Subject(s)
Clinical Trials as Topic/standards , Outcome Assessment, Health Care/standards , Pain Measurement/standards , Pain/classification , Pain/diagnosis , Practice Guidelines as Topic , Surveys and Questionnaires/standards , Clinical Trials as Topic/methods , Humans , Outcome Assessment, Health Care/methods , Pain Measurement/methods , Practice Patterns, Physicians'/standards , United StatesSubject(s)
Clinical Trials as Topic/methods , Health Planning Guidelines , Outcome Assessment, Health Care/standards , Pain Management , Chronic Disease , Clinical Trials as Topic/standards , Pain/physiopathology , Pain/psychology , Pain Measurement/methods , Treatment Outcome , Weights and MeasuresABSTRACT
OBJECTIVE: To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of data, encourage more complete reporting of outcomes, simplify the preparation and review of research proposals and manuscripts, and allow clinicians to make informed decisions regarding the risks and benefits of treatment. METHODS: Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 27 specialists from academia, governmental agencies, and the pharmaceutical industry participated in a consensus meeting and identified core outcome domains that should be considered in clinical trials of treatments for chronic pain. CONCLUSIONS: There was a consensus that chronic pain clinical trials should assess outcomes representing six core domains: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events, (6) participant disposition (e.g. adherence to the treatment regimen and reasons for premature withdrawal from the trial). Although consideration should be given to the assessment of each of these domains, there may be exceptions to the general recommendation to include all of these domains in chronic pain trials. When this occurs, the rationale for not including domains should be provided. It is not the intention of these recommendations that assessment of the core domains should be considered a requirement for approval of product applications by regulatory agencies or that a treatment must demonstrate statistically significant effects for all of the relevant core domains to establish evidence of its efficacy.
Subject(s)
Clinical Trials as Topic/methods , Health Planning Guidelines , Pain Management , Chronic Disease , Clinical Trials as Topic/standards , Emotions/physiology , Humans , Pain/physiopathology , Pain/psychology , Quality of Life/psychology , Treatment OutcomeABSTRACT
Chronic neuropathic pain, caused by lesions in the peripheral or central nervous system, comes in many forms. We describe current approaches to the diagnosis and assessment of neuropathic pain and discuss the results of recent research on its pathophysiologic mechanisms. Randomized controlled clinical trials of gabapentin, the 5% lidocaine patch, opioid analgesics, tramadol hydrochloride, and tricyclic antidepressants provide an evidence-based approach to the treatment of neuropathic pain, and specific recommendations are presented for use of these medications. Continued progress in basic and clinical research on the pathophysiologic mechanisms of neuropathic pain may make it possible to predict effective treatments for individual patients by application of a pain mechanism-based approach.
