Corrected Feedback: A Procedure to Enhance Recall of Informed Consent to Research Among Substance Abusing Offenders

Festinger, David S.; Dugosh, Karen L.; Croft, Jason R.; Arabia, Patricia L.; Marlowe, Douglas B.

doi:10.1080/10508422.2010.491767

Cited by 25 publications

(19 citation statements)

References 42 publications

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“…[32, 33] Given that longer-term retention of information is typically poor, this approach allows the investigator to assess understanding at the time decisions are actually made. These exercises are also useful in identifying problem areas and in directing investigator efforts towards targeted discussion.…”

Section: Discussionmentioning

confidence: 99%

Using digital multimedia to improve parents’ and children's understanding of clinical trials

2015

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Objective Data show that many research subjects have difficulty understanding study information using traditional paper consent documents. This study, therefore, was designed to evaluate the effect of an interactive multimedia program on improving parents’ and children’s understanding of clinical trial concepts and participation. Methods Parents (n = 148) and children (n = 135) were each randomized to receive information regarding clinical trials using either a traditional paper format (TF) or an interactive iPad program (IP) with in-line exercises. Participants’ understanding of the information was assessed using semi-structured interviews prior to (pre-test) and after (post-test) receiving the information. Participants also completed a short survey to assess their perceptions of the information delivery and satisfaction with the process. Results Regardless of the mode of information delivery, all participants demonstrated improved pre- to post-test understanding. While there were no statistical differences in parents’ post-test understanding between the TF and IP groups, children in the IP group had significantly greater post-test understanding compared with children in the TF group (11.65(4.1) vs 8.85(4.1) [2.8, 1.4,4.2] 0–18 scale where 18 = complete understanding). Furthermore, the IP was found to be significantly “easier to follow” and “more effective” in presenting information compared with the TF. Conclusions Results demonstrated the importance of providing information regarding clinical trial concepts to parents and children. Importantly, the ability of interactive multimedia to improve understanding of clinical trial concepts and satisfaction with information delivery, particularly among children, supports this approach as a novel and effective vehicle for enhancing the informed consent process.

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Section: Discussionmentioning

confidence: 99%

Using digital multimedia to improve parents’ and children's understanding of clinical trials

2015

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“…Although numerous studies have found cognitive variables (IQ, memory, attention) to be positively correlated with consent recall, 1,2,6,23 in statistical combination, these variables account for less than half of the variance. 24 This suggests that remedial strategies may address only part of the problem and that other factors may be involved.…”

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confidence: 90%

“…Participants are often unaware that they were participating in a research study, fail to recall study-related risks, are unable to describe randomization procedures or placebo interventions, and are unaware that they can withdraw from a study without negative consequences. 3–5 Research in a population of substance abusing offenders 6,7 revealed that participants failed to recall 60% of consent information just two weeks after their initial consent, calling into question whether participants can make informed decisions about their initial or continued involvement in research.…”

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Achieving new levels of recall in consent to research by combining remedial and motivational techniques: Table 1

et al. 2013

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Introduction Research supports the efficacy of both a remedial consent procedure (corrected feedback) and a motivational consent procedure (incentives) for improving recall of informed consent to research. Although these strategies were statistically superior to standard consent, effects were modest and not clinically significant. This study examines a combined incentivized consent and corrected feedback that simplifies the cognitive task and increases motivation to learn consent information. Methods We randomly assigned 104 individuals consenting to an unrelated host study to a consent as usual (CAU) condition (n = 52) or an incentivized corrected feedback (ICF) condition (n = 52). All participants were told they would be quizzed on their consent recall following their baseline assessment and at 4 monthly follow-ups. ICF participants were also informed that they would earn $5.00 for each correct answer and receive corrected feedback as needed. Results Quiz scores in the two conditions did not differ at the first administration (p = 0.39, d = 0.2), however ICF scores were significantly higher at each subsequent administration (second : p = 0.003, Cohen’s d = 0.6; third: p < 0.0001, d = 1.4; fourth: p < 0.0001, d = 1.6; fifth: p < 0.0001, d = 1.8.) Conclusions The ICF procedure increased consent recall from 72% to 83%, compared to the CAU condition in which recall decreased from 69% to 59%. This supports the statistical and clinical utility of a combined remedial and motivational consent procedure for enhancing recall of study information and human research protections.

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“…This could be accomplished by using audio-visual tools, such as videos that clearly communicate the risks and benefits of participating in research (Dunn andJeste, 2001 andFureman et al, 1997). The validity of consent may also be increased by a consent process that assesses participants' understanding of the research study and the risks and benefits of participation, and corrects any misunderstandings (Festinger, Dugosh, Croft, Arabia, & Marlowe, 2010). More research is required on how best to obtain consent to research participation in substance abusing populations (Carter and Hall, 2008, Dunn and Jeste, 2001and Festinger et al, 2010.…”

Section: Studies Of Craving In Formerly Dependent Individualsmentioning

confidence: 99%

Ethical implications of research on craving

Carter

Hall

2013

Addictive Behaviors

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Cravings, intense desires to experience the effects of a drug, are widely regarded as significant impediments to overcoming addiction, although their role in relapse may be overstated. Scientists and clinicians wish to better understand the neurobiological and cognitive basis of craving so that they may develop psychotherapeutic, pharmacological and other medical methods to reduce craving and thereby drug use. The conduct of such research raises significant ethical issues. When recruiting individuals and conducting this research, scientists need to ensure that substance dependent participants have the capacity to provide free and uncoerced consent. This is especially the case in studies in which dependent participants are given their drug of addiction or provided with other inducements to participate (e.g. financial incentives) that may undermine their ability to fully consider the risks of participation. Treatments for addiction that seek to reduce cravings may also carry risks. This includes psychotherapeutic approaches, as well as pharmacological and medical treatments. Clinicians need to consider the risks and benefits of treatment and carefully communicate these to patients. The desire to reduce urges to use drugs should not be employed to justify potentially harmful and ineffective treatments. The safety and effectiveness of emerging treatments should be assessed by well conducted randomized controlled clinical trials.

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Corrected Feedback: A Procedure to Enhance Recall of Informed Consent to Research Among Substance Abusing Offenders

Cited by 25 publications

References 42 publications

Using digital multimedia to improve parents’ and children's understanding of clinical trials

Using digital multimedia to improve parents’ and children's understanding of clinical trials

Achieving new levels of recall in consent to research by combining remedial and motivational techniques: Table 1

Ethical implications of research on craving

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