Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study
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OBJECTIVE: To examine whether deviation from the standard intention to treat analysis has an influence on treatment effect estimates of randomised trials. DESIGN: Meta-epidemiological study. DATA SOURCES: Medline, via PubMed, searched between 2006 and 2010; 43 systematic reviews of interventions and 310 randomised trials were included. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: From each year searched, random selection of 5% of intervention reviews with a meta-analysis that included at least one trial that deviated from the standard intention to treat approach. Basic characteristics of the systematic reviews and randomised trials were extracted. Information on the reporting of intention to treat analysis, outcome data, risk of bias items, post-randomisation exclusions, and funding were extracted from each trial. Trials were classified as: ITT (reporting the standard intention to treat approach), mITT (reporting a deviation from the standard approach), and no ITT (reporting no approach). Within each meta-analysis, treatment effects were compared between mITT and ITT trials, and between mITT and no ITT trials. The ratio of odds ratios was calculated (value <1 indicated larger treatment effects in mITT trials than in other trial categories). RESULTS: 50 meta-analyses and 322 comparisons of randomised trials (from 84 ITT trials, 118 mITT trials, and 108 no ITT trials; 12 trials contributed twice to the analysis) were examined. Compared with ITT trials, mITT trials showed a larger intervention effect (pooled ratio of odds ratios 0.83 (95% confidence interval 0.71 to 0.96), P=0.01; between meta-analyses variance τ(2)=0.13). Adjustments for sample size, type of centre, funding, items of risk of bias, post-randomisation exclusions, and variance of log odds ratio yielded consistent results (0.80 (0.69 to 0.94), P=0.005; τ(2)=0.08). After exclusion of five influential studies, results remained consistent (0.85 (0.75 to 0.98); τ(2)=0.08). The comparison between mITT trials and no ITT trials showed no statistical difference between the two groups (adjusted ratio of odds ratios 0.92 (0.70 to 1.23); τ(2)=0.57). CONCLUSIONS: Trials that deviated from the intention to treat analysis showed larger intervention effects than trials that reported the standard approach. Where an intention to treat analysis is impossible to perform, authors should clearly report who is included in the analysis and attempt to perform multiple imputations.
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Exclusion of participants from RCT analyses was shown to distort outcomes.
“exclusion of participants from RCT analyses was shown to distort outcomes42,43”
From The effectiveness of virtual reality based interventions for symptoms of anxiety and depression: A meta-analysis (2018) · cites this paper as [42]
A meta-epidemiological study of 322 comparisons from 310 randomised trials found that analyses deviating from intention to treat produced larger intervention effect sizes than those applying the intention-to-treat principle.
“A meta-epidemiological study of 322 comparisons from 310 randomised trials found that analyses deviating from intention to treat produced larger intervention effect sizes than those applying the intention-to-treat principle.424”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [424]
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Cochrane Handbook for Systematic Reviews of Interventions: Cochrane Book Series
(2008) · doi:10.1002/9780470712184 · Cited by 25,048 · see citing works
Moher, D., Hopewell, S., Schulz, K. F., Montori, V., Gotzsche, P. C., Devereaux, P. J., Elbourne, D., Egger, M., & Altman, D. G. (2010) · BMJ · doi:10.1136/bmj.c869 · Cited by 8,883 · see citing works
Sterne, J. A. C., White, I. R., Carlin, J. B., Spratt, M., Royston, P., Kenward, M. G., Wood, A. M., & Carpenter, J. R. (2009) · BMJ · doi:10.1136/bmj.b2393 · Cited by 7,299 · see citing works
Assessing Risk of Bias in Included Studies
Higgins, J. P., & Altman, D. G. (2008) · Cochrane Handbook for Systematic Reviews of Interventions · doi:10.1002/9780470712184.ch8 · Cited by 3,396 · see citing works
Cholinesterase inhibitors for Alzheimer's disease
Birks, J. S. (2006) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005593 · Cited by 1,906 · see citing works
Leizorovicz, A., Cohen, A. T., Turpie, A. G. G., Olsson, C., Vaitkus, P. T., & Goldhaber, S. Z. (2004) · Circulation · doi:10.1161/01.cir.0000138928.83266.24 · Cited by 955 · see citing works
Schneider, L. S., Dagerman, K., & Insel, P. S. (2006) · The American Journal of Geriatric Psychiatry · doi:10.1097/01.jgp.0000200589.01396.6d · Cited by 903 · see citing works
Cameron, D., Casey, M., Press, M. F., Lindquist, D. L., Pieńkowski, T., Romieu, C. G., Chan, S. Y. T., Jagiełło-Gruszfeld, A., Kaufman, B., Crown, J. P., et al. (2008) · Breast Cancer Research and Treatment · doi:10.1007/s10549-007-9885-0 · Cited by 794 · see citing works
BAUJAT, B., Mahé, C., Pignon, J., & Hill, C. (2002) · Statistics in Medicine · doi:10.1002/sim.1221 · Cited by 762 · see citing works
Intention-to-Treat Analysis: Implications for Quantitative and Qualitative Research
NEWELL, D. J. (1992) · International Journal of Epidemiology · doi:10.1093/ije/21.5.837 · Cited by 715 · see citing works
Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis
Fergusson, D., Aaron, S. D., Guyatt, G., & Hébert, P. (2002) · BMJ · doi:10.1136/bmj.325.7365.652 · Cited by 708 · see citing works
Savović, J., Jones, H., Altman, D., Harris, R., Jűni, P., Pildal, J., Als-Nielsen, B., Balk, E., Gluud, C., Gluud, L., et al. (2012) · Health Technology Assessment · doi:10.3310/hta16350 · Cited by 668 · see citing works
Statistical Considerations in the Intent-to-Treat Principle
Lachin, J. M. (2000) · Controlled Clinical Trials · doi:10.1016/s0197-2456(00)00046-5 · Cited by 652 · see citing works
Melander, H., Ahlqvist-Rastad, J., Meijer, G., & Beermann, B. (2003) · BMJ · doi:10.1136/bmj.326.7400.1171 · Cited by 626 · see citing works
Small study effects in meta-analyses of osteoarthritis trials: meta-epidemiological study
Nuesch, E., Trelle, S., Reichenbach, S., Rutjes, A. W. S., Tschannen, B., Altman, D. G., Egger, M., & Juni, P. (2010) · BMJ · doi:10.1136/bmj.c3515 · Cited by 559 · see citing works
Wood, A., White, I. R., & Thompson, S. G. (2004) · Clinical Trials · doi:10.1191/1740774504cn032oa · Cited by 546 · see citing works
Influence of trial sample size on treatment effect estimates: meta-epidemiological study
Dechartres, A., Trinquart, L., Boutron, I., & Ravaud, P. (2013) · BMJ · doi:10.1136/bmj.f2304 · Cited by 544 · see citing works
Pederzoli, P., Bassi, C., Vesentini, S., & Campedelli, A. (1993) · PubMed · Cited by 497 · see citing works
Leucht, S., Arbter, D., Engel, R. R., Kissling, W., & Davis, J. M. (2009) · Molecular Psychiatry · doi:10.1038/sj.mp.4002136 · Cited by 489 · see citing works
Balk, E. M. (2002) · JAMA · doi:10.1001/jama.287.22.2973 · Cited by 478 · see citing works
Analyzing incomplete longitudinal clinical trial data
Molenberghs, G. (2004) · Biostatistics · doi:10.1093/biostatistics/5.3.445 · Cited by 463 · see citing works
Optimal search strategies for retrieving systematic reviews from Medline: analytical survey
Montori, V. M., Wilczynski, N. L., Morgan, D., & Haynes, R. B. (2005) · BMJ · doi:10.1136/bmj.38336.804167.47 · Cited by 422 · see citing works
Thigpen, J. T., Brady, M. F., Homesley, H. D., Malfetano, J. H., DuBeshter, B., Burger, R. A., & Liao, S. Y. (2004) · Journal of Clinical Oncology · doi:10.1200/jco.2004.02.088 · Cited by 390 · see citing works
Paul, M., Lador, A., Grozinsky‐Glasberg, S., & Leibovici, L. (2014) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003344.pub3 · Cited by 388 · see citing works
Sterne, J. A. C., Jüni, P., Schulz, K. F., Altman, D. G., Bartlett, C., & Egger, M. (2002) · Statistics in Medicine · doi:10.1002/sim.1184 · Cited by 382 · see citing works
Analyzing incomplete longitudinal clinical trial data
Molenberghs, G. (2004) · Biostatistics · doi:10.1093/biostatistics/kxh001 · Cited by 378 · see citing works
Moreno, S. G., Sutton, A. J., Ades, A., Stanley, T. D., Abrams, K. R., Peters, J. L., & Cooper, N. J. (2009) · BMC Medical Research Methodology · doi:10.1186/1471-2288-9-2 · Cited by 373 · see citing works
Akl, E. A., Briel, M., You, J. J., Sun, X., Johnston, B. C., Busse, J. W., Mulla, S., Lamontagne, F., Bassler, D., Vera, C., et al. (2012) · BMJ · doi:10.1136/bmj.e2809 · Cited by 350 · see citing works
Thompson, M., den Bruel, A. V., Verbakel, J. Y. J., Lakhanpaul, M., Haj-Hassan, T. A., Stevens, R., Moll, H. A., Buntinx, F., Berger, M. Y., Aertgeerts, B., et al. (2012) · Health Technology Assessment · doi:10.3310/hta16150 · Cited by 324 · see citing works
Dechartres, A., Boutron, I., Trinquart, L., Charles, P., & Ravaud, P. (2011) · Annals of Internal Medicine · doi:10.7326/0003-4819-155-1-201107050-00006 · Cited by 307 · see citing works
Michael, Y. L., Whitlock, E. P., Lin, J. S., Fu, R. F., O’Connor, E., & Gold, R. B. (2010) · Annals of Internal Medicine · doi:10.7326/0003-4819-153-12-201012210-00008 · Cited by 306 · see citing works
Duloxetine Versus Placebo for the Treatment of North American Women With Stress Urinary Incontinence
Dmochowski, R. R., Miklos, J. R., Norton, P., et al. (2003) · The Journal of Urology · doi:10.1097/01.ju.0000080708.87092.cc · Cited by 302 · see citing works
Antivirals for influenza in healthy adults: systematic review
Jefferson, T., Demicheli, V., Rivetti, D., Jones, M., Pietrantonj, C. D., & Rivetti, A. (2006) · The Lancet · doi:10.1016/s0140-6736(06)67970-1 · Cited by 286 · see citing works
Hydroxyzine for generalised anxiety disorder
Guaiana, G., Barbui, C., & Cipriani, A. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006815.pub2 · Cited by 274 · see citing works
Rotstein, C., Bow, E. J., Laverdière, M., Ioannou, S., Carr, D., Moghaddam, N., & The Canadian Fluconazole Prophylaxis Study Group (1999) · Clinical Infectious Diseases · doi:10.1086/515128 · Cited by 265 · see citing works
Modified intention to treat reporting in randomised controlled trials: systematic review
Abraha, I., & Montedori, A. (2010) · BMJ · doi:10.1136/bmj.c2697 · Cited by 257 · see citing works
Self-citationNuesch, E., Trelle, S., Reichenbach, S., Rutjes, A. W. S., Burgi, E., Scherer, M., Altman, D. G., & Juni, P. (2009) · BMJ · doi:10.1136/bmj.b3244 · Cited by 248 · see citing works
Intention to treat – who should use ITT?
Lewis, J., & Machin, D. (1993) · British Journal of Cancer · doi:10.1038/bjc.1993.402 · Cited by 236 · see citing works
Dodd, J. M., Flenady, V., Cincotta, R., & Crowther, C. A. (2006) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004947.pub2 · Cited by 232 · see citing works
Investigating patient exclusion bias in meta-analysis
Tierney, J. F. (2004) · International Journal of Epidemiology · doi:10.1093/ije/dyh300 · Cited by 221 · see citing works
Hollander, E., Rossi, N. B., Sood, E., & Pallanti, S. (2003) · The International Journal of Neuropsychopharmacology · doi:10.1017/s1461145703003730 · Cited by 197 · see citing works
Rhorer, J., Ambrose, C. S., Dickinson, S., Hamilton, H., Oleka, N. A., Malinoski, F. J., & Wittes, J. T. (2008) · Vaccine · doi:10.1016/j.vaccine.2008.11.093 · Cited by 187 · see citing works
Humber, C., Tierney, J. F., Symonds, R. P., et al. (2006) · Annals of Oncology · doi:10.1093/annonc/mdl417 · Cited by 186 · see citing works
Discordance between reported intention-to-treat and per protocol analyses
Porta, N., Bonet, C., & Cobo, E. (2007) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2006.09.013 · Cited by 184 · see citing works
F. McKenna, D. B. (2001) · Scandinavian Journal of Rheumatology · doi:10.1080/030097401750065265 · Cited by 182 · see citing works
Immunoactive prophylaxis of recurrent urinary tract infections: a meta-analysis
Naber, K. G., Cho, Y. H., Matsumoto, T., & Schaeffer, A. J. (2008) · International Journal of Antimicrobial Agents · doi:10.1016/j.ijantimicag.2008.08.011 · Cited by 178 · see citing works
Katchamart, W., Trudeau, J., Phumethum, V., & Bombardier, C. (2008) · Annals of the Rheumatic Diseases · doi:10.1136/ard.2008.099861 · Cited by 177 · see citing works
Coomarasamy, A., Afnan, M., Cheema, D., van der Veen, F., Bossuyt, P. M., & van Wely, M. (2007) · Human Reproduction · doi:10.1093/humrep/dem305 · Cited by 177 · see citing works
Schulz, K. F., Grimes, D. A., Altman, D. G., & Hayes, R. J. (1996) · BMJ · doi:10.1136/bmj.312.7033.742 · Cited by 163 · see citing works
Bai, Y., Gao, J., Zou, D., & Li, Z. (2007) · The American Journal of Gastroenterology · doi:10.1111/j.1572-0241.2007.01575.x · Cited by 160 · see citing works
Rudolph, R. L., & Feiger, A. D. (1999) · Journal of Affective Disorders · doi:10.1016/s0165-0327(99)00067-1 · Cited by 158 · see citing works
Mariappan, P., Alhasso, A. A., Ballantyne, Z., et al. (2006) · European Urology · doi:10.1016/j.eururo.2006.08.041 · Cited by 154 · see citing works
Gravel, J., Opatrny, L., & Shapiro, S. (2007) · Clinical Trials · doi:10.1177/1740774507081223 · Cited by 135 · see citing works
Dupont, H. T., Carbon, C., & Carlet, J. M. (2000) · Antimicrobial Agents and Chemotherapy · doi:10.1128/aac.44.8.2028-2033.2000 · Cited by 124 · see citing works
Sparano, J. A., Makhson, A. N., Семиглазов, В. Ф., Tjulandin, S., Balashova, O. I., Bondarenko, I., Bogdanova, N. V., Manikhas, G. M., Oliynychenko, G. P., Chatikhine, V. A., et al. (2009) · Journal of Clinical Oncology · doi:10.1200/jco.2008.20.5013 · Cited by 116 · see citing works
Nikfar, S., Rahimi, R., Rezaie, A. R., & Abdollahi, M. R. (2008) · Digestive Diseases and Sciences · doi:10.1007/s10620-008-0481-x · Cited by 115 · see citing works
Paul, M., Grozinsky‐Glasberg, S., Soares‐Weiser, K., & Leibovici, L. (2006) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003344.pub2 · Cited by 114 · see citing works
Montedori, A., Bonacini, I., Casazza, G., Luchetta, M. L., Duca, P., Cozzolino, F., & Abraha, I. (2011) · Trials · doi:10.1186/1745-6215-12-58 · Cited by 112 · see citing works
Self-citationCranney, A., Wells, G. A., Yetisir, E., Adámi, S., Cooper, C. C., Delmas, P. D., Miller, P. D., Papapoulos, S. E., Reginster, J., Sambrook, P. N., et al. (2008) · Osteoporosis International · doi:10.1007/s00198-008-0653-8 · Cited by 107 · see citing works
Benkert, O., Gründer, G., Wetzel, H., & Hackett, D. (1996) · Journal of Psychiatric Research · doi:10.1016/s0022-3956(96)00029-5 · Cited by 105 · see citing works
Second-generation antipsychotics for obsessive compulsive disorder
Komossa, K., Depping, A. M., Meyer, M., Kissling, W., & Leucht, S. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008141.pub2 · Cited by 96 · see citing works
Vardakas, K. Z., Samonis, G., Michalopoulos, A. S., Soteriades, E. S., & Falagas, M. E. (2006) · Critical Care Medicine · doi:10.1097/01.ccm.0000208357.05675.c3 · Cited by 90 · see citing works
Siersma, V., Als-Nielsen, B. E. T., Chen, W., Hilden, J., Gluud, L. L., & Gluud, C. N. (2006) · Statistics in Medicine · doi:10.1002/sim.2752 · Cited by 83 · see citing works
Ravindran, V. K., Scott, D. L., & Choy, E. (2007) · Annals of the Rheumatic Diseases · doi:10.1136/ard.2007.072652 · Cited by 80 · see citing works
Dopamine agonists in the treatment of early Parkinson's disease: A meta-analysis
Baker, W. L., Silver, D. E., White, C. M., Kluger, J., Aberle, J., Patel, A. A., & Coleman, C. I. (2008) · Parkinsonism & Related Disorders · doi:10.1016/j.parkreldis.2008.07.004 · Cited by 79 · see citing works
Avouac, J., Wipff, J., Kahan, A., & Allanore, Y. (2007) · Annals of the Rheumatic Diseases · doi:10.1136/ard.2007.077149 · Cited by 79 · see citing works
The efficacy of HER2-targeted agents in metastatic breast cancer: a meta-analysis
Harris, C. A., Ward, R. L., Dobbins, T., Drew, A. K., & Pearson, S. (2010) · Annals of Oncology · doi:10.1093/annonc/mdq593 · Cited by 78 · see citing works
SULPHASALAZINE IN THE MANAGEMENT OF PSORIATIC ARTHRITIS
Fraser, S., Hopkins, R., Hunter, J. A., et al. (1993) · Lara D. Veeken · doi:10.1093/rheumatology/32.10.923 · Cited by 76 · see citing works
Själander, A., Jansson, J.-H., Bergqvist, D., et al. (2007) · Journal of Internal Medicine · doi:10.1111/j.1365-2796.2007.01878.x · Cited by 74 · see citing works
Papakostas, G. I., Nelson, J. C., Kasper, S., & Möller, H.-J. (2008) · European Neuropsychopharmacology · doi:10.1016/j.euroneuro.2007.07.005 · Cited by 73 · see citing works
Citalopram versus nortriptyline in late‐life depression: a 12‐week randomized single‐blind study
Navarro, V., Gastó, C., Torres, X., Marcos, T., & Pintor, L. (2001) · Acta Psychiatrica Scandinavica · doi:10.1034/j.1600-0447.2001.00228.x · Cited by 69 · see citing works
Imran, H., Tleyjeh, I. M., Arndt, C. A. S., Baddour, L. M., Erwin, P. J., Tsigrelis, C., Kabbara, N., & Montori, V. M. (2007) · European Journal of Clinical Microbiology & Infectious Diseases · doi:10.1007/s10096-007-0397-y · Cited by 67 · see citing works
Rahimi, R., Nikfar, S., & Abdollahi, M. R. (2006) · Biomedicine & Pharmacotherapy · doi:10.1016/j.biopha.2006.06.022 · Cited by 67 · see citing works
Nemeroff, C. B., & Thase, M. E. (2005) · Journal of Psychiatric Research · doi:10.1016/j.jpsychires.2005.07.009 · Cited by 62 · see citing works
Re-evaluation of the efficacy and tolerability of venlafaxine vs SSRI: meta-analysis
Weinmann, S., Becker, T. M., & Koesters, M. (2007) · Psychopharmacology · doi:10.1007/s00213-007-0975-9 · Cited by 61 · see citing works
Beta lactam monotherapy versus beta lactam-aminoglycoside combination therapy for treating sepsis
Paul, M., Leibovici, L., Grozinsky, S. G., et al. (2001) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003344 · Cited by 60 · see citing works
Metaanalysis of Tirilazad Mesylate in Patients with Aneurysmal Subarachnoid Hemorrhage
Jang, Y. G., Ilodigwe, D., & Macdonald, R. L. (2008) · Neurocritical Care · doi:10.1007/s12028-008-9147-y · Cited by 60 · see citing works
Kärkkäinen, M., Tuppurainen, M. T., Salovaara, K., Sandini, L., Rikkonen, T., Sirola, J. P., Honkanen, R., Arokoski, J. P., Alhava, E. M., & Kröger, H. (2010) · Maturitas · doi:10.1016/j.maturitas.2009.12.018 · Cited by 59 · see citing works
Seo, J. H., Kim, Y. H., & Kim, J. S. (2008) · Cancer Chemotherapy and Pharmacology · doi:10.1007/s00280-008-0735-5 · Cited by 58 · see citing works
Rodrigo, G. J., & Nannini, L. J. (2006) · Pulmonary Pharmacology & Therapeutics · doi:10.1016/j.pupt.2006.02.003 · Cited by 58 · see citing works
Lee, Y. H., Woo, J. H., Rho, Y. H., et al. (2007) · Rheumatology International · doi:10.1007/s00296-007-0475-6 · Cited by 54 · see citing works
Risperidone alone or in combination for acute mania
Rendell, J. M., Gijsman, H. J., Bauer, M. S., Goodwin, G. M., & Geddes, J. R. (2006) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004043.pub2 · Cited by 53 · see citing works
Papageorgiou, S. N., Antonoglou, G. N., Tsiranidou, E., Jepsen, S. V., & Jäger, A. (2014) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2014.04.002 · Cited by 53 · see citing works
Asakura, S., Tajima, O., & Koyama, T. (2006) · The International Journal of Neuropsychopharmacology · doi:10.1017/s1461145706006602 · Cited by 53 · see citing works
Kiilerich, S., Ladefoged, K., Rannem, T., & Ranløv, P. (1992) · Gut · doi:10.1136/gut.33.2.252 · Cited by 51 · see citing works
A Meta‐Analysis of Pain Response in the Treatment of Fibromyalgia
Roskell, N., Beard, S. M., Zhao, Y., & Le, T. K. (2010) · Pain Practice · doi:10.1111/j.1533-2500.2010.00441.x · Cited by 47 · see citing works
Kosmas, I. P., Tatsioni, A., Kolibianakis, E. M., et al. (2007) · Fertility and Sterility · doi:10.1016/j.fertnstert.2007.06.064 · Cited by 42 · see citing works
Brok, J. S., Gluud, L. L., & Gluud, C. N. (2006) · The American Journal of Gastroenterology · doi:10.1111/j.1572-0241.2006.00505.x · Cited by 41 · see citing works
Efficacy of Haemophilus influenzae type b vaccination of children: a meta-analysis
Obonyo, C., & Lau, J. (2006) · European Journal of Clinical Microbiology & Infectious Diseases · doi:10.1007/s10096-006-0092-4 · Cited by 40 · see citing works
Systematic Review of the Comparative Effectiveness of Antiepileptic Drugs for Fibromyalgia
Siler, A. C., Gardner, H., Yanit, K., Cushman, T. E., & McDonagh, M. S. (2010) · Journal of Pain · doi:10.1016/j.jpain.2010.09.007 · Cited by 40 · see citing works
Azim, H. A., Elattar, I. A., Loberiza, F. R., Azim, H. A., Mok, T. S. K., & Ganti, A. K. (2008) · Lung Cancer · doi:10.1016/j.lungcan.2008.08.011 · Cited by 37 · see citing works
Interleukin-2 Receptor Antagonists in Liver Transplantation: A Meta-analysis of Randomized Trials
Wang, X., Li, J. D., Peng, Y., Dai, Y., Shi, G., & Xu, W. (2010) · Transplantation Proceedings · doi:10.1016/j.transproceed.2010.09.169 · Cited by 34 · see citing works
Nikfar, S., Mirfazaelian, H., & Abdollahi, M. R. (2010) · Current Pharmaceutical Design · doi:10.2174/138161210794079236 · Cited by 32 · see citing works
Zou, Z., Xi, G.-L., Yuan, H.-B., Zhu, Q.-F., & Shi, X.-Y. (2008) · Journal of Human Hypertension · doi:10.1038/jhh.2008.132 · Cited by 31 · see citing works
Gao, F., Liao, C., Liu, L., Tan, A., Cao, Y., & Mo, Z. (2008) · Colorectal Disease · doi:10.1111/j.1463-1318.2008.01746.x · Cited by 29 · see citing works
Duloxetine versus Placebo for the Treatment of North American Women with Stress Urinary Incontinence
Dmochowski, R. R., Miklos, J. R., Norton, P., et al. (2004) · Obstetrical & Gynecological Survey · doi:10.1097/01.ogx.0000116046.42679.18 · Cited by 17 · see citing works
Ziakas, P. D., Kourbeti, I. S., Voulgarelis, M., & Mylonakis, E. E. (2010) · Clinical Therapeutics · doi:10.1016/j.clinthera.2011.01.009 · Cited by 17 · see citing works
van den Broek, W. W., Mulder, P., van Os, E., Birkenhäger, T., Pluijms, E. M., & Bruijn, J. A. (2008) · Journal of Psychopharmacology · doi:10.1177/0269881108089821 · Cited by 16 · see citing works
(1996) · International Journal of Gynecology & Obstetrics · doi:10.1016/0020-7292(96)88724-8 · Cited by 14 · see citing works
Xu, H., Xu, Q., & Li, L. (2010) · Journal of Cancer Research and Clinical Oncology · doi:10.1007/s00432-010-0967-8 · Cited by 7 · see citing works
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Understanding the Intention-to-treat Principle in Randomized Controlled Trials
McCoy, E. (2017) · Western Journal of Emergency Medicine · doi:10.5811/westjem.2017.8.35985 · Cited by 767 · see citing works
Abraha, I., Rimland, J. M., Trotta, F. M., Dell'Aquila, G., Cruz-Jentoft, A., Petrovic, M., Gudmundsson, A., Soiza, R., O'Mahony, D., Guaita, A., et al. (2017) · BMJ Open · doi:10.1136/bmjopen-2016-012759 · Cited by 557 · see citing works
Self-citationWhy clinical trial outcomes fail to translate into benefits for patients
Heneghan, C., Goldacre, B., & Mahtani, K. R. (2017) · Trials · doi:10.1186/s13063-017-1870-2 · Cited by 404 · see citing works
Fodor, L. A., Coteț, C. D., Cuijpers, P., Szamoskozi, Ș., David, D., & Cristea, I. A. (2018) · Scientific Reports · doi:10.1038/s41598-018-28113-6 · Cited by 284 · see citing works
Page, M. J., Higgins, J. P. T., Clayton, G., Sterne, J. A. C., Hróbjartsson, A., & Savović, J. (2016) · PLOS ONE · doi:10.1371/journal.pone.0159267 · Cited by 284 · see citing works
Exposure therapy for PTSD: A meta-analysis
McLean, C. P., Levy, H. C., Miller, M. L., & Tolin, D. F. (2022) · Clinical Psychology Review · doi:10.1016/j.cpr.2021.102115 · Cited by 273 · see citing works
Cochrane’s risk of bias tool in the context of psychotherapy outcome research
Munder, T., & Barth, J. (2018) · Psychotherapy Research · doi:10.1080/10503307.2017.1411628 · Cited by 174 · see citing works
Lim, S. M., Shiau, C. W. C., Cheng, L. J., & Lau, Y. (2022) · Behavior Therapy · doi:10.1016/j.beth.2021.09.007 · Cited by 163 · see citing works
Guyatt, G. H., Ebrahim, S., Alonso-Coello, P., Johnston, B. C., Mathioudakis, A. G., Briel, M., Mustafa, R. A., Sun, X., Walter, S. D., Heels-Ansdell, D., et al. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.05.005 · Cited by 163 · see citing works
Open trial of a personalized modular treatment for mood and anxiety
Fisher, A. J., Bosley, H. G., Fernandez, K. C., Reeves, J. W., Soyster, P. D., Diamond, A. E., & Barkin, J. (2019) · Behaviour Research and Therapy · doi:10.1016/j.brat.2019.01.010 · Cited by 156 · see citing works
SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
Hróbjartsson, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081660 · Cited by 171 · see citing works
Mennin, D. S., Fresco, D. M., O'Toole, M. S., & Heimberg, R. G. (2018) · Journal of Consulting and Clinical Psychology · doi:10.1037/ccp0000289 · Cited by 119 · see citing works
French, K., Golijani-Moghaddam, N., & Schröder, T. (2017) · Journal of Contextual Behavioral Science · doi:10.1016/j.jcbs.2017.08.002 · Cited by 100 · see citing works
Empirical evaluation of which trial characteristics are associated with treatment effect estimates
Dechartres, A., Trinquart, L., Faber, T., & Ravaud, P. (2016) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2016.04.005 · Cited by 85 · see citing works
Chen, T., Li, C., Qin, R., Wang, Y., Yu, D., Dodd, J., Wang, D., & Cornelius, V. (2019) · JAMA Network Open · doi:10.1001/jamanetworkopen.2019.7242 · Cited by 68 · see citing works
Wang, Y., Parpia, S., Couban, R., Wang, Q., Armijo-Olivo, S., Bassler, D., Briel, M., Brignardello-Petersen, R., Gluud, L. L., Keitz, S. A., et al. (2024) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2023.11.001 · Cited by 58 · see citing works
Witt, K., de Moraes, D. P., Salisbury, T. T., Arensman, E., Gunnell, D., Hazell, P., Townsend, E., van Heeringen, K., & Hawton, K. (2018) · Journal of Affective Disorders · doi:10.1016/j.jad.2018.04.025 · Cited by 31 · see citing works
Chalmers, I., Matthews, R., Glasziou, P., Boutron, I., & Armitage, P. (2023) · Journal of the Royal Society of Medicine · doi:10.1177/01410768231203936 · Cited by 9 · see citing works
- Authors
- Abraha, I., Cherubini, A., Cozzolino, F., De Florio, R., Luchetta, M. L., Rimland, J. M., Folletti, I., Marchesi, M., Germani, A., Orso, M., Eusebi, P., & Montedori, A.
- Affiliations
- Regione Umbria (IT)
- Istituto Nazionale di Riposo e Cura per Anziani (IT)
- University of Perugia (IT)
- Azienda Ospedaliera di Perugia (IT)
- Corresponding author
- Abraha, I.
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2015-05-27
- Volume
- 350
- Issue
- may27 2
- Pages
- h2445-h2445
- ISSN
- 1756-1833 (ISSN-L)
- PMC
- PMC4445790
- OpenAlex
- W626841314
- Cited by
- 165
- References
- 100
- Citations by year
- 2026: 5 · 2025: 4 · 2024: 12 · 2023: 12 · 2022: 24 · 2021: 15 · 2020: 15 · 2019: 19 · 2018: 16 · 2017: 29 · 2016: 13 · 2015: 1
- FWCI
- 17.74
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Università Politecnica delle Marche (Università Politecnica delle Marche) (submittedVersion)
- Funders
- Ministero della Salute
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- intention-to-treat analysis, randomised trials, treatment effect estimates, meta-epidemiology, risk of bias, trial reporting quality, meta-analysis bias, odds ratio bias, center effects, sample size adjustment, CONSORT, STROBE, risk of bias assessment tools
- MeSH terms
- Humans, Bias, Odds Ratio, Epidemiologic Studies, Randomized Controlled Trials as Topic, Treatment Outcome, Intention to Treat Analysis
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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