Dataset Information

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.

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.

SUBMITTER: Rebers S

PROVIDER: S-EPMC4814081 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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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 S Vermeulen E E Brandenburg A P AP Stoof T J TJ Zupan-Kajcovski B B Bos W J W WJ Jonker M J MJ Bax C J CJ van Driel W J WJ Verwaal V J VJ van den Brekel M W MW Grutters J C JC Tupker R A RA Plusjé L L de Bree R R Schagen van Leeuwen J H JH Vermeulen E G J EG de Leeuw R A RA Brohet R M RM Aaronson N K NK Van Leeuwen F E FE Schmidt M K MK Schmidt M K MK

PloS one 20160330 3

<h4>Background</h4>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.<h4>Methods</h4>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 co ...[more]

PMID: 27028128

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Project description:BACKGROUND/AIMS:Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices. METHODS:We administered a web-based survey to members of a proprietary online panel sample selected to match national US demographics. Respondents were randomized to one of five arms: four content-equivalent informational aids (animated videos, slideshows with voice-over, comics, and text) and one no-intervention control. We measured knowledge of research on medical practices using a summary knowledge score from 10 questions based on the content of the informational aids. We used analysis of variance and paired t-tests to compare knowledge scores between arms. RESULTS:There were 1500 completed surveys (300 in each arm). Mean knowledge scores were highest for the slideshows with voice-over (65.7%), followed by the animated videos (62.7%), comics (60.7%), text (57.2%), and control (50.3%). Differences between arms were statistically significant except between the slideshows with voice-over and animated videos and between the animated videos and comics. Informational aids that included an audio component (animated videos and slideshows with voice-over) had higher knowledge scores than those without an audio component (64.2% vs 59.0%, p?<?.0001). There was no difference between informational aids with a character-driven story component (animated videos and comics) and those without. CONCLUSION:Our results show that simple multimedia aids that use a dual-channel approach, such as voice-over with visual reinforcement, can improve participant knowledge more effectively than text alone. However, the relatively low knowledge scores suggest that targeted informational aids may be needed to teach some particularly challenging concepts. Nonetheless, our results demonstrate the potential to improve informed consent for research on medical practices using multimedia aids that include simplified language and visual metaphors.

Project description:ObjectivesTo establish the views of research volunteers on the consent process; to explore their views on the consent process in different research scenarios; to inform debate on emerging models of consent for participation in research.Design, setting and participants2,308 adult volunteers from the TwinsUK Registry (www.twinsuk.ac.uk) completed an online survey about their views on the consent process for use of their DNA and medical information in research. Their views on the re-consenting process in different scenarios were assessed.ResultsThe majority of volunteers preferred to be informed of the identity of the main researcher of a study in which they are participating, which is contrary to current practice. Over 80% were willing to complete the consent process online instead of face to face. On the whole, respondents did not view their DNA differently from their medical information with regard to the consent process. Research participants were more willing to give broad consent to cover future research if their DNA was to be used by the original researcher than by another researcher, even if the disease under investigation varied, in contrast to the traditional 'gold standard' whereby specific consent is required for all new research projects.DiscussionIn some scenarios, research participants reported that they would be comfortable with not signing a new consent form for future research uses of their data and DNA, and are comfortable with secure, online consent processes rather than traditional face-to-face consent processes. Our findings indicate that the perceived relationship between research participants and researchers plays an important role in shaping preferences regarding the consent process and suggest that this relationship is not captured by traditional consent processes. We argue that the development of new formats of consent should be informed by empirical research on volunteers' perceptions and preferences regarding the consent process.

Project description:As a critical component of medical practice, it is alarming that patient informed consent does not always reflect (1) adequate information provision, (2) comprehension of provided information, and (3) a voluntary decision. Consequences of poor informed consent include low patient satisfaction, compromised treatment adherence, and litigation against medical practitioners. To ensure a well-informed, well-comprehended, and voluntary consent process, the objective and replicable measurement of these domains via psychometrically sound self-report measures is critical. This systematic review aimed to evaluate the adequacy of existing measures in terms of the extent to which they assess the three domains of informed consent, are psychometrically sound and acceptable for use by patients. Extensive searching of multiple databases (PsychINFO, PubMed, Sociological Abstracts, CINAHL, AMED) yielded 10,000 potential studies, with 16 relevant scales identified. No existing scale was found to measure all three consent domains, with most only narrowly assessing aspects of any one domain. Information provision was the most frequently assessed domain, followed by comprehension, and then voluntariness. None of the identified scales were found to have adequate evidence for either high quality psychometric properties or patient user acceptability. No existing scale is fit for purpose in comprehensively assessing all domains of informed consent. In the absence of any existing measure meeting the necessary criteria relating to information, comprehension and voluntariness, there is an urgent need for a new measure of medical consent to be developed that is psychometrically sound, spans all three domains and is acceptable to patients and clinicians alike. These findings provide the impetus and justification for the redesign of the informed consent process, with the aim to provide a robust, reliable and replicable process that will in turn improve the quality of the patient experience and care provided.

Project description:BackgroundPatient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent.Purpose. To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources. A systematic literature search of English-language articles in MEDLINE (1949-2008) and EMBASE (1974-2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection. Randomized controlled trials and controlled trials with nonrandom allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction. Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis. Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations. Many studies failed to include adequate description of the study population, and outcome measures varied widely.Conclusions. A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations.

Project description:BackgroundScientific researchers who wish to reuse health data pertaining to individuals can obtain consent through an opt-in procedure or opt-out procedure. The choice of procedure may have consequences for the consent rate and representativeness of the study sample and the quality of the research, but these consequences are not well known.ObjectiveThis review aimed to provide insight into the consequences for the consent rate and consent bias of the study sample of opt-in procedures versus opt-out procedures for the reuse of routinely recorded health data for scientific research purposes.MethodsA systematic review was performed based on searches in PubMed, Embase, CINAHL, PsycINFO, Web of Science Core Collection, and the Cochrane Library. Two reviewers independently included studies based on predefined eligibility criteria and assessed whether the statistical methods used in the reviewed literature were appropriate for describing the differences between consenters and nonconsenters. Statistical pooling was conducted, and a description of the results was provided.ResultsA total of 15 studies were included in this meta-analysis. Of the 15 studies, 13 (87%) implemented an opt-in procedure, 1 (7%) implemented an opt-out procedure, and 1 (7%) implemented both the procedures. The average weighted consent rate was 84% (60,800/72,418 among the studies that used an opt-in procedure and 96.8% (2384/2463) in the single study that used an opt-out procedure. In the single study that described both procedures, the consent rate was 21% in the opt-in group and 95.6% in the opt-out group. Opt-in procedures resulted in more consent bias compared with opt-out procedures. In studies with an opt-in procedure, consenting individuals were more likely to be males, had a higher level of education, higher income, and higher socioeconomic status.ConclusionsConsent rates are generally lower when using an opt-in procedure compared with using an opt-out procedure. Furthermore, in studies with an opt-in procedure, participants are less representative of the study population. However, both the study populations and the way in which opt-in or opt-out procedures were organized varied widely between the studies, which makes it difficult to draw general conclusions regarding the desired balance between patient control over data and learning from health data. The reuse of routinely recorded health data for scientific research purposes may be hampered by administrative burdens and the risk of bias.

Project description:Background. Patient comprehension is fundamental to valid informed consent. Current practices often result in inadequate patient comprehension. Purpose. An updated review to evaluate the characteristics and outcomes of interventions to improve patient comprehension in clinical informed consent. Data Sources. Systematic searches of MEDLINE and EMBASE (2008-2018). Study Selection. We included randomized and nonrandomized controlled trials evaluating interventions to improve patient comprehension in clinical informed consent. Data Extraction. Reviewers independently abstracted data using a standardized form, comparing all results and resolving disagreements by consensus. Data Synthesis. Fifty-two studies of 60 interventions met inclusion criteria. Compared with standard informed consent, a statistically significant improvement in patient comprehension was seen with 43% (6/14) of written interventions, 56% (15/27) of audiovisual interventions, 67% (2/3) of multicomponent interventions, 85% (11/13) of interactive digital interventions, and 100% (3/3) of verbal discussion with test/feedback or teach-back interventions. Eighty-five percent of studies (44/52) evaluated patients' understanding of risks, 69% (41/52) general knowledge about the procedure, 35% (18/52) understanding of benefits, and 31% (16/52) understanding of alternatives. Participants' education level was reported heterogeneously, and only 8% (4/52) of studies examined effects according to health literacy. Most studies (79%, 41/52) did not specify participants' race/ethnicity. Limitations. Variation in interventions and outcome measures precluded conduct of a meta-analysis or calculation of mean effect size. Control group processes were variable and inconsistently characterized. Nearly half of studies (44%, 23/52) had a high risk of bias for the patient comprehension outcome. Conclusions. Interventions to improve patient comprehension in informed consent are heterogeneous. Interactive interventions, particularly with test/feedback or teach-back components, appear superior. Future research should emphasize all key elements of informed consent and explore effects among vulnerable populations.

Dataset Information

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.

Publications

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.

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