Definitions of the OMERACT filter criteria.
| OMERACT Filter Criterion | Definition |
|---|---|
| Truth | |
| Face validity (credibility) | Overall appropriateness of method to be used for evaluation of the outcome, as assessed by investigators and clinicians |
| Content validity (comprehensiveness) | Ability of the outcome measure to include or predict all those components of health status relevant to the intervention being assessed. Thus, it was evaluated whether echo measurements cover the whole spectrum of PAH-SSc patients and whether its measurements are specific for PAH |
| Criterion validity (accuracy) | Ability of the outcome measure to reflect best available estimate of true clinical status of the patient. Thus, criterion validity was assessed through comparisons/correlation of echo with RHC as the “gold standard” technique in PAH/PH |
| Construct validity | Ability of the outcome measure to match with the hypothesized expectations of the investigator compared with other indirect assessments. Thus, construct validity was assessed through assessment of convergent and divergent validity based on associations/correlations of echo measures with other clinically relevant disease measures. Since echo has been used frequently as a diagnostic tool in multiple research studies, only associations/correlations with measures defined by PAH experts as important for evaluation of PAH-SSc patients were taken into account for this analysis13 |
| Discrimination | |
| Sensitivity to change over time | Based on calculation of standardized response mean (SRM) using repeated measures performed in a given population at 2 different timepoints without therapeutic intervention in between |
| Discrimination capacity over treatment | Based on calculation of effect size in randomized controlled trials or SRM in open-label trials |
| Reliability (reproducibility) | Based on evaluation of intra-and interclass correlations |
| Feasibility | The measure’s ease of use, cost-effectiveness, availability in different centers, and overall usefulness |
PAH-SSc: pulmonary arterial hypertension-systemic sclerosis; RHC: right-heart catheterization.