This article is part of the supplement: Lupus 2012: New targets, new approaches

Meeting abstract

Poor methodological reporting in lupus clinical trials found in Cochrane reviews

CH Goldsmith

  • Correspondence: CH Goldsmith

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Author affiliations

Arthritis Research Centre of Canada, Vancouver, BC, Canada

Simon Fraser University, Burnaby, BC, Canada

Citation and License

Arthritis Research & Therapy 2012, 14(Suppl 3):A54 doi:10.1186/ar3988


The electronic version of this article is the complete one and can be found online at: http://arthritis-research.com/content/14/S3/A54


Published:27 September 2012

© 2012 Goldsmith; licensee BioMed Central Ltd.

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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].

Acknowledgements

CHG holds the Maureen and Milan Ilich/Merck Chair in Statistics for Arthritis and Musculoskeletal Diseases.

References

  1. Meinert CL: Clinical Trials. Design, Conduct and Analysis. New York: Oxford University Press; 1986. OpenURL

  2. 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. PubMed Abstract | Publisher Full Text OpenURL

  3. 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. Publisher Full Text OpenURL

  4. Miller LE, Stewart ME: The blind leading the blind: use and misuse of blinding in clinical trials.

    Contemp Clin Trials 2011, 23:240-243. OpenURL

  5. Molenburgs G, Kenward MG: Missing Data in Clinical Studies. Toronto, ON: J Wiley & Sons; 2007. OpenURL

  6. 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. PubMed Abstract | Publisher Full Text OpenURL

  7. Schulz KF, Altman DG, Moher D: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials.

    BMJ 2010, 340:c332. PubMed Abstract | Publisher Full Text | PubMed Central Full Text OpenURL

  8. 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. PubMed Abstract | Publisher Full Text OpenURL