Violation of the intent-to-treat principle and rate of missing data in superiority trials assessing structural outcomes in rheumatic diseases

Arthritis and Rheumatism

Volumn 52, Issue 6, 2005, Pages 1858-1865

  Baron, Gabriel ^a   Boutron, Isabelle ^a   Giraudeau, Bruno ^b   Ravaud, Philippe ^a  

^a BICHAT HOSPITAL   (France)

^b INSERM   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CASE CONTROL STUDY; CLINICAL TRIAL; COCHRANE LIBRARY; DATA ANALYSIS; HUMAN; MEDICAL LITERATURE; MEDLINE; METHODOLOGY; OSTEOARTHRITIS; OSTEOPOROSIS; OUTCOMES RESEARCH; PRIORITY JOURNAL; PUBLICATION; QUALITY CONTROL; QUESTIONNAIRE; RHEUMATIC DISEASE; RHEUMATOID ARTHRITIS; STATISTICAL ANALYSIS; STRUCTURAL OUTCOME; SYSTEMATIC REVIEW;

EID: 20744445181     PISSN: 00043591     EISSN: None     Source Type: Journal    
DOI: 10.1002/art.21116     Document Type: Article

References (32)

1. Symmons DP. Disease assessment indices: activity, damage and severity. Baillieres Clin Rheumatol 1995;9:267-85.
2. Lipsky PE, van der Heijde DM, St. Clair EW, Furst DE, Breedveld FC, Kalden JR, et al, and the Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. Infliximab and methotrexate in the treatment of rheumatoid arthritis. N Engl J Med 2000;343:1594-602.
3. Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T, Keller M, et al, and the Vertebral Efficacy With Risedronate Therapy (VERT) Study Group. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. JAMA 1999; 282:1344-52.
4. Van der Heijde D. Structural damage in rheumatoid arthritis as visualized through radiographs. Arthritis Res 2002;4 Suppl 2:529-33.
5. Van der Heijde D, Simon L, Smolen J, Strand V, Sharp J, Boers M, et al. How to report radiographic data in randomized clinical trials in rheumatoid arthritis: guidelines from a roundtable discussion. Arthritis Rheum 2002;47:215-8.
6. Heritier SR, Gebski VJ, Keech AC. Inclusion of patients in clinical trial analysis: the intention-to-treat principle. Med J Aust 2003; 179:438-40.
7. Lewis JA, Machin D. Intention to treat: who should use ITT? Br J Cancer 1993;68:647-50.
8. Lachin JM. Statistical considerations in the intent-to-treat principle. Control Clin Trials 2000;21:167-89.
9. Unnebrink K, Windeler J. Intention-to-treat: methods for dealing with missing values in clinical trials of progressively deteriorating diseases. Stat Med 2001;20:3931-46.
10. Group for the Respect of Ethics and Excellence in Science Rheumatoid Arthritis Section. Recommendations for the registration of drugs used in the treatment of rheumatoid arthritis. Br J Rheumatol 1998;37:211-5.
11. Group for the Respect of Ethics and Excellence in Science Osteoarthritis Section. Recommendations for the registration of drugs used in the treatment of osteoarthritis. Ann Rheum Dis 1996;55:552-7.
12. Cooper C, Kanis JA, Compston J. How to assess drug efficacy in osteoporosis. Lancet 1995;345:743-4.
13. Lee KP, Schotland M, Bacchetti P, Bero LA. Association of journal quality indicators with methodological quality of clinical research articles. JAMA 2002;287:2805-8.
14. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D. et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001;134: 663-94.
15. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996;17:1-12.
16. Verhagen AP, de Vet HC, de Bie RA, Kessels AG, Boers M, Bouter LM, et al. The Delphi list: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus. J Clin Epidemiol 1998; 51:1235-41.
17. Genant HK, Jergas M, Palermo L, Nevitt M, Valentin RS, Black D, et al, and the Study of Osteoporotic Fractures Research Group. Comparison of semiquantitative visual and quantitative morphometric assessment of prevalent and incident vertebral fractures in osteoporosis. J Bone Miner Res 1996;11:984-96.
18. Wu CY, Li J, Jergas M, Genant HK. Comparison of semiquantitative and quantitative techniques for the assessment of prevalent and incident vertebral fractures. Osteoporos Int 1995;5:354-70.
19. Larsen A, Dale K, Eek M. Radiographic evaluation of rheumatoid arthritis and related conditions by standard reference films. Acta Radiol Diagn (Stockh) 1977;18:481-91.
20. Sharp JT, Young DY, Bluhm GB, Brook A, Brower AC, Corbett M, et al. How many joints in the hands and wrists should be included in a score of radiologic abnormalities used to assess rheumatoid arthritis? Arthritis Rheum 1985;28:1326-35.
21. Van der Heijde DM. Plain x-rays in rheumatoid arthritis: overview of scoring methods, their reliability and applicability. Baillieres Clin Rheumatol 1996;10:435-53.
22. Chan AW, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004;291:2457-65.
23. Chan AW, Krleza-Jeric K, Schmid I, Altman DG. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ 2004;171:735-40.
24. CPMP. Points to consider on missing data. The European Agency for the Evaluation of Medicinal Products: 2001. CPMP/EWP/1776/ 99.
25. Hill CL, LaValley MP, Felson DT. Secular changes in the quality of published randomized clinical trials in rheumatology. Arthritis Rheum 2002;46:779-84.
26. Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ 1999;319: 670-4.
27. Ruiz-Canela M, Martinez-Gonzalez MA, de Irala-Estevez J. Intention to treat analysis is related to methodological quality. BMJ 2000;320:1007-8.
28. Hogan JW, Roy J, Korkontzelou C. Handling drop-out in longitudinal studies. Stat Med 2004;23:1455-97.
29. Auleley GR, Giraudeau B, Baron G, Maillefert JF, Dougados M, Ravaud P. The methods for handling missing data in clinical trials influence sample size requirements. J Clin Epidemiol 2004;57: 447-53.
30. Fergusson D, Aaron SD, Guyatt G, Hebert P. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ 2002;325:652-4.
31. Soares HP, Daniels S, Kumar A, Clarke M, Scott C, Swann S, et al. Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group. BMJ 2004;328:22-4.
32. Hill CL, LaValley MP, Felson DT. Discrepancy between published report and actual conduct of randomized clinical trials. J Clin Epidemiol 2002;55:783-6.