Cited by 2,160Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsAdvanced Causal Inference Techniques

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What is meant by intention to treat analysis? Survey of published randomised controlled trials

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Hollis, S., Campbell, F.·1999·BMJ

DOI 10.1136/bmj.319.7211.670PMC PMC28218

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Abstract

Abstract Objectives: To assess the methodological quality of intention to treat analysis as reported in randomised controlled trials in four large medical journals. Design: Survey of all reports of randomised controlled trials published in 1997 in the BMJ, Lancet, JAMA, and New England Journal of Medicine. Main outcome measures: Methods of dealing with deviations from random allocation and missing data. Results: 119 (48%) of the reports mentioned intention to treat analysis. Of these, 12 excluded any patients who did not start the allocated intervention and three did not analyse all randomised subjects as allocated. Five reports explicitly stated that there were no deviations from random allocation. The remaining 99 reports seemed to analyse according to random allocation, but only 34 of these explicitly stated this. 89 (75%) trials had some missing data on the primary outcome variable. The methods used to deal with this were generally inadequate, potentially leading to a biased treatment effect. 29 (24%) trials had more than 10% of responses missing for the primary outcome, the methodsof handling the missing responses were similar in this subset. Conclusions: The intention to treat approach is often inadequately described and inadequately applied. Authors should explicitly describe the handling of deviations from randomised allocation and missing responses and discuss the potential effect of any missing response. Readers should critically assess the validity of reported intention to treat analyses. Key messages Intention to treat gives a pragmatic estimate of the benefit of a change in treatment policy rather than of potential benefit in patients who receive treatment exactly as planned Full application of intention to treat is possible only when complete outcome data are available for all randomised subjects About half of all published reports of randomised controlled trials stated that intention to treat was used, but handling of deviations from randomised allocation varied widely Many trials had some missing data on the primary outcome variable, and methods used to deal with this were generally inadequate, potentially leading to bias Intention to treat analyses are often inadequately described and inadequately applied

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Statistical Analysis With Missing Data
Lahiff, M., Little, R. J. A., & Rubin, D. B. (1989) · Journal of the American Statistical Association · doi:10.2307/2289883 · Cited by 17,385
Time Series Analysis: Forecasting and Control
Kleiner, B., Box, G. E. P., & Jenkins, G. M. (1977) · Technometrics · doi:10.2307/1267710 · Cited by 6,447
Improving the Quality of Reporting of Randomized Controlled Trials: The CONSORT Statement
Begg, C. (1996) · JAMA · doi:10.1001/jama.1996.03540080059030 · Cited by 3,127
Time series analysis forecasting and control
Janacek, G. J. (2009) · Journal of Time Series Analysis · doi:10.1111/j.1467-9892.2009.00643.x · Cited by 2,623
Roderick J.A. Little, Donald B. Rubin — Statistical Analysis with Missing Data
Bo., N., Little, R. J. A., & Rubin, D. B. (1988) · Population · doi:10.2307/1533221 · Cited by 2,163
Randomised study of radical surgery versus radiotherapy for stage Ib-IIa cervical cancer
Landoni, F., Maneo, A., Colombo, A., Placa, F., Milani, R., Perego, P., Favini, G., Ferri, L., & Mangioni, C. (1997) · The Lancet · doi:10.1016/s0140-6736(97)02250-2 · Cited by 1,668
Users' Guides to the Medical Literature
Guyatt, G. H. (1993) · JAMA · doi:10.1001/jama.270.21.2598 · Cited by 1,185
The Effect of Aggressive Lowering of Low-Density Lipoprotein Cholesterol Levels and Low-Dose Anticoagulation on Obstructive Changes in Saphenous-Vein Coronary-Artery Bypass Grafts
The Post Coronary Artery Bypass Graft Trial Investigators (1997) · New England Journal of Medicine · doi:10.1056/nejm199701163360301 · Cited by 969
Randomised trial of basiliximab versus placebo for control of acute cellular rejection in renal allograft recipients
Nashan, B., Moore, R. H., Amlot, P. L., Schmidt, A.-G., Abeywickrama, K. H., & Soulillou, J. (1997) · The Lancet · doi:10.1016/s0140-6736(97)09278-7 · Cited by 746
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

Show all 67 references

Research works printed but not linked: 10

Skog O-J. Interpreting trends in alcohol consumption and alcohol related damage. Alcohol Alcohol 1988;22:193-202.
Robinson WS. Ecological correlations and the behavior of individual. American Sociological Review 1950;15:351-7.
Skog O-J. Liver cirrhosis epidemiology: some methodological problems. Br J Addiction 1980;75:227-43.
Hilton ME. Trends in U.S. drinking patterns: further evidence from the past twenty years. In: Clark WB, Hilton ME, eds. Alcohol in America: drink- ing practices and problems. Albany: State University of New York Press, 1991:121-38.
Schmidt DN. Apparent risk factors for chronic and acute pancreatitis in Stockholm county: spirits but not wine and beer. Int J Pancreatol 1991;8:45-50.
Kling W. Measurement of ethanol consumed in distilled spirits: revision. J Stud Alcohol 1991;52:503-4.
Derr RF. Wine, alcohol, nutrition, and the risk of human mortality: corre- lation with rat and baboon studies. Biochem Arch 1996;12:277-82.
Cochrane Controlled Trials Register. Cochrane library. Cochrane Collabo- ration. Oxford: Update Software, 1997.
Cuzick J, Edwards R, Segnan N. Adjusting for non-compliance and con- tamination in randomized clinical trials. Stat Med 1997;16:1017-29.
Goetghebeur EJ, Shapiro SH. Analysing non-compliance in clinical trials: ethical imperative or mission impossible? Stat Med 1996;15:2813-26.

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Authors: Hollis, S., & Campbell, F.
Affiliations: Lancaster University (GB)
AstraZeneca (United Kingdom) (GB)
Corresponding author: Hollis, S.
ORCID: Campbell, F.
Venue: BMJ
Publisher: BMJ
Published: 1999-09-11
Volume: 319
Issue: 7211
Pages: 670-674
ISSN: 0007-1447 (ISSN-L)
0959-8138
1468-5833
DOI: 10.1136/bmj.319.7211.670
PMC: PMC28218
OpenAlex: W1984052453
Cited by: 2,160
References: 67
Citations by year: 2026: 32 · 2025: 42 · 2024: 40 · 2023: 67 · 2022: 68 · 2021: 66 · 2020: 78 · 2019: 82 · 2018: 74 · 2017: 73 · 2016: 106 · 2015: 107 · 2014: 144 · 2013: 128 · 2012: 128
FWCI: 7.30
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: BMJ (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Research Explorer (The University of Manchester) (submittedVersion)
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 › Advanced Causal Inference Techniques
Keywords: intention-to-treat analysis, randomized controlled trials, methodological quality, missing data, bias in treatment effect estimation, reporting practices, medical journals
MeSH terms: Data Collection, Decision Making, Randomized Controlled Trials as Topic, Treatment Refusal, Treatment Outcome, Patient Selection

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