How do doctors explain randomised clinical trials to their patients?

Abstract

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-effects were described frequently, (68, 82.9%) and (72, 87.8%) respectively, information leaflets 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.

Introduction

Randomised clinical trials (RCT) are an essential component in the validation of new cancer treatments. Low levels of recruitment are a major problem in some cancer trials and it is necessary to find methods which will help to increase the recruitment of patients 1, 2, 3, 4, 5. In the U.K. the recruitment rate is between 5 and 10% for all trials, with lowest rates for patients with common tumours, i.e. 1–2% for lung and 2% for colorectal [6]. These figures cause great concern as low or slow recruitment threatens the validity of the trial. It has also been suggested that patients involved in trials may have better clinical outcomes. Whether this is due to the treatment or the expertise of institutions and individuals committed to trials or other factors such as age and health status has yet to be established [7].

A number of factors have been identified that hinder the entry of patients into trials. These are discussed in detail elsewhere 8, 9, 10 but can be divided into those affecting the clinician and those affecting the patient. The main difficulties facing the clinician include time pressures, no support staff, having to explain randomisation and obtain informed consent [8]. Giving complex information to patients about trials and describing the concept of randomisation in simple terms were the primary problems highlighted in a postal survey of 357 clinicians that established their attitudes to clinical trials of cancer therapy [11]. These communication difficulties were emphasised also by senior U.K. oncologists during communication skill training courses [12].

The patients' difficulties include an overall lack of information, uncertainty about personal benefit, poor comprehension about the value of trials and an aversion to randomisation [9]. The concept of randomisation is a difficult one for many patients newly diagnosed with cancer to comprehend [13]. It emerged as a major barrier in a study that examined patients' attitudes to the randomised clinical trial [14]. Results showed that the majority of cancer patients (287, 91.1%) believed that patients should be asked to take part in medical research. Yet when treatment was randomised only 141 (44.8%) said that they would take part. However, as further information was provided about the randomisation procedure the percentage of patients who would consider participation increased to 260 (82.5%). These results suggest that patients are willing to consider trial entry when they are provided with sufficient information about randomisation. It also implies that low recruitment rates are not entirely due to patient refusal. In a review of the clinical trial literature, Cook-Gotay [15] suggests that the major block in recruitment to trials is the physician. One reason suggested is that clinicians have a preference for a specific treatment option. Another is that they have received little formal training in how to obtain informed consent from patients.

The Helsinki Declaration provides clinicians with guidelines on the information patients should receive when considering entry to a clinical trial. Information needs to be presented in an understandable way so that the patient can make an autonomous decision regarding trial entry. It has been argued elsewhere that full information about clinical trials may depreciate the doctor–patient relationship [8] and that it may be ‘needlessly cruel' to burden patients with too much information at the point of diagnosis or relapse [3]. Simes and colleagues [1] examined the issue of information giving by comparing two approaches to consent for trials. One approach used individual consent based on the doctor's discretion, the other total disclosure of information. The results showed that some patients were able to handle detailed information about trials but others were made overly anxious which implies that consultations tailored to a patient's individual needs are best.

There is little evidence that doctors intuitively know which of their patients would require more or less information, consequently a study is being undertaken using a patient preference and attitude profile to help clinicians understand the concerns of individual patients before discussing randomisation into a treatment trial. As part of this study interviews are tape recorded. The present paper reports the results of an analysis of these recorded interviews.