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 .
The Effects of Pulmonary Rehabilitation in the National Emphysema Treatment Trial.
STUDY OBJECTIVES Pulmonary rehabilitation is an established treatment in patients with chronic lung disease but is not widely utilized . Most trials have been conducted in single centers . The National Emphysema Treatment Trial ( NETT ) provided an opportunity to evaluate pulmonary rehabilitation in a large cohort of patients who were treated in centers throughout the United States . DESIGN Prospect i ve observational study of cohort prior to r and omization in a multicenter clinical trial . SETTING University-based clinical centers and community-based satellite pulmonary rehabilitation programs . PATIENTS AND INTERVENTION A total of 1,218 patients with severe emphysema underwent pulmonary rehabilitation before and after r and omization to lung volume reduction surgery ( LVRS ) or continued medical management .  Rehabilitation was conducted at 17 NETT centers supplemented by 539 satellite centers . MEASUREMENTS AND RESULTS Lung function , exercise tolerance , dyspnea , and quality of life were evaluated at regular intervals . Significant ( p < 0.001 ) improvements were observed consistently in exercise ( cycle ergometry , 3.1 W ; 6-min walk test distance , 76 feet ) , dyspnea ( University of California , San Diego Shortness of Breath Question naire score , -3.2 ; Borg breathlessness score : breathing cycle , -0.8 ; 6-min walk , -0.5 ) and quality of life ( St. George Respiratory Question naire score , -3.5 ; Quality of Well-Being Scale score , + 0.035 ; Medical Outcomes Study 36-item short form score : physical health summary , + 1.3 ; mental health summary , + 2.0 ) . Patients who had not undergone prior rehabilitation improved more than those who had . In multivariate models , only prior rehabilitation status predicted changes after rehabilitation . In 20 % of patients , exercise level changed sufficiently after rehabilitation to alter the NETT subgroup predictive of outcome . Overall , changes after rehabilitation did not predict differential mortality or improvement in exercise ( primary outcomes ) by treatment group . CONCLUSIONS The NETT experience demonstrates the effectiveness of pulmonary rehabilitation in patients with severe emphysema who were treated in a national cross-section of programs . Pulmonary rehabilitation plays an important role in preparing and selecting patients for surgical interventions such as LVRS
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 .