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

Sawada 2019.

Study characteristics
Patient Sampling Retrospective
Patient characteristics and setting Study location: Japan
Study periods: between July 2005 and December 2012
Care setting: the University of Tokyo
Participants enrolled: 189: 106 males and 83 females
Participants included in analysis: 189: 106 males and 83 females
Age: mean age 58 ± 17 years
BMI: 22 ± 3
Classification of PH defined by WHO (diagnosis from right‐heart catheterisation): not reported
Number of patients with asymptomatic or mild symptom: not reported
Number of participants with COPD: not reported
Number of intubated participants: not reported
Inclusion criteria: Patients with heart disease who underwent right‐heart catheterisation were included.
Exclusion criteria: Participants whose images of tricuspid regurgitation could not be documented
Index tests Description of index test: The continuous wave Doppler measurement of peak tricuspid regurgitation velocity was recorded according to the guidelines.
Description of method to estimate right atrial pressure: The right atrial pressure was categorised into three levels (3, 8, and 15 mmHg) on the basis of inferior vena cava diameter, together with its respiratory variation.
Cut‐off value to declare PH: 41 mmHg
Estimated systolic pulmonary arterial pressure: median 27 mmHg (IQR: 21‐37.5 mmHg)
Sonographer qualification: not reported
How to handle the uninterpretable results: not applicable
Target condition and reference standard(s) Target condition: pulmonary hypertension
Description of reference standard: The systolic, diastolic, and mean pulmonary arterial pressure were measured in all participants during the end expiratory period by using a 7F Swan‐Ganz catheter inserted via the femoral or internal jugular vein in the catheter laboratory.
Mean pulmonary arterial pressure: median 16 (IQR: 12‐26 mmHg)
Flow and timing The interval between the index test and reference standard: within 24 hours
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? No    
Could the selection of patients have introduced bias?   High risk  
Are there concerns that the included patients and setting do not match the review question?     Unclear
DOMAIN 2: Index Test (All tests)
Were the index test results interpreted without knowledge of the results of the reference standard? Yes    
If a threshold was used, was it pre‐specified? Unclear    
Could the conduct or interpretation of the index test have introduced bias?   Low 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? Yes    
Were the criteria of reference standard for target condition prespecified? Yes    
Could the reference standard, its conduct, or its interpretation have introduced bias?   Low 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