Patient-centered outcomes studies needed in pain management

PCORI Executive Director Joe B. Selby, MD, MPH, said his organization is pursuing outcomes studies in pain management. "The goal of our work is to determine which of the many healthcare options available to chronic pain patients and those who care for them work best in particular circumstances. We do this through patient-centered outcomes research that addresses questions and concerns most relevant to patients. We involve patients, caregivers, clinicians, and other healthcare stakeholders, along with researchers, throughout the process," Selby explained.

Selby added that PCORI is the largest single research funder that has clinical effectiveness research (CER) as its main focus, and incorporates patients and other stakeholders throughout the process more consistently and intensively than other clinical research funding organizations.

PCOR is a relatively new research field that considers patients' needs and preferences and focuses on outcomes most important to them. PCOR findings can help patients and other healthcare stakeholders, such as caregivers, clinicians, insurers, policymakers and others, make better-informed decisions about their health and healthcare options.

"By including patients and other stakeholder perspectives throughout the research process, PCOR is more likely to address potential barriers to implementation and lead to healthcare strategies that will achieve desired health outcomes," said Selby.

CER is a field of research designed to compare the effectiveness of two or more interventions or approaches to health care, examining their risks and benefits. The direct comparison of two or more interventions distinguishes CER from studies to explore outcomes related to one intervention alone. CER can not only validate a particular intervention but also identify which of available treatments best meet the needs of a given population.

"At PCORI, we are looking for pain research opportunities focused on approaches known to be efficacious but not adequately compared in previous studies. We particularly encourage randomized controlled trials that are conducted in typical clinical populations and address outcomes important to patients," Selby said.

PCORI is evaluating 22 pain and substance abuse "high priority" topics for potential studies. They include treatment options for people with opioid substance abuse, strategies for preventing the progression of episodic back pain into chronic back pain, treatment strategies for adult patients with migraine headache, and integration of mental and behavioral health services into the primary care of the general population.

Selby noted that improving existing PCOR and CER methods will benefit patients, caregivers, and clinicians in making healthcare decisions, researchers planning investigations, and policymakers weighing the value of different approaches to care.

"Understanding how a study was designed and conducted is critically important to determining the usefulness of the findings that result. To be trustworthy, findings must be based on valid, rigorous, patient-centered methods," he said.