| Literature DB >> 32520773 |
Shannon M Smith1,2,3, Robert H Dworkin1,3,4,5, Dennis C Turk6, Michael P McDermott4,5,7, Christopher Eccleston8, John T Farrar9,10, Michael C Rowbotham11, Zubin Bhagwagar12,13, Laurie B Burke14,15, Penney Cowan16, Susan S Ellenberg10, Scott R Evans17, Roy L Freeman18, Louis P Garrison19, Smriti Iyengar20, Alejandro Jadad21, Mark P Jensen22, Roderick Junor23, Cornelia Kamp5,24, Nathaniel P Katz25,26, James Patrick Kesslak27, Ernest A Kopecky28, Dmitri Lissin29, John D Markman30, Philip J Mease31,32, Alec B O'Connor33, Kushang V Patel6, Srinivasa N Raja34, Cristina Sampaio35,36, David Schoenfeld37, Jasvinder Singh38, Ilona Steigerwald39, Vibeke Strand40, Leslie A Tive41, Jeffrey Tobias42, Ajay D Wasan43, Hilary D Wilson44.
Abstract
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 outcome data, and the limitations of the approaches used.Entities:
Year: 2020 PMID： 32520773 PMCID： PMC7572524 DOI： 10.1097/j.pain.0000000000001952
Source DB: PubMed Journal: Pain ISSN： 0304-3959 Impact factor: 6.961