Nevin Manimala

BMJ. 2021 Jun 14;373:n1435. doi: 10.1136/bmj.n1435.

ABSTRACT

OBJECTIVE: To quantify the background incidence rates of 15 prespecified adverse events of special interest (AESIs) associated with covid-19 vaccines.

DESIGN: Multinational network cohort study.

SETTING: Electronic health records and health claims data from eight countries: Australia, France, Germany, Japan, the Netherlands, Spain, the United Kingdom, and the United States, mapped to a common data model.

PARTICIPANTS: 126 661 070 people observed for at least 365 days before 1 January 2017, 2018, or 2019 from 13 databases.

MAIN OUTCOME MEASURES: Events of interests were 15 prespecified AESIs (non-haemorrhagic and haemorrhagic stroke, acute myocardial infarction, deep vein thrombosis, pulmonary embolism, anaphylaxis, Bell’s palsy, myocarditis or pericarditis, narcolepsy, appendicitis, immune thrombocytopenia, disseminated intravascular coagulation, encephalomyelitis (including acute disseminated encephalomyelitis), Guillain-Barré syndrome, and transverse myelitis). Incidence rates of AESIs were stratified by age, sex, and database. Rates were pooled across databases using random effects meta-analyses and classified according to the frequency categories of the Council for International Organizations of Medical Sciences.

RESULTS: Background rates varied greatly between databases. Deep vein thrombosis ranged from 387 (95% confidence interval 370 to 404) per 100 000 person years in UK CPRD GOLD data to 1443 (1416 to 1470) per 100 000 person years in US IBM MarketScan Multi-State Medicaid data among women aged 65 to 74 years. Some AESIs increased with age. For example, myocardial infarction rates in men increased from 28 (27 to 29) per 100 000 person years among those aged 18-34 years to 1400 (1374 to 1427) per 100 000 person years in those older than 85 years in US Optum electronic health record data. Other AESIs were more common in young people. For example, rates of anaphylaxis among boys and men were 78 (75 to 80) per 100 000 person years in those aged 6-17 years and 8 (6 to 10) per 100 000 person years in those older than 85 years in Optum electronic health record data. Meta-analytic estimates of AESI rates were classified according to age and sex.

CONCLUSION: This study found large variations in the observed rates of AESIs by age group and sex, showing the need for stratification or standardisation before using background rates for safety surveillance. Considerable population level heterogeneity in AESI rates was found between databases.

PMID:35727911 | DOI:10.1136/bmj.n1435

Nephrology (Carlton). 2022 Jun 21. doi: 10.1111/nep.14080. Online ahead of print.

ABSTRACT

AIM: To examine whether differences in tacrolimus and mycophenolic acid (MPA) pharmacokinetics contribute to the poorer kidney transplant outcomes experienced by Aboriginal Australians.

METHODS: Concentration-time profiles for tacrolimus and MPA were prospectively collected from 43 kidney transplant recipients: 27 Aboriginal and 16 Caucasian. Apparent clearance (CL/F) and distribution volume (V/F) for each individual were derived from concentration-time profiles combined with population pharmacokinetic priors, with subsequent assessment for between-group difference in pharmacokinetics. In addition, population pharmacokinetic models were developed using the prospective dataset supplemented by previously developed structural models for tacrolimus and MPA. The change in NONMEM objective function was used to assess improvement in goodness of model fit.

RESULTS: No differences were found between Aboriginal and Caucasian groups or empirical Bayes estimates, for CL/F or V/F of MPA or tacrolimus. However, a higher prevalence of CYP3A5 expressers (26% compared with 0%) and wider between-subject variability in tacrolimus CL/F (SD=5.00 compared with 3.25 L/h/70kg) were observed in the Aboriginal group, though these differences failed to reach statistical significance (p=0.07 and p=0.08).

CONCLUSION: There were no differences in typical tacrolimus or MPA pharmacokinetics between Aboriginal and Caucasian kidney transplant recipients. This means that Bayesian dosing tools developed to optimise tacrolimus and MPA dosing in Caucasian recipients may be applied to Aboriginal recipients. In turn, this may improve drug exposure and thereby transplant outcomes in this group. Aboriginal recipients appeared to have greater between-subject variability in tacrolimus CL/F and a higher prevalence of CYP3A5 expressers, attributes that have been linked with inferior outcomes.

PMID:35727904 | DOI:10.1111/nep.14080

PLoS Comput Biol. 2022 Jun 21;18(6):e1010163. doi: 10.1371/journal.pcbi.1010163. Online ahead of print.

ABSTRACT

Single-cell multi-omics assays offer unprecedented opportunities to explore epigenetic regulation at cellular level. However, high levels of technical noise and data sparsity frequently lead to a lack of statistical power in correlative analyses, identifying very few, if any, significant associations between different molecular layers. Here we propose SCRaPL, a novel computational tool that increases power by carefully modelling noise in the experimental systems. We show on real and simulated multi-omics single-cell data sets that SCRaPL achieves higher sensitivity and better robustness in identifying correlations, while maintaining a similar level of false positives as standard analyses based on Pearson and Spearman correlation.

PMID:35727848 | DOI:10.1371/journal.pcbi.1010163

JMIR Res Protoc. 2022 Jun 21;11(6):e38407. doi: 10.2196/38407.

ABSTRACT

BACKGROUND: The field of health information management (HIM) focuses on the protection and management of health information from a variety of sources. The American Health Information Management Association (AHIMA) Council for Excellence in Education (CEE) determines the needed skills and competencies for this field. AHIMA’s HIM curricula competencies are divided into several domains among the associate, undergraduate, and graduate levels. Moreover, AHIMA’s career map displays career paths for HIM professionals. What is not known is whether these competencies and the career map align with industry demands.

OBJECTIVE: The primary aim of this study is to analyze HIM job postings on a US national job recruiting website to determine whether the job postings align with recognized HIM domains, while the secondary aim is to evaluate the AHIMA career map to determine whether it aligns with the job postings.

METHODS: A national job recruitment website was mined electronically (web scraping) using the search term “health information management.” This cross-sectional inquiry evaluated job advertisements during a 2-week period in 2021. After the exclusion criteria, 691 job postings were analyzed. Data were evaluated with descriptive statistics and natural language processing (NLP). Soft cosine measures (SCM) were used to determine correlations between job postings and the AHIMA career map, curricular competencies, and curricular considerations. ANOVA was used to determine statistical significance.

RESULTS: Of all the job postings, 29% (140/691) were in the Southeast, followed by the Midwest (140/691, 20%), West (131/691,19%), Northeast (94/691, 14%), and Southwest (73/691, 11%). The educational levels requested were evenly distributed between high school diploma (219/691, 31.7%), associate degree (269/691, 38.6%), or bachelor’s degree (225/691, 32.5%). A master’s degree was requested in only 8% (52/691) of the postings, with 72% (42/58) preferring one and 28% (16/58) requiring one. A Registered Health Information Technologist (RHIT) credential was the most commonly requested (207/691, 29.9%) in job postings, followed by Registered Health Information Administrator (RHIA; 180/691, 26%) credential. SCM scores were significantly higher in the informatics category compared to the coding and revenue cycle (P=.006) and data analytics categories (P<.001) but not significantly different from the information governance category (P=.85). The coding and revenue cycle category had a significantly higher SCM score compared to the data analytics category (P<.001). Additionally, the information governance category was significantly higher than the data analytics category (P<.001). SCM scores were significantly different between each competency category, except there were no differences in the average SCM score between the information protection and revenue cycle management categories (P=.96) and the information protection and data structure, content, and information governance categories (P=.31).

CONCLUSIONS: Industry job postings primarily sought a high school diploma and associate degrees, with a master’s degree a distant third. NLP analysis of job postings suggested that the correlation between the informatics category and job postings was higher than that of the coding, revenue cycle, and data analytics categories.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38407.

PMID:35727624 | DOI:10.2196/38407

JMIR Hum Factors. 2022 Jun 21;9(2):e35421. doi: 10.2196/35421.

ABSTRACT

The health care management and the medical practitioner literature lack a descriptive conceptual framework for understanding the dynamic and complex interactions between clinicians and artificial intelligence (AI) systems. As most of the existing literature has been investigating AI’s performance and effectiveness from a statistical (analytical) standpoint, there is a lack of studies ensuring AI’s ecological validity. In this study, we derived a framework that focuses explicitly on the interaction between AI and clinicians. The proposed framework builds upon well-established human factors models such as the technology acceptance model and expectancy theory. The framework can be used to perform quantitative and qualitative analyses (mixed methods) to capture how clinician-AI interactions may vary based on human factors such as expectancy, workload, trust, cognitive variables related to absorptive capacity and bounded rationality, and concerns for patient safety. If leveraged, the proposed framework can help to identify factors influencing clinicians’ intention to use AI and, consequently, improve AI acceptance and address the lack of AI accountability while safeguarding the patients, clinicians, and AI technology. Overall, this paper discusses the concepts, propositions, and assumptions of the multidisciplinary decision-making literature, constituting a sociocognitive approach that extends the theories of distributed cognition and, thus, will account for the ecological validity of AI.

PMID:35727615 | DOI:10.2196/35421

JMIR Aging. 2022 Jun 21;5(2):e32790. doi: 10.2196/32790.

ABSTRACT

BACKGROUND: The Caregiver Advise Record Enable (CARE) Act is a state level law that requires hospitals to identify and educate caregivers (“family members or friends”) upon discharge.

OBJECTIVE: This study examined the association between the implementation of the CARE Act in a Pennsylvania health system and health service utilization (ie, reducing hospital readmission, emergency department [ED] visits, and mortality) for older adults with diabetes.

METHODS: The key elements of the CARE Act were implemented and applied to the patients discharged to home. The data between May and October 2017 were pulled from inpatient electronic health records. Likelihood-ratio chi-square tests and multivariate logistic regression models were used for statistical analysis.

RESULTS: The sample consisted of 2591 older inpatients with diabetes with a mean age of 74.6 (SD 7.1) years. Of the 2591 patients, 46.1% (n=1194) were female, 86.9% (n=2251) were White, 97.4% (n=2523) had type 2 diabetes, and 69.5% (n=1801) identified a caregiver. Of the 1801 caregivers identified, 399 (22.2%) received discharge education and training. We compared the differences in health service utilization between pre- and postimplementation of the CARE Act; however, no significance was found. No significant differences were detected from the bivariate analyses in any outcomes between individuals who identified a caregiver and those who declined to identify a caregiver. After adjusting for risk factors (multivariate analysis), those who identified a caregiver (12.2%, 219/1801) was associated with higher rates of 30-day hospital readmission than those who declined to identify a caregiver (9.9%, 78/790; odds ratio [OR] 1.38, 95% CI 1.04-1.87; P=.02). Significantly lower rates were detected in 7-day readmission (P=.02), as well as 7-day (P=.03) and 30-day (P=.01) ED visits, among patients with diabetes whose identified caregiver received education and training than those whose identified caregiver did not receive education and training in the bivariate analyses. However, after adjusting for risk factors, no significance was found in 7-day readmission (OR 0.53, 95% CI 0.27-1.05; P=.07), 7-day ED visit (OR 0.63, 95% CI 0.38-1.03; P=.07), and 30-day ED visit (OR 0.73, 95% CI 0.52-1.02; P=.07). No significant associations were found for other outcomes (ie, 30-day readmission and 7-day and 30-day mortality) in both the bivariate and multivariate analyses.

CONCLUSIONS: Our study found that the implementation of the CARE Act was associated with certain health service utilization. The identification of caregivers was associated with higher rates of 30-day hospital readmission in the multivariate analysis, whereas having identified caregivers who received discharge education was associated with lower rates of readmission and ED visit in the bivariate analysis.

PMID:35727611 | DOI:10.2196/32790

JMIR Form Res. 2022 Jun 21;6(6):e34995. doi: 10.2196/34995.

ABSTRACT

BACKGROUND: Estrogen receptor-positive breast cancer is the most common type of breast cancer in postmenopausal women. Aromatase inhibitors (AIs) are the endocrine therapy of choice recommended for these patients. Up to 50% of those treated with an AI develop arthralgia, often resulting in poor adherence and decreased quality of life.

OBJECTIVE: The study is a single-arm longitudinal pilot study aiming to evaluate the safety, feasibility, acceptability, and potential efficacy of TaiChi4Joint, a remotely delivered 12-week tai chi intervention designed to relieve AI-induced joint pain.

METHODS: Women diagnosed with stage 0-III breast cancer who received an AI for at least 2 months and reported arthralgia with a ≥4 score on a 0 to 10 scale for joint pain were eligible for study enrollment. Participants were encouraged to join tai chi classes delivered over Zoom three times a week for 12 weeks. Program engagement strategies included using a private Facebook study group and a Box cloud for archiving live class recordings. The program uses SMS text messaging and emails with periodic positive quotes and evidence-based information on tai chi for facilitating community bonding and class attendance. Participants were invited to complete the following assessments at baseline and at 1-, 2-, and 3-month intervals from study enrollment: Brief Pain Inventory, Western Ontario and McMaster University Osteoarthritis Index (WOMAC), The Australian Canadian Osteoarthritis Hand Index (AUSCAN), Fatigue Symptom Inventory, Hot Flash Related Daily Interference Scale (HFRDIS), Pittsburgh Sleep Quality Index (PSQI), and Center for Epidemiological Studies-Depression (CES-D).

RESULTS: A total of 55 eligible patients were invited to participate, and 39 (71%) consented and completed the baseline assessments. Participants attended 61% (median) of the suggested classes, with no tai chi-related adverse events reported. Of the 39 participants, 22 completed the 3-month follow-up assessment with a 56% retention rate. Study participants reported improvement from baseline compared to 3 months as follows (paired t test): Brief Pain Inventory (P<.001), AUSCAN pain subscale (P=.007), AUSCAN function subscale (P=.004), Fatigue Symptom Inventory (P=.004) and PSQI (P<.001), and HFRDIS (P=.02) and CES-D (P<.001). In particular, for our primary end point of interest, improvements in hip and knee symptoms, measured by WOMAC’s three subscales, were clinically meaningful and statistically significant when adjusted for multiple comparisons from baseline to 3 months post intervention.

CONCLUSIONS: The COVID-19 global pandemic has resulted in the need to rethink how mind-body therapies can be delivered. This study demonstrated the feasibility, acceptability, and potential efficacy of a telehealth-based tai chi intervention for reducing AI-induced arthralgia. The intervention decreased patient-reported pain and stiffness, and improved sleep quality and depressive symptoms. Fully powered, large, telehealth-based tai chi trials for AI-associated arthralgia are needed considering our promising findings.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04716920; https://www.clinicaltrials.gov/ct2/show/NCT04716920.

PMID:35727609 | DOI:10.2196/34995

JAMA Netw Open. 2022 Jun 1;5(6):e2217653. doi: 10.1001/jamanetworkopen.2022.17653.

NO ABSTRACT

PMID:35727584 | DOI:10.1001/jamanetworkopen.2022.17653

JAMA Netw Open. 2022 Jun 1;5(6):e2217686. doi: 10.1001/jamanetworkopen.2022.17686.

ABSTRACT

IMPORTANCE: Value-based purchasing creates pressure to examine whether newer technologies and care processes, including new surgical techniques, yield any economic advantage.

OBJECTIVE: To compare health care costs and utilization between participants randomized to receive endoscopic vein harvesting (EVH) or open vein harvesting (OVH) during a coronary artery bypass grafting (CABG) procedure.

DESIGN, SETTING, AND PARTICIPANTS: This secondary economic analysis was conducted alongside the 16-site Randomized Endo-Vein Graft Prospective (REGROUP) clinical trial funded by the Department of Veterans Affairs (VA) Cooperative Studies Program. Adults scheduled for urgent or elective bypass involving a vein graft were eligible. The first participant was enrolled in September 2013, with most sites completing enrollment by March 2014. The last participant was enrolled in April 2017. A total of 1150 participants were randomized, with 574 participants receiving OVH and 576 receiving EVH. For this secondary analysis, cost and utilization data were extracted through September 30, 2020. Participants were linked to administrative data in the VA Corporate Data Warehouse and activity-based cost data starting with the index procedure.

INTERVENTIONS: EVH vs OVH, with comparisons based on intention to treat.

MAIN OUTCOMES AND MEASURES: Discharge costs for the index procedure as well as follow-up costs (including intended and unintended events; mean [SD] follow-up time, 33.0 [19.9] months) were analyzed, with results from different statistical models compared to test for robustness (ie, lack of variation across models). All costs represented care provided or paid by the VA, standardized to 2020 US dollars.

RESULTS: Among 1150 participants, the mean (SD) age was 66.4 (6.9) years; most participants (1144 [99.5%] were male. With regard to race and ethnicity, 6 participants (0.5%) self-reported as American Indian or Alaska Native, 10 (0.9%) as Asian or Pacific Islander, 91 (7.9%) as Black, 62 (5.4%) as Hispanic, 974 (84.7%) as non-Hispanic White, and 6 (0.5%) as other race and/or ethnicity; data were missing for 1 participant (0.1%). The unadjusted mean (SD) costs for the index CABG procedure were $76 607 ($43 883) among patients who received EVH and $75 368 ($45 900) among those who received OVH, including facility costs, insurance costs, and physician-related costs (commonly referred to as provider costs in Centers for Medicare and Medicaid and insurance data). No significant differences were found in follow-up costs; per 90-day follow-up period, EVH was associated with a mean (SE) added cost of $302 ($225) per patient. The results were highly robust to the statistical model.

CONCLUSIONS AND RELEVANCE: In this study, EVH was not associated with a reduction in costs for the index CABG procedure or follow-up care. Therefore, the choice to provide EVH may be based on surgeon and patient preferences.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01850082.

PMID:35727582 | DOI:10.1001/jamanetworkopen.2022.17686

Indian J Pediatr. 2022 Jun 21. doi: 10.1007/s12098-022-04151-x. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine sleep disorders and quality of life (QOL) in children with cerebral palsy (CP) and to find the association between them.

METHODS: This cross-sectional study included children (4-12 y) with CP (n = 117) and age- and gender-matched healthy controls (n = 117). Pediatric Sleep Questionnaire (PSQ) was used to record sleep-related symptoms. Sleep-related breathing disorder (SRBD) scale and sleep disturbance scale for children (SDSC) were used to evaluate sleep disorders. Cerebral palsy quality-of-life questionnaire for children (CPQOL-CHILD) was used to assess QOL.

RESULTS: Sleep disorders by SRBD scale (score ≥ 0.33) were significantly more in CP (n = 7, 6%) than controls [(n = 0, 0%) (p value 0.014, OR 15.95)]. Using T score > 70 by SDSC scale, sleep disorders were seen in 7.7% (n = 9) CP children and 0% (n = 0) in controls (p value 0.04, OR 20.6). Using T score ≥ 51, 43.6% CP children and 17% controls had sleep disorders (p value 0.001, CI 2.1, 6.9). About 43.6% CP children had abnormal T score on at least one SDSC factor. Presence of epilepsy, motor disabilities, intellectual disabilities, and type of CP significantly correlated with sleep disorders. The overall SRBD scores and SDSC T scores of CP children were negatively correlated with QOL (r = -0.489, p < 0.001 and r = -0.445, p < 0.001, respectively).

CONCLUSION: Sleep disorders are more common in CP which adversely affect QOL. Routine screening and appropriate treatment are suggested.

PMID:35727526 | DOI:10.1007/s12098-022-04151-x