Patient factors associated with telehealth quality and experience among adults with chronic conditions.

Objective: To evaluate patient-reported experiences of telehealth and disparities in access, use, and satisfaction with telehealth during the COVID-19 pandemic. Materials and methods: We examined data from the fifth wave of the COVID-19 & Chronic Conditions (C3) study conducted between December 2020 and March 2021. Results: Of the 718 participants, 342 (47.6%) reported having a telehealth visit within the past 4 months. Participants who had a recent telehealth visit were younger, reported worse overall health and chronic illness burden, and living below poverty level. Among participants who had a telehealth visit, 66.7% reported telephone visits and most participants (57.6%) rated telehealth quality as better-or-equal-to in-person visits. Inadequate health literacy was associated with lower likelihood of reporting telehealth quality and usefulness. In multivariable analyses, lower patient activation (adjusted odds ratio (AOR) 0.19, 95% CI, 0.05-0.59) and limited English proficiency (AOR 0.12, 95% CI, 0.03-0.47) were less likely to report telehealth as being better than in-person visits; lower patient activation (AOR 0.06, 95% CI, 0.003-0.41) and income below poverty level (AOR 0.36, 95% CI, 0.13-0.98) were associated with difficulty remembering telehealth visit information. Discussion: Most participants reported usefulness and ease of navigating telehealth. Lower socioeconomic status, limited English proficiency, inadequate health literacy, lower educational attainment, and low patient activation are risks for poorer quality telehealth. Conclusion: The COVID pandemic has accelerated the adoption of telehealth, however, disparities in access and self-reported visit quality persist. Since telemedicine is here to stay, we identify vulnerable populations and discuss potential solutions to reduce healthcare disparities in telehealth use.

Multi-institutional Assessment of Pathologist Scoring HER2 Immunohistochemistry.

The HercepTest was approved 20+ years ago as the companion diagnostic test for trastuzumab in human epidermal growth factor 2 (HER2) or ERBB2 gene-amplified/overexpressing breast cancers. Subsequent HER2 immunohistochemistry (IHC) assays followed, including the now most common Ventana 4B5 assay. Although this IHC assay has become the clinical standard, its reliability, reproducibility, and accuracy have largely been approved and accepted on the basis of concordance among small numbers of pathologists without validation in a real-world setting. In this study, we evaluated the concordance and interrater reliability of scoring HER2 IHC in 170 breast cancer biopsies by 18 breast cancer-specialized pathologists from 15 institutions. We used the Observers Needed to Evaluate Subjective Tests method to determine the plateau of concordance and the minimum number of pathologists needed to estimate interrater agreement values for large numbers of raters, as seen in the real-world setting. We report substantial discordance within the intermediate categories (<1% agreement for 1+ and 3.6% agreement for 2+) in the 4-category HER2 IHC scoring system. The discordance within the IHC 0 cases is also substantial with an overall percent agreement (OPA) of only 25% and poor interrater reliability metrics (0.49 Fleiss' kappa, 0.55 intraclass correlation coefficient). This discordance can be partially reduced by using a 3-category system (28.8% vs 46.5% OPA for 4-category and 3-category scoring systems, respectively). Observers Needed to Evaluate Subjective Tests plots suggest that the OPA for the task of determining a HER2 IHC score 0 from not 0 plateaus statistically around 59.4% at 10 raters. Conversely, at the task of scoring HER2 IHC as 3+ or not 3+ pathologists' concordance was much higher with an OPA that plateaus at 87.1% with 6 raters. This suggests that legacy HER2 IHC remains valuable for finding the patients in whom the ERBB2 gene is amplified but unacceptably discordant in assigning HER2-low or HER2-negative status for the emerging HER2-low therapies.

Imaging and genetics in Parkinson's disease: assessment of the GBA1 mutation.

INTRODUCTION: Several genetic variants are associated with an increased risk for developing Parkinson's Disease (PD) and limited genotype/phenotype correlation. Specifically, mutations in GBA1, the gene coding for the lysosomal enzyme glucocerebrosidase, are associated with an earlier age of onset and faster disease progression. Given these phenotypic differences associated with GBA1 variants, we explored whether cortical thickness and other biomarkers of neurodegeneration differed in healthy controls and PD patients with and without GBA1 variants. METHODS: To understand how different GBA1 variants influence PD phenotype early in the disease, we retrieved neuroimaging and biospecimen data from the Parkinson's Progression Markers Initiative database. Using FreeSurfer, we compared T1-weighted MRI images from healthy controls (N = 47) to PD patients with heterozygous N370S (N = 21), heterozygous E326K (N = 18) or heterozygous T369M (N = 8) variants, and GBA1 non-mutation carriers (N = 47). RESULTS: Cortical thickness in PD patients differed from controls in the parietal cortex, with E365K, T369M variants, and GBA1 non-mutation carriers showing more cortical thinning than N370S variants. Patients with N370S variants had significantly higher serum neurofilament light levels among all groups. CONCLUSION: Our results demonstrate significant cortical thinning in PD patients independent of genotype in superior parietal and postcentral regions when compared to the controls. They highlight the impact of GBA1 variants on cortical thickness in the parietal cortex. Finally, they suggest that recently diagnosed PD patients with N370S variants have a higher cortical thickness and increased active neurodegeneration when compared to PD patients without GBA1 mutations and PD patients with E326K or T369M variants.

Prevalence of anxiety and depressive symptoms and impact on self-management among adults with chronic conditions in Chicago, Illinois, USA, during the COVID-19 pandemic: a cross-sectional survey.

OBJECTIVES: To examine the prevalence of mental health symptoms during the first surge of COVID-19 in the USA, and their associations with COVID-19-related emotional distress, health self-management and healthcare utilisation. DESIGN: Cross-sectional analysis of wave 3 (1-22 May 2020) survey data from the ongoing Chicago COVID-19 Comorbidities (C3) study. SETTING: Seven academic and community health centres in Chicago, Illinois. PARTICIPANTS: 565 adults aged 23-88 with one or more chronic conditions completing at least one prior C3 study wave. PRIMARY AND SECONDARY OUTCOME MEASURES: Clinically relevant anxiety and depressive symptoms as measured using Patient-Reported Outcomes Measurement Information System short forms. Self-reported emotional and health-related responses to COVID-19 were measured through a combination of single-item questions and validated measures. RESULTS: Rates of anxiety and depressive symptoms were 14% (81/563) and 15% (84/563), respectively. Anxiety and depressive symptoms were then each separately associated with greater worry about contracting COVID-19 (relative risk (RR) 2.32, 95% CI 1.52 to 3.53; RR 1.67, 95% CI 1.10 to 2.54), greater stress (RR 4.93, 95% CI 3.20 to 7.59; RR 3.01, 95% CI 1.96 to 4.61) and loneliness (RR 3.82, 95% CI 2.21 to 6.60; RR 5.37, 95% CI 3.21 to 8.98), greater avoidance of the doctor (RR 1.62, 95% CI 1.06 to 2.49; RR 1.54, 95% CI 1.00 to 2.36) and difficulty managing health (least square means (LS Means) 6.09, 95% CI 5.25 to 6.92 vs 4.23, 95% CI 3.70 to 4.75; LS Means 5.85, 95% CI 5.04 to 6.65 vs 4.22, 95% CI 3.70 to 4.75) and medications (LS Means 3.71, 95% CI 2.98 to 4.43 vs 2.47, 95% CI 2.02 to 2.92) due to the pandemic. CONCLUSIONS: Identifying and addressing mental health concerns may be an important factor to consider in COVID-19 prevention and management among high-risk medical populations.

Assessment of the Pharmacokinetics, Pharmacodynamics, and Safety of Single Doses of TV-1106, a Long-Acting Growth Hormone, in Healthy Japanese and Caucasian Subjects.

TV-1106 is a human serum albumin genetically fused to recombinant human growth hormone, designed to provide a long-acting alternative to daily growth hormone (GH) injections in patients with GH deficiency. This study investigated the pharmacokinetics, pharmacodynamics, and safety of single subcutaneous doses of TV-1106 (7.5, 15, 50, and 100 mg) in Japanese (n = 44) and caucasian (n = 44) healthy subjects. TV-1106 pharmacokinetics and pharmacodynamics were comparable in Japanese and caucasian populations. TV-1106 demonstrated relatively slow absorption (median tmax , 10-30 hours) and a mean elimination half-life of 26-36 hours. Apparent clearance and volume of distribution decreased with increasing TV-1106 doses in both populations and appeared to increase more than dose proportionality across the tested doses. Insulin-like growth factor-1 (IGF-1) and IGF binding protein-3 (IGFBP-3) increased in a dose-related manner, with maximum responses observed at 33-96 and 42-109 hours, respectively. IGF-1 and IGFBP-3 returned to baseline values at 168 hours following 7.5 and 15 mg of TV-1106, and 336 hours following 50 and 100 mg of TV-1106. TV-1106 appeared safe in both populations. There was no evidence of differences in pharmacokinetics, pharmacodynamics, or safety of TV-1106 between Japanese and caucasian populations. The data also demonstrate long-acting growth hormone properties of TV-1106 and support its potential for once-weekly dosing.

Use of antihypertensive medications and diagnostic tests among privately insured adolescents and young adults with primary versus secondary hypertension.

PURPOSE: To compare the use of antihypertensive medications and diagnostic tests among adolescents and young adults with primary versus secondary hypertension. METHODS: We conducted retrospective cohort analysis of claims data for adolescents and young adults (12-21 years of age) with ≥3 years of insurance coverage (≥11 months/year) in a large private managed care plan during 2003-2009 with diagnosis of primary hypertension or secondary hypertension. We examined their use of antihypertensive medications and identified demographic characteristics and the presence of obesity-related comorbidities. For the subset receiving antihypertensive medications, we examined their diagnostic test use (echocardiograms, renal ultrasounds, and electrocardiograms). RESULTS: The study sample included 1,232 adolescents and young adults; 84% had primary hypertension and 16% had secondary hypertension. The overall prevalence rate of hypertension was 2.6%. One quarter (28%) with primary hypertension had one or more antihypertensive medications, whereas 65% with secondary hypertension had one or more antihypertensive medications. Leading prescribers of antihypertensives for subjects with primary hypertension were primary care physicians (80%), whereas antihypertensive medications were equally prescribed by primary care physicians (43%) and sub-specialists (37%) for subjects with secondary hypertension. CONCLUSIONS: The predominant hypertension diagnosis among adolescents and young adults is primary hypertension. Antihypertensive medication use was higher among those with secondary hypertension compared with those with primary hypertension. Further study is needed to determine treatment effectiveness and patient outcomes associated with differential treatment patterns used for adolescents and young adults with primary versus secondary hypertension.

Clonidine utilization trends for Medicaid children.

OBJECTIVE: To characterize clonidine utilization trends among children. DESIGN/METHODS: Serial cross-sectional analysis of Michigan Medicaid claims data for children aged 6 to 18 years. The authors identified children with ≥1 clonidine prescription; the authors examined their ICD-9 diagnoses categorized as simple and complex attention deficit hyperactivity disorder (ADHD), non-ADHD mental health disorder, hypertension, or others. Also identified were child demographics and prescribing physician specialty. RESULTS: From 2003 to 2008, the proportion of children receiving clonidine prescription nearly doubled in all demographics. Across years, the majority of clonidine prescription was for simple and complex ADHD and other mental health disorders. Leading prescribers were psychiatrists followed by general pediatricians and adult primary care physicians. CONCLUSIONS: Clonidine was used extensively to treat simple and complex ADHD in children although FDA approval for this indication did not occur until 2010. Further study is warranted to better understand clinical outcomes and costs associated with clonidine use for the treatment of children with ADHD.

Antihypertensive prescribing patterns for adolescents with primary hypertension.

BACKGROUND: Hypertension is an increasingly common problem in adolescents yet current medical management of primary hypertension in adolescents has not been well-described. METHODS: We identified adolescents with primary hypertension by International Classification of Diseases, Ninth Revision codes and looked at prescription patterns chronologically for antihypertensive drug class prescribed and the specialty of prescribing physician. We also examined patient demographics and presence of obesity-related comorbidities. RESULTS: During 2003-2008, there were 4296 adolescents with primary hypertension (HTN); 66% were boys; 73% were aged 11 to 14 years; 53% were black, 41% white, and 4% Hispanic; and 48% had obesity-related comorbidity. Twenty-three percent (977) received antihypertensive prescription. White subjects (odds ratio [OR]: 1.61; confidence interval [CI]: 1.39-1.88), older adolescents (≥15 years, OR: 2.11; CI: 1.79-2.48), and those with comorbidity (OR: 1.57; CI: 1.36-1.82) were more likely to receive antihypertensive prescriptions controlling for gender and years of Medicaid eligibility in logistic regression. Angiotensin converting enzyme inhibitors were the most frequently prescribed monotherapy. Nearly two-thirds of adolescents received prescriptions from adult primary care physicians (PCPs) only. More than one-quarter of adolescents who received a prescription received combination therapy, which was most often prescribed by adult PCPs. CONCLUSIONS: Adult PCPs were the leading prescribers of antihypertensives for adolescents with primary HTN. Race differences exist in physicians' prescribing of antihypertensives to adolescents with primary HTN. The choice of antihypertensives by physicians of different specialties warrants additional study to understand the underlying rationale for treatment decisions and to determine treatment effectiveness.

Parental preferences for FDA-approved medications prescribed for their children.

OBJECTIVE: To describe parental preferences for FDA-approved prescription medications for their children. STUDY DESIGN: Cross-sectional Web-enabled survey of a national sample of 1562 parents. RESULTS: Response rate was 61%. Most parents (77%) preferred prescription of only FDA-approved medications for their child. However, one half of parents preferred that their child's doctor prescribe medication that is safest and works best, even if not FDA approved for children. One third of parents (34%) preferred nothing but FDA-approved medications for their child, regardless of drug safety, effectiveness, or cost. Controlling for parent race and education, mothers (odds ratio = 1.52; P = .004) and older parents (odds ratio = 1.60; P = .025) were more likely to prefer nothing but FDA-approved medications for their children compared with fathers and younger parents. CONCLUSIONS: Although most parents initially indicate preference for FDA-approved medications, one half of parents will accept a non-FDA-approved medication for their children with the understanding that it is safer or more effective than the FDA-approved alternative.

Formulary coverage for lipid-lowering drugs recommended for children.

OBJECTIVE/METHODS: A cross-sectional assessment to describe availability, coverage, and pediatric labeling status of lipid-lowering drugs offered by 1 private and 1 public insurance plan formularies. RESULTS: Both insurance plans had equal medication availability of bile acid sequestrants (7), statins (10), and cholesterol-absorption blockers (CAB; 1). The private plan had 3 bile acid sequestrants and 3 statins listed as preferred drugs; the CAB was not preferred. In contrast, the public plan had 5 bile acid sequestrants, 7 statins, and the CAB as preferred drugs. For medications with pediatric labeling, the private plan covered 50% as preferred drugs whereas the public plan covered 70% as preferred drugs. CONCLUSIONS: If new recommendations of the American Academy of Pediatrics for treatment of dyslipidemia in children were implemented today, children with the public plan would have equal choice but better coverage of lipid-lowering drugs as preferred drugs, including those with FDA approval, compared with children with the private plan.

Off-label utilization of antihypertensive medications in children.

OBJECTIVE: To examine off-label use and costs of antihypertensive drugs in children by using a national sample of prescription claims. METHODS: We conducted a cross-sectional study using the 2002 Medstat MarketScan Database, a national sample of outpatient prescription claims of children or=12 years were more likely to be prescribed off-label antihypertensives (53%) compared with children aged

Factors associated with non-attendance at pediatric subspecialty asthma clinics.

BACKGROUND: Children with Medicaid insurance are less likely to receive subspecialty asthma care than non-Medicaid patients. However, it is not clear if such disparities are due to non-attendance at scheduled visits by patients. OBJECTIVE: To determine factors associated with non-attendance at scheduled visits for pediatric subspecialty asthma care. DESIGN/METHODS: We conducted a cross-sectional study of children with scheduled visits at three asthma clinics during a 12-month period. Our outcome of interest was patient non-attendance for a scheduled visit, controlling for age, gender, new patient status, type of insurance, severity of illness, distance to clinic, clinic site, month, and weekday of scheduled visit. We used logistic regression for multivariate comparisons and controlled for clustering effects for children with multiple scheduled visits. RESULTS: There were 1236 scheduled visits for 857 unique patients. Median age: 7 years (IQR 3-11); median distance traveled: 24 miles (IQR 13-41); 20% had Medicaid insurance. The non-attendance rate was 8%. In multivariate analysis, Medicaid insurance (OR 2.33, 95% CI 1.45-3.74) and visits scheduled in September-December (3.26, 2.08-5.11) were associated with non-attendance. CONCLUSIONS: Children with Medicaid insurance are less likely to attend scheduled visits for subspecialty asthma care, controlling for seasonal variation. Programs designed to address disparities in pediatric asthma outcomes regarding subspecialist care may improve their effectiveness by addressing barriers to attendance and anticipating poor attendance in the fall season.

Variation in pediatric asthma quality improvement programs by managed care plans.

Although asthma quality improvement (QI) programs are common, little is known about the scope and content of QI initiatives in managed care arrangements. The authors conducted a cross-sectional survey of all managed care plans in Michigan serving the pediatric Medicaid population. Using semi-structured interviews, they assessed the comprehensiveness of the asthma QI program regarding provider, allied health professional, pharmacy, and member services. Although all QI initiatives included some type of physician-directed component and patient-directed components, only half included allied health professionals and one quarter included pharmacy-directed components. Interactive physician continuing medical education was associated with plans whose members were concentrated in only 1 or 2 counties. The authors noted wide variation in content, format, inclusion of incentives, inclusion of other health professionals, and outcome goals. The variation in QI approaches by each of the managed care organizations suggests that there is a dearth of information on appropriate and cost-effective methods to improve pediatric asthma quality at the plan level.