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

The DOI matches its Crossref record; 64 of the 67 references it cites were found in a registry or an index.

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

Open access

Hollis, S., Campbell, F.·1999·BMJ

DOI 10.1136/bmj.319.7211.670PMC PMC28218

Open this paper in CoChat — free account Open PDF

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

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

Integrity signals

Registry

Crossref · 10.1136/bmj.319.7211.670

Cites

64 of 64 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

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.

Sorted by citations

Items 601–700 of 1,015

Methods for priority setting among clinical preventive services11The full text of this article is available via AJPM Online at www.elsevier.com/locate/ajpmonline.
Maciosek, M. V., Coffield, A. B., McGinnis, J. M., Harris, J. R., Caldwell, M. B., Teutsch, S. M., Atkins, D. C., Richland, J. H., & Haddix, A. C. (2001) · American Journal of Preventive Medicine · doi:10.1016/s0749-3797(01)00309-9 · Cited by 63
Randomized controlled trials in palliative care: overcoming the obstacles
Hudson, P., Aranda, S. K., & McMurray, N. E. (2001) · International Journal of Palliative Nursing · doi:10.12968/ijpn.2001.7.9.9301 · Cited by 63
A randomized, double‐blind, placebo‐controlled trial of polyethylene glycol effects on fasting and postprandial rectal sensitivity and symptoms in hypersensitive constipation‐predominant irritable bowel syndrome
Awad, R. A., & Camacho, S. (2010) · Colorectal Disease · doi:10.1111/j.1463-1318.2009.01990.x · Cited by 62
Quality of Reporting of Key Methodological Items of Randomized Controlled Trials in Clinical Ophthalmic Journals
Lai, T., Wong, V. W., Lam, R., Cheng, A. C., Lam, D., & Leung, G. (2007) · Ophthalmic Epidemiology · doi:10.1080/09286580701344399 · Cited by 53
The creation of evidence in ‘evidence‐based’ drug prevention: a critique of the Strengthening Families Program Plus Life Skills Training evaluation
Gorman, D. M., Conde, E., & Huber, J. C. (2007) · Drug and Alcohol Review · doi:10.1080/09595230701613544 · Cited by 62
Intention-to-treat analyses and missing data approaches in pharmacotherapy trials for alcohol use disorders
Del Re, A. C., Maisel, N. C., Blodgett, J. C., & Finney, J. W. (2013) · BMJ Open · doi:10.1136/bmjopen-2013-003464 · Cited by 62
An open-label pilot study of the efficacy and safety of anakinra in patients with psoriatic arthritis refractory to or intolerant of methotrexate (MTX)
Jung, N., Hellmann, M., Hoheisel, R., Lehmann, C., Haase, I., Perniok, A., Hallek, M. J., & RUBBERT, A. (2010) · Clinical Rheumatology · doi:10.1007/s10067-010-1504-5 · Cited by 62
Sequential versus standard triple first-line therapy forHelicobacter pylorieradication
Nyssen, O. P., McNicholl, A. G., Mégraud, F., Savarino, V., Oderda, G., Fallone, C. A., Fischbach, L. A., Bazzoli, F., & Gisbert, J. P. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd009034.pub2 · Cited by 62
Orthodontics with Customized versus Noncustomized Appliances: A Randomized Controlled Clinical Trial
Penning, E. W., Peerlings, R. H. J., Govers, J. D. M., Rischen, R. J., Zinad, K., Bronkhorst, E. M., Breuning, K. H., & Kuijpers‐Jagtman, A. M. (2017) · Journal of Dental Research · doi:10.1177/0022034517720913 · Cited by 62
Quality of Reporting in Randomized Trials Published in High-Quality Surgical Journals
Sinha, S., Sinha, S., Ashby, E., Jayaram, R., & Grocott, M. P. W. (2009) · Journal of the American College of Surgeons · doi:10.1016/j.jamcollsurg.2009.07.019 · Cited by 79
Repositioning for preventing pressure ulcers: a systematic review and meta-analysis
Avşar, P., Moore, Z. E. H., Patton, D., O’Connor, T., Budri, A., & Nugent, L. (2020) · Journal of Wound Care · doi:10.12968/jowc.2020.29.9.496 · Cited by 61
Mobile media education as a tool to reduce problematic smartphone use: Results of a randomised impact evaluation
Gui, M., Gerosa, T., Argentin, G., & Losi, L. (2022) · Computers & Education · doi:10.1016/j.compedu.2022.104705 · Cited by 83
Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials
Xie, C., Gu, Y., Wang, W., Lü, L., Fu, D.-L., Liu, A., Li, H., Li, J.-H., Lin, Y., Tang, W., et al. (2013) · BMC Complementary and Alternative Medicine · doi:10.1186/1472-6882-13-18 · Cited by 62
Naprapathic Manual Therapy or Evidence-based Care for Back and Neck Pain
Skillgate, E., Vingård, E., & Alfredsson, L. S. (2007) · Clinical Journal of Pain · doi:10.1097/ajp.0b013e31805593d8 · Cited by 61
Preventing Australian football injuries with a targeted neuromuscular control exercise programme: comparative injury rates from a training intervention delivered in a clustered randomised controlled trial
Finch, C. F., Twomey, D., Fortington, L. V., Doyle, T. L. A., Elliott, B. C., Akram, M., & Lloyd, D. G. (2015) · Injury Prevention · doi:10.1136/injuryprev-2015-041667 · Cited by 61
HIV Prevention for Adults With Criminal Justice Involvement: A Systematic Review of HIV Risk-Reduction Interventions in Incarceration and Community Settings
Underhill, K., Dumont, D. M., & Operario, D. (2014) · American Journal of Public Health · doi:10.2105/ajph.2014.302152 · Cited by 62
A Critical Analysis of the Intent-to-Treat Principle in Prevention Research
Gross, D. A., & Fogg, L. (2004) · The Journal of Primary Prevention · doi:10.1023/b:jopp.0000048113.77939.44 · Cited by 60
Reduction in alcohol consumption and health status
Liang, W., & Chikritzhs, T. N. (2010) · Addiction · doi:10.1111/j.1360-0443.2010.03164.x · Cited by 60
A prospective comparison of bone‐patellar tendon‐bone and hamstring tendon grafts for anterior cruciate ligament reconstruction in male patients
Laxdal, G., Sernert, N., Ejerhed, L., Karlsson, J., & Kartus, J. T. (2006) · Knee Surgery Sports Traumatology Arthroscopy · doi:10.1007/s00167-006-0165-z · Cited by 60
Efficacy of nature-based therapy for individuals with stress-related illnesses: randomised controlled trial
Stigsdotter, U. K., Corazon, S. S., Sidenius, U., Nyed, P. K., Larsen, H. B., & Fjorback, L. O. (2018) · The British Journal of Psychiatry · doi:10.1192/bjp.2018.2 · Cited by 61
Isolating the role of time in bed restriction in the treatment of insomnia: a randomised, controlled, dismantling trial comparing sleep restriction therapy with time in bed regularisation.
Maurer, L., Espie, C., Omlin, X., Reid, M. J., Sharman, R., Gavriloff, D., Emsley, R., & Kyle, S. (2020) · Sleep · doi:10.1093/sleep/zsaa096 · Cited by 47
Violation of the intent‐to‐treat principle and rate of missing data in superiority trials assessing structural outcomes in rheumatic diseases
Baron, G., Boutron, I., Giraudeau, B., & Ravaud, P. (2005) · Arthritis & Rheumatism · doi:10.1002/art.21116 · Cited by 59
Sequentially allocated clinical trial of rhythmic stabilization exercises and TENS in women with chronic low back pain
Kofotolis, N. D., Vlachopoulos, S. P., & Kellis, E. (2008) · Clinical Rehabilitation · doi:10.1177/0269215507080122 · Cited by 59
Estratégias para aumentar a sensibilidade da farmacovigilância em Portugal
Ribeiro‐Vaz, I., Herdeiro, M. T., Polónia, J. J., & Figueiras, A. (2011) · LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) · Cited by 59
The Effects of a Multilingual Telephone Quitline for Asian Smokers: A Randomized Controlled Trial
Zhu, S., Cummins, S. E., Wong, S., Gamst, A. C., Tedeschi, G. J., & Reyes-Nocon, J. (2012) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djr530 · Cited by 59
Effectiveness of a Locally Produced, Fish-Based Food Product on Weight Gain among Cambodian Children in the Treatment of Acute Malnutrition: A Randomized Controlled Trial
Sigh, S., Roos, N., Chamnan, C., Laillou, A., Prak, S., & Wieringa, F. T. (2018) · Nutrients · doi:10.3390/nu10070909 · Cited by 59
Series: Pragmatic trials and real world evidence: Paper 5. Usual care and real life comparators
Zuidgeest, M. G. P., Welsing, P. M. J., van Thiel, G. J. M. W., Ciaglia, A., Alfonso-Cristancho, R., Eckert, L., Eijkemans, M. J. C., & Egger, M. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.07.001 · Cited by 59
Febuxostat for the Management of Hyperuricaemia in Patients with Gout
Stevenson, M., & Pandor, A. (2010) · PharmacoEconomics · doi:10.2165/11535770-000000000-00000 · Cited by 58
A randomised clinical trial of activity-focussed physiotherapy on patients with distal radius fractures
Maciel, J. S., Taylor, N. F., & McIlveen, C. (2005) · Archives of Orthopaedic and Trauma Surgery · doi:10.1007/s00402-005-0037-x · Cited by 58
Long-term effectiveness of Basic Body Awareness Therapy in psychiatric outpatient care. A randomized controlled study
Gyllensten, A. L., Ekdahl, C. S., & Hansson, L. I. (2008) · Advances in Physiotherapy · doi:10.1080/14038190802242061 · Cited by 58
An Economic Evaluation of a Video- and Text-Based Computer-Tailored Intervention for Smoking Cessation: A Cost-Effectiveness and Cost-Utility Analysis of a Randomized Controlled Trial
Stanczyk, N. E., Smit, E. S., Schulz, D. N., de Vries, H., Bolman, C. A. W., Muris, J. W. M., & Evers, S. (2014) · PLoS ONE · doi:10.1371/journal.pone.0110117 · Cited by 58
Participation in a population-based physical activity programme as an aid for smoking cessation: a randomised trial
Bize, R., Clair, C., Chioléro, A., Stoianov, R., Payot, S., Locatelli, I., & Cornuz, J. (2010) · Tobacco Control · doi:10.1136/tc.2009.030288 · Cited by 62
Benefits of combining inspiratory muscle with ‘whole muscle’ training in children with cystic fibrosis: a randomised controlled trial
Santana‐Sosa, E., González-Saiz, L., Groeneveld, I. F., Villa-Asensi, J. R., de Agüero, M. I. B. G., Fleck, S. J., López-Mojares, L. M., Pérez, M., & Lucía, A. (2013) · British Journal of Sports Medicine · doi:10.1136/bjsports-2012-091892 · Cited by 60
Evaluation of a regional disease management programme for patients with asthma or chronic obstructive pulmonary disease
Steuten, L., Vrijhoef, H. J., van Merode, F., Wesseling, G., & Spreeuwenberg, C. (2006) · International Journal for Quality in Health Care · doi:10.1093/intqhc/mzl052 · Cited by 58
Wound drainage after plastic and reconstructive surgery of the breast
Khan, S. M., Smeulders, M. J. C., & van der Horst, C. M. A. M. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007258.pub3 · Cited by 58
Interventions for treating traumatized necrotic immature permanent anterior teeth: inducing a calcific barrier & root strengthening.
Ansary, M. A. A., Day, P., Duggal, M., & Brunton, P. (2009) · Dental Traumatology · doi:10.1111/j.1600-9657.2009.00797.x · Cited by 82
Improved Conversation Outcomes After Social Communication Skills Training for People With Traumatic Brain Injury and Their Communication Partners: A Clinical Trial Investigating In-Person and Telehealth Delivery
Rietdijk, R., Power, E., Attard, M., Heard, R., & Togher, L. (2020) · Journal of Speech, Language, and Hearing Research · doi:10.1044/2019_jslhr-19-00076 · Cited by 55
A group mental health randomized controlled trial for female refugees in Malaysia.
Shaw, S. A., Ward, K. P., Pillai, V., & Hinton, D. E. (2018) · American Journal of Orthopsychiatry · doi:10.1037/ort0000346 · Cited by 57
Bile acids for non-alcoholic fatty liver disease and/or steatohepatitis
Orlando, R., Azzalini, L., Orando, S., & Lirussi, F. (2007) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005160.pub2 · Cited by 57
Retracted
A randomized controlled trial of the effects of nursing care based on Watson's Theory of Human Caring on distress, self‐efficacy and adjustment in infertile women
Özkan, İ. A., Okumuş, H., & Buldukoğlu, K. (2013) · Journal of Advanced Nursing · doi:10.1111/jan.12338 · Cited by 57
Older siblings benefit from a family-based preventive intervention for preschoolers at risk for conduct problems.
Brotman, L. M., Dawson‐McClure, S., Gouley, K. K., McGuire, K., Burraston, B. O., & Bank, L. (2005) · Journal of Family Psychology · doi:10.1037/0893-3200.19.4.581 · Cited by 57
The influence of smear layer removal on primary tooth pulpectomy outcome: a 24‐month, double‐blind, randomized, and controlled clinical trial evaluation
Barcelos, R., Tannure, P. N., Gleiser, R., Luiz, R. R., & Primo, L. G. (2011) · International Journal of Paediatric Dentistry · doi:10.1111/j.1365-263x.2011.01210.x · Cited by 57
Yttrium-90 microsphere radioembolisation for unresectable hepatocellular carcinoma
Abdel-Rahman, O. M., & Elsayed, Z. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd011313.pub2 · Cited by 57
Farm Animal-Assisted Intervention for People with Clinical Depression: A Randomized Controlled Trial
Pedersen, I., Martinsen, E. W., Berget, B., & Braastad, B. O. (2012) · Anthrozoös · doi:10.2752/175303712x13316289505260 · Cited by 68
The impact of adherence on sports injury prevention effect estimates in randomised controlled trials: Looking beyond the CONSORT statement
Verhagen, E. A. L. M., Hupperets, M., Finch, C. F., & van Mechelen, W. (2011) · Journal of science and medicine in sport · doi:10.1016/j.jsams.2011.02.007 · Cited by 56
A falls prevention programme to improve quality of life, physical function and falls efficacy in older people receiving home help services: study protocol for a randomised controlled trial
Bjerk, M., Brovold, T., Skelton, D. A., & Bergland, A. (2017) · BMC Health Services Research · doi:10.1186/s12913-017-2516-5 · Cited by 56
Abstinence-only programs for HIV infection prevention in high-income countries
Underhill, K., Operario, D., & Montgomery, P. (2007) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005421.pub2 · Cited by 62
Physical therapy and active exercises – An adequate treatment for prevention of late whiplash syndrome?
Vassiliou, T., Kaluza, G., Putzke, C., Wulf, H., & Schnabel, M. (2006) · Pain · doi:10.1016/j.pain.2006.03.017 · Cited by 56
Advance Care Planning Improves Psychological Symptoms But Not Quality of Life and Preferred End-of-Life Care of Patients With Cancer
Tang, S. T., Chen, J.-S., Wen, F.-H., Chou, W.-C., Chang, J. W.-C., Hsieh, C.-H., & Chen, C. H. (2019) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2018.7106 · Cited by 58
Using Moxibustion in Primary Healthcare to Correct Non-Vertex Presentation: A Multicentre Randomised Controlled Trial
Vas, J., Aranda‐Regules, J. M., Modesto, M., Ramos-Monserrat, M., Barón, M., Aguilar, I., Benítez-Parejo, N., Ramírez-Carmona, C., & Rivas‐Ruiz, F. (2012) · Acupuncture in Medicine · doi:10.1136/acupmed-2012-010261 · Cited by 55
Function-Centered Rehabilitation Increases Work Days in Patients With Nonacute Nonspecific Low Back Pain: 1-Year Results From a Randomized Controlled Trial
Kool, J., Bachmann, S., Oesch, P. R., Knüsel, O., Ambergen, T., de Bie, R. A., & van den Brandt, P. A. (2007) · Archives of Physical Medicine and Rehabilitation · doi:10.1016/j.apmr.2007.05.022 · Cited by 55
Interventions to Promote Repeat Breast Cancer Screening With Mammography: A Systematic Review and Meta-Analysis
Vernon, S. W., McQueen, A., Tiro, J. A., & del Junco, D. J. (2010) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djq223 · Cited by 55
'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial
Veldhuis, L., Struijk, M. K., Kroeze, W., Oenema, A., Renders, C. M., Bulk-Bunschoten, A. M. W., Hirasing, R. A., & Raat, H. (2009) · BMC Public Health · doi:10.1186/1471-2458-9-177 · Cited by 55
A review of clinical trial designs used to detect a disease-modifying effect of drug therapy in Alzheimer’s disease and Parkinson’s disease
McGhee, D. J. M., Ritchie, C. W., Zajicek, J., & Counsell, C. E. (2016) · BMC Neurology · doi:10.1186/s12883-016-0606-3 · Cited by 60
Evaluation of outcomes in community-acquired pneumonia: a guide for patients, physicians, and policy-makers
Barlow, G. D., Lamping, D. L., Davey, P. G., & Nathwani, D. (2003) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(03)00721-7 · Cited by 55
Effectiveness of a Computerized Decision Aid in Primary Care on Decision Making and Quality of Life in Menorrhagia: Results of the MENTIP Randomized Controlled Trial
Protheroe, J., Bower, P., Chew-Graham, C. A., Peters, T. J., & Fahey, T. P. (2007) · Medical Decision Making · doi:10.1177/0272989x07306785 · Cited by 55
To each his own well-being boosting intervention: using preference to guide selection
Schueller, S. M. (2011) · The Journal of Positive Psychology · doi:10.1080/17439760.2011.577092 · Cited by 53
Citicoline for treating people with acute ischemic stroke
Martí-Carvajal, A. J., Valli, C., Martí-Amarista, C. E., Solà, I., Martí‐Fábregas, J., & Bonfill, X. (2020) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013066.pub2 · Cited by 58
Intention-to-treat analysis when only a baseline value is available
Twisk, J. W. R., Rijnhart, J. J. M., Hoekstra, T., Schuster, N. A., ter Wee, M. M., & Heymans, M. W. (2020) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2020.100684 · Cited by 54
The effect of sleep restriction therapy for insomnia on sleep pressure and arousal: a randomized controlled mechanistic trial
Maurer, L., Espie, C. A., Omlin, X., Emsley, R., & Kyle, S. D. (2021) · SLEEP · doi:10.1093/sleep/zsab223 · Cited by 59
Workshop- and Telephone-Based Interventions to Improve Adverse Drug Reaction Reporting
Herdeiro, M. T., Ribeiro‐Vaz, I., Ferreira, M., Polónia, J. J., Falcão, A. C., & Figueiras, A. (2012) · Drug Safety · doi:10.1007/bf03261962 · Cited by 54
Methotrexate for primary biliary cirrhosis
Giljača, V., Poropat, G., Štimac, D., & Gluud, C. N. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004385.pub3 · Cited by 53
Comparative Effectiveness of Di'ao Xin Xue Kang Capsule and Compound Danshen Tablet in Patients With Symptomatic Chronic Stable Angina
Yu, Y., Hu, S.-Y., Li, G., Xue, J., Li, Z., Liu, X., Xi-yan, Y., Dong, B., Wang, D., Wang, X., et al. (2014) · Scientific Reports · doi:10.1038/srep07058 · Cited by 54
Modified intention-to-treat analysis did not bias trial results
Døssing, A., Tarp, S., Furst, D. E., Gluud, C. N., Wells, G. A., Beyene, J., Hansen, B. B., Bliddal, H., & Christensen, R. (2015) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2015.11.003 · Cited by 56
The Effect of Subscription Video-on-Demand on Piracy: Evidence from a Household-Level Randomized Experiment
de Matos, M. G., Ferreira, P., & Smith, M. D. (2017) · Management Science · doi:10.1287/mnsc.2017.2875 · Cited by 54
Swedish randomized controlled trial of cardiotocography only versus cardiotocography plus ST analysis of fetal electrocardiogram revisited: analysis of data according to standard versus modified intention‐to‐treat principle
Amer‐Wåhlin, I., Kjellmer, I., Maršál, K., Olofsson, P., & Rosén, K. G. (2011) · Acta Obstetricia Et Gynecologica Scandinavica · doi:10.1111/j.1600-0412.2011.01203.x · Cited by 53
Effectiveness of treatment of calcific tendinitis of the shoulder by disodium EDTA
Cacchio, A., Blasis, E. D., Desiati, P., Spacca, G., Santilli, V., & Paulis, F. D. (2008) · Arthritis Care & Research · doi:10.1002/art.24370 · Cited by 53
The Association between Alcohol Exposure and Self-Reported Health Status: The Effect of Separating Former and Current Drinkers
Liang, W., & Chikritzhs, T. N. (2013) · PLoS ONE · doi:10.1371/journal.pone.0055881 · Cited by 53
Reducing the risk of bias in health behaviour change trials: Improving trial design, reporting or bias assessment criteria? A review and case study
de Bruin, M., McCambridge, J., & Prins, J. M. (2014) · Psychology and Health · doi:10.1080/08870446.2014.953531 · Cited by 57
Item Sum: A New Technique for Asking Quantitative Sensitive Questions
Trappmann, M., Krumpal, I., Kirchner, A., & Jann, B. (2013) · Journal of Survey Statistics and Methodology · doi:10.1093/jssam/smt019 · Cited by 53
A systematic review of wound cleansing for pressure ulcers
Moore, Z. E. H., & Cowman, S. (2008) · Journal of Clinical Nursing · doi:10.1111/j.1365-2702.2008.02381.x · Cited by 53
The CONSORT Statement: Application within and adaptations for orthodontic trials
Pandis, N., Fleming, P. S., Hopewell, S., & Altman, D. G. (2015) · American Journal of Orthodontics and Dentofacial Orthopedics · doi:10.1016/j.ajodo.2015.03.014 · Cited by 54
Greater Than 95% Success with 14‐day B ismuth Quadruple Anti‐ H elicobacter pylori Therapy: A Pilot Study in US H ispanics
Salazar, C. O., Cardenas, V. M., Reddy, R., Domínguez, D. C., Snyder, L. K., & Graham, D. Y. (2012) · Helicobacter · doi:10.1111/j.1523-5378.2012.00962.x · Cited by 52
The Consolidated Standards of Reporting Trials (CONSORT) Statement applied to allergen-specific immunotherapy with inhalant allergens: A Global Allergy and Asthma European Network (GA2LEN) article
Bousquet, P., Calderón, M. A., Demoly, P. M., Larenas‐Linnemann, D. E., Passalacqua, G., Bachert, C., Brożek, J., Canonica, G. W., Casale, T. B., Fonseca, J., et al. (2010) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2010.09.017 · Cited by 52
Impact of a multimedia intervention “Skinsafe” on patients' knowledge and protective behaviors
Glazebrook, C., Garrud, P., Avery, A. J., Coupland, C. A. C., & Williams, H. C. (2006) · Preventive Medicine · doi:10.1016/j.ypmed.2006.02.007 · Cited by 52
How to review journal manuscripts
Rosenfeld, R. M. (2010) · Otolaryngology · doi:10.1016/j.otohns.2010.02.010 · Cited by 52
Meta-Analysis of Placebo Rates in Major Depressive Disorder Trials
Stolk, P., ten Berg, M. J., Hemels, M. E. H., & Einarson, T. R. (2003) · Annals of Pharmacotherapy · doi:10.1345/aph.1d172 · Cited by 52
A systematic review of the effectiveness of Pilates on pain, disability, physical function, and quality of life in older adults with chronic musculoskeletal conditions
Denham‐Jones, L., Gaskell, L., Spence, N., & Pigott, T. (2021) · Musculoskeletal Care · doi:10.1002/msc.1563 · Cited by 51
Using modified intention-to-treat as a principal stratum estimator for failure to initiate treatment
Kahan, B. C., White, I. R., Edwards, M., & Harhay, M. O. (2023) · Clinical Trials · doi:10.1177/17407745231160074 · Cited by 58
The quality of reports of randomized clinical trials on traditional Chinese medicine treatments: a systematic review of articles indexed in the China National Knowledge Infrastructure database from 2005 to 2012
Li, J.-N., Liu, Z., Chen, R., Hu, D., Li, W., Li, X., Chen, X., Huang, B., & Liao, L. (2014) · BMC Complementary and Alternative Medicine · doi:10.1186/1472-6882-14-362 · Cited by 51
No reduction in instrumental vaginal births and no increased risk for adverse perineal outcome in nulliparous women giving birth on a birth seat: results of a Swedish randomized controlled trial
Thies‐Lagergren, L., Kvist, L. J., Christensson, K., & Hildingsson, I. (2011) · BMC Pregnancy and Childbirth · doi:10.1186/1471-2393-11-22 · Cited by 51
Is There a Benefit to Extending the Duration of Helicobacter pylori Sequential Therapy to 14 Days?
Hsu, P. I., Wu, D., Wu, J., & Graham, D. Y. (2011) · Helicobacter · doi:10.1111/j.1523-5378.2011.00829.x · Cited by 51
Alternative analyses for handling incomplete follow-up in the intention-to-treat analysis: the randomized controlled trial of balloon kyphoplasty versus non-surgical care for vertebral compression fracture (FREE)
Ranstam, J., Turkiewicz, A., Boonen, S., Meirhaeghe, J. V. V., Bastian, L., & Wardlaw, D. (2012) · BMC Medical Research Methodology · doi:10.1186/1471-2288-12-35 · Cited by 62
Percutaneous ethanol injection or percutaneous acetic acid injection for early hepatocellular carcinoma
Weis, S., Franke, A., Berg, T., Mössner, J., Fleig, W. E., & Schoppmeyer, K. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006745.pub3 · Cited by 51
The Effects of Home-Based Cognitive Training on Verbal Working Memory and Language Comprehension in Older Adulthood
Payne, B. R., & Stine‐Morrow, E. A. L. (2017) · Frontiers in Aging Neuroscience · doi:10.3389/fnagi.2017.00256 · Cited by 57
Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients
Hodson, E., Barclay, P. G., Craig, J. C., Jones, C., Kable, K., Strippoli, G., Vimalachandra, D., & Webster, A. (2005) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003774.pub2 · Cited by 52
Venlafaxine in management of hot flashes in women with breast cancer: a systematic review and meta-analysis
Ramaswami, R., Villarreal, M. D., Pitta, D. M., Carpenter, J. S., Stebbing, J., & Kalesan, B. (2015) · Breast Cancer Research and Treatment · doi:10.1007/s10549-015-3465-5 · Cited by 49
Cost-benefit analysis of a preventive intervention for divorced families: Reduction in mental health and justice system service use costs 15 years later
Herman, P. M., Mahrer, N. E., Wolchik, S. A., Porter, M. M., Jones, S., & Sandler, I. N. (2015) · Prevention Science · doi:10.1007/s11121-014-0527-6 · Cited by 50
Schmerztherapie bei chronisch schmerzkranken, schwer beeinträchtigten Kindern und Jugendlichen
Dobe, M., Hechler, T., Behlert, J., Kosfelder, J., & Zernikow, B. (2011) · Der Schmerz · doi:10.1007/s00482-011-1051-2 · Cited by 50
Improved virological suppression in children on antiretroviral treatment receiving community-based adherence support: A multicentre cohort study from South Africa
Fatti, G., Shaikh, N. B., Eley, B., & Grimwood, A. (2013) · AIDS Care · doi:10.1080/09540121.2013.855699 · Cited by 50
Manual therapy in addition to physiotherapy does not improve clinical or economic outcomes after ankle fracture
Lin, C., Moseley, A. M., Haas, M. R., Refshauge, K. M., & Herbert, R. (2008) · Journal of Rehabilitation Medicine · doi:10.2340/16501977-0187 · Cited by 50
Effect of the use of low and high potency statins and sepsis outcomes
Ou, S., Chu, H., Chao, P.-W., Ou, S., Lee, Y.-J., Kuo, S., Li, S., Shih, C.-J., & Chen, Y. (2014) · Intensive Care Medicine · doi:10.1007/s00134-014-3418-1 · Cited by 50
Calcium supplementation for the prevention of colorectal adenomas: A systematic review and meta-analysis of randomized controlled trials
Bonovas, S. (2016) · World Journal of Gastroenterology · doi:10.3748/wjg.v22.i18.4594 · Cited by 51
Reporting of Randomized Controlled Trials in Hodgkin Lymphoma in Biomedical Journals
Kober, T., Trelle, S., & Engert, A. (2006) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djj160 · Cited by 50
Meta‐analysis: folic acid in the chemoprevention of colorectal adenomas and colorectal cancer
Carroll, C., Cooper, K. L., Papaioannou, D. E., Hind, D., Tappenden, P., Pilgrim, H., & Booth, A. (2010) · Alimentary Pharmacology & Therapeutics · doi:10.1111/j.1365-2036.2010.04238.x · Cited by 49
A Randomized Controlled Trial of Bibliotherapy for Carers of Young People With First-Episode Psychosis
McCann, T. V., Lubman, D. I., Cotton, S., Murphy, B., Crisp, K., Catania, L., Marck, C. H., & Gleeson, J. (2012) · Schizophrenia Bulletin · doi:10.1093/schbul/sbs121 · Cited by 49
A graphical sensitivity analysis for clinical trials with non‐ignorable missing binary outcome
Hollis, S. (2002) · Statistics in Medicine · doi:10.1002/sim.1276 · Cited by 49
Self-citation
A systematic review finds variable use of the intention-to-treat principle in musculoskeletal randomized controlled trials with missing data
Joseph, R., Sim, J., Ogollah, R., & Lewis, M. (2015) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2014.09.002 · Cited by 50
Incomplete adherence to an adjunctive systemic antibiotic regimen decreases clinical outcomes in generalized aggressive periodontitis patients: a pilot retrospective study
Guerrero, A., Echeverría, J. J., & Tonetti, M. S. (2007) · Journal Of Clinical Periodontology · doi:10.1111/j.1600-051x.2007.01130.x · Cited by 48
Clinical, metabolic and psychological outcomes and treatment costs of a prospective randomized trial based on different educational strategies to improve diabetes care (PRODIACOR)
Gagliardino, J. J., Lapertosa, S., Pfirter, G., Villagra, M., Caporale, J., Gonzalez, C. C. G., Elgart, J. E., González, L., Cernadas, C., Rucci, E., et al. (2013) · Diabetic Medicine · doi:10.1111/dme.12230 · Cited by 49

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

About these checks

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.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review

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

Abstract

Overview

Integrity signals

Verification

Claims the paper makes

Claims other papers make about this one

Self-check

Citations

Cites

Cited by

Related

Metadata

Record

About these checks