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Table 2 Reporting of serious adverse events, adverse events and complications

From: The IMPROVE-GAP Trial aiming to improve evidence-based management of community-acquired pneumonia: study protocol for a stepped-wedge randomised controlled trial

Complication group Complication
Pneumonia-associated complications Respiratory failure requiring intubation
  Hypotension requiring vasopressors
  Empyema
Defined as: documented in registrar admission assessment, radiologist chest X-ray report or medical discharge summary
  Acute respiratory distress syndrome
Defined as: documented in registrar admission assessment, radiologist chest X-ray report or medical discharge summary
  Pleural effusion
Defined as: diagnosed on radiologist chest X-ray report
  Increased confusion from baseline
Other adverse events Death from any cause
  Fall with fracture
  Cardiac decompensation
Defined as: documented in registrar admission assessment, radiologist chest X-ray report or medical discharge summary
  Cardiac event
Defined as: diagnosed episode of cardiac ischaemia or new cardiac arrhythmia
  Acute stroke
Defined as: documented in registrar admission assessment, radiologist report or medical discharge summary
  Thromboembolic event
Defined as: pulmonary embolus or deep vein thrombosis documented in registrar admission assessment, radiologist report or medical discharge summary
  Confirmed or suspected gastrointestinal bleeding
Adverse events in patients receiving corticosteroids Adverse drug reaction where it is required that the drug is stopped (percentage of total number receiving burst corticosteroid dose)
  In-hospital hyperglycaemia requiring new insulin prescription (percentage of known diabetics)
Adverse events compatible with antibiotic use Adverse drug reaction, where it is required that the drug use is stopped
Adverse events in patients receiving early mobilisation Falls during physiotherapy (percentage of total physiotherapy sessions delivered)
  Clinical deterioration during physiotherapy requiring urgent medical review (percentage of total physiotherapy sessions delivered) (see Additional file 2)
  Mobilisation ceased owing to sustained observations outside target range (percentage of total physiotherapy sessions delivered) (see Additional file 2)