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Original research
Association of patient-reported outcomes and ovarian cancer recurrence
  1. Anette Stolberg Kargo1,2,
  2. Pernille Tine Jensen3,4,
  3. Kristina Lindemann5,6,
  4. Niels Henrik Hjøllund7,8,
  5. Gabor Istvan Liposits9,
  6. Nicoline Raaschou-Jensen10,
  7. Bettina Mølri Knudsen11,12,
  8. Sören Möller13,14,
  9. Dorte Gilså Hansen15,16 and
  10. Karina Dahl Steffensen1,2
  1. 1 Department of Oncology, Lillebaelt Hospital - University Hospital of Southern Denmark, Vejle, Denmark
  2. 2 Institute of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark
  3. 3 Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
  4. 4 Department of Gynecology and Obstetrics, Aarhus University Hospital, Aarhus, Denmark
  5. 5 Department of Gynecological Oncology, Division of Cancer Medicine, Oslo University Hospital, Oslo, Norway
  6. 6 Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway
  7. 7 Department of Clinical Epidemiology, Aarhus University Denmark, Aarhus, Denmark
  8. 8 AmbuFlex, Center for Patient-Reported Outcomes, Hospital Unit West Jutland, Herning, Denmark
  9. 9 Department of Oncology, Regional Hospital West Jutland, Herning, Denmark
  10. 10 Herlev Hospital Department of Oncology, Herlev, Denmark
  11. 11 Administration, Lillebaelt Hospital - University Hospital of Southern Denmark, Vejle, Denmark
  12. 12 Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark
  13. 13 Department of Clinical Research, University of Southern Denmark, Odense, Denmark
  14. 14 OPEN - Open Patient data Explorative Network, Odense Universitetshospital, Odense, Denmark
  15. 15 Institute of Regional Health Research, University of Southern Denmark, Odense, Syddanmark, Denmark
  16. 16 Center for Shared Decision Making, Lillebaelt Hospital - University Hospital of Southern Denmark, Vejle, Denmark
  1. Correspondence to Dr Anette Stolberg Kargo, Department of Oncology, Lillebaelt Hospital - University Hospital of Southern Denmark, Vejle, Odense 5000, Denmark; Anette.Stolberg.Kargo{at}rsyd.dk

Abstract

Background The vast majority of patients with advanced ovarian cancer experience disease recurrence after primary treatment.

Objective To explore the diagnostic accuracy of repeated measurement of patient-reported outcomes and quality-of-life scores in relation to ovarian cancer recurrence.

Methods Patients with ovarian cancer were recruited to the PROMova study by the end of their primary treatment at eight centers in Denmark. The purpose of the PROMova study was to explore the applicability of repeated use of patient-reported outcomes, which consisted of the European Organization for Research and Treatment of Cancer generic questionnaire and the ovarian specific questionnaire. The patient-reported outcomes were completed 3, 6, 9, 12, and 15 months after enrollment or until recurrence. The 3-month interval between completions was the period in which recurrence was assessed. Imaging and the biomarker CA125 were used as reference modality for recurrence. Mixed effects logistic regression was used to investigate the association between mean patient-reported outcome scores and recurrence. Receiver operating curves were used to establish cut-off scores. The diagnostic accuracy of patient-reported outcomes, including sensitivity, specificity, and positive and negative predictive values was estimated based on the Youden index. For combined scales, diagnostic accuracy was investigated based on multivariate analysis.

Results The analysis included 196 patients with an overall recurrence rate of 50.5% and an overall mean time to recurrence of 302 days. With imaging as reference, patients with recurrence reported significantly lower global health, worse physical functioning, and more abdominal symptoms preceding recurrence. With CA125 as reference, global health, physical and emotional functioning were impaired. Despite the worsening of a number of symptoms prior to recurrence whichever reference modality was applied, the patient-reported outcome scores did not provide adequate diagnostic accuracy.

Conclusion Repeated use of patient-reported outcomes during surveillance of ovarian cancer was not of diagnostic value. Future efforts should be directed at improving the administration of patient-reported outcomes as well as exploring the potential of using these outcomes as an indicator of clinical relevance.

  • ovarian neoplasms
  • quality of life (pro)/palliative care
  • medical oncology

Data availability statement

All data are available upon reasonable request.

https://doi.org/10.1136/ijgc-2021-002550

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    Data availability statement

    All data are available upon reasonable request.

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    Footnotes

    • Contributors ASK drafted the first version of this article. PTJ, KL, DGH, and KDS revised this article with a substantial contribution. NHH was responsible for the AmbuFlex IT platform. BMK revised the editing of the manuscript. SM was responsible for the data analysis. GIL and NR-J participated with insight into the clinical routines at their departments and patient inclusion.

    • Funding The PROMova study was financially supported by the Family Hede Nielsen Foundation, the chief physician Jørgen Werner Schou and wife Else Marie Schou, born Wonge Foundation, the Research Council of Lillebaelt Hospital, the Danish Cancer Society (00 262 120), and the Region of Southern Denmark (grant A188).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.