Rosacea Core Domain Set for Clinical Trials and Practice: A Consensus Statement

McKenzie A. Dirr; Areeba Ahmed; Daniel I. Schlessinger; Misha Haq; Victoria Shi; Eric Koza; Melissa Ma; Rachel E. Christensen; Sarah A. Ibrahim; Jochen Schmitt; Lena Johannsen; Yuka Asai; Hilary E. Baldwin; Enzo Berardesca; Brian Berman; Ana Carolina Vieira; Anna L. Chien; David E. Cohen; James Q. Del Rosso; Jacquelyn Dosal; Lynn A. Drake; Steven R. Feldman; Alan B. Fleischer; Adam Friedman; Emmy Graber; Julie C. Harper; Yolanda R. Helfrich; Gregor B. Jemec; Sandra M. Johnson; Rajani Katta; Peter Lio; Lisa E. Maier; George Martin; Arielle R. Nagler; Isaac M. Neuhaus; Melis Palamar; Lawrence C. Parish; Theodore Rosen; Stephen P. Shumack; James A. Solomon; Emil A. Tanghetti; Guy F. Webster; Allison Weinkle; Jonathan S. Weiss; Edward J. Wladis; Ian A. Maher; Joseph F. Sobanko; Todd V. Cartee; Brian A. Cahn; Murad Alam; Bianca Y. Kang; Sanjana Iyengar; Noor Anvery; Erkan Alpsoy; Anthony Bewley; Clio Dessinioti; Alexander Egeberg; Burhan Engin; Harald P.M. Gollnick; Dimitrios Ioannides; Hei Sung Kim; Elizabeth Lazaridou; Ji Li; Hester Gail Lim; Giuseppe Micali; Clivia Maria Moraes De Oliveira; Lucero Noguera-Morel; Aurora Parodi; Markus Reinholz; Dae Hun Suh; Qiuning Sun; Esther J. Van Zuuren; Uwe Wollina; Youwen Zhou; Catherine Zip; Emily Poon; Ross Pearlman

doi:10.1001/jamadermatol.2024.0636

Rosacea Core Domain Set for Clinical Trials and Practice: A Consensus Statement

McKenzie A. Dirr, Areeba Ahmed, Daniel I. Schlessinger, Misha Haq, Victoria Shi, Eric Koza, Melissa Ma, Rachel E. Christensen, Sarah A. Ibrahim, Jochen Schmitt, Lena Johannsen, Yuka Asai, Hilary E. Baldwin, Enzo Berardesca, Brian Berman, Ana Carolina Vieira, Anna L. Chien, David E. Cohen, James Q. Del Rosso, Jacquelyn DosalLynn A. Drake, Steven R. Feldman, Alan B. Fleischer, Adam Friedman, Emmy Graber, Julie C. Harper, Yolanda R. Helfrich, Gregor B. Jemec, Sandra M. Johnson, Rajani Katta, Peter Lio, Lisa E. Maier, George Martin, Arielle R. Nagler, Isaac M. Neuhaus, Melis Palamar, Lawrence C. Parish, Theodore Rosen, Stephen P. Shumack, James A. Solomon, Emil A. Tanghetti, Guy F. Webster, Allison Weinkle, Jonathan S. Weiss, Edward J. Wladis, Ian A. Maher, Joseph F. Sobanko, Todd V. Cartee, Brian A. Cahn, Murad Alam, Bianca Y. Kang, Sanjana Iyengar, Noor Anvery, Erkan Alpsoy, Anthony Bewley, Clio Dessinioti, Alexander Egeberg, Burhan Engin, Harald P.M. Gollnick, Dimitrios Ioannides, Hei Sung Kim, Elizabeth Lazaridou, Ji Li, Hester Gail Lim, Giuseppe Micali, Clivia Maria Moraes De Oliveira, Lucero Noguera-Morel, Aurora Parodi, Markus Reinholz, Dae Hun Suh, Qiuning Sun, Esther J. Van Zuuren, Uwe Wollina, Youwen Zhou, Catherine Zip, Emily Poon, Ross Pearlman

Dermatology

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

Abstract

Importance: Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea. Objective: To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice. Evidence Review: A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set. Findings: The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting. Conclusions and Relevance: This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.

Original language	English (US)
Pages (from-to)	658-666
Number of pages	9
Journal	JAMA Dermatology
Volume	160
Issue number	6
DOIs	https://doi.org/10.1001/jamadermatol.2024.0636
State	Published - Jun 19 2024

Bibliographical note

Publisher Copyright:
© 2024 Dirr MA et al. JAMA Dermatol.

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Dirr, M. A., Ahmed, A., Schlessinger, D. I., Haq, M., Shi, V., Koza, E., Ma, M., Christensen, R. E., Ibrahim, S. A., Schmitt, J., Johannsen, L., Asai, Y., Baldwin, H. E., Berardesca, E., Berman, B., Vieira, A. C., Chien, A. L., Cohen, D. E., Del Rosso, J. Q., ... Pearlman, R. (2024). Rosacea Core Domain Set for Clinical Trials and Practice: A Consensus Statement. JAMA Dermatology, 160(6), 658-666. https://doi.org/10.1001/jamadermatol.2024.0636

Dirr, MA, Ahmed, A, Schlessinger, DI, Haq, M, Shi, V, Koza, E, Ma, M, Christensen, RE, Ibrahim, SA, Schmitt, J, Johannsen, L, Asai, Y, Baldwin, HE, Berardesca, E, Berman, B, Vieira, AC, Chien, AL, Cohen, DE, Del Rosso, JQ, Dosal, J, Drake, LA, Feldman, SR, Fleischer, AB, Friedman, A, Graber, E, Harper, JC, Helfrich, YR, Jemec, GB, Johnson, SM, Katta, R, Lio, P, Maier, LE, Martin, G, Nagler, AR, Neuhaus, IM, Palamar, M, Parish, LC, Rosen, T, Shumack, SP, Solomon, JA, Tanghetti, EA, Webster, GF, Weinkle, A, Weiss, JS, Wladis, EJ, Maher, IA, Sobanko, JF, Cartee, TV, Cahn, BA, Alam, M, Kang, BY, Iyengar, S, Anvery, N, Alpsoy, E, Bewley, A, Dessinioti, C, Egeberg, A, Engin, B, Gollnick, HPM, Ioannides, D, Kim, HS, Lazaridou, E, Li, J, Lim, HG, Micali, G, De Oliveira, CMM, Noguera-Morel, L, Parodi, A, Reinholz, M, Suh, DH, Sun, Q, Van Zuuren, EJ, Wollina, U, Zhou, Y, Zip, C, Poon, E & Pearlman, R 2024, 'Rosacea Core Domain Set for Clinical Trials and Practice: A Consensus Statement', JAMA Dermatology, vol. 160, no. 6, pp. 658-666. https://doi.org/10.1001/jamadermatol.2024.0636

@article{89c0b727015f4908b3ae5a1362012388,

title = "Rosacea Core Domain Set for Clinical Trials and Practice: A Consensus Statement",

abstract = "Importance: Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea. Objective: To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice. Evidence Review: A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set. Findings: The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting. Conclusions and Relevance: This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.",

author = "Dirr, {McKenzie A.} and Areeba Ahmed and Schlessinger, {Daniel I.} and Misha Haq and Victoria Shi and Eric Koza and Melissa Ma and Christensen, {Rachel E.} and Ibrahim, {Sarah A.} and Jochen Schmitt and Lena Johannsen and Yuka Asai and Baldwin, {Hilary E.} and Enzo Berardesca and Brian Berman and Vieira, {Ana Carolina} and Chien, {Anna L.} and Cohen, {David E.} and {Del Rosso}, {James Q.} and Jacquelyn Dosal and Drake, {Lynn A.} and Feldman, {Steven R.} and Fleischer, {Alan B.} and Adam Friedman and Emmy Graber and Harper, {Julie C.} and Helfrich, {Yolanda R.} and Jemec, {Gregor B.} and Johnson, {Sandra M.} and Rajani Katta and Peter Lio and Maier, {Lisa E.} and George Martin and Nagler, {Arielle R.} and Neuhaus, {Isaac M.} and Melis Palamar and Parish, {Lawrence C.} and Theodore Rosen and Shumack, {Stephen P.} and Solomon, {James A.} and Tanghetti, {Emil A.} and Webster, {Guy F.} and Allison Weinkle and Weiss, {Jonathan S.} and Wladis, {Edward J.} and Maher, {Ian A.} and Sobanko, {Joseph F.} and Cartee, {Todd V.} and Cahn, {Brian A.} and Murad Alam and Kang, {Bianca Y.} and Sanjana Iyengar and Noor Anvery and Erkan Alpsoy and Anthony Bewley and Clio Dessinioti and Alexander Egeberg and Burhan Engin and Gollnick, {Harald P.M.} and Dimitrios Ioannides and Kim, {Hei Sung} and Elizabeth Lazaridou and Ji Li and Lim, {Hester Gail} and Giuseppe Micali and {De Oliveira}, {Clivia Maria Moraes} and Lucero Noguera-Morel and Aurora Parodi and Markus Reinholz and Suh, {Dae Hun} and Qiuning Sun and {Van Zuuren}, {Esther J.} and Uwe Wollina and Youwen Zhou and Catherine Zip and Emily Poon and Ross Pearlman",

note = "Publisher Copyright: {\textcopyright} 2024 Dirr MA et al. JAMA Dermatol.",

year = "2024",

month = jun,

day = "19",

doi = "10.1001/jamadermatol.2024.0636",

language = "English (US)",

volume = "160",

pages = "658--666",

journal = "JAMA Dermatology",

issn = "2168-6068",

publisher = "American Medical Association",

number = "6",

}

TY - JOUR

T1 - Rosacea Core Domain Set for Clinical Trials and Practice

T2 - A Consensus Statement

AU - Dirr, McKenzie A.

AU - Ahmed, Areeba

AU - Schlessinger, Daniel I.

AU - Haq, Misha

AU - Shi, Victoria

AU - Koza, Eric

AU - Ma, Melissa

AU - Christensen, Rachel E.

AU - Ibrahim, Sarah A.

AU - Schmitt, Jochen

AU - Johannsen, Lena

AU - Asai, Yuka

AU - Baldwin, Hilary E.

AU - Berardesca, Enzo

AU - Berman, Brian

AU - Vieira, Ana Carolina

AU - Chien, Anna L.

AU - Cohen, David E.

AU - Del Rosso, James Q.

AU - Dosal, Jacquelyn

AU - Drake, Lynn A.

AU - Feldman, Steven R.

AU - Fleischer, Alan B.

AU - Friedman, Adam

AU - Graber, Emmy

AU - Harper, Julie C.

AU - Helfrich, Yolanda R.

AU - Jemec, Gregor B.

AU - Johnson, Sandra M.

AU - Katta, Rajani

AU - Lio, Peter

AU - Maier, Lisa E.

AU - Martin, George

AU - Nagler, Arielle R.

AU - Neuhaus, Isaac M.

AU - Palamar, Melis

AU - Parish, Lawrence C.

AU - Rosen, Theodore

AU - Shumack, Stephen P.

AU - Solomon, James A.

AU - Tanghetti, Emil A.

AU - Webster, Guy F.

AU - Weinkle, Allison

AU - Weiss, Jonathan S.

AU - Wladis, Edward J.

AU - Maher, Ian A.

AU - Sobanko, Joseph F.

AU - Cartee, Todd V.

AU - Cahn, Brian A.

AU - Alam, Murad

AU - Kang, Bianca Y.

AU - Iyengar, Sanjana

AU - Anvery, Noor

AU - Alpsoy, Erkan

AU - Bewley, Anthony

AU - Dessinioti, Clio

AU - Egeberg, Alexander

AU - Engin, Burhan

AU - Gollnick, Harald P.M.

AU - Ioannides, Dimitrios

AU - Kim, Hei Sung

AU - Lazaridou, Elizabeth

AU - Li, Ji

AU - Lim, Hester Gail

AU - Micali, Giuseppe

AU - De Oliveira, Clivia Maria Moraes

AU - Noguera-Morel, Lucero

AU - Parodi, Aurora

AU - Reinholz, Markus

AU - Suh, Dae Hun

AU - Sun, Qiuning

AU - Van Zuuren, Esther J.

AU - Wollina, Uwe

AU - Zhou, Youwen

AU - Zip, Catherine

AU - Poon, Emily

AU - Pearlman, Ross

PY - 2024/6/19

Y1 - 2024/6/19

N2 - Importance: Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea. Objective: To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice. Evidence Review: A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set. Findings: The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting. Conclusions and Relevance: This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.

AB - Importance: Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea. Objective: To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice. Evidence Review: A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set. Findings: The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting. Conclusions and Relevance: This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.

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U2 - 10.1001/jamadermatol.2024.0636

DO - 10.1001/jamadermatol.2024.0636

M3 - Review article

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AN - SCOPUS:85191839363

SN - 2168-6068

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EP - 666

JO - JAMA Dermatology

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ER -

Rosacea Core Domain Set for Clinical Trials and Practice: A Consensus Statement

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