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Intention-to-Treat Analysis: Implications for Quantitative and Qualitative Research
Open accessAbstract
Newell D J (Department of Medical Statistics, University of Newcastle upon Tyne, UK). Intention-to-treat analysis: implications for quantitative and qualitative research. International Journal of Epidemiology 1992, 21: 837–841 Intention-to-treat analysis is an important aspect of randomized controlled trials of health care interventions. The concept is now widely accepted in theory, but not always implemented in practice. Failure to analyse by intention-to-treat can give misleading and indeed life-threatening interpretations. In some studies, a case is put for estimating the effect that would have been observed if all patients had received the allocated treatment. Situations where this is valid are rare, but an example is given of such an exceptional study. The relevance of the intention-to-treat concept is not always taken into account in qualitative research. Interviews with new mothers who delivered their babies at home in a hypothetical controlled trial of home versus hospital confinement would provide fascinating accounts of the pleasures of successful delivery at home. But by definition the interviews would exclude the hazard and drama of necessary transfers to hospital due to complications in late pregnancy and early labour. The intention-to-treat approach would avoid this bias.
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“All enrolled participants who completed the baseline assessment were included in the intention-to-treat analysis [31].”
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Joussemet, M., Mageau, G. A., Larose, M., Robichaud, J., Dufour, S., Vitaro, F., & Koestner, R. (2025) · Family Process · doi:10.1111/famp.70081 · Cited by 1
“All participants were thus retained in all analyses, regardless of the extent to which they missed program sessions (Newell 1992).”
Neumann, A., Seifert, M., Kliemt, R., Claus, F., Schmitt, J. M., Swart, E., & Baum, F. (2025) · Zeitschrift für Kinder- und Jugendpsychiatrie und Psychotherapie · doi:10.1024/1422-4917/a001054 · Cited by 1
Human stem cells for decompensated cirrhosis in adults
Aung, H. H., Naing, C. M., Ni, H., Aye, S. N., Htet, N. H., Kew, S. T., & Pavlov, C. S. (2025) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd015173.pub2 · Cited by 1
Clinical drug trials: practical problems of phase III.
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Metadata
- Authors
- NEWELL, D. J.
- Affiliations
- Newcastle University (GB)
- Corresponding author
- NEWELL, DAVID J
- ORCID
- NEWELL, DAVID J
- Venue
- International Journal of Epidemiology
- Publisher
- Oxford University Press (OUP)
- Published
- 1992
- Volume
- 21
- Issue
- 5
- Pages
- 837-841
- ISSN
- 0300-5771 (ISSN-L)
- 1464-3685
- OpenAlex
- W2106051200
- Cited by
- 715
- References
- 6
- Citations by year
- 2026: 4 · 2025: 15 · 2024: 24 · 2023: 22 · 2022: 21 · 2021: 16 · 2020: 16 · 2019: 16 · 2018: 25 · 2017: 36 · 2016: 31 · 2015: 35 · 2014: 51 · 2013: 62 · 2012: 34
- FWCI
- 5.99
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- International Journal of Epidemiology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- intention-to-treat analysis, randomized controlled trials, health interventions, qualitative research, home birth, hospital confinement, allocation bias, treatment effect estimation
- MeSH terms
- Data Interpretation, Statistical, Evaluation Studies as Topic, Humans, Patient Compliance, Random Allocation, Research Design, Therapeutics, Cohort Studies, Randomized Controlled Trials as Topic
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