187 Classifying study participants in clinical trials 14. Pleuritis sicca Prerequisite: there are no radiologic findings. Patient is in pain; mostly related to breathing. The physical examination describes “pleural rub”. Specific echographic finding: irregular visceral pleura. In case of pain without pleural rub or a specific echographic finding: assign the diagnostic label “Thoracic pain of unknown origin”. 15. Pneumothorax The radiology report confirms a pneumothorax. References: [11] 16. Interstitial Lung Disease Prerequisite: the patient has a medical history of lung fibrosis or interstitial lung disease (ILD), this had worsened and/or was relevant at ED presentation and (additional) treatment was started for the ILD. Exception: • This was a first episode or a suspicion of a first episode of ILD. This case should be referred to the Adjudication Committee. Examples of ILD that can be found in a patient’s medical history: • Sarcoidosis • Usual interstitial pneumonia (UIP) • Non-specific interstitial pneumonia (NSIP) • Extrinsic allergic alveolitis (EAA) • Organizing pneumonia • Pigeon breeder’s lung, mushroom worker’s lung, cheese-washer’s lung, farmer’s lung, asbestosis • Drug-induced pneumonitis or drug-induced lung fibrosis (due to amiodarone, nitrofurantoin, methotrexate) • ILD within the context of systemic diseases like rheumatoid arthritis and scleroderma. References: [12] 17. Acute Chest Syndrome Please assign this diagnostic label when the following criteria apply: • The patient has a medical history of sickle cell anemia AND • The radiology report confirms a consolidation AND • There is at least one of the following symptoms present: fever (temperature ≥38.5° Celsius), tachypnea (>25/min), intercostal retractions, “nasal flaring”, use of accessory muscles during breathing, chest pain, cough, bronchial breath sounds, >2% decrease in SpO2 (O2 saturation) of a documented steady-state value at room air (FiO2=0.21), PaO2 < 60mmHg/8 kPa. NB: Do not assign the diagnostic labels “Acute Chest Syndrome” and pneumonia to the same patient. It is difficult to make this clinical distinction. Therefore only this diagnostic label (Acute Chest Syndrome) must be assigned to such cases. References: [13, 14] 8
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