Colle 2003.

Study characteristics
Patient Sampling	Prospective
Patient characteristics and setting	Study location: France Study periods: between April 1993 and August 2001 Care setting: Service d’H ´epatologie and INSERM Participants enrolled: 165: 116 males and 49 females Participants included in analysis: 165: 116 males and 49 females Age: mean age 48 ± 8 years BMI: not reported Classification of PH defined by WHO (diagnosis from right‐heart catheterisation): Class I: 17, Class II: 0, Class III: 0, Class IV: 0, Class V: 0 Number of patients with asymptomatic or mild symptom: not reported Number of participants with COPD: not reported Number of intubated participants: 0 Inclusion criteria: consecutive patients who were evaluated for liver transplantation and for whom transvenous liver biopsy was needed were prospectively included in this study Exclusion criteria: none
Index tests	Description of index test: All patients were evaluated with a 2‐dimensional Doppler echocardiography on a Sonos 1500 Hewlett‐Packard or a Supervision 800 Vingmed machine. Continuous wave Doppler of tricuspid regurgitant jet, when present, was used to calculate right ventricular systolic pulmonary artery pressure with the formula: systolic pulmonary artery pressure (4 maximum velocity of the tricuspid regurgitant jet2) mean right atrial pressure. Description of method to estimate right atrial pressure: setting mean right atrial pressure at 5 mmHg, except when the inferior vena cava was collapsed (0 mmHg) or clearly enlarged with no collapse during inspiration (10 mmHg) Cut‐off value to declare PH: 30 mmHg Estimated systolic pulmonary arterial pressure: not reported 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: a catheter was inserted into the right or left jugular vein under local anaesthesia. Haemodynamic measurements including pulmonary artery pressure, right atrial pressure, and pulmonary capillary wedge pressure were performed using a Swan‐Ganz catheter. Cardiac output was measured by the thermodilution method (Baxter Healthcare Corporation, Santa Ana, CA). Cardiac output was obtained by the average of 3 consecutive measurements. Arterial pressure was measured using a noninvasive external sphygmomanometer (Dinamap; Critikon, Tampa, FL). Systemic vascular resistance was calculated as follows: systemic vascular resistance (dynes.s.cm 5) (mean arterial pressure‐mean right atrial pressure) 80/cardiac output. Pulmonary vascular resistance (PVR) was calculated as follows: pulmonary vascular resistance (dynes.s.cm 5) (mean pulmonary arterial pressure‐pulmonary capillary wedged pressure) 80/cardiac output. Mean pulmonary arterial pressure: mean 18.8 ± 7.6 mmHg
Flow and timing	The interval between the index test and reference standard: within the same week 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?	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?	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?	Yes
Could the patient flow have introduced bias?		High risk