Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials

Andrew Bottomley; Madeline Pe; Jeff Sloan; Ethan Basch; Franck Bonnetain; Melanie Calvert; Alicyn Campbell; Charles Cleeland; Kim Cocks; Laurence Collette; Amylou C. Dueck; Nancy Devlin; Hans Henning Flechtner; Carolyn Gotay; Eva Greimel; Ingolf Griebsch; Mogens Groenvold; Jean Francois Hamel; Madeleine King; Paul G. Kluetz; Michael Koller; Daniel C. Malone; Francesca Martinelli; Sandra A. Mitchell; Carol M. Moinpour; Jammbe Z. Musoro; Daniel O’Connor; Kathy Oliver; Elisabeth Piault-Louis; Martine Piccart; Francisco L. Pimentel; Chantal Quinten; Jaap C. Reijneveld; Christoph Schürmann; Ashley Wilder Smith; Katherine M. Soltys; Rajeshwari Sridhara; Martin J.B. Taphoorn; Galina Velikova; Corneel Coens

doi:10.1177/1740774518795637

Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials

Andrew Bottomley, Madeline Pe, Jeff Sloan, Ethan Basch, Franck Bonnetain, Melanie Calvert, Alicyn Campbell, Charles Cleeland, Kim Cocks, Laurence Collette, Amylou C. Dueck, Nancy Devlin, Hans Henning Flechtner, Carolyn Gotay, Eva Greimel, Ingolf Griebsch, Mogens Groenvold, Jean Francois Hamel, Madeleine King, Paul G. KluetzMichael Koller, Daniel C. Malone, Francesca Martinelli, Sandra A. Mitchell, Carol M. Moinpour, Jammbe Z. Musoro, Daniel O’Connor, Kathy Oliver, Elisabeth Piault-Louis, Martine Piccart, Francisco L. Pimentel, Chantal Quinten, Jaap C. Reijneveld, Christoph Schürmann, Ashley Wilder Smith, Katherine M. Soltys, Rajeshwari Sridhara, Martin J.B. Taphoorn, Galina Velikova, Corneel Coens

Pharmacy Practice and Science

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

43 Scopus citations

Abstract

Background: There is currently a lack of consensus on how health-related quality of life and other patient-reported outcome measures in cancer randomized clinical trials are analyzed and interpreted. This makes it difficult to compare results across randomized controlled trials (RCTs) synthesize scientific research, and use that evidence to inform product labeling, clinical guidelines, and health policy. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data for Cancer Clinical Trials (SISAQOL) Consortium aims to develop guidelines and recommendations to standardize analyses of patient-reported outcome data in cancer RCTs. Methods and Results: Members from the SISAQOL Consortium met in January 2017 to discuss relevant issues. Data from systematic reviews of the current state of published research in patient-reported outcomes in cancer RCTs indicated a lack of clear reporting of research hypothesis and analytic strategies, and inconsistency in definitions of terms, including “missing data,”“health-related quality of life,” and “patient-reported outcome.” Based on the meeting proceedings, the Consortium will focus on three key priorities in the coming year: developing a taxonomy of research objectives, identifying appropriate statistical methods to analyze patient-reported outcome data, and determining best practices to evaluate and deal with missing data. Conclusion: The quality of the Consortium guidelines and recommendations are informed and enhanced by the broad Consortium membership which includes regulators, patients, clinicians, and academics.

Original language	English (US)
Pages (from-to)	624-630
Number of pages	7
Journal	Clinical Trials
Volume	15
Issue number	6
DOIs	https://doi.org/10.1177/1740774518795637
State	Published - Dec 1 2018

Keywords

Guidelines
cancer clinical trials
health-related quality of life
patient-reported outcomes
standards

ASJC Scopus subject areas

Pharmacology

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10.1177/1740774518795637

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Bottomley, A., Pe, M., Sloan, J., Basch, E., Bonnetain, F., Calvert, M., Campbell, A., Cleeland, C., Cocks, K., Collette, L., Dueck, A. C., Devlin, N., Flechtner, H. H., Gotay, C., Greimel, E., Griebsch, I., Groenvold, M., Hamel, J. F., King, M., ... Coens, C. (2018). Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials. Clinical Trials, 15(6), 624-630. https://doi.org/10.1177/1740774518795637

Bottomley, A, Pe, M, Sloan, J, Basch, E, Bonnetain, F, Calvert, M, Campbell, A, Cleeland, C, Cocks, K, Collette, L, Dueck, AC, Devlin, N, Flechtner, HH, Gotay, C, Greimel, E, Griebsch, I, Groenvold, M, Hamel, JF, King, M, Kluetz, PG, Koller, M, Malone, DC, Martinelli, F, Mitchell, SA, Moinpour, CM, Musoro, JZ, O’Connor, D, Oliver, K, Piault-Louis, E, Piccart, M, Pimentel, FL, Quinten, C, Reijneveld, JC, Schürmann, C, Smith, AW, Soltys, KM, Sridhara, R, Taphoorn, MJB, Velikova, G & Coens, C 2018, 'Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials', Clinical Trials, vol. 15, no. 6, pp. 624-630. https://doi.org/10.1177/1740774518795637

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title = "Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials",

abstract = "Background: There is currently a lack of consensus on how health-related quality of life and other patient-reported outcome measures in cancer randomized clinical trials are analyzed and interpreted. This makes it difficult to compare results across randomized controlled trials (RCTs) synthesize scientific research, and use that evidence to inform product labeling, clinical guidelines, and health policy. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data for Cancer Clinical Trials (SISAQOL) Consortium aims to develop guidelines and recommendations to standardize analyses of patient-reported outcome data in cancer RCTs. Methods and Results: Members from the SISAQOL Consortium met in January 2017 to discuss relevant issues. Data from systematic reviews of the current state of published research in patient-reported outcomes in cancer RCTs indicated a lack of clear reporting of research hypothesis and analytic strategies, and inconsistency in definitions of terms, including “missing data,”“health-related quality of life,” and “patient-reported outcome.” Based on the meeting proceedings, the Consortium will focus on three key priorities in the coming year: developing a taxonomy of research objectives, identifying appropriate statistical methods to analyze patient-reported outcome data, and determining best practices to evaluate and deal with missing data. Conclusion: The quality of the Consortium guidelines and recommendations are informed and enhanced by the broad Consortium membership which includes regulators, patients, clinicians, and academics.",

keywords = "Guidelines, cancer clinical trials, health-related quality of life, patient-reported outcomes, standards",

author = "Andrew Bottomley and Madeline Pe and Jeff Sloan and Ethan Basch and Franck Bonnetain and Melanie Calvert and Alicyn Campbell and Charles Cleeland and Kim Cocks and Laurence Collette and Dueck, {Amylou C.} and Nancy Devlin and Flechtner, {Hans Henning} and Carolyn Gotay and Eva Greimel and Ingolf Griebsch and Mogens Groenvold and Hamel, {Jean Francois} and Madeleine King and Kluetz, {Paul G.} and Michael Koller and Malone, {Daniel C.} and Francesca Martinelli and Mitchell, {Sandra A.} and Moinpour, {Carol M.} and Musoro, {Jammbe Z.} and Daniel O{\textquoteright}Connor and Kathy Oliver and Elisabeth Piault-Louis and Martine Piccart and Pimentel, {Francisco L.} and Chantal Quinten and Reijneveld, {Jaap C.} and Christoph Sch{\"u}rmann and Smith, {Ashley Wilder} and Soltys, {Katherine M.} and Rajeshwari Sridhara and Taphoorn, {Martin J.B.} and Galina Velikova and Corneel Coens",

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doi = "10.1177/1740774518795637",

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T1 - Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials

AU - Bottomley, Andrew

AU - Pe, Madeline

AU - Sloan, Jeff

AU - Basch, Ethan

AU - Bonnetain, Franck

AU - Calvert, Melanie

AU - Campbell, Alicyn

AU - Cleeland, Charles

AU - Cocks, Kim

AU - Collette, Laurence

AU - Dueck, Amylou C.

AU - Devlin, Nancy

AU - Flechtner, Hans Henning

AU - Gotay, Carolyn

AU - Greimel, Eva

AU - Griebsch, Ingolf

AU - Groenvold, Mogens

AU - Hamel, Jean Francois

AU - King, Madeleine

AU - Kluetz, Paul G.

AU - Koller, Michael

AU - Malone, Daniel C.

AU - Martinelli, Francesca

AU - Mitchell, Sandra A.

AU - Moinpour, Carol M.

AU - Musoro, Jammbe Z.

AU - O’Connor, Daniel

AU - Oliver, Kathy

AU - Piault-Louis, Elisabeth

AU - Piccart, Martine

AU - Pimentel, Francisco L.

AU - Quinten, Chantal

AU - Reijneveld, Jaap C.

AU - Schürmann, Christoph

AU - Smith, Ashley Wilder

AU - Soltys, Katherine M.

AU - Sridhara, Rajeshwari

AU - Taphoorn, Martin J.B.

AU - Velikova, Galina

AU - Coens, Corneel

PY - 2018/12/1

Y1 - 2018/12/1

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AB - Background: There is currently a lack of consensus on how health-related quality of life and other patient-reported outcome measures in cancer randomized clinical trials are analyzed and interpreted. This makes it difficult to compare results across randomized controlled trials (RCTs) synthesize scientific research, and use that evidence to inform product labeling, clinical guidelines, and health policy. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data for Cancer Clinical Trials (SISAQOL) Consortium aims to develop guidelines and recommendations to standardize analyses of patient-reported outcome data in cancer RCTs. Methods and Results: Members from the SISAQOL Consortium met in January 2017 to discuss relevant issues. Data from systematic reviews of the current state of published research in patient-reported outcomes in cancer RCTs indicated a lack of clear reporting of research hypothesis and analytic strategies, and inconsistency in definitions of terms, including “missing data,”“health-related quality of life,” and “patient-reported outcome.” Based on the meeting proceedings, the Consortium will focus on three key priorities in the coming year: developing a taxonomy of research objectives, identifying appropriate statistical methods to analyze patient-reported outcome data, and determining best practices to evaluate and deal with missing data. Conclusion: The quality of the Consortium guidelines and recommendations are informed and enhanced by the broad Consortium membership which includes regulators, patients, clinicians, and academics.

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Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials

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