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The ultimate goal of our public health system is to reduce the incidence of disability and premature death. Evidence suggests that, by this standard, the USA falls behind most other developed countries largely as a function of disparities in health outcomes among significant portions of the US population. We present a framework for addressing these disparities that attributes them, not simply to differences in the behavioral and physical risk factors, but to social, environmental, and structural inequities such as poverty, discrimination, toxic physical setting, and the marketing of harmful products. These inequities result from de facto and instituted public policies. An analysis of the NIH research portfolio indicates a relative lack of investment in experimental evaluations of preventive interventions—especially studies targeting disadvantaged populations. Moreover, experimental research on reducing social inequities is almost entirely lacking. A line of research focusing on the drivers of inequities and their dissolution must include experimental evaluation of strategies for getting policies adopted that will reduce inequities. In conclusion, a summary is provided of the types of research that are needed and the challenges involved in conducting the experimental research that is essential for reducing inequities and disparities and, in turn, prolonging life. [ABSTRACT FROM AUTHOR]

Introduction: As the identification of Lewy body dementia (LBD) is often confirmed postmortem, there is a paucity of evidence on the progression of disease antemortem. This study aimed to comprehensively assess the course of LBD over time across cognitive, functional, and neuropsychiatric outcomes using real-world data. Methods: Adults with at least one visit to an Alzheimer's Disease Center with a diagnosis of mild cognitive impairment/dementia (index date), indication of LBD, and at least one follow-up visit were identified in the National Alzheimer's Coordinating Center database (September 2005–June 2020). Participant characteristics, medication use, comorbidities, and changes in outcomes were assessed over a 5-year follow-up period and stratified by disease severity based on the Clinical Dementia Rating (CDR®) Dementia Staging Instrument-Sum of Boxes (CDR-SB) score at index. Results: A total of 2052 participants with LBD (mean age at index 73.4 years) were included (mild, 219; moderate, 988; severe, 845). Mean annualized increase over 5 years was 0.9 points for CDR-Global Score, 5.6 points for CDR-SB, 10.4 points for the Functional Activities Questionnaire, and 2.0 points for the Neuropsychiatric Inventory-Questionnaire. Disease progression was greater among participants with moderate and severe LBD at index compared with those with mild LBD. Conclusion: Participants with LBD experienced decline across all outcomes over time, and impairment increased with disease severity. Findings highlight the substantial clinical burden associated with LBD and the importance of earlier diagnosis and effective treatment. Further research is needed to understand the predictors of cognitive and functional decline in LBD which may help inform clinical trials. [ABSTRACT FROM AUTHOR]

Background: PRESENCE was a Phase 2 trial assessing mevidalen for symptomatic treatment of Lewy body dementia (LBD). Participants received daily doses (10, 30, or 75 mg) of mevidalen (LY3154207) or placebo for 12 weeks. Objective: To evaluate if frequent cognitive and motor tests using an iPad app and wrist-worn actigraphy to track activity and sleep could detect mevidalen treatment effects in LBD. Methods: Of 340 participants enrolled in PRESENCE, 238 wore actigraphy for three 2-week periods: pre-, during, and post-intervention. A subset of participants (n = 160) enrolled in a sub-study using an iPad trial app with 3 tests: digital symbol substitution (DSST), spatial working memory (SWM), and finger-tapping. Compliance was defined as daily test completion or watch-wearing ≥23 h/day. Change from baseline to week 12 (app) or week 8 (actigraphy) was used to assess treatment effects using Mixed Model Repeated Measures analysis. Pearson correlations between sensor-derived features and clinical endpoints were assessed. Results: Actigraphy and trial app compliance was > 90% and > 60%, respectively. At baseline, daytime sleep positively correlated with Epworth Sleepiness Scale score (p < 0.01). Physical activity correlated with improvement on Movement Disorder Society –Unified Parkinson Disease Rating Scale (MDS-UPDRS) part II (p < 0.001). Better scores of DSST and SWM correlated with lower Alzheimer Disease Assessment Scale –Cognitive 13-Item Scale (ADAS-Cog13) (p < 0.001). Mevidalen treatment (30 mg) improved SWM (p < 0.01), while dose-dependent decreases in daytime sleep (10 mg: p < 0.01, 30 mg: p < 0.05, 75 mg: p < 0.001), and an increase in walking minutes (75 mg dose: p < 0.001) were observed, returning to baseline post-intervention. Conclusion: Devices used in the LBD population achieved adequate compliance and digital metrics detected statistically significant treatment effects. [ABSTRACT FROM AUTHOR]

To describe the trends in epidemiology, healthcare resource use (HCRU), and costs associated with Lewy body dementia (LBD), dementia with Lewy bodies (DLB), and Parkinson's disease dementia (PDD) in the United States. This retrospective study used administrative claims data for Medicare fee-for-service (2010–2018) and commercially-insured beneficiaries (2010–2017). The annual prevalence and incidence were calculated among the Medicare beneficiaries by dividing the number of prevalent or incident LBD, DLB, and PDD patients by the total eligible population of that calendar year. Baseline patient characteristics, HCRU, and costs over time were described for Medicare and commercially insured patients with continuous health plan enrollment for ≥12 months before and ≥24 months after first cognitive impairment (CI) diagnosis. From 2010 to 2016, the incidence and prevalence rates of LBD among Medicare beneficiaries ranged from 0.21%–0.18% and 0.90%–0.83%, respectively. Of 9019 Medicare patients with LBD who met other inclusion criteria, 4796 (53.2%) had DLB and 4223 (46.8%) had PDD. The mean age was 78 years and the mean Charlson Comorbidity Index score was 1.6. On average, patients with LBD incurred $18,309 in medical costs during the 1-year pre-diagnosis and $29,174 and $22,814 at years 1 and 5 after diagnosis, respectively. The main cost drivers were inpatient and outpatient visits. Similar trends were observed for DLB and PDD as well as for commercially-insured patients. Our findings highlight the substantial epidemiological and economic burden across the LBD spectrum and underscore a high unmet need for effective treatments to improve patient outcomes. [ABSTRACT FROM AUTHOR]

Background: Mevidalen is a selective positive allosteric modulator (PAM) of the dopamine D1 receptor subtype. Objective: To assess the safety and efficacy of mevidalen for treatment of cognition in patients with Lewy body dementia (LBD). Methods: PRESENCE was a phase 2, 12‐week study in participants with LBD (N = 344) randomly assigned (1:1:1:1) to daily doses of mevidalen (10, 30, or 75 mg) or placebo. The primary outcome measure was change from baseline on Cognitive Drug Research Continuity of Attention (CoA) composite score. Secondary outcomes included Alzheimer's Disease Assessment Scale‐Cognitive Subscale 13 (ADAS‐cog13), Movement Disorder Society‐Unified Parkinson's Disease Rating Scale (MDS‐UPDRS), and Alzheimer's Disease Cooperative Study‐Clinical Global Impression of Change (ADCS‐CGIC). Numerous safety measures were collected. Results: Mevidalen failed to meet primary or secondary cognition endpoints. Mevidalen resulted in significant, dose‐dependent improvements of MDS‐UPDRS total score (sum of Parts I−III, 10 mg P < 0.05, 30 mg P < 0.05, 75 mg P < 0.01, compared to placebo). The 30 mg and 75 mg mevidalen doses significantly improved ADCS‐CGIC scores compared to placebo (minimal or better improvement: 30 mg P < 0.01, 75 mg P < 0.01; moderate or better improvement: 30 mg P < 0.05, 75 mg P < 0.001). Increases in blood pressure, adverse events, and cardiovascular serious adverse events were most pronounced at the 75 mg dose. Conclusions: Mevidalen harnesses a novel mechanism of action that improves motor symptoms associated with LBD on top of standard of care while improving or not worsening non‐motor symptoms associated with traditional dopaminergic therapy. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society [ABSTRACT FROM AUTHOR]

Mevidalen (LY3154207) is a positive allosteric modulator of the dopamine D1 receptor that enhances the affinity of dopamine for the D1 receptor. The safety, tolerability, motor effects, and pharmacokinetics of mevidalen were studied in patients with Parkinson disease. Mevidalen or placebo was given once daily for 14 days to 2 cohorts of patients (cohort 1, 75 mg; cohort 2, titration from 15 to 75 mg). For both cohorts, the median time to maximum concentration for mevidalen plasma concentration was about 2 hours, the apparent steady‐state clearance was 20–25 L/h, and mevidalen plasma concentrations were similar between the 1st and 14th administration in cohort 1, indicating minimal accumulation upon repeated dosing. Mevidalen was well tolerated, and most treatment‐emergent adverse events were mild. Blood pressure and pulse rate increased when taking mevidalen, but there was considerable overlap with patients taking placebo, and vital signs normalized with repeated dosing. In the Movement Disorder Society–United Parkinson's Disease Rating Scale, all patients taking mevidalen showed a better motor examination sub‐score on day 6 compared to only some patients in the placebo group. These data support examining mevidalen for symptomatic treatment of patients with Parkinson disease and Lewy body dementia. [ABSTRACT FROM AUTHOR]

Background: This paper describes the development and psychometric evaluation of a behavioral assessment instrument primarily intended for use with workgroups in any type of organization. The instrument was developed based on the Nurturing Environments framework which describes four domains important for health, well-being, and productivity; minimizing toxic social interactions, teaching and reinforcing prosocial behaviors, limiting opportunities for problem behaviors, and promoting psychological flexibility. The instrument is freely available to use and adapt under a CC-BY license and intended as a tool that is easy for any group to use and interpret to identify key behaviors to improve their psychosocial work environment.Methods: Questionnaire data of perceived frequency of behaviors relevant to nurturance were collected from nine different organizations in Sweden. Data were analyzed using confirmatory factor analysis, Rasch analysis, and correlations to investigate relationships with relevant workplace measures.Results: The results indicate that the 23-item instrument is usefully divided in two factors, which can be described as risk and protective factors. Toxic social behaviors make up the risk factor, while the protective factor includes prosocial behavior, behaviors that limit problems, and psychological flexibility. Rasch analysis showed that the response categories work as intended for all items, item fit is satisfactory, and there was no significant differential item functioning across age or gender. Targeting indicates that measurement precision is skewed towards lower levels of both factors, while item thresholds are distributed over the range of participant abilities, particularly for the protective factor. A Rasch score table is available for ordinal to interval data transformation.Conclusions: This initial analysis shows promising results, while more data is needed to investigate group-level measurement properties and validation against concrete longitudinal outcomes. We provide recommendations for how to work in practice with a group based on their assessment data, and how to optimize the measurement precision further. By using a two-dimensional assessment with ratings of both frequency and perceived importance of behaviors the instrument can help facilitate a participatory group development process. The Group Nurturance Inventory is freely available to use and adapt for both commercial and non-commercial use and could help promote transparent assessment practices in organizational and group development. [ABSTRACT FROM AUTHOR]

In 2019, the Lewy Body Dementia Association formed an Industry Advisory Council to bring together a collaborative group of stakeholders with the goal of accelerating clinical research into Lewy body dementia treatments. At the second annual meeting of the Industry Advisory Council, held virtually on June 18, 2020, the key members presented ongoing and planned efforts toward the council's goals. The meeting also featured a discussion about the effects of the COVID-19 pandemic on Lewy body dementia clinical research, lessons learned from that experience, and how those lessons can be applied to the design and conduct of future clinical trials. This report provides a brief summary of the meeting proceedings with a focus on efforts to improve and adapt future Lewy body dementia clinical research. [ABSTRACT FROM AUTHOR]

Background: Characterizing patients with Parkinson's disease (PD) and cognitive impairment is important toward understanding their natural history. Objective: Understand clinical, treatment, and cost characteristics of patients with PD pre- and post-cognitive impairment (memory loss/mild cognitive impairment/dementia or dementia treatment) recognition. Methods: 2,711 patients with PD newly diagnosed with cognitive impairment (index) were identified using administrative claims data. They were matched (1:1) on age and gender to patients with PD and no cognitive impairment (controls). These two cohorts were compared on patient characteristics, healthcare resource utilization, and total median costs for 3 years pre- and post-index using Chi-square tests, t-tests, and Wilcoxon rank-sum tests. Logistic regression was used to identify factors predicting cognitive impairment. Results: Comorbidity indices for patients with cognitive impairment increased during the 6-year study period, especially after the index. Enrollment in Medicare Advantage Prescription Drug plans vs. commercial (OR = 1.60), dual Medicare/Medicaid eligibility (OR = 1.36), cerebrovascular disease (OR = 1.24), and PD medication use (OR = 1.46) were associated with a new cognitive impairment diagnosis (all p < 0.05). A greater proportion of patients with cognitive impairment had hospitalizations and emergency department visits and higher median total healthcare costs than controls for each year pre- and post-index. Conclusion: In patients with PD newly diagnosed with cognitive impairment, comorbidity burden, hospitalizations, emergency department visits, and total costs peaked 1-year pre- and post-identification. These data coupled with recommendations for annual screening for cognitive impairment in PD support the early diagnosis and management of cognitive impairment in order to optimize care for patients and their caregivers. [ABSTRACT FROM AUTHOR]

Activation of the brain dopamine D1 receptor has attracted attention because of its promising role in neuropsychiatric diseases. Although efforts to develop D1 agonists have been challenging, a positive allosteric modulator (PAM), represents an attractive approach with potential better drug‐like properties. Phase 1 single‐ascending‐dose (SAD; NCT03616795) and multiple‐ascending‐dose (MAD; NCT02562768) studies with the D1PAM mevidalen (LY3154207) were conducted with healthy subjects. There were no treatment‐related serious adverse events (AEs) in these studies. In the SAD study, 25‐200 mg administered orally showed dose‐proportional pharmacokinetics (PK) and acute dose‐related increases in systolic blood pressure (SBP) and diastolic blood pressure DBP) and pulse rate at doses ≥ 75 mg. AE related to central activation were seen at doses ≥ 75 mg. At 25 and 75 mg, central penetration of mevidalen was confirmed by measurement of mevidalen in cerebrospinal fluid. In the MAD study, once‐daily doses of mevidalen at 15‐150 mg for 14 days showed dose‐proportional PK. Acute dose‐dependent increases in SBP, DBP, and PR were observed on initial administration, but with repeated dosing the effects diminished and returned toward baseline levels. Overall, these findings support further investigation of mevidalen as a potential treatment for a range of neuropsychiatric disorders. [ABSTRACT FROM AUTHOR]

Objective: The expanding power and accessibility of personal technology provide an opportunity to reduce burdens and costs of traditional clinical site‐centric therapeutic trials in Parkinson's disease and generate novel insights. The value of this approach has never been more evident than during the current COVID‐19 pandemic. We sought to (1) establish and implement the infrastructure for longitudinal, virtual follow‐up of clinical trial participants, (2) compare changes in smartphone‐based assessments, online patient‐reported outcomes, and remote expert assessments, and (3) explore novel digital markers of Parkinson's disease disability and progression. Methods: Participants from two recently completed phase III clinical trials of inosine and isradipine enrolled in Assessing Tele‐Health Outcomes in Multiyear Extensions of Parkinson's Disease trials (AT‐HOME PD), a two‐year virtual cohort study. After providing electronic informed consent, individuals complete annual video visits with a movement disorder specialist, smartphone‐based assessments of motor function and socialization, and patient‐reported outcomes online. Results: From the two clinical trials, 226 individuals from 42 states in the United States and Canada enrolled. Of these, 181 (80%) have successfully downloaded the study's smartphone application and 161 (71%) have completed patient‐reported outcomes on the online platform. Interpretation: It is feasible to conduct a large‐scale, international virtual observational study following the completion of participation in brick‐and‐mortar clinical trials in Parkinson's disease. This study, which brings research to participants, will compare established clinical endpoints with novel digital biomarkers and thereby inform the longitudinal follow‐up of clinical trial participants and design of future clinical trials. [ABSTRACT FROM AUTHOR]

This paper describes the culture and components of the PAX Good Behavior Game and offers it as one model for how to enhance the well-being of populations through the diffusion of nurturing practices into several venues of society. The PAX components, also known as evidence-based kernels, are proposed to be useful in classrooms, families, organizations, criminal justice, and in improving public discussion and government. Kernels affect behavior in the short- and long-term through combinations of antecedents, reinforcers, relational networks, and physiological effects. Identifying common strategies, tools, and clear targets of change is suggested as a way to work towards evolving freely available evidence-based tools that can be combined to improve social conditions in multiple contexts. [ABSTRACT FROM AUTHOR]

Background: There is rising interest in remote clinical trial assessments, particularly in the setting of the COVID-19 pandemic. Objective: To demonstrate the feasibility, reliability, and value of remote visits in a phase III clinical trial of individuals with Parkinson's disease. Methods: We invited individuals with Parkinson's disease enrolled in a phase III clinical trial (STEADY-PD III) to enroll in a sub-study of remote video-based visits. Participants completed three remote visits over one year within four weeks of an in-person visit and completed assessments performed during the remote visit. We evaluated the ability to complete scheduled assessments remotely; agreement between remote and in-person outcome measures; and opinions of remote visits. Results: We enrolled 40 participants (mean (SD) age 64.3 (10.4), 29% women), and 38 (95%) completed all remote visits. There was excellent correlation (ICC 0.81–0.87) between remote and in-person patient-reported outcomes, and moderate correlation (ICC 0.43–0.51) between remote and in-person motor assessments. On average, remote visits took around one quarter of the time of in-person visits (54 vs 190 minutes). Nearly all participants liked remote visits, and three-quarters said they would be more likely to participate in future trials if some visits could be conducted remotely. Conclusion: Remote visits are feasible and reliable in a phase III clinical trial of individuals with early, untreated Parkinson's disease. These visits are shorter, reduce participant burden, and enable safe conduct of research visits, which is especially important in the COVID-19 pandemic. [ABSTRACT FROM AUTHOR]

Background: The rise of direct-to-consumer genetic testing has enabled many to learn of their possible increased risk for rare diseases, some of which may be suitable for gene-targeted therapies. However, recruiting a large and representative population for rare diseases or genetically defined sub-populations of common diseases is slow, difficult, and expensive. Objective: To assess the feasibility of recruiting and retaining a cohort of individuals who carry a genetic mutation linked to Parkinson's disease (G2019S variant of LRRK2); to characterize this cohort relative to the characteristics of traditional, in-person studies; and to evaluate this model's ability to create an engaged study cohort interested in future clinical trials of gene-directed therapies. Methods: This single-site,3-year national longitudinal observational study will recruit between 250 to 350 LRRK2 carriers without Parkinson's disease and approximately 50 with the condition. Participants must have undergone genetic testing by the personal genetics company, 23andMe, Inc., have knowledge of their carrier status, and consent to be contacted for research studies. All participants undergo standardized assessments, including video-based cognitive and motor examination, and complete patient-reported outcomes on an annual basis. Results: 263 individuals living in 33 states have enrolled. The cohort has a mean (SD) age of 56.0 (15.9) years, 59% are female, and 76% are of Ashkenazi Jewish descent. 233 have completed the baseline visit: 47 with self-reported Parkinson's disease and 186 without. Conclusions: This study establishes a promising model for developing a geographically dispersed and well-characterized cohort ready for participation in future clinical trials of gene-directed therapies. [ABSTRACT FROM AUTHOR]

Despite significant progress in research on the treatment and prevention of psychological, behavioral, and health problems, the translation of this knowledge into population-wide benefit remains limited. This paper reviews the state of America's children and families, highlighting the influence of stressful contextual and social conditions on child and family well-being and the concentration of disadvantage in numerous neighborhoods and communities throughout the nation. It then briefly reviews the progress that has been made in pinpointing policies that can reduce stressful contextual conditions such as poverty, discrimination, and the marketing of unhealthful foods and substances. It also describes numerous family and school interventions that have proven benefit in preventing psychological and behavioral problems as diverse as tobacco, alcohol, and other drug use; depression; antisocial behavior; academic failure; obesity prevention; and early childbearing. We argue that progress in translating existing knowledge into widespread benefit will require a nationwide effort to intervene comprehensively in neighborhoods and communities of concentrated disadvantage. We present a strategic plan for how such an effort could be organized. The first step in this organizing would be the creation of a broad and diverse coalition of organizations concerned with advancing public health and well-being. Such a coalition could increase public support both for the policies needed to focus on these disadvantaged areas and the research needed to incrementally improve our ability to help these areas. [ABSTRACT FROM AUTHOR]

This paper examines the misalignment between modern human society and certain male phenotypes, a misalignment that has been highlighted and explored in great detail in the work of Tom Dishion. We begin by briefly enumerating the ongoing developmental difficulties of many boys and young men and how these difficulties affect them and those around them. We then suggest that the qualities that have been advantageous for men and their families in our earlier evolution but that are often no longer functional in modern society are a source of these problems. Finally, we provide a brief review of prevention programs that can contribute to preventing this type of problematic development and eliciting more prosocial behavior from at-risk boys and men. We conclude with an overview of research and policy priorities that could contribute to reducing the proportion of boys and young men who experience developmental difficulties in making their way in the world. [ABSTRACT FROM AUTHOR]

Background: There is limited understanding of the feasibility of conducting long-term research among undiagnosed (pre-symptomatic) adults at risk to develop Huntington disease (HD), while protecting their emotional well-being and safety. Objective: To assess pre-specified events pertaining to emotional well-being, safety, and feasibility among healthy consenting adults at risk for developing HD who have chosen not to undergo genetic testing. Methods: PHAROS research participants prospectively reported the occurrence of events pertaining to psychological distress (psychiatric evaluations, depression, suicidality) and feasibility (maintaining confidentiality, study attrition). PHAROS enrolled 1001 participants. Results: Events pertaining to psychological distress were reported by 35% of participants. The most common events included heightened suicide risk (26%), new onset depression (12%), and new mental health evaluation (9%); all occurred significantly more frequently among participants with expanded trinucleotide CAG repeats (≥37). Five deaths occurred, none related to suicide. Forty-one percent of participants reported self-disclosure of their HD at-risk status, and 15% reported that someone else (usually a family member) had done so. Confidentiality of CAG test results was maintained by investigators. The withdrawal rate was largely uniform over the study period and did not differ significantly by gender or CAG status. Conclusions: The potentially vulnerable research participants in PHAROS showed good emotional tolerability and safety. Individual CAG data were not disclosed, and confidentiality about disclosure of at-risk HD status was well maintained by others (family, friends, etc.). Long-term research participation of adults at risk for HD who choose not to undergo pre-symptomatic DNA testing is well tolerated, safe and feasible. [ABSTRACT FROM AUTHOR]

Background: The appropriate timing of dopaminergic treatment initiation in Parkinson's disease (PD) remains a matter of debate. The primary objective of this study was to determine whether earlier initiation of treatment was associated with less worsening of total UPDRS scores over 48 months. Methods: We performed a secondary analysis of data from the CALM‐PD (Comparison of the Agonist Pramipexole With Levodopa on Motor Complications of Parkinson's Disease) trial to examine the associations between years since diagnosis and 48‐month changes in total and component UPDRS scores, Parkinson's Disease Quality of Life Scale (PDQUALIF) score, and the EuroQol‐5D visual analogue scale (VAS) score. Results: There were no associations between years since PD diagnosis and 48‐month changes in total UPDRS, component UPDRS scores, PDQUALIF score, or EuroQol‐5D VAS score. Conclusion: Earlier treatment was not associated with improved long‐term outcomes in this secondary analysis. Prospective studies are required to determine the appropriate timing of initiation of dopaminergic treatment to inform clinical practice. [ABSTRACT FROM AUTHOR]

Cross-sectional, longitudinal, and experimental studies have found a link between youth exposure to cigarette marketing and youth initiation of smoking. These decisive research findings led to regulations of cigarette marketing to youth-including no television or radio ads, prohibitions on the use of cartoons, bans on transit and billboard advertisements, and disallowing tobacco brand sponsorships of sporting events or concerts. Similar products that may cause more harm than benefits include alcohol, electronic cigarettes, and opioids. We review the evidence linking problematic use of these products with exposure to marketing and discuss standards for assessing the potential harmfulness of marketing. We next address how public health agencies might apply regulatory principles to these harmful products similar to those applied to cigarette advertising, in the advancement of public health. [ABSTRACT FROM AUTHOR]

Reward & Reminder has been a component of community-based preventive efforts against sales of substances (e.g., tobacco) to youths. To date, there has not been a randomized trial of Reward & Reminder as a stand-alone prevention program targeting youth access to alcohol. In this study, we address that gap. Data were collected as part of a randomized trial of a school- and community-based prevention program. Our analysis included 23 vendors in control communities and 33 vendors in intervention communities. We visited each vendor at least two times, and vendors in intervention communities received the Reward & Reminder protocol. Using McNemar's test, which evaluates the degree to which the outlets in each condition moved to a different cell in the contingency table from the first visit to the second (i.e., from yes to no or vice versa), we found that the control outlets did not change (all p values were non-significant). In contrast, the intervention outlets were significantly more likely to ask for identification (p <.05) and significantly less willing to sell alcohol to young-looking project confederates (p <.05); Asked for Age did not change. We conclude that Reward & Reminder could assist in preventing underage access to alcohol. [ABSTRACT FROM AUTHOR]

The authors present a critical analysis of Fiedler's Contingency Model of Leadership Effectiveness. These criticisms are discussed and various solutions are suggested. [ABSTRACT FROM AUTHOR]

Type II translational research tends to emphasize getting evidence-based programs implemented in real world settings. To fully realize the aspirations of prevention scientists, we need a broader strategy for translating knowledge about human wellbeing into population-wide improvements in wellbeing. Far-reaching changes must occur in policies and cultural practices that affect the quality of family, school, workplace, and community environments. This paper describes a broad cultural movement, not unlike the tobacco control movement, that can make nurturing environments a fundamental priority of public policy and daily life, thereby enhancing human wellbeing far beyond anything achieved thus far. [ABSTRACT FROM AUTHOR]

Background and Introduction: Delivering care through telemedicine directly into the patient's home is increasingly feasible, valuable, and beneficial. However, qualitative data on how patients' and physicians' perceive these virtual house calls are lacking. We conducted a qualitative analysis of perceptions of these visits for Parkinson's disease to (1) determine how patients and physicians perceive virtual visits and (2) identify components contributing to positive and negative perceptions. Materials and Methods: Qualitative survey data were collected from patients and physicians during a 12-month randomized controlled trial of virtual house calls for Parkinson's disease. Data from 149 cases were analyzed using case-based qualitative content analysis and quantitative sentiment analysis techniques. Results: Positive and negative perceptions of virtual visits were driven by three themes: (1) personal benefits of the virtual visit, (2) perceived quality of care, and (3) perceived quality of interpersonal engagement. In general, participants who identified greater personal benefit, high quality of care, and good interpersonal engagement perceived visits positively. Technical problems with the software were commonly mentioned. The sentiment analysis for patients was strongly favorable (+2.5) and moderately favorable for physicians (+0.8). Physician scores were lowest (−0.3) for the ability to perform a detailed motor examination remotely. Discussion: Patients and providers generally view telemedicine favorably, but individual experiences are dependent on technical issues. Conclusions: Satisfaction with and effectiveness of remote care will likely increase as common technical problems are resolved. [ABSTRACT FROM AUTHOR]

Background: In Huntington's disease, 60% of the variance in onset age is not explained by the huntingtin gene mutation. Huntington's disease onset was earlier in caffeine users.Objective: The objective of this study was to assess the relationship of lifestyle factors with motor phenoconversion among persons at risk for Huntington's disease.Methods: The associations of motor phenoconversion and exposure to selected lifestyle and health factors were examined using Cox proportional hazards analyses adjusted for age, gender, and repeat length.Results: Of 247 participants, 36 (14.6%) phenoconverted. Mean follow-up was 4.2 years. Greater caffeinated soda use was associated with an increased hazard of phenoconversion: moderate use hazard ratio 2.26 (95% confidence interval 0.59-8.71), high use hazard ratio 4.05 (95% confidence interval 1.18-13.96).Conclusions: Huntington's disease onset was earlier among consumers of caffeinated soda, but not other caffeinated beverages. This finding may be spurious or not related to caffeine. © 2018 International Parkinson and Movement Disorder Society. [ABSTRACT FROM AUTHOR]

Background: Challenges in clinical trial recruitment threaten the successful development of improved therapies. This is particularly true in Parkinson's disease (PD) studies of disease modification where the population of interest is difficult to find and study design is more complex. Objective: This paper seeks to understand how STEADY PD III, a National Institute of Neurological Disorders and Stroke (NINDS) funded phase 3 trial evaluating the efficacy of isradipine as a disease modifying agent for PD, was able to recruit their full target population 6 months ahead of schedule. Methods: STEADY PD III aimed to enroll 336 individuals with early stage idiopathic PD within 18 months using 57 sites across the United States and Canada. The study included a 10% NIH minority recruitment goal. Eligible participants agreed to be followed for up to 36 months, complete 12 in-person visits and 4 telephone visits. A Recruitment Committee of key stakeholders was critical in the development of a comprehensive recruitment strategy involving: multi-modal outreach, protocol modifications and comprehensive site selection and activation. Efforts to increase site-specific minority recruitment strategies were encouraged through additional funding. Results:Atotal of 336 individuals, including 34 minorities, were enrolled within 12 months - 6 months ahead of the projected timeline. Quantitative analysis of recruitment activity questionnaires found that of the sites that completed them (n = 54), (20.4%) met goals, (24.1%) exceeded goals, and (55.6%) fell below projected goals. Referral sources completed at time of screening indicate top four study referral sources as: site personnel (53.8%); neurologists (24%); Fox Trial Finder (10.2%); and communications from The Michael J. Fox Foundation (3.9%). Conclusions:STEADYPDIII serves as an important example of methods that can be used to increase clinical trial recruitment. This research highlights a continued need to improve site infrastructure and dedicate more resources to increased participation of minorities in clinical research. [ABSTRACT FROM AUTHOR]

Objective To describe the rationale for a novel study design and baseline characteristics of a disease-modifying trial of isradipine 10 mg daily in early Parkinson disease ( PD). Methods STEADY- PDIII is a 36-month, Phase 3, parallel group, placebo-controlled study of the efficacy of isradipine 10 mg daily in 336 participants with early PD as measured by the change in the Unified Parkinson Disease Rating Scale ( UPDRS) Part I- III score in the practically defined ON state. Secondary outcome measures include clinically meaningful measures of disability progression in early PD: (1) Time to initiation and utilization of dopaminergic therapy; (2) Time to onset of motor complications; (3) Change in nonmotor disability. Exploratory measures include global measures of functional disability, quality of life, change in the ambulatory capacity, cognitive function, and pharmacokinetic analysis. Rationale for the current design and alternative design approaches are discussed. Results The entire cohort of 336 participants was enrolled at 55 Parkinson Study Group sites in North America. The percentage of male participants were 68.5% with a mean age of 61.9 years (sd 9.0), mean Hoehn and Yahr stage of 1.7 (sd 0.5), mean UPDRS total of 23.1 (sd 8.6), and Mo CA of 28.1 (sd 1.4). Interpretation STEADY- PD III has a novel and innovative design allowing for the determination of longer duration benefits on clinically relevant outcomes in a relatively small cohort on top of the benefit derived from symptomatic therapy. Baseline characteristics are similar to those in previously enrolled de novo PD trials. This study represents a unique opportunity to evaluate the potential impact of a novel therapy to slow progression of PD disability and provide clinically meaningful benefits. [ABSTRACT FROM AUTHOR]

While the legalization of marijuana for medical and recreational use has raised concerns about potential influences on marijuana use and beliefs among youth, few empirical studies have addressed this issue. We examined the association between medical marijuana patients and licensed growers per 1000 population in 32 Oregon counties from 2006 to 2015, and marijuana use among youth over the same period. We obtained data on registered medical marijuana patients and licensed growers from the Oregon Medical Marijuana Program and we obtained data on youth marijuana use, perceived parental disapproval, and demographic characteristics from the Oregon Healthy Teens Survey. Across 32 Oregon counties, the mean rate of marijuana patients per 1000 population increased from 2.9 in 2006 to 18.3 in 2015, whereas the grower rate increased from 3.8 to 11.9. Results of multi-level analyses indicated significant positive associations between rates of marijuana patients and growers per 1000 population and the prevalence of past 30-day marijuana use, controlling for youth demographic characteristics. The marijuana patient and grower rates were also inversely associated with parental disapproval of marijuana use, which decreased from 2006 to 2015 and acted as a mediator. These findings suggest that a greater number of registered marijuana patients and growers per 1000 population in Oregon counties was associated with a higher prevalence of marijuana use among youth from 2006 to 2015, and that this relationship was partially attributable to perceived norms favorable towards marijuana use. [ABSTRACT FROM AUTHOR]

In many ways, the care of individuals with Parkinson disease does not meet their needs. Despite the documented benefits of receiving care from clinicians with Parkinson disease expertise, many patients (if not most) do not. Moreover, current care models frequently require older individuals with impaired mobility, cognition, and driving ability to be driven by overburdened caregivers to large, complex urban medical centers. Moving care to the patient's home would make Parkinson disease care more patient-centered. Demographic factors, including aging populations, and social factors, such as the splintering of the extended family, will increase the need for home-based care. Technological advances, especially the ability to assess and deliver care remotely, will enable the transition of care back to the home. However, despite its promise, this next generation of home-based care will have to overcome barriers, including outdated insurance models and a technological divide. Once these barriers are addressed, home-based care will increase access to high quality care for the growing number of individuals with Parkinson disease. © 2016 International Parkinson and Movement Disorder Society. [ABSTRACT FROM AUTHOR]

Background: Delivering specialty care remotely directly into people's homes can enhance access for and improve the healthcare of individuals with chronic conditions. However, evidence supporting this approach is limited. Materials and Methods: Connect.Parkinson is a randomized comparative effectiveness study that compares usual care of individuals with Parkinson's disease in the community with usual care augmented by virtual house calls with a Parkinson's disease specialist from 1 of 18 centers nationally. Individuals in the intervention arm receive four virtual visits from a Parkinson's disease specialist over 1 year via secure, Web-based videoconferencing directly into their homes. All study activities, including recruitment, enrollment, and assessments, are conducted remotely. Here we report on interest, feasibility, and barriers to enrollment in this ongoing study. Results: During recruitment, 11,734 individuals visited the study's Web site, and 927 unique individuals submitted electronic interest forms. Two hundred ten individuals from 18 states enrolled in the study from March 2014 to June 2015, and 195 were randomized. Most participants were white (96%) and college educated (73%). Of the randomized participants, 73% had seen a Parkinson's disease specialist within the previous year. Conclusions: Among individuals with Parkinson's disease, national interest in receiving remote specialty care directly into the home is high. Remote enrollment in this care model is feasible but is likely affected by differential access to the Internet. [ABSTRACT FROM AUTHOR]

Remote assessments of individuals with a neurological disease via telemedicine have the potential to reduce some of the burdens associated with clinical care and research participation. We aim to evaluate the feasibility of conducting the Montreal Cognitive Assessment remotely in individuals with movement disorders. A pilot study derived from two telemedicine trials was conducted. In total, 17 individuals with movement disorders (8 with Parkinson disease and 9 with Huntington disease) had Montreal Cognitive Assessment examinations evaluated in-person and remotely via web-based video conferencing to primarily determine feasibility and potential barriers in its remote administration. Administering the Montreal Cognitive Assessment remotely in a sample of movement disorder patients with mild cognitive impairment is feasible, with only minor common complications associated with technology, including delayed sound and corrupted imaging for participants with low connection speeds. The Montreal Cognitive Assessment has the potential to be used in remote assessments of patients and research participants with movement disorders. [ABSTRACT FROM AUTHOR]

Behavior analysis has produced a robust theoretical analysis of the contingencies involved in cultural evolution. Yet, thus far, the empirical yield of this work remains quite limited. With this paper, I attempt to provide specific examples of the ways to advance an experimental analysis of the contingencies involved in cultural evolution. I begin with a review of the theoretical analyses developed by behavior analysts and other contextually oriented scientists. Next, I submit that, if the goal of our science is both predicting and influencing cultural phenomena, we must produce experimental analyses of the impact of meta-contingencies on organizations' practices. There is no more pressing reason for doing this than the threat of climate change posed by the continuing growth in human use of fossil fuels. Therefore, the paper provides an analysis of the contingencies influencing organizational practices now affecting continued use of fossil fuels and the contingencies for organizations seeking to prevent their use. One concrete step to advance a science of cultural change relevant to climate change would be to create a database of organizations that are promoting vs. working to prevent fossil fuel consumption and the consequences that seem to maintain their practices. I call for experimental analysis of the impact of altering consequences for these practices and for experimental analyses of interventions intended to change the norms, values, and behavior of organizational leaders who can influence fossil fuel consumption. I then discuss the role of prosocial behavior and values in affecting behavior relevant to reducing fossil fuel consumption because the empirical evidence shows that prosociality favors more 'green' behavior. Recent advances in prevention research have identified interventions to promote prosociality, but we need experimental analyses of how advocacy organizations can be more effective in getting these interventions widely adopted. [ABSTRACT FROM AUTHOR]

Background: The Unified Huntington's Disease Rating Scale (UHDRS) is the principal means of assessing motor impairment in Huntington disease but is subjective and generally limited to in-clinic assessments. Objective: To evaluate the feasibility and ability of wearable sensors to measure motor impairment in individuals with Huntington disease in the clinic and at home. Methods: Participants with Huntington disease and controls were asked to wear five accelerometer-based sensors attached to the chest and each limb for standardized, in-clinic assessments and for one day at home. A second chest sensor was worn for six additional days at home. Gait measures were compared between controls, participants with Huntington disease, and participants with Huntington disease grouped by UHDRS total motor score using Cohen's d values. Results: Fifteen individuals with Huntington disease and five controls completed the study. Sensor data were successfully captured from 18 of the 20 participants at home. In the clinic, the standard deviation of step time (time between consecutive steps) was increased in Huntington disease (p < 0.0001; Cohen's d = 2.61) compared to controls. At home with additional observations, significant differences were observed in seven additional gait measures. The gait of individuals with higher total motor scores (50 or more) differed significantly from those with lower total motor scores (below 50) on multiple measures at home. Conclusions: In this pilot study, the use of wearable sensors in clinic and at home was feasible and demonstrated gait differences between controls, participants with Huntington disease, and participants with Huntington disease grouped by motor impairment. [ABSTRACT FROM AUTHOR]

Major advances in population health will not occur unless we translate existing knowledge into effective multicomponent interventions, implement and maintain these in communities, and develop rigorous translational research and evaluation methods to ensure continual improvement and sustainability. We discuss challenges and offer approaches to evaluation that are key for translational research stages 3 to 5 to advance optimized adoption, implementation, and maintenance of effective and replicable multicomponent strategies. The major challenges we discuss concern (a) multiple contexts of evaluation/research, (b) complexity of packages of interventions, and (c) phases of evaluation/research questions. We suggest multiple alternative research designs that maintain rigor but accommodate these challenges and highlight the need for measurement systems. Longitudinal data collection and a standardized continuous measurement system are fundamental to the evaluation and refinement of complex multicomponent interventions. To be useful to T3-T5 translational research efforts in neighborhoods and communities, such a system would include assessments of the reach, implementation, effects on immediate outcomes, and effects of the comprehensive intervention package on more distal health outcomes. [ABSTRACT FROM AUTHOR]

The success of translational research can ultimately be judged by the degree to which it reduces the incidence and prevalence of psychological, behavioral, and physical disorders and the major factors influencing them. In our view, we currently place insufficient emphasis on assessing our impact on the social determinants of disorders. As a result, we are failing to affect the incidence and prevalence of critical disorders. Moreover, translational research fails to take into account the full range of interventions that could significantly reduce the incidence and prevalence of our most pressing disorders. These include policy changes, media, and broad cultural change movements. In this paper, we discuss the momentous achievements the tobacco prevention movement made over the last half-century, describe how the lessons gleaned from this success can apply to other prevention efforts, and contrast this success with progress made in battling other major public health concerns. We call for an expansion of the translational research agenda to develop and evaluate broader and more comprehensive strategies to affect well-being in entire populations. [ABSTRACT FROM AUTHOR]

A correction to the article "Virtual house calls for Parkinson disease (Connect.Parkinson): study protocol for a randomized, controlled trial," that was published in the 2014 issue is presented.

The author comments on Timothy M. Waring and Ethan Tremblay's article "An Evolutionary Approach to Sustainability Science" and mentions topics including the role of the fossil fuel industry and the need for a coalition of governments, corporations and other entities to ensure human well-being.