185 Classifying study participants in clinical trials Exceptions: • All asthma patients with a pneumonia or other LRTI, should be labelled “Exacerbation asthma” as well as “Pneumonia” or “Other LRTI”. That is, if the patient has a medical history of asthma and presents at the ED with pneumonia, he or she should automatically be labelled both “Pneumonia” and “Exacerbation asthma”, irrespectively of the treatment that might or might not be started for the exacerbation. However, this does not apply for concurrent sinusitis or other upper respiratory tract infection. When a patient has an exacerbation of asthma and sinusitis or other upper respiratory tract infection, additional treatment for the exacerbation should have been started in order to assign both diagnostic labels. • This was a first episode of asthma. This case should be referred to the Adjudication Committee. • If the patient has a medical history of both asthma and chronic obstructive pulmonary disease (COPD), the case should be referred to the Adjudication Committee. References: [5] 10. Exacerbation chronic obstructive pulmonary disease (COPD) Prerequisite: the patient has a medical history of COPD. Exacerbation COPD An acute or sub-acute exacerbation of the symptoms the patient normally experiences: 1. Patient has at least one of the following: worsening of dyspnea, wheezing, cough, or sputum production, or more purulent sputum AND 2. Additional treatment was started. NB: nebulized β2-sympathomimetics are also considered treatment. Exceptions: • All COPD patients with a pneumonia or other LRTI, should be labelled “Exacerbation COPD” as well as “Pneumonia” or “Other LRTI”. That is, if the patient has a medical history of COPD and presents at the ED with pneumonia, he or she should automatically be labelled both “Pneumonia” and “Exacerbation COPD”, irrespectively of the treatment that might or might not be started for the exacerbation. However, this does not apply for concurrent sinusitis or other upper respiratory tract infection. When a patient has an exacerbation of COPD and sinusitis or other upper respiratory tract infection, additional treatment for the exacerbation should have been started in order to assign both diagnostic labels. • This was a first episode of COPD. This case should be referred to the Adjudication Committee. • If the patient has a medical history of both asthma and COPD, the case should be referred to the Adjudication Committee. References: [6, 7] 8
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