Background
Methods
Study design
Setting and population
Inclusion/exclusion criteria
Chart review data collection methods
Qualitative data collection methods
Definitions
Adverse drug event
Best practice-based preventability assessment
Error-based preventability assessment
Algorithm-based preventability assessment
Definitely Preventable ADE | |
1. Was there a history of allergy or previous reactions to the drug or drug class? | Yes/No/Uncertain |
-If yes, was the re exposure inappropriate?a* | Yes/No/Uncertain |
2. Was any drug involved inappropriate for the patient’s clinical condition?a | Yes/No/Uncertain |
3. Was the dose, route or frequency of administration inappropriate for the patient’s age, weight or disease state?a | Yes/No/Uncertain |
4.Was a toxic serum drug concentration (or laboratory monitoring test) documented?a | Yes/No/Uncertain |
5. Was there a known treatment for the ADE? (eg. To prevent predictable drug side effects)a | Yes/No/Uncertain |
Probably Preventable ADE | |
6. Was required therapeutic drug monitoring or other necessary tests not performed?b | Yes/No/Uncertain |
7. Was a drug interaction involved in the ADE?b | Yes/No/Uncertain |
8. Was poor compliance involved in the ADE?b | Yes/No/Uncertain |
9. Were preventative measures not prescribed or administered to the patient? (eg. Untreated indication?) | Yes/No/Uncertain |
-If yes, were preventative measures not contraindicated?b* | Yes/No/Uncertain |
Additional Criteria for ADE Preventability | |
10. Was there an error in ADE diagnosis that contributed to the event persisting/getting worse?a* | Yes/No/Uncertain |
11. Was there a delay in ADE diagnosis that contributed to the event persisting/getting worse?b* | Yes/No/Uncertain |
12. Was there a failure to act on the result of monitoring or testing?a* | Yes/No/Uncertain |
13. Were there errors in the transcription of the culprit drug(s) order?a* | Yes/No/Uncertain |
14. Were there any errors in dispensing of the culprit drug(s) order?a* | Yes/No/Uncertain |
15. Were there any errors in the administration of the culprit drug(s)?a* | Yes/No/Uncertain |
16. Was a superior alternative treatment available (without contraindication) that is less likely to cause an ADE?b* | Yes/No/Uncertain |
17. Was there any failure in communication that contributed to the ADE?a* | Yes/No/Uncertain |
18. Was there any equipment failure that contributed to the ADE?a* | Yes/No/Uncertain |
Automated preventability assessment based on algorithm | Definitely/Probably/Not |
Analysis
Quantitative
Qualitative
Results
Quantitative results
Preventability Rating | Best Practice-Based [4] | Error-Based [23] | Algorithm-Based [24] |
---|---|---|---|
Definitely or probably preventable, n (%, 95 CI) | 869 (64.1, 61.5–66.6) | 930 (68.5, 66.1–71.1) | 873 (64.3, 61.8–66.9) |
Definitely, n (%, 95 CI) | 87 (6.4, 5.1–7.7) | 93 (6.9, 5.5–8.2) | 613 (45.2, 42.6–47.9) |
Probably, n (%, 95 CI) | 782 (57.7, 55.0–60.3) | 780 (57.5, 54.9–60.2) | 317 (23.4, 21.1–25.6) |
Not preventable, n (%, 95 CI) | 487 (35.9, 33.4–38.5) | 483 (35.6, 33.1–38.2) | 426 (31.4, 28.9–33.9) |
Agreement between reviewers and assessment method
Preventability Assessment | Inter-rater agreement Kappa (95% CIs) n = 1356 |
---|---|
Best Practice-Based [4] | 0.53 (0.48–0.59) |
Error -Based [23] | 0.55 (0.50–0.60) |
Algorithm-Based [24] | 0.55 (0.49–0.60) |
Preventability Definition | Inter-rater Agreement Kappa (95% CIs) |
---|---|
Best Practice-Based [4] (n = 869) | 0.33 (0.23–0.44) |
Error -Based [23] (n = 873) | 0.30 (0.20–0.40) |
Algorithm-Based [24](n = 930) | 0.40 (0.33–0.46) |
Consensus Ratings by Definition | Instrumental Agreement Kappa (95% CIs) n = 1356 |
---|---|
0.88 (0.85–0.91) | |
0.89 (0.86–0.91) | |
0.99 (0.98–1.00) |
Qualitative results
Schmock and Thornton algorithm questions (response) | Frequency, n (%) n = 508 |
---|---|
Was there a history of allergy or previous reactions to the drug or drug class? (YES) Was the re-exposure appropriate? (NO) | 148 (29.1) |
Was a toxic serum drug concentration (or laboratory monitoring test) documented? (YES) | 144 (28.4) |
Was any drug involved inappropriate for the patient’s clinical condition? (YES) | 78 (15.4) |
Was the dose, route or frequency of administration inappropriate for the patient’s age, weight or disease state? (YES) | 66 (13.0) |
Was there a known treatment for the ADE? (e.g., to prevent predictable drug side effects?) (YES) Was a known treatment not prescribed or administered to the patient? (YES) Was the known treatment contraindicated? (NO) | 38 (7.5) |
Was there any failure in communication that contributed to the ADE? (YES) | 17 (3.4) |
Was there a failure to act on the results of monitoring or testing? (YES) | 11 (2.2) |
Were there any errors in the administration of the culprit drug(s)? (YES) | 5 (1.0) |
Was there an error in ADE diagnosis that contributed to the event persisting/getting worse? (YES) | 1 (0.2) |