Journal ArticleDOI
Personality characteristics of volunteers in Phase 1 studies and likelihood of reporting adverse events.
Luís Pereira de Almeida,Amílcar Falcão,M. Vaz-da-Silva,Rui Coelho,António Albino-Teixeira,Patrício Soares-da-Silva +5 more
- Vol. 46, Iss: 7, pp 340-348
TLDR
Defining a personality of a volunteer may assume significant importance in Phase 1 studies because participants who volunteer for Phase1 studies, differ from the general population in their personality characteristics.Abstract:
Objective: To evaluate the personality characteristics of a group of participants in Phase 1 studies and to study the relation between the personality traits and the adverse events during participation. Methods: Study population consisted of 139 healthy volunteers to Phase 1 studies. Personality was assessed through the Revised NEO Personality Inventory (NEO-PI-R) and adverse events were monitored during participation. Results: Participants showed lower levels of Neuroticism (p < 0.001), and higher levels of Extraversion (p < 0.001) and Openness to Experience (p < 0.001) than the norm. In the Neuroticism domain, participants were lower in anxiety (p < 0.001), angry-hostility (p < 0.001), depression (p < 0.001), self-consciousness (p < 0.001) and vulnerability (p < 0.001), and higher in impulsiveness (p < 0.001). All facets of the Extraversion domain and all facets but "openness to esthetics" of the Openness to Experience domain were higher (p < 0.001) in the participants in relation to the norm. Participants were significantly lower (p < 0.05) on the overall Agreeableness domain, however, they were remarkably higher in altruism (p < 0.001) and trust (p - 0.001). Participants did not differ from the norm in the overall Conscientiousness domain, but they scored higher in competence (p < 0.001), achievement striving (p = 0.001) and self-discipline (p < 0.001). Females showed to report significantly more adverse events than males, and extraverted subjects showed to report less adverse events than introverted subjects. Conclusion: Participants who volunteer for Phase 1 studies, differ from the general population in their personality characteristics. Some personality characteristics may have an effect on the probability of reporting adverse events during participation. Therefore, defining a personality of a volunteer may assume significant importance in Phase 1 studies.read more
Citations
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Personality is of central concern to understand health: towards a theoretical model for health psychology
TL;DR: A theoretical framework to understand the links between personality and health drawing on current theorising in the biology, evolution, and neuroscience of personality is developed and argued that health psychology needs to move from its traditional focus on the individual level to engage group and organisational levels.
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Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome
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Volunteerism and self-selection bias in human positron emission tomography neuroimaging research.
TL;DR: Demographic characteristics, personality traits, and task performance of subjects who consented to the latter study were compared with those who declined participation, and findings showed that the principal personality trait that distinguished the two groups was sensation-seeking; volunteers scored significantly higher on this dimension than non-volunteers.
Dissertation
Déterminants psychologiques de l'acceptation et du refus de participer à un essai clinique destiné à prévenir la maladie d'Alzheimer en population âgée fragilisée
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Journal ArticleDOI
Credibility and comprehension of healthy volunteers in lengthy inpatient drug studies.
TL;DR: It is demonstrated that subjects who are paid larger stipends may not be more likely to report abnormalities on their medical history, and possible associations between demographic data and the reliability of information provided by normal healthy research volunteers should be examined.