CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement

Journal of Clinical Epidemiology

Volumn 76, Issue , 2016, Pages 9-17

  Vohra, Sunita ^a   Shamseer, Larissa ^b   Sampson, Margaret ^c   Bukutu, Cecilia ^d   Schmid, Christopher H ^e   Tate, Robyn ^f   Nikles, Jane ^g   Zucker, Deborah R ^h   Kravitz, Richard ⁱ   Guyatt, Gordon ^j   Altman, Douglas G ^k   Moher, David ^b   Clark, Jocalyn ^l   Cogo, Elise ^l   Gabler, Nicole B ^l   Janosky, Janine ^l   Johnston, Bradley C ^l   Li, Bob ^l   Mahon, Jeff ^l   Marles, Robin ^l   Shadish, William R ^l   more..

^a UNIVERSITY OF ALBERTA   (Canada)

^b OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^c CHILDREN S HOSPITAL OF EASTERN ONTARIO   (Canada)

^d Family and Community Research   (Canada)

^e BROWN UNIVERSITY   (United States)

^f UNIVERSITY OF SYDNEY   (Australia)

^g UNIVERSITY OF QUEENSLAND   (Australia)

^h TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ UNIVERSITY OF CALIFORNIA   (United States)

^j MCMASTER UNIVERSITY   (Canada)

^k UNIVERSITY OF OXFORD   (United Kingdom)

^l NONE

more..

Author keywords

CENT; CONSORT; N of 1; Reporting guideline

Indexed keywords

ADVERSE OUTCOME; ARTICLE; CHECKLIST; CLINICAL DECISION MAKING; CLINICAL TRIAL (TOPIC); COMORBIDITY; COMPARATIVE EFFECTIVENESS; EVIDENCE BASED MEDICINE; HUMAN; PATIENT SAFETY; PERSONALIZED MEDICINE; PRACTICE GUIDELINE; PRIORITY JOURNAL; RARE DISEASE; VALIDITY; MEDICAL RESEARCH; METHODOLOGY; NOMENCLATURE; PUBLISHING; RESEARCH; STANDARDS;

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

EID: 84939839141     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2015.05.004     Document Type: Article

References (27)

1. Gitterman, D.P., Hay, W.W. Jr., That sinking feeling, again? The state of National Institutes of Health pediatric research funding, fiscal year 1992-2010. Pediatr Res, 64, 2008, 462.
2. Fortin, M., Dionne, J., Pinho, G., Gignac, J., Almirall, J., Lapointe, L., Randomized controlled trials: do they have external validity for patients with multiple comorbidities?. Ann Fam Med 4 (2006), 104–108.
3. Guyatt, G., Jaeschke, R., McGinn, T., PART 2B1: therapy and validity. N-of-1 randomized controlled trials. Guyatt, G., Rennie, D., Meade, M.O., Cook, D.J., (eds.) Users’ guides to the medical literature, 2002, American Medical Association, McGraw-Hill, 275–290.
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 December 2014.
5. Punja, S., Bukutu, C., Shamseer, L., Sampson, M., Hartling, L., Urichuk, L., et al. Systematic review of the methods, statistical analysis and meta-analysis of N-of-1 trials. 2014, University of Alberta Libraries.
6. Begg, C., Cho, M., Eastwood, S., Horton, R., Moher, D., Olkin, I., et al. Improving the quality of reporting of randomized clinical trials: the CONSORT statement. JAMA 276 (1996), 637–639.
7. Schulz, K.F., Altman, D.G., Moher, D., for the CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med, 7, 2010, e1000251.
8. Moher, D., Hopewell, S., Schulz, K.F., Montori, V., Gøtzsche, P.C., Devereaux, P.J., et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 63 (2010), e1–37.
9. Zwarenstein, M., Treweek, S., Gagnier, J.J., Altman, D.G., Tunis, S., Haynes, B., et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ, 337, 2008, a2390.
10. Campbell, M.K., Piaggio, G., Elbourne, D.R., Altman, D.G., CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ, 345, 2012, e5661.
11. Piaggio, G., Elbourne, D.R., Pocock, S.J., Evans, S.J., Altman, D.G., Reporting of noninferiority and equivalence randomized trials. JAMA 308 (2012), 2594–2604.
12. Gagnier, J.J., Boon, H., Rochon, P., Moher, D., Barnes, J., Bombardier, C., et al. Recommendations for reporting randomized controlled trials of herbal interventions: explanation and elaboration. J Clin Epidemiol 59 (2006), 1134–1149.
13. Boutron, I., Moher, D., Altman, D.G., Schulz, K.F., Ravaud, P., Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med, 148, 2008, 295.
14. MacPherson, H., Altman, D.G., Hammerschlag, R., Li, Y., Wu, T., White, A., et al. Revised standards for reporting interventions in clinical trials of acupuncture (STRICTA): extending the CONSORT statement. Acupunct Med 28 (2010), 83–93.
15. Ioannidis, J.P.A., Evans, S.J.W., Gotzsche, P.C., O'Neill, R.T., Altman, D.G., Schulz, K., et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 141 (2004), 781–788.
16. Hopewell, S., Clarke, M., Moher, D., Wager, E., Middleton, P., Altman, D.G., et al. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet 371 (2008), 281–283.
17. Calvert, M., Blazeby, J., Altman, D.G., Revicki, D.A., Moher, D., Brundage, M.D., et al. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA 309 (2013), 814–822.
18. Glasziou, P., Altman, D.G., Bossuyt, P., Boutron, I., Clarke, M., Julious, S., et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet 383 (2014), 267–276.
19. Edgington, E.S., Statistical inference from N=1 experiments. J Psychol 65 (1967), 195–199.
20. Tate, R.L., McDonald, S., Perdices, M., Togher, L., Schultz, R., Savage, S., Rating the methodological quality of single-subject designs and n-of-1 trials: introducing the single-case experimental design (SCED) scale. Neuropsychol Rehabil 18 (2008), 385–401.
21. 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.
22. Tate, R., Togher, L., Perdices, M., McDonald, S., Rosenkoetter, U., on behalf of the SCRIBE Steering Committee. Developing reporting guidelines for single-case experimental designs: the SCRIBE project. Brain Impair, 13, 2012, 135.
23. Moher, D., Schulz, K.F., Simera, I., Altman, D.G., Guidance for developers of health research reporting guidelines. PLoS Med, 7, 2010, e1000217.
24. Shamseer, L., Sampson, M., Bukutu, C., Schmid, C.H., Nikles, J., Tate, R., et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015: explanation and elaboration. BMJ, 350, 2015, h1793.
25. Enhancing reproducibility. Nat Meth, 10, 2013, 367.
26. Turner, L., Shamseer, L., Altman, D.G., Weeks, L., Peters, J., Kober, T., et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomized controlled trials published in medical journals: an updated review. Cochrane Database Syst Rev, 11, 2012, MR000030.
27. Stevens, A., Shamseer, L., Weinstein, E., Yazdi, F., Turner, L., Thielman, J., et al. Relation of completeness of reporting of health research to journals’ endorsement of reporting guidelines: systematic review. BMJ, 348, 2014, g3804.