Hogben and Sim, 1953 |
Hogben L, Sim M (1953). The self-controlled and self-recorded clinical trial for low-grade morbidity. Br J Prev Soc Med 7:163–179. |
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Hare, 1955 |
Hare EH (1955). Comparative efficacy of hypnotics: a self-controlled, self-recorded clinical trial in neurotic patients. British Journal of Preventive and Social Medicine 9:140–146. |
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Guyatt, 1986 |
Guyatt G, Sackett D, Taylor DW, Ghong J, Roberts R, Pugsley S (1986). Determining Optimal Therapy – – Randomized Trials in Individual Patients. N Engl J Med 314:889-892. |
N-of-1 trials are first brought to the attention of a wide medical readership |
Guyatt, 1988 |
Guyatt G, Sackett D, Adachi J, Roberts R, Chong J (1988). A clinician’s guide for conducting randomized trials in individual patients. CMAJ 139: 497–503. |
The practical approach presented encourages clinicians to conduct N-of-1 trials |
Guyatt, 1990 |
Guyatt GH, Keller JL, Jaeschke R, Rosenbloom D, Adachi JD, Newhouse MT (1990b). The n-of-1 randomized controlled trial: clinical usefulness. Our three-year experience. Ann Intern 112:293–299. |
Results of the first N-of-1 trial clinical service |
Guyatt, 1990 |
Guyatt GGH, Heyting A, Jaeschke R, Keller J, Adachi JD, Roberts RS (1990a). N of 1 randomized trials for investigating new drugs. Control Clin Trials 11:88–100. |
A proposal that individual N-of-1 randomised controlled trials could be used to elucidate drug effects at an early stage of development |
Molloy, 1991 |
Molloy DW, Guyatt GH, Wilson DB, Duke R, Rees L, Singer J (1991). Effect of tetrahydroaminoacridine on cognition, function and behaviour in Alzheimer’s disease. CMAJ 144:29–34. |
Early use of multiple N-of-1 trials in a particular condition to address drug effectiveness |
Zucker, 1997 |
Zucker DR, Schmid CH, McIntosh MW, D’Agostino RB, Selker HP, Lau J (1997). Combining single patient (N-of-1) trials to estimate population treatment effects and to evaluate individual patient responses to treatment. J Clin Epidemiol 50:401–410. |
Using Bayesian technique to combine N-of-1 trials |
Guyatt et al., 2000 |
Guyatt G, Haynes RB, Jaeschke RZ, Cook DJ, Naylor CD, Wilson MC, Richardson WS (2000). Users; guide to the medical literature: XXV. Evidence-based medicine: principles for applying the users’ guides to patient care. Evidence-Based Medicine Working Group. JAMA 284:1290–96. |
N-of-1 trial described as top of methodological hierarchy for informing treatment decisions |
Guyatt, 2002 |
Guyatt G, Zhang Y, Jaeschke R, McGinn T (2002). Therapy and Validity: N of 1 Randomized Controlled Trials. Users’ Guides to the Medical Literature: A manual for Evidence-Based Clinical Practice. Chicago, IL: American Medical Association 275–290. |
Users’ guide to N-of-1 trials |
Nikles, 2006 |
Nikles C, Mitchell G, Mar C Del, Clavarino A, McNairn N (2006). An N of 1 trial service in clinical practice: Testing the effectiveness of stimulants for attention-deficit/ hyperactivity disorder. Pediatrics 2006;117:2040–2046. |
One of the largest series of N-of-1 trials carried out in children with ADHD -carried out by a National Service to support the conduct of N-of-1 trials (the first ever) in Australia |
Zucker, 2006 |
Zucker DR, Ruthazer R, Schmid CH, Feuer JM, Fischer PA, Kieval RI, Mogavero N, Rapoport RJ, Selker HP, Stotsky SA, Winston E, Goldenberg DL (2006). Lessons learned combining N-of-1 trials to assess fibromyalgia therapies. J Rheumatol 33:2069–2077. |
Using Bayesian technique to combine N-of-1 trials |
Tate, 2008 |
Tate RL, McDonald S, Perdices M, Togher L, Schultz R, Savage S (2008). Rating the methodological quality of single-subject designs and N of 1 trials: Introducing the single-case experimental design (SCED) scale. Neuropsychol Rehabil 18:385–401. |
Single-Case Experimental Design (SCED) Scale |
Zucker, 2010 |
Zucker DR, Ruthazer R, Schmid CH (2010). Individual (N of 1) trials can be combined to give population comparative treatment effect estimates: methodological considerations. Journal of Clinical Epidemiology 63:1312–1323. |
Using Bayesian technique to combine N-of-1 trials |
Gabler, 2011 |
Gabler NB, Duan N, Vohra S, Kravitz RL (2011). N-of-1 Trials in the Medical Literature: a systematic review. Med Care 49:761–768. |
Systematic overview of the N-of-1 literature |
OCEBM, 2011 |
OCEBM Levels of Evidence Working Group*. “The Oxford Levels of Evidence 2”. Oxford Centre for Evidence-Based Medicine. http://www.cebm.net/index.aspx?o=5653
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N-of-1 trials are considered level 1 evidence by the Oxford Centre for Evidence-Based Medicine |
Tate, 2013 |
Tate RL, Perdices M, Rosenkoetter U, Wakim D, Godbee K, Togher L, McDonald S (2013). Revision of a method quality rating scale for single-case experimental designs and N of 1 trials: The 15-item Risk of Bias in N of 1 Trials (RoBiNT) Scale. Neuropsychological Rehabilitation 23:619–38. |
15-item Risk of Bias in N-of-1 Trials (RoBiNT) Scale |
DEcIDE Methods Center N of 1 Guidance Panel, 2014 |
Kravitz RL, Duan N, eds, and the DEcIDE Methods Center N of 1 Guidance Panel (Duan N, Eslick I, Gabler NB, Kaplan HC, Kravitz RL, Larson EB, Pace WD, Schmid CH, Sim I, Vohra S) (2014). Design and Implementation of N of 1 Trials: A User’s Guide. AHRQ Publication No. 13(14)-EHC122-EF. Rockville, MD: Agency for Healthcare Research and Quality; February 2014. www.effectivehealthcare.ahrq.gov/N-1-Trials.cfm. |
N-of-1 AHRQ Publication |
Tate, 2014 |
Tate RL, Perdices M, McDonald S, Togher L, Rosenkoetter U (2014). The design, conduct and report of single-case research: Resources to improve the quality of the neurorehabilitation literature. Neuropsychological Rehabilitation 2014;24:315–31. |
Reporting guidelines: Risk of Bias in N of 1 Trials (RoBiNT) Scale; Single-Case Reporting guideline In BEhavioural interventions (SCRIBE) |
Shamseer, 2015 |
Shamseer L, Sampson M, Bukutu C, et al. CONSORT extension for reporting N of 1 trials (CENT) 2015: Explanation and elaboration. BMJ 2015;350:18–46 |
CENT explanation and elaboration |
Vohra, 2015 |
Vohra S, Shamseer L, Sampson M, Bukutu C, Schmid CH, Tate R, Nikles J, Zucker DR, Kravitz R, Guyatt G, Altman DG, Moher D, CENT group (2015). CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ 350:h1738 |
CENT checklist |
Punja, 2016 |
Punja S, Bukutu C, Shamseer L, Sampson M, Hartling L, Urichuk L, Vohra S (2016c). N-of-1 trials are a tapestry of heterogeneity. J Clin Epidemiol 76:47–56 |
A systematic review of the methods of design, analysis, and meta–analysis used in published N-of-1 trials |
Punja, 2016 |
Punja S, Schmid CH, Hartling L, Urichuk L, Nikles CJ, Vohra S (2016). To meta-analyze or not to meta-analyze? A combined meta-analysis of N of 1 trial data with RCT data on amphetamines and methylphenidate for pediatric ADHD. J Clin Epidemiol 76:76–81. |
Combined meta-analysis of N-of-1 trials with randomised controlled trial data |
Punja, 2016 |
Punja S, Xu D, Schmid CH, Hartling L, Urichuk L, Nikles CJ, Vohra S (2016a). N of 1 trials can be aggregated to generate group mean treatment effects: A systematic review and meta-analysis. J Clin Epidemiol 76:65–75. |
Meta-analysis of N-of-1 trials |
Tate, 2016 |
Tate RL, Perdices M, Rosenkoetter U, Shadish W, Vohra S, Barlow DH, Horner R, Kazdin A, Kratochwill T, McDonald S, Sampson M, Shamseer L, Togher L, Albin R, Backman C, Douglas J, Evans JJ, Gast D, Manolov R, Mitchell G, Nickels L, Nikles J, Ownsworth T, Rose M, Schmid CH and Wilson B (2016). The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement. J Clin Epidemiol 73:142–152. |
Provides authors, readers and reviewers of single case design studies with a tool to maximise clarity, transparency and completeness in reports of such trials |