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 301–400 of 1,015

Strength-balance supplemented with computerized cognitive training to improve dual task gait and divided attention in older adults: a multicenter randomized-controlled trial
Reve, E. V. H., & de Bruin, E. D. (2014) · BMC Geriatrics · doi:10.1186/1471-2318-14-134 · Cited by 140
Respite for Dementia Caregivers: The Effects of Adult Day Service Use on Caregiving Hours and Care Demands
Gaugler, J. E., Jarrott, S. E., Zarit, S. H., Stephens, M. P., Townsend, A. L., & Greene, R. (2003) · International Psychogeriatrics · doi:10.1017/s1041610203008743 · Cited by 133
Beyond good intentions: The role of proactive coping in achieving sustained behavioural change in the context of diabetes management
Thoolen, B. J., Ridder, D. D., Bensing, J., Gorter, K., & Rutten, G. (2009) · Psychology & Health · doi:10.1080/08870440701864504 · Cited by 127
Endoscopic injection of cyanoacrylate glue versus other endoscopic procedures for acute bleeding gastric varices in people with portal hypertension
Castellanos, E. R., Pamela Serón, S., Gisbert, J. P., & Bonfill, X. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd010180.pub2 · Cited by 127
Topical antibiotics for preventing surgical site infection in wounds healing by primary intention
Heal, C. F., Banks, J. L., Lepper, P. D., Kontopantelis, E., & van Driel, M. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd011426.pub2 · Cited by 131
Activating brown adipose tissue through exercise (ACTIBATE) in young adults: Rationale, design and methodology
Sánchez‐Delgado, G., Martínez‐Téllez, B., Olza, J., Aguilera, C. M., Labayen, I., Ortega, F. B., Chillón, P., Fernandez-Reguera, C., Alcántara, J. M. A., Martinez-Avila, W. D., et al. (2015) · Contemporary Clinical Trials · doi:10.1016/j.cct.2015.11.004 · Cited by 135
Impact of a mindfulness stress management program on stress, anxiety, depression and quality of life in women with polycystic ovary syndrome: a randomized controlled trial
Stefanaki, C., Bacopoulou, F., Livadas, S., Kandaraki, A., Karachalios, A., Chrousos, G. P., & Diamanti‐Kandarakis, E. (2014) · Stress · doi:10.3109/10253890.2014.974030 · Cited by 128
DEMO-II Trial. Aerobic Exercise versus Stretching Exercise in Patients with Major Depression—A Randomised Clinical Trial
Krogh, J., Videbech, P., Thomsen, C. E., Gluud, C. N., & Nordentoft, M. (2012) · PLoS ONE · doi:10.1371/journal.pone.0048316 · Cited by 129
Inconsistent Definitions for Intention-To-Treat in Relation to Missing Outcome Data: Systematic Review of the Methods Literature
Alshurafa, M., Briel, M., Akl, E. A., Haines, T., Moayyedi, P., Gentles, S. J., Rios, L., Tran, C., Bhatnagar, N., Lamontagne, F., et al. (2012) · PLoS ONE · doi:10.1371/journal.pone.0049163 · Cited by 126
DESIGN OF THE SILENT CEREBRAL INFARCT TRANSFUSION (SIT) TRIAL
Casella, J. F., King, A. A., BARTON, B. A., White, D. A., Noetzel, M. J., Ichord, R., Terrill, C. M., Hirtz, D., McKinstry, R. C., Strouse, J. J., et al. (2010) · Pediatric Hematology and Oncology · doi:10.3109/08880010903360367 · Cited by 125
Optimum duration of regimens for Helicobacter pylori eradication
Yuan, Y., Ford, A. C., Khan, K. J., Forman, D., Oderda, G., Calvet, X., Leontiadis, G. I., Fallone, C. A., Gisbert, J. P., Fischbach, L. A., et al. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008337 · Cited by 125
Effects of coping skills training in school‐age children with type 1 diabetes
Grey, M. J., Whittemore, R., Jaser, S. S., Ambrosino, J. M., Lindemann, E., Liberti, L. S., Northrup, V. S., & Dziura, J. D. (2009) · Research in Nursing & Health · doi:10.1002/nur.20336 · Cited by 124
Effectiveness of Trigger Point Dry Needling for Plantar Heel Pain: A Randomized Controlled Trial
Cotchett, M., Munteanu, S. E., & Landorf, K. B. (2014) · Physical Therapy · doi:10.2522/ptj.20130255 · Cited by 126
Monitoring of Psychological Well-Being in Outpatients With Diabetes
Pouwer, F., Snoek, F. J., van der Ploeg, H. M., Adèr, H. J., & Heine, R. J. (2001) · Diabetes Care · doi:10.2337/diacare.24.11.1929 · Cited by 122
Interventions for Hemolytic Uremic Syndrome and Thrombotic Thrombocytopenic Purpura: A Systematic Review of Randomized Controlled Trials
Michael, M., Elliott, E. J., Craig, J. C., Ridley, G. F., & Hodson, E. M. (2008) · American Journal of Kidney Diseases · doi:10.1053/j.ajkd.2008.07.038 · Cited by 123
Effectiveness of physical activity in reducing pain in patients with fibromyalgia: a blinded randomized clinical trial
Kayo, A., Peccin, M. S., Sanches, C. M., & Trevisani, V. F. M. (2011) · Rheumatology International · doi:10.1007/s00296-011-1958-z · Cited by 123
A Parent-Led Family-Focused Treatment Program for Overweight Children Aged 5 to 9 Years: The PEACH RCT
Magarey, A., Perry, R. A., Baur, L. A., Steinbeck, K. S., SAWYER, M. G., Hills, A. P., Wilson, G. T., Lee, A., & Daniels, L. (2011) · PEDIATRICS · doi:10.1542/peds.2009-1432 · Cited by 123
Systematic review of topical antimicrobial therapy for acute otitis externa
Rosenfeld, R. M., Singer, M. C., Wasserman, J. M., & Stinnett, S. S. (2006) · Otolaryngology · doi:10.1016/j.otohns.2006.02.013 · Cited by 123
Nattokinase decreases plasma levels of fibrinogen, factor VII, and factor VIII in human subjects
Hsia, C., Shen, M., Lin, J., Wen, Y.-K., Hwang, K.-L., Cham, T., & Yang, N.-C. (2009) · Nutrition Research · doi:10.1016/j.nutres.2009.01.009 · Cited by 123
Intention-to-treat analysis
Elkins, M. R., & Moseley, A. M. (2015) · Journal of Physiotherapy · doi:10.1016/j.jphys.2015.05.013 · Cited by 122
Progressive resistance exercise for people with multiple sclerosis
Taylor, N. F., Dodd, K., Prasad, D., & Denisenko, S. M. (2006) · Disability and Rehabilitation · doi:10.1080/09638280500531834 · Cited by 122
Efficacy of Partial Body Weight–Supported Treadmill Training Compared With Overground Walking Practice for Children With Cerebral Palsy: A Randomized Controlled Trial
Willoughby, K. L., Dodd, K., Shields, N., & Foley, S. (2010) · Archives of Physical Medicine and Rehabilitation · doi:10.1016/j.apmr.2009.10.029 · Cited by 122
Tai chi Qigong improves lung functions and activity tolerance in COPD clients: a single blind, randomized controlled trial
Chan, A. W. K., Lee, A., Suen, L. K. P., & Tam, W. W. S. (2011) · Complementary Therapies in Medicine · doi:10.1016/j.ctim.2010.12.007 · Cited by 121
Azithromycin as an adjunctive treatment of aggressive periodontitis: 12‐months randomized clinical trial
Haas, A. N., de Castro, G. D., Moreno, T., Susin, C., Albandar, J. M., Oppermann, R. V., & Rõsing, C. K. (2008) · Journal Of Clinical Periodontology · doi:10.1111/j.1600-051x.2008.01254.x · Cited by 120
A meta‐analysis of the placebo response in complementary and alternative medicine trials of irritable bowel syndrome
Dorn, S. D., Kaptchuk, T. J., Park, J. B., Nguyen, L. T., Canenguez, K., Nam, B. H., Woods, K. B., Conboy, L. A., Stason, W. B., & Lembo, A. J. (2007) · Neurogastroenterology & Motility · doi:10.1111/j.1365-2982.2007.00937.x · Cited by 119
Association between framing of the research question using the PICOT format and reporting quality of randomized controlled trials
Rios, L. P., Ye, C., & Thabane, L. (2010) · BMC Medical Research Methodology · doi:10.1186/1471-2288-10-11 · Cited by 123
Evidence that boosters augment the long-term impact of implementation intentions on fruit and vegetable intake
Chapman, J., & Armitage, C. J. (2009) · Psychology and Health · doi:10.1080/08870440802642148 · Cited by 124
Nonabsorbable disaccharides for hepatic encephalopathy
Als-Nielsen, B. E. T., Gluud, L. L., & Gluud, C. N. (2004) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003044.pub2 · Cited by 119
Intrauterine insemination with ovarian stimulation versus expectant management for unexplained infertility (TUI): a pragmatic, open-label, randomised, controlled, two-centre trial
Farquhar, C. M., Liu, E., Armstrong, S., Arroll, N., Lensen, S. F., & Brown, J. (2017) · The Lancet · doi:10.1016/s0140-6736(17)32406-6 · Cited by 117
Disability in patients with chronic patellofemoral pain syndrome: A randomised controlled trial of VMO selective training versus general quadriceps strengthening
Syme, G., Rowe, P. J., Martin, D., & Daly, G. (2008) · Manual Therapy · doi:10.1016/j.math.2008.02.007 · Cited by 117
A student-led progressive resistance training program increases lower limb muscle strength in adolescents with Down syndrome: a randomised controlled trial
Shields, N., & Taylor, N. F. (2010) · Journal of physiotherapy · doi:10.1016/s1836-9553(10)70024-2 · Cited by 116
Treatment with human, recombinant FSH improves sperm DNA fragmentation in idiopathic infertile men depending on the FSH receptor polymorphism p.N680S: a pharmacogenetic study
Simoni, M., Santi, D., Negri, L., Hoffmann, I., Muratori, M., Baldi, E., Cambi, M., Marcou, M., Greither, T., Baraldi, E., et al. (2016) · Human Reproduction · doi:10.1093/humrep/dew167 · Cited by 115
Probiotics for the prevention of pediatric antibiotic-associated diarrhea
Johnston, B. C., Supina, A. L., Ospina, M. B., & Vohra, S. (2007) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004827.pub2 · Cited by 115
Effect of a 5-min cold-water immersion recovery on exercise performance in the heat
Peiffer, J. J., Abbiss, C. R., Watson, G., Nosaka, K., & Laursen, P. B. (2008) · British Journal of Sports Medicine · doi:10.1136/bjsm.2008.048173 · Cited by 114
Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients
Hodson, E. M., Craig, J. C., Strippoli, G. F., & Webster, A. C. (2008) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003774.pub3 · Cited by 117
Mindfulness-based therapy and behavioral activation: A randomized controlled trial with depressed college students
McIndoo, C. C., File, A. A., Preddy, T., Clark, C. G., & Hopko, D. R. (2016) · Behaviour Research and Therapy · doi:10.1016/j.brat.2015.12.012 · Cited by 111
Physical activity and physical self-concept among sedentary adolescent females: An intervention study
Schneider, M. L., Dunton, G. F., & Cooper, D. M. (2007) · Psychology of sport and exercise · doi:10.1016/j.psychsport.2007.01.003 · Cited by 120
Virtual reality‐based cognitive‐motor training for middle‐aged adults at high Alzheimer's disease risk: A randomized controlled trial
Doniger, G. M., Beeri, M. S., Bahar‐Fuchs, A., Gottlieb, A., Tkachov, A., Kenan, H., Livny, A., Bahat, Y., Sharon, H., Ben‐Gal, O., et al. (2018) · Alzheimer s & Dementia Translational Research & Clinical Interventions · doi:10.1016/j.trci.2018.02.005 · Cited by 114
Artificial and bioartificial support systems for liver failure
Liu, J., Gluud, L. L., Als-Nielsen, B. E. T., & Gluud, C. N. (2004) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003628.pub2 · Cited by 115
Evaluating offending behaviour programmes
Hollin, C. R. (2008) · Criminology & Criminal Justice · doi:10.1177/1748895807085871 · Cited by 112
A randomized controlled trial of guided internet-delivered cognitive behaviour therapy for older adults with generalized anxiety
Jones, S. L., Hadjistavropoulos, H. D., & Soucy, J. N. (2016) · Journal of Anxiety Disorders · doi:10.1016/j.janxdis.2015.10.006 · Cited by 110
Modified versus standard intention-to-treat reporting: Are there differences in methodological quality, sponsorship, and findings in randomized trials? A cross-sectional study
Montedori, A., Bonacini, I., Casazza, G., Luchetta, M. L., Duca, P., Cozzolino, F., & Abraha, I. (2011) · Trials · doi:10.1186/1745-6215-12-58 · Cited by 112
Supporting adherence for people starting a new medication for a long-term condition through community pharmacies: a pragmatic randomised controlled trial of the New Medicine Service
Elliott, R. A., Boyd, M., Salema, N.-E., Davies, J. E., Barber, N., Mehta, R. L., Tanajewski, Ł., Waring, J. J., Latif, A., Gkountouras, G., et al. (2015) · BMJ Quality & Safety · doi:10.1136/bmjqs-2015-004400 · Cited by 113
The efficacy of positive psychology interventions from non-Western countries: A systematic review and metaanalysis
Hendriks, T., Schotanus-Dijkstra, M., Hassankhan, A., Graafsma, T., Bohlmeijer, E. T., & de Jong, J. T. V. M. (2018) · International Journal of Wellbeing · doi:10.5502/ijw.v8i1.711 · Cited by 125
Westeinde Sciatica Trial: randomized controlled study of bed rest and physiotherapy for acute sciatica
Hofstee, D. J., Gijtenbeek, J. M. M., Hoogland, P. H., van Houwelingen, H. C., Kloet, A., Lötters, F. J. B., & Tans, J. T. J. (2002) · Journal of Neurosurgery Spine · doi:10.3171/spi.2002.96.1.0045 · Cited by 112
Treatments for paediatric femoral fractures: a randomised trial
Wright, J. G., Wang, E. E. L., Owen, J. L., Stephens, D., Graham, H. K., Hanlon, M., Nattrass, G. R., Reynolds, R. A., & Coyte, P. C. (2005) · The Lancet · doi:10.1016/s0140-6736(05)71878-x · Cited by 112
Health Related Quality of Life in burn patients – A review of the literature
Stavrou, D., Weissman, O., Tessone, A., Zilinsky, I., Holloway, S., Boyd, J., & Haik, J. (2014) · Burns · doi:10.1016/j.burns.2013.11.014 · Cited by 111
‘Intention-to-treat’ meets ‘missing data’: implications of alternate strategies for analyzing clinical trials data
Nich, C., & Carroll, K. M. (2002) · Drug and Alcohol Dependence · doi:10.1016/s0376-8716(02)00111-4 · Cited by 112
Honey as a topical treatment for wounds
Jull, A., Rodgers, A., & Walker, N. K. (2008) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005083.pub2 · Cited by 114
A systematic review and economic evaluation of computerised cognitive behaviour therapy for depression and anxiety
Kaltenthaler, E., Shackley, P., Stevens, K., Beverley, C., Parry, G., & Chilcott, J. (2002) · Health Technology Assessment · doi:10.3310/hta6220 · Cited by 109
Perspective: Randomized Controlled Trials Are Not a Panacea for Diet-Related Research
Hébert, J. R., Frongillo, E. A., Adams, S. A., Turner‐McGrievy, G. M., Hurley, T. G., Miller, D. R., & Ockene, I. S. (2016) · Advances in Nutrition · doi:10.3945/an.115.011023 · Cited by 114
Social Value Orientation Moderates the Effects of Intuition versus Reflection on Responses to Unfair Ultimatum Offers
Bieleke, M., Gollwitzer, P. M., Oettingen, G., & Fischbacher, U. (2016) · Journal of Behavioral Decision Making · doi:10.1002/bdm.1975 · Cited by 112
Clodronate prevents prosthetic migration: A randomized radiostereometric study of 50 total knee patients
Hilding, M., Ryd, L., Toksvig‐Larsen, S., & Aspenberg, P. (2000) · Acta Orthopaedica Scandinavica · doi:10.1080/000164700317362163 · Cited by 110
A randomised controlled trial of vaginal clindamycin for early pregnancy bacterial vaginosis
Kurkinen‐Räty, M., Vuopala, S., Koskela, M., Kekki, M., Kurki, T., Paavonen, J. A., & Jouppila, P. I. (2000) · BJOG An International Journal of Obstetrics & Gynaecology · doi:10.1111/j.1471-0528.2000.tb11660.x · Cited by 110
Training family members to manage heroin overdose and administer naloxone: randomized trial of effects on knowledge and attitudes
Williams, A., Marsden, J., & Strang, J. (2013) · Addiction · doi:10.1111/add.12360 · Cited by 109
Design of the Dutch Obesity Intervention in Teenagers (NRG-DOiT): systematic development, implementation and evaluation of a school-based intervention aimed at the prevention of excessive weight gain in adolescents
Singh, A. S., Paw, M. J. C. A., Kremers, S., Visscher, T. L. S., Brug, J., & van Mechelen, W. (2006) · BMC Public Health · doi:10.1186/1471-2458-6-304 · Cited by 107
Effectiveness of a worksite lifestyle intervention on vitality, work engagement, productivity, and sick leave: results of a randomized controlled trial
Strijk, J. E., Proper, K. I., van Mechelen, W., & van der Beek, A. J. (2012) · Scandinavian Journal of Work Environment & Health · doi:10.5271/sjweh.3311 · Cited by 109
Progressive High-Intensity Resistance Training and Bone Mineral Density Changes Among Premenopausal Women
James, M. M.-S., & Carroll, S. (2006) · Sports Medicine · doi:10.2165/00007256-200636080-00005 · Cited by 75
Breaking the Access Barrier
Cicutto, L. C., Murphy, S., Coutts, D., O'Rourke, J., Lang, G., Chapman, C., & Coates, P. (2005) · CHEST Journal · doi:10.1378/chest.128.4.1928 · Cited by 108
Abstinence-plus programs for HIV infection prevention in high-income countries
Underhill, K., Montgomery, P., & Operario, D. (2008) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007006 · Cited by 111
Amoxicillin and metronidazole as an adjunctive treatment in generalized aggressive periodontitis at initial therapy or re-treatment: a randomized controlled clinical trial
Griffiths, G. S., Ayob, R., Guerrero, A., Nibali, L., Suvan, J. E., Moles, D. R., & Tonetti, M. S. (2010) · Journal Of Clinical Periodontology · doi:10.1111/j.1600-051x.2010.01632.x · Cited by 107
Catheter-directed Venous Thrombolysis in acute iliofemoral vein thrombosis-the CaVenT Study: Rationale and design of a multicenter, randomized, controlled, clinical trial (NCT00251771)
Enden, T. R., Sandvik, L., Kløw, N., Hafsahl, G., Holme, P. A., Holmen, L. O., Ghanima, W., Njaastad, A. M., Sandbæk, G., Slagsvold, C.-E., et al. (2007) · American Heart Journal · doi:10.1016/j.ahj.2007.07.010 · Cited by 107
Antibiotics for acute pyelonephritis in children
Strohmeier, Y., Hodson, E. M., Willis, N. S., Webster, A. C., & Craig, J. C. (2014) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003772.pub4 · Cited by 107
An illustrated guide to the methods of meta‐analysis
Sutton, A. J., Abrams, K. R., & Jones, D. R. (2001) · Journal of Evaluation in Clinical Practice · doi:10.1046/j.1365-2753.2001.00281.x · Cited by 106
Improving medication adherence in diabetes type 2 patients through Real Time Medication Monitoring: a Randomised Controlled Trial to evaluate the effect of monitoring patients' medication use combined with short message service (SMS) reminders
Vervloet, M., van Dijk, L., Santen-Reestman, J., van Vlijmen, B., Bouvy, M. L., & de Bakker, D. H. (2011) · BMC Health Services Research · doi:10.1186/1472-6963-11-5 · Cited by 108
Smoothing the Transition to Postsecondary Education: The Impact of the Early College Model
Edmunds, J. A., Unlu, F., Glennie, E. J., Bernstein, L., Fesler, L., Furey, J., & Arshavsky, N. (2016) · Journal of Research on Educational Effectiveness · doi:10.1080/19345747.2016.1191574 · Cited by 106
Long-acting reversible contraceptive acceptability and unintended pregnancy among women presenting for short-acting methods: a randomized patient preference trial
Hubacher, D., Spector, H., Monteith, C. W., Chen, P., & Hart, C. W. (2016) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2016.08.033 · Cited by 115
Chronic fatigue in general practice: is counselling as good as cognitive behaviour therapy? A UK randomised trial.
Ridsdale, L., Godfrey, E. L., Chalder, T., Seed, P. T., King, M., Wallace, P., & Wessely, S. C. (2001) · Research Portal (King's College London) · Cited by 106
A randomised controlled trial of post-operative rehabilitation after surgical decompression of the lumbar spine
Mannion, A. F., Denzler, R., Dvořák, J., Müntener, M., & Grob, D. (2007) · European Spine Journal · doi:10.1007/s00586-007-0399-6 · Cited by 106
Home training with and without additional group training in physically frail old people living at home: effect on health-related quality of life and ambulation
Helbostad, J. L., Sletvold, O., & Moe‐Nilssen, R. (2004) · Clinical Rehabilitation · doi:10.1191/0269215504cr761oa · Cited by 102
Cyclosporin A is superior to cyclophosphamide in children with steroid-resistant nephrotic syndrome—a randomized controlled multicentre trial by the Arbeitsgemeinschaft für Pädiatrische Nephrologie
Nephrologie, F. A. F. P., Plank, C., Kalb, V., Hinkes, B. G., Hildebrandt, F., Gefeller, O., & Rascher, W. (2008) · Pediatric Nephrology · doi:10.1007/s00467-008-0794-1 · Cited by 105
Benzodiazepine receptor antagonists for hepatic encephalopathy
Als-Nielsen, B. E. T., Gluud, L. L., & Gluud, C. N. (2004) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd002798.pub2 · Cited by 105
Effect of a nutrition education programme on clinical status and dietary behaviours of adults with type 2 diabetes in a resource-limited setting in South Africa: a randomised controlled trial
Muchiri, J. W., Gericke, G. J., & Rheeder, P. (2015) · Public Health Nutrition · doi:10.1017/s1368980015000956 · Cited by 110
Manipulative Therapy for Lower Extremity Conditions: Expansion of Literature Review
Brantingham, J. W., Globe, G. A., Pollard, H. P., Hicks, M., Korporaal, C., & Hoskins, W. T. (2008) · Journal of Manipulative and Physiological Therapeutics · doi:10.1016/j.jmpt.2008.09.013 · Cited by 104
Randomized Trial of Effect of Bifocal and Prismatic Bifocal Spectacles on Myopic Progression
Cheng, D. (2010) · Archives of Ophthalmology · doi:10.1001/archophthalmol.2009.332 · Cited by 104
Internet-based cognitive—behavior therapy for procrastination: A randomized controlled trial.
Rozental, A., Forsell, E., Svensson, A., Andersson, G., & Carlbring, P. (2015) · Journal of Consulting and Clinical Psychology · doi:10.1037/ccp0000023 · Cited by 103
Decreasing Divorce in U.S. Army Couples: Results from a Randomized Controlled Trial Using PREP for Strong Bonds
Stanley, S. M., Allen, E. S., Markman, H. J., RHOADES, G. K., & Prentice, D. L. (2010) · Journal of Couple & Relationship Therapy · doi:10.1080/15332691003694901 · Cited by 103
Methylprednisolone Injections for the Treatment of Morton Neuroma
Thomson, C. E., Beggs, I., Martin, D., McMillan, D., Edwards, R. T., Russell, D., Yeo, S. T., Russell, I. T., & Gibson, J. N. A. (2013) · Journal of Bone and Joint Surgery · doi:10.2106/jbjs.i.01780 · Cited by 103
Cross‐pin femoral fixation versus metal interference screw fixation in anterior cruciate ligament reconstruction with hamstring tendons: Results of a controlled prospective randomized study with 2‐year follow‐up
Harilainen, A., Sandelin, J., & Jansson, K. A. (2005) · Arthroscopy The Journal of Arthroscopic and Related Surgery · doi:10.1016/j.arthro.2004.09.013 · Cited by 103
Effectiveness of dementia follow-up care by memory clinics or general practitioners: randomised controlled trial
Meeuwsen, E. J., Melis, R. J. F., van der Aa, G. C. H. M., Golüke-Willemse, G. A., Leest, B. J. M. D., van Raak, F. H. J. M., Schölzel-Dorenbos, C. J. M., Verheijen, D., Verhey, F. R. J., de Visser, M. C. H., et al. (2012) · BMJ · doi:10.1136/bmj.e3086 · Cited by 102
The efficacy of long-term conjugated linoleic acid (CLA) supplementation on body composition in overweight and obese individuals: a systematic review and meta-analysis of randomized clinical trials
Onakpoya, I., Posadzki, P., Watson, L. K., Davies, L. A., & Ernst, E. (2011) · European Journal of Nutrition · doi:10.1007/s00394-011-0253-9 · Cited by 102
A randomised controlled trial of the effectiveness of providing free fluoride toothpaste from the age of 12 months on reducing caries in 5-6 year old children.
Davies, G., Worthington, H. V., Ellwood, R. P., Bentley, E., Blinkhorn, A. S., Taylor, G. O., & Davies, R. M. (2002) · PubMed · Cited by 101
Splinting the hand in the functional position after brain impairment: A randomized, controlled trial
Lannin, N. A., Horsley, S. A., Herbert, R., McCluskey, A., & Cusick, A. (2003) · Archives of Physical Medicine and Rehabilitation · doi:10.1053/apmr.2003.50031 · Cited by 101
Preventing Falls in Physically Active Community-Dwelling Older People: A Comparison of Two Intervention Techniques
Freiberger, E., Menz, H. B., Abu‐Omar, K., & Rütten, A. (2007) · Gerontology · doi:10.1159/000103256 · Cited by 101
Resistance Training for Strength: Effect of Number of Sets and Contraction Speed
MUNN, J., HERBERT, R. D., HANCOCK, M. J., & GANDEVIA, S. C. (2005) · Medicine & Science in Sports & Exercise · doi:10.1249/01.mss.0000177583.41245.f8 · Cited by 132
Enteral nutrition formulations for acute pancreatitis
Poropat, G., Giljača, V., Hauser, G., & Štimac, D. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd010605.pub2 · Cited by 100
Use of low-dose pregabalin in patients undergoing laparoscopic cholecystectomy
Peng, P., Li, C., Farcas, E., Haley, A., Wong, W., Bender, J. S., & Chung, F. F. (2010) · British Journal of Anaesthesia · doi:10.1093/bja/aeq116 · Cited by 100
The value of pre-operative treatment with GnRH analogues in women with submucous fibroids: a double-blind, placebo-controlled randomized trial
Mavrelos, D., Nagi, J. B., Davies, A., Lee, C., Salim, R., & Jurkovic, D. (2010) · Human Reproduction · doi:10.1093/humrep/deq188 · Cited by 100
Efficacy of patient education and supervised exercise vs patient education alone in patients with hip osteoarthritis: a single blind randomized clinical trial
Fernandes, L., Storheim, K., Sandvik, L., Nordsletten, L., & Risberg, M. A. (2010) · Osteoarthritis and Cartilage · doi:10.1016/j.joca.2010.05.015 · Cited by 100
Antioxidant supplements for non-alcoholic fatty liver disease and/or steatohepatitis
Lirussi, F., Azzalini, L., Orando, S., Orlando, R., & Angelico, F. (2007) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004996.pub3 · Cited by 100
The future of health care in Africa
Dare, L., & Buch, E. (2005) · BMJ · doi:10.1136/bmj.331.7507.1 · Cited by 100
Dynamic wait-listed designs for randomized trials: new designs for prevention of youth suicide
Brown, C. H., Wyman, P. A., Guo, J., & Peña, J. (2006) · Clinical Trials · doi:10.1191/1740774506cn152oa · Cited by 99
Internet-based exercise intervention systems: Are more interactive designs better?
Hurling, R., Fairley, B. W., & Dias, M. B. (2006) · Psychology & Health · doi:10.1080/14768320600603257 · Cited by 94
Randomized, Double‐blind, Placebo‐controlled Trial: Effect of Lactobacillus GG Supplementation on Helicobacter Pylori Eradication Rates and Side Effects During Treatment in Children
Szajewska, H., Albrecht, P., & Topczewska-Cabanek, A. (2009) · Journal of Pediatric Gastroenterology and Nutrition · doi:10.1097/mpg.0b013e318182e716 · Cited by 99
Cognitive analytic therapy for personality disorder: randomised controlled trial
Clarke, S., Thomas, P., & James, K. (2013) · British Journal of Psychiatry · doi:10.1192/bjp.bp.112.108670 · Cited by 94
Interventions for haemolytic uraemic syndrome and thrombotic thrombocytopenic purpura
Michael, M., Elliott, E. J., Ridley, G. F., Hodson, E. M., & Craig, J. C. (2009) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003595.pub2 · Cited by 99
Immunoglobulins, vaccines or interferon for preventing cytomegalovirus disease in solid organ transplant recipients
Hodson, E. M., Jones, C., Strippoli, G. F., Webster, A. C., & Craig, J. C. (2007) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005129.pub2 · Cited by 99
Two Distinct Oral Routes of Misoprostol in Mifepristone Medical Abortion
Winikoff, B., Dzuba, I. G., Creinin, M. D., Crowden, W. A., Goldberg, A. B., Gonzales, J., Howe, M., Moskowitz, J., Prine, L. W., & Shannon, C. S. (2008) · Obstetrics and Gynecology · doi:10.1097/aog.0b013e31818d8eb4 · Cited by 99
Strategies to improve retention in randomised trials
Brueton, V. C., Tierney, J., Stenning, S., Harding, S., Meredith, S., Nazareth, I., & Rait, G. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.mr000032.pub2 · Cited by 279
The long-term efficacy of two computer-tailored physical activity interventions for older adults: Main effects and mediators.
van Stralen, M. M., de Vries, H., Mudde, A. N., Bolman, C. A. W., & Lechner, L. (2011) · Health Psychology · doi:10.1037/a0023579 · Cited by 98

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