Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations

Shannon M. Smith, Robert H. Dworkin, Dennis C. Turk, Michael McDermott, Christopher Eccleston, John T. Farrar, Michael C. Rowbotham, Zubin Bhangwagar, Laurie Burke, Penny Cowan, Susan S. Ellenberg, Scott R. Evans, Roy L. Freeman, Louis P. Garrison, Smriti Iyengar, Alejandro Jadad, Mark P. Jensen, Roderick Junor, Cornelia Kamp, Nathaniel P. KatzJ. Patrick Kesslak, Ernest A. Kopecky, Dmitri Lissin, John D. Markman, Philip J. Mease, Alec B. O'Connor, Kushang V. Patel, Srinivasa N. Raja, Cristina Sampaio, David Schoenfeld, Jasvinder Singh, Ilona Steigerwald, Vibeke Strand, Leslie A. Tive, Jeffrey Tobias, Ajay D. Wasan, Hilary D. Wilson

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)2446-2461
JournalPain
Volume161
Issue number11
Early online date8 Jun 2020
DOIs
Publication statusE-pub ahead of print - 8 Jun 2020

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