Limits...
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.

Rebers S, Vermeulen E, Brandenburg AP, Stoof TJ, Zupan-Kajcovski B, Bos WJ, Jonker MJ, Bax CJ, van Driel WJ, Verwaal VJ, van den Brekel MW, Grutters JC, Tupker RA, Plusjé L, de Bree R, Schagen van Leeuwen JH, Vermeulen EG, de Leeuw RA, Brohet RM, Aaronson NK, Van Leeuwen FE, Schmidt MK - PLoS ONE (2016)

Bottom Line: 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.We 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.

View Article: PubMed Central - PubMed

Affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.

ABSTRACT

Background: Despite 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.

Methods: We 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.

Results: We 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.

Conclusion: We 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.

Trial registration: Dutch Trial Register NTR2982.

Show MeSH

Related in: MedlinePlus

Consent procedure preferences in the questionnaire for all respondents, respondents in the three intervention arms, and interviewees and non-interviewees*.*The results of logistic regression analyses testing the statistical significance of the differences between these groups are reported in S4 Table.
© Copyright Policy
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4814081&req=5

pone.0152509.g002: Consent procedure preferences in the questionnaire for all respondents, respondents in the three intervention arms, and interviewees and non-interviewees*.*The results of logistic regression analyses testing the statistical significance of the differences between these groups are reported in S4 Table.

Mentions: Respondents who preferred opt-out plus in the questionnaire were more likely to be interviewed (Fig 2 and S4 Table). Moreover, whether a patient changed preference during the interview depended on their intervention arm. Of those patients indicating a preference for opt-out plus in the questionnaire, 45% did not change their preference in the interview, and 13% changed towards informed consent. Of those respondents indicating a preference for informed consent in the questionnaire, 26% did not change their mind in the interview, but 31% changed their preference to opt-out plus (Fig 2 and S4 Table).


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.

Rebers S, Vermeulen E, Brandenburg AP, Stoof TJ, Zupan-Kajcovski B, Bos WJ, Jonker MJ, Bax CJ, van Driel WJ, Verwaal VJ, van den Brekel MW, Grutters JC, Tupker RA, Plusjé L, de Bree R, Schagen van Leeuwen JH, Vermeulen EG, de Leeuw RA, Brohet RM, Aaronson NK, Van Leeuwen FE, Schmidt MK - PLoS ONE (2016)

Consent procedure preferences in the questionnaire for all respondents, respondents in the three intervention arms, and interviewees and non-interviewees*.*The results of logistic regression analyses testing the statistical significance of the differences between these groups are reported in S4 Table.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4814081&req=5

pone.0152509.g002: Consent procedure preferences in the questionnaire for all respondents, respondents in the three intervention arms, and interviewees and non-interviewees*.*The results of logistic regression analyses testing the statistical significance of the differences between these groups are reported in S4 Table.
Mentions: Respondents who preferred opt-out plus in the questionnaire were more likely to be interviewed (Fig 2 and S4 Table). Moreover, whether a patient changed preference during the interview depended on their intervention arm. Of those patients indicating a preference for opt-out plus in the questionnaire, 45% did not change their preference in the interview, and 13% changed towards informed consent. Of those respondents indicating a preference for informed consent in the questionnaire, 26% did not change their mind in the interview, but 31% changed their preference to opt-out plus (Fig 2 and S4 Table).

Bottom Line: 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.We 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.

View Article: PubMed Central - PubMed

Affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.

ABSTRACT

Background: Despite 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.

Methods: We 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.

Results: We 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.

Conclusion: We 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.

Trial registration: Dutch Trial Register NTR2982.

Show MeSH
Related in: MedlinePlus