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2.4 The doctor as tailor - applying research to the individual

'Stuff: material for making garments.' (1462)
'Bespoke: arranged for.' (1583)
'To tailor: to fit or furnish a person with clothes.' (1832)

Shorter Oxford English Dictionary

Research produces 'stuff', information, and the knowledge revolution that has taken place in the last decade has not only indicated how the stuff produced by research has many imperfections, but has also demonstrated that the quality of the stuff can be greatly improved, initially by creating systematic reviews, and then by editing and clarifying the text that is produced. Although the quality of the product that has been created is increasingly improved by the process of purification and distillation known as systematic reviewing, research still produces 'stuff' which is no more useful for helping an individual patient make a decision than a roll of cloth is to the person who wishes to dress smartly for an important function.

Just as the tailor has to turn the stuff into garments arranged specifically for the individual person, so the clinician has to arrange the knowledge produced by research, even when its quality has been established, into a form fit for decision-making. This task has become more challenging as the stuff of research has become more plentiful and of a higher quality.

2.4.1 Tailoring 19th century stuff

In the 19th century, research products were fairly simple, usually consisting of reports of single cases or of small numbers of cases. In those days the clinician could only consider the degree to which their patient corresponded to the cases about which they had been taught or about which they had read, and make decisions accordingly. Unfortunately we now know that this approach to research gives highly biased results or results which could have occurred by chance.

2.4.2 Tailoring 20th century stuff

In the 20th century, clinical research methods developed dramatically, particularly in the latter half of the century as statistics were increasingly used.

The development of statistics took place not in medicine but in other sciences, notably in mathematics, from which statistics became a healthy offshoot, with the work being led by people like Ronald Fisher, whose classic designs for agricultural experiments later provided the model for clinical experiments. After the Second World War, the randomised controlled trial became prominent as a means of assessing the effectiveness of a new treatment of tuberculosis with streptomycin. The most important conceptual leap that statisticians made was to indicate that research had to focus not merely on single patients or small numbers of patients but on populations, namely a group of patients with common characteristics. This required an increasingly precise definition of the populations being studied, for example, the 'participants' in a trial of treatment for chronic obstructive lung disease were 'men and women aged between 40 and 70 years with a mean forced expiratory volume in one second (FEV1) 50% of predicted normal'. Patients were excluded from this study for a number of reasons if, for example, 'they used betablockers'. Consider now the problem of the clinician and the patient if the patient is 39 years old, or 72, or has used betablockers once at some time in the past.

One of the jobs of the clinician, therefore, is to take the knowledge derived from studies of populations and turn it into figures which are relevant to the individual, and this is one of the core skills of evidence-based clinical practice.

2.4.3 Evidence-based clinical practice

Evidence-based medicine developed during the 1990s, and has been defined as:

…the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgement that individual clinicians acquire through clinical experience and clinical practice. (3)

Key steps in evidence-based medicine are:

  • asking the right question
  • finding the evidence
  • appraising the evidence
  • tailoring that evidence to be relevant and applicable to the individual patient

Research often produces results stated as probabilities, indicating the relative benefit likely to be achieved from the treatment. There is, however, good evidence that providing information about the relative reduction of risk biases decision-making, a phenomenon called framing, and it is therefore essential to turn the information into absolute figures; this is one of the jobs of the clinician as tailor.

2.4.4 Giving patients information about absolute risk reduction

The first step the clinician as tailor has to take is to turn relative risk data into absolute risk data, and the technique used to do this is called the number needed to treat (NNT). This indicates the number of patients who have to be treated for one patient to benefit, and the technique has been well described and popularised by the journal Bandolier. Even having converted the data into absolute figures, the clinician still has to tailor it to the individual patient and the book Evidence-based Medicine gives guidance as to how important results from a research perspective might be applicable to a particular patient (Table 1).

Table 1: are these valid, important results applicable to our patient?

Is our patient so different from those in the study that its results cannot apply?

Is the treatment feasible in our setting?

What are our patient's potential benefits and harms from the therapy?

What are our patient's values and expectations for both the outcome we are trying to prevent and the treatment we are offering?

Sackett et al, Evidence-based Medicine (4)

The clinician then has to follow the same process of:

  • producing data about the absolute risk of harm, if only the relative risks are given in the scientific paper, and
  • considering the applicability of the number to needed to harm (NNH), namely the number who were treated for one to be harmed, and then seeking to assess the relevance of those data to the individual patient, using a checklist such as that set out below (Table 2).
Table 2: Guides for deciding whether valid important evidence about harm can be applied to our patient

Is our patient so different from those included in the study that its results don't apply?

What is our patient's risk of the adverse event?

What is our patient's potential benefit from the therapy?

What are our patient's preferences, concerns and expectations from this treatment?

What alternative treatments are available?

Sackett et al, Evidence-based Medicine (4)


2.4.5 Integrating preferences and values

Having provided the patient with the best data available, tailored to his or her particular condition, the clinician then has to help the patient weigh up the options and decide the value that they will assign to either a beneficial or an adverse outcome. An example of this approach in practice is given in the resources section describing the tailoring of information about aspirin, where the data apparently indicate a simple decision but in which the patient's condition, which determines the relevance of the data to him as an individual, and his values and preferences, have to be incorporated.

Because of the complexity of the process, different approaches have been used to develop decision aids to facilitate some of these steps.

2.4.6 The legal view of risk communication

The degree to which the doctor should disclose risk is also influenced by the courts because doctors and their employers are mindful of the possible legal consequences of any failure to disclose risk. For years legal judgements on negligence have been made with respect to the Bolam principle which was established in a case in 1957 and which states that medical actions and decisions are justifiable if they are 'in accordance with a practice accepted by a responsible body of medical men.' However, the courts are not bound by this principle, recognising that such a consensus may not be based on best current evidence, and a judgement by Lord Woolf provides the principle on which courts will accept the adequacy of the consent procedure.

The judgement, in the Pearce case in 1999, states that: 'If there is a significant risk which would affect the judgement of a reasonable patient then …. it is the responsibility of a doctor to inform the patient of that risk if the information is needed so that the patient can determine …. what course he or she should adopt.' By 'significant', the defence societies advise that the doctor should consider risks with a frequency of 1% or greater, and all risks of death or serious complications, no matter how rarely they occur. Lord Woolf's Pearce judgement also states that the clinician needs to ask himself or herself: 'Is there a significant risk which would affect the judgement of a reasonable patient in this situation, which has not been disclosed, and which I need to convey to my patient so that he or she can determine what course to adopt?'

In Australia, clearer guidance has been given, summarised below.

Relevant factors

The high court of Australia considers the following factors important in deciding whether a risk is material and must be mentioned to a patient:

  • The nature of the matter to be disclosed - More likely and more serious harms require disclosure.
  • The nature of the proposed procedure - Complex interventions require more information, as do procedures where the patient has no illness.
  • The patient's desire for information - Patients who ask questions make known their desire for information and should be told.
  • The temperament and health of the patient - Anxious patients and patients with health problems or other relevant circumstances that make a risk more important for them (such as their medical condition or occupation) may need more information.
  • The general surrounding circumstances - The information necessary for elective procedures, where several consultations are possible, may be different from that required in an emergency department

Recognising that the recollection of what patient and clinician said, never mind what they understood, during the consultation, which may have taken place months or years before the complaint or the court case, clinicians are also exhorted to keep good records of the consultation, but paper has its limitations and for difficult decisions a tape recording may provide the best record, as recommended in the enquiry into the cardiac surgery deaths in Bristol.

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