Last week we hosted a webinar with Ethan Basch, MD, MSc, titled “Patient-Reported Outcomes: Why They Matter”. This post is intended to address the frequently asked questions that were submitted by participants and that, due to time ,weren’t answered during the webinar.
1. Is electronic patient reported outcome reporting better than that of standard way of reporting outcomes?
Electronic patient-reported outcomes (ePROs) is one of multiple ways to collect information about how patients feel and function during routine medical care. Other options include telephone calls with patients, conversations at clinic visits, and paper surveys. An advantage of electronic PROs is that questionnaires can be available to patients at their convenience via the device of their choice, the data are saved and available electronically, and alerts can be automatically triggered to clinicians in real time for concerning problems. For these reasons, ePROs have several appealing advantages over other approaches.
2. Which patient reported outcomes do you think are most important for more research to be conducted on?
There are several areas where research can be beneficial. First, it would be useful to know which PROs are most relevant to specific subgroups of patients, based in their illness or treatment(s). Second, we need research on how clinicians can best view PROs in the medical record, and how PROs are optimally integrated into clinical workflow. Figuring out how to ask about multiple issues briefly will be useful moving forward. Specifically, I think that research on items evaluating patient-reported “performance status” (e.g., ECOG and KPS) would be useful. Also, items evaluating decreased oral intake and dehydration would be helpful. Finally, research evaluating whether certain patient-level variables affect responses in real world contexts would be beneficial.
3. What are your views on active monitoring for vital signs using sensors and wearables? Do you think these can further improve patient care?
I think there are exciting opportunities to integrate wearable devices and biometric monitoring into clinical care, and this information is complementary to PROs. There is ongoing research in this area. As an oncologist, I would find it useful to have information about my patients’ levels of activity and sleep, and possibly other information like heart rate, depending on the context. Investigators like Dr. Bill Wood and Dr. Antonia Bennett are actively studying the use of wearables with PROs and their work is promising — showing the data are clinically meaningful, complementary, and feasible to collect.
4. In your study, you integrated severity & functional impact into one question. The latest PRO-CTCAE separates these two aspects. Is one approach better than the other?
For clinical trials I prefer to separate the domains of severity, frequency, and interference with activities. When we developed the PRO-CTCAE for the NCI, we took this approach. But clinical care, where we want to be as brief as possible, the balance between detail and parsimony is less clear to me. In our ongoing national study of PROs in routine care, the PRO-TECT trial, we are using selected PRO-CTCAE items that spilt up the domains, but then we retrieve single summary score for each symptom for the clinician.
5. Was the patient communication limited to weekly surveys or was there a “hot line” as well to report urgent or extreme symptoms? If not hot line, would you think the addition of one might further increase the benefit of ePRO?
In our prior STAR study, patients received a weekly email remainder to self report, but could log in any time they wanted to self-report. They carried a wallet card with login information to make this easy. I like this approach, as it allows consistent access to the system.
6. Did you have to have a study coordinator sit down with the “non-computer” users to give them more of a demo and support them? Or what was the process for this?
We used a standard training process where a staff member sat down to train patients to use the system. Patients without prior experience needed a bit more time for computer fundamentals, and we adjusted to the needs of each patient. Often there were family members or caregivers there who helped such patients and we often trained them too, with permission of the patient.
7. How often did computer-inexperienced patients in your trial engage with symptom reporting? Did they only do it at office visits, since by definition they did NOT have regular access to a computer? Very curious for the answer to this question as it might provide some visibility into how important “dose” is with respect to proactive symptom monitoring.
In general, computer inexperienced patients only reported at their clinic visits, although they could also report remotely if they gained access to a computer, for example through a family member or job. That said, most only reported at visits. Nonetheless, they had substantial clinical benefits. This suggests that reporting from clinic alone carries benefits. One hypothesis is that people without substantial prior computer or email experience might also have less developed communication skills — thus, any intervention to improve communication can yield particular benefits in this group. Our feeling is that there are benefits both to reporting in clinic, and between visits. The former improves awareness of problems at the point of care, and the latter enhances remote monitoring when patients are otherwise often out of contact with the care team.
