Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials
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Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials. / Bottomley, Andrew; Pe, Madeline; Sloan, Jeff; Basch, Ethan; Bonnetain, Franck; Calvert, Melanie; Campbell, Alicyn; Cleeland, Charles; Cocks, Kim; Collette, Laurence; Dueck, Amylou C; Devlin, Nancy; Flechtner, Hans-Henning; Gotay, Carolyn; Greimel, Eva; Griebsch, Ingolf; Grønvold, Mogens; Hamel, Jean-Francois; King, Madeleine; Kluetz, Paul G; Koller, Michael; Malone, Daniel C; Martinelli, Francesca; Mitchell, Sandra A; Moinpour, Carol M; Musoro, Jammbe Z; O'Connor, Daniel; Oliver, Kathy; Piault-Louis, Elisabeth; Piccart, Martine; Pimentel, Francisco L; Quinten, Chantal; Reijneveld, Jaap C; Schürmann, Christoph; Smith, Ashley Wilder; Soltys, Katherine M; Sridhara, Rajeshwari; Taphoorn, Martin J B; Velikova, Galina; Coens, Corneel.
I: Clinical trials (London, England), Bind 15, Nr. 6, 12.2018, s. 624-630.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
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 - Grønvold, 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
Y1 - 2018/12
N2 - 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.
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.
U2 - 10.1177/1740774518795637
DO - 10.1177/1740774518795637
M3 - Journal article
C2 - 30141714
VL - 15
SP - 624
EP - 630
JO - Clinical Trials
JF - Clinical Trials
SN - 1740-7745
IS - 6
ER -
ID: 209176570