Modified intention-to-treat analysis did not bias trial results.

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Abstract

To investigate whether analysis of the modified intention-to-treat (mITT) population with postrandomization exclusion of patients from analysis is associated with biased estimates of treatment effect compared to the conservative intention-to-treat (ITT) population.

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Journal

Journal ID (iso-abbrev): J Clin Epidemiol

Title: Journal of clinical epidemiology

Publisher: Elsevier BV

ISSN (Electronic): 1878-5921

ISSN (Print): 0895-4356

Publication date (Electronic): Apr 2016

Volume: 72

Affiliations

[1 ] Department of Rheumatology, Musculoskeletal Statistics Unit, The Parker Institute, Frederiksberg Hospital, Nordre Fasanvej 57, 2000 Copenhagen, Denmark.

[2 ] Department of Medicine, David Geffen School of Medicine, University of California, 10833 Le Conte Avenue, Los Angeles, CA 90095, USA.

[3 ] Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.

[4 ] Clinical Epidemiology Program, Department of Epidemiology and Community Medicine, Ottawa Hospital Research Institute, University of Ottawa, Room 3105, 451 Smyth Road, Ottawa, Ontario K1H 8M5, Canada.

[5 ] Department of Clinical Epidemiology & Biostatistics, Faculty of Health Sciences, McMaster University, 1200 Main Street West, Hamilton, Ontario L8N 3Z5, Canada.

[6 ] Department of Rheumatology, The Parker Institute, Frederiksberg Hospital, Nordre Fasanvej 57, 2000 Copenhagen, Denmark.

[7 ] Department of Rheumatology, Musculoskeletal Statistics Unit, The Parker Institute, Frederiksberg Hospital, Nordre Fasanvej 57, 2000 Copenhagen, Denmark. Electronic address: Robin.Christensen@regionh.dk.

Article

Publisher Item ID: S0895-4356(15)00506-5

DOI: 10.1016/j.jclinepi.2015.11.003

PubMed ID: 26562052

SO-VID: cd220c98-2d0f-48db-bdf1-69f79cf0d67b

History

Keywords: Rheumatoid arthritis,Bias,Biological disease-modifying antirheumatic drugs (DMARD),Epidemiology,Intention-to-treat analysis,Meta-analysis

Data availability:

Keywords: Rheumatoid arthritis, Bias, Biological disease-modifying antirheumatic drugs (DMARD), Epidemiology, Intention-to-treat analysis, Meta-analysis

Modified intention-to-treat analysis did not bias trial results.

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