Journal of Multidisciplinary Healthcare (May 2022)

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

  • Susilo R,
  • Diantini A,
  • Lukman K,
  • Perwitasari DA,
  • Kunaedi A

Journal volume & issue
Vol. Volume 15
pp. 1153 – 1161

Abstract

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Rinto Susilo,1,2 Ajeng Diantini,2 Kiki Lukman,3 Dyah Aryani Perwitasari,4 Aan Kunaedi1 1Department of Pharmacology and Clinical Pharmacy, College of Pharmacy Muhammadiyah Cirebon, Cirebon, Indonesia; 2Faculty of Pharmacy, Padjadjaran University, Bandung, Indonesia; 3Faculty of Medicine, Padjadjaran University, Indonesia, Digestive Surgeon Consultant at Hasan Sadikin Hospital, Bandung, Indonesia; 4Faculty of Pharmacy, Ahmad Dahlan University, Yogyakarta, IndonesiaCorrespondence: Dyah Aryani Perwitasari, Faculty of Pharmacy, Ahmad Dahlan University, Prof. Dr. Soepomo Janturan, Yogyakarta, 55165, Indonesia, Tel +62 812-2965-376, Fax +62 0274563515, Email [email protected]: 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.Keywords: chemotherapy, cancer, assessment, severity ADR

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