Design, quality, and bias in randomized controlled trials of systemic lupus erythematosus
| dc.contributor.author | Karassa, F. B. | en |
| dc.contributor.author | Tatsioni, A. | en |
| dc.contributor.author | Ioannidis, J. P. | en |
| dc.date.accessioned | 2015-11-24T19:25:09Z | |
| dc.date.available | 2015-11-24T19:25:09Z | |
| dc.identifier.issn | 0315-162X | - |
| dc.identifier.uri | https://olympias.lib.uoi.gr/jspui/handle/123456789/22579 | |
| dc.rights | Default Licence | - |
| dc.subject | Bias (Epidemiology) | en |
| dc.subject | Humans | en |
| dc.subject | Lupus Erythematosus, Systemic/*drug therapy | en |
| dc.subject | Randomized Controlled Trials as Topic/*methods/*standards | en |
| dc.subject | Research Design/standards | en |
| dc.subject | Sample Size | en |
| dc.title | Design, quality, and bias in randomized controlled trials of systemic lupus erythematosus | en |
| heal.abstract | OBJECTIVE: To appraise systematically the study design and quality of reporting of randomized controlled trials (RCT) on systemic lupus erythematosus (SLE) and to identify potential defects and biases. METHODS: RCT with at least 5 patients with SLE were retrieved from MEDLINE, EMBASE, and the Cochrane Library. We analyzed study design, quality of reporting, and trial results. RESULTS: Ninety-four trial reports (37 on lupus nephritis) were eligible with 2,257 SLE patients (n = 795 in lupus nephritis trials). Median sample size was 28 patients. Fifty-one trials (54.3%) were double blind, but only 31 (33.0%) mentioned the randomization mode, only 19 (20.2%) described allocation concealment, and only 7 (7.5%) were adequately powered. Sixty-three trials (67%) described adequately reasons for withdrawals. Nephritis trials had on average longer followup (p = 0.001) and were less likely to be double blind (p < 0.001), to describe reasons for withdrawals [both overall (p = 0.008) and per arm (p = 0.009)] and to involve a comparison against placebo or no treatment (p < 0.001). Larger trials scored higher on several quality characteristics. Significant efficacy or trend for efficacy was claimed in 72 reports (76.6%) and this was even more common in trials published in 1999-2002 (89.5%). Significant efficacy was found more frequently in trials that clearly specified withdrawals per arm (p = 0.001) and outcomes (p = 0.001) and used intention-to-treat analyses (p = 0.03). Besides outcome specification, no other quality variables seemed to improve significantly over time. CONCLUSION: Several aspects of the design and reporting of RCT on SLE can be improved. Larger, adequately powered, and accurately reported trials are needed. | en |
| heal.access | campus | - |
| heal.fullTextAvailability | TRUE | - |
| heal.identifier.secondary | http://www.ncbi.nlm.nih.gov/pubmed/12734892 | - |
| heal.journalName | J Rheumatol | en |
| heal.journalType | peer-reviewed | - |
| heal.language | en | - |
| heal.publicationDate | 2003 | - |
| heal.recordProvider | Πανεπιστήμιο Ιωαννίνων. Σχολή Επιστημών Υγείας. Τμήμα Ιατρικής | el |
| heal.type | journalArticle | - |
| heal.type.el | Άρθρο Περιοδικού | el |
| heal.type.en | Journal article | en |
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