Table 1

Criteria to evaluate the operating characteristics of coeliac disease activity instruments

+?0
Content validityPROs: component items based on focus groups, patient interviews or qualitative cognitive interviews
Other evaluative instruments: component items based on expert consensus
PROs: component items not based on focus groups, patient interviews or qualitative cognitive interviews
Other evaluative instruments: component items not based on expert consensus
Limited or conflicting data preclude firm conclusionsNo data available
Construct validityCorrelation with established coeliac disease activity markers
Able to distinguish among groups that are known to be different
No correlation with established coeliac disease activity markers
Unable to distinguish among groups that are known to be different
Limited or conflicting data preclude firm conclusionsNo data available
ReliabilityAcceptable intraobserver and interobserver agreement (intraclass correlation coefficient ≥0.8 and interclass correlation coefficient ≥0.5)Unacceptable intraobserver and interobserver agreement (intraclass correlation coefficient <0.8 and interclass correlation coefficient <0.5)Limited or conflicting data preclude firm conclusionsNo data available
ResponsivenessAdequate and measurable change in response to a gluten challenge or a treatment of known efficacyInadequate or no change in response to a gluten challenge or a treatment of known efficacyLimited or conflicting data preclude firm conclusionsNo data available
FeasibilityNo technical expertise required
Favourable cost/benefit ratio
High patient acceptability (for PROs, >90% of patients respond to all questions)
Technical expertise required
Unfavourable cost/benefit ratio
Low patient acceptability (for PROs, <90% of patients respond to all questions)
Limited or conflicting data preclude firm conclusionsNo data available
  • +, positive; ?, indeterminate; −, negative; 0, no information available; PRO, patient-reported outcome.