None of our business?BMJ 1998; 316 doi: https://doi.org/10.1136/bmj.316.7129.482 (Published 07 February 1998) Cite this as: BMJ 1998;316:482
Her condition was intimate, embarrassing, and, it seemed, intractable. The various creams and tablets I had supplied over the past few months had been exposed as expensive placebos given only to punctuate the passage of time that cures so much of the primary care caseload. We both agreed it was high time for specialist referral.
She saw the top man at the nearest teaching hospital, who immediately referred her on to a research fellow with a special interest in the condition. She was offered personal follow up in a dedicated clinic, where she was invited to participate in a research trial sponsored by an independent charity. The objective of the research was, firstly, to document in more detail the features and natural history of the disease, including its effect on emotional wellbeing, and, secondly, to assess through a randomised trial the comparative effects of the current market leaders in pharmacotherapy.
I heard the research fellow present some cases at an academic meeting. She was mature, articulate, and, I thought, sensitive to the priorities and choices of the patients being discussed. I later discovered that she had redesigned the consent form to give more prominence to the right to withdraw from the trial at any stage. Any patient choosing not to participate in the trial would still be seen in her clinic and offered the best available care.
Given this background, I was surprised when my patient returned within a month of her auspicious first appointment and expressed anger at having been sent there at all. She readily agreed that the doctor had been “excellent,” and had shown considerable knowledge of her rare and distressing disease. Her symptoms were now better controlled than they had been for years. Nevertheless, she said, she had found the research experience unexpected and traumatic.
I asked the patient to return for a full and frank discussion in protected time. Contrary to my initial impression, she was not planning litigation and had no grievance about any aspect of her clinical care. The professor who acted as middle man was described as “lovely.”
I asked her what she thought of clinical research in general. She immediately cited the case of a relative who owed his life to medical science, and agreed that patients had a moral responsibility to participate in trials of new drugs, not just for their own benefit but for the greater good. She had no problem with doing just that. But medical research, she explained, ought to be about the “medical” aspects of the disease, not about how patients feel about it. It was the inquiry into her wellbeing that had triggered her feelings of exploitation and betrayal.
These days, research which fails to address patients' priorities or assess the impact of interventions on their quality of life is rightly dismissed as irrelevant and sometimes unethical. But perhaps those (myself included) who bang the drum for this essential aspect of the research agenda should reflect on the paradox that the more “patient centred” the research becomes, the more some patients will find it intrusive and unacceptable.