Electronic Data Capture (EDC) using cellular technology: Implications for clinical trials and practice, and preliminary experience with the m-Womac® Index in hip and knee OA patients

Abstract

Patient reported ratings indicated the m-WOMAC application performed well on all three phones. EDC provides unique opportunities for using quantitative measurement in both clinical practice and research.

Electronic data capture using the Womac® NRS 3.1 Index (m-Womac®): a pilot study of repeated independent remote data capture in OA

“…The importance of EDC as a technique for capturing patient-reported outcomes is different for the clinical research and clinical practice environments, and has been discussed in our previous publication in this journal (Bellamy et al 2009). In clinical research, from a regulatory perspective, the EDC device should comply with the FDA 21 CFR Part II Guideline (USFDA 2003), and be capable of capturing patient reported outcomes using an Index that follows FDA PRO Guidelines (USFDA 2006).…”

“…The numerical rating scale (NRS) version of the WOMAC Ò 3.1 Index was selected for this particular study, over the visual analog scaled version because of the micro-screen format of the mobile phone, and over the five-point Likert scaled version of the Index, because it provides more response options for patients (Bellamy et al 1999). The developmental history and technical specifications of the Exco InTouch EDC application for the WOMAC Ò NRS3.1 Index have previously been reported (Bellamy et al 2009). The WOMAC Ò Index is available in 85 language translations (Bellamy 2008) and the capability to potentially deliver the index in all of these languages was considered a key element in the development of the application.…”

“…An application, capable of remotely and electronically capturing WOMAC Ò Index data is potentially, therefore, very important, in both clinical research and clinical practice environments. We have previously reported in this journal, the results of a pilot study exploring the feasibility of capturing WOMAC Ò data on three different mobile phones (Bellamy et al 2009). We have subsequently successfully validated the m-WOMAC Ò application comparing its performance against the standard paper-based method of data capture using the WOMAC Ò NRS3.1 Index (Bellamy et al 2010).…”

Validation of the Chinese Western Ontario and McMaster Universities Osteoarthritis Index in Patients From Mainland China With Osteoarthritis of the Knee

“…These questions measure the amount of pain, degree of difficulty in completing various day-to-day activities, and stiffness experienced in the hip or knee, respectively, in the previous 48 hours. Usually subject self-administered, the index is amenable to electronic data capture formats (18)(19)(20).…”

Osteoarthritis Index delivered by mobile phone (m-WOMAC) is valid, reliable, and responsive

“…Exco InTouch, Harlow, UK on three different mobile phone brands [24]. The purpose of the present validation study was to evaluate the validity, reliability, and responsiveness of the m-WOMAC Index on Motorola V3 phones and extend prior experience on the time to completion and patient preference for the m-WOMAC application.…”