Patient self reporting for CR is trend expected to grow

Pain, quality of life, now AEs all collected

As clinical research continues to show the benefit of using patient self-reporting, investigators and clinical trial sites should expect to see this practice expanding and improving.

As one recent study shows, patient self-reporting is not necessarily a substitute for clinical reports, but it can enhance and improve the overall data collected.

Investigators enrolled 163 lung cancer patients and their clinicians, asking them to independently report on the adverse symptoms of fatigue, pain, nausea, vomiting, diarrhea, and constipation.1

The study found that patients tended to report worse severity and incidence of symptoms than clinicians, and patients tend to report adverse symptoms earlier in the course of their care. This suggests that drug labels that are based solely on clinician reports are underestimating the frequency and severity of AEs as compared with patients' perspective.1

This difference was due to clinicians being more attuned to patients' trajectories to major disease benchmarks, while patient reporting better reflected real-time suffering, the study shows.

The study's authors concluded that the perspectives are complementary and both should be included in clinical trial results.1

When clinical trial investigators begin to ask patients routinely for information about adverse events, they'll be following a trend in recent years that is shifting focus to patient self-reports, notes Ethan M. Basch, MD, a medical oncologist with Memorial Sloan-Kettering Cancer Center in New York, NY.

For example, investigators previously used physicians' reports when collecting information about patients' pain.

"That is not the case anymore," Basch says. "Now we look only at what the patient reports, and the same is true with the quality of life reports, where the gold standard is the patient's point of view."

One day, researchers might routinely ask patients about their adverse events.

"This paper suggests the clinician's view also provides useful information," Basch says.

The National Cancer Institute (NCI) has sponsored an initiative that would have a standardized item bank of adverse symptom questions that could be used in clinical trials, Basch says.

"The first step is to institute a questionnaire administration approach so patients could answer toxicity questions on a regular basis at clinic visits or between visits, either electronically or on paper," he explains.

A second step would be to administer symptom questions used in phase II studies to get a sense of specific adverse symptoms in a particular population, he adds.

"There would be broad screening for a lot of items in phase II, and then more in-depth screening about specific items in phase III and post-marketing research," Basch says.

A shared model of toxicity reporting could be developed, he adds.

"I suspect the ultimate model that will be developed is patient self-reported information that is then relayed to clinicians and investigators," he says. "And the final report of toxicities for documentation and regulatory purposes will be filed by the clinician with the benefit of the patient's perspective."

Reference

  1. Basch E, Jia X, Heller G, et al. Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes. JNCI. 2009;101:1-9.