when evaluating patients with intraocular inflammation.

PMID:37991790 | DOI:10.1001/jamaophthalmol.2023.5386

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Risk of Mortality Following Surgery in Patients With a Previous Cardiovascular Event

JAMA Surg. 2023 Nov 22. doi: 10.1001/jamasurg.2023.5951. Online ahead of print.

ABSTRACT

IMPORTANCE: There is a lack of consensus regarding the interval of time-dependent postoperative mortality risk following acute coronary syndrome or stroke.

OBJECTIVE: To determine the magnitude and duration of risk associated with the time interval between a preoperative cardiovascular event and 30-day postoperative mortality.

DESIGN, SETTING, AND PARTICIPANTS: This is a longitudinal retrospective population-based cohort study. This study linked data from the Hospital Episode Statistics for National Health Service England, Myocardial Ischaemia National Audit Project and the Office for National Statistics mortality registry. All adults undergoing a National Health Service-funded noncardiac, nonneurologic surgery in England between April 1, 2007, and March 31, 2018, registered in Hospital Episode Statistics Admitted Patient Care were included. Data were analyzed from July 2021 to July 2022.

EXPOSURE: The time interval between a previous cardiovascular event (acute coronary syndrome or stroke) and surgery.

MAIN OUTCOMES AND MEASURES: The primary outcome was 30-day all-cause mortality. Secondary outcomes were postoperative mortality at 60, 90, and 365 days. Multivariable logistic regression models with restricted cubic splines were used to estimate adjusted odds ratios.

RESULTS: There were 877 430 patients with and 20 582 717 without a prior cardiovascular event (overall mean [SD] age, 53.4 [19.4] years; 11 577 157 [54%] female). Among patients with a previous cardiovascular event, the time interval associated with increased risk of postoperative mortality was surgery within 11.3 months (95% CI, 10.8-11.7), with subgroup risks of 14.2 months before elective surgery (95% CI, 13.3-15.3) and 7.3 months for emergency surgery (95% CI, 6.8-7.8). Heterogeneity in these timings was noted across many surgical specialties. The time-dependent risk intervals following stroke and myocardial infarction were similar, but the absolute risk was greater following a stroke. Regarding surgical urgency, the risk of 30-day mortality was higher in those with a prior cardiovascular event for emergency surgery (adjusted hazard ratio, 1.35; 95% CI, 1.34-1.37) and an elective procedure (adjusted hazard ratio, 1.83; 95% CI, 1.78-1.89) than those without a prior cardiovascular event.

CONCLUSIONS AND RELEVANCE: In this study, surgery within 1 year of an acute coronary syndrome or stroke was associated with increased postoperative mortality before reaching a new baseline, particularly for elective surgery. This information may help clinicians and patients balance deferring the potential benefits of the surgery against the desire to avoid increased mortality from overly expeditious surgery after a recent cardiovascular event.

PMID:37991772 | DOI:10.1001/jamasurg.2023.5951

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Nevin Manimala Statistics

Molecular Diagnostic Yield of Exome Sequencing in Patients With Congenital Hydrocephalus: A Systematic Review and Meta-Analysis

JAMA Netw Open. 2023 Nov 1;6(11):e2343384. doi: 10.1001/jamanetworkopen.2023.43384.

ABSTRACT

IMPORTANCE: Exome sequencing (ES) has been established as the preferred first line of diagnostic testing for certain neurodevelopmental disorders, such as global developmental delay and autism spectrum disorder; however, current recommendations are not specific to or inclusive of congenital hydrocephalus (CH).

OBJECTIVE: To determine the diagnostic yield of ES in CH and whether ES should be considered as a first line diagnostic test for CH.

DATA SOURCES: PubMed, Cochrane Library, and Google Scholar were used to identify studies published in English between January 1, 2010, and April 10, 2023. The following search terms were used to identify studies: congenital hydrocephalus, ventriculomegaly, cerebral ventriculomegaly, primary ventriculomegaly, fetal ventriculomegaly, prenatal ventriculomegaly, molecular analysis, genetic cause, genetic etiology, genetic testing, exome sequencing, whole exome sequencing, genome sequencing, microarray, microarray analysis, and copy number variants.

STUDY SELECTION: Eligible studies included those with at least 10 probands with the defining feature of CH and/or severe cerebral ventriculomegaly that had undergone ES. Studies with fewer than 10 probands, studies of mild or moderate ventriculomegaly, and studies using genetic tests other than ES were excluded. A full-text review of 68 studies was conducted by 2 reviewers. Discrepancies were resolved by consensus.

DATA EXTRACTION AND SYNTHESIS: Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and Meta-Analysis of Observational Studies in Epidemiology guidelines were used by 2 reviewers to extract data. Data were synthesized using a random-effects model of single proportions. Data analysis occurred in April 2023.

MAIN OUTCOMES AND MEASURES: The primary outcome was pooled diagnostic yield. Additional diagnostic yields were estimated for specific subgroups on the basis of clinical features, syndromic presentation, and parental consanguinity. For each outcome, a 95% CI and estimate of interstudy heterogeneity (I2 statistic) was reported.

RESULTS: From 498 deduplicated and screened records, 9 studies with a total of 538 CH probands were selected for final inclusion. The overall diagnostic yield was 37.9% (95% CI, 20.0%-57.4%; I2 = 90.1). The yield was lower for isolated and/or nonsyndromic cases (21.3%; 95% CI, 12.8%-31.0%; I2 = 55.7). The yield was higher for probands with reported consanguinity (76.3%; 95% CI, 65.1%-86.1%; I2 = 0) than those without (16.2%; 95% CI, 12.2%-20.5%; I2 = 0).

CONCLUSIONS AND RELEVANCE: In this systematic review and meta-analysis of the diagnostic yield of ES in CH, the diagnostic yield was concordant with that of previous recommendations for other neurodevelopmental disorders, suggesting that ES should also be recommended as a routine diagnostic adjunct for patients with CH.

PMID:37991765 | DOI:10.1001/jamanetworkopen.2023.43384

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Rapid Access Addiction Medicine Clinics for People With Problematic Opioid Use

JAMA Netw Open. 2023 Nov 1;6(11):e2344528. doi: 10.1001/jamanetworkopen.2023.44528.

ABSTRACT

IMPORTANCE: New approaches are needed to provide care for individuals with problematic opioid use (POU). Rapid access addiction medicine (RAAM) clinics offer a flexible, low-barrier, rapid access care model for this population.

OBJECTIVE: To assess the associations of RAAM clinics with emergency department (ED) visits, hospitalizations, and mortality for people with POU.

DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study involving a matched control group was performed using health administrative data from Ontario, Canada. Anonymized data from 4 Ontario RAAM clinics (cities of Ottawa, Toronto, Oshawa, and Sudbury) were linked with health administrative data. Analyses were performed on a cohort of individuals who received care at participating RAAM clinics and geographically matched controls who did not receive care at a RAAM clinic. All visits occurred between October 2, 2017, and October 30, 2019, and data analyses were completed in spring 2023. A propensity score-matching approach was used to balance confounding factors between groups, with adjustment for covariates that remained imbalanced after matching.

EXPOSURES: Individuals who initiated care through the RAAM model (including assessment, pharmacotherapy, brief counseling, harm reduction, triage to appropriate level of care, navigation to community services and primary care, and related care) were compared with individuals who did not receive care through the RAAM model.

MAIN OUTCOMES AND MEASURES: The primary outcome was a composite measure of ED visits for any reason, hospitalization for any reason, and all-cause mortality (all measured up to 30 days after index date). Outcomes up to 90 days after index date, as well as outcomes looking at opioid-related ED visits and hospitalizations, were also assessed.

RESULTS: In analyses of the sample of 876 patients formed using propensity score matching, 440 in the RAAM group (mean [SD] age, 36.5 [12.6] years; 276 [62.7%] male) and 436 in the control group (mean [SD] age, 36.8 [13.8] years; 258 [59.2%] male), the pooled odds ratio (OR) for the primary, 30-day composite outcome of all-cause ED visit, hospitalization, or mortality favored the RAAM model (OR, 0.68; 95% CI, 0.50-0.92). Analysis of the same outcome for opioid-related reasons only also favored the RAAM intervention (OR, 0.47; 95% CI, 0.29-0.76). Findings for the individual events of hospitalization, ED visit, and mortality at both 30-day and 90-day follow-up also favored the RAAM model, with comparisons reaching statistical significance in most cases.

CONCLUSIONS AND RELEVANCE: In this cohort study of individuals with POU, RAAM clinics were associated with reductions in ED visits, hospitalizations, and mortality. These findings provide valuable evidence toward a broadened adoption of the RAAM model in other regions of North America and beyond.

PMID:37991762 | DOI:10.1001/jamanetworkopen.2023.44528

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Nevin Manimala Statistics

Racial and Ethnic Discrimination and Hypertension by Educational Attainment Among a Cohort of US Women

JAMA Netw Open. 2023 Nov 1;6(11):e2344707. doi: 10.1001/jamanetworkopen.2023.44707.

ABSTRACT

IMPORTANCE: Although understudied, there are likely within-group differences among minoritized racial and ethnic groups in associations between racial and ethnic discrimination (RED) and hypertension risk, as minoritized individuals with higher educational attainment may more frequently encounter stress-inducing environments (eg, professional workplace settings, higher-income stores and neighborhoods) characterized by, for instance, exclusion and antagonism.

OBJECTIVES: To investigate educational attainment as a potential effect modifier of associations between RED and hypertension risk among US women; the study hypothesis was that the magnitude of associations would be stronger among participants with higher vs lower educational attainment.

DESIGN, SETTING, AND PARTICIPANTS: This is a nested case-control study using Sister Study data collected at enrollment (2003-2009) and over follow-up visits until September 2019. Among eligible US Black or African American (hereafter Black), Latina, and non-Hispanic White women without prior hypertension diagnoses, incidence density sampling was performed to select self-reported hypertension cases that developed over a mean (SD) follow-up 11 (3) years. Data were analyzed August 2022 to February 2023.

EXPOSURES: Participants reported lifetime everyday (eg, unfair treatment at a business) and major (eg, mistreatment by police) RED via a self-administered questionnaire.

MAIN OUTCOME AND MEASURES: Adjusting for sociodemographic characteristics, conditional logistic regression was used to estimate odds ratios (ORs) and 95% CIs for associations between RED and hypertension by educational attainment category at baseline (college or higher, some college, and high school or less) within racial and ethnic groups.

RESULTS: Among 5179 cases (338 [6.5%] Black; 200 [3.9%] Latina; and 4641 [89.6%] non-Hispanic White) and 10:1 race and ethnicity- and age-matched control participants with a mean (SD) age of 55 (9) years at enrollment, half (49.9%) of women reported attaining college or higher education, and Black women with college or greater education had the highest burden of RED (eg, 83% of case participants with college or higher education reported everyday RED compared with 64% of case participants with high school or less education). Everyday RED was associated with higher hypertension risk among Black women with college or higher education (OR, 1.56 [95% CI, 1.06-2.29]) but not among Black women with some college (OR, 0.72 [95% CI, 0.47-1.11]), with evidence of both multiplicative and additive interaction. Results for Black women with high school or less education suggested increased risk, but confidence intervals were wide, and the result was not statistically significant but may be clinically significant (OR, 1.89 [95% CI, 0.83-4.31]). Educational attainment was not a modifier among other racial and ethnic groups or for associations with major RED.

CONCLUSIONS AND RELEVANCE: In this nested case-control study of RED and hypertension risk, chronic or everyday RED-associated hypertension disproportionately affected Black women with the highest levels of educational attainment.

PMID:37991758 | DOI:10.1001/jamanetworkopen.2023.44707

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Assessing Response for Nivolumab Plus Ipilimumab in Squamous Cell Carcinoma of the Head and Neck

JAMA Oncol. 2023 Nov 22. doi: 10.1001/jamaoncol.2023.5401. Online ahead of print.

NO ABSTRACT

PMID:37991750 | DOI:10.1001/jamaoncol.2023.5401

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Nevin Manimala Statistics

Ethics Education in U.S. Allopathic Medical Schools: A National Survey of Medical School Deans and Ethics Course Directors

J Clin Ethics. 2023 Winter;34(4):328-341. doi: 10.1086/727433.

ABSTRACT

AbstractPurpose: to characterize ethics course content, structure, resources, pedagogic methods, and opinions among academic administrators and course directors at U.S. medical schools.

METHOD: An online questionnaire addressed to academic deans and ethics course directors identified by medical school websites was emailed to 157 Association of American Medical Colleges member medical schools in two successive waves in early 2022. Descriptive statistics were utilized to summarize responses.

RESULTS: Representatives from 61 (39%) schools responded. Thirty-two (52%) respondents were course directors; 26 (43%) were deans of academic affairs, medical education, or curriculum; and 3 with other roles also completed the survey (5%). All 61 schools reported some form of formal ethics education during the first year of medical school, with most (n = 54, 89%) reporting a formal mandatory introductory course during preclinical education. Schools primarily utilized lecture and small-group teaching methods. Knowledge-based examinations, attendance, and participation were most commonly used for assessment. A large majority regarded ethics as equally or more important than other foundational courses, but fewer (n = 37, 60%) provided faculty training for teaching ethics.

CONCLUSIONS: Despite a response rate of 39 percent, the authors conclude that medical schools include ethics in their curricula in small-group and lecture formats with heterogeneity regarding content taught. Preclinical curricular redesigns must innovate and implement best practices for ensuring sound delivery of ethics content in future curricula. Additional large-scale research is necessary to determine said best practices.

PMID:37991733 | DOI:10.1086/727433

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Meeting Report Sex Differences in Radiation Research

Int J Radiat Biol. 2023 Nov 22:1-70. doi: 10.1080/09553002.2023.2283089. Online ahead of print.

ABSTRACT

PURPOSE: The Sex Differences in Radiation Research workshop addressed the role of sex as a confounder in radiation research and its implication in real-world radiological and nuclear applications.

METHODS: In April 2022, HHS-wide partners from the Radiation and Nuclear Countermeasures Program, the Office of Research on Women’s Health National Institutes of Health Office of Women’s Health, U.S. Food and Drug Administration, and the Radiological and Nuclear Countermeasures Branch at the Biomedical Advanced Research and Development Authority conducted a workshop to address the scientific implication and knowledge gaps in understanding sex in basic and translational research. The goals of this workshop were to examine sex differences in 1. Radiation animal models and understand how these may affect radiation medical countermeasure development; 2. Biodosimetry and/or biomarkers used to assess acute radiation syndrome, delayed effects of acute radiation exposure, and/or predict major organ morbidities; 3. medical research that lacks representation from both sexes. In addition, regulatory policies that influence inclusion of women in research, and the gaps that exist in drug development and device clearance were discussed. Finally, real-world sex differences in human health scenarios were also considered.

RESULTS: This report provides an overview of the two-day workshop, and open discussion among academic investigators, industry researchers, and U.S. government representatives.

CONCLUSIONS: This meeting highlighted that current study designs lack the power to determine statistical significance based on sex, and much is unknown about the underlying factors that contribute to these differences. Investigators should accommodate both sexes in all stages of research to ensure that the outcome is robust, reproducible, and accurate, and will benefit public health.

PMID:37991728 | DOI:10.1080/09553002.2023.2283089