Cited by 50Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsStatistical Methods and Bayesian Inference

A systematic review finds variable use of the intention-to-treat principle in musculoskeletal randomized controlled trials with missing data

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Joseph, Royes, Sim, Julius, Ogollah, Reuben, Lewis, Martyn·2015·Journal of Clinical Epidemiology

Abstract

OBJECTIVES: In randomized trials, the primary analysis should be consistent with the intention-to-treat (ITT) principle and should address missing data appropriately to draw valid inferences. This review focuses on current practices relating to the ITT principle and methods to handle missing data in the major musculoskeletal journals. STUDY DESIGN AND SETTING: A systematic review of randomized trials published in 2010 and 2011 in five musculoskeletal journals was performed. RESULTS: We reviewed 91 trials: 38% performed a full ITT analysis (analyzing outcome data for all randomized participants) and 31% performed a partial ITT analysis (excluding participants with no follow-up data). The overall median dropout was 12%; 60% of trials had more than 10% dropouts, and 32% of trials had more than 20% dropouts. Among those that performed an ITT analysis, the majority adopted a form of single imputation; last observation carried forward was the designated approach in most cases. Mixed models for repeated measures and/or multiple imputations were limited to eight trials. CONCLUSION: It appears that many trials reporting missing data are inappropriately analyzed and may therefore be prone to biased estimates and invalid inferences.

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  • A modified type of intention-to-treat analysis that excludes randomized patients who never started an intervention is frequently applied in the literature.

    “Such a modified type of intention-to-treat analysis is frequently applied in the literature [27–29].”

    From Is sleep disturbance in patients with chronic pain affected by physical exercise or ACT-based stress management? - A randomized controlled study (2018) · cites this paper as [28]

    The Introduction describes a modified or partial intention-to-treat approach that excludes randomized participants with no follow-up data, and the Discussion reports that 28 of 39 reviewed trials with early dropouts used it. The paper does not define those excluded patients as people who never started the intervention; lack of follow-up is a different criterion. The review also concerns musculoskeletal trials, rather than the literature generally. Page numbers are unavailable in our copy. (LLM, conf=0.86)

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Research works printed but not linked: 2

  1. Lewis JA, Machin D. Intention to treatdwho should use ITT? Br J Cancer 1993;68:647e50.
  2. Lachin JM. Statistical consideration in the intention-to-treat princi- ple. Control Clin Trials 2000;21:167e89.

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Authors
Joseph, R., Sim, J., Ogollah, R., & Lewis, M.
Affiliations
Arthritis Research UK (GB)
Corresponding author
Lewis, Martyn
Venue
Journal of Clinical Epidemiology
Publisher
Elsevier BV
Published
2015-01
Volume
68
Issue
1
Pages
15-24
ISSN
0895-4356 (ISSN-L)
OpenAlex
W2025262111
Cited by
50
References
57
Citations by year
2026: 3 · 2025: 5 · 2024: 4 · 2023: 6 · 2022: 6 · 2021: 5 · 2020: 7 · 2019: 4 · 2018: 2 · 2017: 3 · 2016: 1 · 2015: 4
FWCI
0.34
Type
journal article
Language
en
Open access
Locations
  • Journal of Clinical Epidemiology (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • Repository@Nottingham (University of Nottingham) (acceptedVersion, other-oa)
  • Keele Research Repository (Keele University) (submittedVersion, cc-by)
  • Repository@Nottingham (University of Nottingham) (submittedVersion, cc-by)
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods and Bayesian Inference
Keywords
intention-to-treat analysis, missing data, dropout, single imputation, last observation carried forward, multiple imputation, primary analysis
MeSH terms
Data Interpretation, Statistical, Humans, Musculoskeletal Diseases, Patient Dropouts, Publications, Randomized Controlled Trials as Topic, Intention to Treat Analysis

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