What if really useful electronic tools for comprehensively tracking pain were available, but neither physicians nor patients could be persuaded to use them?
Technology is becoming a more important part of pain medicine, ushering in changes great and small, including enabling more advanced alternatives to the paper-based pain diaries that have long been recommended for pain management. But what if really useful electronic tools for comprehensively tracking pain were available, but neither physicians nor patients could be persuaded to use them?
In the beginning, there was paper and pencil. And the patients who suffered from various forms of chronic pain used these tools to record their experiences in pain diaries. They documented when they experienced pain, its severity, and the activities they were engaged in when the pain surfaced. Their doctors reviewed this information during regular office visits, and treatment regimens were adjusted accordingly. It was a very good system, but it was not without its flaws.
“There’s pretty good compliance with paper diaries, but it’s hard for patients to carry them around all day,” says Ruben Kalra, MD, MBA, partner at Pain Medicine Consultants, which has offices in Novato, Walnut Creek, and San Ramon, CA. “The biggest problem is parking lot compliance—patients in the physician office parking lot back-fill their diaries, and that ends up not being helpful for anyone. They’re essentially filling in entries just to make sure the physician is happy, and that may not be a true reflection of their pain ratings.”
Electronic diaries offer significant benefits over the paper-based versions. However, their use to date has largely been limited to clinical and instrument development and validation studies.
Robert Jamison, PhD, assistant professor of anesthesia and psychiatry, Harvard Medical School, and psychologist, Brigham and Women’s Hospital’s Pain Management Center, Boston, is a leading figure in the study of electronic pain diary use and effectiveness. Usage is expanding, he says, citing several private firms and pharmaceutical companies that have conducted research in this area. The key question is: How do you come up with a software program to help monitor pain for people with chronic pain? “It’s still rather new work,” says Jamison, “and there’s certainly a lot to be learned. Implementing it, as with all things, will be a challenge.”
Cost is one of the key issues, at least where PDA-based electronic diaries are concerned. The upfront cost can run several hundred dollars, which is not currently reimbursed by insurance. And total expenses associated with keeping an electronic pain diary extend beyond the cost of the device to include the cost of the programming and system validation testing.
Lisa Marceau, MPH, vice president of media and communications for New England Research Institutes, says an even bigger issue is having good information. “There’s a need for some really good effectiveness studies to know that electronic pain diaries are working and doing something that’s helpful for the clinician in terms of diagnosis management that will enable them to be more efficient rather than just adding tasks to an already busy day,” says Marceau, noting that studies have already demonstrated that data quality from electronic diary tracking is as good as if not better than data collected with paper-based diaries. “The question is, if we’re looking at the electronic piece of diary tracking, what is the real benefit?”
When Jamison talks about the benefits of electronic pain diaries versus paper-based records, he emphasizes the idea of ecological momentary assessment, which refers to a repeated sampling of subjects’ current behaviors and experiences in real time, in subjects’ natural environments. In other words, it’s better to assess how patients are doing right now with their pain in their regular environment versus returning to the doctor’s office a month later and attempting to reconstruct events since their previous visit. The reason for this is simple: people have a hard time remembering the day-to-day particulars of a condition they live and struggle with every day.
“If I ask you how many headaches you have had in the past two months, you could take your best guess,” says Jamison. “But your memory might not be as accurate as if you had kept a diary over those two months. With pain, it’s a subjective experience, and it varies both day to day and hour to hour.”
Therein lies the advantage of electronic pain diaries. They’re time-stamped, so the pain information must be entered in real time— promoting greater accuracy and providing context—which makes it more valuable to both patient and physician. “With accurate data, I can tailor a patient’s treatment plan,” says Kalra. “Maybe we had been focusing on medication to reduce the pain, but we find that stress is a trigger. We can now focus on reducing a patient’s stress, maybe through some relaxation exercises, and allow them to take better control of their pain.”
The benefits of electronic pain diaries are not exclusive to PDA-based tools. Peggy Moloney, RN, PhD, ANP, associate professor at the Byrdine F. Lewis School of Nursing, Georgia State University in Atlanta, has conducted numerous studies of women with migraine headaches in which the study participants kept online pain diaries (http://chhs.gsu.edu/nursing/1730.html). “We had as good or better completion rates as people using paper diaries,” says Moloney. “Our rates were also probably about as good as people using PDA-based diaries. We were also able to send participants reminders so they could complete a day if they forgot.”
Moloney is currently conducting a pilot project that gathers baseline data, and then follows up with Internet-based educational intervention modules that women will be able to read following the first two months of data collection. “With women, a lot of migraines are menstrual-related, so you can’t get very good information about headaches that are related to somebody’s period with just two weeks of data,” says Moloney.
Validating the tools
Sonya Eremenco, MA, is an electronic patient-reported outcomes (ePRO) systems manager for United Biosource Corporation, a pharmaceutical services organization. Working in the company’s healthcare analytics division, Eremenco oversees instrument development and validation to see if certain tools work before they’re used in clinical trials or implemented in a medical practice.
“It sounds simple, but sometimes pain diaries can get very detailed, using different adjectives to describe the pain at different times of the day, and the different degrees of pain severity,” says Eremenco. “With validation studies, we’re assessing whether the questions are measuring what they’re intended to measure.”
And that can get complicated. For example, a patient could be monitored during treatment to make sure his or her regimen is keeping the pain under control. Or, a patient who is not currently being treated for pain could be monitored to see if treatment is needed. As such, the information-gathering questions asked by the diaries need to be tailored to the specific purpose and eventual use of that data.
For example, Kalra explains that it’s not enough merely to know a patient’s pain score throughout the day. In order to provide effective treatment, physicians must also understand how that score relates to the patient’s activity at a particular time of day, as well as the patient’s mood and use of medication. A patient with rheumatoid arthritis, which is generally more severe in the morning, might require more medication early in the day versus someone with osteoarthritis, which tends to be worse later in the day. “[Having the correct data] can help elucidate what might be triggering a patient’s pain,” says Kalra. “Severe pain later in the day, such as after working, might just require a change in daily lifestyle habits.”
Perception of pain from a patient’s perspective, says Marceau, is one of the next big hurdles in better understanding and treating chronic pain. “Using diaries helps patients better understand where they are in the pain process; the psychological aspects of it,” she explains. “Is it helping patients understand their pain better by being able to see it over time?”
Despite the apparent advantages of electronic pain diaries over paper-based records, that value is merely theoretical if the data collected is not utilized by providers. That, says Jamison, became crystal clear when reviewing the results of a recently completed study.
In a randomized trial of 160 people who had back pain, half of the participants were given electronic diaries to monitor their pain for 10 months, and the other half used paper diaries. Those with the electronic diaries received feedback on the spot about their progress. The electronic diaries created charts that plotted out patients’ pain, correlating it with their mood and activity, and how well their medication was working. Participants took these charts with them to doctor visits (the doctor was also sent this information directly by the patient’s electronic medical record). The hypothesis, recalls Jamison, was simple: providing people with electronic diary data accompanied by feedback will improve their care. “We were absolutely sure it would, but the fact of the matter was that there wasn’t any difference,” says Jamison. “And there wasn’t any difference between people using electronic diaries and those using the paper diaries, both in terms of treatment satisfaction and how much they benefited.”
All patients felt that keeping a diary was a good thing because it made them more aware of how they were doing. They thought it was useful to have some feedback. But the most sobering thing about the study results was that in the follow-up interview with the participants, Jamison and his colleagues learned that despite its availability, doctors didn’t use the information—they rarely asked their patients about the charts. Even the patients seldom made a point of referencing the charts with their physician. “That underscores the fact that you can have the best program ever out there, generating useful information, but if people don’t want to accept it or change their practice and use it, nothing will get done,” Jamison says.
Jamison is the first to admit that there are still many aspects of electronic pain diaries that need to be fine-tuned. For example, there are times when portable PDA-based devices don’t work as they should, or are misplaced by patients. Other times, patients don’t hear the “beep” that prompts them for a diary entry. And even though computer use is widespread, a significant percentage of the population does not have regular access to a computer.
“It’s not all wonderful, new, and exciting,” he says. “There are still situations for some people in which paper diaries could be just as effective as electronic versions. But having said that, I think there’s great potential for the future.”
That future, says Kalra, should see pain diary features on cell phones. The function would allow real-time uptake of information to a database that doctors could easily review. “In five or 10 years, if I’m a patient with pain, I will be able to automatically upload my diary to my computer, the doctor can see it flagged in his or her e-mail, and that would alert the physician to contact the patient. It’s thinking a little bit ahead, but I think that’s the direction we’re heading.”
Actually, according to Eremenco, that day is a lot closer than five years off. She explains that several PDA manufacturers are involved in clinical trials using smart phones, such as an iPhone or Blackberry, that have Web-based capabilities. One company in the United Kingdom is even working on programming for common, everyday cell phones, and recently began using them in clinical trials. “That’s the direction,” she says. “Most phones already have electronic diary capabilities, and they’re convenient because they’re something people use every day.”
Ed Rabinowitz is a veteran healthcare journalist based in Bangor, PA.