Core outcome measures for chronic pain clinical trials: IMMPACT recommendations (original) (raw)

Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations

Pain, 2020

Interpreting randomized clinical trials (RCTs) is crucial to making decisions regarding the use of analgesic treatments in clinical practice. In this article, we report on an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, the purpose of which was to recommend approaches that facilitate interpretation of analgesic RCTs. We review issues to consider when drawing conclusions from RCTs, as well as common methods for reporting RCT results and the limitations of each method. These issues include the type of trial, study design, statistical analysis methods, magnitude of the estimated beneficial and harmful effects and associated precision, availability of alternative treatments and their benefit–risk profile, clinical importance of the change from baseline both within and between groups, presentation of the out...

Evidence-based outcomes in pain research and clinical practice

Pain practice : the official journal of World Institute of Pain

The growing emphasis on evidence-based medicine dictates that reliable, evidence-based outcomes be utilized in documenting response to treatment, as well as determining the treatment efficacy and cost-effectiveness of different treatment modalities. The biopsychosocial model conceptualizes pain as a complex multifactorial interaction of biological, psychological, and social components that play a role in the development, exacerbation, and perpetuation of pain. As a result, outcomes relevant to pain management are necessarily complex and multifactorial in nature. Two broad categories of evidence-based outcomes relevant to pain management are discussed: patient-reported outcomes and objective outcomes. Patient-reported outcomes are discussed within the context of pain measures, health-related quality of life, and psychological constructs. Objective outcomes are discussed within the context of healthcare utilization and occupational status. The discussion within each section highlights...