Transcript CRITICAL APPRAISAL OF ARTICLE ON HARM

CRITICAL APPRAISAL OF ARTICLE
ON HARM
Clinical
question
• Among patients with acute rheumatic fever,
will administration of non steroidal antiinflammatory drugs have adverse effects?
Population:
• patients with rheumatic fever taking NSAIDs
Intervention:
Outcome:
• non steroidal anti-inflammatory drugs
• Harm, complications
Incidence of Serious Upper Gastrointestinal Bleeding in patients taking Non Steroidal
Anti-inflammatory Drugs in Japan
Ishikawa S, Inaba T, Mizuno M, Okada H, Kuwaki K, Kuzume T,
Search terms: gastrointestinal bleeding, non steroidal anti-inflammatory drugs, salicylates,
rheumatic fever
Relevance
Is the objective of the article
similar to your dilemma?
• Yes. The objective of the study is to determine the
annual incidence of serious upper gastrointestinal
bleeding among Japanese patients in whom NSAIDs
were used while the recommended treatment for our
patient in this case which is salicylate falls under this
drug family.
• (page 29,Abstract,1st paragraph)
Validity
Were there clearly identified comparison
groups?
• Yes. The investigator only included patients who were 30 – 70 yrs old,
from both sexes who were taking NSAIDs for cardiovascular disease,
cerebrovascular disease, arthritis, fever and pain control. The subjects
were categorized as a) patients on low dose aspirin and b)patients on
non aspirin NSAIDs.
• (page 30,Materials and Methods, 2nd paragraph)
• (page 31,Results, 1st paragraph)
Were the exposures and outcomes
measured in the same way in the groups
compared?
• Yes. The exposures and outcomes were measured in the same way in
the groups compared. The outcomes of all groups were determined
through endoscopic examination of bleeding ulcers in all groups.
• (page 30, Materials and Methods, 4th paragraph)
Was follow-up sufficiently long and
complete?
• Yes. Follow up was done after two years from the start of
administration of non steroidal anti – inflammatory drugs
which is from June 2003 to June 2005.
• (page 30, Materials and Methods, 2nd paragraph)
• 18,048 subjects were identified in the study. 629 were lost to
follow up whie 148 died of other causes. Of the remaining
17,270, 8,815 periodically came for hospital visits, 7,613
returned after their last NSAID prescription, 992 were
interviewed by telephone. They therefore have a 96 % follow
up.
• (page 31, Results, 2nd paragraph)
Is the temporal relationship
between the exposure and outcome
correct and dose response gradient
present?
• Yes. The study administered NSAIDs before any event of
bleeding ulcer so the temporal relationship was correct.
(page 30, Table 1)
• NSAIDs used in this study were low dose aspirin (80-325
m; Bufferin 81mg and Bayaspirin, a 100mg enteric coated
tablet) and other NSAID
(page 30, Table 2)
Overall, is the study valid?
• Since all the answers for the
validity guides are valid, the
study can be considered valid.