191 Classifying study participants in clinical trials 27. Thoracic pain of unknown origin Includes all patients with thoracic pain, in whom none of the aforementioned diagnostic labels is applicable, and for whom no other treatment was started except painkillers. May be indicated in the EHR as: “myogenic pain”, “costomyogenic pain”, “pain during extensive cough”. Exceptions: • Verify if the patient has visited the ED within 28 days after the first presentation with similar complaints. If so, please refer this case to the Adjudication Committee. • If one or more of the other “… of unknown origin” labels is also applicable (i.e. “Dyspnea of unknown origin” and “Fever of unknown origin”), please refer this case to the Adjudication Committee. 28. Dyspnea of unknown origin Includes all patients that have been discharged with shortness of breath, dyspnea or respiratory distress, in whom none of the aforementioned diagnostic labels is applicable. Exceptions: • Verify if the patient has visited the ED within 28 days after the first presentation with similar complaints. If so, please refer this case to the Adjudication Committee. • If one or more of the other “… of unknown origin” labels is also applicable (i.e. “Thoracic pain of unknown origin” and “Fever of unknown origin”), please refer this case to the Adjudication Committee. • Please refer hypoxemia without an explanatory cause to the Adjudication Committee. Some examples of what may be indicated in the EHR: • Hyperventilation is labelled “Dyspnea of unknown origin” • Hyperventilation without dyspnea is labelled “Extrathoracic pathology” • Hypoventilation syndrome related to obesity is labelled “Extrathoracic pathology” 29. Fever of unknown origin Includes all patients with fever (temperature >38.0° Celsius), either measured at home or documented at the ED, without a focus. This can also be a single episode of documented fever. Exceptions: • Verify if the patient has visited the ED within 28 days after the first presentation with similar complaints. If so, please refer this case to the Adjudication Committee. • If one or more of the other “… of unknown origin” labels is also applicable (i.e. “Thoracic pain of unknown origin” and “Dyspnea of unknown origin”), please refer this case to the Adjudication Committee. Some examples of what may be indicated in the EHR: • Sepsis without focus is labelled “Fever of unknown origin” • Bacteremia or fever without focus are labelled “Fever of unknown origin” • Sepsis due to a pneumonia is labelled “Pneumonia” 8
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