The DOI matches its Crossref record; 73 of the 73 references it cites were found in a registry or an index.
Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement
Abstract
In response to overwhelming evidence and the consequences of poor-quality reporting of randomized, controlled trials (RCTs), many medical journals and editorial groups have now endorsed the CONSORT (Consolidated Standards of Reporting Trials) statement, a 22-item checklist and flow diagram. Because CONSORT primarily aimed at improving the quality of reporting of efficacy, only 1 checklist item specifically addressed the reporting of safety. Considerable evidence suggests that reporting of harms-related data from RCTs also needs improvement. Members of the CONSORT Group, including journal editors and scientists, met in Montebello, Quebec, Canada, in May 2003 to address this problem. The result is the following document: the standard CONSORT checklist with 10 new recommendations about reporting harms-related issues, accompanying explanation, and examples to highlight specific aspects of proper reporting. We hope that this document, in conjunction with other CONSORT-related materials (http://www.consort-statement.org), will help authors improve their reporting of harms-related data from RCTs. Better reporting will help readers critically appraise and interpret trial results. Journals can support this goal by revising Instructions to Authors so that they refer authors to this document.
Overview
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
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?
In the citing paper
“Most MBI studies use data only from the treatment completers and lack data from long-term follow-ups and dropouts—the groups most likely to have negative effects [56,60].”
From Can mindfulness be too much of a good thing? The value of a middle way (2019) · cites this paper as [60]
In the citing paper
“In addition, very few MBI trials actively measure adverse effects [58], relying instead on passive monitoring, which can underestimate the actual frequency by more than 20-fold [59,60].”
From Can mindfulness be too much of a good thing? The value of a middle way (2019) · cites this paper as [60]
In the citing paper
“the use of means and effect sizes typically obscures individual differences and extreme scores [60].”
From Can mindfulness be too much of a good thing? The value of a middle way (2019) · cites this paper as [60]
In the citing paper
“The recognition that the reporting of harms in randomized controlled trials is unsatisfactory led to the CONSORT group suggesting 10 new recommendations in the reporting of harms [16].”
From The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials (2014) · cites this paper as [16]
Citations
Cites
Writing Group for the Women's Health Initiative Investigators (2002) · JAMA: The Journal of the American Medical Association · doi:10.1001/jama.288.3.321 · Cited by 15,889
The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
Altman, D. G., Schulz, K. F., Moher, D., Egger, M., Davidoff, F., Elbourne, D., Gøtzsche, P. C., Lang, T., & for the CONSORT Group (2001) · Annals of Internal Medicine · doi:10.7326/0003-4819-134-8-200104170-00012 · Cited by 3,835
Self-citationAdverse drug reactions: definitions, diagnosis, and management
Edwards, I. R., & Aronson, J. K. (2000) · The Lancet · doi:10.1016/s0140-6736(00)02799-9 · Cited by 2,988
Moher, D., Schulz, K. F., & Altman, D. G. (2001) · BMC Medical Research Methodology · doi:10.1186/1471-2288-1-2 · Cited by 2,755
Self-citationMoher, D. (2001) · JAMA · doi:10.1001/jama.285.15.1987 · Cited by 2,545
Self-citationChan, A.-W., Hróbjartsson, A., Haahr, M. T., Gøtzsche, P. C., & Altman, D. G. (2004) · JAMA · doi:10.1001/jama.291.20.2457 · Cited by 1,845
Self-citationRisk of Cardiovascular Events Associated with Selective COX-2 Inhibitors
Mukherjee, D. (2001) · JAMA · doi:10.1001/jama.286.8.954 · Cited by 1,741
Yusuf, S. (1991) · JAMA: The Journal of the American Medical Association · doi:10.1001/jama.1991.03470010097038 · Cited by 1,014
A consumer's guide to subgroup analyses
Oxman, A. D., & Guyatt, G. H. (1992) · Annals of Internal Medicine · doi:10.7326/0003-4819-116-1-78 · Cited by 914
Marshall, M., Lockwood, A., Bradley, C., Adams, C., Joy, C., & Fenton, M. (2000) · British Journal of Psychiatry · doi:10.1192/bjp.176.3.249 · Cited by 870
Quality of Complication Reporting in the Surgical Literature
Martin, R. C. G., Brennan, M. F., & Jaques, D. P. (2002) · Annals of Surgery · doi:10.1097/00000658-200206000-00007 · Cited by 624
Waters, D. D., Alderman, E. L., Hsia, J. A., Howard, B. V., Cobb, F. R., Rogers, W. J., Ouyang, P., Thompson, P. D., Tardif, J., Higginson, L., et al. (2002) · JAMA · doi:10.1001/jama.288.19.2432 · Cited by 580
Efficacy of Recombinant Human Erythropoietin in Critically Ill Patients
Corwin, H. L., Gettinger, A., Pearl, R. G., Fink, M. P., Levy, M. M., Shapiro, M. J., Corwin, M. J., Colton, T., & for the EPO Critical Care Trials Group (2002) · JAMA · doi:10.1001/jama.288.22.2827 · Cited by 497
Self-citationCastle, W. M., Fuller, R. W., Hall, J., & Palmer, J. (1993) · BMJ · doi:10.1136/bmj.306.6884.1034 · Cited by 481
Gøtzsche, P. C. (1989) · Controlled Clinical Trials · doi:10.1016/0197-2456(89)90017-2 · Cited by 339
Self-citationEffects of Initiating Carvedilol in Patients With Severe Chronic Heart Failure
Krum, H., Roecker, E. B., Mohaçsi, P., Rouleau, J. L., Tendera, M., Coats, A. J. S., Katus, H. A., Fowler, M. B., Packer, M., & for the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) Study Group (2003) · JAMA · doi:10.1001/jama.289.6.712 · Cited by 312
Self-citationAn Assessment of the Safety of Pediatric Ibuprofen
Lesko, S. M. (1995) · JAMA · doi:10.1001/jama.1995.03520360043037 · Cited by 310
Pandya, K. J., Raubertas, R. F., Flynn, P. J., Hynes, H. E., Rosenbluth, R. J., Kirshner, J. J., Pierce, H. I., Dragalin, V., & Morrow, G. R. (2000) · Annals of Internal Medicine · doi:10.7326/0003-4819-132-10-200005160-00004 · Cited by 310
Reporting on quality of life in randomised controlled trials: bibliographic study
Sanders, C., Egger, M., Donovan, J., Tallon, D., & Frankel, S. (1998) · BMJ · doi:10.1136/bmj.317.7167.1191 · Cited by 304
Comparison of Oral Fluconazole and Itraconazole for Progressive, Nonmeningeal Coccidioidomycosis
Galgiani, J. N., Catanzaro, A., Cloud, G. A., Johnson, R. H., Williams, P. L., Mirels, L. F., Nassar, F., Lutz, J. E., Stevens, D. A., Sharkey, P. K., et al. (2000) · Annals of Internal Medicine · doi:10.7326/0003-4819-133-9-200011070-00009 · Cited by 294
Ely, E. W., Laterre, P., Angus, D. C., Helterbrand, J. D., Levy, H. A., Dhainaut, J.-F., Vincent, J., Macias, W. L., & Bernard, G. R. (2003) · Critical Care Medicine · doi:10.1097/00003246-200301000-00002 · Cited by 278
Recombinant Human Relaxin in the Treatment of Scleroderma
Seibold, J. R., Korn, J. H., Simms, R. W., Clements, P. J., Moreland, L. W., Mayes, M. D., Fürst, D. E., Rothfield, N. F., Steen, V. D., Weisman, M. H., et al. (2000) · Annals of Internal Medicine · doi:10.7326/0003-4819-132-11-200006060-00004 · Cited by 273
Verdier, R.-I., Fitzgerald, D. W., Johnson, W. D., et al. (2000) · Annals of Internal Medicine · doi:10.7326/0003-4819-132-11-200006060-00006 · Cited by 240
Randomised double blind trial of etoricoxib and indometacin in treatment of acute gouty arthritis
Schumacher, H. R., Jr., Boice, J. A., Daikh, D. I., et al. (2002) · BMJ · doi:10.1136/bmj.324.7352.1488 · Cited by 237
The consent form as a possible cause of side effects
Myers, M. G., Cairns, J. A., & Singer, J. (1987) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.1987.142 · Cited by 220
Risk of cardiovascular events associated with selective COX-2 inhibitors
Mukherjee, D., Nissen, S. E., & Topol, E. J. (2002) · ACC Current Journal Review · doi:10.1016/s1062-1458(01)00545-1 · Cited by 211
Lassen, M. R., Borris, L. C., & Nakov, R. (2002) · New England Journal of Medicine · doi:10.1056/nejmoa011327 · Cited by 201
The case for structuring the discussion of scientific papers
Docherty, M., & Smith, R. (1999) · BMJ · doi:10.1136/bmj.318.7193.1224 · Cited by 183
Weiner, D. L., Hibberd, P. L., Betit, P., Cooper, A. B., Botelho, C. A., & Brugnara, C. (2003) · JAMA · doi:10.1001/jama.289.9.1136 · Cited by 180
Premawardhena, A., de Silva, C. E., Fonseka, M. M. D., Gunatilake, S. B., & de Silva, H. J. (1999) · BMJ · doi:10.1136/bmj.318.7190.1041 · Cited by 177
Hammer, S. M. (2002) · JAMA · doi:10.1001/jama.288.2.169 · Cited by 173
Dropout rates in randomised antipsychotic drug trials
Wahlbeck, K., Tuunainen, A., Ahokas, A., & Leucht, S. (2001) · Psychopharmacology · doi:10.1007/s002130100711 · Cited by 167
Reporting of Adverse Effects in Clinical Trials Should Be Improved
Edwards, J. E., McQuay, H. J., Moore, R. A., & Collins, S. (1999) · Journal of Pain and Symptom Management · doi:10.1016/s0885-3924(99)00093-7 · Cited by 165
Bonhoeffer, J., Kohl, K. S., Chen, R. H., DUCLOS, P. J., Heijbel, H., Heininger, U., Jefferson, T., & Loupi, E. (2002) · Vaccine · doi:10.1016/s0264-410x(02)00449-8 · Cited by 165
Zidovudine, Didanosine, or Both as the Initial Treatment for Symptomatic HIV-Infected Children
Englund, J. A., Baker, C. J., Raskino, C., McKinney, R. E., Petrie, B., Fowler, M. G., Pearson, D. A., Gershon, A. A., McSherry, G., Abrams, E. J., et al. (1997) · New England Journal of Medicine · doi:10.1056/nejm199706123362403 · Cited by 156
The Need for Adverse Effects Reporting Standards in Oncology Clinical Trials
Trotti, A., & Bentzen, S. M. (2003) · Journal of Clinical Oncology · doi:10.1200/jco.2004.10.911 · Cited by 151
Reporting of adverse drug reactions in randomised controlled trials – a systematic survey
Loke, Y. K., & Derry, S. (2001) · BMC Clinical Pharmacology · doi:10.1186/1472-6904-1-3 · Cited by 128
Extracts from "Clinical Evidence": Non-steroidal anti-inflammatory drugs
Gøtzsche, P. C. (2000) · BMJ · doi:10.1136/bmj.320.7241.1058 · Cited by 127
Self-citationDiscussion Sections in Reports of Controlled Trials Published in General Medical Journals
Clarke, M. J. (2002) · JAMA · doi:10.1001/jama.287.21.2799 · Cited by 123
Derry, S., Loke, Y. K., & Aronson, J. K. (2001) · BMC Medical Research Methodology · doi:10.1186/1471-2288-1-7 · Cited by 110
Adverse Behavioral Effects of Treatment for Acute Exacerbation of Asthma in Children
Kayani, S., & Shannon, D. C. (2002) · CHEST Journal · doi:10.1378/chest.122.2.624 · Cited by 108
Balancing benefits and harms in health care
Cuervo, L. G., & Clarke, M. J. (2003) · BMJ · doi:10.1136/bmj.327.7406.65 · Cited by 105
Sutton, A. G. C., Finn, P., Grech, E. D., et al. (2001) · American Heart Journal · doi:10.1067/mhj.2001.113570 · Cited by 99
Improving Safety Reporting from Randomised Trials
Ioannidis, J. P. A., & Lau, J. (2002) · Drug Safety · doi:10.2165/00002018-200225020-00002 · Cited by 97
Self-citationReporting of safety data from randomised trials
Ioannidis, J. P. A., & Contopoulos‐Ioannidis, D. G. (1998) · The Lancet · doi:10.1016/s0140-6736(05)79825-1 · Cited by 97
Self-citationGulick, R. M., Hu, X. J., Fiscus, S. A., et al. (2000) · The Journal of Infectious Diseases · doi:10.1086/315867 · Cited by 91
Sadhasivam, S., Saxena, A., Kathirvel, S., et al. (1999) · Anesthesia & Analgesia · doi:10.1097/00000539-199912000-00002 · Cited by 87
Adverse events in phase-I studies: a report in 1015 healthy volunteers
Sibille, M., Deigat, N., Janin, A., et al. (1998) · European Journal of Clinical Pharmacology · doi:10.1007/s002280050413 · Cited by 87
Safety Reporting in Randomized Trials of Mental Health Interventions
Papanikolaou, P. N., Churchill, R., Wahlbeck, K., Ioannidis, J. P. A., & The EU-PSI Project (2004) · American Journal of Psychiatry · doi:10.1176/appi.ajp.161.9.1692 · Cited by 84
Self-citationMaskens, A. P., & Dujardin‐Loits, R. (1981) · Cancer · doi:10.1002/1097-0142(19810101)47:1 · Cited by 75
Sadhasivam, S., Saxena, A., Kathirvel, S., et al. (1999) · Anesthesia & Analgesia · doi:10.1213/00000539-199912000-00002 · Cited by 70
The Brighton Collaboration: enhancing comparability of vaccine safety data
Kohl, K. S., Bonhoeffer, J., Chen, R. E., et al. (2003) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.851 · Cited by 59
Fanelli, C. G., Pampanelli, S., Porcellati, F., Rossetti, P., Brunetti, P., & Bolli, G. B. (2002) · Annals of Internal Medicine · doi:10.7326/0003-4819-136-7-200204020-00007 · Cited by 57
How Can We Improve the Assessment of Safety in Child and Adolescent Psychopharmacology?
Vitiello, B., Riddle, M. A., Walkup, J. T., Labellarte, M. J., VARIPATIS, E., Greenhill, L. L., Davies, M., Capasso, L., March, J. S., Levine, J., et al. (2003) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1097/01.chi.0000046840.90931.36 · Cited by 55
Safety Evaluation and Confidence Intervals When the Number of Observed Events Is Small or Zero
Jovanovic, B. D., & Zalenski, R. J. (1997) · Annals of Emergency Medicine · doi:10.1016/s0196-0644(97)70165-3 · Cited by 44
Standardized retrieval of side effects data for meta-analysis of safety outcomes
Ioannidis, J. P. A., Chew, P. W., & Lau, J. (2002) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(02)00393-1 · Cited by 42
Self-citationDevelopment of a Questionnaire for Detecting Potential Adverse Drug Reactions
Corso, D. M., Pucino, F., DeLeo, J. M., Calis, K. A., & Gallelli, J. F. (1992) · Annals of Pharmacotherapy · doi:10.1177/106002809202600704 · Cited by 39
Jacobson, J. M., Greenspan, J. S., Spritzler, J., et al. (2001) · The Journal of Infectious Diseases · doi:10.1086/317928 · Cited by 36
Are Randomized Control Trial Outcomes Influenced by the Inclusion of a Placebo Group?
Rochon, P. A., Binns, M. A., Litner, J. A., Litner, G. M., Fischbach, M., Eisenberg, D. M., Kaptchuk, T. J., Stason, W. B., & Chalmers, T. C. (1999) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(98)00149-8 · Cited by 34
WOODWORTH, T. G., Furst, D. E., Strand, V., et al. (2001) · PubMed · Cited by 34
Regulatory perspectives on data monitoring
O’Neill, R. T. (2002) · Statistics in Medicine · doi:10.1002/sim.1287 · Cited by 32
Self-citationJapanese and American reports of randomized trials: differences in the reporting of adverse effects
Hayashi, K., & Walker, A. M. (1996) · Controlled Clinical Trials · doi:10.1016/s0197-2456(96)80001-8 · Cited by 30
Optimal two‐stage designs for clinical trials based on safety and efficacy
Thall, P. F., & Cheng, S. (2001) · Statistics in Medicine · doi:10.1002/sim.717 · Cited by 27
Detection of adverse drug reactions in a clinical trial using two types of questioning.
Wallin, J. E., & Sjövall, J. (1981) · PubMed · Cited by 23
Brown, M. M. (2003) · Evidence-Based Eye Care · doi:10.1097/00132578-200304000-00011 · Cited by 22
Laboratory Data in Clinical Trials: A Statistician's Perspective
Chuang‐Stein, C. (1998) · Controlled Clinical Trials · doi:10.1016/s0197-2456(97)00123-2 · Cited by 20
Roehrborn, C. G. (2002) · Urology · doi:10.1016/s0090-4295(02)01649-7 · Cited by 14
Reporting drug safety in clinical trials: getting the emphasis right
Mucklow, J. C. (2001) · The Lancet · doi:10.1016/s0140-6736(00)04619-5 · Cited by 11
Majoko, F., Nyström, L., & Lindmark, G. (2002) · Journal of Obstetrics and Gynaecology · doi:10.1080/0144361021000020376 · Cited by 9
A critical appraisal of toxicity indexes in rheumatology.
Peloso, P. M., Wright, J. G., & Bombardier, C. (1995) · PubMed · Cited by 6
Premarketing Adverse Drug Experiences: Data Management Procedures
Cato, A. E. (1987) · Drug Information Journal · doi:10.1177/009286158702100103 · Cited by 4
Completeness of Safety Reporting in Randomized Trials: An Evaluation of 7 Medical Areas
Ioannidis, J. P. A., & Lau, J. (2001) · JAMA · doi:10.1001/jama.285.4.437 · Cited by 3
Self-citationBuyse, M. (1999) · doi:10.1002/(sici)1097-0258(19991230)18:24
Research works printed but not linked: 4
- Peloso PM, 1995, J Rheumatol, 22, 989
- Woodworth TG, 2001, J Rheumatol, 28, 1163
- Wallin J, 1981, Clin Ther, 3, 450
- 10.1001/jama.289.6.712 · DOI
Cited by
Sorted by citations
von Elm, E., Altman, D. G., Egger, M., Pocock, S. J., Gøtzsche, P. C., Vandenbroucke, J. P., & Initiative, F. T. S. (2007) · PLoS Medicine · doi:10.1371/journal.pmed.0040296 · Cited by 23,020
“]. Some studies are essentially exploratory and raise interesting hypotheses. Others pursue clearly defined hypotheses in available data. In yet another type of studies, the collection of new data is planned carefully on the basis of an existing hypothesis. We believe the present checklist can be useful for all these…”
Self-citationvon Elm, E., Altman, D. G., Egger, M., Pocock, S. J., Gøtzsche, P. C., & Vandenbroucke, J. P. (2007) · The Lancet · doi:10.1016/s0140-6736(07)61602-x · Cited by 21,320
Self-citationvon Elm, E., Altman, D. G., Egger, M., Pocock, S. J., Gøtzsche, P. C., Vandenbroucke, J. P., & Initiative, F. T. S. (2007) · Annals of Internal Medicine · doi:10.7326/0003-4819-147-8-200710160-00010 · Cited by 17,796
Self-citationvon Elm, E., Altman, D. G., Egger, M., Pocock, S. J., Gøtzsche, P. C., & Vandenbroucke, J. P. (2008) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2007.11.008 · Cited by 17,893
Self-citationCONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
the CONSORT Group, Schulz, K. F., Altman, D. G., & Moher, D. (2010) · BMC Medicine · doi:10.1186/1741-7015-8-18 · Cited by 13,371
Self-citation
Metadata
- Authors
- Ioannidis, J. P. A., Evans, S. J. W., Gøtzsche, P. C., O'Neill, R. T., Altman, D. G., Schulz, K., Moher, D., & for the CONSORT Group*
- Affiliations
- National Health Service (GB)
- Corresponding author
- Ioannidis, John P.A.
- Venue
- Annals of Internal Medicine
- Publisher
- American College of Physicians
- Published
- 2004-11-16
- Volume
- 141
- Issue
- 10
- Pages
- 781-788
- ISSN
- 0003-4819 (ISSN-L)
- 1539-3704
- OpenAlex
- W1986360186
- Cited by
- 1,593
- References
- 73
- Citations by year
- 2026: 55 · 2025: 64 · 2024: 90 · 2023: 76 · 2022: 99 · 2021: 89 · 2020: 111 · 2019: 88 · 2018: 72 · 2017: 73 · 2016: 89 · 2015: 76 · 2014: 87 · 2013: 69 · 2012: 50
- FWCI
- 62.04
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Annals of Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
- Keywords
- CONSORT statement, harms reporting, safety reporting, randomized controlled trials, reporting quality, trial reporting checklist, adverse events, author guidelines, critical appraisal
- MeSH terms
- Publishing, Quality Control, Safety, Randomized Controlled Trials as Topic, Evidence-Based Medicine
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
