A Physician-Directed Intervention: Teaching and Measuring Better Informed Consent

Yap, Tsiao Yi; Yamokoski, Amy D.; Noll, Robert B.; Drotar, Dennis; Zyzanski, S. J.; Kodish, Eric

doi:10.1097/acm.0b013e3181acfbcd

Cited by 47 publications

(88 citation statements)

References 20 publications

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“…Previous research on the 'look' of trial communication has been critical of how practitioners communicate about trials and encouraged them to facilitate interactivity. 12,33,35,40,[135][136][137] We found that parents and young people said very little in trial discussions and asked few questions. Evidence suggests that low family interactivity is common to many types of practitioner-family consultation, not just trial discussions.…”

Section: Parents' and Practitioners' Experiences Of The Trial Approachmentioning

confidence: 99%

“…75,76 This means that when a parent's and young person's wishes differ, they must discuss the decision. While interventions to improve parental understanding of trials have been reported, 35,36 we are not aware of any studies investigating interventions to promote young people's understanding of research. not in others.…”

Section: Young Peoplementioning

confidence: 99%

“…It is important to extend the evidence base to families who have been approached about 'real' clinical trials across a range of different specialties and to include the perspectives of those who decline as well as those who consent. Existing interventions to improve recruitment and its conduct in children's trials have generated some promising findings, 35,36 although these are in the early stages of development. This study is therefore important to provide a comprehensive investigation of the processes of recruitment, with the aim of identifying strategies to improve recruitment and its conduct that can be applied across the spectrum of trials of medicines for children.…”

Section: Rationale and Objectivesmentioning

confidence: 99%

“…148 However, previous research on communication about trials has suggested that face-to-face trial discussions have an important role in improving participants' understanding, 149 and that efforts by practitioners to facilitate patient interactivity may be important in helping patients to understand trials. 35,40 In our study, practitioners rarely asked open questions to explore parents' views or understanding of the trial. We also found that several parents misunderstood aspects of the trials.…”

Section: Comparison With Existing Evidence: What Does This Study Add?mentioning

confidence: 99%

“…An intervention based on this feedback, and on studies stressing the importance of encouraging parental participation, 12,23,33 was used to train practitioners in communication techniques, such as simplifying information, prompting parents' interactions and encouraging them to ask questions. 35 The training was evaluated using researcher-assessed measures of parental understanding. Improvements were found in parents' understanding of the voluntary nature of the trial but not in their understanding of randomisation.…”

Section: Interventions To Improve Understandingmentioning

confidence: 99%

See 4 more Smart Citations

Processes in recruitment to randomised controlled trials of medicines for children (RECRUIT): a qualitative study

Shilling

Williamson²,

Hickey³

et al. 2011

Health Technol Assess

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How to obtain copies of this and other HTA programme reports An electronic version of this title, in Adobe Acrobat format, is available for downloading free of charge for personal use from the HTA website (www.hta.ac.uk). A fully searchable DVD is also available (see below).Printed copies of HTA journal series issues cost £20 each (post and packing free in the UK) to both public and private sector purchasers from our despatch agents.Non-UK purchasers will have to pay a small fee for post and packing. For European countries the cost is £2 per issue and for the rest of the world £3 per issue. How to order:-fax (with credit card details) -post (with credit card details or cheque) -phone during office hours (credit card only).Additionally the HTA website allows you to either print out your order or download a blank order form. Contact details are as follows:Synergie UK (HTA Department) Digital House, The Loddon Centre Wade Road Basingstoke Hants RG24 8QW Email: orders@hta.ac.uk Tel: 0845 812 4000 -ask for 'HTA Payment Services' (out-of-hours answer-phone service) Fax: 0845 812 4001 -put 'HTA Order' on the fax header Payment methods Paying by chequeIf you pay by cheque, the cheque must be in pounds sterling, made payable to University of Southampton and drawn on a bank with a UK address.Paying by credit card You can order using your credit card by phone, fax or post. SubscriptionsNHS libraries can subscribe free of charge. Public libraries can subscribe at a reduced cost of £100 for each volume (normally comprising 40-50 titles). The commercial subscription rate is £400 per volume (addresses within the UK) and £600 per volume (addresses outside the UK). Please see our website for details. Subscriptions can be purchased only for the current or forthcoming volume.How do I get a copy of HTA on DVD?Please use the form on the HTA website (www.hta.ac.uk/htacd/index.shtml). HTA on DVD is currently free of charge worldwide.The website also provides information about the HTA programme and lists the membership of the various committees. HTAProcesses in recruitment to randomised controlled trials of medicines for children (RECRUIT): a qualitative study NIHR Health Technology Assessment programmeThe Health Technology Assessment (HTA) programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care. The research findings from the HTA programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the 'National Knowledge Service' . The HTA programme is n...

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Section: Parents' and Practitioners' Experiences Of The Trial Approachmentioning

confidence: 99%

Section: Young Peoplementioning

confidence: 99%

Section: Rationale and Objectivesmentioning

confidence: 99%

Section: Comparison With Existing Evidence: What Does This Study Add?mentioning

confidence: 99%

Section: Interventions To Improve Understandingmentioning

confidence: 99%

See 3 more Smart Citations

Processes in recruitment to randomised controlled trials of medicines for children (RECRUIT): a qualitative study

Shilling

Williamson²,

Hickey³

et al. 2011

Health Technol Assess

View full text Add to dashboard Cite

show abstract

Assessment of Factors Associated With Parental Perceptions of Voluntary Decisions About Child Participation in Leukemia Clinical Trials

et al. 2021

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Key Points Question Are health literacy, contextual factors, or sociodemographic characteristics associated with parental perception of voluntariness during informed consent for pediatric leukemia clinical trials? Findings In this cross-sectional study that included 97 parents of children with newly diagnosed leukemia, lower perception of voluntariness was significantly associated with lower health literacy. Meaning Low health literacy may have a role in parents not making complete and meaningful informed decisions for their child’s participation in cancer clinical trials.

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The Limits of Informed Consent for an Overwhelmed Patient: Clinicians' Role in Protecting Patients and Preventing Overwhelm

Bester

Cole

Kodish

2016

AMA Journal of Ethics

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In this paper, we examine the limits of informed consent with particular focus on ways in which various factors can overwhelm decision-making capacity. We introduce overwhelm as a phenomenon commonly experienced by patients in clinical settings and distinguish between emotional overwhelm and informational overload. We argue that in these situations, a clinician's primary duty is prevention of harm and suggest ways in which clinicians can discharge this obligation. To illustrate our argument, we consider the clinical application of genetic sequencing testing, which involves scientific and technical information that can compromise the understanding and decisional capacity of most patients. Finally, we consider and rebut objections that this could lead to paternalism.

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A Physician-Directed Intervention: Teaching and Measuring Better Informed Consent

Abstract: Academic physicians who are involved in the current transformation of clinical research should be trained to conduct effective ICCs. The "see one, do one, teach one" approach is no longer adequate for informed consent.

Cited by 47 publications

References 20 publications

Processes in recruitment to randomised controlled trials of medicines for children (RECRUIT): a qualitative study

Processes in recruitment to randomised controlled trials of medicines for children (RECRUIT): a qualitative study

Assessment of Factors Associated With Parental Perceptions of Voluntary Decisions About Child Participation in Leukemia Clinical Trials

The Limits of Informed Consent for an Overwhelmed Patient: Clinicians' Role in Protecting Patients and Preventing Overwhelm

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