Conclusion Our findings suggest that people with low literacy skills or learning disabilities are left out of the development of PROMs .
Background  Patient-reported outcome measures ( PROMs ) are intended to reflect outcomes relevant to patients .
They are increasingly used for healthcare quality improvement .
To produce valid measures , patients should be involved in the development process but it is unclear whether this usually includes people with low literacy skills or learning disabilities .
A randomized controlled trial to evaluate the effect of informing patients about their pretreatment responses to two respiratory questionnaires.
STUDY OBJECTIVES Previous studies with short recall periods have suggested that informed administration ( previous responses available ) may improve the responsiveness and validity of health-related quality -of-life ( HRQL ) question naires in comparison to blind administration ( previous responses unavailable ) . Informed administration may , however , have less impact in studies with longer recall periods . The objective of this r and omized trial was to compare the validity and responsiveness of the blind and informed Chronic Respiratory Question naire ( CRQ ) and the St. George 's Respiratory Question naire ( SGRQ ) with a 3-month interval between question naire completion . STUDY DESIGN We r and omized 85 patients to blind or informed administration of the CRQ and SGRQ before and after they underwent a st and ard respiratory rehabilitation program . Patients also completed other HRQL instruments . RESULTS At the follow-up administration , we observed important and statistically significant improvement in all four CRQ domains and three SGRQ domains . The results of blind and informed administration differed little . This was true for both the CRQ and the SGRQ , and for both responsiveness and validity . CONCLUSIONS In contrast to the improved measurement properties after shorter recall periods , the administration of the informed version after > or = 12 weeks may not result in improvements in responsiveness or validity
Conclusion Our findings suggest that people with low literacy skills or learning disabilities are left out of the development of PROMs .
Background  Patient-reported outcome measures ( PROMs ) are intended to reflect outcomes relevant to patients .
They are increasingly used for healthcare quality improvement .
To produce valid measures , patients should be involved in the development process but it is unclear whether this usually includes people with low literacy skills or learning disabilities .