Parents' Perceptions of Randomization in Pediatric Clinical Trials

Wiley, Frances M.; Ruccione, Kathy; Moore, Ida M.; McGuire‐Cullen, Patsy; Fergusson, Jean H.; Waskerwitz, Mary J.; Perin, Gail; Ge, Q. J.; Sather, Harland N.

doi:10.1046/j.1523-5394.1999.75010.x

Cited by 51 publications

(39 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The randomization process should be explained more explicitly: Parents need to be clearly informed that random assignment is one of the procedures that differentiates participating in the randomized clinical trial (and other trial designs) from standard treatment [18, 35,[44][45][46]. Therefore it is necessary to indicate to parents when the clinician is discussing trial-related issues and when they are discussing standard treatment issues [35].…”

Section: Discussionmentioning

confidence: 99%

“…The randomization process should be explained more clearly: Parents need to be clearly informed that random assignment is one of the procedures that differentiates participating in the RCT from standard treatment [18,35,[44][45][46]. The lack of understanding of randomization may result in a parent's disappointment [32,43] that their child was assigned to the control group.…”

Section: Parent's Comprehensionmentioning

confidence: 99%

See 1 more Smart Citation

Determinants of decision-making and patient participation in paediatric clinical trials: A literature review

Wulf¹,

Krasuska²,

Bullinger³

2012

OJPed

View full text Add to dashboard Cite

Background: Studies have shown that many drugs used in children may not have been authorised for use in this age group. This poses significant risks on children. A new EU regulation came into effect in 2007 to ensure that medicinal products that are researched, developed and authorised will also meet the therapeutic needs of children. This will mean an increased demand for children to participate in clinical trials. Objectives: To identify the needs and motivations of children and their families who have participated, might participate or declined to participate in clinical trials. Methods: We did a literature search and reviewed empirical studies which examined eligible outcomes. The findings of these studies were analyzed in a broad qualitative and descriptive bottom-up process. Results: We found that the understanding of advanced concepts of research such as randomisation is often insufficient. The needs of families affected by a serious disease are not addressed explicitly. Personal benefit and altruistic motives were two important reasons for participation. Conclusions: The comprehension of information given in the consent process should be secured by improving the information material. The communication process should be more mutual. Children and their families should be empowered to address their needs in the process of considering participation in a clinical trial.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Parent's Comprehensionmentioning

confidence: 99%

Determinants of decision-making and patient participation in paediatric clinical trials: A literature review

Wulf¹,

Krasuska²,

Bullinger³

2012

OJPed

View full text Add to dashboard Cite

show abstract

“…43 Altruism, although frequently cited by parents as a motivation for participation in trials, 49,62,63 may be a secondary consideration in their decision. 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.…”

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

View full text Add to dashboard Cite

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...

show abstract

“…The first issue involves the unique challenges that arise when subjects of the proposed trial are minors, and both the parent and child preferences need to be considered, separately and jointly. Relatively little empirical information is available concerning the determinants of parental permission for participation in a randomized controlled 66 . However, attitudes, beliefs, and values, such as the desire for decisional control, have been cited as barriers to participation.…”

Section: Discussionmentioning

confidence: 99%

Preference Assessment of Recruitment into a Randomized Trial for Adolescent Idiopathic Scoliosis

Dolan

Sabesan

Weinstein

et al. 2008

The Journal of Bone and Joint Surgery-American Volume

View full text Add to dashboard Cite

show abstract

Parents' Perceptions of Randomization in Pediatric Clinical Trials

Cited by 51 publications

References 14 publications

Determinants of decision-making and patient participation in paediatric clinical trials: A literature review

Determinants of decision-making and patient participation in paediatric clinical trials: A literature review

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

Preference Assessment of Recruitment into a Randomized Trial for Adolescent Idiopathic Scoliosis

Contact Info

Product

Resources

About