Patients' perceptions on informed consent and the quality of information disclosure in clinical trials

Verheggen, Frank W.S.M.; Jonkers, Ruud; Kok, Gerjo

doi:10.1016/0738-3991(96)00859-2

Cited by 63 publications

(50 citation statements)

References 7 publications

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“…Clinicians may be aware of this disconnect between participant satisfaction and adequate understanding. Verheggen and colleagues assessed the beliefs of trial-clinicians regarding patient understanding [16]. Many clinicians felt that their patients had inadequate understanding of aspects of clinical trial participation.…”

Section: Discussionmentioning

confidence: 99%

Satisfaction with the decision to participate in cancer clinical trials is high, but understanding is a problem

Jefford

Mileshkin

Matthews

et al. 2010

Support Care Cancer

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Section: Discussionmentioning

confidence: 99%

Satisfaction with the decision to participate in cancer clinical trials is high, but understanding is a problem

Jefford

Mileshkin

Matthews

et al. 2010

Support Care Cancer

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“…26,45,64 The seriousness of the child's condition and the urgency surrounding trial entry and parents' resulting sense of vulnerability have also been found to be important influences on how parents experience recruitment to trials. 31,32,55,65 However, the relationship between anxiety, vulnerability and trial decisions may be mediated or moderated by factors such as trust in medical research 66 and the parent-practitioner relationship. 23,56,[67][68][69][70] The practicalities of trial participation are less commonly mentioned; 71 this may reflect the fact that most studies have been conducted in neonatology and oncology, when the child is usually in hospital at the time of the trial approach.…”

Section: Influences On Parents' Decision To Enter Their Child Into a mentioning

confidence: 99%

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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“…Previous studies have explored other aspects of the informed consent process in the ED setting such as the readability of consent forms 8 or patient recall of aspects of the informed consent process. 9,10 Other investigators have used a mock study format to examine the potential impact of the title and length of a survey instrument on response rates. 11 We believe that ours is the first study that has at-tempted to measure the potential impact of different risk presentations on participation in a hypothetical clinical trial.…”

Section: Discussionmentioning

confidence: 99%

Evaluating Acceptance and Understanding of Risk in the Emergency Department:Are All Risk Statements Created Equally?

Feldman

Risbano

Mitchell

et al. 2002

Academic Emergency Medicine

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Abstract. Objective: To determine whether mathematically equivalent but conceptually different presentations of risk from radioactive isotope exposure might affect the rate of agreement to participate in a hypothetical research study. Methods: This was a prospective study of consenting English-speaking subjects more than 18 years of age who were asked whether they would agree to participate in a mock study when presented with six mathematically equivalent statements of research-related risk. Participants were classified as recognizing the equivalence of the risk statements if they accepted all or refused all of the risk statements. Results: Three hundred forty-six subjects were enrolled. There were 55 subjects (16%; 95% CI = 12% to 20%) who refused all of the six risk statements, and 23 participants (6.7%; 95% CI = 4% to 9%) who accepted all of the given risk statements. Most of the participants (77%; 95% CI = 73% to 82%) did not recognize that the six risk statements were equivalent and agreed to some, or did not understand some of the risk statements. In stepwise multivariate logistic regression, being white, being of older age, and having higher education were associated with a higher likelihood of accepting or rejecting all six of the risk statements. Conclusions: Ethnicity, age, and education affected whether patients recognized the equivalence of six risk statements for a hypothetical study of low-dose radiation. Risk acceptance may be more likely when familiar concepts are used to express research risks. Researchers must focus on strategies that enhance the understanding of research risks and address the reasons for nonparticipation by subjects who are younger, of different ethnic or cultural background, or of lower education.

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Patients' perceptions on informed consent and the quality of information disclosure in clinical trials

Cited by 63 publications

References 7 publications

Satisfaction with the decision to participate in cancer clinical trials is high, but understanding is a problem

Satisfaction with the decision to participate in cancer clinical trials is high, but understanding is a problem

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

Evaluating Acceptance and Understanding of Risk in the Emergency Department:Are All Risk Statements Created Equally?

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