Signal Detection of Adverse Drug Reactions through LASSO Logistic Regression Using an Electronic Health Records Database：A Case-Control Study / 薬剤疫学

Objective：The objective of this study was to apply Least Absolute Shrinkage and Selection Operator （LASSO）logistic regression to detection of adverse drug reaction （ADR） signals using an electronic health records database as a comprehensive and quantitative method to supplement the current pharmacovigilance activities in Japan.Design：case-control studyMethods：We analyzed data from 40767 inpatients using a single-institution hospital database and identified two ADRs, suspected pancreatitis and thrombocytopenia, using abnormal laboratory test results. LASSO logistic regression analysis was applied to detect ADR signals with adjustment for age, sex, comorbidities and medical procedures. The positive predictive value （PPV） was calculated using reference standard of known drug-ADR associations based on drug product labels.Results：The number of case group was 6735 for suspected pancreatitis and 11561 for thrombocytopenia. The number of ADR signals detected using LASSO logistic regression was 27 for suspected pancreatitis and 40 for thrombocytopenia. The calculated PPV was 3.7% for suspected pancreatitis and 55.0% for thrombocytopenia.Conclusion：LASSO logistic regression analysis efficiently detects ADR signals by adjusting for confounding factors such as comorbidities and medical procedures. The false positive signals may contain unknown signals and further signal assessment will be needed.

<b>Signal Detection of Adverse Drug Reactions through LASSO Logistic Regression </b><b>Using an Electronic Health Records Database</b>：<b>A Case-Control Study </b> / 薬剤疫学

<p><b>Objective</b>：The objective of this study was to apply Least Absolute Shrinkage and Selection Operator （LASSO）logistic regression to detection of adverse drug reaction （ADR） signals using an electronic health records database as a comprehensive and quantitative method to supplement the current pharmacovigilance activities in Japan.</p><p><b>Design</b>：case-control study</p><p><b>Methods</b>：We analyzed data from 40767 inpatients using a single-institution hospital database and identified two ADRs, suspected pancreatitis and thrombocytopenia, using abnormal laboratory test results. LASSO logistic regression analysis was applied to detect ADR signals with adjustment for age, sex, comorbidities and medical procedures. The positive predictive value （PPV） was calculated using reference standard of known drug-ADR associations based on drug product labels.</p><p><b>Results</b>：The number of case group was 6735 for suspected pancreatitis and 11561 for thrombocytopenia. The number of ADR signals detected using LASSO logistic regression was 27 for suspected pancreatitis and 40 for thrombocytopenia. The calculated PPV was 3.7% for suspected pancreatitis and 55.0% for thrombocytopenia.</p><p><b>Conclusion</b>：LASSO logistic regression analysis efficiently detects ADR signals by adjusting for confounding factors such as comorbidities and medical procedures. The false positive signals may contain unknown signals and further signal assessment will be needed.</p><p></p>

General Survey of Balneal Treatment in the Tohoku Region / 日本温泉気候物理医学会雑誌

The results of our general and medical surveys are summarized as follows:<br>1) The visitors to this spa are inhabitants of Yamagata prefecture, farmers being the largest in number.<br>2) Considering the fact that more than half the number of spa visitors come here with therapeutic or convalescing purpose, this spa may be said to be a spa to which visitors come with the sole object of curative treatment.<br>3) Visitors came for the treatment of common cold, hypertension, neuralgia and diseases of the stomach and intestines respetively from the frequency of diseases. The fact that the visitors with cold were largest in number was probably because of the prevalence of common cold at the time of our survey.<br>4) Half the number of spa visitors stayed for about 2 weeks, and most of them took bath four to five times a day for curative treatment.<br>5) 40.1% spa visitors drank hot spring water for curative treatment. Which incidence is higher than that in our previous reports for other Tohoku Area.<br>6) Only 6.1% of the visitors came to the spa under doctor's direction. Those who noted the bathing reaction: anorexia, feeling of weakness etc., were 23.1%<br>7) In the tubeless gastric analysis (Gastrotest) scarcely any change was observable for successive drinking of hot spring water.<br>8) In most cases the oral temperature measured at the time of bathing in this spa never returned to the value before bathing for two hours and the feeling of warmth remained for a long time. This is probably due to the chemical properties of the spring waters and proper treatment after bathing.