mobilePRO Solution for Patient Data Capture by Exco InTouch
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In collaboration with The University of Queensland, Exco InTouch conducted an evaluation of mobile phone technology for independent remote data capture, using the Western Ontario and McMaster Osteoarthritis (WOMAC®) NRS 3.1 Index. This study was designed to test the feasibility and effectiveness of using mobile phones to capture patient data in clinical trials, overcoming the challenges of traditional data capture methods.
Traditional paper-based methods of data capture can be costly and unsuitable due to potential compliance and validity concerns. Exco InTouch wanted to identify an alternative, regulatory compliant, standardized method that could be implemented across all clinical trials driving efficiencies and accelerating the data capture process, resulting in faster database lock. The company says that its mobilePRO can enable easy and reliable capture of real-time patient data, as well as increased patient safety by eliminating inaccuracies caused by spurious patient information or incomplete paper diaries.
The WOMAC index (a knee and hip osteoarthritis index, which accesses the three dimensions of the condition: pain, disability and joint stiffness) has been successfully deployed for 28 years. The index author, Professor Nicholas Bellamy MD, Director of the Centre of National Research on Disability and Rehabilitation Medicine (CONROD), University of Queensland, Australia, investigated developing a patient-acceptable format of WOMAC that can be delivered on a mobile phone.
In collaboration with CONROD, Exco InTouch developed the mobile version of the WOMAC index (m-WOMAC NRS3.1) and successfully validated in an osteoarthritis study that using mobilePRO is more powerful than traditional PRO techniques for patient data capture.
Professor Bellamy comments, “The pilot study revealed that m-WOMAC (WOMAC delivered using a mobile phone application) is a valid, reliable and responsive alternative to paper WOMAC (p-WOMAC). Based on overall preference ratings, 81% of the study participants were either indifferent or preferred the m-WOMAC application. Furthermore, there was no significant difference in ease of completion of the m-WOMAC or p-WOMAC for those with, compared to those without, concomitant hand osteoarthritis.”
With 70% of the world’s population owning one of the five billion mobile phones in circulation today, mobilePRO technology is accessible to all, crosses all age boundaries and can even be used by those subjects who have severe movement restrictions. The ubiquitous adoption of mobile phones around the world gives sponsors a distinct advantage in data collection.
When compared against other methods of patient reported outcomes (PROs), such as paper diaries, electronics diaries (PDAs) and Interactive Voice Response Systems (IVRS), mobile phone technology clearly provides distinct advantages. As well as being the most cost-effective of all electronic PRO solutions, key advantages include no requirement for specialist devices or end user training, no complex logistical and shipping issues and ease of combination with retention and compliance alerts, the company informs.
Exco InTouch offers three different mobilePRO solutions, linear text messaging, online mobile data capture and downloaded mobilePRO applications, giving users choice and flexibility to leverage different study protocols and budgets. mobilePRO technology can easily be used for studies using validated scales and assessments.
Professor Bellamy continues: “mobilePRO provides unique opportunities for using quantitative measurement in clinical practice and research.” Exco InTouch has worked with more than 500,000 patients in 60 countries, delivering more than 3 million texts, and has only needed to provide mobile phones to 1000 patients.
A recent paper, authored by Tim Davis and other members of the EDC Study Group*, has been published in The Journal of Clinical Epidemiology. Entitled “Osteoarthritis Index delivered by mobile phone (m-WOMAC) is valid, reliable, and responsive” this paper is available to view at: http://www.jclinepi.com/article/S0895-4356(10)00142-3/abstract.
At a recent webinar entitled “Using mobilePRO for Patient Data Capture with Validated Scales and Assessments”, a poll conducted among attendees revealed that 63% of responders would consider using mobilePRO to capture PRO data for validated scales and assessments, showing there are no longer barriers to the use of mobilePRO technology.