Search

Few studies of the concordance between patient self-report and medical record data have examined how concordance varies with patient characteristics, and results of such studies have been mixed. Given discrepancies in the quality of care received across patient cohorts, it is important to understand the degree to which concordance metrics are robust across patient characteristics. We hypothesized that concordance between ambulatory medical record and patient survey data varies by patient demographic characteristics, especially education, income, and race/ethnicity. We present the results of bivariate and multivariate analyses including data from 1,270 patients with at least one of: diabetes, ischemic heart disease, asthma or COPD, or low back pain sampled from 39 West Coast medical organizations. We present total agreement, kappa, and survey sensitivity and specificity, stratified by patient demographic and health status characteristics. We conducted logistic regressions to test the impact of patient demographic characteristics, domain of medical care, and health status on these three measures of concordance. Survey sensitivity varied significantly by race/ethnicity in bivariate analyses, but this effect was erased in multivariate analyses. Our findings do not support the hypothesis that patient education, income, or race/ethnicity have an independent effect on concordance when controlling for other factors. However, concordance varied significantly by patient health status. The medical record and patient self-report do not measure quality comparably across patient cohorts. We recommend continued efforts to improve survey data collection across different patient populations and to improve the quality of clinical data. © Springer Science+Business Media, LLC 2006.

Objectives: We aimed to compare the effectiveness of antiretroviral therapy (ART) classes for achieving HIV RNA suppression to < 50 HIV‐1 RNA copies/mL within 6 months of initiation with high viral loads (VLs). Secondary objectives were to compare viral suppression (VS) at 12 weeks and 12 months, partial HIV RNA suppression to < 200 copies/mL, time to VS, time to rebound, and change in CD4 cell count. Methods: This was a multicentre, retrospective, observational study. Adult patients were included if they initiated ART between January 2005 and December 2016 with a VL ≥ 100 000 copies/mL. Results: There were 220 patients included in the study. The median VL was 252 919 [interquartile range (IQR) 149 472–500 000] copies/mL. Nonnucleoside reverse transcriptase inhibitor (NNRTI) recipients were more likely to achieve VS by 6 months compared to those initiating ART containing protease inhibitors (PIs) [75.4% vs. 44.1%, respectively; odds ratio (OR) 3.34; 95% confidence interval (CI) 1.62–6.90] or integrase strand transfer inhibitors (INSTIs) (75.4% vs. 55.8%, respectively; OR 2.40; 95% CI 1.03–5.58). VS at 12 weeks was more frequent with INSTI‐containing regimens than with PIs (28.9% vs. 9.0%, respectively; OR 4.10; 95% CI 1.69–9.92). VS at 12 months did not significantly differ between treatment regimens. Median time to complete VS for INSTI, PI and NNRTI recipients was 22.3 (95% CI 13.4–33), 30.1 (95% CI 25–36) and 19.9 (95% CI 16–22.3) weeks, respectively. There were no significant differences in time to viral rebound or change in CD4 cell counts. Conclusions: Patients with high VLs initiated on NNRTIs were more likely to achieve VS by 6 months on ART compared to INSTI and PI recipients. [ABSTRACT FROM AUTHOR]

Background: Insurance products with incentives for patients to choose physicians classified as offering lower-cost care on the basis of cost-profiling tools are increasingly common. However, no rigorous evaluation has been undertaken to determine whether these tools can accurately distinguish higher-cost physicians from lower-cost physicians.Methods: We aggregated claims data for the years 2004 and 2005 from four health plans in Massachusetts. We used commercial software to construct clinically homogeneous episodes of care (e.g., treatment of diabetes, heart attack, or urinary tract infection), assigned each episode to a physician, and created a summary profile of resource use (i.e., cost) for each physician on the basis of all assigned episodes. We estimated the reliability (signal-to-noise ratio) of each physician's cost-profile score on a scale of 0 to 1, with 0 indicating that all differences in physicians' cost profiles are due to a lack of precision in the measure (noise) and 1 indicating that all differences are due to real variation in costs of services (signal). We used the reliability results to estimate the proportion of physicians in each specialty whose cost performance would be classified inaccurately in a two-tiered insurance product in which the physicians with cost profiles in the lowest quartile were labeled as "lower cost."Results: Median reliabilities ranged from 0.05 for vascular surgery to 0.79 for gastroenterology and otolaryngology. Overall, 59% of physicians had cost-profile scores with reliabilities of less than 0.70, a commonly used marker of suboptimal reliability. Using our reliability results, we estimated that 22% of physicians would be misclassified in a two-tiered system.Conclusions: Current methods for profiling physicians with respect to costs of services may produce misleading results. [ABSTRACT FROM AUTHOR]

As is the case with most health care program evaluations, disease management (DM) programs typically follow an observational study design, indicating that randomization to treatment or control was not performed. The foremost limitation of observational studies, compared to randomized studies, is that the only biases that can be controlled for are those associated with observed variables. Hidden bias refers to all those unobserved covariates that may distort the conclusions of the study. This paper introduces a sensitivity analysis that is used to determine the magnitude of hidden bias necessary to alter the conclusion that a DM program intervention was indeed effective. [ABSTRACT FROM AUTHOR]

Background: The validity of quality of care assessments relies upon data quality, yet little is known about the relative completeness and validity of data sources for evaluating the quality of care.Objectives: We evaluated concordance between ambulatory medical record and patient survey data. Levels of concordance, variations by type of item, sources of disagreement between data sources, and implications for quality of care assessment efforts are discussed.Design and Subjects: This was an observational study that included 1270 patients sampled from 39 West Coast medical organizations with at least 1 of the following: diabetes, ischemic heart disease, asthma or chronic obstructive pulmonary disease, or low back pain.Measures: Items from both data sources were grouped into 4 conceptual domains: diagnosis, clinical services delivered, counseling and referral, and medication use. We present total agreement, kappa, sensitivity, and specificity at the item and domain-levels and for all items combined.Results: We found good concordance between survey and medical records overall, but there was substantial variation within and across domains. The worst concordance was in the counseling and referrals domain, the best in the medication use domain. Patients were able to report with good sensitivity on memorable items.Conclusions: Quality ratings are likely to vary in differing directions, depending on the data source used. The most appropriate data source for analyses of components of and overall quality of care must be considered in light of study objectives and resources. We recommend data collection from multiple sources to most accurately portray the patient and provider experience of medical care. [ABSTRACT FROM AUTHOR]

BACKGROUND: We examined the effect of sociodemographic factors on the receipt of mammography, colorectal cancer screening, and influenza vaccinations by women enrolled in two Medicare+Choice health plans. METHODS: Administrative and survey data for 2,698 female health plan members was analyzed using multivariate logistic and ordinal logistic regression to assess the effects of enrollee characteristics on use of preventive services. RESULTS: Age, race and wealth were associated with the receipt of one or more preventive services. Older women were less likely to receive mammograms, wealthier women were more likely to receive mammograms and CRC screening, and Black women were more likely to receive CRC screening but less likely to receive influenza vaccinations. Wealthier women received a greater number of preventive services, other things equal, while older women received fewer preventive services. CONCLUSIONS: Race and wealth continue to be important factors in the receipt of preventive services by elderly women, though not always consistent with historical trends. Medicare+Choice plans should consider strategies to further reduce racial and wealth disparities in the use of preventive services. © 2004 The Institute For Cancer Prevention and Elsevier Inc. All rights reserved. [ABSTRACT FROM AUTHOR]

Objective: To assess the association of county-level bias about black and white people with patient experience, influenza immunisation, and quality of clinical care for black and white older US adults (age 65+ years)., Design: Linear multivariable regression measured the cross-sectional association of county-level estimates of implicit and explicit bias about black and white people with patient experiences, influenza immunisation, and clinical quality-of-care for black and white older US adults., Participants: We used data from 1.9 million white adults who completed implicit and explicit bias measures during 2003-2018, patient experience and influenza immunisation data from respondents to the 2009-2017 Medicare Consumer Assessment of Healthcare Providers and Systems (MCAHPS) Surveys, and clinical quality-of-care data from patients whose records were included in 2009-2017 Healthcare Effectiveness Data and Information Set (HEDIS) submissions (n=0.8-2.9 million per measure)., Main Outcome Measures: Three patient experience measures and patient-reported influenza immunisation from the MCAHPS Survey; five HEDIS measures., Results: In county-level models, higher pro-white implicit bias was associated with lower immunisation rates and worse scores for some patient experience measures for black and white adults as well as larger-magnitude black-white disparities. Higher pro-white implicit bias was associated with worse scores for some HEDIS measures for black and white adults but not with black-white disparities in clinical quality of care. Most significant associations were small in magnitude (effect sizes of 0.2-0.3 or less)., Conclusions: To the extent that county-level pro-white implicit bias is indicative of bias among healthcare providers, there may be a need for interventions designed to prevent such bias from adversely affecting the experiences and preventive care of black patients and the clinical quality of care for all patients., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

This commentary underscores the diagnosis and prescribing skills essential to the pharmacists' role on the healthcare team. It advocates for the integration of these skills into pharmacy curricula and emphasizes the urgent need for collaboration among pharmacy educators and the academy to address the omission of diagnosis and prescribing from key frameworks and standards, including the Pharmacists' Patient Care Process (PPCP), the Curricular Outcomes and Entrustable Professional Activities (COEPA), and the Accreditation Council for Pharmacy Education (ACPE) Draft Accreditation Standards 2025. The commentary draws on a case study of one college of pharmacy's integration of diagnosis and prescribing skills into its PharmD curriculum, in a state where pharmacists were granted full diagnostic and prescriptive authority. The integration was achieved through faculty-led modifications to the PPCP and COEPA, making diagnosis and prescribing an explicit part of the curriculum. The commentary concludes with a call to action for educational organizations to recognize and include these aspects in educational outcomes, accreditation standards, and practice frameworks. By doing so, the future of pharmacy education can be reshaped to improve patient care and advance the profession forward., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Conflicts of Interest The authors have no conflicts of interest or financial disclosures., (Copyright © 2024 American Association of Colleges of Pharmacy. Published by Elsevier Inc. All rights reserved.)

Understanding what matters to people with Parkinson's and their family is essential to derive relevant clinical outcome measures and guide clinical care. The purpose of this study was to explore what is important to people with Parkinson's disease vs. family over time. A qualitative content-analysis of online survey data collected by Parkinson's UK was conducted to identify types and frequencies of important symptoms and impacts of Parkinson's for people with the disease vs. family of people with Parkinson's. Independent T-tests were used to identify significance of between group differences for patients vs. family at < 2, 2-5, 6-10, 11-20, > 20-year durations. ANOVA was used to assess for within group differences by disease duration. We found that symptom priority changed significantly over time with longer disease duration. Tremor was reported less often later on, whereas mobility, dyskinesias, gait and speech/communication symptoms gained priority. In general, patients identified movement-related symptoms (e.g., walking, bradykinesia) as the most bothersome at all durations while family more strongly prioritized the physical and psychosocial impacts of disease (e.g., mobility, safety, interpersonal interactions, independence, and family impact). We conclude that important differences exist between family and patient perspectives of what matters and change over time with longer duration of disease., (© 2024. The Author(s).)

Prevalence estimates of Parkinson's disease (PD)-the fastest-growing neurodegenerative disease-are generally underestimated due to issues surrounding diagnostic accuracy, symptomatic undiagnosed cases, suboptimal prodromal monitoring, and limited screening access. Remotely monitored wearable devices and sensors provide precise, objective, and frequent measures of motor and non-motor symptoms. Here, we used consumer-grade wearable device and sensor data from the WATCH-PD study to develop a PD screening tool aimed at eliminating the gap between patient symptoms and diagnosis. Early-stage PD patients ( n = 82) and age-matched comparison participants ( n = 50) completed a multidomain assessment battery during a one-year longitudinal multicenter study. Using disease- and behavior-relevant feature engineering and multivariate machine learning modeling of early-stage PD status, we developed a highly accurate (92.3%), sensitive (90.0%), and specific (100%) random forest classification model (AUC = 0.92) that performed well across environmental and platform contexts. These findings provide robust support for further exploration of consumer-grade wearable devices and sensors for global population-wide PD screening and surveillance.

Introduction: Digital health technologies (DHTs) have the potential to alleviate challenges experienced in clinical trials through more objective, naturalistic, and frequent assessments of functioning. However, implementation of DHTs come with their own challenges, including acceptability and ease of use for study participants. In addition to acceptability, it is also important to understand device proficiency in the general population and within patient populations who may be asked to use DHTs for extended periods of time. We thus aimed to provide an overview of participant feedback on acceptability of DHTs, including body-worn sensors used in the clinic and a mobile application used at-home, used throughout the duration of the Wearable Assessments in the Clinic and at Home in Parkinson's Disease (WATCH-PD) study, an observational, longitudinal study looking at disease progression in early Parkinson's Disease (PD)., Methods: 82 participants with PD and 50 control participants were enrolled at 17 sites throughout the United States and followed for 12 months. We assessed participants' general device proficiency at baseline, using the Mobile Device Proficiency Questionnaire (MDPQ). The mean MDPQ score at Baseline did not significantly differ between PD patients and healthy controls (20.6 [2.91] vs 21.5 [2.94], p = .10)., Results: Questionnaire results demonstrated that participants had generally positive views on the comfort and use of the digital technologies throughout the duration of the study, regardless of group., Discussion: This is the first study to evaluate patient feedback and impressions of using technology in a longitudinal observational study in early Parkinson's Disease. Results demonstrate device proficiency and acceptability of various DHTs in people with Parkinson's does not differ from that of neurologically healthy older adults, and, overall, participants had a favorable view of the DHTs deployed in the WATCH-PD study., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Kangarloo, Latzman, Adams, Dorsey, Kostrzebski, Severson, Anderson, Horak, Stephenson and Cosman.)

Purpose/objective: Imposter phenomenon (IP) depicts the feeling of being a fraud. Stress and perfection are associated with IP, impairing professional and academic performance and negatively impacting mental health. The purpose of this study was to explore the prevalence of IP and perfectionism in dental hygiene students and the relationship with stress., Methods: This study used cross-sectional survey research with a nonprobability sampling of dental hygiene students (n = 258). The study used three validated instruments: the Imposter Profile (IPP30) with six subscales, the Frost Multidimensional Perfectionism Scale Brief with two subscales, and the Perceived Stress Scale (PSS10). Descriptive, correlation, and linear regression were used for analysis., Results: The completion rate was 74.8% (n = 193). Linear regression analysis found the competence doubt (CD) subscale of the Imposter-Profile and perfectionistic striving (PS) were the only statistically significant predictors of stress (F = 10.01, p < .001, R 2  = .16). CD (b = 0.36, p < 0.001) was twice as strong as PS (b = 0.15, p < 0.05) in predicting stress in dental hygiene students., Conclusion: In this sample of dental hygiene students, the doubt about competence aspect of imposter phenomenon increased stress more than the striving for perfectionism. Faculty may minimize stress and support students by identifying the feelings associated with imposter phenomenon and highlighting student achievements to build confidence and feelings of self-efficacy., (© 2024 American Dental Education Association.)

Increasingly, visualization practitioners are working with, using, and studying private and sensitive data. There can be many stakeholders interested in the resulting analyses-but widespread sharing of the data can cause harm to individuals, companies, and organizations. Practitioners are increasingly turning to differential privacy to enable public data sharing with a guaranteed amount of privacy. Differential privacy algorithms do this by aggregating data statistics with noise, and this now-private data can be released visually with differentially private scatterplots. While the private visual output is affected by the algorithm choice, privacy level, bin number, data distribution, and user task, there is little guidance on how to choose and balance the effect of these parameters. To address this gap, we had experts examine 1,200 differentially private scatterplots created with a variety of parameter choices and tested their ability to see aggregate patterns in the private output (i.e. the visual utility of the chart). We synthesized these results to provide easy-to-use guidance for visualization practitioners releasing private data through scatterplots. Our findings also provide a ground truth for visual utility, which we use to benchmark automated utility metrics from various fields. We demonstrate how multi-scale structural similarity (MS-SSIM), the metric most strongly correlated with our study's utility results, can be used to optimize parameter selection.

Digital measures may provide objective, sensitive, real-world measures of disease progression in Parkinson's disease (PD). However, multicenter longitudinal assessments of such measures are few. We recently demonstrated that baseline assessments of gait, tremor, finger tapping, and speech from a commercially available smartwatch, smartphone, and research-grade wearable sensors differed significantly between 82 individuals with early, untreated PD and 50 age-matched controls. Here, we evaluated the longitudinal change in these assessments over 12 months in a multicenter observational study using a generalized additive model, which permitted flexible modeling of at-home data. All measurements were included until participants started medications for PD. Over one year, individuals with early PD experienced significant declines in several measures of gait, an increase in the proportion of day with tremor, modest changes in speech, and few changes in psychomotor function. As measured by the smartwatch, the average (SD) arm swing in-clinic decreased from 25.9 (15.3) degrees at baseline to 19.9 degrees (13.7) at month 12 (P = 0.004). The proportion of awake time an individual with early PD had tremor increased from 19.3% (18.0%) to 25.6% (21.4%; P < 0.001). Activity, as measured by the number of steps taken per day, decreased from 3052 (1306) steps per day to 2331 (2010; P = 0.16), but this analysis was restricted to 10 participants due to the exclusion of those that had started PD medications and lost the data. The change of these digital measures over 12 months was generally larger than the corresponding change in individual items on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale but not greater than the change in the overall scale. Successful implementation of digital measures in future clinical trials will require improvements in study conduct, especially data capture. Nonetheless, gait and tremor measures derived from a commercially available smartwatch and smartphone hold promise for assessing the efficacy of therapeutics in early PD., (© 2024. The Author(s).)

Huntington's disease (HD), like many other neurological disorders, affects both lower and upper limb function that is typically assessed in the clinic - providing a snapshot of disease symptoms. Wearable sensors enable the collection of real-world data that can complement such clinical assessments and provide a more comprehensive insight into disease symptoms. In this context, almost all studies are focused on assessing lower limb function via monitoring of gait, physical activity and ambulation. In this study, we monitor upper limb function during activities of daily living in individuals with HD (n = 16), prodromal HD (pHD, n = 7), and controls (CTR, n = 16) using a wrist-worn wearable sensor, called PAMSys ULM, over seven days. The participants were highly compliant in wearing the sensor with an average daily compliance of 99% (100% for HD, 98% for pHD, and 99% for CTR). Goal-directed movements (GDM) of the hand were detected using a deep learning model, and kinematic features of each GDM were estimated. The collected data was used to predict disease groups (i.e., HD, pHD, and CTR) and clinical scores using a combination of statistical and machine learning-based models. Significant differences in GDM features were observed between the groups. HD participants performed fewer GDMs with long duration (> 7.5 seconds) compared to CTR (p-val = 0.021, d = -0.86). In velocity and acceleration metrics, the highest effect size feature was the entropy of the velocity zero-crossing length segments (HD vs CTR p-val <0.001, d = -1.67; HD vs pHD p-val = 0.043, d=-0.98; CTR vs pHD p-val = 0.046, d=0.96). In addition, this same variable showed a strongest correlation with clinical scores. Classification models achieved good performance in distinguishing HD, pHD and CTR individuals with a balanced accuracy of 67% and a 0.72 recall for the HD group, while regression models accurately predicted clinical scores. Notably the explained variance for the upper extremity function subdomain scale of Unified Huntington's Disease Rating Scale (UHDRS) was the highest, with the model capturing 60% of the variance. Our findings suggest the potential of wearables and machine learning for early identification of phenoconversion, remote monitoring in HD, and evaluating new treatments efficacy in clinical trials and medicine., Competing Interests: Additional Declarations: There is NO Competing Interest.

Introduction: Studies have found that sodium-glucose cotransporter 2 inhibitors (SGLT2) and glucagon-like peptide 1 receptor agonists (GLP1) have cardiovascular benefits for patients with type 2 diabetes (DM2) and atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), or heart failure (HF). The literature does not provide evidence specifically for patients with these conditions who are adding one of these medicines to two glucose-lowering medications (ie, as "third-step" therapy). We explored the effects of different third-step medications on cardiovascular outcomes in patients with diabetes and these comorbid conditions. Specifically, we compared third-step SGLT2 or GLP1 to third-step dipeptidyl peptidase-4 inhibitors (DPP4), insulin, or thiazolidinediones (TZD)., Research Design and Methods: We assembled a retrospective cohort of adults at five Kaiser Permanente sites with DM2 and ASCVD, CKD, or HF, initiating third-step treatment between 2016 and 2020. Propensity score weighted Poisson models were used to calculate adjusted rate ratios (ARRs) for all-cause mortality, incident major adverse cardiovascular event (MACE), and incident HF hospitalization in patients initiating SGLT2 or GLP1 compared with DPP4, insulin, or TZD., Results: We identified 27 542 patients initiating third-step treatment with one or more of these conditions (19 958 with ASCVD, 14 577 with CKD, and 3919 with HF). ARRs for GLP1 and SGLT2 versus DPP4, insulin, and TZD in the patient subgroups ranged between 0.22 and 0.55 for all-cause mortality, 0.38 and 0.81 for MACE, and 0.46 and 1.05 for HF hospitalization. Many ARRs were statistically significant, and all significant ARRs showed a benefit (ARR <1) for GLP1 or SGLT2 when compared with DPP4, insulin, or TZD., Conclusions: Third-step SGLT2 and GLP1 are generally associated with a benefit for these outcomes in these patient groups when compared with third-step DPP4, insulin, or TZD. Our results add to evidence of a cardiovascular benefit of SGLT2 and GLP1 and could inform clinical guidelines for choosing third-step diabetes treatment., Competing Interests: Competing interests: JPM provided paid consulting services to an expert panel with the American Academy of HIV Medicine. All other authors declare no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Competing Interests: Declaration of Competing Interest None declared.

Background: Digital health technologies show promise for improving the measurement of Parkinson's disease in clinical research and trials. However, it is not clear whether digital measures demonstrate enhanced sensitivity to disease progression compared to traditional measurement approaches., Methods: To this end, we develop a wearable sensor-based digital algorithm for deriving features of upper and lower-body bradykinesia and evaluate the sensitivity of digital measures to 1-year longitudinal progression using data from the WATCH-PD study, a multicenter, observational digital assessment study in participants with early, untreated Parkinson's disease. In total, 82 early, untreated Parkinson's disease participants and 50 age-matched controls were recruited and took part in a variety of motor tasks over the course of a 12-month period while wearing body-worn inertial sensors. We establish clinical validity of sensor-based digital measures by investigating convergent validity with appropriate clinical constructs, known groups validity by distinguishing patients from healthy volunteers, and test-retest reliability by comparing measurements between visits., Results: We demonstrate clinical validity of the digital measures, and importantly, superior sensitivity of digital measures for distinguishing 1-year longitudinal change in early-stage PD relative to corresponding clinical constructs., Conclusions: Our results demonstrate the potential of digital health technologies to enhance sensitivity to disease progression relative to existing measurement standards and may constitute the basis for use as drug development tools in clinical research., (© 2024. The Author(s).)

Background: Environmental exposure to trichloroethylene (TCE), a carcinogenic dry-cleaning chemical, may be linked to Parkinson's disease (PD)., Objective: The objective of this study was to determine whether PD and cancer were elevated among attorneys who worked near a contaminated site., Methods: We surveyed and evaluated attorneys with possible exposure and assessed a comparison group., Results: Seventy-nine of 82 attorneys (96.3%; mean [SD] age: 69.5 [11.4] years; 89.9% men) completed at least one phase of the study. For comparison, 75 lawyers (64.9 [10.2] years; 65.3% men) underwent clinical evaluations. Four (5.1%) of them who worked near the polluted site reported PD, more than expected based on age and sex (1.7%; P = 0.01) but not significantly higher than the comparison group (n = 1 [1.3%]; P = 0.37). Fifteen (19.0%), compared to four in the comparison group (5.3%; P = 0.049), had a TCE-related cancer., Conclusions: In a retrospective study, diagnoses of PD and TCE-related cancers appeared to be elevated among attorneys who worked next to a contaminated dry-cleaning site. © 2024 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society., (© 2024 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.)

Post hoc analyses evaluated cariprazine, a dopamine D 3 -preferring D 3 /D 2 receptor partial agonist, in patients with bipolar I depression and high baseline anxiety. Data were pooled from two phase 3, randomized, double-blind, placebo-controlled studies in adults with bipolar I disorder and a major depressive episode (NCT02670538, NCT02670551). Cariprazine 1.5 and 3 mg/d were evaluated in patient subgroups with higher and lower baseline anxiety. In patients with higher baseline anxiety, significant differences for cariprazine 1.5 mg/d versus placebo were observed on change in Montgomery-Åsberg Rating Scale (MADRS) total score, Hamilton Anxiety Rating Scale (HAM-A) total score and subscale scores, and rates of MADRS remission ( P < 0.05 all); nonsignificant numerical improvements were observed for cariprazine 3 mg/d versus placebo. In patients with lower anxiety, differences versus placebo were significant for HAM-A (cariprazine 3 mg/d) and MADRS (cariprazine 1.5 and 3 mg/d) total score changes ( P < 0.05 all). Rates of treatment-emergent mania were low and similar for cariprazine and placebo. Cariprazine 1.5 mg/d had consistent effects on anxiety and depression symptoms in patients with bipolar I depression and higher baseline anxiety; tolerability was favorable. Given few proven treatments for this common comorbidity, these preliminary results are promising., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Speech changes are an early symptom of Huntington disease (HD) and may occur prior to other motor and cognitive symptoms. Assessment of HD commonly uses clinician-rated outcome measures, which can be limited by observer variability and episodic administration. Speech symptoms are well suited for evaluation by digital measures which can enable sensitive, frequent, passive, and remote administration., Methods: We collected audio recordings using an external microphone of 36 (18 HD, 7 prodromal HD, and 11 control) participants completing passage reading, counting forward, and counting backwards speech tasks. Motor and cognitive assessments were also administered. Features including pausing, pitch, and accuracy were automatically extracted from recordings using the BioDigit Speech software and compared between the three groups. Speech features were also analyzed by the Unified Huntington Disease Rating Scale (UHDRS) dysarthria score. Random forest machine learning models were implemented to predict clinical status and clinical scores from speech features., Results: Significant differences in pausing, intelligibility, and accuracy features were observed between HD, prodromal HD, and control groups for the passage reading task (e.g., p  < 0.001 with Cohen'd = -2 between HD and control groups for pause ratio). A few parameters were significantly different between the HD and control groups for the counting forward and backwards speech tasks. A random forest classifier predicted clinical status from speech tasks with a balanced accuracy of 73% and an AUC of 0.92. Random forest regressors predicted clinical outcomes from speech features with mean absolute error ranging from 2.43-9.64 for UHDRS total functional capacity, motor and dysarthria scores, and explained variance ranging from 14 to 65%. Montreal Cognitive Assessment scores were predicted with mean absolute error of 2.3 and explained variance of 30%., Conclusion: Speech data have the potential to be a valuable digital measure of HD progression, and can also enable remote, frequent disease assessment in prodromal HD and HD. Clinical status and disease severity were predicted from extracted speech features using random forest machine learning models. Speech measurements could be leveraged as sensitive marker of clinical onset and disease progression in future clinical trials., Competing Interests: AN, RM, and AV were employed by BioSensics. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2024 Nunes, Pawlik, Mishra, Waddell, Coffey, Tarolli, Schneider, Dorsey, Vaziri and Adams.)

Laws and regulations are intended to protect the public; however, overregulation of the profession can block initiatives focused on patient safety and public health. This article discusses the 3 main regulatory approaches to pharmacy practice: standard of care (SOC), bright line, and right touch. An SOC regulatory model supports practitioners delivering patient care within their scope of practice and clinical training. Patient safety is maintained by measuring care against other practitioners within the same practice setting while supporting practitioners practicing at the top of their clinical ability. Compared with bright line and right touch approaches, the SOC regulatory model provides the adaptability needed to respond to different practice scenarios and settings, thus increasing access to health care and opportunities for innovation. To have a lasting impact on the profession and support patients, all pharmacy professionals must be fluent in regulatory approaches and advocate for states to transition to SOC regulatory models., Competing Interests: Disclosure The authors declare no relevant conflicts of interest or financial relationships., (Copyright © 2023 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Background: In April 2020, pharmacists were added as medical providers under Idaho Medicaid in response to recent scope expansion for pharmacists and to increase beneficiaries' access to coronavirus disease 2019 (COVID-19) testing and services. The COVID-19 pandemic prompted expedited Medicaid enrollment for pharmacists but did not address coverage of medical services provided to privately insured individuals for pharmacy-based testing services. Objective: This study aimed to describe processes used by independently owned, community-based pharmacies in Idaho to credential with private insurers and report outcomes. Methods: Relevant information and forms required to credential with the four major payers in the state of Idaho were collected. Packets were obtained via medical insurers' websites and by direct contact. Questions that arose from community pharmacists during the submission process were collected and answered on a shared spreadsheet, and insurance representatives were contacted directly to resolve questions. Results: Eight out of 13 participating pharmacies submitted an average of three credentialing packets for their facilities. Thirty-five pharmacists also submitted an average of four credentialing packets for themselves. As of mid-May 2021, nearly 20 weeks after submission, only 67 out of 129 pharmacists had received word regarding the status of their applications. Less than half of all pharmacist applications were approved (after their first attempt). Conclusion: Efforts to support the education of both pharmacists and medical insurers may streamline the credentialing processes in the future.

Importance: Variability in intervention participation within care management programs can complicate standard analysis strategies., Objective: To evaluate whether care management was associated with reduced hospital readmissions among individuals with higher participation probabilities., Design, Setting, and Participants: A total of 800 hospitalized patients aged 18 years and older were randomized as part of the Health Care Hotspotting randomized clinical trial, which was conducted in Camden, New Jersey, from June 2014 to September 2017. Data were collected through October 2018. In this new analysis performed between April 6, 2022, and April 23, 2023, the distillation method was applied to account for variable intervention participation. A gradient-boosting machine learning model produced predicted probabilities of engaged participation using baseline covariates only. Predicted probabilities were used to trim both intervention and control populations in an equivalent manner, and intervention effects were reevaluated within study population subsets that were increasingly concentrated with patients having higher participation probabilities. Patients had 2 or more hospitalizations in the 6-month preenrollment period and documented evidence of chronic illness and social complexity., Intervention: Multidisciplinary teams provided services to patients in the intervention arm for a mean 120 days after hospital discharge. Patients in the control group received usual postdischarge care., Main Outcomes and Measures: Hospital readmission rates and counts 30, 90, and 180 days postdischarge., Results: Of 800 eligible patients, 782 had complete discharge information and were included in this analysis (mean [SD] age, 56.6 [12.7] years; 395 [50.5%] female). In the intent-to-treat analysis, the unadjusted 180-day readmission rate for treatment and control groups was 60.1% vs 61.7% (adjusted odds ratio, 0.95; 95% CI, 0.71-1.28; P = .73) and the mean (SD) number of 180-day readmissions was 1.45 (1.89) vs 1.48 (1.94) (adjusted incidence rate ratio, 0.99, 95% CI, 0.88-1.12; P = .86). Among the population with the highest participation probabilities, the mean (SD) 180-day readmission count was 1.22 (1.74) vs 1.57 (1.74) and the incidence rate ratio attained statistical significance (adjusted incidence rate ratio, 0.74; 95% CI, 0.56-0.99; P = .045). Adjusted odds ratios and adjusted incidence rate ratios for 30- and 90-day outcomes reached statistical significance after population distillation., Conclusions and Relevance: This secondary analysis of a randomized clinical trial found that care management was associated with reduced readmissions among patients with higher participation probabilities, suggesting that program operation could be improved by addressing barriers to participation and refining inclusion criteria to identify patients most likely to benefit., Trial Registration: ClinicalTrials.gov Identifier: NCT02090426.