Begaud et al described a system in France for determining if a drug could be implicated as the cause for an adverse event in a patient based on clinical and temporal findings.
Elements to the evaluation:
(1) chronological imputation
(2) semeiological (symptomatologic) imputation
(3) intrinsic imputability based on the chronological and semeiological findings
Challenge |
Dechallenge |
Rechallenge |
Chronology |
---|---|---|---|
very suggestive |
suggestive |
positive |
C3 (suggestive) |
very suggestive |
suggestive |
not done |
C3 (suggestive) |
very suggestive |
suggestive |
negative |
C1 (dubious) |
very suggestive |
inconclusive |
positive |
C3 (suggestive) |
very suggestive |
inconclusive |
not done |
C2 (possible) |
very suggestive |
inconclusive |
negative |
C1 (dubious) |
very suggestive |
unsuggestive |
positive |
C1 (dubious) |
very suggestive |
unsuggestive |
not done |
C1 (dubious) |
very suggestive |
unsuggestive |
negative |
C1 (dubious) |
compatible |
suggestive |
positive |
C3 (suggestive) |
compatible |
suggestive |
not done |
C2 (possible) |
compatible |
suggestive |
negative |
C1 (dubious) |
compatible |
inconclusive |
positive |
C3 (suggestive) |
compatible |
inconclusive |
not done |
C1 (dubious) |
compatible |
inconclusive |
negative |
C1 (dubious) |
compatible |
unsuggestive |
positive |
C1 (dubious) |
compatible |
unsuggestive |
not done |
C1 (dubious) |
compatible |
unsuggestive |
negative |
C1 (dubious) |
incompatible |
suggestive |
positive |
C0 (incompatible) |
incompatible |
inconclusive |
not done |
C0 (incompatible) |
incompatible |
unsuggestive |
negative |
C0 (incompatible) |
where:
• Suggestive dechallenge: event regressions seems linked to drug withdrawal
• Inconclusive dechallenge: (a) event regression spontaneous; (b) event regression induced by non-specific treatment known to be effective; (c) unknown evolution; (d) follow-up to short; (e) irreversible lesion; (f) drug not withdrawn
• Unsuggestive dechallenge: no regression of reversible event, or complete regression without drug withdrawal
Alternative Non-drug Related Explanation |
Symptomatology or Other Factor Favoring Drug |
Findings of a Reliable and Specific Test |
Semeiological Criteria |
---|---|---|---|
none |
present |
positive |
S3 (suggestive) |
none |
present |
not done or not available |
S3 (suggestive) |
none |
present |
negative |
S1 (dubious) |
none |
absent |
positive |
S3 (suggestive) |
none |
absent |
not done or not available |
S2 (possible) |
none |
absent |
negative |
S1 (dubious) |
possible or present |
present |
positive |
S3 (suggestive) |
possible or present |
present |
not done or not available |
S2 (possible) |
possible or present |
present |
negative |
S1 (dubious) |
possible or present |
absent |
positive |
S3 (suggestive) |
possible or present |
absent |
not done or not available |
S1 (dubious) |
possible or present |
absent |
negative |
S1 (dubious) |
Chronology |
Semeiology |
Interpretation |
---|---|---|
C0 |
S1 |
unlikely (appears excluded) |
C0 |
S2 |
unlikely (appears excluded) |
C0 |
S3 |
unlikely (appears excluded) |
C1 |
S1 |
dubious |
C1 |
S2 |
dubious |
C1 |
S3 |
possible |
C2 |
S1 |
dubious |
C2 |
S2 |
possible |
C2 |
S3 |
likely |
C3 |
S1 |
likely |
C3 |
S2 |
likely |
C3 |
S3 |
very likely |
Purpose: To evaluate a drug as a possible explanation for an adverse event in a patient using a method employed in France.
Specialty: Toxicology, Emergency Medicine, Critical Care
Objective: adverse effects
ICD-10: Z86.4,