Journal of Patient-Reported Outcomes

Table 3 Key points of data abstraction and assessment for concepts measured using evaluation criteria by phase for patient-reported outcome measure-development across SLE-PRO measures

From: Capturing the patient experience in systemic lupus erythematosus: Are widely used measures fit-for-purpose and adherent to FDA PRO guidance recommendations?

	LupusQoL	LupusQoL-US	LupusPRO v1.7	LupusPRO v1.8
Adequacy of item generation process
Derivation of items is appropriate	The study population’s representativeness of the target population is questionable with no evidence to support semi-structured nature of interviews	Limitations exist; did not conduct concept elicitation for target population as content validity was assumed	The study population’s representativeness of the target population is questionable with no evidence to support semi-structured nature of interviews	Limitations exist; did not conduct concept elicitation for target population as content validity was assumed
Derivation of items is comprehensive	No evidence that concepts affected majority of patients representing the target population or whether a wide range of patients representing target population were used. No evidence of achievement of saturation, except statement in text (e.g., no saturation grid)	Limitations exist; did not conduct concept elicitation for target population as content validity was assumed	No evidence that concepts affected majority of patients representing the target population or whether a wide range of patients representing target population were used. No evidence of achievement of saturation, except statement in text (e.g., no saturation grid)	Limitations exist; did not conduct concept elicitation for target population as content validity was assumed
Adequacy of cognitive interviewing process
Cognitive interviewing with patient input	Limitations exist concerning the representativeness of the study population to the target population and insufficient documentation of details	Limitations exist; did not conduct cognitive debriefing for target population as content validity was assumed	Limitations exist; target population and documentation of details	Limitations exist; did not conduct cognitive debriefing for target population as content validity was assumed
Cognitive interviewing until saturation is reached	No evidence of achievement of saturation, except statement in text (e.g., no saturation grid)	Limitations exist; did not conduct cognitive debriefing for target population as content validity was assumed	Limitations exist; target population and insufficient documentation of details	Limitations exist; did not conduct debriefing for target population as content validity was assumed
Testing of other psychometric properties
Testing of items/concepts	Limitations exist for the “target population” component of development Transparency lacking	Limitations exist for the “target population” component of development. Transparency lacking	Limitations exist for the “target population” component of development Transparency lacking	Limitations exist for the “target population” component of development. Transparency lacking

Back to article page