Who is willing to participate in low-risk pragmatic clinical trials without consent?

Autor: Rafael Dal-Ré, Xavier Carné, Antonio J. Carcas
Rok vydání: 2017
Předmět:
Adult
Male
Risk
medicine.medical_specialty
Adolescent
Pragmatic randomized controlled trial
030204 cardiovascular system & hematology
Written informed consent
law.invention
Young Adult
03 medical and health sciences
0302 clinical medicine
Consistency (negotiation)
Learning health care system
Randomized controlled trial
Informed consent
law
Pragmatic Clinical Trials as Topic
medicine
Humans
Pharmacology (medical)
030212 general & internal medicine
Patient participation
Survey
Probability
Randomized Controlled Trials as Topic
Pharmacology
Research ethics
Informed Consent
General notification
business.industry
General Medicine
Middle Aged
Clinical Trial
humanities
Preference
Clinical trial
Low-intervention clinical trial
Cross-Sectional Studies
Family medicine
Respondent
Female
Patient Participation
business
Zdroj: European Journal of Clinical Pharmacology
Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid
Consejería de Sanidad de la Comunidad de Madrid
ISSN: 1432-1041
0031-6970
Popis: Purpose General notification offers a possible alternative to written informed consent for pragmatic randomized controlled trials (pRCTs). It involves patients being informed through brochures, posters, and letters that research is being conducted simultaneously to providing clinical care and that patients will be enrolled in pRCTs without study-specific consent. A previous survey found that a substantial minority of respondents endorsed general notification. We aimed to know who is willing to enroll in this type of trials using general notification rather than written consent. Methods The previous study was a cross-sectional, probability-based survey, with a 2 × 2 factorial design. Two scenarios were assessed: two low-risk pRCTs in hypertension, one comparing two drugs with similar benefit/risk ratio and the other taking the same drug in the morning or at night. Each scenario had two routes: written consent vs verbal consent and written consent vs general notification. In this study, we were interested in the latter route in both scenarios. Respondents’ preferences were measured based on their recommendation to the research ethics committee and the respondent’s personal preference. We aimed to investigate the characteristics of those supporting general notification in either outcome or the variables explaining consistency and inconsistency between their personal preference and their recommendation. Based on the results of the original survey, we aimed to have at least 200 inconsistent respondents; to this end, the sample size was increased accordingly in a second wave of the survey. Results One thousand six hundre and ten respondents were included; 1003 from the original survey and 607 new ones belonging to the second wave. Thirty-nine percent of respondents chose general notification as personal preference and/or recommendation. Respondents with lower education levels were more prone to accept general notification than those holding a university degree [OR (95% CI)], primary school [2.959 (2.069–4.232)], secondary school [2.899 (2.09–4.021)], or high school [1.620 (1.184–2.217)]. Also unemployed [1.372 (1.064–1.770)] and retired [1.445 (1.049–1.990)], but not students, showed preference for general notification in comparison with those employed. Individuals more than 24 years old and having received high school or university (or postgraduate) education were statistically significantly more consistent in their decisions. Conclusions Thirty-nine percent of respondents is open to not to be asked for their informed consent in low-risk pRCTs; of these, those being less educated and not having current job or being retired are significantly more open to general notification. The use of this alternative method to written consent for simultaneous conduct of pRCTs and care should be considered and educational programs settled up to, in the case of public acceptance, ensure its ethical appropriateness. Electronic supplementary material The online version of this article (10.1007/s00228-017-2332-1) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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