Chumbley 2002.

Methods	RCT Risk of Bias: Moderate Trial aim: To formulate and evaluate an information leaflet for patients using patient‐controlled analgesia (PCA).
Participants	100 patients with no former experience of using PCA were recruited on the day before having surgery. They were randomised to evaluate a patient information leaflet developed with consumer input (n = 50) compared to a leaflet developed by health professionals only (n = 50). Mean age: 48 years (21 to 85). The patients had undergone different types of surgery. Setting: 10 surgical wards. Country: UK.
Interventions	Type of process: Consumer involvement in developing of patient information material. A new patient information leaflet about PCA developed with input from patients (intervention) was compared to an old patient information leaflet developed by health professionals (control). The patient information which was included in the new leaflet was obtained via focus groups.
Outcomes	Main outcomes: Worries about using PCA; the clarify of information regarding PCA; knowledge of PCA.
Notes	This trial consisted of two parts. Consumer involvement in development of information took place in the first part (qualitative study). Seven focus groups were established to obtain consumer views on content and design of the leaflet.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate