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2. Harms and Adverse Events
a. In patients with chronic pain, what are the risks of opioids versus placebo or no opioid on: (1) opioid use disorder, abuse, or misuse; (2) overdose (intentional and unintentional); and (3) other harms, including gastrointestinal-related harms, falls, fractures, motor vehicle accidents, endocrinological harms, infections, cardiovascular events, cognitive harms, and psychological harms (e.g., depression)?
b. How do harms vary depending on: (1) the specific type or cause of pain (e.g., neuropathic, musculoskeletal [including low back pain], visceral pain, fibromyalgia, sickle cell disease, inflammatory pain, headache disorders, and degree of nociplasticity); (2) patient demographics; (3) patient comorbidities (including past or current opioid use disorder or at high risk for opioid use disorder); (4) the dose of opioids used and duration of therapy; (5) the mechanism of action of opioids used (e.g., pure opioid agonists, partial opioid agonists such as buprenorphine, or drugs with opioid and nonopioid mechanisms of action such as tramadol and tapentadol); (6) use of sedative hypnotics; (7) use of gabapentinoids; (8) use of cannabis?
c. In patients with chronic pain, what are the comparative risks of opioids versus nonopioid therapies on: (1) opioid use disorder, abuse, or misuse; (2) overdose (intentional and unintentional); and (3) other harms, including gastrointestinal-related harms, falls, fractures, motor vehicle accidents, endocrinological harms, infections, cardiovascular events, cognitive harms, and mental health harms (e.g., depression)?
d. In patients with chronic pain, what are the comparative risks of opioids plus nonopioid interventions (pharmacologic or nonpharmacologic, including cannabis) versus opioids or nonopioid interventions alone on: (1) opioid use disorder, abuse, or misuse; (2) overdose (intentional and unintentional); and (3) other harms, including gastrointestinal-related harms, falls, fractures, motor vehicle accidents, endocrinological harms, infections, cardiovascular events, cognitive harms, and mental health harms (e.g., depression)?