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. Katz; J. 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 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

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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
Pages (from-to)	2446-2461
Journal	Pain
Volume	161
Issue number	11
Early online date	8 Jun 2020
DOIs	https://doi.org/10.1097/j.pain.0000000000001952
Publication status	Published - 30 Nov 2020

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PAIN-D-19-01166_R2 text tables figuresAccepted author manuscript, 7.71 MBLicence: CC BY-NC

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Smith, S. M., Dworkin, R. H., Turk, D. C., McDermott, M., Eccleston, C., Farrar, J. T., Rowbotham, M. C., Bhangwagar, Z., Burke, L., 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, M, Eccleston, C, Farrar, JT, Rowbotham, MC, Bhangwagar, Z, Burke, L, 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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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.",

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

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AU - Eccleston, Christopher

AU - Farrar, John T.

AU - Rowbotham, Michael C.

AU - Bhangwagar, Zubin

AU - Burke, Laurie

AU - Cowan, Penny

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, J. 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.

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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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ER -

Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations

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