Dopamine D1 Agonists: First Potential Treatment for Late-Stage Parkinson's Disease.

Current pharmacotherapy has limited efficacy and/or intolerable side effects in late-stage Parkinson's disease (LsPD) patients whose daily life depends primarily on caregivers and palliative care. Clinical metrics inadequately gauge efficacy in LsPD patients. We explored if a D1/5 dopamine agonist would have efficacy in LsPD using a double-blind placebo-controlled crossover phase Ia/b study comparing the D1/5 agonist PF-06412562 to levodopa/carbidopa in six LsPD patients. Caregiver assessment was the primary efficacy measure because caregivers were with patients throughout the study, and standard clinical metrics inadequately gauge efficacy in LsPD. Assessments included standard quantitative scales of motor function (MDS-UPDRS-III), alertness (Glasgow Coma and Stanford Sleepiness Scales), and cognition (Severe Impairment and Frontal Assessment Batteries) at baseline (Day 1) and thrice daily during drug testing (Days 2-3). Clinicians and caregivers completed the clinical impression of change questionnaires, and caregivers participated in a qualitative exit interview. Blinded triangulation of quantitative and qualitative data was used to integrate findings. Neither traditional scales nor clinician impression of change detected consistent differences between treatments in the five participants who completed the study. Conversely, the overall caregiver data strongly favored PF-06412562 over levodopa in four of five patients. The most meaningful improvements converged on motor, alertness, and functional engagement. These data suggest for the first time that there can be useful pharmacological intervention in LsPD patients using D1/5 agonists and also that caregiver perspectives with mixed method analyses may overcome limitations using methods common in early-stage patients. The results encourage future clinical studies and understanding of the most efficacious signaling properties of a D1 agonist for this population.

Provider Perspectives of Transitions of Care at a Tertiary Care Children's Hospital With a Hospitalist-Run Discharge Clinic.

Children's hospitals are discharging patients to home with increasingly complex outpatient needs, making safe transitions of care (ToCs) of vital importance. Our study involved a survey of both outpatient providers and pediatric hospitalists associated with our medical center to better describe providers' views on the ToC process. The survey included questions assessing views on patient care responsibilities, resource availability, our hospitalist-run postdischarge clinic (PDC), and comfort with telemedicine. Our hospitalists generally believed that primary care providers (PCPs) did not have adequate access to important ToC elements, whereas PCPs felt their access was adequate. Both provider types felt it was the inpatient team's responsibility to manage patient events between discharge and PCP follow-up and that a hospitalist-run PDC may reduce interim emergency room visits. This study challenges perceptions about the ToC process in children and describes a generalizable approach to assessing provider perceptions surrounding the ToC within individual health systems.

Gynaecological care of women with chronic pelvic pain: Patient perspectives and care preferences.

OBJECTIVE: To explore the experiences and care preferences of women with chronic pelvic pain, with or without a history of sexual trauma, seeking gynaecological care. DESIGN: Qualitative study. SETTING: Ambulatory endometriosis centre. POPULATION OR SAMPLE: Women aged 18-55 years with chronic pelvic pain. METHODS: Baseline demographics and sexual trauma history were obtained, and participants were assigned to focus groups according to a positive (four groups, 13 participants) or negative (two groups, nine participants) screen for a history of sexual trauma. The focus groups were led by a clinical psychologist and a gynaecological surgeon and consisted of semi-structured interviews. The interviews were audio-recorded and transcribed, and the transcripts were coded in NVivo 12. MAIN OUTCOME MEASURES: Content analysis was used to derive themes according to the participants' own words. RESULTS: Participants with chronic pelvic pain, with or without a history of sexual trauma, experienced delay in diagnosis and repetitive dismissals by clinicians. Participants' experiences of dismissals included: clinicians not listening, insufficient allocation of time to appointments and perceived redundant medical testing (i.e. sexually transmitted infection testing, urine cultures, ultrasounds). Participants identified clinician interactions as pivotal in coping with both pelvic pain and sexual abuse. Participants also provided feedback regarding trauma-informed practices and care delivery specific to patients with chronic pelvic pain. CONCLUSION: Patients with chronic pelvic pain, with or without a history of sexual trauma, report negative experiences when interacting with the healthcare system. They have clear needs and preferences regarding gynaecological care and provide feasible suggestions for improving care delivery.

Mixed-methods Analysis of Adults Likely versus Unlikely to Get a COVID-19 Vaccination.

Objectives: This mixed-methods study compared perspectives of those 'very likely' versus 'very unlikely' to receive a hypothetical COVID-19 vaccine. Methods: We used an explanatory, sequential, mixed- methods design to analyze quantitative data from a rural Pennsylvania sample. Of the 976 participants, 67 selected 'very unlikely' to get the COVID-19 vaccine. Responses to open-ended questions: "What worries you the most about the COVID 19 pandemic?" and "What are your thoughts about a potential COVID 19 vaccine?" were qualitatively compared to answers from the 67 participants who selected 'very likely' to get the COVID-19 vaccine. We used descriptive content analysis to compare themes across the 2 groups. Results: Both groups had thematic commonalities related to their concerns. Themes that were more common among those 'very unlikely' to get vaccinated included concern for politics overriding vaccine safety and rushed vaccine development timeline, whereas themes related to hope and optimism about vaccination were exclusive to the 'very likely' group. Conclusions: Shared beliefs existed across groups with different intents to vaccinate; yet, identification with vaccine spokespersons differed. Messaging campaigns can use these commonalities to address vaccine hesitancy.

Transformative learning of medical trainees during the COVID-19 pandemic: A mixed methods study.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has had a transformative effect on individuals across the world, including those in healthcare. Transformative learning is an educational theory in which an individual's worldview is fundamentally altered through conscious reflection (Cognitive Rational), insights (Extrarational), or social reform (Social Critique). We utilized transformative learning theory to characterize the experiences of medical trainees during the pandemic. METHODS: We used the Transformative Learning Survey in September and October 2020 to evaluate the processes and outcomes of transformative learning in health professions students and housestaff at an academic medical center during the pandemic. We analyzed survey scores for three process domains and four outcome subdomains. We inductively coded the survey's two open-ended questions and performed qualitative and mixed-methods analyses. RESULTS: The most prominent TL outcome was Self-Awareness, Acting Differently was intermediate, and Openness and Worldview Shifts were lowest. Cognitive Rational and Social Critique processes were more prominent than Extrarational processes. Students were more likely than housestaff to undergo transformative learning through the Social Critique process (p = 0.025), in particular the sub-processes of Social Action (p = 0.023) and Ideology Critique (p = 0.010). Qualitative analysis via the aggregation of codes identified four responses to the pandemic: negative change, positive change, existential change, or no change. Negative changes (67.7%) were most common, with students reporting more of these changes than housestaff (74.8% vs 53.6%; p < 0.01). Only 8.4% of reported changes could be defined as transformative. CONCLUSIONS: Through the theoretical lens of transformative learning, our study provides insight into the lives of learners during the pandemic. Our finding that medical students were more likely to use Social Critique processes has multiple parallels in the literature. If leaders in academic medicine desire to create enlightened change agents through transformative learning, such education must continue throughout graduate medical education and beyond.

Perceptions and knowledge regarding the COVID-19 pandemic between U.S. and China: a mixed methods study.

BACKGROUND: SARS-CoV-2, a new coronavirus first reported by China on December 31st, 2019, has led to a global health crisis that continues to challenge governments and public health organizations. Understanding COVID-19 knowledge, attitudes, and practices (KAP) is key for informing messaging strategies to contain the pandemic. Cross-national studies (e.g.: comparing China to the U.S.) are needed to better understand how trans-cultural differences may drive differences in pandemic response and behaviors. The goal of the study is to compare knowledge and perceptions of COVID-19 between adults in China and the U.S. These data will provide insight into challenges these nations may face in coordinating pandemic response. METHODS: This is a convergent mixed methods study comparing responses from China and the U.S. to a multinational COVID-19 KAP online survey. The survey included five quantitative constructs and five open-ended questions. Chinese respondents (n = 56) were matched for gender, age, education, perceived social standing, and time of survey completion with a U.S. cohort (n = 57) drawn from 10,620 U.S. RESPONDENTS: Quantitative responses were compared using T-test & Fisher-Exact tests. Inductive thematic analysis was applied to open-ended questions. RESULTS: Both U.S. and Chinese samples had relatively high intention to follow preventive behaviors overall. Differences in intended compliance with a specific recommendation appear to be driven by the different cultural norms in U.S. and China. Both groups expressed trepidation about the speed of COVID-19 vaccine development, driven by concern for safety among Chinese respondents, and concern for efficacy among U.S. RESPONDENTS: The Chinese cohort expressed worries about other countries' passive handling of the pandemic while the U.S. cohort focused on domestic responses from individuals and government. U.S. participants appeared more knowledgeable on some aspects of COVID-19. Different perspectives regarding COVID-19 origins were identified among the two groups. Participants from both samples reported high trust in health professionals and international health organizations. CONCLUSIONS: Mixed methods data from this cross-national analysis suggests sociocultural differences likely influence perceptions and knowledge of COVID-19 and its related public health policies. Discovering and addressing these culturally-based differences and perceptions are essential to coordinate a global pandemic response.

Preparing for the future of medical education: A case series of traditional and virtual clinical rotations in addiction medicine spanning the COVID pandemic.

Background: Substance use accounts for more than 400,000 deaths annually in the United States and overdose rates surged during the COVID pandemic. While the pandemic created increased pressure for better prepared providers, it simultaneously placed restrictions on medical training programs. The purpose of this educational case series is to assess the feasibility of a virtual addiction medicine training program and conduct a qualitative evaluation of medical student attitudes toward caring for people with substance use disorders, both before and after their addiction medicine training experience. Methods: We conducted a qualitative analysis related to course content focused on strengths and limitations of in-person and virtual training modalities. Individual quotes were evaluated and content themes were developed after a thorough review of all codes and detailed examination of interviewee quotes. Results: The primary themes that emerged were (1) Addiction medicine content is important to improve care of patients with substance disorders and is not fully addressed in undergraduate medical education (2) In-person and virtual training contain unique strengths and weaknesses and (3) Students perceived that both experiences provided positive and needed training in addiction medicine that shifted perspective and enhanced confidence to practice. Conclusions: Remote training via virtual lectures and patient visits may enhance training opportunities for students with limited exposure to addiction medicine patients and faculty with addiction medicine expertise. There is a need to further refine virtual care for patients with SUDs and virtual training to meet the needs of patients and learners across the country.

Factors Driving Resistance to Clinical Decision Support: Finding Inspiration in Radiology 3.0.

PURPOSE: The effectiveness of evidence-based guidelines (EBGs) and clinical decision support (CDS) is significantly hampered by widespread clinician resistance to it. Our study was designed to better understand the reasons for this resistance to CDS and explore the factors that drive it. METHODS: We used a mixed-methods approach to explore and identify the drivers of resistance for CDS among clinicians, including a web-based multispecialty survey exploring clinicians' impressions of the strengths and weaknesses of CDS, two clinician focus groups, and several one-on-one focused clinician interviews in which individual participants were asked to comment on their rationale for choosing imaging utilization that might not be supported by EBGs. Additionally, a unique electronic learning and assessment module known as Amplifire was used to probe clinician knowledge gaps regarding EBGs and CDS. RESULTS: In both the quantitative and qualitative portions of the study, the primary factor driving resistance to CDS was a desire to order studies not supported by EBGs, primarily for the purpose of reducing the clinician's diagnostic uncertainty. CONCLUSIONS: Our results suggest that to enhance the effectiveness of CDS, we must first address the issue of clinician discomfort with diagnostic uncertainty and the role of imaging via educational outreach and ongoing radiologist consultation.

'Us-Versus-Them': Othering in COVID-19 public health behavior compliance.

OBJECTIVE: We explored public perceptions about the COVID-19 pandemic to learn how those attitudes may affect compliance with health behaviors. METHODS: Participants were Central Pennsylvania adults from diverse backgrounds purposively sampled (based on race, gender, educational attainment, and healthcare worker status) who responded to a mixed methods survey, completed between March 25-31, 2020. Four open-ended questions were analyzed, including: "What worries you most about the COVID-19 pandemic?" We applied a pragmatic, inductive coding process to conduct a qualitative, descriptive content analysis of responses. RESULTS: Of the 5,948 respondents, 538 were sampled for this qualitative analysis. Participants were 58% female, 56% with ≥ bachelor's degree, and 50% from minority racial backgrounds. Qualitative descriptive analysis revealed four themes related to respondents' health and societal concerns: lack of faith in others; fears of illness or death; frustration at perceived slow societal response; and a desire for transparency in communicating local COVID-19 information. An "us-versus-them" subtext emerged; participants attributed non-compliance with COVID-19 behaviors to other groups, setting themselves apart from those Others. CONCLUSION: Our study uncovered Othering undertones in the context of the COVID-19 pandemic, occurring between groups of like-minded individuals with behavioral differences in 'compliance' versus 'non-compliance' with public health recommendations. Addressing the 'us-versus-them' mentality may be important for boosting compliance with recommended health behaviors.

Lower Intent to Comply with COVID-19 Public Health Recommendations Correlates to Higher Disease Burden in Following 30 Days.

OBJECTIVES: We sought to determine whether self-reported intent to comply with public health recommendations correlates with future coronavirus disease 2019 (COVID-19) disease burden. METHODS: A cross-sectional, online survey of US adults, recruited by snowball sampling, from April 9 to July 12, 2020. Primary measurements were participant survey responses about their intent to comply with public health recommendations. Each participant's intent to comply was compared with his or her local COVID-19 case trajectory, measured as the 7-day rolling median percentage change in COVID-19 confirmed cases within participants' 3-digit ZIP code area, using public county-level data, 30 days after participants completed the survey. RESULTS: After applying raking techniques, the 10,650-participant sample was representative of US adults with respect to age, sex, race, and ethnicity. Intent to comply varied significantly by state and sex. Lower reported intent to comply was associated with higher COVID-19 case increases during the following 30 days. For every 3% increase in intent to comply with public health recommendations, which could be achieved by improving average compliance by a single point for a single item, we estimate a 9% reduction in new COVID-19 cases during the subsequent 30 days. CONCLUSIONS: Self-reported intent to comply with public health recommendations may be used to predict COVID-19 disease burden. Measuring compliance intention offers an inexpensive, readily available method of predicting disease burden that can also identify populations most in need of public health education aimed at behavior change.

Developing and testing an automated qualitative assistant (AQUA) to support qualitative analysis.

Qualitative research remains underused, in part due to the time and cost of annotating qualitative data (coding). Artificial intelligence (AI) has been suggested as a means to reduce those burdens, and has been used in exploratory studies to reduce the burden of coding. However, methods to date use AI analytical techniques that lack transparency, potentially limiting acceptance of results. We developed an automated qualitative assistant (AQUA) using a semiclassical approach, replacing Latent Semantic Indexing/Latent Dirichlet Allocation with a more transparent graph-theoretic topic extraction and clustering method. Applied to a large dataset of free-text survey responses, AQUA generated unsupervised topic categories and circle hierarchical representations of free-text responses, enabling rapid interpretation of data. When tasked with coding a subset of free-text data into user-defined qualitative categories, AQUA demonstrated intercoder reliability in several multicategory combinations with a Cohen's kappa comparable to human coders (0.62-0.72), enabling researchers to automate coding on those categories for the entire dataset. The aim of this manuscript is to describe pertinent components of best practices of AI/machine learning (ML)-assisted qualitative methods, illustrating how primary care researchers may use AQUA to rapidly and accurately code large text datasets. The contribution of this article is providing guidance that should increase AI/ML transparency and reproducibility.

Perceptions of Diseases of Despair by Members of Rural and Urban High-Prevalence Communities: A Qualitative Study.

Importance: Diseases of despair (ie, mortality or morbidity from suicidality, drug abuse, and alcoholism) were first characterized as increasing in rural White working-class populations in midlife with low educational attainment and associated with long-term economic decline. Excess mortality now appears to be associated with working-class citizens across demographic and geographic boundaries, but no known qualitative studies have engaged residents of rural and urban locales with high prevalence of diseases of despair to learn their perspectives. Objective: To explore perceptions about despair-related illness and potential intervention strategies among diverse community members residing in discrete rural and urban hotspots. Design, Setting, and Participants: In this qualitative study, high-prevalence hotspots for diseases of despair were identified from health insurance claims data in Central Pennsylvania. Four focus groups were conducted with 60 community members in organizations and coalitions from 3 census block group hotspot clusters in the health system between September 2019 and January 2020. Focus groups explored awareness and beliefs about causation and potential intervention strategies. Main Outcomes and Measures: A descriptive phenomenological approach was applied to thematic analysis, and a preliminary conceptual model was constructed to describe how various factors may be associated with perpetuating despair and with public health. Results: In total, 60 adult community members participated in 4 focus groups (44 women, 16 men; 40 White non-Hispanic, 17 Black, and 3 Hispanic/Latino members). Three focus groups with 43 members were held in rural areas with high prevalence of diseases of despair, and 1 focus group with 17 members in a high-prevalence urban area. Four themes emerged with respect to awareness and believed causation of despair-related illness, and participants identified common associated factors, including financial distress, lack of critical infrastructure and social services, deteriorating sense of community, and family fragmentation. Intervention strategies focused around 2 themes: (1) building resilience to despair through better community and organizational coordination and peer support at the local level and (2) encouraging broader state investments in social services and infrastructure to mitigate despair-related illness. Conclusions and Relevance: In this qualitative study, rural and urban community members identified common factors associated with diseases of despair, highlighting the association between long-term political and economic decline and public health and a need for both community- and state-level solutions to address despair. Health care systems participating in addressing community health needs may improve processes to screen for despair (eg, social history taking) and codesign primary, secondary, and tertiary interventions aimed at addressing factors associated with distress. Such actions have taken on greater urgency with the COVID-19 pandemic.

Knowledge, Perceptions, and Preferred Information Sources Related to COVID-19 Among Central Pennsylvania Adults Early in the Pandemic: A Mixed Methods Cross-Sectional Survey.

PURPOSE: To explore public knowledge, understanding of public health recommendations, perceptions, and trust in information sources related to COVID-19. METHODS: A cross-sectional survey of central Pennsylvanian adults evaluated self-reported knowledge, and a convergent, mixed methods design was used to assess beliefs about recommendations, intended behaviors, perceptions, and concerns related to infectious disease risk, and trust of information sources. RESULTS: The survey was completed by 5,948 adults. The estimated probability of correct response for the basic knowledge score, weighted with confidence, was 0.79 (95% CI, 0.79-0.80). Knowledge was significantly higher in patients with higher education and nonminority race. While the majority of respondents reported that they believed following CDC recommendations would decrease the spread of COVID-19 in their community and intended to adhere to them, only 65.2% rated social isolation with the highest level of belief and adherence. The most trusted information source was federal public health websites (42.8%). Qualitative responses aligned with quantitative data and described concerns about illness, epidemiologic issues, economic and societal disruptions, and distrust of the executive branch's messaging. The survey was limited by a lack of minority representation, potential selection bias, and evolving COVID-19 information that may impact generalizability and interpretability. CONCLUSIONS: Knowledge about COVID-19 and intended adherence to behavioral recommendations were high. There was substantial distrust of the executive branch of the federal government, however, and concern about mixed messaging and information overload. These findings highlight the importance of consistent messaging from trusted sources that reaches diverse groups.

The impact of COVID-19-related changes in media consumption on public knowledge: results of a cross-sectional survey of Pennsylvania adults.

OBJECTIVE: During the COVID-19 pandemic, Americans have increasingly relied on internet versus television news. The extent to which this change in health news consumption practice impacts health knowledge is not known. This study investigates the relationship between most trusted information source and COVID-19 knowledge. METHODS: A cross-sectional online survey was sent to a convenience sample from a list of adults on a central Pennsylvania health system's marketing database 25-31 March 2020. Respondents were grouped by their trusted news sources and comparison of respondent COVID-19 knowledge was made between these groups for 5948 respondents. RESULTS: Those who selected government health websites as their most trusted source were more likely to answer COVID-19 questions correctly than those who selected other internet news sources or television news (OR 1.21, p < .05; 1.08, p > .05; and 0.87, p < .05, respectively). Those who used Facebook as an additional source of news in any way were less likely to answer COVID-19 questions correctly than those who did not (OR 0.93, p < .05). CONCLUSIONS: COVID-19 knowledge correlates with trusted news source. To increase public knowledge of COVID-19 in order to maximize information dissemination and compliance with COVID-19-related public health recommendations, those who provide health information should consider use of the public's most trusted sources of information, as well as monitoring and correcting misinformation presented by other sources. Independent content review for accuracy in media may be warranted in public health emergencies to improve knowledge.

Knowledge, Perceptions, and Preferred Information Sources Related to COVID-19 Among Healthcare Workers: Results of a Cross Sectional Survey.

PURPOSE: To compare COVID-19 related knowledge, perceptions, and preferred information sources between healthcare workers and non-healthcare workers. DESIGN: Cross-sectional survey. SETTING: Web-based. SUBJECTS: Convenience sample of Pennsylvanian adults. MEASURES: Primary outcomes were binary responses to 15 COVID-19 knowledge questions weighted by a Likert scale assessing response confidence. ANALYSIS: Generalized linear mixed-effects models to assess comparisons between clinical decision makers (CDM), non-clinical decision makers working in healthcare (non-CDM) and non-healthcare workers (non-HCW). RESULTS: CDMs (n = 91) had higher overall knowledge than non-CDMs (n = 854; OR 1.81 [1.51, 2.17], p < .05). Overall knowledge scores were not significantly different between non-CDMs (n = 854) and non-HCW (n = 4,966; OR 1.03 [0.97, 1.09], p > .05). CONCLUSION: The findings suggest a need for improved education about COVID-19 for healthcare workers who are not clinical decision makers, as they play key roles in patient perceptions and compliance with preventive medicine during primary care visits.

Self-reported influenza and influenza-like symptoms in U.S. adults age 18-64 between September 1, 2019 and April 15, 2020.

BACKGROUND: The Influenza-like Illness Surveillance Network (ILINet) can indicate the presence of novel, widespread community pathogens. Comparing week-to-week reported influenza-like illness percentages may identify the time of year a novel pathogen is introduced. However, changes in health-seeking behavior during the COVID-19 pandemic call in to question the reliability of 2019-2020 ILINet data as a comparison to prior years, potentially rendering this system less reliable as a novel pathogen surveillance tool. Corroboration of trends seen in the 2019-2020 ILINet data lends confidence to the validity of those trends. This study compares predicted versus reported influenza and influenza-like illnesses in vaccinated adults as a surrogate measure of novel pathogen surveillance. METHODS: An online survey was used to ask US adults their influenza vaccination status, whether they were diagnosed with influenza after vaccination, and whether they experienced an influenza-like illness other than flu. RESULTS: Prevalence of self-reported flu diagnosis in adults age 18-64 who received the flu vaccine between September 1, 2019 and April 15, 2020 (n = 3,225) was 5.8 %, while self-reported flu or flu-like illness (without a flu diagnosis) was 17.9 %. CONCLUSION: Flu and flu-like illness in this sample of flu-vaccinated U.S. adults is significantly higher than predicted, consistent with substantially higher ILI's in 2019-20 compared to ILI's from 2018-19, suggesting that the ILI values reported during the COVID-19 pandemic may be appropriate for comparison to prior years.

The D1/D5 Dopamine Partial Agonist PF-06412562 in Advanced-Stage Parkinson's Disease: A Feasibility Study.

BACKGROUND: Current drug treatments have little efficacy in advanced-to-end-stage Parkinson's disease (advPD), yet there are no reports of interventional trials in advPD. D1 dopamine agonists have the potential to provide benefit. OBJECTIVE: To determine the feasibility and safety of the selective D1/D5 dopamine partial agonist PF 06412562 in advPD. METHODS: A two-week, randomized, double blind, crossover phase Ib study in advPD patients compared standard-of-care (SoC) carbidopa/levodopa with PF 06412562. Each week, there was a Day 1 baseline evaluation with overnight levodopa washout, then treatment on Days 2 and 3 with either SoC or PF-06412562 (split dose 25 + 20 mg), followed by discharge on Day 4. Primary endpoints were safety and tolerability. Secondary endpoints were global clinical impression of change (GCI-C) rated by clinicians and caregivers. RESULTS: Eight advPD patients and their caregivers consented to participate and six were randomized (average disease duration: 22 y). None withdrew voluntarily. One participant with baseline Day 1 dehydration, pre-renal kidney injury, and autonomic dysfunction experienced symptomatic and serious hypotension after receiving PF-06412562 in Week 1 and was discontinued from the study. All other adverse events were rated mild (PF-06412562: n = 1, SoC: n = 0), moderate (PF-06412562: n = 1, SoC: n = 1), or severe but non-serious (PF-06412562: n = 3, SoC: n = 2). No clinically meaningful laboratory changes were observed. Among the five participants who completed the study, GCI-C favored PF-06412562 in two per clinicians' and four participants per caregivers' rating. CONCLUSION: PF-06412562 was tolerated in advPD patients. This study provides the feasibility for future safety and efficacy studies in this population with unmet needs.

Public Intent to Comply with COVID-19 Public Health Recommendations.

Stay-at-home orders have been an essential component of coronavirus 2019 (COVID-19) management in the United States. As states start lifting these mandates to reopen the economy, voluntary public compliance with public health recommendations may significantly influence the extent of resurgence in COVID-19 infection rates. Population-level risk from reopening may therefore be predicted from public intent to comply with public health recommendations. We are conducting a global, convergent design mixed-methods survey on public knowledge, perceptions, preferred health information sources, and understanding of and intent to comply with public health recommendations. With over 9,000 completed surveys from every US state and over 70 countries worldwide, to our knowledge this is the largest pandemic messaging study to date. Although the study is still ongoing, we have conducted an analysis of 5,005 US surveys completed from April 9-15, 2020 on public intent to comply with public health recommendations and offer insights on the COVID-19 pandemic-related risk of reopening. We found marked regional differences in intent to follow key public health recommendations. Regional efforts are urgently needed to influence public behavior changes to decrease the risk of reopening, particularly in higher-risk areas with low public intent to comply with preventive health recommendations. [HLRP: Health Literacy Research and Practice. 2020;4(3):e160-e165.].

Clinical Progression of Parkinson's Disease: Insights from the NINDS Common Data Elements.

BACKGROUND/OBJECTIVE: To synchronize data collection, the National Institute of Neurological Disorders and Stroke (NINDS) recommended Common Data Elements (CDEs) for use in Parkinson's disease (PD) research. This study delineated the progression patterns of these CDEs in a cohort of PD patients. METHODS: One hundred-twenty-five PD patients participated in the PD Biomarker Program (PDBP) at Penn State. CDEs, including MDS-Unified PD Rating Scale (UPDRS)-total, questionnaire-based non-motor (-I) and motor (-II), and rater-based motor (-III) subscales; Montreal Cognitive Assessment (MoCA); Hamilton Depression Rating Scale (HDRS); University of Pennsylvania Smell Identification Test (UPSIT); and PD Questionnaire (PDQ-39) were obtained at baseline and three annual follow-ups. Annual change was delineated for PD or subgroups [early = PDE, disease duration (DD) <1 y; middle = PDM, DD = 1-5 y; and late = PDL, DD > 5 y] using mixed effects model analyses. RESULTS: UPDRS-total, -II, and PDQ-39 scores increased significantly, and UPSIT decreased, whereas UPDRS-I, -III, MoCA, and HDRS did not change, over 36 months in the overall PD cohort. In the PDE subgroup, UPDRS-II increased and UPSIT decreased significantly, whereas MoCA and UPSIT decreased significantly in the PDM subgroup. In the PDL subgroup, UPDRS-II and PDQ-39 increased significantly. Other metrics within each individual subgroup did not change. Sensitivity analyses using subjects with complete data confirmed these findings. CONCLUSION: Among CDEs, UPDRS-total, -II, PDQ-39, and UPSIT all are sensitive metrics to track PD progression. Subgroup analyses revealed that these CDEs have distinct stage-dependent sensitivities, with UPSIT for DD < 5 y, PDQ-39 for DD > 5 y, UPDRS-II for early (DD < 1) or later stages (DD > 5).

Incorporation of telehealth into a multidisciplinary ALS Clinic: feasibility and acceptability.

OBJECTIVE: The practice of telehealth in the care of patients with ALS has received little attention, but has the potential to change the multidisciplinary care model. This study was carried out to assess the feasibility and acceptability of telehealth for ALS care via real-time videoconferencing from the clinic to patients' homes. METHODS: Patients and caregivers engaged in live telehealth videoconferencing from their homes with members of a multidisciplinary ALS care team who were located in an ALS clinic, in place of their usual in-person visit to the clinic. Participating patients, their caregivers, and health care providers (HCPs) completed surveys assessing satisfaction with the visit, quality of care, and confidence with the interface. Mixed methods analysis was used for survey responses. RESULTS: Surveys from 11 patients, 12 caregivers, and 15 HCPs were completed. All patients and caregivers, and most HCPs, agreed that the system allowed for good communication, description of concerns, and provision of care recommendations. The most common sentiment conveyed by each group was that telehealth removed the burdens of travel, resulting in lower stress and more comfortable interactions. Caregivers and HCPs expressed more concerns than patients about the ways in which telehealth fell short of in-person care. CONCLUSIONS: Telehealth was generally viewed favourably by ALS patients, caregivers, and multidisciplinary team members. Improvements in technology and in methods to provide satisfactory remote care without person-to-person contact should be explored.