Describing randomisation: patients' and the public's preferences compared with clinicians' practice

Jenkins, Valerie; Leach, Laura; Fallowfield, Lesley; Nicholls, Karen; Newsham, Alex

doi:10.1038/sj.bjc.6600527

Cited by 42 publications

(47 citation statements)

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“…In contrast to our previous study, the description that included the analogy 'toss of a coin' did not produce such fervent dislike by the majority of patients (Jenkins et al, 2002). One explanation is that the analogy did not stand alone, it was prefaced by the statement that a computer would choose 'like the toss of a coin' together with an explanation that it is done to prevent bias.…”

Section: Discussioncontrasting

confidence: 88%

“…Although providing accurate ethical and understandable descriptions of randomisation is important, there is surprisingly little direct research elucidating the preferences of patients (Corbett et al, 1996;Featherstone and Donovan, 2002;Jenkins et al, 2002;Simon et al, 2004).…”

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confidence: 99%

“…Results showed that one explanation did not suit all. Analogies for allocation of treatment such as a 'toss of a coin' were disliked by 31% of patients and almost a quarter of the public, although this was a favoured description used by 26% clinicians in the survey (Jenkins et al, 2002). The primary limitations of this publication was that it utilised the contrived descriptions employed by the original Corbett study (Corbett et al, 1996).…”

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confidence: 99%

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The preferences of 600 patients for different descriptions of randomisation

2005

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A total of 600 patients from cancer centres throughout the UK identified their most preferred and most disliked descriptions of randomisation found in current patient information sheets and websites. The CancerBACUP description, which describes both the process of randomisation and why it is done, was most preferred 151 out of 533 (28%) There is an increasing expectation that patients should participate actively in decision making and evidence that properly informed patients are more likely to adhere to treatment (Epstein et al, 2004); thus, communicating clearly with patients and their relatives is paramount. One discussion that challenges many health professionals, even those with previous training in general communication skills (Jenkins et al, in press), is talking about randomised clinical trials (RCTs). The trial dialogue has many aspects that must be explained clearly and be tailored to an individual's needs and level of understanding to enable educated decision making. Random allocation of treatment is a key feature that patients have to appreciate prior to giving informed consent .The concept of randomisation produces difficulties for both patients and health professionals Donovan, 1998, 2002;Fleissig et al, 2001;Kerr et al, 2004;Robinson et al, 2004;Simon et al, 2004) and among members of the public (Corbett et al, 1996;Kerr et al, 2004;Robinson et al, 2004). A series of studies exploring lay conceptions of the scientific and ethical justifications for random allocation and equipoise showed that while most participants could correctly identify whether or not a method such as tossing a coin was random, they did not find randomisation itself acceptable nor that a clinician would not know which treatment was best Robinson et al, 2004).Although providing accurate ethical and understandable descriptions of randomisation is important, there is surprisingly little direct research elucidating the preferences of patients (Corbett et al, 1996;Featherstone and Donovan, 2002;Jenkins et al, 2002;Simon et al, 2004).Patient information sheets about RCTs describe the randomisation process in a variety of ways, from 'allocate patients to a treatment group at random (this means by chance, a bit like drawing lots)' (TACT trial) (TACT -Standard anthracycline-based chemotherapy with fluorouracil, epirubicin and cyclophosphamide or epirubicin and CMF vs FEC followed by sequential docetaxel as adjuvant treatment for women with early breast cancer) 'randomisation means that neither you nor your doctor picks the treatment, but a computer will decide' (VICTOR trial) (VICTOR -double blind, placebo-controlled trial of rofecoxib in colorectal cancer patients following potentially curative therapy) to 'randomisation means that for each patient a computer will be used in the central office in London at the Medical Research Council Trials Office to allocate by chance rather than a medical decision' (REO4 trial) (RE04 -a trial of interferon-a, interleukin-2 and 5-fluorouracil vs interferon-a alone in advanced renal cell cancer). Ex...

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The preferences of 600 patients for different descriptions of randomisation

2005

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“…The importance of a trusting and confident doctor-patient relationship as a part of any clinical encounter is undeniable, and in this interplay the physician's communication behaviours as perceived by the patient are of paramount importance [8,10,11,29]. However, problems arise when doctors are also researchers [6,12,25].…”

Section: Discussionmentioning

confidence: 98%

Participating in a cancer clinical trial? The balancing of options in the loneliness of autonomy: A grounded theory interview study

2007

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“…15 For example, the frequently used "flip of the coin" metaphor was clearly disliked by women and older members of the public in a 2002 study. 16 An unintended effect of its use was that some patients perceived this term as trivializing their situation. One study participant remarked, "If I had cancer I would not like to think of my fate resting on the toss of a coin."…”

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confidence: 99%

Power of an Effective Clinical Conversation: Improving Accrual Onto Clinical Trials

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The National Cancer Institute (NCI) is actively transforming clinical trials to revitalize the clinical trials system and improve patient accrual. For more than 30 years, NCI has provided information and communication resources about cancer clinical trials. The Institute supports a clinical trials Web site (www.cancer.gov/clinicaltrials) that receives nearly a half million page views a month. In addition, NCI's Cancer Information Service (800-4-CANCER, chat and e-mail) responds to 1,750 clinical trial inquiries every month. Although these numbers suggest that a high volume of clinical trial information is being exchanged between NCI, the public, and providers, most patients decide whether to participate in clinical trials during the patient-provider interaction.

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Describing randomisation: patients' and the public's preferences compared with clinicians' practice

Cited by 42 publications

References 20 publications

The preferences of 600 patients for different descriptions of randomisation

The preferences of 600 patients for different descriptions of randomisation

Participating in a cancer clinical trial? The balancing of options in the loneliness of autonomy: A grounded theory interview study

Power of an Effective Clinical Conversation: Improving Accrual Onto Clinical Trials

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