What’s missing in patient-reported outcome reporting? A scoping review and aggregated trial-level analysis of completion rates in oncology randomized controlled trials

Krepper, Daniela; Hubel, Niclas J.; Vorbach, Samuel M.; der, Lotte van; Machingura, Abigirl; Seidl, Claudia; Giesinger, Johannes M.; Sztankay, Monika; Kern, Scottie; Fitzsimmons, Deborah; Pe, Madeline; Holzner, Bernhard; Lehmann, Jens

doi:10.1016/j.critrevonc.2025.105100

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What’s missing in patient-reported outcome reporting? A scoping review and aggregated trial-level analysis of completion rates in oncology randomized controlled trials

Daniela Krepper, Niclas J. Hubel, Samuel M. Vorbach, Lotte van der Weijst, Abigirl Machingura, Claudia Seidl, Johannes M. Giesinger, Monika Sztankay, Scottie Kern, Deborah Fitzsimmons

, Madeline Pe, Bernhard Holzner, Jens Lehmann

Critical Reviews in Oncology/Hematology, Volume: 218, Start page: 105100

Swansea University Author: Deborah Fitzsimmons

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DOI (Published version): 10.1016/j.critrevonc.2025.105100

Abstract

BackgroundMissing patient-reported outcome (PRO) data undermine the ability to draw robust conclusions from PRO endpoints included in cancer randomized controlled trials (RCTs). This review aimed to systematically evaluate PRO completion rates and identify trial characteristics associated with compl...

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Published in:	Critical Reviews in Oncology/Hematology
ISSN:	1040-8428
Published:	Elsevier BV 2026
Online Access:	Check full text
URI:	https://cronfa.swan.ac.uk/Record/cronfa71179

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This review aimed to systematically evaluate PRO completion rates and identify trial characteristics associated with completion.MethodsWe conducted a scoping review searching for RCTs published on PubMed between 2019 and 2023. We searched for RCTs evaluating biomedical interventions in patients with solid tumors (breast, bladder, colorectal, gynecological, prostate, or lung). Trials were eligible if they used commonly applied cancer-specific PRO measures and reported information on completion. For each trial, we extracted or calculated completion rates at baseline and first post-baseline assessment, reasons for missingness, and trial characteristics. We used regression models to examine associations between trial characteristics and completion.FindingsWe identified 222 eligible trials from 9331 screened references. Mean baseline PRO completion rates were 91·3 % (control) and 92·1 % (intervention), declining to 82·1 % and 82·9 % at the first post-baseline assessment. Reasons for missing PRO data were documented in only 18 % of trials. Industry-sponsored trials exhibited significantly higher completion rates compared to non-industry-sponsored trials. Trials with double-blind designs had higher completion rates than open-label trials, while no difference between treatment arms was found. Electronic PRO assessment was not significantly associated with higher completion rates.InterpretationPRO completion rates in cancer RCTs remain challenging as they vary across settings, particularly beyond baseline, and reporting on missing data is often inadequate. 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spelling	2026-01-16T16:45:26.9996781 v2 71179 2025-12-30 What’s missing in patient-reported outcome reporting? A scoping review and aggregated trial-level analysis of completion rates in oncology randomized controlled trials e900d99a0977beccf607233b10c66b43 0000-0002-7286-8410 Deborah Fitzsimmons Deborah Fitzsimmons true false 2025-12-30 HSOC BackgroundMissing patient-reported outcome (PRO) data undermine the ability to draw robust conclusions from PRO endpoints included in cancer randomized controlled trials (RCTs). This review aimed to systematically evaluate PRO completion rates and identify trial characteristics associated with completion.MethodsWe conducted a scoping review searching for RCTs published on PubMed between 2019 and 2023. We searched for RCTs evaluating biomedical interventions in patients with solid tumors (breast, bladder, colorectal, gynecological, prostate, or lung). Trials were eligible if they used commonly applied cancer-specific PRO measures and reported information on completion. For each trial, we extracted or calculated completion rates at baseline and first post-baseline assessment, reasons for missingness, and trial characteristics. We used regression models to examine associations between trial characteristics and completion.FindingsWe identified 222 eligible trials from 9331 screened references. Mean baseline PRO completion rates were 91·3 % (control) and 92·1 % (intervention), declining to 82·1 % and 82·9 % at the first post-baseline assessment. Reasons for missing PRO data were documented in only 18 % of trials. Industry-sponsored trials exhibited significantly higher completion rates compared to non-industry-sponsored trials. Trials with double-blind designs had higher completion rates than open-label trials, while no difference between treatment arms was found. Electronic PRO assessment was not significantly associated with higher completion rates.InterpretationPRO completion rates in cancer RCTs remain challenging as they vary across settings, particularly beyond baseline, and reporting on missing data is often inadequate. These findings highlight the need for improved reporting and greater prioritization of PRO completion regardless of trial design. Journal Article Critical Reviews in Oncology/Hematology 218 105100 Elsevier BV 1040-8428 1 2 2026 2026-02-01 10.1016/j.critrevonc.2025.105100 COLLEGE NANME Health and Social Care School COLLEGE CODE HSOC Swansea University Another institution paid the OA fee Funding for this study was provided by the EORTC Quality of Life Group (grant number 008–2023). 2026-01-16T16:45:26.9996781 2025-12-30T17:33:02.5422326 Faculty of Medicine, Health and Life Sciences School of Health and Social Care - Public Health Daniela Krepper 1 Niclas J. Hubel 2 Samuel M. Vorbach 3 Lotte van der Weijst 4 Abigirl Machingura 5 Claudia Seidl 6 Johannes M. Giesinger 7 Monika Sztankay 8 Scottie Kern 9 Deborah Fitzsimmons 0000-0002-7286-8410 10 Madeline Pe 11 Bernhard Holzner 12 Jens Lehmann 0000-0002-4670-7517 13 71179__36028__bb1364f121594f5693f0cd7708e01827.pdf 71179.VoR.pdf 2026-01-16T16:44:44.4147234 Output 1470463 application/pdf Version of Record true © 2025 The Author(s). This is an open access article under the CC BY license. true eng http://creativecommons.org/licenses/by/4.0/
title	What’s missing in patient-reported outcome reporting? A scoping review and aggregated trial-level analysis of completion rates in oncology randomized controlled trials
spellingShingle	What’s missing in patient-reported outcome reporting? A scoping review and aggregated trial-level analysis of completion rates in oncology randomized controlled trials Deborah Fitzsimmons
title_short	What’s missing in patient-reported outcome reporting? A scoping review and aggregated trial-level analysis of completion rates in oncology randomized controlled trials
title_full	What’s missing in patient-reported outcome reporting? A scoping review and aggregated trial-level analysis of completion rates in oncology randomized controlled trials
title_fullStr	What’s missing in patient-reported outcome reporting? A scoping review and aggregated trial-level analysis of completion rates in oncology randomized controlled trials
title_full_unstemmed	What’s missing in patient-reported outcome reporting? A scoping review and aggregated trial-level analysis of completion rates in oncology randomized controlled trials
title_sort	What’s missing in patient-reported outcome reporting? A scoping review and aggregated trial-level analysis of completion rates in oncology randomized controlled trials
author_id_str_mv	e900d99a0977beccf607233b10c66b43
author_id_fullname_str_mv	e900d99a0977beccf607233b10c66b43_***_Deborah Fitzsimmons
author	Deborah Fitzsimmons
author2	Daniela Krepper Niclas J. Hubel Samuel M. Vorbach Lotte van der Weijst Abigirl Machingura Claudia Seidl Johannes M. Giesinger Monika Sztankay Scottie Kern Deborah Fitzsimmons Madeline Pe Bernhard Holzner Jens Lehmann
format	Journal article
container_title	Critical Reviews in Oncology/Hematology
container_volume	218
container_start_page	105100
publishDate	2026
institution	Swansea University
issn	1040-8428
doi_str_mv	10.1016/j.critrevonc.2025.105100
publisher	Elsevier BV
college_str	Faculty of Medicine, Health and Life Sciences
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hierarchy_top_id	facultyofmedicinehealthandlifesciences
hierarchy_top_title	Faculty of Medicine, Health and Life Sciences
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hierarchy_parent_title	Faculty of Medicine, Health and Life Sciences
department_str	School of Health and Social Care - Public Health{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Health and Social Care - Public Health
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description	BackgroundMissing patient-reported outcome (PRO) data undermine the ability to draw robust conclusions from PRO endpoints included in cancer randomized controlled trials (RCTs). This review aimed to systematically evaluate PRO completion rates and identify trial characteristics associated with completion.MethodsWe conducted a scoping review searching for RCTs published on PubMed between 2019 and 2023. We searched for RCTs evaluating biomedical interventions in patients with solid tumors (breast, bladder, colorectal, gynecological, prostate, or lung). Trials were eligible if they used commonly applied cancer-specific PRO measures and reported information on completion. For each trial, we extracted or calculated completion rates at baseline and first post-baseline assessment, reasons for missingness, and trial characteristics. We used regression models to examine associations between trial characteristics and completion.FindingsWe identified 222 eligible trials from 9331 screened references. Mean baseline PRO completion rates were 91·3 % (control) and 92·1 % (intervention), declining to 82·1 % and 82·9 % at the first post-baseline assessment. Reasons for missing PRO data were documented in only 18 % of trials. Industry-sponsored trials exhibited significantly higher completion rates compared to non-industry-sponsored trials. Trials with double-blind designs had higher completion rates than open-label trials, while no difference between treatment arms was found. Electronic PRO assessment was not significantly associated with higher completion rates.InterpretationPRO completion rates in cancer RCTs remain challenging as they vary across settings, particularly beyond baseline, and reporting on missing data is often inadequate. These findings highlight the need for improved reporting and greater prioritization of PRO completion regardless of trial design.
published_date	2026-02-01T05:34:47Z
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What’s missing in patient-reported outcome reporting? A scoping review and aggregated trial-level analysis of completion rates in oncology randomized controlled trials

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