CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration

Sally Hopewell, Mike Clarke, David Moher, Elizabeth Wager, Philippa Middleton, Douglas G Altman, Kenneth F Schulz, CONSORT Group, Sally Hopewell, Mike Clarke, David Moher, Elizabeth Wager, Philippa Middleton, Douglas G Altman, Kenneth F Schulz, CONSORT Group

Abstract

Background: Clear, transparent, and sufficiently detailed abstracts of conferences and journal articles related to randomized controlled trials (RCTs) are important, because readers often base their assessment of a trial solely on information in the abstract. Here, we extend the CONSORT (Consolidated Standards of Reporting Trials) Statement to develop a minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract.

Methods and findings: We generated a list of items from existing quality assessment tools and empirical evidence. A three-round, modified-Delphi process was used to select items. In all, 109 participants were invited to participate in an electronic survey; the response rate was 61%. Survey results were presented at a meeting of the CONSORT Group in Montebello, Canada, January 2007, involving 26 participants, including clinical trialists, statisticians, epidemiologists, and biomedical editors. Checklist items were discussed for eligibility into the final checklist. The checklist was then revised to ensure that it reflected discussions held during and subsequent to the meeting. CONSORT for Abstracts recommends that abstracts relating to RCTs have a structured format. Items should include details of trial objectives; trial design (e.g., method of allocation, blinding/masking); trial participants (i.e., description, numbers randomized, and number analyzed); interventions intended for each randomized group and their impact on primary efficacy outcomes and harms; trial conclusions; trial registration name and number; and source of funding. We recommend the checklist be used in conjunction with this explanatory document, which includes examples of good reporting, rationale, and evidence, when available, for the inclusion of each item.

Conclusions: CONSORT for Abstracts aims to improve reporting of abstracts of RCTs published in journal articles and conference proceedings. It will help authors of abstracts of these trials provide the detail and clarity needed by readers wishing to assess a trial's validity and the applicability of its results.

Conflict of interest statement

Competing Interests: All authors are involved in many initiatives in health care and healthcare research which should benefit from a wide uptake of the CONSORT for Abstracts statement.

References

    1. Scherer RW, Langenberg P, von Elm E. Full publication of results initially presented in abstracts. Cochrane Database of Systematic Reviews. 2007. Art. No.: MR000005. doi: . Available: . Accessed 1 May 2007.
    1. Harbourt AM, Knecht LS, Humphreys BL. Structured abstracts in MEDLINE, 1989–1991. Bull Med Libr Assoc. 1995;83:190–195.
    1. Hopewell S, McDonald S, Clarke M, Egger M. Grey literature in meta-analyses of randomized trials of health care interventions. Cochrane Database of Systematic Reviews. 2007. Art. No.: MR000010. doi: . Available: . Accessed 1 May 2007.
    1. Hopewell S, Eisinga A, Clarke M. Better reporting of randomized trials in biomedical journal and conference abstracts. J Info Sci. 2007. doi: .
    1. Chalmers I, Adams M, Dickersin K, Hetherington J, Tarnow-Mordi W, et al. A cohort study of summary reports of controlled trials. JAMA. 1990;263:1401–1405.
    1. Herbison P. The reporting quality of abstracts of randomised controlled trials submitted to the ICS meeting in Heidelberg. Neurourol Urodyn. 2005;24:21–24.
    1. Hopewell S, Clarke M. Abstracts presented at the American Society of Clinical Oncology conference: how completely are trials reported? Clin Trials. 2005;2:265–268.
    1. Krzyzanowska MK, Pintilie M, Tannock IF. Factors associated with failure to publish large randomized trials presented at an oncology meeting. JAMA. 2003;290:495–501.
    1. Scherer R. Are harms reported in abstracts of trial results from conference proceedings?; XIV Cochrane Colloquium; 23–26 October,; Dublin, Ireland:. 2006. p. 63.
    1. Hopewell S, Clarke M, Askie L. Reporting of trials presented in conference abstracts needs to be improved. J Clin Epidemiol. 2006;59:681–684.
    1. Toma M, McAlister FA, Bialy L, Adams D, Vandermeer B, et al. Transition from meeting abstract to full-length journal article for randomized controlled trials. JAMA. 2006;295:1281–1287.
    1. Dundar Y, Dodd S, Dickson R, Walley T, Haycox A, et al. Comparison of conference abstracts and presentations with full-text articles in the health technology assessments of rapidly evolving technologies. Health Technol Assess. 2006;10:1–145.
    1. Chokkalingam A, Scherer R, Dickersin K. Agreement of data abstracts compared to full publications. Control Clin Trials. 1998;19:61S–62S.
    1. Estrada CA, Bloch RM, Antonacci D, Basnight LL, Patel SR, et al. Reporting and concordance of methodologic criteria between abstracts and articles in diagnostic test studies. J Gen Intern Med. 2000;15:183–187.
    1. Froom P, Froom J. Deficiencies in structured medical abstracts. J Clin Epidemiol. 1993;46:591–594.
    1. Harris AH, Standard S, Brunning JL, Casey SL, Golderg JH, et al. The accuracy of abstracts in psychology journals. J Psychol. 2002;136:141–148.
    1. Pitkin RM, Branagan MA, Burmeister LF. Accuracy of data in abstracts of published research articles. JAMA. 1999;281:1110–1111.
    1. Ward LG, Kendrach MG, Price SO. Accuracy of abstracts for original research articles in pharmacy journals. Ann Pharmacother. 2004;38:1173–1177.
    1. Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA. 2001;285:437–443.
    1. Ioannidis JP, Evans SJ, Gøtzsche PC, O'Neill RT, Altman DG, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141:781–788.
    1. Begg C, Cho M, Eastwood S, Horton R, Moher D, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276:637–639.
    1. Moher D, Schulz KF, Altman DG, Lepage L. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357:1191–1194.
    1. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. 2006. [Updated February 2006.] Available: . Accessed 1 December 2006.
    1. Schriger DL, Arora S, Altman DG. The content of medical journal Instructions for authors. Ann Emerg Med. 2006;48:743–749.
    1. Ad Hoc Working Group for Critical Appraisal of the Medical Literature. A proposal for more informative abstracts of clinical articles. Ann Intern Med. 1987;106:598–604.
    1. Haynes RB, Mulrow CD, Huth EJ, Altman DG, Gardner MJ. More informative abstracts revisited. Ann Intern Med. 1990;113:69–76.
    1. Haynes RB, Mulrow CD, Huth EJ, Altman DG, Gardner MJ. More informative abstracts revisited. Cleft Palate-Craniofac J. 1996;33:1–9.
    1. Deeks JJ, Altman DG. Inadequate reporting of controlled trials as short reports. Lancet. 1998;318:193–194.
    1. Hopewell S. Impact of grey literature on systematic reviews of randomized trials. Oxford (UK): Wolfson College, University of Oxford; 2004. [PhD dissertation].
    1. Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey method. J Adv Nurs. 2000;32:1008–1015.
    1. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134:663–694.
    1. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, et al. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Ann Intern Med. 2003;138:W1–12.
    1. Thiam S, LeFevre AM, Hane F, Ndiaye A, Ba F, et al. Effectiveness of a strategy to improve adherence to tuberculosis treatment in a resource-poor setting: a cluster randomized controlled trial. JAMA. 2007;297:380–386.
    1. Dickersin K, Manheimer E, Wieland S, Robinson KA, Lefebvre C, et al. Development of the Cochrane Collaboration's CENTRAL register of controlled clinical trials. Eval Health Prof. 2002;25:38–64.
    1. Campbell MK, Elbourne DR, Altman DG, CONSORT group CONSORT statement: extension to cluster randomised trials. BMJ. 2004;328:702–708.
    1. Halonen J, Halonen P, Jarvinen O, Taskinen P, Auvinen T, et al. Corticosteroids for the prevention of atrial fibrillation after cardiac surgery: a randomized controlled trial. JAMA. 2007;297:1562–1567.
    1. Oosterheert JJ, Bonten MJ, Schneider MM, Buskens E, Lammers JW, et al. Effectiveness of early switch from intravenous to oral antibiotics in severe community acquired pneumonia: multicentre randomised trial. BMJ. 2006;33:1193.
    1. Mebazaa A, Nieminen MS, Packer M, Cohen-Solal A, Kleber FX, et al. Levosimendan vs dobutamine for patients with acute decompensated heart failure: the SURVIVE randomized trial. JAMA. 2007;297:1883–1891.
    1. Chan AW, Hrobjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004A;291:2457–2465.
    1. Chan AW, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ. 2004B;330:753.
    1. Williamson PR, Gamble C. Identification and impact of outcome selection bias in meta-analysis. Stat Med. 2005;24:1547–1561.
    1. Johnson NP, Farquhar CM, Hadden WE, Suckling J, Yu Y, et al. The FLUSH trial: flushing with lipiodol for unexplained (and endometriosis-related) subfertility by hysterosalpingography: a randomized trial. Hum Reprod. 2004;19:2043–2051.
    1. Gluud LL. Bias in clinical intervention research. Am J Epidemiol. 2006;163:493–501.
    1. Pildal J, Hrobjartsson A, Jorgensen K, Hilden J, Altman D, et al. Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials. Int J Epidemiol. 2007;36:847–857.
    1. Juni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ. 2001;323:42–46.
    1. Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending against deciphering. Lancet. 2002;359:614–618.
    1. Scherer RW, Crawley B. Reporting of randomized clinical trial descriptors and use of structured abstracts. JAMA. 1998;280:269–272.
    1. Burns KEA, Adhikari NKJ, Kho M, Meade MO, Patel RV, et al. Abstract reporting in randomized clinical trials of acute lung injury: an audit and assessment of a quality of reporting score. Crit Care Med. 2005;33:1937–1945.
    1. Taddio A, Pain T, Fassos FF, Boon H, Ilersich AL, et al. Quality of nonstructured and structured abstracts of original research articles in the British Medical Journal, the Canadian Medical Association Journal and the Journal of the American Medical Association. CMAJ. 1994;150:1611–1618.
    1. Clark E, Plint AC, Correll R, Gaboury I, Passi B. A randomized, controlled trial of acetaminophen, ibuprofen, and codeine for acute pain relief in children with musculoskeletal trauma. Pediatrics. 2007;119:460–467.
    1. Schulz KF, Grimes DA. The Lancet handbook of essential concepts in clinical research. London: Elsevier; 2006.
    1. Schulz KF, Altman DG, Moher D. Blinding is better than masking. BMJ. 2007;334:918.
    1. Devereaux PJ, Manns BJ, Ghali WA, Quan H, Lacchetti C, et al. Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials. JAMA. 2001;285:2000–2003.
    1. Poolman RW, Struijs PA, Krips R, Sierevelt IN, Marti RK, et al. Reporting of outcomes in orthopaedic randomized trials: does blinding of outcome assessors matter? J Bone Joint Surg. 2007;89-A:550–558.
    1. Sazawal S, Dhingra U, Dhingra P, Hiremath G, Kumar J, et al. Effects of fortified milk on morbidity in young children in north India: community based, randomised, double masked placebo controlled trial. BMJ. 2007;334:140.
    1. Kim KB, Legha SS, Gonzalez R, Anderson C, Papadopoulos NE, et al. A phase III randomized trial of adjuvant biochemotherapy (BC) versus interferon-α-2b (IFN) in patients (pts) with high risk for melanoma recurrence. J Clin Oncol. 2006;24:8003. ASCO Annual Meeting Proceedings Part I. Vol.
    1. Pocock SJ, Hughes MD, Lee RJ. Statistical problems in the reporting of clinical trials. N Engl J Med. 1987;317:426–432.
    1. Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, et al. Randomized trials stopped early for benefit: a systematic review. JAMA. 2005;294:2203–2209.
    1. Bhandari M, Devereaux PJ, Guyatt GH, Cook DJ, Swiontkowski MF, et al. An observational study of orthopaedic abstracts and subsequent full-text publications. J Bone Joint Surg. 2002;84-A:615–621.
    1. Dryver E, Hux JE. Reporting of numerical and statistical differences in abstracts: improving but not optimal. J Gen Intern Med. 2002;17:203–206.
    1. Gøtzsche PC. Believability of relative risks and odds ratios in abstracts: cross sectional study. BMJ. 2006;333:231–234.
    1. Schwartz LM, Woloshin S, Dvorin EL, Welch HG. Ratio measures in leading medical journals: structured review of accessibility of underlying absolute risks. BMJ. 2006;333:1248–1250.
    1. Johnson BA, Rosenthal N, Capece JA, Wiegand F, Mao L, et al. Topiramate for treating alcohol dependence: a randomized controlled trial. JAMA. 2007;298:1641–1651.
    1. Derry S, Kong Loke Y, Aronson JK. Incomplete evidence: the inadequacy of databases in tracing published adverse drug reactions in clinical trials. BMC Med Res Methodol. 2001;1:7.
    1. Fawzi WW, Msamanga GI, Urassa W, Hertzmark E, Petraro P, et al. Vitamins and perinatal outcomes among HIV-negative women in Tanzania. N Engl J Med. 2007;356:1423–1431.
    1. Dickersin K. How important is publication bias? A synthesis of available data. AIDS Educ Prev. 1997;9(Supplement A):15–21.
    1. Tramer MR, Reynolds DJ, Moore RA, McQuay HJ. Impact of covert duplicate publication on meta-analysis: a case study. BMJ. 1997;315:635–640.
    1. Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin Oncol. 1986;4:1529–1541.
    1. Whittington CJ, Kendall T, Fonagy P, Cottrell D, Cotgrove A, et al. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet. 2004;363:1341–1345.
    1. De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, et al. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. Lancet. 2005;365:1827–1829.
    1. Zarin DA, Ide NC, Tse T, Harlan WR, West JC, et al. Issues in the registration of clinical trials. JAMA. 2007;297:2112–2120.
    1. Zellars RC, Frassica D, Stearns V, Fetting JH, Armstrong DK, et al. Partial breast irradiation (PBI) concurrent with adjuvant dose-dense doxorubicin and dyclophosphamide (ddAC) chemotherapy in early-stage breast cancer: Preliminary safety results from a feasibility trial. J Clin Oncol. 2006;Vol 24(No. 18S (June 20 Supplement), 2006):10675. ASCO Annual Meeting Proceedings Part I.
    1. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003;326:1167–1170.
    1. Bero L, Oostvogel F, Bacchetti P, Lee K. Factors associated with findings of published trials of drug-drug comparisons: why some statins appear more efficacious than others. PLoS Med. 2007;4:e184. doi: .
    1. Hartley J. Current findings from research on structured abstracts. J Med Libr Assoc. 2004;92:368–371.
    1. Guimaraes CA. Structured abstracts: narrative review. Acta Cir Bras. 2006;21:263–268.
    1. Sollaci LB, Pereira MG. The introduction, methods, results, and discussion (IMRAD) structure: a fifty-year survey. J Med Libr Assoc. 2004;92:364–367.
    1. Gulmezoglu AM, Pang T, Horton R, Dickersin K. WHO facilitates international collaboration in setting standards for clinical trial registration. Lancet. 2005;365:1829–1831.
    1. World Health Organisation. International Clinical Trials Registry Platform. 2007. . Accessed 12 June 2007.
    1. Laine C, Horton R, Deangelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: looking back and moving ahead. BMJ. 2007;334:1177–1178.
    1. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJW. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006;295:1152–1160.
    1. National Library of Medicine. MEDLINE / PubMed data element (field) descriptions. 2007. Available: . Accessed 16 April 2007.
    1. Hill CL, Buchbinder R, Osborne R. Quality of reporting of randomized clinical trials in abstracts of the 2005 Annual Meeting of the American College of Rheumatology. J Rheumatol. 2007;34:2476–2480.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit