Incorporating patient-reported outcome measures (PROMs) into a clinical quality registry (CQR) for ovarian cancer: considerations and challenges

Yael R Lefkovits; Natalie Heriot; Alice Sporik; Sharnel Perera; Michael Friedlander; Cyril Dixon; Paul A Cohen; Yeh Chen Lee; Simon Hyde; Gary Richardson; Penelope Webb; Robert Rome; Madeleine King; John Zalcberg; Penelope Schofield

doi:10.1186/s12913-024-11042-8

Incorporating patient-reported outcome measures (PROMs) into a clinical quality registry (CQR) for ovarian cancer: considerations and challenges

BMC Health Serv Res. 2024 Jul 8;24(1):778. doi: 10.1186/s12913-024-11042-8.

Authors

Yael R Lefkovits^{1

2

3}, Natalie Heriot⁴, Alice Sporik⁴, Sharnel Perera⁴, Michael Friedlander⁵, Cyril Dixon⁶, Paul A Cohen^{7

8

9}, Yeh Chen Lee^{10

11

12}, Simon Hyde¹³, Gary Richardson¹⁴, Penelope Webb¹⁵, Robert Rome¹⁶, Madeleine King¹⁷, John Zalcberg⁴, Penelope Schofield^{18

19

20

21}

Affiliations

¹ Royal Melbourne Hospital, Parkville, Melbourne, Victoria, Australia. [email protected].
² School of Public Health and Preventive Medicine, Faculty of Medicine, Monash University, Melbourne, Australia. [email protected].
³ Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Melbourne, Victoria, Australia. [email protected].
⁴ School of Public Health and Preventive Medicine, Faculty of Medicine, Monash University, Melbourne, Australia.
⁵ Department of Medical Oncology, University of New South Wales, Sydney, Australia.
⁶ Ovarian Cancer Australia, Melbourne, Victoria, Australia.
⁷ Discipline of Obstetrics and Gynaecology, Medical School, University of Western Australia, Crawley, Western Australia, Australia.
⁸ Department of Gynaecological Oncology, St John of God Subiaco Hospital, Subiaco, Western Australia, Australia.
⁹ Institute of Health Research, University of Notre Dame, Fremantle, Western Australia, Australia.
¹⁰ Medical Oncology Department, Prince of Wales Hospital, Randwick, New South Wales, Australia.
¹¹ Faculty of Medicine and Health, University of New South Wales, Randwick, New South Wales, Australia.
¹² NHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.
¹³ Department of Gynaecological Oncology, Mercy Hospital for Women, Heidelberg, Victoria, Australia.
¹⁴ Szalmuk Family Department of Medical Oncology, Cabrini Research, Malvern, Victoria, Australia.
¹⁵ QIMR Berghofer Medical Research Institute, Herston, Queensland, Australia.
¹⁶ Clinical Institute of Obstetrics and Gynaecology, Epworth HealthCare, East Melbourne, Victoria, Australia.
¹⁷ School of Psychology, University of Sydney, Sydney, NSW, Australia.
¹⁸ Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Melbourne, Victoria, Australia.
¹⁹ Behavioural Sciences Unit, Health Services Research and Implementation Sciences, Peter MacCallum Centre, Melbourne, Victoria, Australia.
²⁰ Department of Psychology and Iverson Health Innovation Research Institute, Swinburne University, Melbourne, Victoria, Australia.
²¹ Department of Behavioural Sciences in Cancer, Swinburne University, Hawthorne, Victoria, Australia.

Abstract

As medical treatment increasingly focuses on improving health-related quality of life, patient-reported outcome measures (PROMs) are an essential component of clinical research. The National Gynae-Oncology Registry (NGOR) is an Australian clinical quality registry. A suitable PROM was required for the NGOR ovarian cancer module to complement clinical outcomes and provide insights into outcomes important to patients. Our narrative review aimed to identify existing ovarian cancer-specific PROMs and ascertain which tool would be most appropriate for implementation into the NGOR ovarian cancer module.A literature review of Cochrane Library, Embase, MEDLINE and PubMed databases was performed to identify existing ovarian cancer-specific PROM tools. A steering committee was convened to (1) determine the purpose of, and criteria for our required PROM; and (2) to review the available tools against the criteria and recommend the most appropriate one for implementation within the NGOR.The literature review yielded five tools: MOST, EORTC QLQ-OV28, FACIT-O, NFOSI-18 and QOL-OVCA. All were developed and validated for use in clinical trials, but none had been validated for use in clinical quality registry. Our expert steering committee pre-determined purpose of a PROM tool for use within the NGOR was to enable cross-service comparison and benchmarking to drive quality improvements. They identified that while there was no ideal, pre-existing, ovarian cancer-specific PROM tool for implementation into the NGOR, on the basis of its psychometric properties, its available translations, its length and its ability to be adapted, the EORTC tool is most fit-for-purpose for integration into the NGOR.This process enabled identification of the tool most appropriate to provide insights into how ovarian cancer treatments impact patients' quality of life and permit benchmarking across health services.

Keywords: Clinical quality registry; Gynaecological cancer; Ovarian cancer; Patient reported outcome measures; Quality of life.

Publication types

Review

MeSH terms

Australia
Female
Humans
Ovarian Neoplasms* / therapy
Patient Reported Outcome Measures*
Quality of Life*
Registries*