By Deborah Borfitz

July 7, 2008 | Electronic patient diaries, relative to the paper variety, improve patient compliance by a factor of three, according to research recently released by Waltham, MA-based CRF Inc. The finding emerged from a review of clinical trials involving more than 30,000 subjects across 23 different indications from 42 countries.

Perhaps the most intriguing result was India’s 97.4 percent compliance rate, the highest among nations. The reason may be India’s rule-based culture coupled with its highly qualified study monitors and investigators, theorizes Rachael King, CRF’s vice president of European and Asian operations. Other authority-oriented countries, such as Russia, Poland, and Hungary, demonstrated compliance over 90 percent. In Mexico and Argentina, by contrast, compliance was around 75 percent, “perhaps reflecting different priorities in life and cultural differences. Even at 75 percent, compliance is still far higher than using traditional paper methods.”

If patient compliance within a single study is differentially poor in one country versus all others, an e-diary’s design is not likely the issue, says King. “Perhaps there are issues with the translations, or patients were not trained properly, or the demands in their lives were different. There’s rarely one answer. The interplay of the various factors affecting compliance is complex. Training of site users and monitors is critical as it is their responsibility to train and motivate subjects to complete their diaries,” she adds.

Compliance among the elderly (91.9 percent) was higher than for either children (91.1 percent) or other adults (88.6 percent), says King, probably because they tend to be “more rule-based” and have less busy lives. This contradicts the popularly held belief that trials making use of e-dairies have lower levels of compliance among elderly patients who cannot “get to grips” with the technology.

American subjects, with their 88.9 percent compliance rate, are twenty-third in the list of most compliant subjects. Their position is probably not because they’re techno-phobic, says King, “but because they’re more apt to ask, ‘Why should I?’ It’s part of their education to question things.”

The analysis also showed that males were on average 13 percent less compliant than females. The gender difference in compliance is one of the study’s softer findings, says King. It emerged from relatively large female-only studies and a small sampling of male-only trials, so other factors could be easily be having an influence. Gender wasn’t determinable in mixed trials, making a “direct comparison” impossible at this stage. “There is an impression that women are more compliant than men, but we will test this in future analyses using data from mixed-gender trials.”

The compliance rate for children could be a reflection of caretakers fulfilling their role as parents, says King. “There’s also fairly high compliance with teenagers, possibly because an e-diary is more ‘cool’ to fill in than a paper diary, and it’s private. Privacy is a big factor with all age and gender groups, as it doesn’t label them with a disease condition or make them stand out.” Similarly, the discreet nature of e-diaries improves compliance in general health studies, including those of men with erectile dysfunction.

By therapeutic category, trials of vaccines and treatments for overactive bladder showed the greatest level of compliance, says King. Among patients with back pain, breakthrough pain, and migraines, compliance tended to be lower because of the difficulty in meeting diary demands in the midst of a pain episode. CRF assists sponsors with protocol design so that patients can opt out of recording pain relief at the merely “nice to have” time points. “We can put in different levels of alerts and alarms for the critical ones…to make it as easy as possible to comply and to help guarantee collection of the most important data.”

The trials examined in the study all used the TrialMax solution of CRF. But any electronic tool that does “anywhere near a decent job” should be able to greatly improve the usual compliance return of paper-based trials, which according to various studies is approximately 30 percent, says King. Across all study phases, CRF boasts a 90 percent compliance rate. 

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