Evaluating the performance of temporal pattern discovery: new application using statins and rhabdomyolysis in OMOP databases.

BACKGROUND: Temporal pattern discovery (TPD) is a method of signal detection using electronic healthcare databases, serving as an alternative to spontaneous reporting of adverse drug events. Here, we aimed to replicate and optimise a TPD approach previously used to assess temporal signals of statins with rhabdomyolysis (in The Health Improvement Network (THIN) database) by using the OHDSI tools designed for OMOP data sources. METHODS: We used data from the Truven MarketScan US Commercial Claims and the Commercial Claims and Encounters (CCAE). Using an extension of the OHDSI ICTemporalPatternDiscovery package, we ran positive and negative controls through four analytical settings and calculated sensitivity, specificity, bias and AUC to assess performance. RESULTS: Similar to previous findings, we noted an increase in the Information Component (IC) for simvastatin and rhabdomyolysis following initial exposure and throughout the surveillance window. For example, the change in IC was 0.266 for the surveillance period of 1-30 days as compared to the control period of - 180 to - 1 days. Our modification of the existing OHDSI software allowed for faster queries and more efficient generation of chronographs. CONCLUSION: Our OMOP replication matched the we can account forwe can account for of the original THIN study, only simvastatin had a signal. The TPD method is a useful signal detection tool that provides a single statistic on temporal association and a graphical depiction of the temporal pattern of the drug outcome combination. It remains unclear if the method works well for rare adverse events, but it has been shown to be a useful risk identification tool for longitudinal observational databases. Future work should compare the performance of TPD with other pharmacoepidemiology methods and mining techniques of signal detection. In addition, it would be worth investigating the relative TPD performance characteristics using a variety of observational data sources.

Large body size and sedentary lifestyle during childhood and early adulthood and esophageal squamous cell carcinoma in a high-risk population.

BACKGROUND: Little is known about the association of obesity and physical activity at young ages with subsequent risk of esophageal squamous cell carcinoma (ESCC). PATIENTS AND METHODS: Between 2003 and 2007, we conducted a case-control study in a high-risk population in northeastern Iran. Three hundred ESCC cases and 571 matched controls were recruited. Each individual was shown a standard pictogram, to report body size at ages 15 and 30. Demographic and health-related information, including physical activity at these ages was also collected. RESULTS: In the fully adjusted models, very obese body size (last two pictograms) at age 15 [odds ratio (OR) 3.2, 95% confidence interval (CI) 1.3-7.7] and age 30 (OR 3.1; 95% CI 1.1-8.5) were associated with ESCC in women, but not in men. Sedentary work at age 15 (OR 3.3, 95% CI 1.3-8.3) and 30 (OR 18.2, 95% CI 3.9-86.2) were also associated with ESCC risk in women only. The increased risk in women at age 15 remained high after later reduction in body size, while women who became very obese only at age 30 did not show a significantly increased risk. CONCLUSION: These results highlight the importance of early lifestyle modifications in the context of cancer prevention, particularly in women.

Morphine analgesia in patients with acute appendicitis: a randomised double-blind clinical trial.

BACKGROUND: The administration of analgesics to patients with acute abdominal pain due to acute appendicitis is controversial. A study was undertaken to assess the analgesic effect of morphine in patients with acute appendicitis. METHODS: A randomised double-blind clinical trial was conducted in Sina hospital, a general teaching hospital, from January 2004 to March 2005. Patients scheduled for appendectomy were randomised to receive 0.1 mg/kg morphine sulfate or saline (0.9%) to a maximum dose of 10 mg over a 5 min period. Patients were examined by surgeons not involved in their care before and after drug administration and their pain intensity and signs were recorded at each visit. The physicians were also asked to indicate their own treatment plan. The main outcome measures were pain intensity using a visual analogue scale (VAS) and signs of acute appendicitis. A favourable reduction in VAS score was defined as a change of >13 mm. RESULTS: Of the 71 patients enrolled in the study, 35 were allocated to receive morphine and 36 to receive placebo. One patient left the hospital before receiving morphine. No significant differences were seen between the two groups with regard to age, sex and initial VAS score. A more favourable change in VAS score was reported in the morphine group with a significantly greater reduction in the median VAS score than in the placebo group. Morphine administration did not cause significant changes in patients' signs or in the physicians' plans or diagnoses. No adverse events were seen in either group. CONCLUSION: Morphine can reduce pain in patients with acute appendicitis without affecting diagnostic accuracy. TRIAL REGISTRATION NUMBER: NCT00477061.