The impact of the COVID-19 pandemic on quality of life, physical and psychosocial wellbeing in breast cancer patients – a prospective, multicenter cohort study

  1. C. Bargon
  2. M. Batenburg
  3. L. van Stam
  4. D.Mink van der Molen
  5. I. van Dam
  6. F. van der Leij
  7. I. Baas
  8. M. Ernst
  9. W. Maarse
  10. N. Vermulst
  11. E. Schoenmaeckers
  12. T. van Dalen
  13. R. Bijlsma
  14. D. Young-Afat
  15. A. Doeksen
  16. H. Verkooijen

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Abstract

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  1. Version published to 10.1016/s0959-8049(20)30563-3
  2. ScreenIT

    SciScore for 10.1101/2020.06.26.20140657: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementConsent: Participants provided informed consent for the longitudinal collection of clinical data and patient-reported outcomes (PROs) through paper or online questionnaires at regular intervals during and after treatment.
    IRB: The study was approved by the Medical Ethics Committee of the UMCU (NL52651.041.15, METC 15/165) and is registered on clinicaltrials.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Each subscale of the EORTC questionnaires includes one to five items, all measured by a 4-point Likert scale.
    EORTC
    suggested: (EORTC, RRID:SCR_004070)
    Statistical analyses were performed with the use of IBM Statistical Package for Social Sciences (SPSS) software, version 25 (IBM Corp, Armonk, NY).
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    A limitation of this study is the fact that only 51 patients (4·9%) in our cohort received active treatment during COVID-19, causing relatively wide 95% confidence intervals in this group. As a consequence, the results of this study are predominantly influenced by the large group of breast cancer survivors, while the impact of COVID-19 might be more severe for newly diagnosed patients who, for example, experienced adjusted treatment protocols such as deferred surgery. Second, even though baseline characteristics of responders and non-responders were comparable, an under- or overestimation of the results due to selective (non-)response could not be ruled out as the reasons for 34% non-response were unclear. Third, this study measured the impact of COVID-19 approximately six weeks after the start of COVID-19. Therefore, it is unclear whether the results of this study represent a short-term, or a longer-lasting effect. However, previous literature on the 2009 H1N1 viral threat showed that the psychological effects can persist up to 30 months after the outbreak.13 Last, in this study, we could not compare the impact of COVID-19 on patients (being) treated for breast cancer to the impact on a healthy reference population. An important strength of this study is that the UMBRELLA cohort provided a unique opportunity to longitudinally compare validated PRO scores during COVID-19 with the scores before COVID-19 in an identical population, in a representative population of patients wit...

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT02839863RecruitingUtrecht Cohort for Multiple Breast Cancer Intervention Studi…

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2020.06.26.20140657v1 on medRxiv