Cell Phones and EDC Aid in Patient Outcome Reporting

Pharmaceutical Commerce, Pharmaceutical Commerce - January/February 2009,

Researchers find comparable effectiveness of self-reported outcomes via cell phones and paper questionnaires among osteoarthritis sufferers.

Both within and outside the clinic, the importance of patient outcome data is on the rise.

So too is the need to efficiently collect such data from far-flung patients, using products

on the market today. “Health outcome and registry programs now have as much to do

with safety as with product efficacy and consumer satisfaction,” says Tim Davis, CEO at

healthcare communication solutions provider Exco InTouch (Harlow, UK).

Following a successful pilot trial, the company has begun a full study of cell phone

electronic data capture (EDC) technology among osteoarthritis sufferers. EDC promises

clinical trial efficiencies and savings: it can streamline data collection and storage for

researchers, while using a technology familiar and friendly to most clinical trial subjects.

The goal of Exco’s pilot study, according to Davis, was to compare cell phones to

determine which would be most appropriate to the patient demographic. The full study,

now underway, will compare the effectiveness of patient self-reported outcome

questionnaires completed on paper with those completed via a mobile phone using the

Western Ontario and McMaster Osteoarthritis (WOMAC) NRS 3.1 index. The index is

validated for assessing hip and knee osteoarthritis. It consists of 24 self-assessment

questions that address pain, disability, and joint stiffness.

The pilot study involved 12 patients. Each of the patients—ten of whom also have hand

osteoarthritis—completed three EDC questionnaires on a cell phone using m-WOMAC,

Exco’s electronic version of the WOMAC index. WOMAC questions were sent to

patients’ phones via text message and patients were prompted to respond. Completion

time was recorded and the method was judged convenient and efficient, according to

Exco. Initial data suggest that m-WOMAC is comparable to the traditional paper-based

version of the questionnaire.

Researchers selected one phone from each of the three major international brands: the

Nokia 6300, Samsung A711, and Motorola V3. The Motorola phone was “slightly

favored” by subjects over the others because of its larger screen and buttons, according to researchers. Standard cell phone technology, according to Exco, is currently being used by hundreds of thousands of patients in more than 70 countries, delivered in the local

language and compliant with HIPAA regulations, FDA CFR 21 Part 11, and electronic

communication privacy directives.

The initial study is highlighted in Exco’s

technical poster

, Electronic Data Capture Using

WOMAC NRS 3.1 Index: a Pilot Study of Cellular Technology in OA. Recruitment for the

full trial is underway.