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 validation of the Capacity of Daily Living during the Morning questionnaire and the Global Chest Symptoms Questionnaire in COPD
This report concerns the development and validation of two patient-reported outcomes question naires developed to assess chronic obstructive pulmonary disease ( COPD ) patients ’ ability to perform morning activities and to evaluate their morning symptoms . Based on interviews with COPD patients , the Capacity of Daily Living during the Morning ( CDLM ) question naire and the Global Chest Symptoms Question naire ( GCSQ ) were developed , linguistically vali date d and incorporated into two multicentre , r and omised trials involving a total of 1,100 COPD patients ; those trials were registered at Clinical Trials.gov ( NCT00496470 and NCT00542880 ) . Data from these trials were used to determine the reliability , validity and responsiveness of the question naires and to derive estimates of minimal important differences ( MIDs ) . Both question naires displayed good-to-high reliability ( Cronbach ’s & agr ; 0.75–0.93 ) . Analysis of convergent validity showed that CDLM and GCSQ scores correlated significantly ( p<0.001 ) with symptoms , health-related quality of life ( HRQoL ) and use of rescue medication . In both trials , CDLM and GCSQ scores discriminated between patients with different levels of HRQoL , as assessed by the St George 's Respiratory Question naire for COPD patients ( SGRQ-C ) , but not with disease severity , as assessed by the Global Initiative for Chronic Obstructive Lung Disease ( GOLD ) criteria . A significant improvement in CDLM and GCSQ scores occurred in response to treatment . Estimations of MID scores , corresponding to an SGRQ-C MID of 4 , were 0.20 for the CDLM question naire and 0.15 for the GCSQ . Both the CDLM question naire and the GCSQ are easy-to-use , reliable , responsive , self-administered question naires that report on patients ' symptoms and ability to perform morning activities
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 .