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 .
Panax ginseng C.A Meyer root extract for moderate Chronic Obstructive Pulmonary Disease (COPD): study protocol for a randomised controlled trial
Background Chronic obstructive pulmonary disease ( COPD ) impairs quality of life and leads to premature mortality . COPD sufferers experience progressive deterioration of lung function and decreased ability to undertake day-to-day activities . Ginseng has been used for thous and s of years in Chinese medicine for respiratory symptoms . Several controlled clinical trials using ginseng for COPD have shown promising clinical effect , however these studies were generally small and with some potential bias , prompting the need for rigorously design ed studies . Aim The objective of this study is to evaluate the therapeutic value and safety profile of a st and ardised root extract of Panax ginseng C.A Meyer ( ginseng ) for symptomatic relief , with a focus on quality of life ( QoL ) improvements in individuals with moderate ( Stage II ) COPD FEV1/FVC < 0.7 and FEV1 50 % - 80 % predicted . Methods This paper describes the design of a r and omised , multi-centre , double-blind , placebo controlled , two-armed parallel clinical trial . Two trial sites in Melbourne Australia will proportionately r and omise a total of 168 participants to receive either ginseng capsule ( 100 mg ) or matching placebo twice daily for 24 weeks . The primary outcomes will be based on three vali date d QoL question naires , St Georges Respiratory Question naire ( SGRQ ) , Short Form Health Survey ( SF-36 ) and the COPD Assessment Test ( CAT ) . Secondary outcomes are based on lung function testing , relief medication usage and exacerbation frequency and severity . Safety endpoints include blood tests and adverse event reporting . Intention-to-treat will be applied to all data analyses . Discussion Findings from this study may lead to new therapeutic development for chronic respiratory diseases , particularly COPD . This protocol may also guide other investigators to develop quality herbal medicine clinical trials in the future . Trial registration Australia and New Zeal and Clinical Trials Register ( ANZCTR ) :
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 .