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Introduction/Hypothesis

Recruitment of participants into phase 1 vaccine clinical trials can be challenging since these vaccines have not been used in humans and there is no perceived benefit to the participant. Occasionally, as was the case with a phase 1 clinical trial of an Ebola vaccine in Halifax, Canada, during the 2014–2016 West African Ebola virus outbreak, recruitment is less difficult. In this study, we explored the motivations of participants in two phase 1 vaccine trials that were concurrently enrolling at the same centre and compared the motivations of participants in a high-profile phase 1 Ebola vaccine trial to those in a less high-profile phase 1 adjuvanted seasonal influenza vaccine study.

Methods

An online survey which included participants’ prior experience with clinical trials, motivations to participate (including financial incentives), and demographic information was developed to examine the motivations of healthy participants in two phase 1 clinical vaccine trials conducted at the Canadian Center for Vaccinology in Halifax, Nova Scotia. Participants were invited via email to complete the online survey. Readability and clarity were assessed through pilot testing.

Results

A total of 49 (55.7%) of 88 participants of the two studies completed the survey (22 [55%] of 40 participants from the Ebola vaccine study and 27 [56.3%] of 48 from the adjuvanted influenza vaccine study). Motivations that were most frequently ranked among participants' top three in both trials were (1) wanting to contribute to the health of others, (2) wanting to participate in something important, (3) wanting to contribute to the advancement of science, and (4) wanting to receive an incentive such as money or a tablet.

Conclusions/Recommendations

Although media attention and financial compensation were more often cited by Ebola vaccine trial participants as a reason to participate, both altruistic and self-interested factors were important motivations for participants in their decision to participate in a phase 1 vaccine clinical trial.  相似文献   
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Objectives

The current study investigated the effects of two exercise interventions on cognitive function amongst breast cancer survivors.

Design

Pilot randomised-controlled trial.

Methods

Seventeen female cancer survivors (mean: 62.9 ± 7.8 years) were randomised into three groups: high-intensity interval training (HIIT, n = 6); moderate-intensity continuous training (MOD, n = 5); or wait-list control (CON, n = 6). The HIIT and MOD groups exercised on a cycle ergometer 3 days/week for 12-weeks. Primary outcomes were cognitive function assessments utilising CogState. Secondary outcomes were resting middle cerebral artery blood flow velocity, cerebrovascular reactivity and aerobic fitness (VO2peak). Data were analysed with General Linear Mixed Models and Cohen’s d effect sizes were calculated.

Results

All 17 participants who were randomised were available for follow-up analysis and adherence was similar for HIIT and MOD (78.7 ± 13.2% vs 79.4 ± 12.0%; p = 0.93). Although there were no significant differences in the cognitive and cerebrovascular outcomes, HIIT produced moderate to large positive effects in comparison to MOD and CON for outcomes including episodic memory, working memory, executive function, cerebral blood flow and cerebrovascular reactivity. HIIT significantly increased VO2peak by 19.3% (d = 1.28) and MOD had a non-significant 5.6% (d = 0.72) increase, compared to CON which had a 2.6% decrease.

Conclusions

This study provides preliminary evidence that HIIT may be an effective exercise intervention to improve cognitive performance, cerebrovascular function and aerobic fitness in breast cancer survivors. Considering the sample size is small, these results should be confirmed through larger clinical trials.  相似文献   
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Background  

Self-report recall questionnaires are commonly used to measure physical activity, energy expenditure and time use in children and adolescents. However, self-report questionnaires show low to moderate validity, mainly due to inaccuracies in recalling activity in terms of duration and intensity. Aside from recall errors, inaccuracies in estimating energy expenditure from self-report questionnaires are compounded by a lack of data on the energy cost of everyday activities in children and adolescents. This article describes the development of the Multimedia Activity Recall for Children and Adolescents (MARCA), a computer-delivered use-of-time instrument designed to address both the limitations of self-report recall questionnaires in children, and the lack of energy cost data in children.  相似文献   
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INTRODUCTION: There are no measures of health-related absenteeism and presenteeism validated for use in the large and increasing US Spanish-speaking population. Before using a Spanish translation of an available English-language questionnaire, the linguistic validity of the Spanish version must be established to ensure its conceptual equivalence to the original and its cultural appropriateness. OBJECTIVE: The objective of this study was to evaluate the linguistic validity of the US Spanish version of the Work Productivity and Activity Impairment questionnaire, General Health Version (WPAI:GH). METHODS: A US Spanish translation of the US English WPAI:GH was created through a reiterative process of creating harmonized forward and back translations by independent translators. Spanish-speaking and English-speaking subjects residing in the US self-administered the WPAI:GH in their primary language and were subsequently debriefed by a bilingual (Spanish-English) interviewer. RESULTS: US Spanish subjects (N = 31) and English subjects (N = 35), stratified equally by educational level, with and without a high school degree participated in the study. The WPAI-GH item comprehension rate was 98.6% for Spanish and 99.6% for English. Response revision rates during debriefing were 1.6% for Spanish and 0.5% for English. Responses to hypothetical scenarios indicated that both language versions adequately differentiate sick time taken for health and non-health reasons and between absenteeism and presenteeism. CONCLUSION: Linguistic validity of the US Spanish translation of the WPAI:GH was established among a diverse US Spanish-speaking population, including those with minimal education.  相似文献   
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We describe a familial case of Marfan's syndrome with associated intrathoracic stomach detected during the neonatal period. The patient developed a primitive leukemia at 3 months of age. Acute leukemia in a patient with Marfan's syndrome has not previously been reported.  相似文献   
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