267
Views
0
CrossRef citations to date
0
Altmetric
Original Research

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

ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon & ORCID Icon
Pages 1153-1161 | Published online: 19 May 2022

References

  • BPOM RIb. Basic Pharmacovigilance Module. BPOM RI; 2020.
  • Pérez-Ricart A, Gea-Rodríguez E, Roca-Montañana A, Gil-Máñez E, Pérez-Feliu A. Integrating pharmacovigilance into the routine of pharmacy department: experience of nine years. Farm Hosp. 2019;43(4):128–133. doi:10.7399/fh.11169
  • Meeting IA. 18th ISoP annual meeting “Pharmacovigilance without borders” Geneva, Switzerland, 11–14 November, 2018. Drug Saf. 2018;41(11):1103–1273. doi:10.1007/s40264-018-0719-2.
  • Khan Z, Muhammad K, Karatas Y, Bilen C, Khan FU, Khan FU. Pharmacovigilance and incidence of adverse drug reactions in hospitalized pediatric patients: a mini systematic review. Egypt Pediatr Assoc Gaz. 2020;68(1). doi:10.1186/s43054-020-00038-8
  • BPOM RIa. Pharmacovigilance module for healthcare professionals. BPOM RI; 2020.
  • NCI. Common Terminology Criteria for Adverse Events (CTCAE); 2017.
  • Karpov A, Parcero C, Mok CPY, et al. Performance of trigger tools in identifying adverse drug events in emergency department patients: a validation study. Br J Clin Pharmacol. 2016;82(4):1048–1057. doi:10.1111/bcp.13032
  • Insani WN, Whittlesea C, Alwafi H, Man KKC, Chapman S, Wei L. Prevalence of adverse drug reactions in the primary care setting: a systematic review and meta-analysis. PLoS One. 2021;16(5):1–24. doi:10.1371/journal.pone.0252161
  • Hartwig SC, Jerry Siegel APJS. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992. doi:10.1093/ajhp/49.9.2229
  • Kemenkes RI. Decree of the Minister of Health of the Republic of Indonesia No HK.01.07/MENKES/406/2018on the National Guidelines for Colorectal Cancer Management Medical Services; 2018:1–160.
  • Lim H, Kim SY, Lee E, et al. Sex-dependent adverse drug reactions to 5-fluorouracil in colorectal cancer. Biol Pharm Bull. 2019;42(4):594–600. doi:10.1248/bpb.b18-00707
  • Salehifar E, Gheibi S, Janbabaei G, Mousavi K. Adverse effects of chemotherapy regimens used in colorectal cancer patients in a referral cancer center in North of Iran, 2008–2014. J Pharmaceut Care. 2016;3:3–7.
  • Mastini IAK. Evaluation of chemotherapy regimens and side effects in patients with colorectal cancer stage iii at dr. moewardi hospital surakarta ida ayu kade mastini. Repositori UGM; 2015. http://etd.repository.ugm.ac.id/. Accessed April 7, 2022.
  • RI BPOM. Guidelines for monitoring drug side effects (MESO) for health workers. BPOM RI; 2012.
  • Khalil H, Huang C. Adverse drug reactions in primary care: a scoping review. BMC Health Serv Res. 2020;20(1):1–13. doi:10.1186/s12913-019-4651-7
  • Ratjen I, Schafmayer C, Enderle J, et al. Health-related quality of life in long-term survivors of colorectal cancer and its association with all-cause mortality: a German cohort study. BMC Cancer. 2018;18(1):1–15. doi:10.1186/s12885-018-5075-1
  • Wang VC, Mayer F, Ottawa F, Wippert P. Translation Reliability and Test-Retest Reliability for Elite Athlete ’ s Injury Translation Reliability and Test-Retest Reliability for Elite Athlete ’ s Injury Risk Factor Questionnaire. College Sports Journal. 2015;17(2):231–241. doi:10.5297/ser.1702.009
  • Lee WL, Chinna K, Lim Abdullah K, Zainal Abidin I. The forward-backward and dual-panel translation methods are comparable in producing semantic equivalent versions of a heart quality of life questionnaire. Int J Nurs Pract. 2019;25(1):1–9. doi:10.1111/ijn.12715
  • National Institute of Diabetes and Digestive and Kidney Diseases. Adverse drug reaction probability scale (Naranjo) in drug induced liver injury. In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury; 2012.
  • Oreagba IA, Usman SO; World Health Organization. The use of the WHO-UMC system for standardized case causality assessment. Uppsala Uppsala Monit Cent. 2014;48(3):194–203.
  • Zamanzadeh V, Ghahramanian A, Rassouli M, Abbaszadeh A, Alavi H. Design and implementation content validity study: development of an instrument for measuring patient-centered communication. J Caring Sci. 2015;4(5):165–178. doi:10.15171/jcs.2015.017
  • Lawshe CH. A quantitative approach to content validity. Pers Psychol. 1975;28(4):563–575. doi:10.1111/j.1744-6570.1975.tb01393.x
  • Azwar S. Reliability and validity. Pustaka Pelajar; 2019.
  • Rodrigues IB, Adachi JD, Beattie KA, Macdermid JC. Development and validation of a new tool to measure the facilitators, barriers and preferences to exercise in people with osteoporosis. BMC Musculoskelet Disord. 2017;1–9. doi:10.1186/s12891-017-1914-5
  • Giuseppe P. StaTips Part IV: selection, interpretation and reporting of the intraclass correlation coefficient. South Eur J Orthod Dentofac Res. 2018;5(1):3–5.
  • Koo TK, Li MY. A guideline of selecting and reporting intraclass correlation coefficients for reliability research. J Chiropr Med. 2016;15(2):155–163. doi:10.1016/j.jcm.2016.02.012