N-of-1 trials are a tapestry of heterogeneity

Journal of Clinical Epidemiology

Volumn 76, Issue , 2016, Pages 47-56

  Punja, Salima ^a   Bukutu, Cecilia ^a   Shamseer, Larissa ^b   Sampson, Margaret ^c   Hartling, Lisa ^d   Urichuk, Liana ^e   Vohra, Sunita ^a  

^a UNIVERSITY OF ALBERTA   (Canada)

^b OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^c CHILDREN S HOSPITAL OF EASTERN ONTARIO   (Canada)

^d UNIVERSITY OF ALBERTA   (Canada)

^e ALBERTA HEALTH SERVICES   (Canada)

Author keywords

Analysis; Clinical trial; Evidence based medicine; Meta analysis; N of 1 trial; Systematic review

Indexed keywords

ADVERSE OUTCOME; ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); FUNDING; HUMAN; METHODOLOGY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZATION; STATISTICAL ANALYSIS; STUDY DESIGN; TREATMENT RESPONSE; MEDICAL RESEARCH; META ANALYSIS; NOMENCLATURE; PRACTICE GUIDELINE; PUBLISHING; RESEARCH; STANDARDS;

BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; GUIDELINES AS TOPIC; HUMANS; PUBLISHING; RESEARCH DESIGN; RESEARCH REPORT; TERMINOLOGY AS TOPIC;

EID: 84965063876     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2016.03.023     Document Type: Article

References (21)

1. [1] Guyatt, G., Keller, J., Jaeschke, R., Rosenbloom, D., Adachi, J.D., Newhouse, M.T., The N-of-1 randomized controlled trial: clinical usefulness. Our three-year experience. Ann Intern Med 112 (1990), 293–299.
2. [2] Kazdin, A.E., Single-case research designs: methods for clinical and applied settings. 1982, Oxford University Press, New York.
3. [3] Guyatt, G., Sackett, D., Adachi, J., Roberts, R., Chong, J., Rosenbloom, D., et al. A clinician's guide for conducting randomized trials in individual patients. Can Med Assoc J 139 (1988), 497–503.
4. [4] OCEBM Levels of Evidence Working Group, The Oxford levels of evidence 2, 2011, Oxford Centre for Evidence-Based Medicine. Available at www.cebm.net/index.aspx?o=5653. Accessed April 28, 2016.
5. [5] Johannessen, T., Petersen, H., Kristensen, P., Fosstvedt, D., The controlled single subject trial. Scand J Prim Health Care 9 (1991), 17–21.
6. [6] Senn, S., Suspended judgment: N-of-1 trials. Controlled Clin Trials 14 (1993), 1–5.
7. [7] Vohra, S., Shamseer, L., Sampson, M., Bukutu, C., Schmid, S.H., Tate, R., et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015 statement. J Clin Epidemiol 76 (2016), 9–17.
8. [8] Tate, R.L., Perdices, M., Rosenkoetter, U., Wakim, D., Godbee, K., Togher, L., et al. 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. Neuropsychol Rehabil 23 (2013), 619–638.
9. [9] Zarin, D.A., Young, J.L., West, J.C., Challenges to evidence-based medicine. Soc Psychiatry Psychiatr Epidemiol 40 (2005), 27–35.
10. [10] Zucker, D.R., Ruthazer, R., Schmid, C.H., Individual (N-of-1) trials can be combined to give population comparative treatment effect estimates: methodologic considerations. J Clin Epidemiol 63 (2010), 1312–1323.
11. [11] Punja, S., Eslick, I., Duan, N., Vohra, S., the DEcIDE Methods Center N-of-1 Guidance Panel (Gabler N, Kaplan H, Kravitz R, Larson E, Pace W, Schmid C, Sim I). Design and implementation of N-of-1 trials: a user's guide. An ethical framework for N-of-1-Trials: clinical care, quality improvement, or human subject research? (Chapter 2). AHRQ Publication No.13(14)-EHC122-EF, 2014, Agency for Healthcare Research and Quality, Rockville, MD.
12. [12] Schmid, C., Duan, N., the DEcIDE Methods Center N-of-1 Guidance Panel (Eslikc I, Gabler N, Kaplan H, Kravitz R, Larson E, Pace W, Schmid C, Sim I, Vohra S). Design and implementation of N-of-1 trials: a user's guide. Statistical design and analytic considerations for N-of-1 trials (Chapter 4). AHRQ Publication No.13(14)-EHC122-EF, 2014, Agency for Healthcare Research and Quality, Rockville, MD.
13. [13] Ross, M., Olson, J.M., An expectancy-attribution model of the effects of placebos. Psychol Rev 88:5 (1981), 408–437.
14. [14] Rutherford, B.R., Marcus, S.M., Wang, P., Sneed, J.R., Pelton, G., Devanand, D., et al. A randomized, prospective pilot study of patient expectancy and antidepressant outcome. Psychol Med 43 (2013), 975–982.
15. [15] Paterson, C., Seeking the patient's perspective: a qualitative assessment of EuroQol, COOP-WONCA Charts and MYMOP2. Qual Life Res 13 (2004), 871–881.
16. [16] Zucker, D.R., Schmid, C.H., McIntosh, M.W., D'Agostino, R.B., Selker, H.P., 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 50 (1997), 401–410.
17. [17] Schmid, C.H., Brown, E.N., Bayesian hierarchical models. Methods Enzymol 321 (2000), 305–330.
18. [18] Sampson M, Shamseer L, Bukutu C, Barrowman N, Moher D, Vohra S. Systematic reviews of N-of-1 methods, analysis and meta-analysis. Cochrane Canada 8th Annual Symposium, Ottawa: 2010.
19. [19] Gabler, N.B., Duan, N., Vohra, S., Kravitz, R.L., N-of-1 trials in the medical literature: a systematic review. Med Care 49 (2011), 761–768.
20. [20] Schulz, K.F., Altman, D.G., Moher, D., for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ, 340, 2010, c332.
21. [21] Plint, A.C., Moher, D., Morrison, A., Schulz, K., Altman, D.G., Hill, C., et al. Does the CONSORT checklist improve the quality of reports of randomized controlled trials? A systematic review. Med J Aust 185 (2006), 263–267.