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

Lafitte 2013.

Study characteristics
Patient Sampling Retrospective
Patient characteristics and setting Study location: France
Study periods: between June 2011 and March 2012
Care setting: the cardiac catheterisation department, which performs approximately 4500 right‐heart catheterisation procedures every year, and from the echocardiography department, which conducts > 15,000 trans‐thoracic Doppler echocardiographic studies every year
Participants enrolled: 310: 162 males and 148 females
Participants included in analysis: 155: gender not reported
Age: mean age 64.8 ± 15.9 years
BMI: mean 26.3± 5.7
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: 0
Inclusion criteria: The inclusion criterion for patient enrolment was having undergone both haemodynamic and echocardiographic investigations (with estimation of pulmonary pressures by Doppler on tricuspid regurgitant flow) between June 2011 and March 2012, irrespective of the causal disease, during a single hospitalisation period.
Exclusion criteria: a lack of pulmonary pressures estimation on the basis of tricuspid regurgitant flow using Doppler echocardiography
Index tests Description of index test: All echocardiographic measurements were performed according to American Society of Echocardiography and European Association of Echocardiography recommendations in line with UERD standard operating procedure. Accordingly, tricuspid regurgitant maximum velocities were measured on the basis of adequate acquisitions, and estimated systolic pulmonary arterial pressure levels were determined using the modified Bernoulli equation when tricuspid regurgitant jets were analysable, in conjunction with echocardiographic estimation of right atrial pressure.
Description of method to estimate right atrial pressure: Echocardiographic right atrial pressure estimation was performed on the basis of IVC size and collapsibility. Right atrial pressure was estimated to be 3 mmHg when the IVC diameter was < 21 mm with > 50% collapsibility, 8 mmHg when the IVC diameter was < 21 mm with < 50% collapsibility, and 15 mmHg when the IVC diameter was > 21 mm with < 50% collapsibility.
Cut‐off value to declare PH: 38 mmHg
Estimated systolic pulmonary arterial pressure: mean 49.6 ± 21.7 mmHg
Sonographer qualification: underwent systematic validation by one of the senior cardiologists
How to handle the uninterpretable results: excluded from analysis
Target condition and reference standard(s) Target condition: pulmonary hypertension
Description of reference standard: Senior physicians specialising in invasive techniques performed the catheterisations according to standard procedures. Fluid‐filled catheters were used for patients not sedated. Systolic, diastolic, and mean PPs were averaged and calculated over five beats.
Mean pulmonary arterial pressure: mean 32.7 ± 15.3 mmHg
Flow and timing The interval between the index test and reference standard: mean interval 2 days ± 2.9 days
Number of indeterminates for whom the results of reference standard was available: 0 (0%)
Number of patients who were excluded from the analysis: not stated
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?     Unclear
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? Unclear    
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? No    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? No    
Could the patient flow have introduced bias?   High risk