Development Of Patient-Reported Outcomes (Pro) And Observer-Reported Outcomes (Obsro) Measures For Pediatric Ulcerative Colitis: Concept Elicitation Findings

Abstract

surgery occurred a mean of 4.2±2.5 years ago. Based on the HADS, 31% and 16% of patients had clinically meaningful anxiety and depression, respectively. Depression was significantly associated with poorer totaI IBDQ scores (p<0.0001) and higher BIQ scores (p<0.0001). Females are 2.15 times more likely to have anxiety than males (OR 2.15, 95% CI 1.19-3.88). Other factors associated with anxiety include loss of work productivity (OR 1.39, 95% CI 1.18-1.64) and poorer body image (OR 1.12, 95% CI 1.04-1.20). CONCLUSIONS: The findings from this multi-national study provide insight on important factors to inform patientphysician communications both prior to and post-colectomy.

Can We Use Social Media to Support Content Validity of Patient-Reported Outcome Instruments in Medical Product Development?

“…In a comparison of semi-structured interviews with blogs for purposes of PRO development, Acaster and Wild [12] reported a high degree of convergence about symptoms experienced by women with menopausal hot flashes, with no major discrepancies in themes elicited between the two methods. In a study eliciting concepts among children from ulcerative colitis, Yen et al [13] used blogs to substantiate concepts identified through traditional interviews and found these data to be supportive. This area is still developing, however, and the most recent ISPOR PRO Good Practices Task Force guidance makes no mention of data gathered online [14].…”