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Supportive Care in Cancer

, Volume 22, Issue 11, pp 3089–3099 | Cite as

Quantitative tool to evaluate the somatic burden due to chemotherapy-induced adverse events: the somatic burden score

  • Michael KoehlerEmail author
  • Thomas Fischer
  • Siegfried Kropf
  • Joerg Frommer
Original Article

Abstract

Purpose

Although there are several established methods like the Common Terminology Criteria for Adverse Events (CTCAE), heretofore, no objective, quantitative measurement exists for the somatic burden due to chemotherapy-induced adverse events (SB-CHINAE). We developed the Somatic Burden Score (SBS-AE) that combines the severity grade and duration of an AE. This paper describes the development and validation of the SBS-AE.

Methods

SBS-AE’s calculation was based on the number of days of CTCAE grades of a particular AE. The target value was the weighted, relative duration of an AE grade using CTCAE v3.0. We applied the SBS-AE in 64 patients with hematological malignancies and high-dose chemotherapy (HDC). The ratio measurement scale of the SBS-AE allows all statistical measures using SBS-AE, as all necessary mathematical operations are defined for it. We calculated an overall-SBS-HDC, defined as the total SB-CHINAE of HDC. To determine SBS-AE’s criterion and construct validity, three self-rating scales and one clinician rating scale were used (German Clinical Trials Register, Main ID: DRKS00003453).

Results

The SBS-AE’s criterion validity could be verified both with statistical significance and at least medium-to-large effects (p < 0.05, Cohen’s d > 0.79, f 2 > 0.18). The quantitative measured SB-CHINAE was equally associated with subjectively assessed physical health-related quality of life (0.15 ≤ R 2 ≤ 0.49), objectively evaluated toxicities (0.48 ≤ R 2 ≤ 0.67), transfusion-dependent thrombocytopenia, and anemia (Cohen’s d > 0.89). Patients’ somatic burden of HDC was 5.8-fold greater compared with standard chemotherapy regimens.

Conclusions

The SBS-AE indicates psychometric and clinical properties and may prove useful in the future design of cancer clinical trials and supportive care interventions inside of the inpatient setting.

Keywords

Quality of life Adverse events Validation Antineoplastic therapy Cancer Somatic Burden Score 

Notes

Acknowledgments

We are indebted to the patients who participated in the study. We are grateful to Theda von Toll for her contribution and expert advice regarding the grading of the AE data. We thank the nurses and medical oncologists who participated in the study.

Conflict of interest

All authors indicated no potential conflicts of interest. The corresponding author had full access to all the raw data and had final responsibility for the decision to submit for publication.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Michael Koehler
    • 1
    Email author
  • Thomas Fischer
    • 1
  • Siegfried Kropf
    • 2
  • Joerg Frommer
    • 3
  1. 1.Department of Hematology and OncologyOtto-von-Guericke-University MagdeburgMagdeburgGermany
  2. 2.Institute for Biometry and Medical InformaticsOtto-von-Guericke-University MagdeburgMagdeburgGermany
  3. 3.Department of Psychosomatic Medicine and PsychotherapyOtto-von-Guericke-University MagdeburgMagdeburgGermany

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