Background

The day-to-day diagnosis, care and treatment of patients with inflammatory bowel disease is an area of medicine in which professional judgement and experience are at the heart of good practice. It is also an area of practice which is characterised by a great deal of uncertainty for both clinicians, and for patients and their families.  Determining the clinical pathway for an IBD sufferer is complicated by the fact that presenting symptoms may point to a range of disease trajectories, which each would require interventions of different levels of severity.  Dependent upon how unwell the patient is upon first contact with gastroenterology services, a trial and error approach is adopted, wherein less severe and invasive interventions are used first in the hope that the patient will stabilise and that use of steroids or surgery will not be required. The patient and clinician will embark upon a journey together in which maintaining a relationship of trust is important as both parties attempt to reduce uncertainty about the trajectory of the disease.  The introduction of new technologies has the potential to aid clarity and introduce new areas of ambiguity.  On the one hand, clinical uncertainty about the causes and progression of disease may be reduced, while patients might be pleased to know that there is a ‘genetic cause’ for their illness.  On the other hand, it will be necessary for both patients and clinicians to assimilate new sets of probabilities into their understandings and judgements.

For health professionals, the uncertainties of practice concern the difficult clinical judgements which need to be made about:

• the allocation of patients to ‘mild’, ‘moderate’ or ‘severe’ pathways in the first instance
• the assessment and management of the appropriate care and treatment of patients along those pathways e.g. decisions about appropriate drug and dietary regimens or the shift from controlling inflammation to surgery
• the movement of patients between pathways e.g. the movement of a patient who is initially considered to be ‘mild’ to the ‘severe’ pathway following a failure to respond to treatment, a worsening of symptoms or on evidence from exploratory procedures.
• implications for patients long and short term  ‘quality of life’
• These uncertainties are compounded by the patients’ own values, knowledge about their condition and their judgements about what constitutes quality of life.

For patients too, inflammatory bowel disease is characterised by a great deal of uncertainty relating to the range of possibilities for disease progression. Patients can be concerned about a wide range of issues. Four concerns that seem to be particularly important are:

• the effects of living with on-going uncertainty on social and psychological well-being
• concerns about the long and short term side effects of the drugs used to treat IBD, (ranging from cushingoid signs to more serious and potentially debilitating conditions)
• anxieties about the possibility of surgery at some point in the future, and in particular concern about the implications of having an ostomy
• for women in particular, if the disease is known to be ‘in the family’, there also seems to be a concern about offspring developing IBD the impact this will have upon their lives

Ethical issues arising in day-to-day practice

The uncertainties characterising the identification, diagnosis and treatment of patients with IBD and the patient experience of living with IBD can generate a number of practical ethical problems in the day to day practice of health professionals working in this area. These include the following:

• What should clinicians do in situations in which patients wish to choose a course of action that the clinician considers to be a ‘mistake’? An example might be a situation in which a patient wishes to avoid surgery even though the clinician strongly believes that this is in the patient’s best interests. To what extent is it acceptable (or even required) for clinicians to encourage patients to change their mind? When is this inappropriate?
• What should the health service and clinicians do when patients wish to opt for a course of action which is not cost effective because of important personal values e.g. a patient who prefers continued drug treatments and clinical visits to surgery because of concerns about the impact of an ostomy on their marriage?
• There is evidence that some patients will refuse an ostomy even in situations in which this means risking their lives? What is the clinician’s duty of care in such situations?  For example, how far should the social circumstances of patients be taken into account?
• What are the clinician’s duties of care in situations in which patients refuse information e.g. in situations where patients ask doctors to make decisions on their behalf?
• Should surgery be suggested at an early stage, where symptoms are severe, in order to avoid the prolonged use of high doses of strong steroids, which have potentially harmful long term consequences?

Possible implications of introducing IBD chip based screening

Against this background, what are the potential ethical implications of the introduction of an IBD chip for day-to-day care and treatment of IBD patients? Clearly, if the chip is effective at identifying patients who would gain from surgery at an early stage this has the potential to offer benefits to patients and clinicians through the removal of at least one source of anxiety.  It could also enable a reduction in the use of steroids to control the condition and time spent in hospital.  It could inform decisions about the merits of surgery for different categories of people based on their genetic risk. However, the chip also has the potential to generate a number of important ethical questions for clinicians, patients and policy-makers.  These are likely to include the following:

• To what extent will clinicians believe in the information generated by the chip when it contradicts their experience and clinical judgement? What are their ethical obligations in such situations?
• Given the evidence that the move to surgery is one major area of concern for IBD patients, to what extent will patients be reluctant to use the chip or act on it e.g. give their consent to surgery when the chip suggests that this is a course of action from which they will benefit?
• What are the implications of this for the doctor-patient relationship?
• There is some evidence that for IBD patients disease severity is not the key factor in quality of life. Given the likelihood that patient values will be important in the uptake of the chip, to what extent will patient values and patient choice be important in the judgement of the cost-effectiveness of the introduction of the chip into clinical services?
• To what extent will the chip generate rather than remove uncertainty? This has been a characteristic of much innovation in the area of genetic testing and screening.
• Clinicians in their role as trusted expert will need to communicate trust in the information provided by the chip to patients; this trust will need to be balanced with an explanation of the probabilistic link between genotype and phenotype.
• To what extent will the chip generate or reinforce anxieties about the health of family members, e.g offspring and how will this affect relationships within these families?

This EU-funded research project will investigate the ethical and social implications of the possible translation of IBD-Chip technology into the care and treatment of patients with inflammatory bowel disease.

If you would like to know more about this research project, contact catherine.heeney@ethox.ox.ac.uk