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 .
Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD
Clinical manifestations of chronic obstructive pulmonary disease ( COPD ) , including airflow limitation , dyspnea , and activity limitation , ultimately lead to impaired health-related quality of life ( HRQoL ) . This 9-month , r and omized , double-blind , multicenter study compared the effect of once-daily tiotropium 18 μg and placebo on HRQoL , spirometric parameters , and exacerbations in 554 patients with moderate-to-severe COPD .  HRQoL was assessed using the St. George ’s Respiratory Question naire ( SGRQ ) and the new 8-item Visual Simplified Respiratory Question naire ( VSRQ ) , which is currently being vali date d. The primary efficacy endpoint was the proportion of patients achieving a reduction of at least 4 units in the SGRQ total score at study end ( Month 9 ) . Mean ± SD baseline SGRQ total score was 47.4 ± 18.1 . Significantly more tiotropium-treated patients achieved a reduction of at least 4 units in the SGRQ score  vs placebo at study end ( 59.1 % vs 48.2 % , respectively ;  p = 0.029 ) . Tiotropium  significantly improved spirometric parameters ( forced expiratory volume in 1 second [ FEV1 ] : 0.11 ± 0.02 L vs 0.01 ± 0.02 L ; between-group difference : 0.10 ± 0.03 L , p = 0.0001 ) and reduced exacerbations vs placebo . Maintenance treatment with tiotropium provided significant and clinical ly relevant improvements in HRQoL , as measured by the SGRQ
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 .