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New grant focuses on pain, fatigue and other common, disabling, undertreated symptoms


INDIANAPOLIS — Symptoms like pain and fatigue account for 400 million appointments with physicians annually — 50 percent of all visits in the United States — but have received far less attention in research, training and, consequently, patient care than many diseases. A two-year, $670,000 grant from Patient Centered Outcomes Research Institute supports a new randomized controlled study of sleep problems, pain, anxiety, depression and energy/fatigue, known as the SPADE symptom pentad.

“These five symptoms are the bread and butter of primary care but have not received much attention from the research community or enough attention from clinicians,” said Regenstrief Institute investigator Kurt Kroenke, M.D., Indiana University School of Medicine Chancellor’s professor of medicine and Veterans Affairs Center for Health Information and Communication investigator. The principal investigator of the SPADE study, Dr. Kroenke is an internationally respected expert in medical symptoms. He is a former president of both the Society of General Internal Medicine and the Association of Clinical Research Training.

Dr. Kroenke will conduct a new study of 300 adult primary-care patients with one or more of the SPADE symptoms — the five most prevalent, chronic, disabling and undertreated symptoms in clinical practice. These symptoms occur frequently in most medical and mental disorders; patients often have more than one of these symptoms.

“Much of health care in the U.S. is focused on test results — lowering blood-pressure readings, getting A1C test score for diabetics into the normal range, bringing down cholesterol levels — but there are few quality improvement initiatives focused on symptoms,” Dr. Kroenke said. “We hope that the SPADE study will tell us whether symptom measures can be valuable in clinical practice and how patients will benefit in terms of improved sleep, less fatigue and more manageable pain.”

Some measurement tools for symptoms do exist, including the highly reliable PHQ-9 depression screening tool — known as the “blood pressure cuff” for depression — and the GAD-7 anxiety screener, both co-developed by Dr. Kroenke.

As Dr. Kroenke and colleagues investigate whether providing symptom scores to physicians improves patients’ symptoms, they will involve the dual perspectives of doctor and patient. The study will be conducted in IU Health and Eskenazi Health primary-care clinics that serve a wide range of patients from diverse socioeconomic and racial/ethnic backgrounds.

“With our SPADE study, we have the opportunity to learn more about how patients can help physicians treat symptoms as well as how doctors can improve the care they provide patients with these common, disabling, undertreated symptoms,” Dr. Kroenke said.

The Patient-Centered Outcomes Research Institute, which is funding the study, is a nonprofit, nongovernmental organization. Congress authorized the establishment of PCORI in the Patient Protection and Affordable Care Act of 2010.