- Meeting abstract
- Open access
- Published:
Poor methodological reporting in lupus clinical trials found in Cochrane reviews
Arthritis Research & Therapy volume 14, Article number: A54 (2012)
Background
Results of randomized clinical trials depend on the credibility of the methods reporting to support study findings.
Methods
We studied 24 trials from those in the Cochrane Database of Systematic Reviews with 'lupus' in the title and were printable. Each paper was scored by one reviewer using methodological criteria for design, allocation [1], blinding [2–4], reporting and imputation [5]. Scores used yes, no, or ? when it was unclear. Yes n (integer %) for all 24 papers are reported for each criterion.
Results
Design
Four (17%) papers had a sample size justification; 22 (92%) contained two groups and two (8%) contained three groups. Five (21%) stratified patients; yet two (8%) used stratification in the analysis.
Allocation
Six (25%) stated random numbers generated and three (12%) blocked the balance associated with the allocation ratio; yet zero (0%) used blocking in the analysis. Six (25%) used a randomization list concealed from the person deciding patient eligibility, zero (0%) provided an audit trail for randomization, one (4%) stated randomization integrity. Seven (29%) mentioned the randomization constructed with a computer program or random number table.
Blinding
Four (17%) stated the person deciding on the patient eligibility was blinded to block structure and eight (33%) claimed the study was double blinded, even though it was not clear who the two were; indeed one was really triple blinded! For three (12%) patient blinded, six (25%) therapy, four (17%) therapist, one (4%) other caregivers; two (8%) the outcome assessor; zero (0%) data analyst, zero (0%) manuscript writer.
Reporting/analysis
One (4%) checked statistical assumptions, 23 (96%) provided baseline data, not all for every patient randomized. Twenty-one (88%) provided P values for group comparisons, four (17%) provided confidence intervals and zero (0%) provided numbers needed to treat. One (4%) specified subgroups in advance [6], six (25%) adjusted for baseline differences as one of the reported analyses. Four (17%) stated statistical software, but not version, zero (0%) provided the computer used for analyses.
Imputation
Seventeen (71%) had missing data, yet one (4%) mentioned using last observation carried forward, zero (0%) used multiple imputation and zero (0%) mentioned impact on study conclusions [5]. Two (8%) provided a flowchart as suggested by CONSORT [7, 8].
Conclusion
Lupus trials did not report many of the methodological criteria that give papers credibility and validity to the study being reported. Reporting should be improved in future reports of studies of patients with lupus and related health problems. Possibly using the CONSORT checksheets would help make lupus papers more credible [7, 8].
References
Meinert CL: Clinical Trials. Design, Conduct and Analysis. 1986, New York: Oxford University Press
Akl EA, Sun X, Busse JW, Johnston BC, Briel M, Mulla S, You JJ, Bassler D, Lamontagne F, Vera C, Alshurafa M, Katsios CM, Heels-Ansdell D, Zhou Q, Mills EJ, Guyatt GH: Specific instructions for unclearly reported blinding status in randomized trials were reliable and valid. J Clin Epidemiol. 2012, 65: 262-267. 10.1016/j.jclinepi.2011.04.015.
Montori VM, Bhandari M, Devereauz PJ, Manns BJ, Ghali WA, Guyatt GH: In the dark. The reporting of blinding status in randomized controlled trials. J Clin Epdemiol. 2002, 55: 787-790. 10.1016/S0895-4356(02)00446-8.
Miller LE, Stewart ME: The blind leading the blind: use and misuse of blinding in clinical trials. Contemp Clin Trials. 2011, 23: 240-243.
Molenburgs G, Kenward MG: Missing Data in Clinical Studies. 2007, Toronto, ON: J Wiley & Sons
Sun X, Briel M, Busse JW, You JJ, Akl EA, Mejza F, Bala MM, Bassler D, Mertz D, Diaz-Granados N, Vandvik PO, Makaga G, Srinathan SK, Dahm P, Johnston BC, Alonso-Coello P, Hassouneh B, Walter SD, Heels-Ansdell D, Bhatnager N, Altman DG, Guyatt GH: Credibility of claims of subgroup effects in randomised controlled trials: systematic review. BMJ. 2012, 344: e1553-10.1136/bmj.e1553.
Schulz KF, Altman DG, Moher D: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010, 340: c332-10.1136/bmj.c332.
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.
Acknowledgements
CHG holds the Maureen and Milan Ilich/Merck Chair in Statistics for Arthritis and Musculoskeletal Diseases.
Author information
Authors and Affiliations
Rights and permissions
This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
About this article
Cite this article
Goldsmith, C. Poor methodological reporting in lupus clinical trials found in Cochrane reviews. Arthritis Res Ther 14 (Suppl 3), A54 (2012). https://doi.org/10.1186/ar3988
Published:
DOI: https://doi.org/10.1186/ar3988