The patient-reported outcome content of international ovarian cancer randomised controlled trial protocols

Rebecca Mercieca-Bebber^{1

2}, Michael Friedlander^{3

4}, Peey-Sei Kok^{3

4}, Melanie Calvert⁵, Derek Kyte⁵, Martin Stockler³, Madeleine T King^{6

7

4}

Affiliations

¹ Central Clinical School, Sydney Medical School, University of Sydney, Sydney, NSW, 2006, Australia. Rebecca.mercieca@sydney.edu.au.
² Quality of Life Office, Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Level 6 North, Chris O'Brien Lifehouse C39Z, Sydney, NSW, 2006, Australia. Rebecca.mercieca@sydney.edu.au.
³ NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, 2006, Australia.
⁴ Australian New Zealand Gynecological Oncology Group (ANZGOG), Camperdown, NSW, 2050, Australia.
⁵ Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
⁶ Central Clinical School, Sydney Medical School, University of Sydney, Sydney, NSW, 2006, Australia.
⁷ Quality of Life Office, Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Level 6 North, Chris O'Brien Lifehouse C39Z, Sydney, NSW, 2006, Australia.

PMID: 27294435
DOI: 10.1007/s11136-016-1339-x

Review

The patient-reported outcome content of international ovarian cancer randomised controlled trial protocols

Rebecca Mercieca-Bebber et al. Qual Life Res. 2016 Oct.

. 2016 Oct;25(10):2457-2465.

doi: 10.1007/s11136-016-1339-x. Epub 2016 Jun 13.

Authors

Rebecca Mercieca-Bebber^{1

2}, Michael Friedlander^{3

4}, Peey-Sei Kok^{3

4}, Melanie Calvert⁵, Derek Kyte⁵, Martin Stockler³, Madeleine T King^{6

7

4}

Affiliations

¹ Central Clinical School, Sydney Medical School, University of Sydney, Sydney, NSW, 2006, Australia. Rebecca.mercieca@sydney.edu.au.
² Quality of Life Office, Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Level 6 North, Chris O'Brien Lifehouse C39Z, Sydney, NSW, 2006, Australia. Rebecca.mercieca@sydney.edu.au.
³ NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, 2006, Australia.
⁴ Australian New Zealand Gynecological Oncology Group (ANZGOG), Camperdown, NSW, 2050, Australia.
⁵ Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
⁶ Central Clinical School, Sydney Medical School, University of Sydney, Sydney, NSW, 2006, Australia.
⁷ Quality of Life Office, Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Level 6 North, Chris O'Brien Lifehouse C39Z, Sydney, NSW, 2006, Australia.

PMID: 27294435
DOI: 10.1007/s11136-016-1339-x

Erratum in

Erratum to: The patient-reported outcome content of international ovarian cancer randomised controlled trial protocols.
Mercieca-Bebber R, Friedlander M, Kok PS, Calvert M, Kyte D, Stockler M, King MT. Mercieca-Bebber R, et al. Qual Life Res. 2017 Aug;26(8):2249-2250. doi: 10.1007/s11136-017-1578-5. Qual Life Res. 2017. PMID: 28434060 No abstract available.

Abstract

Purpose: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Clinical trials as topic; Guideline adherence; Ovarian cancer; Patient-reported outcomes; Protocol checklist; Quality of life.

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References

1. BMJ. 2013 Jan 08;346:e7586 - PubMed
1. Lancet. 2014 Jan 18;383(9913):267-76 - PubMed
1. PLoS One. 2016 Jan 19;11(1):e0144658 - PubMed
1. Ann Intern Med. 2013 Feb 5;158(3):200-7 - PubMed
1. Lancet. 2015 Mar 21;385(9973):1073-4 - PubMed

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The patient-reported outcome content of international ovarian cancer randomised controlled trial protocols

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The patient-reported outcome content of international ovarian cancer randomised controlled trial protocols

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