Do doctors know best? Comments on a failed trial

Structured problem solving is emerging as an effective treatment for clinical depression.^3-6 This treatment aims to teach patients to use their own resources to deal with their problems and includes skills such as identifying and simplifying problems, "brainstorming" potential solutions, and implementing these solutions. The treatment is brief, has clearly identified stages, and is very suitable for delivery by primary healthcare professionals. However, little research in primary care settings has used general practitioners as the main treatment providers, and thus the degree to which the evidence for the effectiveness of structured problem solving can be generalised to general practice is questionable. For this reason we designed a randomised trial with all treatment conducted by GPs (Box 1). The study was, in part, a replication of an earlier United Kingdom project that showed that problem solving was better than placebo, but equivalent to amitriptyline.⁴

Six months after the trial commenced no patients had been recruited.

Why did the trial fail?

• We used GPs who had participated in a Masters program designed to improve the recognition and management of mental disorders in general practice;

• We involved the participating GPs in the development of the protocols;

• We made every effort to minimise tasks involved in the study for the GPs; and

• The chief investigator was responsible for the teaching on the Masters program, and had developed a close working relationship with the GPs.

While our original intention was not to address the complexity of conducting randomised trials in clinical practice, the apparent unease of many of the GPs with randomisation raises some potential reasons for the failure (Box 2). Apparent ambivalence towards randomisation in medicine, despite strong support in the scientific literature, has been reported previously.¹¹ Silverman argues that as medicine shifts from the traditional authoritarian stance of "doctor knows best" towards the use of clinical guidelines and standardised treatment protocols, there is an increased discomfort in any approach that might be seen to admit a lack of crucial knowledge on the part of the doctor.¹¹ In other words, asking patients to consent to randomisation between two conditions admits an uncertainty that compromises the traditional doctor-patient relationship.

However, it has not been difficult to engage doctors in trials involving randomisation of their patients, and there is evidence that many are prepared to follow simple randomisation protocols.¹² For example, one of the first randomised controlled trials of giving aspirin to patients very early after myocardial infarction (to stop or reverse the thrombotic process) enrolled 2500 GPs. These GPs, who were blind to the treatment condition they were offering, agreed to give the allocated capsules (aspirin or placebo) to any patient who presented with chest pain or other symptoms likely to be caused by a myocardial infarct. Two thousand patients were recruited into the trial, suggesting that, in this example, randomisation was not a substantial concern. If it is not randomisation per se that causes reluctance to recruit, then other factors need consideration.

In our study, the audit results indicated that one in six patients had been excluded because the GPs lacked confidence that structured problem solving would be of benefit. Perhaps the GPs lacked confidence in their ability to deliver the psychological treatment effectively. If this is the case, the failure of this trial may have been influenced by the inclusion of a psychological treatment. We have argued elsewhere that doctors remain cautious about using non-drug treatments, partly because of the lack of organised promotion of non-proprietary treatments, and partly because of the difficulty in ensuring quality control.¹³ Yet, these GPs had agreed problem solving was a useful treatment, had demonstrated competence as part of their training, and two GPs in the group had conducted their own research projects where they taught structured problem solving to other doctors.

It is also possible that, given the obvious differences between the psychological and pharmacological approaches, the GPs had formed an opinion early in the recruitment process that one or other approach would better suit a particular patient. In this case, exclusion from the trial was based on the presumption that the doctor already knew what treatment was best.^11,14 In a disturbing example of "doctor knows best", two-thirds of suitable patients were not enrolled in a randomised trial of antiarrhythmia drugs because their doctors were so convinced of the benefits of the drugs that they did not want their patients allocated to the placebo group.¹⁵ The study eventually showed that these drugs were capable of causing fatal arrhythmias, so those doctors were essentially withholding from their patients the 50% chance of being allocated to the safer placebo alternative.

Other factors may cause doctors to hesitate when faced with recruiting patients, including the complexities of obtaining informed consent, the need to complete clinical ratings or ask patients to complete self-report questionnaires for measurement of outcome, or the need to work within a specific treatment protocol. Although tasks for the GPs were minimal, it is likely that the necessary role change from practitioner to scientist-practitioner was too great to facilitate a shift in treating behaviour. If this is the case, the inherent contradiction between research and delivery of care in the minds of many clinicians is a basic problem for clinical research.¹⁶

Nevertheless, treatments that are efficacious in research settings need to be evaluated under the conditions of routine care, and it may not be sufficient to rely on the use of qualitative methods to evaluate outcome in primary care.¹⁷ Perhaps an explicit use of the "uncertainty principle" in randomised controlled trials within routine clinical care will enhance recruitment rates.¹⁸ That is, if there is apparent certainty about what treatment is best, it is ethically untenable that patients should have their treatment chosen at random, so only patients for whom there is uncertainty about which treatment would be best should be recruited into a randomised trial. In this way the ethical dilemma for clinicians is solved, and the heterogeneity of the patient sample maintained, as clinicians will differ significantly in the types of patients they will be uncertain about. Financial incentives might increase the involvement of clinicians in research, but have caused public outcry in the United States;^19,20 the resulting assertive recruiting can also erode informed consent.^21,22

We argue instead that a more fundamental shift in ethos and knowledge of principles that underlie research in clinical practice is required. This argument has parallels in the recent Royal Australian College of General Practitioners report on an implementation strategy for evidence-based clinical practice guidelines.²³ The report points to a lack of understanding of the principles underpinning the use of clinical practice guidelines in general practice, and the need to develop a culture in which such guidelines are used and valued. In regard to outcome research, until doctors accept a scientist-practitioner model of practice it is unlikely that they will feel comfortable using conventional research protocols.

Clinical research conducted in routine care will help clinicians make informed decisions about what may be the best treatment for their patients based on scientifically derived knowledge. We hope that the questions raised in this article will stimulate debate and research that will directly address this important issue.

Acknowledgements

References

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Authors' details

Clinical Research Unit for Anxiety Disorders, St Vincent's Hospital, Sydney, NSW.
Louise M Shepherd, BA(Hons), MPsych, Clinical Psychologist.
Reprints will not be available from the authors.
Correspondence: Dr C J Hunt, Department of Psychology (F12), University of Sydney, NSW, 2006.
carolineATpsych.usyd.edu.au

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