Table 7

Relation of CTD-ILD preliminary core set instruments to aspects of OMERACT filter in CTD-ILD

CTD-ILDDyspnoeaCoughHRQoLLung
physiology
Lung
imaging
Survival
InstrumentsD-12MRCLCMSGRQSF-36PtGAFVCDLCOHRCT—overall
extent of disease
All-cause
mortality
Time to decline
in FVC
Truth
 Face validityYYYYYYYYYYY
 Content validityYYYYYYYYYYY
 Construct validityYYNTYYNTY±YYNT
 Criterion validityNTNTNTNTNTNTNoNoYYNT
Discrimination
 DiscriminatoryYYNTYYNT±±Yes, except± for GGONoY
 ReliableYYNTNTYNTYNYes, except± for GGOYNT
 ReproducibleNTNTNTNTNTNTY±YN/ANT
 Sensitive to changeYYNTNTYNTY±Yes but relatively slowN/AY
Feasibility
 Cost effectiveYYYYYYYYYNo*Y
 InterpretabilityYYYYYYYYYYY
 Readily availableYYYYYYYYYYY
 Safe for patientsYYYYYYYY±YY
Patient-derived content†YNoNoNoNoN/AN/AN/AN/AN/AN/A
  • PtGA is adopted under HRQoL, though it is an independent instrument.

  • *Not cost effective as a primary efficacy endpoint but highly cost effective as a secondary endpoint to detect treatment toxicity—see text for discussion on ‘survival’

  • †US Food and Drug Administration advocates patient-reported instruments be developed by qualitative data supplied by patients.18 ,19

  • ±, ambiguous; CTD-ILD, connective tissue disease associated interstitial lung disease; D-12, Dyspnea-12; DLCO, diffusion capacity of lung for carbon monoxide; FVC, forced vital capacity; GGO, ground glass opacity; HRCT, high-resolution CT; LCM, Leicester Cough Monitor; MRC, Medical Research Council Dyspnea Scale; N/A, not applicable; NT, not yet tested; OMERACT, Outcome Measures in Rheumatology; PtGA, Patient Global Disease Activity; SGRQ, St George's Respiratory Questionnaire; SF-36, Short Form 36; Y, yes.