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

Nowak 2018.

Study characteristics
Patient Sampling Retrospective
Patient characteristics and setting Study location: Poland
Study periods: between April 2007 and December 2011
Care setting: the Silesian Center of Heart Disease
Participants enrolled: 65: 49 males and 16 females
Participants included in analysis: 37: males and females
Age: mean age 53.3 ± 9.5 years
BMI: mean 24.1 ± 4.3
Classification of PH defined by WHO (diagnosis from right‐heart catheterisation): not reported
Number of patients with asymptomatic or mild symptom: 2 (3%)
Number of participants with COPD: 31
Number of intubated participants: 0
Inclusion criteria: patients with advanced lung disease who underwent right‐heart catheterisation
Exclusion criteria: patients with IPH were excluded.
Index tests Description of index test: All patients underwent transthoracic echocardiography, including M‐mode, 2‐dimensional, pulsed, continuous‐wave, and colour‐flow Doppler imaging using the GE VIVID 5 system and a transducer array of 2.5 MHz, according to the guidelines of the American Society of Cardiology.
Description of method to estimate right atrial pressure: not reported
Cut‐off value to declare PH: 43 mmHg
Estimated systolic pulmonary arterial pressure: mean 54.2 ± 21.5 mmHg
Sonographer qualification: not reported
How to handle the uninterpretable results: excluded from analysis
Target condition and reference standard(s) Target condition: pulmonary hypertension
Description of reference standard: All patients were clinically stable with no changes in medical therapy. This procedure was performed at rest in supine position, using a Swan‐ganz catheter. Measurements were performed using supplemental oxygen, if needed, to achieve saturation over 90%.
Mean pulmonary arterial pressure: mean 28.8 ± 11.5 mmHg
Flow and timing The interval between the index test and reference standard: mean interval 3 days ± 1.7 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?     Low concern
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?     Unclear
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? Unclear    
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? 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