Skip to main content

Table 3 Common Reasons for Changing PRO Instruments During Initial Development

From: Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance

Item Property

Reason for Change or Deletion

Clarity or relevance

• Reported as not relevant by a large segment of the population of interest

• Generates an unacceptably large amount of missing data points

• Generates many questions or requests for clarification from patients as they complete the PRO instrument

• Patients interpret items and responses in a way that is inconsistent with the conceptual framework

Response range

• A high percent of patients respond at the floor (worst end of the response scale) or ceiling (optimal end of the response scale)

• Patients note that none of the response choices apply to them

• Item means are highly skewed

Variability

• All patients give the same answer (i.e., no variance)

• Most patients choose only one of the response choices

• Differences among patients are not detected when important differences are known

Reproducibility

• Unstable scores over time when there is no logical reason for variation from one assessment to the next

Inter-item correlation

• Item uncorrelated with other items in the same concept of interest

Ability to detect change

• Item is nonresponsive (i.e., does not change when there is a known change in the concepts of interest)

Item discrimination

• Item is highly correlated with measures of concepts other than the one it is intended to measure

Redundancy

• Item duplicates information collected with other items that have equal or better measurement properties