The patient-reported outcome content of international ovarian cancer randomised controlled trial protocols
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Patient-reported outcomes (PROs) provide the patient’s perspective of the impact of treatment. Evidence suggests that PRO content of randomised controlled trials (RCTs) protocols is generally sub-optimal. This study aimed to describe and evaluate the PRO-specific content of ovarian cancer RCT protocols.
Published, phase III, ovarian cancer RCTs with PRO endpoints were identified following a systematic search of Medline and Cochrane databases (Jan 2000 to Feb 2016). Corresponding RCT protocols were downloaded (if published) or obtained by contacting authors. Two investigators independently assessed adherence of PRO-specific content of included protocols to a checklist of 58 recommended PRO protocol items currently being developed by the International Society for Quality of Life Research. Discrepancies were resolved with a third investigator.
Of 41 eligible trials identified, 26 protocols were assessed (developed 1995–2010). We were unable to obtain the remaining 15 protocols. Protocols addressed a mean of 28 % PRO checklist items (range 8–66 %). Fifteen (58 % of assessed protocols) provided a rationale for PRO assessment, 8 (31 %) described a PRO objective, 24 (92 %) included a PRO assessment schedule, but only 6 (23 %) justified timing of PRO assessments. Twelve protocols (46 %) provided staff data collection instructions, 4 (15 %) included plans for monitoring PRO compliance, and 16 (62 %) included a PRO analysis plan.
On average, protocols addressed less than one-third of PRO protocol checklist items. In some cases, key guidance regarding PRO administration was lacking, which may lead to inconsistent and sub-optimal PRO methodology. Efforts are needed to improve PRO protocol content in cancer trials.
KeywordsQuality of life Patient-reported outcomes Protocol checklist Ovarian cancer Clinical trials as topic Guideline adherence
We are grateful to the Gynaecologic Cancer Inter-Group (GCIG) Symptom Benefit Working Group (SBWG), ImPROVeD Contributor’s Group leaders Professors Michael Friedlander, Felix Hilpert and Florence Joly, and to RCT investigators for providing access to trial protocols; specifically (in alphabetical order), D.K. Armstrong, J. Berek, N. Colombo, M. Bookman, M. Brady, J. Bryce, A. du Bois, G. Elser, A. Harkin, S. Kaye, J. Ledermann, K. Lindemann, B. Monk, T. Perren, M. Piccart, S. Pignata, J. Pfisterer, E. Pujade-Lauraine, N. Reed, G. Rustin, J. Sehouli, P. Vasey, and I. Vergote. We also acknowledge F. Roncolato and A. Long for their assistance identifying eligible trials and the International Society for Quality of Life Research Best Practices for PROs Protocol Checklist Taskforce for their contribution to developing the PRO Protocol Checklist.
This project did not receive specific grant funding. RMB is supported by Sydney Catalyst courtesy of the Cancer Institute NSW. MK is supported by the Australian Government courtesy of Cancer Australia.
Compliance with ethical standards
Conflicts of interest
This article is an analysis of PRO-specific content of RCT protocols. It did not involve direct study of human participants, and therefore, human ethics approval was not required.
This article is an analysis of PRO-specific content of RCT protocols. It did not involve direct study of human participants, and therefore, informed consent was not required.
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