Pain
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Although pain reduction is commonly the primary outcome in chronic pain clinical trials, physical functioning is also important. A challenge in designing chronic pain trials to determine efficacy and effectiveness of therapies is obtaining appropriate information about the impact of an intervention on physical function. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and Outcome Measures in Rheumatology (OMERACT) convened a meeting to consider assessment of physical functioning and participation in research on chronic pain. ⋯ Investigators should consider the inclusion of both PROs and performance-based measures as they provide different but also important complementary information. The development and use of reliable and valid PROs and performance-based measures of physical functioning may expedite development of treatments, and standardization of these measures has the potential to facilitate comparison across studies. We provide recommendations regarding important domains to stimulate research to develop tools that are more robust, address consistency and standardization, and engage patients early in tool development.
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Pediatric surgeries are common and painful for children. Postoperative pain is commonly managed with analgesics; however, pain is often still problematic. Despite evidence for psychological interventions for procedural pain, there is currently no evidence synthesis for psychological interventions in managing postoperative pain in children. ⋯ Subgroup analysis indicated that distraction/imagery interventions were effective in reducing self-reported pain in the short term (24 hours, SMD = -0.63, 95% CI = -1.04 to -0.23), whereas preparation/education interventions were not effective (SMD = -0.27, 95% CI = -0.61 to 0.08). Data on the effects of interventions on longer term pain outcomes were limited. Psychological interventions may be effective in reducing short-term postoperative pain intensity in children, as well as longer term pain and other outcomes (eg, adverse events) require further study.
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There is tremendous interpatient variability in the response to analgesic therapy (even for efficacious treatments), which can be the source of great frustration in clinical practice. This has led to calls for "precision medicine" or personalized pain therapeutics (ie, empirically based algorithms that determine the optimal treatments, or treatment combinations, for individual patients) that would presumably improve both the clinical care of patients with pain and the success rates for putative analgesic drugs in phase 2 and 3 clinical trials. ⋯ In this article, we present evidence on the most promising of these phenotypic characteristics for use in future research, including psychosocial factors, symptom characteristics, sleep patterns, responses to noxious stimulation, endogenous pain-modulatory processes, and response to pharmacologic challenge. We provide evidence-based recommendations for core phenotyping domains and recommend measures of each domain.