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Chronic low back pain is a leading cause of disability and reduced quality of life for nearly 100 million individuals in the United States. Approximately 5 to 10 percent of these individuals are prescribed opioids for treating their chronic low back pain. Limited data exists on the long-term efficacy of opioid treatment while much concern exists regarding the harm they can do to a person. Despite medication treatment patients still suffer from inadequate pain relief, impaired function, and quality of life.

This study sought to compare the long-term effectiveness of two types of alternative therapy approaches - mindfulness based therapy (MBT) and cognitive behavioral therapy (CBT) - for treating chronic low back pain especially those being treated by opioids.

INtegrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE) was a pragmatic randomized trial conducted from 2019 to 2023 with adults receiving chronic opioid therapy (COT) of at least 20 morphine milligram equivalents (MME) daily for chronic noncancer pain (CNCP). Participants were recruited from primary care and specialty pain clinics at three academic health centers in North Carolina and Tennessee. The study compared the effectiveness of the two behavioral interventions, 1) shared decision making (SDM) versus 2) motivational interviewing plus cognitive behavioral therapy for chronic pain (MI+CBT), on change in opioid dose, physical function, and pain interference. INSPIRE combined data from electronic health records (EHR) on opioid dose from baseline to 18 months and comorbidities with participant survey data at baseline, 6, and 12 months on the following topics:

• physical function,
• pain interference,
• pain intensity,
• anxiety,
• depression,
• pain severity,
• discontinuation of opioids,
• intent to reduce opioids,
• opioid use relative to baseline,
• adverse events,
• demographics,
• health insurance coverage,
• health literacy,
• patient-centered communication, and
• types of pain treatment used.

The collection includes three analysis datasets:

1. Adverse Events Dataset - one record per subject per adverse event
2. Opioid Prescriptions Dataset (post-processed opioid prescriptions used to derive the study's primary outcome) - one record per subject per opioid prescription
3. Outcomes Dataset (contains all of the study's demographics, primary, secondary, exploratory, and subgroup analysis variables) - one record per subject per timepoint

The Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) Study was a 12-month pragmatic randomized comparative effectiveness trial. The target population was primary care patients (n=820) at ten sites within the United States Department of Veterans Affairs (VA) Health Care System with moderate to severe pain despite treatment with moderate or high-dose long-term opioid treatment (LTOT). The study's primary aim was to compare integrated pain team (IPT) versus pharmacist telecare collaborative management (TCM) for improving pain and reducing opioid use among patients with chronic pain prescribed LTOT. In TCM, a lower-intensity intervention, a clinical pharmacist provides care management, structured symptom monitoring, and pain medication optimization. In IPT, a higher-intensity intervention, an interdisciplinary clinician team delivers care using a multi-modal approach to target biopsychosocial contributors to pain and disability with emphasis on non-drug therapies and behavioral activation sessions.

All participants were randomized to receive either IPT or TCM interventions for 12 months. Common elements of both interventions included individualized pain care and opioid taper recommendations tailored to patient preferences and treatment goals. Outcomes were assessed every three months and the primary time point for comparisons was 12 months. The primary outcome was pain, assessed with the Brief Pain Inventory (BPI) total score, with secondary outcomes as opioid daily dose and quality of life measures.

The main objective of this pragmatic randomized clinical trial (PCT) is to identify the optimal dose of aspirin for secondary prevention in atherosclerotic cardiovascular disease (ASCVD). A total of 15,076 high-risk patients with a history of a myocardial infarction (MI) or documented ASCVD were randomized in a 1:1 ratio to receive 81 mgs versus 325 mgs of aspirin every day. This trial addressed the following specific aims:

1. To compare the effectiveness of two doses of aspirin (81 mg and 325 mg) in reducing a composite of all-cause mortality and hospitalization for nonfatal MI, or nonfatal stroke, and the primary safety endpoint of major bleeding. Secondary endpoints include the components of the primary endpoint and hospitalization for transient ischemic attack, unstable angina, or coronary revascularization procedures.
2. To compare the effects of aspirin in selected subgroups of patients by sex, age, race, Internet users vs. non-users, and those with diabetes or advanced chronic kidney disease (CKD).
3. To develop and refine the infrastructure for PCORnet to conduct multiple comparative effectiveness trials in the future.
4. To explore biological mediators of heterogeneity of response to aspirin and of impact on clinical events.