Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the COVID-19 pandemic.

INTRODUCTION: Emergency clinical research has played an important role in improving outcomes for acutely ill patients. This is due in part to regulatory measures that allow Exception From Informed Consent (EFIC) trials. The Food and Drug Administration (FDA) requires sponsor-investigators to engage in community consultation and public disclosure activities prior to initiating an Exception From Informed Consent trial. Various approaches to community consultation and public disclosure have been described and adapted to local contexts and Institutional Review Board (IRB) interpretations. The COVID-19 pandemic has precluded the ability to engage local communities through direct, in-person public venues, requiring research teams to find alternative ways to inform communities about emergency research. METHODS: The PreVent and PreVent 2 studies were two Exception From Informed Consent trials of emergency endotracheal intubation, conducted in one geographic location for the PreVent Study and in two geographic locations for the PreVent 2 Study. During the period of the two studies, there was a substantial shift in the methodological approach spanning across the periods before and after the pandemic from telephone, to in-person, to virtual settings. RESULTS: During the 10 years of implementation of Exception From Informed Consent activities for the two PreVent trials, there was overall favorable public support for the concept of Exception From Informed Consent trials and for the importance of emergency clinical research. Community concerns were few and also did not differ much by method of contact. Attendance was higher with the implementation of virtual technology to reach members of the community, and overall feedback was more positive compared with telephone contacts or in-person events. However, the proportion of survey responses received after completion of the remote, live event was substantially lower, with a greater proportion of respondents having higher education levels. This suggests less active engagement after completion of the synchronous activity and potentially higher selection bias among respondents. Importantly, we found that engagement with local community leaders was a key component to develop appropriate plans to connect with the public. CONCLUSION: The PreVent experience illustrated operational advantages and disadvantages to community consultation conducted primarily by telephone, in-person events, or online activities. Approaches to enhance community acceptance included partnering with community leaders to optimize the communication strategies and trust building with the involvement of Institutional Review Board representatives during community meetings. Researchers might need to pivot from in-person planning to virtual techniques while maintaining the ability to engage with the public with two-way communication approaches. Due to less active engagement, and potential for selection bias in the responders, further research is needed to address the costs and benefits of virtual community consultation and public disclosure activities compared to in-person events.

"It makes me a better person": The unique experiences of parenting multiple children who experience neurodevelopmental disability.

BACKGROUND: Much research has explored how raising a child with a neurodevelopmental disability influences parents' well-being. However, little research has focused on the unique experiences of parenting multiple children with neurodevelopmental disabilities. We explored the unique experiences of parenting multiple children with neurodevelopmental disabilities with a focus on mothers' well-being and social participation. METHODS: Ten mothers who parent multiple children with neurodevelopmental disabilities participated in semi-structured interviews. Interviews were analyzed using a reflexive thematic approach. RESULTS: Three themes were identified: 'Knowledge is power' described positive influences of enhanced disability knowledge and advocacy with each child who experienced disability. 'Shifts in wellbeing' acknowledged these mothers' exhaustion, decreased time for self-care, and invisible work, yet also increased feelings of empowerment, purpose and empathy for others. '(Dis)Connection and engagement with others' reflected struggles of balancing responsibilities, social and community participation, and experiences with isolation. Yet, mothers' also experienced enhanced disability community and family connections, and a sense of meaning and purpose. CONCLUSIONS AND IMPLICATIONS: Findings highlighted challenges, and many rewarding and unique experiences of parenting multiple children with neurodevelopmental disabilities. Health, education and social service practitioners are encouraged to acknowledge parent's challenges, but also celebrate and draw on families' strengths and knowledge.

Voice Symptoms and Wellbeing in School Teachers in England.

INTRODUCTION: Negative psychological factors such as depression and other common mental disorders have been found to be associated with voice problems in teachers. However, there is little research with teachers that investigates the relationship between positive psychological factors such as wellbeing and voice problems. Although negative and positive mental states are on a continuum of psychological health, research suggests negative and positive effects are not necessarily inversely correlated and therefore need to be investigated separately. OBJECTIVE/HYPOTHESIS: To explore the relationship between voice symptoms and wellbeing in teachers working in primary and secondary schools in England. We hypothesise that as wellbeing increases voice symptoms will decrease. DESIGN: Cross sectional study using a self-administered web-based questionnaire conducted with primary and secondary school teachers in England. METHODS: The study included 1205 teachers from 608 primary and secondary schools, including state and fee paying, and mainstream and special schools. Voice symptoms were measured using The Voice Symptom Scale and wellbeing was measured using the Warwick Edinburgh Mental Wellbeing Scale. Information was also obtained on health, lifestyle, sociodemographic and environmental factors. Analysis was conducted using a linear multi-level regression model. RESULTS: A statistically significant relationship between voice symptoms and wellbeing was identified (-0.31 95% CI -0.41, -0.20 P =< 0.001). Other factors found to be statistically significantly associated with voice symptoms were age, sex, gastroesophageal reflux, class size, background noise, speaking louder than normal and respiratory infection. Hours teaching per week, deprivation of school, voice training, teaching subject, smoking status and asthma were not associated with voice symptoms. CONCLUSIONS: This study suggests that there is an association between vocal symptoms and wellbeing. Teachers with higher wellbeing had fewer voice symptoms.

Synaptic density and cognitive performance in Alzheimer's disease: A PET imaging study with [11 C]UCB-J.

INTRODUCTION: For 30 years synapse loss has been referred to as the major pathological correlate of cognitive impairment in Alzheimer's disease (AD). However, this statement is based on remarkably few patients studied by autopsy or biopsy. With the recent advent of synaptic vesicle glycoprotein 2A (SV2A) positron emission tomography (PET) imaging, we have begun to evaluate the consequences of synaptic alterations in vivo. METHODS: We examined the relationship between synaptic density measured by [11 C]UCB-J PET and neuropsychological test performance in 45 participants with early AD. RESULTS: Global synaptic density showed a significant positive association with global cognition and performance on five individual cognitive domains in participants with early AD. Synaptic density was a stronger predictor of cognitive performance than gray matter volume. CONCLUSION: These results confirm neuropathologic studies demonstrating a significant association between synaptic density and cognitive performance, and suggest that this correlation extends to the early stages of AD.

Unusual presentation of canine Mycobacterium avium infection.

This short communication describes the clinical and morphological findings, diagnosis and treatment of a case of Mycobacterium avium infection in a golden retriever that presented with a progressive nasal swelling and lymphadenopathy. Although well documented in cats, where cutaneous lesions are frequently recognised, canine M avium infection is less commonly reported, and cutaneous lesions are rare. To the authors' knowledge this is the first documented case of canine M avium infection that presented with a cutaneous lesion but no systemic clinical signs. It occurred in a dog with no previously reported breed predisposition and highlights that in cases of cutaneous histiocytic infiltrate in dogs mycobacterial infection should remain a differential diagnosis, even in the absence of suggestive organisms on histopathological examination.

Openness declines in advance of death in late adulthood.

Openness to experience has been found to be a correlate of successful aging outcomes yet also has been found to decline from middle age onward. We hypothesized that decline in openness would be associated with death. Using longitudinal data from the Swedish Adoption/Twin Study of Aging (SATSA), the analytic sample encompassed 1954 individuals, approximately two-thirds of whom were deceased. We tested whether openness declines across late adulthood and, central to our hypothesis, whether the decline correlated with age at death. Multivariate modeling adjusted for age at study entry, sex, education, as well as the time-varying effects of physical illness, depressive symptoms, and cognitive ability. Correlations between change in neuroticism and extraversion and death were modeled for comparison. A follow-up cotwin control analysis adjusted for genetic and environmental familial confounders. Significant mean-level change was identified in all personality traits, but only for openness was change correlated with age at death, in support of our hypothesis. The findings were not explained by health factors or cognition. Cotwin control analyses indicated that the twin who died earlier showed a greater drop in openness prior to death, compared with their cotwin measured at the same time points. There was no cotwin finding for neuroticism or extraversion. We suggest that declines in openness may reflect a change in goal orientation due to the experience of a shortened time horizon, leading to an optimized selection of experiences as people approach the end of life. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Effects of Normative Adjustments to the Montreal Cognitive Assessment.

OBJECTIVE: To investigate optimal cutoff scores and the effects of normative adjustments on the performance of the Montreal Cognitive Assessment (MoCA) as a screening instrument for Mild Cognitive Impairment (MCI) and dementia due to Alzheimer's disease (AD-dementia). METHODS: 499 adults 48 to 91 years-old enrolled in the Alzheimer's Disease Neuroimaging Initiative (ADNI) and were administered the MoCA during baseline. Participants were classified as either cognitively normal (CN), MCI, or AD-dementia by clinical assessment. Receiver operating characteristic (ROC) analyses were performed using raw MoCA scores, education-adjusted MoCA scores, and a regression-based adjustment derived from the National Alzheimer's Coordinating Center data (NACC). Test performance characteristics were calculated for various cutoffs after each normative correction method. RESULTS: Areas under the curve (AUC) were similar for raw, education-adjusted, and NACC-adjusted MoCA scores, and demonstrated minimal improvement when adjustments of increasing complexity were applied. Our results suggest that the optimal cutoff score for distinguising MCI is 24 and for distinguising AD-dementia is 22. CONCLUSIONS: This study adds to the understanding of how normative adjustments affect the sensitivity and specificity of the MoCA. Suggested corrections based on education alone do not yield improved test characteristics, but small improvements are attained when a regression-based correction that accounts for age, sex, and education is applied. Furthermore, optimal cutoffs for distinguishing CN from MCI or CN from AD-dementia were lower than previously reported. Optimal cutoffs to detect MCI and AD-dementia may vary in different populations, and further study is needed to determine appropriate use of the MoCA as a screening tool.

Personality Predicts Mortality Risk: An Integrative Data Analysis of 15 International Longitudinal Studies.

This study examined the Big Five personality traits as predictors of mortality risk, and smoking as a mediator of that association. Replication was built into the fabric of our design: we used a Coordinated Analysis with 15 international datasets, representing 44,094 participants. We found that high neuroticism and low conscientiousness, extraversion, and agreeableness were consistent predictors of mortality across studies. Smoking had a small mediating effect for neuroticism. Country and baseline age explained variation in effects: studies with older baseline age showed a pattern of protective effects (HR<1.00) for openness, and U.S. studies showed a pattern of protective effects for extraversion. This study demonstrated coordinated analysis as a powerful approach to enhance replicability and reproducibility, especially for aging-related longitudinal research.

Factors affecting community-agency trust before, during and after a wildfire: an Australian case study.

Trust has been identified as a critical relationship component in contexts of high uncertainty and complexity such as wildfire management, and as a primary factor in public support for wildland fire management strategies. However, little attention has been paid to identifying and comparing factors across fire management stages (i.e. before, during, after a fire) that may influence trust between community members and fire management agencies. This paper attempts to address this gap by exploring factors affecting community-agency trusting relationships before, during and after a wildfire event. We draw upon 26 semi-structured interviews with 38 residents of a community directly impacted by fires in December 2006 and January 2007 in Victoria, Australia. Communication, cooperation, trustworthiness, and integration of local concerns and knowledge influenced trust in more than one fire management stage. Institutional structures and reduction of uncertainty were particularly strong influences during a fire. After a fire, resolving negative outcomes and immediately meeting perceived needs arising from the fire were factors unique to this stage.

Relationship between education and dementia: an updated systematic review.

OBJECTIVE: The purpose of this study was to review the relationship between education and dementia. METHODS: A systematic literature review was conducted of all published studies examining the relationship between education and dementia listed in the PubMed and PsycINFO databases from January 1985 to July 2010. The inclusion criteria were a measure of education and a dementia diagnosis by a standardized diagnostic procedure. Alzheimer disease and Total Dementia were the outcomes. RESULTS: A total of 88 study populations from 71 studies met inclusion criteria. Overall, 51 studies (58%) reported significant effects of lower education on risk for dementia, whereas 37 studies (42%) reported no significant relationship. A relationship between education and risk for dementia was more consistent in developed regions compared with developing regions. Age, sex, race/ethnicity, and geographical region moderated the relationship. CONCLUSIONS: Lower education was associated with a greater risk for dementia in many but not all studies. The level of education associated with risk for dementia varied by study population and more years of education did not uniformly attenuate the risk for dementia. It seemed that a more consistent relationship with dementia occurred when years of education reflected cognitive capacity, suggesting that the effect of education on risk for dementia may be best evaluated within the context of a lifespan developmental model.

Cognitive engagement and cognitive aging: is openness protective?

The purpose of this study was to examine whether openness to experience is related to longitudinal change in cognitive performance across advancing age. Participants were 857 individuals from the Swedish Adoption/Twin Study of Aging (SATSA). Factors for 5 cognitive domains were created, including verbal ability, spatial ability, memory, processing speed, and a global score, g. Latent growth curve models were used to assess level and longitudinal trajectories of cognitive performance. It was hypothesized that individuals who endorsed higher levels of openness would have higher cognitive test scores and lesser rates of cognitive decline. As predicted, higher openness to experience was associated with significantly higher performance across all cognitive tests for both men and women even after adjusting for education, cardiovascular disease, and activities of daily living. Openness, however, was not predictive of differences in the trajectories of cognitive performance over age.

Does "no" mean "sometimes"? How older adults respond to the same depression symptoms with different response formats.

In this report we describe problems associated with the administration of binary choice response questionnaires, with particular attention to depression measures given to older adults. A convenience sample of 77 respondents aged 70+ completed two different versions of the 8-item Center for Epidemiologic Studies-Depression (CES-D) scale. Versions were identical except for having either two- or four- response option formats. Within-person responses were compared to determine equivalence across formats. We found that a binary-response option format over- or under-estimated depressive symptomatology. Thus, a four-response option for the CES-D may be a more precise estimate of currently experienced symptoms.

Enhanced fitness conferred by naturally occurring variation in the circadian clock.

Natural variation in clock parameters is necessary for the circadian clock to contribute to organismal fitness over a broad geographic range. Considerable variation is evident in the period, phase, and amplitude of 150 Arabidopsis accessions, and the period length is correlated with the day length at the latitude of origin, implying the adaptive significance of correctly regulated circadian timing. Quantitative trait loci analysis of recombinant inbred lines indicates that multiple loci interact to determine period, phase, and amplitude. The loss-of-function analysis of each member of the ARABIDOPSIS PSEUDO-RESPONSE REGULATOR family suggests that they are candidates for clock quantitative trait loci.