Describing randomisation: Patients' and the public's preferences compared with clinicians' practice (original) (raw)
Related papers
How do doctors explain randomised clinical trials to their patients?
European Journal of Cancer, 1999
As part of a larger study designed to improve doctor±patient communication in randomised clinical trials (RCT), we audiotaped the discussions between doctor and patient in which consent was being obtained for a RCT. This paper reports on 82 discussions conducted by 5 clinical oncologists in both District General and University Hospital outpatient departments. When introducing the subject of trials, uncertainty about treatment decisions was expressed by the doctors in the majority of cases (79, 96.3%). This was most often stated in a general sense (78, 95.1%), but some mentioned personal uncertainty (12, 14.6%), an approach which helps to maintain a trusting doctor±patient relationship. The word randomisation was mentioned in 51 (62.2%) consultations, although the process itself was usually described implicitly (78, 95.1%), e.g. by telling the patient that they would be allocated either one or other treatment. Analogies were used in 28 (34.1%) cases to describe the randomisation process. In addition, although treatments and side-eVects were described frequently, (68, 82.9%) and (72, 87.8%) respectively, information lea¯ets about the trials were not given to 23 (28%) patients. The study shows that U.K. clinicians adopt individual methods when providing information and eliciting consent to trials.
Attitudes of patients to randomised clinical trials of cancer therapy
European Journal of Cancer, 1998
The aim of this study was to test an instrument which might be useful for doctors in explaining the randomisation procedure to an individual patient. The sample comprised 323 patients with cancer attending for outpatient appointments and/or chemotherapy treatment in two major cancer centres in the U.K. 315 patients completed a self-report questionnaireÐThe Attitudes to Randomised Trials Questionnaire (ARTQ). The results show that the majority of subjects 287 (91.1%) believe that patients should be asked to take part in medical research, but only 242 (76.8%) would be prepared to take part in a study comparing two treatments. If treatment was randomised, only 141 (44.8%) would agree to participate. When given further information about the randomisation procedure, 119 (68.4%) of the 174 (55.2%) who initially said`no' to randomisation or who were unsure, would change their minds and take part in a trial. The ARTQ discriminated between three categories of patient with the following prevailing attitudes: (a) those who seem comfortable with the concept of randomisation; (b) those with some concerns, who with fuller explanation are prepared to consider randomisation; and (c) those ®rmly against randomisation and participation in trials whatever information is provided. Prior knowledge of patients' attitudes might assist communication about trials and encourage more doctors to approach eligible patients.
Journal of clinical epidemiology, 2018
To explore how the concept of randomisation is described by clinicians and understood by patients in randomised clinical trials (RCTs), and how it contributes to patient understanding and recruitment. Qualitative analysis of seventy-three audio recordings of recruitment consultations from five, multi-centre, UK based RCTs with identified or anticipated recruitment difficulties. One in ten appointments did not include any mention of randomisation. Most included a description of the method or process of allocation. Descriptions often drew on gambling-related metaphors or similies, or referred to allocation by a computer. Where reference was made to a computer, some patients assumed that they would receive the treatment that was 'best for them'. Descriptions of the rationale for randomisation were rarely present, and often only came about as a consequence of patients questioning the reason for a random allocation. The methods and processes of randomisation were usually describe...
Social Science & Medicine, 2004
Randomised controlled trials (RCTs) play a central role in modern medical advance, and they require participants who understand and accept the procedures involved. Published evidence suggests that RCT participants often fail to understand that treatments are allocated at random and that clinicians are in equipoise about which treatment is best. We examine background assumptions that members of the public might draw upon if invited to take part in a RCT. Four studies (N ¼ 82; 67; 67; 128), in the UK, identified whether members of the public (i) accept that an individual clinician might be genuinely unsure which of two treatments was better; (ii) judge that when there is uncertainty it is acceptable to suggest deciding at random; (iii) recognise scientific benefits of random allocation to treatment conditions in a trial. Around half the participants were loathe to accept that a clinician could be completely uncertain, and this was no different whether the context was one of individual treatment or research. Most participants found it unacceptable to suggest allocating treatment at random, though there was weak evidence that a research context may reduce the unacceptability. Participants did not judge that more certain knowledge would be gained about which treatment was best when treatments were allocated at random rather than by patient/doctor choice: scientific benefits of randomisation were apparently not recognised. Judgements were no different in non-medical contexts. Results suggest a large mismatch between the assumptions underlying the trial design, and the assumptions that lay participants can bring to bear when they try to make sense of descriptive information about randomisation and equipoise. Previous attempts to improve understanding by improving the clarity or salience of trial information, or of making explicit the research context, while helpful, may need to be supplemented with accessible explanations for random allocation.
Journal of Cancer Education, 2015
Comprehension of randomization is a vital, but understudied, component of informed consent to participate in cancer randomized clinical trials (RCTs). This study examines patient comprehension of the randomization process as well as sources of ongoing uncertainty that may inhibit a patient's ability to provide informed consent to participate in RCTs. Cancer patients living in rural Appalachia who were offered an opportunity to participate in a cancer treatment RCT completed in-depth interviews and a brief survey. No systematic differences in randomization comprehension between patients who consented and those who declined participation in a cancer RCT were detected. Comprehension is conceptually distinct from uncertainty, with patients who had both high and low comprehension experiencing randomization-related uncertainty. Uncertainty about randomization was found to have cognitive and affective dimensions. Not all patients enrolling in RCTs have a sufficient understanding of the randomization process to provide informed consent. Healthcare providers need to be aware of the different types of randomization-related uncertainty. Efforts to improve informed consent to participate in RCTs should focus on having patients teach back their understanding of randomization. This practice could yield valuable information about the patient's cognitive and affective understanding of randomization as well as opportunities to correct misperceptions. Education about RCTs should reflect patient expectations of individualized care by explaining how all treatments being compared are appropriate to the specifics of a patient's disease.
Qualitative differences among cancer clinical trial explanations
Social Science & Medicine, 2002
This paper examines how medical oncologists present to breast cancer patients the option of participating in experimental treatment trials. The investigation takes a case study approach, comparing two contrasting presentations of the clinical trial option. One presentation constructs the experimental trial as a locally organized, joint physicianpatient effort to determine ''best'' treatments, and minimizes uncertainty by oversimplification of the randomization process; the second presentation situates the clinical trial within the larger national research effort, underscores the uncertainty created by randomization, and casts non-enrollment as a reasonable option. These observations provide initial evidence that physician presentation of the clinical trial varies substantially and provides the first detailed look at actual discourse practices used in the United States to recruit patients to experimental protocols.
Randomised controlled trials: important but overrated?
The Journal of the Royal College of Physicians of Edinburgh, 2011
Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial (RCT) is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons. Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered?