Translation and Validation of the Indonesian Version of the Adverse Drug Reaction Severity Level Instruments in Colorectal Cancer Patients

Abstract

Introduction

Assessment of the severity of adverse drug reaction (ADR) is very rare in Indonesia. The severity of ADR can describe how serious this affects the clinical condition of the patient. In Indonesia, there are no instruments used to measure the severity of ADR.

Purpose

This study aims to translate, pilot test, and validate Hartwig instruments for measuring the severity of ADR in colorectal cancer patients in Indonesia.

Patients and Methods

The translation method was used forward-backward technique from English to Indonesian, then being retranslated from Indonesia to English. The instrument of Indonesian version was used to assess the severity of ADR as the effect of chemotherapy. The assessment was conducted to 10 colorectal cancer patients by 30 health workers. The test validity was done based on content validity ratio (CVR) and content validity index (CVI); meanwhile, the test reliability was based on intraclass coefficient correlation (ICC).

Results

All of the results of CVR present a value of >0.33, while the range of CVI moves between 0.8 to 1.0, which declares that the instrument is valid. The satisfactory alpha value for reliability is 0.996 with signification of 0.197 (p > 0.05) based on ANOVA analysis. Meanwhile, the ICC value of 0.896 indicates a good reliability among raters.

Conclusion

Indonesian version of Hartwig Instrument can be applied in measuring the severity of ADR caused by chemotherapy in colorectal cancer patients.

Graphical abstract

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Keywords:

• chemotherapy
• cancer
• assessment
• severity ADR

Acknowledgments

Authors thank the Directorate General of Higher Education Ministry of Education and Culture of the Republic of Indonesia and Direktorat Riset dan Pengabdian pada Masyarakat (DRPM) of Padjadjaran University  for the support of funds, Dr. Hasan Sadikin Central General Hospital Bandung, GunungJati Regional Public Hospital Cirebon, Waled Regional Public Hospital Cirebon for being willing to become the assessment team and provide research facilities. Also, we appreciate Indonesian Applied Linguistics Association (ALTI) of The State Institute for Islamic Studies Syekh Nurjati Cirebon, Language Center of Faculty of Teacher Training and Education Gunung Jati University (UGJ) Cirebon, Mr. Gary William Dobbs and Mr. Timur Omarov for their assistance for being the translator in our research.

Disclosure

There is no conflict of interest from all authors regarding the content of this manuscript. Research and publication are conducted solely for the education and development of science.