In mid-September 2022, the United States Food and Drug Administration (FDA) held a webinar on Real-World Evidence (RWE), providing an overview of the FDA-funded clinical trial, “Real-World Data to Assess Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations.” The FDA acknowledged that there are many studies that report the efficacy of opioids for acute pain, but few address the ideal dose and duration of treatment for various types of pain.
Therefore, the Acute Pain Pathways study was launched to better understand the trajectories of pain and treatments experienced by a diverse group of patients who are prescribed an opioid analgesic for acute pain. Data from the clinical trial was intended to inform the FDA’s prescribing guidelines and involved no intervention and was instead intended to gather data about patients who are offered an opioid prescription, irrespective of whether they filled the prescription.
Molly Moore Jeffery, PhD, MPP, Principal Investigator of the Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation (CERSI) walked attendees through the study’s design and preliminary results. Dr. Jeffery noted that the study used Hugo software to collect data in four parts: (1) patient-reported outcome measures (PROM); (2) electronic health record data (EHR); (3) pharmacy data; and (4) personal digital device data (patients received a Fitbit activity tracker for data on steps and sleep).
Recruiting
As of the end of July 2022, almost 1500 patients were enrolled and enrollment is planned to end by the end of 2022. More than half of those enrolled were recruited in the emergency room. Interestingly, despite most opioid prescriptions coming from the primary care setting, primary care patients are difficult to recruit as they are generally chronic pain patients – not opioid naïve – and therefore are ineligible for the study.
Type of Pain
The different types of pain patients had that led to their involvement in the survey, varied, from 293 with dental pain, 230 with trauma/injury, 167 with musculoskeletal pain, 157 with OB pain, 95 with abdominal pain, 80 with kidney stone pain, 70 with skin pain, 55 with pain due to a procedure, and 63 with “other” pain. Additionally, there are 256 patients that are enrolled where the pain is unknown at this time, but it is expected that those patients will be better categorized after a review of data.
Regular Surveys
Study participants are responsible for completing surveys regularly, starting with the beginning of the study, where they responded to questions regarding demographics, pain/care, patient-reported outcome measures baseline, and medication beliefs. Patients also took daily surveys when in pain (considered not in pain after three days of reporting no pain) that measured pain severity, treatments, and relief. Patients also take weekly surveys when in pain about medication use and storage and patient-reported outcome measures. Finally, for regular surveys, patients take a monthly survey. When in pain, the monthly survey focuses on remailing pills and their sources, as well as patient-determined disease steps. When not in pain, the monthly survey asks patient-reported outcome measure questions.
At the end of a patient’s use of opioids, they were also sent a survey asking: why the participant used (and stopped), care satisfaction, pain resolution, pain medication misuse, and disposal of medication.
At the end of the study, patients were sent another survey the same as the end of opioid use, plus additional questions about their patient-reported outcome measures, storage, remaining pills, and any demographic updates/changes.
Current Status
The study is currently still completing enrollment and working with the survey data. Reviewers are starting to dig into the EHR and Fitbit data and looking to see how often opioids are prescribed versus how often (and how much) they are used.
So far, the study has found that opioid users received about 60% pain relief. Interestingly, non-opioid users also reported 60% pain relief. Non-pharmacological treatments resulted in a 49% pain relief.
The FDA and study authors will continue to delve through the data and continue to release relevant updates.