Table 4

Operating properties of coeliac disease patient-reported outcome indices

Classification/grade/itemsContent validityConstruct validityReliabilityResponsivenessFeasibility
Celiac Disease Symptom Diary (CDSD, Alvine Pharmaceuticals)29*Diarrhoea, constipation, abdominal pain, bloating, gas, nausea, skin rash, fatigue, headache and difficulty thinking clearly++†++0
Coeliac Disease Quality of Life survey30Coeliac disease-related limitations, dysphoria, health concerns and inadequate treatment++†?0+
Celiac Disease Questionnaire31Emotional problems, social problems, disease-related worries and GI symptoms++†+?+
Celiac Symptom Index32Coeliac disease-related symptoms and general health++†++0
Celiac Disease Patient-Reported Outcome (CeD PRO, Alba Therapeutics)28*Abdominal symptoms, headache and tiredness++†++0
  • *Operating characteristics based on the approved US Food and Drug Administration application for use of PROs in clinical trials to support marketing claims.

  • †Some patients may be clinically asymptomatic but exhibit histological activity.

  • +, positive; ?, indeterminate; 0, no information available.