Validation of the QLQ-EN24 instrument for the assessment of health-related quality of life for women with endometrial cancer in México

Abstract

Purpose

The impact of disease activity or treatments on health-related quality of life (HRQL) is crucial in Oncology, but adequate instruments for this assessment are scarce. Our aim is to validate the Mexican-Spanish version of the QLQ-EN24 questionnaire to evaluate HRQL in women with endometrial cancer (EC).

Methods

This is a prospective study of Mexican women with EC, attending a single cancer centre, who responded the QLQ-C30 and QLQ-EN24 instruments; usual psychometric analysis were performed as well as the association of HRQL scales and relevant clinical data. Correlation analysis was performed with the Spearman’s method, reliability analysis with the Cronbach’s alpha, known-group comparisons with the Kruskal–Wallis test, and survival analysis with the Kaplan–Meier method and Log-rank test.

Results

One hundred and eighty-nine women with EC were assessed. Most functional scales reported high values, and most symptom scales, low. Questionnaire compliance rates were high and internal consistency tests demonstrated adequate convergent and divergent validity. Cronbach’s α coefficients of the five multi-item scales the QLQ-EN24 instruments were from 0.659 to 0.887. Scales of the QLQ-C30 and QLQ-EN24 instruments distinguished among clinically distinct groups of patients, particularly based on serum albumin levels. The Urological symptoms, Gastrointestinal symptoms, Body image, Pelvic pain and Taste change scales were significantly associated with OS.

Conclusion

The Mexican-Spanish version of the QLQ-EN24 questionnaire is reliable and valid for the assessment of HRQL in patients with EC and can be broadly used in multi-national clinical trials. However, conclusions derived from scales evaluating sexual function should be handled carefully.

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Fig. 1

Availability of data and material

The database in XLS format for this study is included in the supplementary material.

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Acknowledgments

The authors sincerely thank the European Organization for Research and Treatment of Cancer, Quality of Life Group, particularly Ms. Maria Arnott, for her extensive support. We also thank Professor Deborah Aleman-Hoey, MD., for her English-language editorial review.

Funding

The INCan provided all funds for this study, and no external support has been received.

Author information

Affiliations

Authors

Contributions

DGR, ATL, ABG, ElMS, DDCH and LFOO: study concepts, literature review, protocol writing. DGR and LFOO: project development. GCAG, ARPM, EMS and DDCH: interviews, data acquisition, database construction. DGR, ATL, ABG, ElMS, EdMS, DDCH and LFOO: data management and quality control of the database. DGR, ATL, EdMS and LFOO: data analysis and interpretation. DGR, ATL, ABG, ElMS and LFOO: manuscript drafting. All authors: manuscript final review and approval.

Corresponding author

Correspondence to Luis F. Oñate-Ocaña.

Ethics declarations

Conflict of interest

All authors declare that there are no financial or non-financial conflict of interest.

Ethics approval

The “Comité de Investigación” and the “Comité de Ética en Investigación” (registration numbers 016/046/ICI and CEI1049, respectively) approved the research protocol.

Informed consent

Both committees belong to the “Instituto Nacional de Cancerología, México” and all patients signed an informed consent form.

Consent for publication

The original questionnaires in their European-Spanish versions were adapted and pilot tested, whilst these entire processes were supervised by EORTC. Both instruments were used with the permission of EORTC.

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Cite this article

Gallardo-Rincón, D., Toledo-Leyva, A., Bahena-González, A. et al. Validation of the QLQ-EN24 instrument for the assessment of health-related quality of life for women with endometrial cancer in México. Arch Gynecol Obstet (2021). https://doi.org/10.1007/s00404-021-05990-3

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Keywords

  • Quality of life
  • Endometrial cancer
  • European organization for research and treatment of cancer (EORTC)
  • Outcome assessment
  • Questionnaires