Abstract
Purpose :
Patient reported outcomes (PROs) are increasingly being used in ophthalmic research and clinical practice. Novel methods of PRO administration, such as on subjects’ own mobile smartphones, are also being utilized in clinical trials and have been shown to increase subject retention and engagement. In accordance with guidance issued by the International Society for Pharmacoeconomic Research (ISPOR) on electronic migration of paper PROs, we developed and validated electronic versions of two ophthalmic PROs to be administered via mobile smartphone platform in the MNK14084113 study (A Multicenter, Open-Label Study to Assess the Efficacy and Safety of Acthar® Gel in Subjects with Severe Keratitis).
Methods :
Paper versions of IDEEL and VAS were migrated to an electronic platform on mobile smartphones; the only changes were non-substantive updates to the instructions to reflect the change to a mobile interface. Cognitive interviews were performed in a group of participants (N=5) with self-reported dry eye to assess the equivalence of the paper and electronic versions of the Impact of Dry Eye Disease on Everyday Life (IDEEL) and a Visual Analog Scale for dry eye (VAS). As supportive evidence of equivalence, correlational analyses were also performed on data from a community cohort (N=42) who received two electronic versions of IDEEL and VAS: one through an app on their mobile devices and one using a common online survey platform.
Results :
The cognitive interview participants had similar scores in each domain of the IDEEL (Table 1); most differences in responses between the paper and mobile versions were attributed to recall of different symptomatic episodes during each administration of each version of the IDEEL. The community sample participants gave highly correlated responses on the two electronic versions of IDEEL and VAS (Table 2).
Conclusions :
Cognitive interviews and community sample analyses indicate equivalence between paper and electronic mobile versions of IDEEL and VAS that were developed for a severe keratitis study. Electronic PROs that are developed and validated on an electronic mobile platform represent a novel means of collecting PRO data in ophthalmic clinical trials.
This is a 2020 ARVO Annual Meeting abstract.