Patient Advisory Committee for a Chronic Opioid Therapy Risk Reduction Evaluation: Engaging Diverse Patients.

BACKGROUND: Active patient engagement in research is critically important, but can be difficult in controversial areas where patients have conflicting perspectives. OBJECTIVES: In this Lesson's Learned report, we describe engagement of patients with divergent views in guiding a controlled interrupted time series evaluation of chronic opioid therapy risk reduction initiatives implemented by a large health plan. METHODS: A nine-person Patient Advisory Committee (PAC) advised the scientific team on the evaluation and reporting of results on diverse outcomes important to patients, including pain and function, opioid use disorder, overdose, motor vehicle accidents, and medically attended injuries. Patients were selected with varied perspectives on opioid prescribing for chronic pain. Multiple strategies facilitated PAC engagement: making room for personal experience; investing upfront in setting the stage for working together including an initial face to face meeting; clarifying shared values; and including individuals skilled in group process and collaboration. PAC meetings were organized separately from regular meetings of the scientific team. RESULTS: Shared values identified to guide the research were: Safety, respect, autonomy, compassion, knowledge and teamwork. PAC guidance altered key scientific decisions regarding assessment of patient outcomes, doctor-patient collaboration, and analytic approaches. CONCLUSIONS: Separate meetings of the PAC and scientific team enhanced opportunities for patients to influence the study design, analyses and interpretation of evaluation results. Convening a large group of patients with diverse perspectives and experiences was productive and influential in guiding the evaluation. Patient selection and building rapport allowed PAC members with divergent perspectives to work together effectively.

Opioids for low back pain.

Back pain affects most adults, causes disability for some, and is a common reason for seeking healthcare. In the United States, opioid prescription for low back pain has increased, and opioids are now the most commonly prescribed drug class. More than half of regular opioid users report back pain. Rates of opioid prescribing in the US and Canada are two to three times higher than in most European countries. The analgesic efficacy of opioids for acute back pain is inferred from evidence in other acute pain conditions. Opioids do not seem to expedite return to work in injured workers or improve functional outcomes of acute back pain in primary care. For chronic back pain, systematic reviews find scant evidence of efficacy. Randomized controlled trials have high dropout rates, brief duration (four months or less), and highly selected patients. Opioids seem to have short term analgesic efficacy for chronic back pain, but benefits for function are less clear. The magnitude of pain relief across chronic non-cancer pain conditions is about 30%. Given the brevity of randomized controlled trials, the long term effectiveness and safety of opioids are unknown. Loss of long term efficacy could result from drug tolerance and emergence of hyperalgesia. Complications of opioid use include addiction and overdose related mortality, which have risen in parallel with prescription rates. Common short term side effects are constipation, nausea, sedation, and increased risk of falls and fractures. Longer term side effects may include depression and sexual dysfunction. Screening for high risk patients, treatment agreements, and urine testing have not reduced overall rates of opioid prescribing, misuse, or overdose. Newer strategies for reducing risks include more selective prescription of opioids and lower doses; use of prescription monitoring programs; avoidance of co-prescription with sedative hypnotics; and reformulations that make drugs more difficult to snort, smoke, or inject.