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Published in: Trials 1/2012

Open Access 01-12-2012 | Methodology

Assessment of adherence to the CONSORT statement for quality of reports on randomized controlled trial abstracts from four high-impact general medical journals

Authors: Saurav Ghimire, Eunjung Kyung, Wonku Kang, Eunyoung Kim

Published in: Trials | Issue 1/2012

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Abstract

Background

The extended Consolidated Standards of Reporting Trials (CONSORT) Statement for Abstracts was developed to improve the quality of reports of randomized controlled trials (RCTs) because readers often base their assessment of a trial solely on the abstract. To date, few data exist regarding whether it has achieved this goal. We evaluated the extent of adherence to the CONSORT for Abstract statement for quality of reports on RCT abstracts by four high-impact general medical journals.

Methods

A descriptive analysis of published RCT abstracts in The New England Journal of Medicine (NEJM), The Lancet, The Journal of American Medical Association (JAMA), and the British Medical Journal (BMJ) in the year 2010 was conducted by two reviewers, independently extracting data from a MEDLINE/PubMed search.

Results

We identified 271 potential RCT abstracts meeting our inclusion criteria. More than half of the abstracts identified the study as randomized in the title (58.7%; 159/271), reported the specific objective/hypothesis (72.7%; 197/271), described participant eligibility criteria with settings for data collection (60.9%; 165/271), detailed the interventions for both groups (90.8%; 246/271), and clearly defined the primary outcome (94.8%; 257/271). However, the methodological quality domains were inadequately reported: allocation concealment (11.8%; 32/271) and details of blinding (21.0%; 57/271). Reporting the primary outcome results for each group was done in 84.1% (228/271). Almost all of the abstracts reported trial registration (99.3%; 269/271), whereas reports of funding and of harm or side effects from the interventions were found in only 47.6% (129/271) and 42.8% (116/271) of the abstracts, respectively.

Conclusions

These findings show inconsistencies and non-adherence to the CONSORT for abstract guidelines, especially in the methodological quality domains. Improvements in the quality of RCT reports can be expected by adhering to existing standards and guidelines as expressed by the CONSORT group.
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Literature
1.
go back to reference Concato J, Shah N, Horwitz RI: Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000, 342: 1887-1892. 10.1056/NEJM200006223422507.CrossRefPubMedPubMedCentral Concato J, Shah N, Horwitz RI: Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000, 342: 1887-1892. 10.1056/NEJM200006223422507.CrossRefPubMedPubMedCentral
2.
go back to reference Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF: Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996, 276: 637-639. 10.1001/jama.1996.03540080059030.CrossRefPubMed Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF: Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996, 276: 637-639. 10.1001/jama.1996.03540080059030.CrossRefPubMed
3.
go back to reference Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001, 134: 657-662.CrossRefPubMed Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001, 134: 657-662.CrossRefPubMed
4.
go back to reference Sanchez-Thorin JC, Cortes MC, Montenegro M, Villate N: The quality of reporting of randomized clinical trials published in Ophthalmology. Ophthalmology. 2001, 108: 410-415. 10.1016/S0161-6420(00)00500-5.CrossRefPubMed Sanchez-Thorin JC, Cortes MC, Montenegro M, Villate N: The quality of reporting of randomized clinical trials published in Ophthalmology. Ophthalmology. 2001, 108: 410-415. 10.1016/S0161-6420(00)00500-5.CrossRefPubMed
5.
go back to reference Kane RL, Wang J, Garrard J: Reporting in randomized clinical trials improved after adoption of the CONSORT statement. J Clin Epidemiol. 2007, 60: 241-249. 10.1016/j.jclinepi.2006.06.016.CrossRefPubMed Kane RL, Wang J, Garrard J: Reporting in randomized clinical trials improved after adoption of the CONSORT statement. J Clin Epidemiol. 2007, 60: 241-249. 10.1016/j.jclinepi.2006.06.016.CrossRefPubMed
6.
go back to reference Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG: CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010, 63: e1-e37. 10.1016/j.jclinepi.2010.03.004.CrossRefPubMed Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG: CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010, 63: e1-e37. 10.1016/j.jclinepi.2010.03.004.CrossRefPubMed
7.
go back to reference Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF: CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008, 5: e20-10.1371/journal.pmed.0050020.CrossRefPubMedPubMedCentral Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF: CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008, 5: e20-10.1371/journal.pmed.0050020.CrossRefPubMedPubMedCentral
8.
go back to reference Uniform requirements for manuscripts submitted to biomedical journals: Writing and editing for biomedical publication. J Pharmacol Pharmacother. 2010, 1: 42-58. Uniform requirements for manuscripts submitted to biomedical journals: Writing and editing for biomedical publication. J Pharmacol Pharmacother. 2010, 1: 42-58.
9.
go back to reference Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, Gaboury I: Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. The Medical Journal of Australia. 2006, 185: 263-267.PubMed Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, Gaboury I: Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. The Medical Journal of Australia. 2006, 185: 263-267.PubMed
10.
go back to reference Folkes A, Urquhart R, Grunfeld E: Are leading medical journals following their own policies on CONSORT reporting?. Contemp Clin Trials. 2008, 29: 843-846. 10.1016/j.cct.2008.07.004.CrossRefPubMed Folkes A, Urquhart R, Grunfeld E: Are leading medical journals following their own policies on CONSORT reporting?. Contemp Clin Trials. 2008, 29: 843-846. 10.1016/j.cct.2008.07.004.CrossRefPubMed
11.
go back to reference Mills EJ, Wu P, Gagnier J, Devereaux PJ: The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement. Contemp Clin Trials. 2005, 26: 480-487. 10.1016/j.cct.2005.02.008.CrossRefPubMed Mills EJ, Wu P, Gagnier J, Devereaux PJ: The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement. Contemp Clin Trials. 2005, 26: 480-487. 10.1016/j.cct.2005.02.008.CrossRefPubMed
12.
go back to reference Berwanger O, Ribeiro RA, Finkelsztejn A, Watanabe M, Suzumura EA, Duncan BB, Devereaux PJ, Cook D: The quality of reporting of trial abstracts is suboptimal: survey of major general medical journals. J Clin Epidemiol. 2009, 62: 387-392. 10.1016/j.jclinepi.2008.05.013.CrossRefPubMed Berwanger O, Ribeiro RA, Finkelsztejn A, Watanabe M, Suzumura EA, Duncan BB, Devereaux PJ, Cook D: The quality of reporting of trial abstracts is suboptimal: survey of major general medical journals. J Clin Epidemiol. 2009, 62: 387-392. 10.1016/j.jclinepi.2008.05.013.CrossRefPubMed
17.
go back to reference Campbell MK, Elbourne DR, Altman DG: CONSORT statement: extension to cluster randomised trials. BMJ (Clinical Research ed). 2004, 328: 702-708. 10.1136/bmj.328.7441.702.CrossRef Campbell MK, Elbourne DR, Altman DG: CONSORT statement: extension to cluster randomised trials. BMJ (Clinical Research ed). 2004, 328: 702-708. 10.1136/bmj.328.7441.702.CrossRef
18.
go back to reference Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Moher D, Rennie D, de Vet HC, Lijmer JG: The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Clinical Chemistry. 2003, 49: 7-18. 10.1373/49.1.7.CrossRefPubMed Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Moher D, Rennie D, de Vet HC, Lijmer JG: The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Clinical Chemistry. 2003, 49: 7-18. 10.1373/49.1.7.CrossRefPubMed
19.
go back to reference Viera AJ, Garrett JM: Understanding interobserver agreement: the kappa statistic. Family Medicine. 2005, 37: 360-363.PubMed Viera AJ, Garrett JM: Understanding interobserver agreement: the kappa statistic. Family Medicine. 2005, 37: 360-363.PubMed
20.
go back to reference Nakayama T, Hirai N, Yamazaki S, Naito M: Adoption of structured abstracts by general medical journals and format for a structured abstract. Journal of the Medical Library Association: JMLA. 2005, 93: 237-242.PubMedPubMedCentral Nakayama T, Hirai N, Yamazaki S, Naito M: Adoption of structured abstracts by general medical journals and format for a structured abstract. Journal of the Medical Library Association: JMLA. 2005, 93: 237-242.PubMedPubMedCentral
21.
go back to reference Xu L, Li J, Zhang M, Ai C, Wang L: Chinese authors do need CONSORT: reporting quality assessment for five leading Chinese medical journals. Contemporary clinical trials. 2008, 29: 727-731. 10.1016/j.cct.2008.05.003.CrossRefPubMed Xu L, Li J, Zhang M, Ai C, Wang L: Chinese authors do need CONSORT: reporting quality assessment for five leading Chinese medical journals. Contemporary clinical trials. 2008, 29: 727-731. 10.1016/j.cct.2008.05.003.CrossRefPubMed
22.
go back to reference Wang L, Li Y, Li J, Zhang M, Xu L, Yuan W, Wang G, Hopewell S: Quality of reporting of trial abstracts needs to be improved: using the CONSORT for abstracts to assess the four leading Chinese medical journals of traditional Chinese medicine. Trials. 2010, 11: 75-10.1186/1745-6215-11-75.CrossRefPubMedPubMedCentral Wang L, Li Y, Li J, Zhang M, Xu L, Yuan W, Wang G, Hopewell S: Quality of reporting of trial abstracts needs to be improved: using the CONSORT for abstracts to assess the four leading Chinese medical journals of traditional Chinese medicine. Trials. 2010, 11: 75-10.1186/1745-6215-11-75.CrossRefPubMedPubMedCentral
23.
go back to reference Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF: CONSORT for reporting randomised trials in journal and conference abstracts. Lancet. 2008, 371: 281-283. 10.1016/S0140-6736(07)61835-2.CrossRefPubMed Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF: CONSORT for reporting randomised trials in journal and conference abstracts. Lancet. 2008, 371: 281-283. 10.1016/S0140-6736(07)61835-2.CrossRefPubMed
24.
go back to reference Mann E, Meyer G: Reporting quality of conference abstracts on randomised controlled trials in gerontology and geriatrics: a cross-sectional investigation. Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen. 2011, 105: 459-462. 10.1016/j.zefq.2010.07.011.CrossRefPubMed Mann E, Meyer G: Reporting quality of conference abstracts on randomised controlled trials in gerontology and geriatrics: a cross-sectional investigation. Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen. 2011, 105: 459-462. 10.1016/j.zefq.2010.07.011.CrossRefPubMed
25.
go back to reference Hopewell S, Clarke M, Askie L: Reporting of trials presented in conference abstracts needs to be improved. Journal of Clinical Epidemiology. 2006, 59: 681-684. 10.1016/j.jclinepi.2005.09.016.CrossRefPubMed Hopewell S, Clarke M, Askie L: Reporting of trials presented in conference abstracts needs to be improved. Journal of Clinical Epidemiology. 2006, 59: 681-684. 10.1016/j.jclinepi.2005.09.016.CrossRefPubMed
26.
go back to reference Zhang D, Yin P, Freemantle N, Jordan R, Zhong N, Cheng KK: An assessment of the quality of randomised controlled trials conducted in China. Trials. 2008, 9: 22-10.1186/1745-6215-9-22.CrossRefPubMedPubMedCentral Zhang D, Yin P, Freemantle N, Jordan R, Zhong N, Cheng KK: An assessment of the quality of randomised controlled trials conducted in China. Trials. 2008, 9: 22-10.1186/1745-6215-9-22.CrossRefPubMedPubMedCentral
27.
go back to reference Lexchin J, Bero LA, Djulbegovic B, Clark O: Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ (Clinical research ed). 2003, 326: 1167-1170. 10.1136/bmj.326.7400.1167.CrossRef Lexchin J, Bero LA, Djulbegovic B, Clark O: Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ (Clinical research ed). 2003, 326: 1167-1170. 10.1136/bmj.326.7400.1167.CrossRef
28.
go back to reference Moher D, Jones A, Lepage L: Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA: the Journal of the American Medical Association. 2001, 285: 1992-1995. 10.1001/jama.285.15.1992.CrossRefPubMed Moher D, Jones A, Lepage L: Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA: the Journal of the American Medical Association. 2001, 285: 1992-1995. 10.1001/jama.285.15.1992.CrossRefPubMed
29.
go back to reference Gulmezoglu AM, Pang T, Horton R, Dickersin K: WHO facilitates international collaboration in setting standards for clinical trial registration. Lancet. 2005, 365: 1829-1831. 10.1016/S0140-6736(05)66589-0.CrossRefPubMed Gulmezoglu AM, Pang T, Horton R, Dickersin K: WHO facilitates international collaboration in setting standards for clinical trial registration. Lancet. 2005, 365: 1829-1831. 10.1016/S0140-6736(05)66589-0.CrossRefPubMed
30.
go back to reference De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ: Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. Lancet. 2005, 365: 1827-1829. 10.1016/S0140-6736(05)66588-9.CrossRefPubMed De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ: Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. Lancet. 2005, 365: 1827-1829. 10.1016/S0140-6736(05)66588-9.CrossRefPubMed
31.
go back to reference Hopewell S, Eisinga A, Clarke M: Better reporting of randomized trials in biomedical journal and conference abstracts. Journal of Information Science. 2007, 34: 162-173. 10.1177/0165551507080415.CrossRef Hopewell S, Eisinga A, Clarke M: Better reporting of randomized trials in biomedical journal and conference abstracts. Journal of Information Science. 2007, 34: 162-173. 10.1177/0165551507080415.CrossRef
32.
go back to reference Taddio A, Pain T, Fassos FF, Boon H, Ilersich AL, Einarson TR: 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: Canadian Medical Association journal = Journal de l’Association Medicale Canadienne. 1994, 150: 1611-1615.PubMed Taddio A, Pain T, Fassos FF, Boon H, Ilersich AL, Einarson TR: 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: Canadian Medical Association journal = Journal de l’Association Medicale Canadienne. 1994, 150: 1611-1615.PubMed
33.
go back to reference Dupuy A, Khosrotehrani K, Lebbe C, Rybojad M, Morel P: Quality of abstracts in 3 clinical dermatology journals. Archives of Dermatology. 2003, 139: 589-593. 10.1001/archderm.139.5.589.CrossRefPubMed Dupuy A, Khosrotehrani K, Lebbe C, Rybojad M, Morel P: Quality of abstracts in 3 clinical dermatology journals. Archives of Dermatology. 2003, 139: 589-593. 10.1001/archderm.139.5.589.CrossRefPubMed
34.
go back to reference Hildebrandt M, Vervolgyi E, Bender R: Calculation of NNTs in RCTs with time-to-event outcomes: a literature review. BMC Medical Research Methodology. 2009, 9: 21-10.1186/1471-2288-9-21.CrossRefPubMedPubMedCentral Hildebrandt M, Vervolgyi E, Bender R: Calculation of NNTs in RCTs with time-to-event outcomes: a literature review. BMC Medical Research Methodology. 2009, 9: 21-10.1186/1471-2288-9-21.CrossRefPubMedPubMedCentral
35.
go back to reference Polit DF, Gillespie BM: Intention-to-treat in randomized controlled trials: recommendations for a total trial strategy. Research in Nursing and Health. 2010, 33: 355-368. 10.1002/nur.20386.CrossRefPubMed Polit DF, Gillespie BM: Intention-to-treat in randomized controlled trials: recommendations for a total trial strategy. Research in Nursing and Health. 2010, 33: 355-368. 10.1002/nur.20386.CrossRefPubMed
36.
go back to reference Schulz KF, Altman DG, Moher D: CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010, 11: 32-10.1186/1745-6215-11-32.CrossRefPubMedPubMedCentral Schulz KF, Altman DG, Moher D: CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010, 11: 32-10.1186/1745-6215-11-32.CrossRefPubMedPubMedCentral
Metadata
Title
Assessment of adherence to the CONSORT statement for quality of reports on randomized controlled trial abstracts from four high-impact general medical journals
Authors
Saurav Ghimire
Eunjung Kyung
Wonku Kang
Eunyoung Kim
Publication date
01-12-2012
Publisher
BioMed Central
Published in
Trials / Issue 1/2012
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-13-77

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