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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)