A randomised controlled trial of consent procedures for the use of residual tissues for medical research
| Autor: | B. Zupan-Kajcovski, J. H. Schagen van Leeuwen, A. P. Brandenburg, W.J. van Driel, R. A. Tupker, Marjanka K. Schmidt, M.W.M. van den Brekel, R. de Bree, Eric Vermeulen, F.E. van Leeuwen, Victor J. Verwaal, T. J. Stoof, L. Plusjé, E. Vermeulen, Marcel C.J. Jonker, Richard M. Brohet, Neil K. Aaronson, Susanne Rebers, Caroline J. Bax, R. A. de Leeuw, Jan C. Grutters, W. J. W. Bos |
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| Přispěvatelé: | Psychology Other Research (FMG), Klinische Psychologie (Psychologie, FMG), Obstetrics and Gynaecology, Oral and Maxillofacial Surgery, Dermatology, Obstetrics and gynaecology, Otolaryngology / Head & Neck Surgery, Epidemiology and Data Science, EMGO - Quality of care |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Male
Questionnaires Biomedical Research Health Care Providers Alternative medicine lcsh:Medicine Social Sciences Biochemistry law.invention 0302 clinical medicine Randomized controlled trial Sociology law Informed consent Surveys and Questionnaires Health care Medicine and Health Sciences Medicine Ethnicities 030212 general & internal medicine lcsh:Science Non-U.S. Gov't Netherlands Medicine(all) Aged 80 and over Multidisciplinary Agricultural and Biological Sciences(all) Research Support Non-U.S. Gov't Middle Aged Medical research Clinical Practice Multicenter Study Oncology Research Design 030220 oncology & carcinogenesis Randomized Controlled Trial Female Research Article Adult medicine.medical_specialty Drug Research and Development Adolescent Patients MEDLINE Research Support Research and Analysis Methods Education 03 medical and health sciences Journal Article Humans Clinical Trials Educational Attainment Aged Dutch People Pharmacology Survey Research business.industry Biochemistry Genetics and Molecular Biology(all) lcsh:R Randomized Controlled Trials Clinical trial Health Care Family medicine People and Places lcsh:Q Population Groupings Clinical Medicine business Genetics and Molecular Biology(all) |
| Zdroj: | PLoS ONE PLoS ONE [E], 11(3). Public Library of Science Rebers, S, Vermeulen, E, Brandenburg, A P, Stoof, T J, Zupan-Kajcovski, B, Bos, W J W, Jonker, M, Bax, C J, van Driel, W J, Verwaal, V J, van den Brekel, M W M, Grutters, J C, Tupker, R A, Plusje, L, de Bree, R, van Leeuwen, J H S, Vermeulen, E G J, de Leeuw, R A, Brohet, R, Aaronson, N K, Van Leeuwen, F E & Schmidt, M K 2016, ' A Randomised Controlled Trial of Consent Procedures for the Use of Residual Tissues for Medical Research: Preferences of and Implications for Patients, Research and Clinical Practice ', PLoS ONE, vol. 11, no. 3, e0152509 . https://doi.org/10.1371/journal.pone.0152509 PLoS ONE, 11(3):e0152509. Public Library of Science PLoS ONE, Vol 11, Iss 3, p e0152509 (2016) |
| ISSN: | 1932-6203 |
| DOI: | 10.1371/journal.pone.0152509 |
| Popis: | BackgroundDespite much debate, there is little evidence on consequences of consent procedures for residual tissue use. Here, we investigated these consequences for the availability of residual tissue for medical research, clinical practice, and patient informedness. MethodsWe conducted a randomised clinical trial with three arms in six hospitals. Participants, patients from whom tissue had been removed for diagnosis or treatment, were randomised to one of three arms: informed consent, an opt-out procedure with active information provision (opt-out plus), and an opt-out procedure without active information provision. Participants received a questionnaire six weeks post-intervention; a subsample of respondents was interviewed. Health care providers completed a pre- and post-intervention questionnaire. We assessed percentage of residual tissue samples available for medical research, and patient and health care provider satisfaction and preference. Health care providers and outcome assessors could not be blinded. ResultsWe randomised 1,319 patients, 440 in the informed consent, 434 in the opt-out plus, and 445 in the opt-out arm; respectively 60.7%, 100%, and 99.8% of patients’ tissue samples could be used for medical research. Of the questionnaire respondents (N = 224, 207, and 214 in the informed consent, opt-out plus, and opt-out arms), 71%, 69%, and 31%, respectively, indicated being (very) well informed. By questionnaire, the majority (53%) indicated a preference for informed consent, whereas by interview, most indicated a preference for opt-out plus (37%). Health care providers (N = 35) were more likely to be (very) satisfied with opt-out plus than with informed consent (p = 0.002) or opt-out (p = 0.039); the majority (66%) preferred opt-out plus. ConclusionWe conclude that opt-out with information (opt-out plus) is the best choice to balance the consequences for medical research, patients, and clinical practice, and is therefore the most optimal consent procedure for residual tissue use in Dutch hospitals. |
| Databáze: | OpenAIRE |
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