Type 2 diabetes is linked to higher physiologic markers of effort during exercise.

Background: People with type 2 diabetes (T2D) have lower rates of physical activity (PA) than the general population. This is significant because insufficient PA is linked to cardiovascular morbidity and mortality, particularly in individuals with T2D. Previously, we identified a novel barrier to physical activity: greater perceived effort during exercise in women. Specifically, women with T2D experienced exercise at low-intensity as greater effort than women without T2D at the same low-intensity - based on self-report and objective lactate measurements. A gap in the literature is whether T2D confers greater exercise effort in both sexes and across a range of work rates. Objectives: Our overarching objective was to address these gaps regarding the influence of T2D and relative work intensity on exercise effort. We hypothesized that T2D status would confer greater effort during exercise across a range of work rates below the aerobic threshold. Methods: This cross-sectional study enrolled males and post-menopausal females aged 50-75 years. Measures of exercise effort included: 1) heart rate, 2) lactate and 3) self-report of Rating of Perceived Exertion (RPE); each assessment was during the final minute of a 5-minute bout of treadmill exercise. Treadmill exercise was performed at 3 work rates: 1.5 mph, 2.0 mph, and 2.5 mph, respectively. To determine factors influencing effort, separate linear mixed effect models assessed the influence of T2D on each outcome of exercise effort, controlling for work rate intensity relative to peak oxygen consumption (%VO2peak). Models were adjusted for any significant demographic associations between effort and age (years), sex (male/female), baseline physical activity, or average blood glucose levels. Results: We enrolled n=19 people with T2D (47.4% female) and n=18 people (55.6% female) with no T2D. In the models adjusted for %VO2peak, T2D status was significantly associated with higher heart rate (p = 0.02) and lactate (p = 0.01), without a significant association with RPE (p = 0.58). Discussions: Across a range of low-to-moderate intensity work rates in older, sedentary males and females, a diagnosis of T2D conferred higher objective markers of effort but did not affect RPE. Greater objective effort cannot be fully attributed to impaired fitness, as it persisted despite adjustment for %VO2peak. In order to promote regular exercise and reduce cardiovascular risk for people with T2D, 1) further efforts to understand the mechanistic targets that influence physiologic exercise effort should be sought, and 2) comparison of the effort and tolerability of alternative exercise training prescriptions is warranted.

Patient Weight Should Be Included on All Medication Prescriptions.

Medication prescriptions for both children and adults often require the patient's current weight to determine a safe and effective dose. Medication orders in the inpatient setting typically require a patient weight be recorded prior to order verification. However, in the ambulatory setting a very different standard exists; weights are not required on prescriptions and are rarely provided by practitioners. Without this information, the community pharmacist must either ask the caregiver, who may not know an accurate weight, or simply assume that the prescriber used a current and accurate weight and calculated the dose correctly. Standard doses are prescribed for most adult prescriptions, which makes it possible for the pharmacist to identify a dosing error. Without a current patient weight, the pharmacist is not able to provide the same level of patient care to pediatric patients or adults whose prescriptions require weight-based doses. The Pediatric Pharmacy Association recommends that patient weight, recorded in kilograms, be required on all medication prescriptions in both the inpatient and outpatient settings.

Modulation of tau tubulin kinases (TTBK1 and TTBK2) impacts ciliogenesis.

Tau tubulin kinase 1 and 2 (TTBK1/2) are highly homologous kinases that are expressed and mediate disease-relevant pathways predominantly in the brain. Distinct roles for TTBK1 and TTBK2 have been delineated. While efforts have been devoted to characterizing the impact of TTBK1 inhibition in diseases like Alzheimer's disease and amyotrophic lateral sclerosis, TTBK2 inhibition has been less explored. TTBK2 serves a critical function during cilia assembly. Given the biological importance of these kinases, we designed a targeted library from which we identified several chemical tools that engage TTBK1 and TTBK2 in cells and inhibit their downstream signaling. Indolyl pyrimidinamine 10 significantly reduced the expression of primary cilia on the surface of human induced pluripotent stem cells (iPSCs). Furthermore, analog 10 phenocopies TTBK2 knockout in iPSCs, confirming a role for TTBK2 in ciliogenesis.

Using smartphone-GPS data to quantify human activity in green spaces.

Cities are growing in density and coverage globally, increasing the value of green spaces for human health and well-being. Understanding the interactions between people and green spaces is also critical for biological conservation and sustainable development. However, quantifying green space use is particularly challenging. We used an activity index of anonymized GPS data from smart devices provided by Mapbox (www.mapbox.com) to characterize human activity in green spaces in the Greater Toronto Area, Canada. The goals of our study were to describe i) a methodological example of how anonymized GPS data could be used for human-nature research and ii) associations between park features and human activity. We describe some of the challenges and solutions with using this activity index, especially in the context of green spaces and biodiversity monitoring. We found the activity index was strongly correlated with visitation records (i.e., park reservations) and that these data are useful to identify high or low-usage areas within green spaces. Parks with a more extensive trail network typically experienced higher visitation rates and a substantial proportion of activity remained on trails. We identified certain land covers that were more frequently associated with human presence, such as rock formations, and find a relationship between human activity and tree composition. Our study demonstrates that anonymized GPS data from smart devices are a powerful tool for spatially quantifying human activity in green spaces. These could help to minimize trade-offs in the management of green spaces for human use and biological conservation will continue to be a significant challenge over the coming decades because of accelerating urbanization coupled with population growth. Importantly, we include a series of recommendations when using activity indexes for managing green spaces that can assist with biomonitoring and supporting sustainable human use.

Increased rate of listening difficulties in autistic children.

INTRODUCTION: Auditory challenges are both common and disruptive for autistic children and evidence suggests that listening difficulties may be linked to academic underachievement (Ashburner, Ziviani & Rodger, 2008). Such deficits may also contribute to issues with attention, behavior, and communication (Ashburner et al., 2008; Riccio, Cohen, Garrison & Smith, 2005). The present study aims to summarize the auditory challenges of autistic children with normal pure-tone hearing thresholds, and perceived listening difficulties, seen at auditory-ASD clinics in the US and Australia. METHODS: Data were compiled on a comprehensive, auditory-focused test battery in a large clinical sample of school-age autistic children with normal pure-tone hearing to date (N = 71, 6-14 years). Measures included a parent-reported auditory sensory processing questionnaire and tests of speech recognition in noise, binaural integration, attention, auditory memory and listening comprehension. Individual test performance was compared to normative data from children with no listening difficulties. RESULTS: Over 40% of patients exhibited significantly reduced speech recognition in noise and abnormal dichotic integration that were not attributed to deficits in attention. The majority of patients (86%) performed abnormally on at least one auditory measure, suggesting that functional auditory issues can exist in autistic patients despite normal pure-tone sensitivity. CONCLUSION: Including functional listening measures during audiological evaluations may improve clinicians' ability to detect and manage the auditory challenges impacting this population. Learner Outcomes: 1) Readers will be able to describe the auditory difficulties experienced by some autistic patients (ASD). 2) Readers will be able to describe clinical measures potentially useful for detecting listening difficulties in high-functioning autistic children.

Evaluation of Potential Benefits and Limitations of Noise-Management Technologies for Children with Hearing Aids.

BACKGROUND: Children with hearing loss frequently experience difficulty understanding speech in the presence of noise. Although remote microphone systems are likely to be the most effective solution to improve speech recognition in noise, the focus of this study centers on the evaluation of hearing aid noise management technologies including directional microphones, adaptive noise reduction (ANR), and frequency-gain shaping. These technologies can improve children's speech recognition, listening comfort, and/or sound quality in noise. However, individual contributions of these technologies as well as the effect of hearing aid microphone mode on localization abilities in children is unknown. PURPOSE: The objectives of this study were to (1) compare children's speech recognition and subjective perceptions across five hearing aid noise management technology conditions and (2) compare localization abilities across three hearing aid microphone modes. RESEARCH DESIGN: A single-group, repeated measures design was used to evaluate performance differences and subjective ratings. STUDY SAMPLE: Fourteen children with mild to moderately severe hearing loss. DATA COLLECTION AND ANALYSIS: Children's sentence recognition, listening comfort, sound quality, and localization were assessed in a room with an eight-loudspeaker array. RESULTS AND CONCLUSION: The use of adaptive directional microphone technology improves children's speech recognition in noise when the signal of interest arrives from the front and is spatially separated from the competing noise. In contrast, the use of adaptive directional microphone technology may result in a decrease in speech recognition in noise when the signal of interest arrives from behind. The use of a microphone mode that mimics the natural directivity of the unaided auricle provides a slight improvement in speech recognition in noise compared with omnidirectional use with limited decrement in speech recognition in noise when the signal of interest arrives from behind. The use of ANR and frequency-gain shaping provide no change in children's speech recognition in noise. The use of adaptive directional microphone technology, ANR, and frequency-gain shaping improve children's listening comfort, perceived ability to understand speech in noise, and overall listening experience. Children prefer to use each of these noise management technologies regardless of whether the signal of interest arrives from the front or from behind. The use of adaptive directional microphone technology does not result in a decrease in children's localization abilities when compared with the omnidirectional condition. The best localization performance occurred with use of the microphone mode that mimicked the directivity of the unaided auricle.

Integrating a physical activity coaching intervention into diabetes care: a mixed-methods evaluation of a pilot pragmatic trial.

Physical activity (PA) counseling is under-utilized in primary care for patients with type 2 diabetes mellitus (T2D), despite improving important health outcomes, including physical function. We adapted evidence-based PA counseling programs to primary care patients, staff, and leader's needs, resulting in "Be ACTIVE" comprised of shared PA tracker data (FitBit©), six theory-informed PA coaching calls, and three in-person clinician visits. In a pilot randomized pragmatic trial, we evaluated the feasibility, acceptability, and effectiveness of Be ACTIVE. Sedentary patients with T2D were randomized to Be ACTIVE versus an enhanced control condition. Mixed methods assessments of feasibility and acceptability included costs. Objective pilot effectiveness outcomes included PA (primary outcome, accelerometer steps/week), the Short Physical Performance Battery (SPPB) physical function measure, and behavioral PA predictors. Fifty patients were randomized to Be ACTIVE or control condition. Acceptability was >90% for patients and clinic staff. Coaching and PA tracking costs of ~$90/patient met Medicare reimbursement criteria. Pre-post PA increased by ~11% (Be ACTIVE) and ~6% in controls (group difference: 1574 ± 4391 steps/week, p = .72). As compared to controls, Be ACTIVE participants significantly improved SPPB (0.9 ± 0.3 vs. -0.1 ± 0.3, p = .01, changes >0.5 points prevent falls clinically), and PA predictors of self-efficacy (p = .02) and social-environmental support (p < .01). In this pilot trial, Be ACTIVE was feasible and highly acceptable to stakeholders and yielded significant improvements in objective physical function consistent with lower fall risk, whereas PA changes were less than anticipated. Be ACTIVE may need additional adaptation or a longer duration to improve PA outcomes.

We report results from a pragmatic and behavioral theory-based physical activity (PA) coaching program, termed "Be ACTIVE," for patients with type 2 diabetes that was designed to improve PA and function for patients and to be reimbursable and feasible for primary care teams. As compared to those who did not receive coaching, patients who received Be ACTIVE had physical function improvements that lowered their risk of falls. Be ACTIVE was delivered with fidelity and was highly acceptable to the key primary care stakeholders of patients, clinic staff coaches, and clinicians. Patients particularly liked the focus on setting goals to do enjoyable activities, the accountability of wearing a PA monitor, and the support of their coach. Clinical care professionals felt that their role of encouraging behavior change (coach) and safety monitoring (clinician) aligned well with their clinical expertise, and was professionally rewarding. Coaches felt the program helped them guide many patients to overcome preexisting negative perceptions of PA and develop intrinsic motivations to be active. The costs of clinic coach time and PA tracker rental needed to deliver the 12-week program could be reimbursed by the Medicare Chronic Disease Management programs, albeit with a patient co-payment required.

Low-Level Speech Recognition of Children with Hearing Aids.

BACKGROUND: For children with hearing loss, the primary goal of hearing aids is to provide improved access to the auditory environment within the limits of hearing aid technology and the child's auditory abilities. However, there are limited data examining aided speech recognition at very low (40 decibels A [dBA]) and low (50 dBA) presentation levels. PURPOSE: Due to the paucity of studies exploring aided speech recognition at low presentation levels for children with hearing loss, the present study aimed to (1) compare aided speech recognition at different presentation levels between groups of children with "normal" hearing and hearing loss, (2) explore the effects of aided pure tone average and aided Speech Intelligibility Index (SII) on aided speech recognition at low presentation levels for children with hearing loss ranging in degree from mild to severe, and (3) evaluate the effect of increasing low-level gain on aided speech recognition of children with hearing loss. RESEARCH DESIGN: In phase 1 of this study, a two-group, repeated-measures design was used to evaluate differences in speech recognition. In phase 2 of this study, a single-group, repeated-measures design was used to evaluate the potential benefit of additional low-level hearing aid gain for low-level aided speech recognition of children with hearing loss. STUDY SAMPLE: The first phase of the study included 27 school-age children with mild to severe sensorineural hearing loss and 12 school-age children with "normal" hearing. The second phase included eight children with mild to moderate sensorineural hearing loss. INTERVENTION: Prior to the study, children with hearing loss were fitted binaurally with digital hearing aids. Children in the second phase were fitted binaurally with digital study hearing aids and completed a trial period with two different gain settings: (1) gain required to match hearing aid output to prescriptive targets (i.e., primary program), and (2) a 6-dB increase in overall gain for low-level inputs relative to the primary program. In both phases of this study, real-ear verification measures were completed to ensure the hearing aid output matched prescriptive targets. DATA COLLECTION AND ANALYSIS: Phase 1 included monosyllabic word recognition and syllable-final plural recognition at three presentation levels (40, 50, and 60 dBA). Phase 2 compared speech recognition performance for the same test measures and presentation levels with two differing gain prescriptions. CONCLUSION: In phase 1 of the study, aided speech recognition was significantly poorer in children with hearing loss at all presentation levels. Higher aided SII in the better ear (55 dB sound pressure level input) was associated with higher Consonant-Nucleus-Consonant word recognition at a 40 dBA presentation level. In phase 2, increasing the hearing aid gain for low-level inputs provided a significant improvement in syllable-final plural recognition at very low-level inputs and resulted in a nonsignificant trend toward better monosyllabic word recognition at very low presentation levels. Additional research is needed to document the speech recognition difficulties children with hearing aids may experience with low-level speech in the real world as well as the potential benefit or detriment of providing additional low-level hearing aid gain.

Educational Challenges During the Pandemic for Students Who Have Hearing Loss.

Purpose The COVID-19 pandemic introduced new educational challenges for students, teachers, and caregivers due to the changed and varied learning environments, use of face masks, and social distancing requirements. These challenges are particularly pronounced for students with hearing loss who often require specific accommodations to allow for equal access to the curriculum. The purpose of this study was to document the potential difficulties that students with hearing loss faced during the pandemic and to generate recommendations to promote learning and engagement based on findings. Method A qualitative survey was designed to document the frequency of various learning situations (i.e., in person, remote virtual, and blended), examine the accessibility of technology and course content, and quantify hearing issues associated with safety measures and technology use in school-age students with hearing loss. Survey questions were informed from key educational issues reported in published articles and guidelines. The survey was completed by 416 educational personnel who work with students with hearing loss. Results Respondents indicated that most of their schools were providing remote or blended (in-person and remote) learning consisting of synchronous and asynchronous learning. Common accommodations for students with hearing loss were only provided some of the time with the exception of sign language interpreters, which were provided for almost all students who required them. According to the respondents, both students and caregivers reported issues or discomfort with the technology required for remote learning. Conclusion To ensure that students with hearing loss are provided equal access to the curriculum, additional accommodations should be considered to address issues arising from pandemic-related changes to school and learning practices including closed captioning, transcripts/notes, recordings of lectures, sign language interpreters, student check-ins, and family-directed resources to assist with technology issues.

Physical Activity and Incident Depression: A Meta-Analysis of Prospective Cohort Studies.

OBJECTIVE: The authors examined the prospective relationship between physical activity and incident depression and explored potential moderators. METHOD: Prospective cohort studies evaluating incident depression were searched from database inception through Oct. 18, 2017, on PubMed, PsycINFO, Embase, and SPORTDiscus. Demographic and clinical data, data on physical activity and depression assessments, and odds ratios, relative risks, and hazard ratios with 95% confidence intervals were extracted. Random-effects meta-analyses were conducted, and the potential sources of heterogeneity were explored. Methodological quality was assessed using the Newcastle-Ottawa Scale. RESULTS: A total of 49 unique prospective studies (N=266,939; median proportion of males across studies, 47%) were followed up for 1,837,794 person-years. Compared with people with low levels of physical activity, those with high levels had lower odds of developing depression (adjusted odds ratio=0.83, 95% CI=0.79, 0.88; I2=0.00). Furthermore, physical activity had a protective effect against the emergence of depression in youths (adjusted odds ratio=0.90, 95% CI=0.83, 0.98), in adults (adjusted odds ratio=0.78, 95% CI=0.70, 0.87), and in elderly persons (adjusted odds ratio=0.79, 95% CI=0.72, 0.86). Protective effects against depression were found across geographical regions, with adjusted odds ratios ranging from 0.65 to 0.84 in Asia, Europe, North America, and Oceania, and against increased incidence of positive screen for depressive symptoms (adjusted odds ratio=0.84, 95% CI=0.79, 0.89) or major depression diagnosis (adjusted odds ratio=0.86, 95% CI=0.75, 0.98). No moderators were identified. Results were consistent for unadjusted odds ratios and for adjusted and unadjusted relative risks/hazard ratios. Overall study quality was moderate to high (Newcastle-Ottawa Scale score, 6.3). Although significant publication bias was found, adjusting for this did not change the magnitude of the associations. CONCLUSIONS: Available evidence supports the notion that physical activity can confer protection against the emergence of depression regardless of age and geographical region.

How can clinical practices pragmatically increase physical activity for patients with type 2 diabetes? A systematic review.

Although regular physical activity (PA) is a cornerstone of treatment for type 2 diabetes (T2D), most adults with T2D are sedentary. Randomized controlled trials (RCTs) have proven the effectiveness of PA behavioral interventions for adults with T2D but have rarely been conducted in healthcare settings. We sought to identify PA interventions that are effective and practical to implement in clinical practice settings. Our first aim was to use the valid Pragmatic-Explanatory Continuum Indicator Summary 2 (PRECIS-2) tool to assess the potential for future implementation of PA interventions in clinical practice settings. Our second aim was to identify interventions that effectively increased PA and glycemic control among the interventions in the top tertile of PRECIS-2 scores. We searched PubMed MEDLINE from January 1980 through May 2015 for RCTs of behavioral PA interventions coordinated by clinical practices for patients with T2D. Dual investigators assessed pragmatism by PRECIS-2 scores, and study effectiveness was extracted from original RCT publications. The PRECIS-2 scores of the 46 behavioral interventions (n = 13,575 participants) ranged from 3.0 to 4.8, where 5 is the most pragmatic score. In the most pragmatic tertile of interventions (n = 16) by PRECIS-2 scores, 30.8 and 31.3% of interventions improved PA outcomes and hemoglobin A1c, respectively. A minority of published evidence-based PA interventions for adults with T2D were both effective and pragmatic for clinical implementation. These should be tested for dissemination using implementation trial designs.

A yoga & exercise randomized controlled trial for vasomotor symptoms: Effects on heart rate variability.

OBJECTIVES: Heart rate variability (HRV) reflects the integration of the parasympathetic nervous system with the rest of the body. Studies on the effects of yoga and exercise on HRV have been mixed but suggest that exercise increases HRV. We conducted a secondary analysis of the effect of yoga and exercise on HRV based on a randomized clinical trial of treatments for vasomotor symptoms in peri/post-menopausal women. DESIGN: Randomized clinical trial of behavioral interventions in women with vasomotor symptoms (n=335), 40-62 years old from three clinical study sites. INTERVENTIONS: 12-weeks of a yoga program, designed specifically for mid-life women, or a supervised aerobic exercise-training program with specific intensity and energy expenditure goals, compared to a usual activity group. MAIN OUTCOME MEASURES: Time and frequency domain HRV measured at baseline and at 12 weeks for 15min using Holter monitors. RESULTS: Women had a median of 7.6 vasomotor symptoms per 24h. Time and frequency domain HRV measures did not change significantly in either of the intervention groups compared to the change in the usual activity group. HRV results did not differ when the analyses were restricted to post-menopausal women. CONCLUSIONS: Although yoga and exercise have been shown to increase parasympathetic-mediated HRV in other populations, neither intervention increased HRV in middle-aged women with vasomotor symptoms. Mixed results in previous research may be due to sample differences. Yoga and exercise likely improve short-term health in middle-aged women through mechanisms other than HRV.

Generalization of multisensory perceptual learning.

Life in a multisensory world requires the rapid and accurate integration of stimuli across the different senses. In this process, the temporal relationship between stimuli is critical in determining which stimuli share a common origin. Numerous studies have described a multisensory temporal binding window-the time window within which audiovisual stimuli are likely to be perceptually bound. In addition to characterizing this window's size, recent work has shown it to be malleable, with the capacity for substantial narrowing following perceptual training. However, the generalization of these effects to other measures of perception is not known. This question was examined by characterizing the ability of training on a simultaneity judgment task to influence perception of the temporally-dependent sound-induced flash illusion (SIFI). Results do not demonstrate a change in performance on the SIFI itself following training. However, data do show an improved ability to discriminate rapidly-presented two-flash control conditions following training. Effects were specific to training and scaled with the degree of temporal window narrowing exhibited. Results do not support generalization of multisensory perceptual learning to other multisensory tasks. However, results do show that training results in improvements in visual temporal acuity, suggesting a generalization effect of multisensory training on unisensory abilities.

Fitting Frequency-Lowering Signal Processing Applying the American Academy of Audiology Pediatric Amplification Guideline: Updates and Protocols.

BACKGROUND: Although guidelines for fitting hearing aids for children are well developed and have strong basis in evidence, specific protocols for fitting and verifying technologies can supplement such guidelines. One such technology is frequency-lowering signal processing. Children require access to a broad bandwidth of speech to detect and use all phonemes including female /s/. When access through conventional amplification is not possible, the use of frequency-lowering signal processing may be considered as a means to overcome limitations. Fitting and verification protocols are needed to better define candidacy determination and options for assessing and fine tuning frequency-lowering signal processing for individuals. PURPOSE: This work aims to (1) describe a set of calibrated phonemes that can be used to characterize the variation in different brands of frequency-lowering processors in hearing aids and the verification with these signals and (2) determine whether verification with these signal are predictive of perceptual changes associated with changes in the strength of frequency-lowering signal processing. Finally, we aimed to develop a fitting protocol for use in pediatric clinical practice. STUDY SAMPLE: Study 1 used a sample of six hearing aids spanning four types of frequency lowering algorithms for an electroacoustic evaluation. Study 2 included 21 adults who had hearing loss (mean age 66 yr). DATA COLLECTION AND ANALYSIS: Simulated fricatives were designed to mimic the level and frequency shape of female fricatives extracted from two sources of speech. These signals were used to verify the frequency-lowering effects of four distinct types of frequency-lowering signal processors available in commercial hearing aids, and verification measures were compared to extracted fricatives made in a reference system. In a second study, the simulated fricatives were used within a probe microphone measurement system to verify a wide range of frequency compression settings in a commercial hearing aid, and 27 adult listeners were tested at each setting. The relation between the hearing aid verification measures and the listener's ability to detect and discriminate between fricatives was examined. RESULTS: Verification measures made with the simulated fricatives agreed to within 4 dB, on average, and tended to mimic the frequency response shape of fricatives presented in a running speech context. Some processors showed a greater aided response level for fricatives in running speech than fricatives presented in isolation. Results with listeners indicated that verified settings that provided a positive sensation level of /s/ and that maximized the frequency difference between /s/ and /∫/ tended to have the best performance. CONCLUSIONS: Frequency-lowering signal processors have measureable effects on the high-frequency fricative content of speech, particularly female /s/. It is possible to measure these effects either with a simple strategy that presents an isolated simulated fricative and measures the aided frequency response or with a more complex system that extracts fricatives from running speech. For some processors, a more accurate result may be achieved with a running speech system. In listeners, the aided frequency location and sensation level of fricatives may be helpful in predicting whether a specific hearing aid fitting, with or without frequency-lowering, will support access to the fricatives of speech.

The temporal binding window for audiovisual speech: Children are like little adults.

During a typical communication exchange, both auditory and visual cues contribute to speech comprehension. The influence of vision on speech perception can be measured behaviorally using a task where incongruent auditory and visual speech stimuli are paired to induce perception of a novel token reflective of multisensory integration (i.e., the McGurk effect). This effect is temporally constrained in adults, with illusion perception decreasing as the temporal offset between the auditory and visual stimuli increases. Here, we used the McGurk effect to investigate the development of the temporal characteristics of audiovisual speech binding in 7-24 year-olds. Surprisingly, results indicated that although older participants perceived the McGurk illusion more frequently, no age-dependent change in the temporal boundaries of audiovisual speech binding was observed.

Is heart rate variability associated with frequency and intensity of vasomotor symptoms among healthy perimenopausal and postmenopausal women?

OBJECTIVE: Research has suggested that the autonomic nervous system (ANS) is involved in the experience of vasomotor symptoms (VMS) during menopause. We examined the relationship of VMS intensity and heart rate variability (HRV), a measure of ANS function. METHODS: Women (n = 282) were recruited from three American states for a clinical trial of yoga, exercise, and omega-3 fatty acid supplements for VMS. To be eligible, women had to report at least 14 VMS per week, with some being moderate to severe. Sitting electrocardiograms were recorded for 15 min using Holter monitors at both baseline and 12-week follow-up. Time and frequency domain HRV measures were calculated. Women completed daily diary measures of VMS frequency and intensity for 2 weeks at baseline and for 1 week at the follow-up assessment 12 weeks later. Multivariable linear regression was used to assess the relationship between VMS and baseline HRV measures and to compare change in HRV with change in VMS over the 12 weeks. RESULTS: Baseline HRV was not associated with either VMS frequency or intensity at baseline. Change in HRV was not associated with change in VMS frequency or intensity across the follow-up. INTERPRETATION: Heart rate variability (HRV) was not associated with basal VMS frequency or intensity in perimenopausal and postmenopausal women experiencing high levels of VMS. Autonomic function may be associated with the onset or presence of VMS, but not with the number or intensity of these symptoms.

"My hair or my health:" Overcoming barriers to physical activity in African American women with a focus on hairstyle-related factors.

Physical activity disparities among African American (AA) women may be related to sociocultural barriers, including difficulties with restyling hair after exercise. We sought to identify physical activity barriers and facilitators in AA women with a focus on sociocultural factors related to hairstyle maintenance. Participants (n = 51) were AA women aged 19-73 years who completed valid surveys and participated in structured focus groups, stratified by age and physical activity levels, from November 2012 to February 2013. The Constant Comparison method was used to develop qualitative themes for barriers and facilitators. The most frequently reported general physical activity barrier among exercisers was "lack of money" (27%) and among non-exercisers was "lack of self-discipline" (57%). A hairstyle-related barrier of "sweating out my hairstyle" was reported by 7% of exercisers and 29% of non-exercisers. This hairstyle-related barrier included the need for extra time and money to restyle hair due to perspiration. Hairstyle-related facilitators included: prioritizing health over hairstyle and high self-efficacy to restyle hair after perspiration. Participants were interested in resources to simplify hairstyle maintenance. AA women whose hairstyle is affected by perspiration may avoid physical activity due to time and financial burdens. Increasing self-efficacy to restyle hair after perspiration may help to overcome this barrier.

Developing a patient-directed policy framework for managing orphan and ultra-orphan drugs throughout their lifecycle.

INTRODUCTION: Policy decisions related to orphan and ultra-orphan drugs challenge traditional decision-making processes and often frustrate those affected by them. In general, these drugs are associated with significant uncertainties around clinical benefit, 'value for money', affordability, and 'adoption/diffusion', all of which arise from a lack of available high-quality evidence. Increasingly, patients with rare diseases and their families are looking for opportunities to contribute to initiatives aimed at reducing these uncertainties. Therefore, a policy framework for guiding their involvement is needed to optimize the impact of any evidence generated. OBJECTIVES: The aims of this study were (1) to explore opportunities for patient involvement in reducing decision uncertainties throughout the lifecycle of orphan and ultra-orphan drugs from the perspectives of patients within the Canadian rare disease community; and (2) to develop a policy framework for patient input that maximizes the impact of their involvement on decision uncertainties around orphan and ultra-orphan drugs. METHODS: Two one-day conferences and four workshops involving patients and/or families from rare disease communities in Canada were held to discuss issues around orphan and ultra-orphan drug development, access, and coverage, and identify opportunities for patient input to reduce related decision uncertainties. Their feedback and the findings from a recent literature review on patient involvement in rare diseases were combined into a draft policy framework based upon Kingdon's multiple streams model of decision making. The framework was presented to a group of patients and other stakeholders, including providers, pharmaceutical drug plan managers, and industry representatives, and then revised accordingly. RESULTS: Patients and family members/caregivers identified tangible ways of contributing to the generation of information at all stages of the drug lifecycle. However, the proximity of that information to the reduction of a specific decision uncertainty varied. While the scope of possible ways mentioned was less broad when compared with the findings of the literature review, the focus was similar-capturing the clinical benefit of an orphan or ultra-orphan drug. A policy framework comprising three stages, each with a key question and corresponding set of sub-questions to be asked by patients, was developed. The three main sequential questions were as follows. (1) What uncertainties need to be addressed? (2) What roles should patients play? (3) Is each role feasible? CONCLUSIONS: Reducing decision uncertainties around orphan and ultra-orphan drugs requires a policy framework that explicates when and what type of information needs to be generated, and recognizes the role of patients as important sources of such information throughout the lifecycle of these drugs.

Involving patients in reducing decision uncertainties around orphan and ultra-orphan drugs: a rare opportunity?

INTRODUCTION: Uncertainty influences the amount of risk in decision making, and is typically related to clinical benefit, value for money, affordability, and/or adoption/diffusion of the technology (e.g., drug, device, procedure, etc.). Although evidence-based review processes within each stage of the technology lifecycle have been implemented to minimize uncertainty, high-quality information addressing that related to orphan and ultra-orphan drugs is often unavailable. The role that patients, as experts in their disease, may play in providing such information has yet to be fully explored. OBJECTIVE: The objective of this systematic review was to identify existing and proposed opportunities for patients with rare diseases and their families to provide input aimed at reducing decision uncertainties throughout the lifecycle of an orphan or ultra-orphan drug. METHODS: A comprehensive review of published and gray literature describing roles for patients and families in activities related to orphan and ultra-orphan drugs was conducted. In addition, the websites of regulatory and centralized reimbursement decision-making bodies in the top 22 OECD (Organisation for Economic Cooperation and Development) countries by gross domestic product (GDP) were scanned to identify current opportunities for patients with rare diseases in both stages. The websites of umbrella patient organizations for rare diseases in these countries were also scanned. These roles were then mapped onto a matrix to determine the stage in the technology lifecycle and types of uncertainties they directly or indirectly addressed. RESULTS: Across the 22 countries, nine roles for patients within regulatory related processes were identified, with at least one in each country. These roles were not specific to patients with rare diseases. Similarly, six different opportunities for patient input in centralized drug review processes were identified, all of which applied to patients, in general, rather than just those with rare diseases. 'Real-world' examples of patient involvement explicitly related to rare diseases centered around 11 different themes. Seven fell within the research and development or clinical trial stages of a drug's lifecycle. Of the remaining four, three were associated with education and advocacy. All of the proposed roles identified focused on greater involvement in (1) the design and conduct of clinical trials, or (2) the 'valuation' of evidence during reimbursement decision making. When mapped onto the matrix of decision uncertainties, almost all of the existing and proposed roles addressed 'clinical benefit'. Roles for patients in reducing 'value for money', affordability, or adoption/diffusion uncertainties were mainly indirect, and a result of patient involvement in activities aimed at generating information on clinical benefit, which is then used to inform discussions around these uncertainties. CONCLUSIONS: While patient involvement in activities that directly address uncertainties in clinical benefit may not be 'rare', opportunities for reducing those related to 'value for money', affordability, and adoption/diffusion remain scarce.