Seeking informed consent to cancer clinical trials:: describing current practice

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Abstract

Clinical trials have come to be regarded as the gold standard for treatment evaluation. However, many doctors and their patients experience difficulties when discussing trials, leading to poor accrual to trials and questionable quality of informed consent. We have previously developed a typology for ethical communication about Phase II and III clinical trials within four domains: (a) shared decision making, (b) sequencing information, (c) type and clarity of information, and (d) disclosure/coercion. The aim of this study was to compare current clinical practice when seeking informed consent with this typology. Fifty-nine consultations in which 10 participating oncologists sought informed consent were audiotaped. Verbatim transcripts were analysed using a coding system to (a) identify the presence or absence of aspects of the four domains and (b) rate the quality of aspects of two domains: (i) shared decision-making and (ii) type and clarity of information. Oncologists rarely addressed aspects of shared decision-making, other than offering to delay a treatment decision (78%). Moreover, many of these discussions scored poorly with respect to ideal content. The oncologists were rarely consistent with the sequence of information provision. A general rationale for randomising was only described in 46% of consultations. In almost one third of the consultations (28.8%) doctors made implicit statements favouring one option over another, either standard or clinical trial treatment. Doctors complied with some but not other aspects of a standard procedure for discussing clinical trials. This reflects the difficulty inherent in seeking ethical informed consent and the need for communication skills training for oncologists.

Introduction

Clinical trials are now regarded as the most effective means of evaluating new cancer treatments; however, many patients do not participate in trials. In the UK it is estimated that between 5% and 10% of eligible patients (including those approached to participate and those who are not) enter clinical trials in institutions promoting clinical trial participation (Jenkins, Fallowfield, Souhami, & Sawtell, 1999). Slow trial accrual delays the assessment and introduction of effective new treatments and delays the abandonment of less effective or dangerous ones.

The reasons that eligible patients refuse participation have been explored in several studies and include concerns regarding experimentation and uncertainty and perceived loss of control over treatment decisions (Gotay, 1991; Schain, 1994). Patients frequently: (i) do not understand the rationale for trials, (ii) have poor recall of information actually provided, and (iii) may be impeded from making fully informed decisions due to physiological and psychological difficulties (Benson, Pregle, & Bean, 1991; Penman, Holland, & Bahna, 1984; Ellis, Dowsett, Butow, & Tattersall, 1999). Misunderstanding has also has been documented in patients who have received information sheets and consent forms for standard treatment protocols (Olver, Turrell, Olszewski, & Wilson, 1995), suggesting that even when the complexities of randomisation are removed, patients have difficulty in understanding the issues required for an informed choice.

In addition to the patient factors noted above, prospective studies have shown that 70–80% of non-accrual is attributable to the doctor (Lee & Breaux, 1983). Many doctors experience problems initiating discussions relating to clinical trials and find the dual roles of caring physician and experimenter difficult to resolve. Fallowfield (1995) noted that doctors included clinical trials among a list of the five most difficult areas of discussion during the consultation. The main difficulties experienced by these doctors were lack of time, lack of support staff and problems explaining difficult concepts such as randomisation. Consequently, doctors may approach only those patients with whom they have established a sufficient rapport or whom they believe will understand complex information, thus potentially reducing the generalisability of results. Clearly the trial discussion between doctor and patient is a crucial step and potential barrier to patient participation, yet little is known about the content and process of this discussion. Institutional ethics committees vet information sheets and consent forms; however, the type and amount of verbal information provided by doctors is not monitored, and the impact of that information on patient accrual and other outcomes is not clear.

Tomamichel et al. (1995) analysed the content of informed consent interviews. They concluded that doctors’ information provision and emotional supportive skills were adequate, however, the quality of negotiation in the interactions, characterised by doctors’ capacity and willingness to perceive and discuss the emotional needs, complaints or objections of patients, needed to be improved. Jenkins et al. (1999) also analysed audiotapes of informed consent interviews by noting the presence or absence of key information items and behaviours. Of note, in 48% of these consent discussions the term randomisation was not used. Information leaflets were not given to 28% of the patients and patient understanding of information about the trial was checked in only 17% of the consultations. The duration of consent consultations was less than 15 min, and most patients signed the consent document at the first consultation where the clinical trial was discussed (Jenkins et al., 1999).

Albrecht, Blanchard, Ruckdeschel, Coovert, and Strongbow (1999) videotaped cancer consultations between 12 oncologists and 48 of their patients in which patients were invited to participate in a clinical trial. The authors developed and applied a coding system (the Moffitt Accrual Analysis System—MAAS) to the videotapes in order to explore the relationship between specific physicians’ behaviours and subsequent patient accrual to clinical trials. The results of the general analysis revealed that cancer patients who joined trials did so when their relationship with their oncologist was coded as: (a) cordial, (b) demonstrating high levels of patient–physician connection and trust, and (c) the oncologist was responsive to patient concerns. In addition, physicians of patients who joined trials mentioned the benefits of the study and the side effects of the treatments more often than those of patients who did not accrue.

These studies were limited to analyses of the part of the consultation pertaining to the clinical trial and have explored the presence or absence of information and behaviours deemed to be significant in the consent discussion. The current study extends these prior analyses to explore the informed consent discussion in the context of the entire consultation in which the array of treatment options is presented. Previously, we developed a typology, incorporating a set of ethical strategies, to describe doctor–patient interactions that occur when participation in phase II and III clinical trials is discussed (Brown, Butow, Butt, Moore, & Tattersall, 2003). Our primary aim here is to describe current practice when Australian oncologists convey treatment information and seek informed consent from their patients to participate in clinical trials, and to compare these practices against the previously developed ideal typology.

Section snippets

Method

Data presented here were collected as part of a larger study exploring the effectiveness of a communication skills training programme designed to assist doctors gain ethical informed consent to Phase II and III clinical trials. The larger study employed a pre-test/post-test design. Patient and doctor variables were measured before and after doctors were involved in an intensive communication skills training workshop based on the typology mentioned previously. The data presented here were

Results

Fourteen medical oncologists from the three participating centres agreed to participate in the study. Four withdrew when they did not accrue patients to trials during the period of this study. Of the 10 remaining, four were female and six male with a mean age of 42.7 years (range, 35–60). Three practiced general oncology while the other participants practiced site-specific oncology, including breast (3), lung and prostate (2), haematologic malignancies (1) and gynecology and sarcomas (1). Three

Discussion

This study explored the communication styles currently utilised by oncologists when seeking informed consent from patients to enter cancer clinical trials. These communication styles were compared against a typology within four domains that were previously proposed as being important to gaining ethical informed consent. A coding system was devised to identify the presence of key features of these themes and to rate the quality of these exchanges.

Other authors have attempted to describe the way

Acknowledgements

We would like to acknowledge the contribution of the oncologists who participated in the study and the research nurses who recruited patients. We would also like to acknowledge Ms. Monika Dzidowski for her work in managing the data and her assistance in coding. This research was funded by the National Health and Medical Research Council of Australia (NH&MRC grant number 950461).

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