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 .
Development of the EXACT-U: a preference-based measure to report COPD exacerbation utilities.
BACKGROUND The exacerbations of chronic obstructive pulmonary disease tool ( EXACT ) is a condition-specific daily diary recently developed to evaluate the frequency , severity , and duration of chronic obstructive pulmonary disease ( COPD ) exacerbations . A preference-based algorithm for the EXACT would allow utilities to be reported from patients during an exacerbation when EQ-5D data are not available . OBJECTIVE To develop the exacerbations of chronic obstructive pulmonary disease tool-utility ( EXACT-U ) , a condition-specific preference-based measure to report utilities from the EXACT for use in cost-effectiveness studies . METHODS Five items with three to five levels comprise the EXACT-U. Two groups of health states and respondents were constructed to allow for model development ( Development group ) and predictive validity testing ( Validation group ) using independent sample s. Members of the UK general public each valued 11 r and omized health states using time trade-offs ( TTOs ) scaled from full health/dead with 10-year duration s. Regression models estimated from the Development group using individual data , mean data , and panel design s. Models assessed by number of inconsistent coefficients estimated and R(2 ) and tested against observed utilities from the Validation group using mean absolute error ( MAE ) and root mean squared error ( RMSE ) . RESULTS A total of 55 health states , including the best and worst states , were valued in TTO interviews conducted with 400 respondents . Ten models were developed . The final preferred model contained no logical inconsistencies and found MAE = 0.04 and RMSE = 0.05 with a predicted utility range from 0.09 to 0.95 . CONCLUSIONS The EXACT-U is a condition-specific preference-based measure with strong predictive validity to report daily utilities during an exacerbation
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 .