Abstract
OBJECTIVES—To study whether the reporting of clinical outcomes in arthritis trials measured on ordinal and interval scales is adequate in relation to meta-analysis. METHODS—Systematic review of randomised trials of non-steroidal anti-inflammatory drugs in patients with rheumatoid arthritis. Optimal reporting was defined as data in the original ordered categories for global evaluation and pain, and as mean and SD for number of tender joints and grip strength, and if a visual analogue scale had been used to measure pain. RESULTS—A total of 144 trials were included. The median sample size was 60 patients. The quality of the reporting increased over time for three of the four variables. Global evaluation was optimally reported in 52 of the 127 trials (41%) in which it was recorded. Pain was optimally reported in 27 of 98 trials (28%), number of tender joints in 41 of 123 trials (33%), and grip strength in 34 of 124 trials (27%). Even if rather broad criteria are adopted, only about half of the data were reported in a potentially useful way for a meta-analysis. CONCLUSIONS—Arthritis trials have been reported inadequately in relation to meta-analysis. As most trials are underpowered, meta-analysis is indispensable and the deficit therefore needs urgent improvement. Investigators should specify a priori what constitutes an important treatment effect and report numbers of patients improved.
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Selected References
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- Egger M., Davey Smith G., Schneider M., Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997 Sep 13;315(7109):629–634. doi: 10.1136/bmj.315.7109.629. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Freiman J. A., Chalmers T. C., Smith H., Jr, Kuebler R. R. The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 "negative" trials. N Engl J Med. 1978 Sep 28;299(13):690–694. doi: 10.1056/NEJM197809282991304. [DOI] [PubMed] [Google Scholar]
- Gøtzsche P. C., Hammarquist C., Burr M. House dust mite control measures in the management of asthma: meta-analysis. BMJ. 1998 Oct 24;317(7166):1105–1110. doi: 10.1136/bmj.317.7166.1105. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Gøtzsche P. C., Johansen H. K. Meta-analysis of short-term low dose prednisolone versus placebo and non-steroidal anti-inflammatory drugs in rheumatoid arthritis. BMJ. 1998 Mar 14;316(7134):811–818. doi: 10.1136/bmj.316.7134.811. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Gøtzsche P. C. Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis. Control Clin Trials. 1989 Mar;10(1):31–56. doi: 10.1016/0197-2456(89)90017-2. [DOI] [PubMed] [Google Scholar]
- Gøtzsche P. C. Sensitivity of effect variables in rheumatoid arthritis: a meta-analysis of 130 placebo controlled NSAID trials. J Clin Epidemiol. 1990;43(12):1313–1318. doi: 10.1016/0895-4356(90)90097-9. [DOI] [PubMed] [Google Scholar]
- Laird N. M., Mosteller F. Some statistical methods for combining experimental results. Int J Technol Assess Health Care. 1990;6(1):5–30. doi: 10.1017/s0266462300008916. [DOI] [PubMed] [Google Scholar]
- Mulward S., Gotzsche P. C. Sample size of randomized double-blind trials 1976-1991. Dan Med Bull. 1996 Feb;43(1):96–98. [PubMed] [Google Scholar]
