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Research participants want to receive results from studies in which they participate. However, health researchers rarely share the results of their studies beyond scientific publication. Little is known about the barriers researchers face in returning study results to participants.
Using a mixed-methods design, health researchers (N = 414) from more than 40 US universities were asked about barriers to providing results to participants. Respondents were recruited from universities with Clinical and Translational Science Award programs and Prevention Research Centers.
Respondents reported the percent of their research where they experienced each of the four barriers to disseminating results to participants: logistical/methodological, financial, systems, and regulatory. A fifth barrier, investigator capacity, emerged from data analysis. Training for research faculty and staff, promotion and tenure incentives, and funding agencies supporting dissemination of results to participants were solutions offered to overcoming barriers.
Study findings add to literature on research dissemination by documenting health researchers’ perceived barriers to sharing study results with participants. Implications for policy and practice suggest that additional resources and training could help reduce dissemination barriers and increase the return of results to participants.
To evaluate the long-term safety and tolerability of deutetrabenazine in patients with tardive dyskinesia (TD) at 2years.
In the 12-week ARM-TD and AIM-TD studies, deutetrabenazine showed clinically significant improvements in Abnormal Involuntary Movement Scale scores compared with placebo, and there were low rates of overall adverse events (AEs) and discontinuations associated with deutetrabenazine.
Patients who completed ARM-TD or AIM-TD were included in this open-label, single-arm extension study, in which all patients restarted/started deutetrabenazine 12mg/day, titrating up to a maximum total daily dose of 48mg/day based on dyskinesia control and tolerability. The study comprised a 6-week titration period and a long-term maintenance phase. Safety measures included incidence of AEs, serious AEs (SAEs), and AEs leading to withdrawal, dose reduction, or dose suspension. Exposure-adjusted incidence rates (EAIRs; incidence/patient-years) were used to compare AE frequencies for long-term treatment with those for short-term treatment (ARM-TD and AIM-TD). This analysis reports results up to 2 years (Week106).
343 patients were enrolled (111 patients received placebo in the parent study and 232 received deutetrabenazine). There were 331.4 patient-years of exposure in this analysis. Through Week 106, EAIRs of AEs were comparable to or lower than those observed with short-term deutetrabenazine and placebo, including AEs of interest (akathisia/restlessness [long-term EAIR: 0.02; short-term EAIR range: 0–0.25], anxiety [0.09; 0.13–0.21], depression [0.09; 0.04–0.13], diarrhea [0.06; 0.06–0.34], parkinsonism [0.01; 0–0.08], somnolence/sedation [0.09; 0.06–0.81], and suicidality [0.02; 0–0.13]). The frequency of SAEs (EAIR 0.15) was similar to those observed with short-term placebo (0.33) and deutetrabenazine (range 0.06–0.33) treatment. AEs leading to withdrawal (0.08), dose reduction (0.17), and dose suspension (0.06) were uncommon.
These results confirm the safety outcomes seen in the ARM-TD and AIM-TD parent studies, demonstrating that deutetrabenazine is well tolerated for long-term use in TD patients.
Presented at: American Academy of Neurology Annual Meeting; April 21–27, 2018, Los Angeles, California,USA
Funding Acknowledgements: Funding: This study was supported by Teva Pharmaceuticals, Petach Tikva, Israel
To evaluate long-term efficacy of deutetrabenazine in patients with tardive dyskinesia (TD) by examining response rates from baseline in Abnormal Involuntary Movement Scale (AIMS) scores. Preliminary results of the responder analysis are reported in this analysis.
In the 12-week ARM-TD and AIM-TD studies, the odds of response to deutetrabenazine treatment were higher than the odds of response to placebo at all response levels, and there were low rates of overall adverse events and discontinuations associated with deutetrabenazine.
Patients with TD who completed ARM-TD or AIM-TD were included in this open-label, single-arm extension study, in which all patients restarted/started deutetrabenazine 12mg/day, titrating up to a maximum total daily dose of 48mg/day based on dyskinesia control and tolerability. The study comprised a 6-week titration and a long-term maintenance phase. The cumulative proportion of AIMS responders from baseline was assessed. Response was defined as a percent improvement from baseline for each patient from 10% to 90% in 10% increments. AlMS score was assessed by local site ratings for this analysis.
343 patients enrolled in the extension study (111 patients received placebo in the parent study and 232 patients received deutetrabenazine). At Week 54 (n=145; total daily dose [mean±standard error]: 38.1±0.9mg), 63% of patients receiving deutetrabenazine achieved ≥30% response, 48% of patients achieved ≥50% response, and 26% achieved ≥70% response. At Week 80 (n=66; total daily dose: 38.6±1.1mg), 76% of patients achieved ≥30% response, 59% of patients achieved ≥50% response, and 36% achieved ≥70% response. Treatment was generally well tolerated.
Patients who received long-term treatment with deutetrabenazine achieved response rates higher than those observed in positive short-term studies, indicating clinically meaningful long-term treatment benefit.
Presented at: American Academy of Neurology Annual Meeting; April 21–27, 2018, Los Angeles, California, USA.
Funding Acknowledgements: This study was supported by Teva Pharmaceuticals, Petach Tikva, Israel.
To determine the rate of recurrent major trauma (i.e., trauma recidivism) using a provincial population-based trauma registry. We compared outcomes between recidivists and non-recidivists, and assessed factors associated with recidivism and mortality.
Review of all adult (>17 years) major trauma patients in Nova Scotia (2001–2015) using data from the Nova Scotia Trauma Registry. Outcomes of interest were mortality, duration of hospital stay, and in-hospital complications. Multiple regression was used to assess factors associated with recidivism and mortality.
Of 9,365 major trauma patients, 2% (150/9365) were recidivists. Mean age at initial injury was 52 ± 21.5 years; 73% were male. The mortality rate for both recidivists and non-recidivists was 31%. However, after adjusting for potential confounders the likelihood of mortality was over 3 times greater for recidivists compared to non-recidivists (OR 3.67, 95% CI 2.06–6.54). Other factors associated with mortality included age, male gender, penetrating injury, Injury Severity Score, trauma team activation (TTA) and admission to the intensive care unit. The only variables associated with recidivism were age (OR 0.98, 95% CI 0.97–1.00) and TTA (OR 0.59, 95% CI 0.34–0.96).
This is the first provincial investigation of major trauma recidivism in Canada. While recidivism was infrequent (2%), the adjusted odds of mortality were over three times greater for recidivists. Further research is warranted to determine the effectiveness of strategies for reducing rates of major trauma recidivism such as screening and brief intervention in cases of violence or substance abuse.
Community characteristics, such as perceived collective efficacy, a measure of community strength, can affect mental health outcomes following disasters. We examined the association of perceived collective efficacy with posttraumatic stress disorder (PTSD) and frequent mental distress (14 or more mentally unhealthy days in the past month) following exposure to the 2004 and 2005 hurricane seasons.
Participants were 1486 Florida Department of Health workers who completed anonymous questionnaires that were distributed electronically 9 months after the 2005 hurricane season. Participant ages ranged from 20 to 79 years (mean, 48; SD, 10.7), and the majority were female (79%), white (75%), and currently married (64%). Fifty percent had a BA/BS degree or higher.
In 2 separate logistic regression models, each adjusted for individual sociodemographics, community socioeconomic characteristics, individual injury/damage, and community storm damage, lower perceived collective efficacy was significantly associated with a greater likelihood of having PTSD (OR, 0.93; 95% CI, 0.90-0.96), and lower collective efficacy was significantly associated with frequent mental distress (OR, 0.94; 95% CI, 0.92-0.96).
Programs enhancing community collective efficacy may be a significant part of prevention practices and possibly lead to a reduction in the rate of PTSD and persistent distress postdisaster. (Disaster Med Public Health Preparedness. 2019;13:44–52).
Building on the recent advances in next-generation sequencing, the integration of genomics, proteomics, metabolomics, and other approaches hold tremendous promise for precision medicine. The approval and adoption of these rapidly advancing technologies and methods presents several regulatory science considerations that need to be addressed. To better understand and address these regulatory science issues, a Clinical and Translational Science Award Working Group convened the Regulatory Science to Advance Precision Medicine Forum. The Forum identified an initial set of regulatory science gaps. The final set of key findings and recommendations provided here address issues related to the lack of standardization of complex tests, preclinical issues, establishing clinical validity and utility, pharmacogenomics considerations, and knowledge gaps.
UK Biobank is a well-characterised cohort of over 500 000 participants that offers unique opportunities to investigate multiple diseases and risk factors.
An online mental health questionnaire completed by UK Biobank participants was expected to expand the potential for research into mental disorders.
An expert working group designed the questionnaire, using established measures where possible, and consulting with a patient group regarding acceptability. Case definitions were defined using operational criteria for lifetime depression, mania, anxiety disorder, psychotic-like experiences and self-harm, as well as current post-traumatic stress and alcohol use disorders.
157 366 completed online questionnaires were available by August 2017. Comparison of self-reported diagnosed mental disorder with a contemporary study shows a similar prevalence, despite respondents being of higher average socioeconomic status than the general population across a range of indicators. Thirty-five per cent (55 750) of participants had at least one defined syndrome, of which lifetime depression was the most common at 24% (37 434). There was extensive comorbidity among the syndromes. Mental disorders were associated with high neuroticism score, adverse life events and long-term illness; addiction and bipolar affective disorder in particular were associated with measures of deprivation.
The questionnaire represents a very large mental health survey in itself, and the results presented here show high face validity, although caution is needed owing to selection bias. Built into UK Biobank, these data intersect with other health data to offer unparalleled potential for crosscutting biomedical research involving mental health.
Declaration of interest
G.B. received grants from the National Institute for Health Research during the study; and support from Illumina Ltd. and the European Commission outside the submitted work. B.C. received grants from the Scottish Executive Chief Scientist Office and from The Dr Mortimer and Theresa Sackler Foundation during the study. C.S. received grants from the Medical Research Council and Wellcome Trust during the study, and is the Chief Scientist for UK Biobank. M.H. received grants from the Innovative Medicines Initiative via the RADAR-CNS programme and personal fees as an expert witness outside the submitted work.
To determine the scope, source, and mode of transmission of a multifacility outbreak of extensively drug-resistant (XDR) Acinetobacter baumannii.
SETTING AND PARTICIPANTS
Residents and patients in skilled nursing facilities, long-term acute-care hospital, and acute-care hospitals.
A case was defined as the incident isolate from clinical or surveillance cultures of XDR Acinetobacter baumannii resistant to imipenem or meropenem and nonsusceptible to all but 1 or 2 antibiotic classes in a patient in an Oregon healthcare facility during January 2012–December 2014. We queried clinical laboratories, reviewed medical records, oversaw patient and environmental surveillance surveys at 2 facilities, and recommended interventions. Pulsed-field gel electrophoresis (PFGE) and molecular analysis were performed.
We identified 21 cases, highly related by PFGE or healthcare facility exposure. Overall, 17 patients (81%) were admitted to either long-term acute-care hospital A (n=8), or skilled nursing facility A (n=8), or both (n=1) prior to XDR A. baumannii isolation. Interfacility communication of patient or resident XDR status was not performed during transfer between facilities. The rare plasmid-encoded carbapenemase gene blaOXA-237 was present in 16 outbreak isolates. Contact precautions, chlorhexidine baths, enhanced environmental cleaning, and interfacility communication were implemented for cases to halt transmission.
Interfacility transmission of XDR A. baumannii carrying the rare blaOXA-237 was facilitated by transfer of affected patients without communication to receiving facilities.
New experimental and theoretical studies of low-density amorphous solid water (H2O(as)) and of polycrystalline ice lh are reported and integrated with other available data. A variety of evidence is put forward to support the conclusion that low-density H20(as) is derived from ice lh by slightly increasing the dispersion in the O—O separation and by introducing a distribution O—O—O angles (width c. 8°). Our theoretical analysis focusses attention on the consequences of strong intermolecular coupling of OH oscillators. The vibrational modes of both ice lh and H20(as) are found to be complex mixtures of molecular motions, so the identification of regions of the Raman or infrared spectra of these materials with particular isolated molecule modes is not useful. The theory developed gives a good, but not perfect, account of the OH stretching regions of the observed Raman and infrared spectra of ice lh and, to a lesser degree of low-density H20(as).
This study explored how coping with war-related traumatic events in Sierra Leone impacted mental health outcomes among 529 youth (aged 10–17 at baseline; 25% female) using longitudinal data from three time points (Time 1 in 2002, Time 2 in 2004, and Time 3 in 2008). We examined two types of coping items (approach and avoidance); used multiple regression models to test their relations with long-term mental health outcomes (internalizing behaviors, externalizing behaviors, adaptive/prosocial behaviors, and posttraumatic stress symptoms); and used mediation analyses to test whether coping explained the relation between previous war exposures (being raped, death of parent(s), or killing/injuring someone during the war) and those outcomes. We found that avoidance coping items were associated with lower internalizing and posttraumatic stress behaviors at Time 3, and provided some evidence of mediating the relation between death of parent(s) during the war and the two outcomes mentioned above. Approach coping was associated with higher Time 3 adaptive/prosocial behaviors, whereas avoidance coping was associated with lower Time 3 adaptive/prosocial behaviors. Avoidance coping may be a protective factor against mental illness, whereas approach coping may be a promotive factor for adaptive/prosocial behaviors in war-affected societies. This study has important implications for designing and implementing mental health interventions for youth in postconflict settings.
A quantitative prediction of global species richness in the lichenized family Trypetheliaceae employing a grid method previously used in similar approaches for the family Graphidaceae and the genus Cora (Hygrophoraceae) is provided. 421 currently known taxa were used as a base for the calculation and we predict a total of nearly 800 species, corresponding to an increase of almost 100%. Most of the unrecognized taxa are predicted to occur in the Neotropics, which have the highest known species richness. The Palaeotropics are less diverse. In contrast to Graphidaceae, which are mostly confined to rainforests, Trypetheliaceae show substantial species richness in dry forest and savannah ecosystems, and future collection efforts should take well-preserved areas representing such ecosystems into consideration.
We sought to conduct a major objective of the CAEP Academic Section, an environmental scan of the academic emergency medicine programs across the 17 Canadian medical schools.
We developed an 84-question questionnaire, which was distributed to academic heads. The responses were validated by phone by the lead author to ensure that the questions were answered completely and consistently. Details of pediatric emergency medicine units were excluded from the scan.
At eight of 17 universities, emergency medicine has full departmental status and at two it has no official academic status. Canadian academic emergency medicine is practiced at 46 major teaching hospitals and 13 specialized pediatric hospitals. Another 69 Canadian hospital EDs regularly take clinical clerks and emergency medicine residents. There are 31 full professors of emergency medicine in Canada. Teaching programs are strong with clerkships offered at 16/17 universities, CCFP(EM) programs at 17/17, and RCPSC residency programs at 14/17. Fourteen sites have at least one physician with a Master’s degree in education. There are 55 clinical researchers with salary support at 13 universities. Sixteen sites have published peer-reviewed papers in the past five years, ranging from four to 235 per site. Annual budgets range from $200,000 to $5,900,000.
This comprehensive review of academic activities in emergency medicine across Canada identifies areas of strengths as well as opportunities for improvement. CAEP and the Academic Section hope we can ultimately improve ED patient care by sharing best academic practices and becoming better teachers, educators, and researchers.
Giant ragweed has been increasing as a major weed of row crops in the last 30 yr, but quantitative data regarding its pattern and mechanisms of spread in crop fields are lacking. To address this gap, we conducted a Web-based survey of certified crop advisors in the U.S. Corn Belt and Ontario, Canada. Participants were asked questions regarding giant ragweed and crop production practices for the county of their choice. Responses were mapped and correlation analyses were conducted among the responses to determine factors associated with giant ragweed populations. Respondents rated giant ragweed as the most or one of the most difficult weeds to manage in 45% of 421 U.S. counties responding, and 57% of responding counties reported giant ragweed populations with herbicide resistance to acetolactate synthase inhibitors, glyphosate, or both herbicides. Results suggest that giant ragweed is increasing in crop fields outward from the east-central U.S. Corn Belt in most directions. Crop production practices associated with giant ragweed populations included minimum tillage, continuous soybean, and multiple-application herbicide programs; ecological factors included giant ragweed presence in noncrop edge habitats, early and prolonged emergence, and presence of the seed-burying common earthworm in crop fields. Managing giant ragweed in noncrop areas could reduce giant ragweed migration from noncrop habitats into crop fields and slow its spread. Where giant ragweed is already established in crop fields, including a more diverse combination of crop species, tillage practices, and herbicide sites of action will be critical to reduce populations, disrupt emergence patterns, and select against herbicide-resistant giant ragweed genotypes. Incorporation of a cereal grain into the crop rotation may help suppress early giant ragweed emergence and provide chemical or mechanical control options for late-emerging giant ragweed.
To demonstrate the feasibility of applying the Healthy Eating Index-2010 (HEI-2010) to the hunger relief setting, specifically by assessing the nutritional quality of foods ordered by food shelves (front-line food provider) from food banks (warehouse of foods).
This Healthy FOOD (Feedback On Ordering Decisions) observational study used electronic invoices detailing orders made by 269 food shelves in 2013 and analysed in 2015 from two large Minnesota, USA food banks to generate HEI-2010 scores. Initial development and processing procedures are described.
The average total HEI-2010 score for the 269 food shelves was 62·7 out of 100 with a range from 28 to 82. Mean component scores for total protein foods, total vegetables, fatty acids, and seafood and plant proteins were the highest. Mean component score for whole grains was the lowest followed by dairy, total fruits, refined grains and sodium. Food shelves located in micropolitan areas and the largest food shelves had the highest HEI-2010 scores. Town/rural and smaller food shelves had the lowest scores. Monthly and seasonal differences in scores were detected. Limitations to this approach are identified.
Calculating HEI-2010 for food shelves using electronic invoice data is novel and feasible, albeit with limitations. HEI-2010 scores for 2013 identify room for improvement in nearly all food shelves, especially the smallest agencies. The utility of providing HEI-2010 scores to decision makers in the hunger relief setting is an issue requiring urgent study.
A “giant” outburst of A 0535+262, a transient X-ray binary pulsar, was observed in 1994 February and March with the Burst and Transient Source Experiment (BATSE) onboard the Compton Gamma-Ray Observatory. During the outburst power spectra of the hard X-ray flux contained a QPO-like component with a FWHM of approximately 50% of its center frequency. Over the course of the outburst the center frequency rose smoothly from 35 mHz to 70 mHz and then fell to below 40 mHz. We compare this QPO frequency with the neutron star spin-up rate, and discuss the observed correlation in terms of the beat frequency and Keplerian frequency QPO models in conjunction with the Ghosh-Lamb accretion torque model.
The Full-sky Astrometric Mapping Explorer (FAME) is designed to perform an all-sky, astrometric survey with unprecedented accuracy. It will create a rigid astrometric catalog of 4 × 107 stars with 5 < mV < 15. For bright stars, 5 < mV < 9, FAME will determine positions and parallaxes accurate to < 50 μas, with proper motion errors < 50 μas/yr. For fainter stars, 9 < mV < 15, FAME will determine positions and parallaxes accurate to < 500 μas, with proper motion errors < 500 μas/yr. It will also collect photometric data on these 4 × 107 stars in four Sloan Digital Sky Survey colors. NASA selected FAME to be one of five MIDEX missions funded for a concept study. In October 1999, NASA selected FAME for launch in 2004 as the MIDEX-4 mission in its Explorer program.