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Clinician-trialist rounds: 4. Why not do an N-of-1 RCT?

Are you frustrated in your attempts to help individual patients with chronic illnesses whose symptoms (despite high compliance with your evidence-based prescriptions) remain poorly controlled with their current arrays of medications? Do you wish there was some way to reliably sort out which drugs and doses are helping them, which are useless or even making them worse, and which additional drugs might help? And if you asked around, would you find that your clinical colleagues were facing similar dilemmas with individual patients in their practices? Would you like to be able to solve your individual patients’ problems, and help your colleagues solve theirs? Finally, wouldn’t it put the frosting on the cake if, by doing so, you generated a higher profile at your institution, and found your clinician-trialist ways of thinking become more widely accepted and appreciated by your clinical colleagues? The foregoing scenario isn’t made up. It accurately describes my situation as I completed my second residency in internal medicine (switching from nephrologist to hospitalist) and began seeing patients in my new referral clinic in 1985. Even when my new diagnoses were confirmed and I was convinced that my patients were taking their new medicines, I frequently failed to relieve – or even improve – the disabling symptoms of their chronic illnesses; sometimes I even made them worse. Often there were no RCTs to guide their therapy; other times they presented as ‘non-responders’ to treatments that had been validated in RCTs. Worst of all, even when a patient improved during one of my uncontrolled ‘therapeutic trials’ of starting a new treatment or stopping an old one, I couldn’t tell whether their illness had simply improved on its own, whether their symptoms had ‘regressed toward the mean,’ whether it was simply a placebo effect, whether I was minimizing their on-going symptoms through hope, or whether they were minimizing them through charity. I simply had no way to objectively determine whether my uncontrolled ‘therapeutic trials’ were really helping individual patients in my practice. When I described my dilemma to a psychologiststatistician colleague, she pointed me to the psychology literature on ‘single-subject’ experimental designs where the units of randomization were times, not persons [1]. Fascinated by this potential solution to my therapeutic dilemmas, I presented what I’d learned at a ‘Continuing Education Round’ in my other department at McMaster, Clinical Epidemiology and Biostatistics. A brilliant mentee of mine, Gordon Guyatt, shared my enthusiasm and we soon embarked on the following N-of-1 RCT: