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 .
Development and first validation of the COPD Assessment Test
There is need for a vali date d short , simple instrument to quantify chronic obstructive pulmonary disease ( COPD ) impact in routine practice to aid health status assessment and communication between patient and physician . Current health-related quality of life question naires provide valid assessment of COPD , but are complex , which limits routine use . The aim of the present study was to develop a short vali date d  patient-completed  question naire , the  COPD Assessment Test ( CAT ) , assessing the impact of COPD on health status . 21 c and i date items identified through qualitative research with COPD patients were used in three prospect i ve international studies ( Europe and the USA , n = 1,503 ) . Psychometric and Rasch analyses identified eight items fitting a unidimensional model to form the CAT . Items were tested for differential functioning between countries . Internal consistency was excellent : Cronbach 's α = 0.88 . Test re-test in stable patients ( n = 53 ) was very good ( intra-class correlation coefficient 0.8 ) . In the sample from the USA , the correlation with the COPD -specific version of the St George ’s Respiratory Question naire was r = 0.80 . The difference between stable  ( n = 229 ) and  exacerbation patients ( n = 67 ) was five units of the 40-point scale ( 12 % ; p<0.0001 ) . The CAT is a short , simple question naire for assessing and monitoring COPD . It has good measurement properties , is sensitive to differences in state and should provide a valid , reliable and st and ardised measure of COPD health status with worldwide relevance
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 .