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New technology results in more interest in patient-reported outcomes
Technology also can improve adherence
[Editor's note: This is the second part in a series about the opportunities, challenges, and benefits of electronic health records (EHRs) and technology used by and for research projects. In this issue we have stories about using electronic patient reported outcomes and the proven benefits of IT and EHRs.]
Patient-reported outcomes have well-known challenges that clinical trial investigators have long sought to overcome. Now it appears that electronic patient-reported outcomes (ePROs) are able to enhance data integrity in the process.
Paper-based patient reported outcomes invariably lead to patients forgetting to complete the forms or finishing them retrospectively or even prospectively.
So there is a growing movement to use ePROs to improve data and efficiency.
Also, results from clinical studies using this technology indicate an improvement in patient adherence.
"The industry is using electronic technology to make research more efficient and less costly," says Keith W. Wenzel, senior product director of ePRO for Perceptive Informatics based in Boston, MA.
An estimated 25% to 30% of all clinical trials use patient-reported outcomes, and approximately 1,500 to 2,000 studies have used ePRO, Wenzel says.
"The adoption rates for ePRO technology are still below 50% market saturation, but it's a growth area for the industry," he adds. "We're in the early stages of sponsors looking to implement ePRO solutions and understanding the full advantages these systems can bring to increasing the efficiency and productivity of clinical trials."
Electronic technology also is growing in popularity for use in improving trial participant adherence, experts note.
"The World Health Organization (WHO) estimates medical adherence at 50%," says Joseph C. Kvedar, MD, director of the Center for Connected Health at Partners Healthcare System Inc. in Boston, MA. Kvedar also is an associate professor of dermatology at Harvard Medical School in Boston.
There is a big gap between what clinicians and investigators tell patients to do and what they actually do, he says.
"One thing about the medical profession is that for about 2,000 years we thought if we instructed you as a patient to do something our job was done," Kvedar says. "You'd go off and do it because we as 'knowledge-workers'were kind enough to give you the knowledge to make you compliant."
In reality, people are fallible, and until fairly recently that has not been adequately addressed by clinicians and researchers.
There is growing recognition on the part of the research industry and regulatory agencies that technology might assist with research participant adherence and patient-reported outcomes.
"I think what is relevant here is that in February, 2006, the FDA [Food and Drug Administration] issued draft guidance on patient-reported outcomes," Wenzel says.
The FDA's guidance acknowledges that interactive voice response systems (IVRS) and other forms of electronic data collection can be used to ensure that patients make entries according to the study design and not just before clinic visits, he says.
The FDA's counterpart in Europe, the European Medicines Agency (EMEA), had addressed patient-reported, health-related quality of life a year earlier, he adds.
"Two of the major regulatory bodies in the world reinforced the importance of patient-reported data in clinical research," Wenzel says. "With ePRO, there is a level of data integrity that is not available in paper."
For instance, electronic reports can be documented at the precise time they are administered. So if a patient forgets to report his or her activity on Tuesday and puts in the information on Wednesday, the electronic report would note the Wednesday date.
Also, ePROs can be linked to electronic reminder tools that will prompt patients to make their reports at a particular time.
For clinical trials this level of data integrity is important.
"It's a critical element of what data are collected in clinical drug trials, which include EKGs, lab data, physician data and patient-reported data," Wenzel says.
"This is not limited to simple diary data," Wenzel says.
Sponsors are using ePRO in trials in a multitude of ways, he adds.
For instance, ePRO is being used to determine study eligibility.
"For instance, in an insomnia study, participants have to average less than six hours of sleep on five of seven nights, or in a depression study participants may have to have a certain level of depression," he explains. "These types of eligibility data can be collected electronically at the beginning of a trial."
When the insomnia trial begins, for instance, and data need to be captured each morning and evening, ePRO can assist in the form of an interactive voice response where the study participant calls into an automated line and answers questions at the specified times, he adds.
"In the morning, the participant would call in to report how many hours he slept, when he awoke, and what the quality of sleep was," Wenzel says. "In the evening, he would report on daily function, for example."
Opportunities after trials
When trials end, there are more opportunities to use ePRO.
"At the end of trials, regulatory authorities are always interested in safety data and want to know about the discontinuation of side effects," he says.
Investigators can use ePRO to answer various types of study follow-up questions, he adds.
While there are clinician-administered tools that can be used in measuring a person's mental state with regard to depression, for instance, the FDA has stated in draft guidance that it's concerned about the impact of clinician interpretation of recorded data. "So having patient-reported outcomes has the advantage of having no bias introduced by a third-party," he adds. "The patient answers questions about his/her mood and eating habits via telephone or hand-held electronic device, and so there is no bias introduced from a clinician in interpreting these data."
Also, certain data are only available from the patient, and these might include the level of pain, insomnia, post-traumatic stress disorder symptoms, and social anxiety disorder, Wenzel says.
Another advantage to ePRO is that it provides easy opportunities for routine reporting, he notes.
"For instance, sites monitor patients who are not being compliant, and overall patient compliance at one location can be compared with compliance at other sites, he explains.
The data collected can be used in metrics reporting to determine which sites were high performing, for example. In addition, just the act of compelling study participants to report their data might have a therapeutic effect, Wenzel says.
When research participants visit the study site for check-ups there is the potential for a nurse or study coordinator to note the patient's condition aloud, and this could impact the research physician's ratings, he explains.
"The computer is totally objective and won't make any interpretations," Wenzel adds. "What the patient says is recorded."
While one could argue that the act of calling in the information could have a therapeutic effect, this would also be true for writing down the information on paper, he notes. "The fact is ePRO is based on a patient's self-assessment, and no questions or comments by another human will positively or negatively affect the patient," he says.
Perhaps one of the benefits that will have a big impact on how quickly ePRO is adopted in the clinical trial industry is its potential for cost savings.
For instance, in Phase IV trials where there potentially are 10,000-plus subjects, clinical trial sponsors are challenged to collect data with integrity and cost-effectiveness, Wenzel says.
"So ePRO can be used to collect eligibility data through an automated screener for a particular disorder," he explains. "Then ePRO can be used to collect data every week."
This leveraging of technology to keep costs down in late-phase trials makes sense and probably would lead to better than average compliance, he adds.
"Many Phase II or Phase III trials have been reported to have 90% compliance with ePRO," Wenzel says.