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

Figures & data

Table 1 The Original Version of Questionnaire Form (English Version)

Severity Assessment
Was the ADR the reason for admission? Yes No
If not the reason for admission, did the ADR cause an increased length of stay (LOS) by at least one day? Yes No
Did the ADR result in the permanent harm to the patient ? Yes No (Explain any Yes response) ?
ADR Severity Assessment Scale (Circle the severity level of the adverse reaction)
Level 1: An ADR occurred but required no change in treatment with the suspected drug
Level 2: The ADR required that treatment with the suspected drug be held, discontinued, or otherwise changed. No antidote or other treatment required. No increase in LOS
Level 3: The ADR required that treatment with the suspected drug be held, discontinued, or otherwise changed, AND/OR An antidote or other treatment was required. No increase in LOS
Level 4: A. Any level 3 ADR which increasing LOS by at least 1 day  OR B. The ADR was the reason for admission
Level 5: Any level 4 ADR which requires intensive medical care
Level 6: The adverse reaction caused permanent harm to the patient
Level 7: The adverse reaction either directly or indirectly led to the death of the patient

Notes: Reprinted from Steven C Hartwig, Jerry Siegel APJS. Preventability and Severity Assessment in Reporting Adverse Drug Reactions. Am J Hosp Pharm. 1992; (June), by permission of Oxford University Press.⁹

Table 2 The Result of Pilot Testing of Hartwig Instrument

No.	Short Narrative of the Case	The Results of Case Assessment Based on Hartwig Severity
		Level of ADR Severity	Number of Raters
1	Mrs. S* vomited 2–3 times during the 10th chemotherapy. Previously, she has given pre-medical therapy according to the protocol for prevention of ondansetron, dexamethasone, and ranitidine. To overcome the vomiting, the doctor instructed to give her anti-emetic therapy again, namely, ondansetron, accompanied by dexamethasone and ranitidine. Then, the complaint of vomiting improved.	Severity 1 Severity 3	4 26
2	Mr. R* complained of any canker sores after the 1st chemotherapy. There was a time when Mr. R* had to go to the emergency room and was treated for 3 days because he could not or had difficulty eating, drinking and walking.	Severity 3 Severity 4	3 27
3	Mrs. S* suffered vomiting during the 2nd chemotherapy, although she had previously been given pre-medication therapy according to the protocol for prevention of ondansetron, dexamethasone, and ranitidine. The doctor instructed to give anti-emetic therapy again, namely, ondansetron, accompanied by dexamethasone and ranitidine to overcome the vomiting complaint. Vomiting has improved.	Severity 1 Severity 3	6 24
4	Mr. AR*, age 29 years, has no comorbid disease, leukocytes occurred unusual after the 2nd chemotherapy. On the 3rd chemotherapy (date 11-3-2020), the result of the leukocyte lab test was 2460/ul, and neutrophils was 10.8%. The result of leukocyte baseline lab test (date 10-13-2020) within the normal limit of 5200/ul, thus the chemotherapy was postponed and given Leucogen^® therapy (Filgrastim) for leukocytopenia improvement.	Severity 3 Severity 4	4 26
5	Mr. R* vomited six times at home after the 1st chemotherapy, although during his previous chemotherapy he had been given pre-medical therapy according to the protocol for prevention of ondansetron, dexamethasone, and ranitidine. The patient was taken to the Emergency Room. Then, the patient’s vomiting complaints improved.	Severity 3 Severity 4	4 26
6	Mrs. NN* had anemia (low Hb) during the 5th chemotherapy (normal Hb baseline data), therefore, chemotherapy schedule was canceled. The patient was hospitalized and given transfusion of Packed Red Cells (PRC) to improve her condition.	Severity 3 Severity 4	4 26
7	Mr. AS* experienced nausea during the 2nd chemotherapy, although he had previously been given pre-medication therapy according to the protocol for prevention of ondansetron, dexamethasone, and ranitidine. No therapy was given to address nausea. The patient’s nausea complaint was getting better.	Severity 1 Severity 2	28 2
8	Mrs. F* experienced hypokalemia (from laboratory examination results) during the 6th chemotherapy (normal baseline potassium data), so that the chemotherapy schedule was canceled. The patient was hospitalized to improve her condition.	Severity 4	30
9	Mr. S* suffered a numb hand and tingling during the 3rd chemotherapy. The patient did not get any pharmacological therapy (medication). The complaints were disappeared within a few days.	Severity 1	30
10	Mr. R* was supposed to do the 7th cycle of chemotherapy, but because of his canker sores, he was not present at the hospital for chemotherapy as scheduled, and eventually the chemotherapy schedule was postponed. His canker sores was painful that he had difficulty eating and drinking after the previous chemotherapy. No medication was needed to treat the canker sores.	Severity 1 Severity 2	2 28

Note: * The initials of the patient’s name withheld.

Table 3 The Feasibility Assessment of Instrument in Assessing the Severity of ADR as Well as the Value of CVR and CVI

No.	Rater Rating Results		CVR	CVI
	Score 1*	Score 0**
1	26	4	0,73	0,87
2	29	1	0,93	0,97
3	26	4	0,73	0,87
4	26	4	0,73	0,87
5	30	0	1	1
6	28	2	0,87	0,93
7	29	1	0,93	0,97
8	30	0	1	1
9	29	1	0,93	0,97
10	29	1	0,93	0,97
Overall	30	0	1	1

Notes: *: rater gives a score of 1 if the Hartwig instrument can assess the severity of ADR. **: rater gives a score of 0 if the Hartwig instrument cannot assess the severity of ADR.

Table 4 The Result of ICC Analysis

No.	Parameters	Value	Interpretation
1	Cronbach’s alpha	0.996	Satisfying
2	ANOVA (signification)	0.197	Meaningless differences between raters (p>0.05)
3	ICC	0.896	Reliability between raters with a good degree of reliability

Table 5 Reliability Test Decision-Making Basis

ICC Value	Interpretation
< 0.5	Poor Reliability
0.5–0.75	Moderate Reliability
0.75–0.9	Good Reliability
> 0.90	Excellent Reliability

Note: Data from Koo and Li.²⁶

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

 PubMedGoogle Scholar

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

 PubMed Web of Science ®Google Scholar