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Clinical Validation of the BREAST-Q Breast-Conserving Therapy Module

  • Breast Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

The BREAST-Q is a patient-reported outcome measure to evaluate satisfaction and health-related quality of life (HRQOL) after breast surgery. The aim of this study is to test the acceptability, reliability, and validity of the most recently developed BREAST-Q module for breast-conserving therapy (BCT) in a prospective clinical cohort.

Methods

The BREAST-Q BCT module was translated into German according to international guidelines. A total of 253 women with primary breast cancer undergoing BCT were recruited preoperatively. This study evaluated the BREAST-Q BCT subscales by using psychometric methods including acceptability, reliability, and validity. To examine construct validity, convergent and discriminant validity were determined by testing the instrument’s scales against the EORTC C30 and BR23 as reference questionnaires.

Results

Acceptability was supported by a high follow-up rate (90%) and low frequency of missing data (< 10%) in all but three scales. Scale reliability was supported by high Cronbach’s alpha coefficients (> 0.86) and item-total correlations (range of means, 0.33–0.89). Validity was shown by convergent and divergent correlations. The hypotheses of relationships between the scales of the BREAST-Q and the EORTC QLQ C30 BR23 revealed moderate to high correlations.

Conclusions

The BREAST-Q BCT module proved to be an accepted, reliable, and valid questionnaire for the assessment of HRQOL and patient satisfaction after BCT in breast cancer patients. It can be recommended as a possible standard PROM for individual clinical analysis, quality assessment, and future trials.

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Acknowledgment

We would like to thank Michael Hanna, Ph.D. (Mercury Medical Research and Writing) for proof-reading the manuscript and providing feedback on it, especially in regards to the high Cronbach’s alphas.

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Authors and Affiliations

  1. Department of Gynecology and Obstetrics, University of Heidelberg, Heidelberg, Germany

    Ilona Stolpner, Jörg Heil MD, Michael Golatta MD, Florian Schütz MD, Christof Sohn MD & André Hennigs MD

  2. Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany

    Manuel Feißt MSc

  3. Department of Gynecology with Breast Center, Charité University Hospital Berlin, Berlin, Germany

    Maria Margarete Karsten MD & Jens-Uwe Blohmer MD

  4. Breast Center, University Hospital Basel and University of Basel, Basel, Switzerland

    Walter P. Weber MD

  5. Department of Radiation Oncology, University of Heidelberg, Heidelberg, Germany

    Tobias Forster MD

Authors
  1. Ilona Stolpner
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  2. Jörg Heil MD
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  3. Manuel Feißt MSc
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  4. Maria Margarete Karsten MD
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  6. Jens-Uwe Blohmer MD
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  7. Tobias Forster MD
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  8. Michael Golatta MD
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  11. André Hennigs MD
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Corresponding author

Correspondence to André Hennigs MD.

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Conflict of interest

There are no conflicts of interests (e.g. employment, consultancies, stock ownership, honoraria, paid expert testimony, patent applications/registrations, and grants or other funding) by any of the authors with regard to this paper.

Ethical Approval

The study was approved by the ethics commission of the University of Heidelberg Medical School. The study was deemed to be without risk, including only anonymized analysis of routinely collected data; consequently the ethics committee of the University of Heidelberg did not request approval for consent for this analysis.

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Stolpner, I., Heil, J., Feißt, M. et al. Clinical Validation of the BREAST-Q Breast-Conserving Therapy Module. Ann Surg Oncol 26, 2759–2767 (2019). https://doi.org/10.1245/s10434-019-07456-y

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