Pain enrollees cite complex reasons
Patients do own risk-benefit calculation
People participating in pain research report having complex combinations of reasons for enrolling — part altruism, part seeking new treatments, part simply having their pain understood and taken seriously.
But pain researcher Ajay Wasan, MD, MSc, says that complexity doesn't mean patients don't understand the limitations of research and it doesn't mean they aren't giving truly informed consent.
"Patients are doing a risk-benefit calculation," says Wasan, an assistant professor of anesthesiology and psychiatry at Brigham and Women's Hospital and Harvard Medical School, Boston, MA. "It may not be the exact way the IRB or ethicists write about as disinterested altruists, but they're clearly following a systematic evaluation process that's reasonable and that balances their own self-interest with the interests of the researcher in doing a study."
He says the findings of his study, which were published in a recent issue of the journal Pain Medicine, should reassure IRBs that subjects are not suffering from therapeutic misconceptions when they enroll in pain studies.1
The survey was administered to 52 back-pain patients after they had participated in a randomized controlled trial of intravenous morphine and placebo. Ethnographic researcher Simone Taubenberger, PhD, of Johns Hopkins University, conducted 15- to 30-minute interviews, asking subjects about their reasons for participation, their interactions with the investigator and their perceptions of the risks and benefits of participation in the study. Bioethicist Walter M. Robinson, MD, MPH, of Dalhousie University in Halifax, Nova Scotia, also contributed to the article.
Wasan says their goal was to see if patients in pain studies had unrealistic expectations of the research. Unreasonable expectations can be a problem both in pain treatment and in research, he says.
"It can actually make patients' pain and disability worse, and they cope less, because they have expectations that someone can just take all their pain away," he says. "It's the same thing in a pain study. If they have unreasonable or uninformed expectations about what's going to happen and why they want to do the study and they're disappointed, they're just going to drop out."
Subjects first cite altruism
Wasan says that when asked, many subjects at first gave the more socially accepted answer of altruism, but as the conversation progressed, they revealed other reasons of self-interest that gave a more nuanced view of pain research participation.
For example, one patient said at first that she wanted to participate in the study because the research could benefit her and other patients. Asked later in the conversation whether she thought the study might make any difference in her care, she said that her main reason for participating was that she currently was taking Celebrex and had heard that it stops working over time.
"So I had been hoping that I'd be getting on the (leading edge) of some research that I could pursue — that would result in solutions for me personally down the line," the woman told the researcher.
Overall, while 60% of patients reported they had participated to contribute to research, 50% of the same group said they participated in order to seek pain relief and 44% to try a different drug. Other reasons stated included monetary compensation (19%), to be taken seriously and listened to (17%), to find a new doctor (12%), to learn about and access new treatments (10%), to get answers or a diagnosis (6%) and to seek a doctor despite being uninsured (2%).
Wasan says that in some cases, people who appeared to have understood the informed consent gave reasons for participating that at first glance wouldn't seem to make sense.
"If you ask them if they understand they're just going to get relief for a day or so, they'll say 'Yes, I understand that'," he says. "But then they'll say that even one day of relief is really important to them – it represents a big improvement in their chronic pain.
"They're still voicing an understanding of the study," Wasan says. "They're telling you everything that you would need for informed consent. Even if they have some self-interested reason which may not make any sense, it can still be informed consent. It's not necessarily a therapeutic misconception."
Ask about motivation
He says investigators may benefit from asking patients during the informed consent process why they want to enroll in a study, in order to make sure that they have an understanding of what it actually entails and to correct any misperceptions.
In fact, such a process can do a better job of giving informed consent than a long and cumbersome document can, Wasan says.
"By asking patients why do they want to do the study, and addressing if they have any unreasonable expectations, that is another way of obtaining informed consent that is truly more informed," Wasan says. "Because you're actually asking the question that the patient has a concern about, as opposed to theoretically addressing every possible issue in an extremely long document that's cumbersome and no one reads it anyway."
He says that the participants in his study also were asked about informed consent, and reported that they merely skimmed the document.
"People said what was more important were discussions with the principal investigator and trust in the institution," Wasan says. "Those factors gave them most of their information about the study as well as assessing the risk and benefits."
- Wasan AJ, Taubenberger SP, Robinson WM. Reasons for Participation in Pain Research: Can They Indicate a Lack of Informed Consent? Pain Med. 2008 Jul 24 E Pub.