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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.