A Medical Device Daily

Personal health record (PHR) systems are being pushed as alternatives for maintaining ... well, personal health records – until the time that a comprehensive, portable electronic medical record is developed.

But can people actually use them, and do they result in improving the individual’s healthcare?

The Agency for Healthcare Research and Quality (AHRQ) has funded a study looking at these issues in terms of one of the nation’s leading chronic diseases, hypertension. The study will give hundreds of patients with hypertension an electronic PHR, enabling them to post their blood pressure, weight, even what they eat in their medical record and e-mail their physicians when needed. Patricia Sodomka, director of Patient and Family Centered Care at the Medical College of Georgia (Augusta), and senior VP for patient and family-centered care for MCG Health, is the principal investigator of the study, funded by a $1.2 million grant from AHRQ.

“From a chronic illness standpoint, the literature is pretty clear,” Sodomka said. “The more involved and engaged I am in managing my own illness, the better my outcome. It just makes common sense.” MCG researchers will work with hypertensive patients in the family medicine and internal medicine practices at MCGHealth to see if the PHR enhances patient involvement. Dr. Peggy Wagner, research director for the MCG Department of Family Medicine and co-investigator in the study, said, “Our first measure is patient activation; if having ready access to information about yourself and to your physician makes you more activated as a patient and if you are more activated, does it lower your blood pressure?”

The enrollers will use the IQHealth system, a PHR developed by Cerner (Kansas City, Missouri). The researchers aid that they will first do two “small” studies to acquire patient and physician feedback on how to make the device more patient-friendly. This will be followed by a year-long study of 720 patients with hypertension, in which half the participants will use the refined PHR, with the remainder receiving standard treatment.

Study participants don’t have to have a computer; study coordinators will help those who don’t find where they can use one. However, one of the many questions being asked is whether or not having a computer affects use of the electronic personal health record.
“Hypertension, which is so pervasive in our society, is a great model because lifestyle has such an impact and the outcomes are relatively easy to measure,” Wagner said. “The hypothesis clearly is, if you have this electronic personal health record that is used by a patient and his primary care doctor, that the patient will be more likely to bring his hypertension under control.” “Patient-care documentation systems today are dominantly in the hands of the providers and written from their perspective,” Sodomka said. “The shift is toward shared information systems with patients and families, where patients and families can put their own information in there, their observations, their tracking, documenting things that are important to them.”

Giving patients more responsibility and participation in their own healthcare, she said, “is a shift that is being made in healthcare, a huge shift and this study is part of that.”
The MCG Center for Patient and Family Centered Care also has received a $30,000 grant from the Institute for Healthcare Improvement/Robert Wood Johnson Foundation (Cambridge, Massachusetts) in 2005 to test the Cerner system, used under the brand name My HealthLink, in patients with multiple sclerosis.

The 12-month study found that patients liked having a secure electronic link to care givers and that the PHR is an effective tool in helping battle chronic disease.
Charlotte Weaver, VP and executive director for nursing research at Cerner, said, “At the end of the day, if you can deliver a personal health record that people will use, that delivers just tremendous value to our healthcare system as well as to individuals.”

The Institute for Family Centered Care (Bethesda, Maryland) is a partner in gathering input on the Cerner system from patients and physicians in diverse geographic locations with experience using other personal health records.

FDA seeking authority over generic biotech drugs

FDA officials on Monday said that the agency will seek authority from Congress to approve generic versions of biotechnology drugs, according to a report by CQ HealthBeat.

John Dyer, COO of the FDA, said that the agency is working on language for the legislative proposal. An aide said that FDA notified the House Energy and Commerce Committee that it would submit a proposal but no timeline was disclosed. FDA officials said the measure would “include necessary provisions to ensure the safety and effectiveness of these biologic products for patients” and call for a “predictable and public guidance process for licensing follow-on protein products.” In addition, the proposal would describe what types of data the agency would require for generic biotech drug applications and would specify what information would be required on product labels.

The draft proposal also would include “adequate intellectual property protections to preserve continued robust research into new and innovative lifesaving medications,” officials said.