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 .
Feasibility of retinoids for the treatment of emphysema study.
BACKGROUND Retinoids promote alveolar septation in the developing lung and stimulate alveolar repair in some animal models of emphysema . METHODS One hundred forty-eight subjects with moderate-to-severe COPD and a primary component of emphysema , defined by diffusing capacity of the lung for carbon monoxide ( Dlco ) [ 37.1 + /- 12.0 % of predicted ] and CT density mask ( 38.5 + /- 12.8 % of voxels < - 910 Hounsfield units ) [ mean + /- SD ] were enrolled into a r and omized , double-blind , feasibility study at five university hospitals . Participants received all-trans retinoic acid ( ATRA ) at either a low dose ( LD ) [ 1 mg/kg/d ] or high dose ( HD ) [ 2 mg/kg/d ] , 13-cis retinoic acid ( 13-cRA ) [ 1 mg/kg/d ] , or placebo for 6 months followed by a 3-month crossover period . RESULTS No treatment was associated with an overall improvement in pulmonary function , CT density mask score , or health-related quality of life ( QOL ) at the end of 6 months . However , time-dependent changes in Dlco ( initial decrease with delayed recovery ) and St. George Respiratory Question naire ( delayed improvement ) were observed in the HD-ATRA cohort and correlated with plasma drug levels . In addition , 5 of 25 participants in the HD-ATRA group had delayed improvements in their CT scores that also related to ATRA levels . Retinoid-related side effects were common but generally mild . CONCLUSIONS No definitive clinical benefits related to the administration of retinoids were observed in this feasibility study . However , time- and dose-dependent changes in Dlco , CT density mask score , and health-related QOL were observed in subjects treated with ATRA , suggesting the possibility of exposure-related biological activity that warrants further investigation
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 .