The ‘n = 1’ randomized controlled trial

Guyatt G , Sackett D , Taylor DW , Chong J , Roberts R , Pugsley S . Determining optimal therapy – randomized trials in individual patients. N Engl J Med 1986; 314: 889–892.

Robin ED , Burke CM . Single-patient Randomized Clinical Trial: opiates for intractable dyspnoea. Chest 1986; 90: 888–892.

McLeod RS , Taylor DW , Cohen Z , Cullen JB . Single-patient randomised clinical trial: use in determining optimum treatment for patient with inflammation of Kock continent ileostomy reservoir. Lancet 1986; i: 726–728.

Woolf GM , Townsend M , Guyatt G . Treatment of cryptosporidiosis with spiramycin in AIDS. J Clin Gastroenterol 1987; 9: 632–634.

Jaeschke R , Guyatt GH . Randomized trials in the study of antihypertensive drugs. Am J Hypertension 1990; 3: 811–814.

March L , Irwig L , Schwarz J , Simpson J , Chock C , Brooks P . n of 1 trials comparing a non-steroidal anti-inflammatory drug with paracetamol in osteoarthritis. Br Med J 1994;309: 1041–1046.

McQuay H . N of 1 trials. In: Max M , Portenoy R , Laska E eds. Advances pain research and therapy, Vol 18. New York: Raven Press, 1991: 179–192.

McQuay HJ , Carroll D , Jadad AR et al. Dextromethorphan for the treatment of neuropathic pain: a double-blind randomised controlled crossover trial with integral n-of-1 design. Pain 1994; 59: 127–133.

Bruera E , Schoeller T , MacEachern T . Symptomatic benefit of supplemental oxygen in hypoxemic patients with terminal cancer: the use of the N of 1 randomised controlled trial. J Pain Symptom Manage 1992; 7: 365–368.

Miller MG. ‘n = 1’ Research method: an exploration of the use of this method investigating the symptom of sweating in a palliative care setting. MSc dissertation, Institute of Cancer Research, University of London. 1996.

Cochrane AL . Effectiveness and efficiency: random reflections on health services, 2nd edn. Cambridge: Cambridge University Press, 1989.

Guyatt GH , Keller JL , Jaeschke R , Rosenbloom D , Adachi JD , Newhouse MT . The n-of-1 randomised controlled trial: clinical usefulness. Ann Intern Med 1990; 112: 293–299.

Johannessen T . Controlled trials in single subjects: value in clinical medicine. Br Med J 1991; 303: 173–174.

Kirkham SR , Abel J . Placebo-controlled trials in palliative care: the argument against. Palliat Med 1997; 11: 489–492.

Calman K , Hanks G . Clinical and health services research in palliative care. In: Doyle D , Hanks GW , MacDonald N eds. Oxford textbook of palliative medicine. Oxford: Oxford University Press, 1994: 73.

Raudonis B . Pearls, pith and ethical provocation: considerations in qualitative research with hospice patients. Qual Health Res 1992; 2: 238–241.

Guyatt GH , Sackett D , Adachi J . A clinician's guide for conducting randomised trials in individual patients. Can Med Assoc J 1988; 139: 497–503.

Guyatt GH . Deciding on the best therapy. In: Sackett DL , Haynes RB , Tugwell P eds. Clinical epidemiology: a basic science for clinical medicine. Boston, MA: Little, Brown, 1985: 223–238.

Larson E , Ellsworth AJ , Oas J . Randomized clinical trials in single patients during a two year period. J Am Med Assoc 1993; 270: 2708–2712.

Guyatt GH , Jaeschke R . N-of-1 randomised trials – where do we stand? Western J Med 1990; 152: 68.

Rochon J . A statistical model for the ‘N-of-1’ study. J Clin Epidemiol 1990; 43: 499–508.

Saunders KB . n Of 1 trials [Letter]. Br Med J 1994; 309: 1584.

Irwig L , Glasziou P , March L . Ethics of n-of-1 trials [Letter]. Lancet 1995; 345: 469.

Lewis JA . Controlled trials in single subjects: limitations of use. Br Med J 1991; 303: 175–176.

Zucker DR , Schmid CH , McIntosh MW , D'Agostino RB , Selker HP , Lau J . Combining single patient (N-of-1) trials to estimate population treatment effects and to evaluate individual patient responses to treatment. J Clin Epidemiol 1997; 50: 401–410.