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 |