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 .
Long-term oxygen therapy improves health-related quality of life.
Guidelines for the prescription of long-term oxygen therapy ( LTOT ) in hypoxemic COPD patients are based on two l and mark studies in which survival was the primary outcome . Such patients are importantly symptomatic with poor health-related quality of life ( HRQL ) but the effect of LTOT on HRQL remains uncertain . We undertook a prospect i ve longitudinal interventional study of consecutive COPD patients referred to our regional oxygen service ; n = 43 fulfilling criteria and commenced on LTOT , n = 25 not fulfilling criteria and continued on st and ard care .  HRQL was measured at baseline , 2 and 6 months . Both patient groups had severe COPD as defined by mean FEV1 < 35 % predicted . At baseline the LTOT group demonstrated significantly worse HRQL as defined by the Chronic Respiratory Question naire ( CRQ ) ( fatigue , emotional function , mastery and total scores ) , total generic Dartmouth COOP Charts and anxiety domain of the Hospital Anxiety and Depression scale . Significant improvements in HRQL were noted at 2 and 6 months in the LTOT group . Conversely the non-LTOT group demonstrated a progressive decline in HRQL . Using vali date d criteria for a minimal clinical ly significant improvement in CRQ , there were 28 ( 67 % ) and 26 ( 68 % ) ' responders ' at 2 and 6 months respectively in the LTOT group . The introduction of LTOT to patients with severe COPD fulfilling st and ard criteria was associated with early significant improvements in HRQL with sustained or further response at 6 months
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 .