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. 2022 May 9;2022(5):CD012809. doi: 10.1002/14651858.CD012809.pub2

Er 2010.

Study characteristics
Patient Sampling Prospective
Patient characteristics and setting Study location: Germany
Study periods: from December 2008 to June 2010
Care setting: the Cardiology Department of the University of Cologne
Participants enrolled: 50
Participants included in analysis: 50: 14 males and 36 females
Age: mean age 66.9 ± 14.5 years
BMI: mean 27.1 ± 5.1
Classification of PH defined by WHO (diagnosis from right‐heart catheterisation): not reported
Number of patients with asymptomatic or mild symptom: 6 (8%)
Number of participants with COPD: not reported
Number of intubated participants: 0
Inclusion criteria: Consecutive patients referred to the Cardiology Department of the University of Cologne were included.
Exclusion criteria: Patients were excluded when tricuspid regurgitation jet was not available.
Index tests Description of index test: using a Phillips iE33 ultrasound device equipped with a standard transducer operating at 1–5 MHz without using saline contrast. The echocardiography was performed by three different cardiologists. In each patient only one cardiologist performed the examination, randomly. Multiple views were recorded to identify optimal view for analysis as recommended in actual guidelines.
Description of method to estimate right atrial pressure: The right atrial pressure was estimated by evaluating IVC diameter and change with respiration: when IVC diameter was less than 20 mm and the collapsibility greater than 50%, right atrial pressure was estimated to be 5 mmHg versus 10 mmHg when the collapsibility was less than 50%. When the IVC diameter was greater than 20 mm, right atrial pressure was estimated to be 15 mmHg when the collapsibility was greater than 50% and to be 20 mmHg when the collapsibility was less than 50%.
Cut‐off value to declare PH: 38 mmHg
Estimated systolic pulmonary arterial pressure: mean 62.3 ± 25.7 mmHg
Sonographer qualification: performed by cardiologists
How to handle the uninterpretable results: not applicable
Target condition and reference standard(s) Target condition: pulmonary hypertension
Description of reference standard: Right‐heart catheterisation was performed without sedation at rest in the cardiac catheter laboratory of the Cardiology Department of the University of Cologne. End‐expiratory pressure measurements were taken from the right atrium, right ventricle, pulmonary artery and pulmonary capillary.
Mean pulmonary arterial pressure: mean 39.5 ± 14.9 mmHg
Flow and timing The interval between the index test and reference standard: within 120 minutes
Number of indeterminates for whom the results of reference standard was available: 0 (0%)
Number of patients who were excluded from the analysis: 0 (0%)
Comparative  
Notes  
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes    
Did the study avoid inappropriate exclusions? Yes    
Could the selection of patients have introduced bias?   Low risk  
Are there concerns that the included patients and setting do not match the review question?     High
DOMAIN 2: Index Test (All tests)
Were the index test results interpreted without knowledge of the results of the reference standard? Unclear    
If a threshold was used, was it pre‐specified? No    
Could the conduct or interpretation of the index test have introduced bias?   Unclear risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     Low concern
DOMAIN 3: Reference Standard
Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear    
Were the criteria of reference standard for target condition prespecified? Unclear    
Could the reference standard, its conduct, or its interpretation have introduced bias?   Unclear risk  
Are there concerns that the target condition as defined by the reference standard does not match the question?     Low concern
DOMAIN 4: Flow and Timing
Was the interval between the index test and reference standard less than one day? Yes    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? Yes    
Could the patient flow have introduced bias?   Low risk