October 2016, Vol. 5, No. 8

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Novel Techniques for Measuring and Assessing Symptoms

Palliative Care

Although symptom management is a cornerstone of high-quality cancer care, according to data presented at the 2016 Palliative Care in Oncology Symposium, clinicians often miss the incidence of patients’ symptoms or underestimate their magnitude. Patient-reported outcomes (PROs), which are direct reports from patients themselves about their symptoms, physical functioning, or health state, offer a solution for these oversights, said Ethan Basch, MD, MSc, but have not been used as a standard approach for symptom monitoring.

“Patient self-reporting improves clinical outcomes,” said Dr Basch, Director of Outcomes Research Program and Professor of Medicine and Public Health at the University of North Carolina-Chapel Hill. “There is a scientific rationale for integrating PROs into routine oncology care. In the future, electronic health record systems need to better integrate patient-reported outcomes for both data collection and data visualization for clinicians, and standardization is needed for outcomes, metrics, and implementation approaches.”

As Dr Basch explained, PROs have been the gold standard for measuring symptoms in cancer clinical research. In clinical trials, he said, patients commonly report their pain using questionnaires that are collected electronically, and a number of published studies have demonstrated that “integrating PROs into routine oncology practice improves communication between patient and providers, patient satisfaction, and health-related quality of life.”

Despite the mounting evidence, this approach has not been widely adopted, although a growing interest in this area has yielded several initiatives from a number of national stakeholder organizations. PROs have been implemented in the Oncology Care Model, for example, which is Medicare’s demonstration project.

Monitoring Symptoms with PROs: A Randomized Controlled Trial

Dr Basch reviewed results from a randomized controlled trial, published late last year, in which 766 patients receiving palliative chemotherapy for incurable or advanced metastatic cancer were randomly assigned to either a self-reporting system for PROs or standard of care. The intervention arm included 12 common symptoms that patients could report using the web. In addition, whenever a patient reported a severe or new symptom, an automated e-mail alert was sent to the clinical nurse involved in that patient’s care.

Feasibility results, said Dr Basch, showed durability of self-reporting over time. On average, 80% of patients eligible to self-report did so at any given time, and this lasted for up to 40 clinic visits or 3 years.

The automated alerts were also a success. Nurses responded with clinical actions to more than three-quarters of the automated alerts sent to them. These clinical actions mostly constituted telephone calls to patients for general advice about symptom management, but they also included referrals to the emergency department (ED) and to other providers. In very rare cases, as a result of these alerts, there was a chemotherapy dose modification or hold, said Dr Basch.

There was a significant improvement in quality of life from baseline to 6 months (34% improvement in the PRO arm vs 18% in standard of care) in patients using the PRO intervention compared with standard of care. Among patients self-reporting their symptoms, there was also a 41% reduction in ED admissions over a 1-year period, compared with 34% in patients receiving standard of care.

Time receiving chemotherapy also differed between arms, said Dr Basch, “presumably due to superior symptom management.” Patients engaged in systematic reporting of their systems received chemotherapy for 8.2 months versus only 6.3 months for standard of care.

Finally, patients receiving PROs had a longer median survival than those receiving standard of care (P = .03).

Research is ongoing in this area, said Dr Basch, but for providers interested in incorporating this approach in their practice today, he recommended downloading the “User’s Guide to Implementing Patient-Reported Outcomes Assessment in Clinical Practice,” created by the International Society for Quality of Life Research (www.isoqol.org).

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