Ethical Approaches for Accurate Patient-Reported Outcome Measures
Patient-reported outcome measures (PROMs) are the gold standard for researchers to monitor study participants’ physical and psychological symptoms, overall function, and quality of life.
“However, in some patients, such as older adults with dementia or other cognitive impairments, reporting of symptoms and function may require input from someone who knows and has closely observed the patient,” says Kurt Kroenke, MD, a research scientist at Regenstrief Institute in Indianapolis.
Kroenke and colleagues wanted to know if these “proxy reports” matched up with what patients reported. The researchers compared reports from 576 caregivers and older adults about quality of life and symptoms like pain, anxiety, and depression. (Learn more about this work here.) Patient and proxy reports tended to be in relatively good agreement, on average.
This suggests when researchers are comparing treatments in clinical trials, proxy reports might be a useful surrogate for patients whose self-report cannot be obtained or is unreliable. “Likewise, in quality improvement initiatives, proxy reporting might have a role when comparing groups of patients,” Kroenke says.
However, at the individual patient level, there was more variability in patient-proxy agreement. There was better agreement on physical functioning and pain than for psychological symptoms, such as depression and anxiety. Symptom severity was more likely to be underestimated when symptom severity was high, and more likely to be overestimated if the proxy was distressed. “Although this study was done in cognitively intact older adults, it may have implications in situations where the patients have problems reporting their symptoms, such as dementia or other brain disorders affecting cognition,” Kroenke adds.
In those cases, a proxy report is the default option and may be needed to guide symptom management (including palliative care). Based on the findings, research staff should consider the fact that if symptoms appear more severe, a caregiver’s proxy report might underestimate symptom severity. Conversely, high levels of caregiver distress might overestimate symptom severity. “In hospitalized patients with cognitive impairment, as well as those who for medical reasons cannot provide reports on their symptoms, management decisions should couple clinician observation with proxy input,” Kroenke advises.
Trust is a foundation of the physician-patient-proxy relationship. “Physicians should always provide truthful, straightforward information about the patient’s condition, treatment options, and prognosis,” says Robert S. Olick, JD, PhD, associate professor emeritus of bioethics and humanities at the State University of New York Upstate Medical University.
Patients and proxies must be honest about their worries, pain and suffering, and their wishes for care as life’s end approaches. “When patients and proxies disagree, the first question is whether the patient has capacity to make their own decisions,” Olick says.
Decisionally capable patients control their own healthcare decisions, and are the most reliable reporters of symptoms and pain. For patients who lack capacity, the proxy becomes the primary decision-maker. Even so, “both proxy and physician should continue to involve the patient in the decision-making process to the extent reasonable,” Olick advises.
This includes eliciting the patient’s report of symptoms and discomfort, along with his or her values and goals for care.
“First and foremost, decisions should be based on the patient’s previously expressed wishes — that is the proxy’s fiduciary duty,” Olick asserts. However, contemporary statements of incapacitated patients also matter. “Facilitating open communication serves to avoid misunderstandings, reveal real or perceived disagreements, and to address those disagreements when they arise,” Olick says.
When researchers are comparing treatments in clinical trials, proxy reports might be a useful surrogate for patients whose self-report cannot be obtained or is unreliable.
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