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 .
Acute exacerbations of COPD in subjects completing pulmonary rehabilitation.
BACKGROUND Improvements in health status following  pulmonary rehabilitation ( PR ) diminish with time . Acute exacerbations of COPD ( AE COPD s ) negatively impact adherence after PR and likely accelerate this diminution of benefit . This study was design ed to characterize the pre-AE COPD status of patients with moderate or severe COPD who had completed PR , and then to measure the impact of AE COPD s on health-related quality of life ( HRQL ) and functional exercise capacity . METHODS Sixty subjects who completed PR were enrolled in a 6-month observational study and were followed up until an AE COPD occurred . In the event of an AE COPD , primary outcome measures , the  6-min walk test ( 6MWT ) and the chronic respiratory disease question naire ( CRDQ ) , were repeated 2 weeks after the onset of symptoms . Between-group and repeated- measures analyses were performed . RESULTS The mean ( + /- SD ) age of the 53 subjects ( 49 % female ) completing the study was 68 + /- 9 years . Baseline airflow obstruction was moderate in 35 subjects ( 66 % ) and severe in 18 subjects ( 34 % ) . Thirty-four subjects experienced a moderate or severe AE COPD . The mean distance walked on the baseline 6MWT in those subjects who experienced AE COPD s was 350 + /- 95 m , compared to 416 + /- 95 m walked in those subjects who did not ( difference , 66 m ; p < 0.02 ) . The presence of an AE COPD was associated with significant reductions in 6MWT distance walked ( difference , 59.3 + /- 80 m ; p < 0.01 ) and in the CRDQ domains of fatigue ( difference , 1 + /- 1.3 ; p < 0.01 ) , emotion ( difference , 0.6 + /- 0.95 ; p < 0.01 ) , and mastery ( difference , 0.5 + /- 1.4 ; p < 0.05 ) . CONCLUSIONS Patients with lower functional exercise capacity are more likely to experience AE COPD s following PR . AE COPD s are associated with significant and clinical ly meaningful reductions in functional exercise capacity and HRQL
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 .