Quality of Reporting in Randomized Trials Published in High-Quality Surgical Journals
Abstract
Background Randomized controlled trials (RCTs) in surgery can provide valuable evidence of the efficacy of interventions if they are well-designed, appropriately executed, and adequately reported. Adequate reporting of methodology in surgical RCTs is known to be poor, and adverse-event reporting in surgical research is inconsistent. The Consolidated Standards of Reporting Trials (CONSORT) statement is a framework to help authors report their findings in a transparent manner. Extensions to the CONSORT statement have been published recently to address deficiencies in adverse-event reporting and in reporting of specific criteria related to nonpharmacologic treatments. The aim of this study was to assess the quality of reporting of trial methodology and adverse events in a sample of general surgical RCTs published in high-quality surgical journals using the criteria specified in the CONSORT statements. Study design We used impact factor to identify the top three ranked surgical journals in 2004. We then obtained information on all RCTs published in these journals in the 2005 calendar year. We assessed quality of reporting using Jadad score, compared the quality of RCTs from CONSORT-endorsing journals with nonendorsers, and assessed the number of RCTs adequately reporting key generic methodologic, adverse-event-related, and specific nonpharmacologic criteria. Results Of 42 RCTs analyzed, only 40% (17 of 42) had a Jadad score > or = 3. There was no significant difference in the num…
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Adherence of authors to the CONSORT guidelines is low and the quality of reporting remains insufficient.
“However, the adherence of authors to these guidelines is low and the quality of reporting remains insufficient [9–21].”
From Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial (2015) · cites this paper as [14]
Cites
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 · see citing works
Why the impact factor of journals should not be used for evaluating research
Seglen, P. O. (1997) · BMJ · doi:10.1136/bmj.314.7079.497 · Cited by 2,447 · see citing works
Boutron, I., Moher, D., Altman, D. G., Schulz, K. F., Ravaud, P., & for the CONSORT Group* (2008) · Annals of Internal Medicine · doi:10.7326/0003-4819-148-4-200802190-00008 · Cited by 2,292 · see citing works
What is meant by intention to treat analysis? Survey of published randomised controlled trials
Hollis, S., & Campbell, F. (1999) · BMJ · doi:10.1136/bmj.319.7211.670 · Cited by 2,160 · see citing works
Moher, D., Schulz, K. F., Altman, D. G., & for the CONSORT Group* (2001) · Annals of Internal Medicine · doi:10.7326/0003-4819-134-8-200104170-00011 · Cited by 1,426 · see citing works
Mills, E. J., Wu, P., Gagnier, J., & Devereaux, P. J. (2005) · Contemporary Clinical Trials · doi:10.1016/j.cct.2005.02.008 · Cited by 216 · see citing works
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Gloy, V. L., Briel, M., Bhatt, D. L., Kashyap, S. R., Schauer, P. R., Mingrone, G., Bucher, H. C., & Nordmann, A. J. (2013) · BMJ · doi:10.1136/bmj.f5934 · Cited by 1,351 · see citing works
Turner, L., Shamseer, L., Altman, D. G., Weeks, L., Peters, J., Kober, T., Dias, S., Schulz, K. F., Plint, A. C., & Moher, D. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.mr000030.pub2 · Cited by 740 · see citing works
Scoping review on interventions to improve adherence to reporting guidelines in health research
Blanco, D., Altman, D., Moher, D., Boutron, I., Kirkham, J. J., & Cobo, E. (2019) · BMJ Open · doi:10.1136/bmjopen-2018-026589 · Cited by 154 · see citing works
Barnes, C., Boutron, I., Giraudeau, B., Porcher, R., Altman, D. G., & Ravaud, P. (2015) · BMC Medicine · doi:10.1186/s12916-015-0460-y · Cited by 142 · see citing works
“However, the adherence of authors to these guidelines is low and the quality of reporting remains insufficient [9–21].”
BackgroundBlumle, A., Meerpohl, J. J., Rucker, G., Antes, G., Schumacher, M., & von Elm, E. (2011) · BMJ · doi:10.1136/bmj.d1828 · Cited by 44 · see citing works
- Authors
- Sinha, S., Sinha, S., Ashby, E., Jayaram, R., & Grocott, M. P. W.
- Affiliations
- North Middlesex Hospital (GB)
- National Health Service (GB)
- John Radcliffe Hospital (GB)
- UCL Biomedical Research Centre (GB)
- Corresponding author
- Sinha, Sidhartha
- Sinha, Shrestha
- Venue
- Journal of the American College of Surgeons
- Published
- 2009-11
- Volume
- 209
- Issue
- 5
- Pages
- 565-571e1
- ISSN
- 1072-7515 (ISSN-L)
- OpenAlex
- W1968946373
- Cited by
- 79
- References
- 6
- Citations by year
- 2024: 1 · 2023: 1 · 2022: 4 · 2020: 1 · 2019: 5 · 2018: 4 · 2017: 6 · 2016: 12 · 2015: 8 · 2014: 4 · 2013: 11 · 2012: 5
- FWCI
- 9.10
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of the American College of Surgeons (publishedVersion)
- PubMed (publishedVersion)
- ePrints Soton (University of Southampton) (submittedVersion)
- UCL Discovery (University College London) (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
- Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
- Keywords
- reporting quality, randomized controlled trials, surgical research, CONSORT statement, adverse event reporting, Jadad score, surgical journals, non-pharmacological treatment, clinical trial design
- MeSH terms
- Humans, Medical Records, Periodicals as Topic, Research Design, General Surgery, Bibliometrics, Randomized Controlled Trials as Topic, MEDLINE, Journalism, Medical, Journal Impact Factor
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