Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations

R.H. Dworkin; D.C. Turk; K.W. Wyrwich; D. Beaton; C.S. Cleeland; J.T. Farrar; J.A. Haythornthwaite; M.P. Jensen; R.D. Kerns; D.N. Ader; N. Brandenburg; L.B. Burke; D. Cella; J. Chandler; P. Cowan; R. Dimitrova; R. Dionne; S. Hertz; A.R. Jadad; N.P. Katz; H. Kehlet; L.D. Kramer; D.C. Manning; C. McCormick; M.P. McDermott; H.J. McQuay; S. Patel; L. Porter; S. Quessy; B.A. Rappaport; C. Rauschkolb; D.A. Revicki; M. Rothman; K.E. Schmader; B.R. Stacey; J.W. Stauffer; Stein T. von; R.E. White; J. Witter; S. Zavisic

Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations

R.H. Dworkin, D.C. Turk, K.W. Wyrwich, D. Beaton, C.S. Cleeland, J.T. Farrar, J.A. Haythornthwaite, M.P. Jensen, R.D. Kerns, D.N. Ader, N. Brandenburg, L.B. Burke, D. Cella, J. Chandler, P. Cowan, R. Dimitrova, R. Dionne, S. Hertz, A.R. Jadad, N.P. KatzH. Kehlet, L.D. Kramer, D.C. Manning, C. McCormick, M.P. McDermott, H.J. McQuay, S. Patel, L. Porter, S. Quessy, B.A. Rappaport, C. Rauschkolb, D.A. Revicki, M. Rothman, K.E. Schmader, B.R. Stacey, J.W. Stauffer, Stein T. von, R.E. White, J. Witter, S. Zavisic

1791 Citations (Scopus)

Abstract

A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments. A group of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT for 4 core chronic pain outcome domains: (1) Pain intensity, assessed by a 0 to 10 numerical rating scale; (2) physical functioning, assessed by the Multidimensional Pain Inventory and Brief Pain Inventory interference scales; (3) emotional functioning, assessed by the Beck Depression Inventory and Profile of Mood States; and (4) participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale. It is recommended that 2 or more different methods be used to evaluate the clinical importance of improvement or worsening for chronic pain clinical trial outcome measures. Provisional benchmarks for identifying clinically important changes in specific outcome measures that can be used for outcome studies of treatments for chronic pain are proposed. PERSPECTIVE: Systematically collecting and reporting the recommended information needed to evaluate the clinical importance of treatment outcomes of chronic pain clinical trials will allow additional validation of proposed benchmarks and provide more meaningful comparisons of chronic pain treatments
Udgivelsesdato: 2008/2

Original language	English
Journal	Journal of Pain and Symptom Management
Volume	9
Issue number	2
Pages (from-to)	105-121
Number of pages	16
ISSN	0885-3924
Publication status	Published - 2008

Cite this

Dworkin, R. H., Turk, D. C., Wyrwich, K. W., Beaton, D., Cleeland, C. S., Farrar, J. T., Haythornthwaite, J. A., Jensen, M. P., Kerns, R. D., Ader, D. N., Brandenburg, N., Burke, L. B., Cella, D., Chandler, J., Cowan, P., Dimitrova, R., Dionne, R., Hertz, S., Jadad, A. R., ... Zavisic, S. (2008). Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. Journal of Pain and Symptom Management, 9(2), 105-121.

Dworkin, RH, Turk, DC, Wyrwich, KW, Beaton, D, Cleeland, CS, Farrar, JT, Haythornthwaite, JA, Jensen, MP, Kerns, RD, Ader, DN, Brandenburg, N, Burke, LB, Cella, D, Chandler, J, Cowan, P, Dimitrova, R, Dionne, R, Hertz, S, Jadad, AR, Katz, NP, Kehlet, H, Kramer, LD, Manning, DC, McCormick, C, McDermott, MP, McQuay, HJ, Patel, S, Porter, L, Quessy, S, Rappaport, BA, Rauschkolb, C, Revicki, DA, Rothman, M, Schmader, KE, Stacey, BR, Stauffer, JW, von, ST, White, RE, Witter, J & Zavisic, S 2008, 'Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations', Journal of Pain and Symptom Management, vol. 9, no. 2, pp. 105-121.

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title = "Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations",

abstract = "A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments. A group of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT for 4 core chronic pain outcome domains: (1) Pain intensity, assessed by a 0 to 10 numerical rating scale; (2) physical functioning, assessed by the Multidimensional Pain Inventory and Brief Pain Inventory interference scales; (3) emotional functioning, assessed by the Beck Depression Inventory and Profile of Mood States; and (4) participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale. It is recommended that 2 or more different methods be used to evaluate the clinical importance of improvement or worsening for chronic pain clinical trial outcome measures. Provisional benchmarks for identifying clinically important changes in specific outcome measures that can be used for outcome studies of treatments for chronic pain are proposed. PERSPECTIVE: Systematically collecting and reporting the recommended information needed to evaluate the clinical importance of treatment outcomes of chronic pain clinical trials will allow additional validation of proposed benchmarks and provide more meaningful comparisons of chronic pain treatments Udgivelsesdato: 2008/2",

author = "R.H. Dworkin and D.C. Turk and K.W. Wyrwich and D. Beaton and C.S. Cleeland and J.T. Farrar and J.A. Haythornthwaite and M.P. Jensen and R.D. Kerns and D.N. Ader and N. Brandenburg and L.B. Burke and D. Cella and J. Chandler and P. Cowan and R. Dimitrova and R. Dionne and S. Hertz and A.R. Jadad and N.P. Katz and H. Kehlet and L.D. Kramer and D.C. Manning and C. McCormick and M.P. McDermott and H.J. McQuay and S. Patel and L. Porter and S. Quessy and B.A. Rappaport and C. Rauschkolb and D.A. Revicki and M. Rothman and K.E. Schmader and B.R. Stacey and J.W. Stauffer and von, {Stein T.} and R.E. White and J. Witter and S. Zavisic",

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language = "English",

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journal = "Journal of Pain and Symptom Management",

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T1 - Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations

AU - Dworkin, R.H.

AU - Turk, D.C.

AU - Wyrwich, K.W.

AU - Beaton, D.

AU - Cleeland, C.S.

AU - Farrar, J.T.

AU - Haythornthwaite, J.A.

AU - Jensen, M.P.

AU - Kerns, R.D.

AU - Ader, D.N.

AU - Brandenburg, N.

AU - Burke, L.B.

AU - Cella, D.

AU - Chandler, J.

AU - Cowan, P.

AU - Dimitrova, R.

AU - Dionne, R.

AU - Hertz, S.

AU - Jadad, A.R.

AU - Katz, N.P.

AU - Kehlet, H.

AU - Kramer, L.D.

AU - Manning, D.C.

AU - McCormick, C.

AU - McDermott, M.P.

AU - McQuay, H.J.

AU - Patel, S.

AU - Porter, L.

AU - Quessy, S.

AU - Rappaport, B.A.

AU - Rauschkolb, C.

AU - Revicki, D.A.

AU - Rothman, M.

AU - Schmader, K.E.

AU - Stacey, B.R.

AU - Stauffer, J.W.

AU - von, Stein T.

AU - White, R.E.

AU - Witter, J.

AU - Zavisic, S.

PY - 2008

Y1 - 2008

N2 - A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments. A group of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT for 4 core chronic pain outcome domains: (1) Pain intensity, assessed by a 0 to 10 numerical rating scale; (2) physical functioning, assessed by the Multidimensional Pain Inventory and Brief Pain Inventory interference scales; (3) emotional functioning, assessed by the Beck Depression Inventory and Profile of Mood States; and (4) participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale. It is recommended that 2 or more different methods be used to evaluate the clinical importance of improvement or worsening for chronic pain clinical trial outcome measures. Provisional benchmarks for identifying clinically important changes in specific outcome measures that can be used for outcome studies of treatments for chronic pain are proposed. PERSPECTIVE: Systematically collecting and reporting the recommended information needed to evaluate the clinical importance of treatment outcomes of chronic pain clinical trials will allow additional validation of proposed benchmarks and provide more meaningful comparisons of chronic pain treatments Udgivelsesdato: 2008/2

AB - A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments. A group of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT for 4 core chronic pain outcome domains: (1) Pain intensity, assessed by a 0 to 10 numerical rating scale; (2) physical functioning, assessed by the Multidimensional Pain Inventory and Brief Pain Inventory interference scales; (3) emotional functioning, assessed by the Beck Depression Inventory and Profile of Mood States; and (4) participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale. It is recommended that 2 or more different methods be used to evaluate the clinical importance of improvement or worsening for chronic pain clinical trial outcome measures. Provisional benchmarks for identifying clinically important changes in specific outcome measures that can be used for outcome studies of treatments for chronic pain are proposed. PERSPECTIVE: Systematically collecting and reporting the recommended information needed to evaluate the clinical importance of treatment outcomes of chronic pain clinical trials will allow additional validation of proposed benchmarks and provide more meaningful comparisons of chronic pain treatments Udgivelsesdato: 2008/2

M3 - Journal article

SN - 0885-3924

VL - 9

SP - 105

EP - 121

JO - Journal of Pain and Symptom Management

JF - Journal of Pain and Symptom Management

IS - 2

ER -