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 .
Quality of life changes in COPD patients treated with salmeterol.
Changes in health-related quality of life ( HRQoL ) were evaluated in patients with chronic obstructive pulmonary disease ( COPD ) following treatment with placebo , salmeterol 50 microg twice a day or 100 microg twice a day by metered-dose inhaler . Patients completed the disease-specific St. George 's Respiratory Question naire ( SGRQ ) and the Medical Outcomes Study Short Form 36 ( SF-36 ) at baseline and after 16 wk of treatment . Data from 283 patients ( 95 patients in the placebo group and 94 in each salmeterol group ) were available for HRQoL analysis . Apart from a small difference in ages , all treatment groups were well matched at baseline in terms of forced expiratory volume in one second ( FEV1 ) and HRQoL scores . Compared with placebo , salmeterol 50 microg twice a day was associated with significant improvements in SGRQ " Total " and " Impacts " scores which exceeded the threshold for a clinical ly significant change . This was not seen with salmeterol 100 microg twice a day . Changes in SGRQ and SF-36 scores correlated . They also showed a weak but significant relationship with FEV1 . This study has shown that a modest change in lung function may be associated with clinical ly significant gain in health and well-being in COPD patients
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 .