TY - JOUR
T1 - Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations
AU - McGrath, Patrick J.
AU - Walco, Gary A.
AU - Turk, Dennis C.
AU - Dworkin, Robert H.
AU - Brown, Mark T.
AU - Davidson, Karina
AU - Eccleston, Christopher
AU - Findley, G. Allen
AU - Goldschneider, Kenneth
AU - Haverkos, Lynne
AU - Hertz, Sharon H.
AU - Ljungman, Gustaf
AU - Palermo, Tonya
AU - Rappaport, Bob A.
AU - Rhodes, Thomas
AU - Schechter, Neil
AU - Scott, Jane
AU - Sethna, Navil
AU - Svensson, Ola K.
AU - Stinson, Jennifer
AU - von Baeyer, Carl L.
AU - Walker, Lynn
AU - Weisman, Steven
AU - White, Richard E.
AU - Zajicek, Anne
AU - Zeltzer, Lonnie
PY - 2008/9
Y1 - 2008/9
N2 - Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 26 professionals from academia, governmental agencies, and the pharmaceutical industry participated in a 2-stage Delphi poll and a consensus meeting that identified core outcome domains and measures that should be considered in clinical trials of treatments for acute and chronic pain in children and adolescents. Consensus was refined by consultation with the international pediatric pain community through announcement of our recommendations on the Pediatric Pain List and inviting and incorporating comments from external sources. There was consensus that investigators conducting pediatric acute pain clinical trials should consider assessing outcomes in pain intensity; global judgment of satisfaction with treatment; symptoms and adverse events; physical recovery; emotional response; and economic factors. There was also agreement that investigators conducting pediatric clinical trials in chronic and recurrent pain should consider assessing outcomes in pain intensity; physical functioning; emotional functioning; role functioning; symptoms and adverse events; global judgment of satisfaction with treatment; sleep; and economic factors. Specific measures or measurement strategies were recommended for different age groups for each domain. PERSPECTIVE: Based on systematic review and consensus of experts, core domains and measures for clinical trials to treat pain in children and adolescents were defined. This will assist in comparison and pooling of data and promote evidence-based treatment, encourage complete reporting of outcomes, simplify the review of proposals and manuscripts, and facilitate clinicians making informed decisions regarding treatment.
AB - Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 26 professionals from academia, governmental agencies, and the pharmaceutical industry participated in a 2-stage Delphi poll and a consensus meeting that identified core outcome domains and measures that should be considered in clinical trials of treatments for acute and chronic pain in children and adolescents. Consensus was refined by consultation with the international pediatric pain community through announcement of our recommendations on the Pediatric Pain List and inviting and incorporating comments from external sources. There was consensus that investigators conducting pediatric acute pain clinical trials should consider assessing outcomes in pain intensity; global judgment of satisfaction with treatment; symptoms and adverse events; physical recovery; emotional response; and economic factors. There was also agreement that investigators conducting pediatric clinical trials in chronic and recurrent pain should consider assessing outcomes in pain intensity; physical functioning; emotional functioning; role functioning; symptoms and adverse events; global judgment of satisfaction with treatment; sleep; and economic factors. Specific measures or measurement strategies were recommended for different age groups for each domain. PERSPECTIVE: Based on systematic review and consensus of experts, core domains and measures for clinical trials to treat pain in children and adolescents were defined. This will assist in comparison and pooling of data and promote evidence-based treatment, encourage complete reporting of outcomes, simplify the review of proposals and manuscripts, and facilitate clinicians making informed decisions regarding treatment.
UR - http://www.scopus.com/inward/record.url?scp=49649128100&partnerID=8YFLogxK
UR - http://dx.doi.org/10.1016/j.jpain.2008.04.007
U2 - 10.1016/j.jpain.2008.04.007
DO - 10.1016/j.jpain.2008.04.007
M3 - Article
VL - 9
SP - 771
EP - 783
JO - Journal of Pain
JF - Journal of Pain
SN - 1526-5900
IS - 9
ER -