Quality of Patient-Reported Outcome reporting across cancer randomized controlled trials according to the CONSORT PRO Extension

a pooled analysis of 557 trials

Fabio Efficace (Corresponding Author), Peter Fayers, Andrea Pusic, Yeliz Cemal, Jane Yanagawa, Marc Jacobs, Andrea la Sala, Valentina Cafaro, Katie Whale, Jonathan Rees, Jane Blazeby

Research output: Contribution to journalArticle

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Abstract

BACKGROUNDThe main objectives of this study were to identify the number of randomized controlled trials (RCTs) including a patient‐reported outcome (PRO) endpoint across a wide range of cancer specialties and to evaluate the completeness of PRO reporting according to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension.METHODSRCTs with a PRO endpoint that had been performed across several cancer specialties and published between 2004 and 2013 were considered. Studies were evaluated on the basis of previously defined criteria, including the CONSORT PRO extension and the Cochrane Collaboration's tool for assessing the risk of bias of RCTs. Analyses were also conducted by the type of PRO endpoint (primary vs secondary) and by the cancer disease site. RESULTSA total of 56,696 potentially eligible records were scrutinized, and 557 RCTs with a PRO evaluation, enrolling 254,677 patients overall, were identified. PROs were most frequently used in RCTs of breast (n = 123), lung (n = 85), and colorectal cancer (n = 66). Overall, PROs were secondary endpoints in 421 RCTs (76%). Four of 6 evaluated CONSORT PRO items were documented in less than 50% of the RCTs. The level of reporting was higher in RCTs with a PRO as a primary endpoint. The presence of a supplementary report was the only statistically significant factor associated with greater completeness of reporting for both RCTs with PROs as primary endpoints (β = .19, P = .001) and RCTs with PROs as secondary endpoints (β = .30, P < .001).CONCLUSIONSImplementation of the CONSORT PRO extension is equally important across all cancer specialties. Its use can also contribute to revealing the robust PRO design of some studies, which might be obscured by poor outcome reporting.
Original languageEnglish
Pages (from-to)3335-3342
Number of pages8
JournalCancer
Volume121
Issue number8
Early online date16 Jun 2015
DOIs
Publication statusPublished - 15 Sep 2015

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Randomized Controlled Trials
Neoplasms
Patient Reported Outcome Measures
Colorectal Neoplasms
Breast
Lung

Keywords

  • Cancer
  • Clinical trials
  • Consolidated Standards of Reporting Trials (CONSORT)
  • Patient-reported outcomes
  • Quality of life

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Quality of Patient-Reported Outcome reporting across cancer randomized controlled trials according to the CONSORT PRO Extension : a pooled analysis of 557 trials. / Efficace, Fabio (Corresponding Author); Fayers, Peter; Pusic, Andrea; Cemal, Yeliz; Yanagawa, Jane; Jacobs, Marc; la Sala, Andrea; Cafaro, Valentina; Whale, Katie; Rees, Jonathan ; Blazeby, Jane .

In: Cancer, Vol. 121, No. 8, 15.09.2015, p. 3335-3342.

Research output: Contribution to journalArticle

Efficace, F, Fayers, P, Pusic, A, Cemal, Y, Yanagawa, J, Jacobs, M, la Sala, A, Cafaro, V, Whale, K, Rees, J & Blazeby, J 2015, 'Quality of Patient-Reported Outcome reporting across cancer randomized controlled trials according to the CONSORT PRO Extension: a pooled analysis of 557 trials', Cancer, vol. 121, no. 8, pp. 3335-3342. https://doi.org/10.1002/cncr.29489
Efficace, Fabio ; Fayers, Peter ; Pusic, Andrea ; Cemal, Yeliz ; Yanagawa, Jane ; Jacobs, Marc ; la Sala, Andrea ; Cafaro, Valentina ; Whale, Katie ; Rees, Jonathan ; Blazeby, Jane . / Quality of Patient-Reported Outcome reporting across cancer randomized controlled trials according to the CONSORT PRO Extension : a pooled analysis of 557 trials. In: Cancer. 2015 ; Vol. 121, No. 8. pp. 3335-3342.
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abstract = "BACKGROUNDThe main objectives of this study were to identify the number of randomized controlled trials (RCTs) including a patient‐reported outcome (PRO) endpoint across a wide range of cancer specialties and to evaluate the completeness of PRO reporting according to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension.METHODSRCTs with a PRO endpoint that had been performed across several cancer specialties and published between 2004 and 2013 were considered. Studies were evaluated on the basis of previously defined criteria, including the CONSORT PRO extension and the Cochrane Collaboration's tool for assessing the risk of bias of RCTs. Analyses were also conducted by the type of PRO endpoint (primary vs secondary) and by the cancer disease site. RESULTSA total of 56,696 potentially eligible records were scrutinized, and 557 RCTs with a PRO evaluation, enrolling 254,677 patients overall, were identified. PROs were most frequently used in RCTs of breast (n = 123), lung (n = 85), and colorectal cancer (n = 66). Overall, PROs were secondary endpoints in 421 RCTs (76{\%}). Four of 6 evaluated CONSORT PRO items were documented in less than 50{\%} of the RCTs. The level of reporting was higher in RCTs with a PRO as a primary endpoint. The presence of a supplementary report was the only statistically significant factor associated with greater completeness of reporting for both RCTs with PROs as primary endpoints (β = .19, P = .001) and RCTs with PROs as secondary endpoints (β = .30, P < .001).CONCLUSIONSImplementation of the CONSORT PRO extension is equally important across all cancer specialties. Its use can also contribute to revealing the robust PRO design of some studies, which might be obscured by poor outcome reporting.",
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note = "FUNDING SUPPORT This work was funded by the Quality-of-Life Group of the European Organization for Research and Treatment of Cancer, the Italian Group for Adult Hematologic Diseases, and the Italian Association Against Leukemia, Lymphoma, and Myeloma.",
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T1 - Quality of Patient-Reported Outcome reporting across cancer randomized controlled trials according to the CONSORT PRO Extension

T2 - a pooled analysis of 557 trials

AU - Efficace, Fabio

AU - Fayers, Peter

AU - Pusic, Andrea

AU - Cemal, Yeliz

AU - Yanagawa, Jane

AU - Jacobs, Marc

AU - la Sala, Andrea

AU - Cafaro, Valentina

AU - Whale, Katie

AU - Rees, Jonathan

AU - Blazeby, Jane

N1 - FUNDING SUPPORT This work was funded by the Quality-of-Life Group of the European Organization for Research and Treatment of Cancer, the Italian Group for Adult Hematologic Diseases, and the Italian Association Against Leukemia, Lymphoma, and Myeloma.

PY - 2015/9/15

Y1 - 2015/9/15

N2 - BACKGROUNDThe main objectives of this study were to identify the number of randomized controlled trials (RCTs) including a patient‐reported outcome (PRO) endpoint across a wide range of cancer specialties and to evaluate the completeness of PRO reporting according to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension.METHODSRCTs with a PRO endpoint that had been performed across several cancer specialties and published between 2004 and 2013 were considered. Studies were evaluated on the basis of previously defined criteria, including the CONSORT PRO extension and the Cochrane Collaboration's tool for assessing the risk of bias of RCTs. Analyses were also conducted by the type of PRO endpoint (primary vs secondary) and by the cancer disease site. RESULTSA total of 56,696 potentially eligible records were scrutinized, and 557 RCTs with a PRO evaluation, enrolling 254,677 patients overall, were identified. PROs were most frequently used in RCTs of breast (n = 123), lung (n = 85), and colorectal cancer (n = 66). Overall, PROs were secondary endpoints in 421 RCTs (76%). Four of 6 evaluated CONSORT PRO items were documented in less than 50% of the RCTs. The level of reporting was higher in RCTs with a PRO as a primary endpoint. The presence of a supplementary report was the only statistically significant factor associated with greater completeness of reporting for both RCTs with PROs as primary endpoints (β = .19, P = .001) and RCTs with PROs as secondary endpoints (β = .30, P < .001).CONCLUSIONSImplementation of the CONSORT PRO extension is equally important across all cancer specialties. Its use can also contribute to revealing the robust PRO design of some studies, which might be obscured by poor outcome reporting.

AB - BACKGROUNDThe main objectives of this study were to identify the number of randomized controlled trials (RCTs) including a patient‐reported outcome (PRO) endpoint across a wide range of cancer specialties and to evaluate the completeness of PRO reporting according to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension.METHODSRCTs with a PRO endpoint that had been performed across several cancer specialties and published between 2004 and 2013 were considered. Studies were evaluated on the basis of previously defined criteria, including the CONSORT PRO extension and the Cochrane Collaboration's tool for assessing the risk of bias of RCTs. Analyses were also conducted by the type of PRO endpoint (primary vs secondary) and by the cancer disease site. RESULTSA total of 56,696 potentially eligible records were scrutinized, and 557 RCTs with a PRO evaluation, enrolling 254,677 patients overall, were identified. PROs were most frequently used in RCTs of breast (n = 123), lung (n = 85), and colorectal cancer (n = 66). Overall, PROs were secondary endpoints in 421 RCTs (76%). Four of 6 evaluated CONSORT PRO items were documented in less than 50% of the RCTs. The level of reporting was higher in RCTs with a PRO as a primary endpoint. The presence of a supplementary report was the only statistically significant factor associated with greater completeness of reporting for both RCTs with PROs as primary endpoints (β = .19, P = .001) and RCTs with PROs as secondary endpoints (β = .30, P < .001).CONCLUSIONSImplementation of the CONSORT PRO extension is equally important across all cancer specialties. Its use can also contribute to revealing the robust PRO design of some studies, which might be obscured by poor outcome reporting.

KW - Cancer

KW - Clinical trials

KW - Consolidated Standards of Reporting Trials (CONSORT)

KW - Patient-reported outcomes

KW - Quality of life

U2 - 10.1002/cncr.29489

DO - 10.1002/cncr.29489

M3 - Article

VL - 121

SP - 3335

EP - 3342

JO - Cancer

JF - Cancer

SN - 0008-543X

IS - 8

ER -