Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations

Simon Haroutounian; Katherine J Holzer; Robert D Kerns; Christin Veasley; Robert H Dworkin; Dennis C Turk; Kristin L Carman; Christine T Chambers; Penney Cowan; Robert R Edwards; James C Eisenach; John T Farrar; McKenzie Ferguson; Laura P Forsythe; Roy Freeman; Jennifer S Gewandter; Ian Gilron; Christine Goertz; Hanna Grol-Prokopczyk; Smriti Iyengar; Isabel Jordan; Cornelia Kamp; Bethea A Kleykamp; Rachel L Knowles; Dale J Langford; Sean Mackey; Richard Malamut; John Markman; Kathryn R Martin; Ewan McNicol; Kushang V Patel; Andrew S C Rice; Michael Rowbotham; Friedhelm Sandbrink; Lee S Simon; Deborah J Steiner; Jan Vollert

doi:10.1097/j.pain.0000000000003121

Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations

Simon Haroutounian^* (Corresponding Author), Katherine J Holzer, Robert D Kerns, Christin Veasley, Robert H Dworkin, Dennis C Turk, Kristin L Carman, Christine T Chambers, Penney Cowan, Robert R Edwards, James C Eisenach, John T Farrar, McKenzie Ferguson, Laura P Forsythe, Roy Freeman, Jennifer S Gewandter, Ian Gilron, Christine Goertz, Hanna Grol-Prokopczyk, Smriti IyengarIsabel Jordan, Cornelia Kamp, Bethea A Kleykamp, Rachel L Knowles, Dale J Langford, Sean Mackey, Richard Malamut, John Markman, Kathryn R Martin, Ewan McNicol, Kushang V Patel, Andrew S C Rice, Michael Rowbotham, Friedhelm Sandbrink, Lee S Simon, Deborah J Steiner, Jan Vollert

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

In the traditional clinical research model, patients are typically involved only as participants. However, there has been a shift in recent years highlighting the value and contributions that patients bring as members of the research team, across the clinical research lifecycle. It is becoming increasingly evident that to develop research that is both meaningful to people who have the targeted condition and is feasible, there are important benefits of involving patients in the planning, conduct, and dissemination of research from its earliest stages. In fact, research funders and regulatory agencies are now explicitly encouraging, and sometimes requiring, that patients are engaged as partners in research. Although this approach has become commonplace in some fields of clinical research, it remains the exception in clinical pain research. As such, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials convened a meeting with patient partners and international representatives from academia, patient advocacy groups, government regulatory agencies, research funding organizations, academic journals, and the biopharmaceutical industry to develop consensus recommendations for advancing patient engagement in all stages of clinical pain research in an effective and purposeful manner. This article summarizes the results of this meeting and offers considerations for meaningful and authentic engagement of patient partners in clinical pain research, including recommendations for representation, timing, continuous engagement, measurement, reporting, and research dissemination.

Original language	English
Number of pages	16
Journal	Pain
Early online date	19 Dec 2023
DOIs	https://doi.org/10.1097/j.pain.0000000000003121
Publication status	E-pub ahead of print - 19 Dec 2023

Bibliographical note

The consensus recommendations are based on the views of IMMPACT meeting participants and do not necessarily represent the views of the organizations with which the authors are affiliated. The following individuals made important contributions to the IMMPACT meeting but were not able to participate in the preparation of this article: David Atkins, MD (Department of Veterans Affairs), Rebecca Baker, PhD (National Institutes of Health), Allan Basbaum, PhD (University of California San Francisco), Robyn Bent, RN, MS (Food and Drug Administration), Nathalie Bere, MPH (European Medicines Agency), Alysha Croker, PhD (Health Canada), Stephen Bruehl, PhD (Vanderbilt University), Michael Cobas Meyer, MD, MBS (Eli Lilly), Scott Evans, PhD (George Washington University), Gail Graham (University of Maryland), Jennifer Haythornthwaite, PhD (Johns Hopkins University), Sharon Hertz, MD (Hertz and Fields Consulting), Jonathan Jackson, PhD (Harvard Medical School), Mark Jensen, PhD (University of Washington), Francis Keefe, PhD (Duke University), Karim Khan, MD, PhD, MBA (Canadian Institutes of Health Research), Lynn Laidlaw (University of Aberdeen), Steven Lane (Patient-Centered Outcomes Research Institute), Karen Morales, BS (University of Maryland), David Leventhal, MBA (Pfizer), Jeremy Taylor, OBE (National Institute for Health Research), and Lena Sun, MD (Columbia University).

The manuscript has not been submitted, presented, or published elsewhere. Parts of the manuscript have been presented in a topical workshop at IASP World Congress on Pain in Toronto, in 2022.

Data Availability Statement

There are not primary data associated with this research. The summary of presentations that lead to the consensus meeting are freely available at http://www.immpact.org/meetings/Immpact25/participants25.html.

Keywords

pain
clinical trials
patient engagement
patient partners

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Haroutounian, S., Holzer, K. J., Kerns, R. D., Veasley, C., Dworkin, R. H., Turk, D. C., Carman, K. L., Chambers, C. T., Cowan, P., Edwards, R. R., Eisenach, J. C., Farrar, J. T., Ferguson, M., Forsythe, L. P., Freeman, R., Gewandter, J. S., Gilron, I., Goertz, C., Grol-Prokopczyk, H., ... Vollert, J. (2023). Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations. Pain. Advance online publication. https://doi.org/10.1097/j.pain.0000000000003121

Haroutounian, S, Holzer, KJ, Kerns, RD, Veasley, C, Dworkin, RH, Turk, DC, Carman, KL, Chambers, CT, Cowan, P, Edwards, RR, Eisenach, JC, Farrar, JT, Ferguson, M, Forsythe, LP, Freeman, R, Gewandter, JS, Gilron, I, Goertz, C, Grol-Prokopczyk, H, Iyengar, S, Jordan, I, Kamp, C, Kleykamp, BA, Knowles, RL, Langford, DJ, Mackey, S, Malamut, R, Markman, J, Martin, KR, McNicol, E, Patel, KV, Rice, ASC, Rowbotham, M, Sandbrink, F, Simon, LS, Steiner, DJ & Vollert, J 2023, 'Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations', Pain. https://doi.org/10.1097/j.pain.0000000000003121

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title = "Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations",

abstract = "In the traditional clinical research model, patients are typically involved only as participants. However, there has been a shift in recent years highlighting the value and contributions that patients bring as members of the research team, across the clinical research lifecycle. It is becoming increasingly evident that to develop research that is both meaningful to people who have the targeted condition and is feasible, there are important benefits of involving patients in the planning, conduct, and dissemination of research from its earliest stages. In fact, research funders and regulatory agencies are now explicitly encouraging, and sometimes requiring, that patients are engaged as partners in research. Although this approach has become commonplace in some fields of clinical research, it remains the exception in clinical pain research. As such, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials convened a meeting with patient partners and international representatives from academia, patient advocacy groups, government regulatory agencies, research funding organizations, academic journals, and the biopharmaceutical industry to develop consensus recommendations for advancing patient engagement in all stages of clinical pain research in an effective and purposeful manner. This article summarizes the results of this meeting and offers considerations for meaningful and authentic engagement of patient partners in clinical pain research, including recommendations for representation, timing, continuous engagement, measurement, reporting, and research dissemination.",

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author = "Simon Haroutounian and Holzer, {Katherine J} and Kerns, {Robert D} and Christin Veasley and Dworkin, {Robert H} and Turk, {Dennis C} and Carman, {Kristin L} and Chambers, {Christine T} and Penney Cowan and Edwards, {Robert R} and Eisenach, {James C} and Farrar, {John T} and McKenzie Ferguson and Forsythe, {Laura P} and Roy Freeman and Gewandter, {Jennifer S} and Ian Gilron and Christine Goertz and Hanna Grol-Prokopczyk and Smriti Iyengar and Isabel Jordan and Cornelia Kamp and Kleykamp, {Bethea A} and Knowles, {Rachel L} and Langford, {Dale J} and Sean Mackey and Richard Malamut and John Markman and Martin, {Kathryn R} and Ewan McNicol and Patel, {Kushang V} and Rice, {Andrew S C} and Michael Rowbotham and Friedhelm Sandbrink and Simon, {Lee S} and Steiner, {Deborah J} and Jan Vollert",

note = "The consensus recommendations are based on the views of IMMPACT meeting participants and do not necessarily represent the views of the organizations with which the authors are affiliated. The following individuals made important contributions to the IMMPACT meeting but were not able to participate in the preparation of this article: David Atkins, MD (Department of Veterans Affairs), Rebecca Baker, PhD (National Institutes of Health), Allan Basbaum, PhD (University of California San Francisco), Robyn Bent, RN, MS (Food and Drug Administration), Nathalie Bere, MPH (European Medicines Agency), Alysha Croker, PhD (Health Canada), Stephen Bruehl, PhD (Vanderbilt University), Michael Cobas Meyer, MD, MBS (Eli Lilly), Scott Evans, PhD (George Washington University), Gail Graham (University of Maryland), Jennifer Haythornthwaite, PhD (Johns Hopkins University), Sharon Hertz, MD (Hertz and Fields Consulting), Jonathan Jackson, PhD (Harvard Medical School), Mark Jensen, PhD (University of Washington), Francis Keefe, PhD (Duke University), Karim Khan, MD, PhD, MBA (Canadian Institutes of Health Research), Lynn Laidlaw (University of Aberdeen), Steven Lane (Patient-Centered Outcomes Research Institute), Karen Morales, BS (University of Maryland), David Leventhal, MBA (Pfizer), Jeremy Taylor, OBE (National Institute for Health Research), and Lena Sun, MD (Columbia University). The manuscript has not been submitted, presented, or published elsewhere. Parts of the manuscript have been presented in a topical workshop at IASP World Congress on Pain in Toronto, in 2022.",

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AU - Dworkin, Robert H

AU - Turk, Dennis C

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AU - Chambers, Christine T

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AU - Iyengar, Smriti

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AU - Rowbotham, Michael

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AU - Simon, Lee S

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N2 - In the traditional clinical research model, patients are typically involved only as participants. However, there has been a shift in recent years highlighting the value and contributions that patients bring as members of the research team, across the clinical research lifecycle. It is becoming increasingly evident that to develop research that is both meaningful to people who have the targeted condition and is feasible, there are important benefits of involving patients in the planning, conduct, and dissemination of research from its earliest stages. In fact, research funders and regulatory agencies are now explicitly encouraging, and sometimes requiring, that patients are engaged as partners in research. Although this approach has become commonplace in some fields of clinical research, it remains the exception in clinical pain research. As such, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials convened a meeting with patient partners and international representatives from academia, patient advocacy groups, government regulatory agencies, research funding organizations, academic journals, and the biopharmaceutical industry to develop consensus recommendations for advancing patient engagement in all stages of clinical pain research in an effective and purposeful manner. This article summarizes the results of this meeting and offers considerations for meaningful and authentic engagement of patient partners in clinical pain research, including recommendations for representation, timing, continuous engagement, measurement, reporting, and research dissemination.

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Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations

Abstract

Bibliographical note

Data Availability Statement

Keywords

Access to Document

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Cite this