Table 2.
Reasons that trials not measuring the COS cited COS reports
| Disease area | Reason for citing COS report |
|---|---|
| Systemic sclerosis (general trial design issues report)a | Acknowledging that clinical trials are recognized to be difficult in the disease area |
| Patient inclusion criteria (two trials) | |
| Patient population | |
| Determination of disease onset | |
| Rheumatoid arthritis (COS-only reports) | Acknowledged COS but limited the number of outcomes to three that could be obtained by self-assessment by the patients |
| The patient's global status and level of overall pain and the physician's global assessment were scored on a visual analogue scale. | |
| Measured the core set of measures apart from radiographs in trial lasting more than 1 year. The trialists acknowledged that this should be done in future trials. | |
| The variables chosen included 4 of 7 measures proposed for assessing disease activity by the ACR in 1993. | |
| Problems with outcomes have been addressed with the development of a COS | |
| Sepsis and critical care (COS-only report)b | Named some of the proposed COS outcomes |
| Inflammatory markers can provide additional support for a phase III study | |
| Sensitivity of organ dysfunction scales | |
| Sepsis and critical care (general trial design issues report) | Definition of sepsis (four trials) |
| Patient inclusion criteria | |
| Female sexual dysfunction (general trial design issues report) | Definition of female sexual arousal disorder (three trials) |
| Definition of hypoactive sexual desire disorder (two trials) |
Abbreviation: COS, core outcome set.
a
There were no citing trials for the systemic sclerosis COS-only report so no sample available.
b
Three citing trials were available for the sepsis and critical care COS-only report that did not measure the COS.