Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations

Shannon M. Smith; Robert H. Dworkin; Dennis C. Turk; Michael P. McDermott; Christopher Eccleston; John T. Farrar; Michael C. Rowbotham; Zubin Bhagwagar; Laurie B. Burke; Penney 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. Katz; James 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

doi:10.1097/j.pain.0000000000001952

Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations

Shannon M. Smith, Robert H. Dworkin, Dennis C. Turk, Michael P. McDermott, Christopher Eccleston, John T. Farrar, Michael C. Rowbotham, Zubin Bhagwagar, Laurie B. Burke, Penney 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. KatzJames 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

School of Medicine

Research output: Contribution to journal › Review article › peer-review

3 Scopus citations

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 language	English (US)
Pages (from-to)	2446-2461
Number of pages	16
Journal	Pain
Volume	161
Issue number	11
DOIs	https://doi.org/10.1097/j.pain.0000000000001952
State	Published - Nov 1 2020

Keywords

Analgesic
Analysis
Interpretation
Pain
Randomized clinical trials

ASJC Scopus subject areas

Clinical Neurology
Neurology
Anesthesiology and Pain Medicine

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10.1097/j.pain.0000000000001952

Cite this

Smith, S. M., Dworkin, R. H., Turk, D. C., McDermott, M. P., Eccleston, C., Farrar, J. T., Rowbotham, M. C., Bhagwagar, Z., Burke, L. B., Cowan, P., Ellenberg, S. S., Evans, S. R., Freeman, R. L., Garrison, L. P., Iyengar, S., Jadad, A., Jensen, M. P., Junor, R., Kamp, C., ... Wilson, H. D. (2020). Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations. Pain, 161(11), 2446-2461. https://doi.org/10.1097/j.pain.0000000000001952

Smith, SM, Dworkin, RH, Turk, DC, McDermott, MP, Eccleston, C, Farrar, JT, Rowbotham, MC, Bhagwagar, Z, Burke, LB, Cowan, P, Ellenberg, SS, Evans, SR, Freeman, RL, Garrison, LP, Iyengar, S, Jadad, A, Jensen, MP, Junor, R, Kamp, C, Katz, NP, Kesslak, JP, Kopecky, EA, Lissin, D, Markman, JD, Mease, PJ, O’Connor, AB, Patel, KV, Raja, SN, Sampaio, C, Schoenfeld, D, Singh, J, Steigerwald, I, Strand, V, Tive, LA, Tobias, J, Wasan, AD & Wilson, HD 2020, 'Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations', Pain, vol. 161, no. 11, pp. 2446-2461. https://doi.org/10.1097/j.pain.0000000000001952

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title = "Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations",

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.",

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T2 - IMMPACT recommended considerations

AU - Smith, Shannon M.

AU - Dworkin, Robert H.

AU - Turk, Dennis C.

AU - McDermott, Michael P.

AU - Eccleston, Christopher

AU - Farrar, John T.

AU - Rowbotham, Michael C.

AU - Bhagwagar, Zubin

AU - Burke, Laurie B.

AU - Cowan, Penney

AU - Ellenberg, Susan S.

AU - Evans, Scott R.

AU - Freeman, Roy L.

AU - Garrison, Louis P.

AU - Iyengar, Smriti

AU - Jadad, Alejandro

AU - Jensen, Mark P.

AU - Junor, Roderick

AU - Kamp, Cornelia

AU - Katz, Nathaniel P.

AU - Kesslak, James Patrick

AU - Kopecky, Ernest A.

AU - Lissin, Dmitri

AU - Markman, John D.

AU - Mease, Philip J.

AU - O’Connor, Alec B.

AU - Patel, Kushang V.

AU - Raja, Srinivasa N.

AU - Sampaio, Cristina

AU - Schoenfeld, David

AU - Singh, Jasvinder

AU - Steigerwald, Ilona

AU - Strand, Vibeke

AU - Tive, Leslie A.

AU - Tobias, Jeffrey

AU - Wasan, Ajay D.

AU - Wilson, Hilary D.

PY - 2020/11/1

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AB - 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.

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KW - Analysis

KW - Interpretation

KW - Pain

KW - Randomized clinical trials

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SN - 0304-3959

VL - 161

SP - 2446

EP - 2461

JO - Pain

JF - Pain

IS - 11

ER -

Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations

Abstract

Keywords

ASJC Scopus subject areas

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