A systematic review found that deviations from intention-to-treat are common in randomized trials and systematic reviews

Journal of Clinical Epidemiology

Volumn 84, Issue , 2017, Pages 37-46

  Abraha, Iosief ^a   Cozzolino, Francesco ^a   Orso, Massimiliano ^a   Marchesi, Mauro ^b   Germani, Antonella ^b   Lombardo, Guido ^c   Eusebi, Paolo ^a   De Florio, Rita ^d   Luchetta, Maria Laura ^e   Iorio, Alfonso ^f   Montedori, Alessandro ^a  

^a Regional Health Authority of Umbria   (Italy)

^b SANTA MARIA DELLA MISERICORDIA HOSPITAL   (Italy)

^c UNIVERSITY OF PERUGIA   (Italy)

^d Azienda USL Umbria 1   (Italy)

^e Azienda USL Umbria 2   (Italy)

^f MCMASTER UNIVERSITY   (Canada)

Author keywords

Bias; Deviation from intention to treat; Epidemiology; Meta analysis; Modified intention to treat; Randomized trials

Indexed keywords

ARTICLE; CLINICAL DECISION MAKING; CONFLICT OF INTEREST; FUNDING; HUMAN; INCIDENCE; INTENTION TO TREAT ANALYSIS; PHARMACOLOGICAL PARAMETERS; PRIORITY JOURNAL; RANDOM SAMPLE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SYSTEMATIC REVIEW; LITERATURE; MEDLINE; STATISTICS AND NUMERICAL DATA;

HUMANS; INTENTION TO TREAT ANALYSIS; MEDLINE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REVIEW LITERATURE AS TOPIC;

EID: 85011568093     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2016.11.012     Document Type: Article

References (30)

1. Newell, D.J., Intention-to-treat analysis: implications for quantitative and qualitative research. Int J Epidemiol 21 (1992), 837–841.
2. Fergusson, D., Aaron, S.D., Guyatt, G., Hebert, P., Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ 325 (2002), 652–654.
3. Lewis, J.A., Machin, D., Intention to treat—who should use ITT?. Br J Cancer 68 (1993), 647–650.
4. Abraha, I., Montedori, A., Modified intention to treat reporting in randomised controlled trials: a systematic review. BMJ, 340, 2010, c2697.
5. Astrup, A., Caterson, I., Zelissen, P., Guy-Grand, B., Carruba, M., Levy, B., et al. Topiramate: long-term maintenance of weight loss induced by a low-calorie diet in obese subjects. Obes Res 12:10 (2004), 1658–1669.
6. Geba, G.P., Weaver, A.L., Polis, A.B., Dixon, M.E., Schnitzer, T.J., Vioxx, A.C.T.G., Efficacy of rofecoxib, celecoxib, and acetaminophen in osteoarthritis of the knee: a randomized trial. JAMA 287 (2002), 64–71.
7. Montedori, A., Bonacini, M.I., Casazza, G., Luchetta, M.L., Duca, P., Cozzolino, F., et al. Modified versus standard intention-to-treat reporting: are there differences in methodological quality, sponsorship, and findings in randomized trials? A cross-sectional study. Trials, 12, 2011, 58.
8. Moher, D., Tetzlaff, J., Tricco, A.C., Sampson, M., Altman, D.G., Epidemiology and reporting characteristics of systematic reviews. PLoS Med, 4(3), 2007, e78.
9. Abraha, I., Cherubini, A., Cozzolino, F., De Florio, R., Luchetta, M.L., Rimland, J.M., et al. Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study. BMJ, 350, 2015, h2445.
10. Montori, V.M., Wilczynski, N.L., Morgan, D., Haynes, R.B., Hedges, T., Optimal search strategies for retrieving systematic reviews from Medline: analytical survey. BMJ, 330, 2005, 68.
11. Gravel, J., Opatrny, L., Shapiro, S., The intention-to-treat approach in randomized controlled trials: are authors saying what they do and doing what they say?. Clin Trials 4 (2007), 350–356.
12. Hollis, S., Campbell, F., What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ 319 (1999), 670–674.
13. Kruse, R.L., Alper, B.S., Reust, C., Stevermer, J.J., Shannon, S., Williams, R.H., Intention-to-treat analysis: who is in? Who is out?. J Fam Pract 51 (2002), 969–971.
14. Baron, G., Boutron, I., Giraudeau, B., Ravaud, P., Violation of the intent-to-treat principle and rate of missing data in superiority trials assessing structural outcomes in rheumatic diseases. Arthritis Rheum 52 (2005), 1858–1865.
15. Porta, N., Bonet, C., Cobo, E., Discordance between reported intention-to-treat and per protocol analyses. J Clin Epidemiol 60 (2007), 663–669.
16. Miladinovic, B., Kumar, A., Hozo, I., Djulbegovic, B., Instrumental variable meta-analysis of individual patient data: application to adjust for treatment non-compliance. BMC Med Res Methodol, 11, 2011, 55.
17. Shrier, I., Steele, R.J., Verhagen, E., Herbert, R., Riddell, C.A., Kaufman, J.S., Beyond intention to treat: what is the right question?. Clin Trials 11 (2014), 28–37.
18. Alshurafa, M., Briel, M., Akl, E.A., Haines, T., Moayyedi, P., Gentles, S.J., et al. Inconsistent definitions for intention-to-treat in relation to missing outcome data: systematic review of the methods literature. PLoS One, 7(11), 2012, e49163.
19. Joseph, R., Sim, J., Ogollah, R., Lewis, M., A systematic review finds variable use of the intention-to-treat principle in musculoskeletal randomized controlled trials with missing data. J Clin Epidemiol 68 (2015), 15–24.
20. Dossing, A., Tarp, S., Furst, D.E., Gluud, C., Wells, G.A., Beyene, J., et al. Modified intention-to-treat analysis did not bias trial results. J Clin Epidemiol 72 (2016), 66–74.
21. Altman, D.G., Missing outcomes in randomized trials: addressing the dilemma. Open Med 3:2 (2009), e51–e53.
22. Wood, A.M., White, I.R., Thompson, S.G., Are missing outcome data adequately handled? A review of published randomized controlled trials in major medical journals. Clin Trials 1 (2004), 368–376.
23. Little, R.J., DAgostino, R., Cohen, M.L., Dickersin, K., Emerson, S.S., Farrar, J.T., et al. The prevention and treatment of missing data in clinical trials. N Engl J Med 367 (2012), 1355–1360.
24. Villanueva, A., Arathoon, E.G., Gotuzzo, E., Berman, R.S., DiNubile, M.J., Sable, C.A., A randomized double-blind study of caspofungin versus amphotericin for the treatment of candidal esophagitis. Clin Infect Dis 33 (2001), 1529–1535.
25. 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. BMJ, 340, 2010, c869.
26. Bell, M., Fiero, M., Horton, N., Hsu, C.-H., Handling missing data in RCTs; a review of the top medical journals. BMC Med Res Methodol, 14, 2014, 118.
27. Sterne, J.A., White, I.R., Carlin, J.B., Spratt, M., Royston, P., Kenward, M.G., et al. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ, 338, 2009, b2393.
28. Schulz, K.F., Grimes, D.A., Altman, D.G., Hayes, R.J., Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology. BMJ 312 (1996), 742–744.
29. Akl, E.A., Kahale, L.A., Agarwal, A., Al-Matari, N., Ebrahim, S., Alexander, P.E., et al. Impact of missing participant data for dichotomous outcomes on pooled effect estimates in systematic reviews: a protocol for a methodological study. Syst Rev, 3, 2014, 137.
30. Orso, M., Abraha, I., Cozzolino, F., Cherubini, A., Rimland, J., Lombardo, G., et al. Incidence of randomised trials with modified intention-to-treat analysis in the medical literature: a systematic review update. XXIII Cochrane Colloquium. 2015, Wiley, Vienna.