Hsu 2008.

Study characteristics
Patient Sampling	Prospective
Patient characteristics and setting	Study location: USA Study periods: between 2002 and 2004 Care setting: not reported Participants enrolled: 55: gender not reported Participants included in analysis: 49: 9 males and 40 females Age: mean age 55 years (range 20‐80 years) BMI: not reported Classification of PH defined by WHO (diagnosis from right‐heart catheterisation): Class I: 16, 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: We performed a prospective review of established or new patients who presented consecutively to the University of Medicine and Dentistry of New Jersey‐Scleroderma Program between 2002 and 2004 with progressive dyspnoea and/or had clinical features suspicious of PH. Exclusion criteria: Patients were excluded if they had left ventricle dysfunction by echo or right‐heart catheterisation, airway obstruction by pulmonary function tests, thromboembolic pulmonary hypertension (excluded by ventilation/perfusion scan), congenital heart disease, porto‐pulmonary PH, or HIV, and those who refused right‐heart catheterisation or cardiac magnetic resonance imaging.
Index tests	Description of index test: Echo images were obtained using a Philips Sonos 7500 model. Tricuspid regurgitant flow velocity was measured by continuous‐wave echo with both an imaging probe and a non‐imaging Pedoff pencil probe. No contrast enhancement was given. RVSP was estimated from the peak tricuspid regurgitant flow velocity (v, in m/s) using a modified Bernoulli equation, P = 4v2 + 10, where P represents the pressure in mmHg. All echo‐Doppler studies were read by a single reader. Description of method to estimate right atrial pressure: 10 mmHg Cut‐off value to declare PH: 47 mmHg Estimated systolic pulmonary arterial pressure: not reported 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: Right‐heart catheterisation was performed by percutaneous approach via the femoral vein using a 7‐French Swan‐Ganz catheter (Edwards Lifesciences). Baseline pressures were recorded in the right atrium, right ventricle, PA, and PCW position .Mean pulmonary arterial pressure: mean 25.3 mmHg (range: 11‐58 mmHg)
Flow and timing	The interval between the index test and reference standard: within 4 hours 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?			High
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?	No
Could the conduct or interpretation of the index test have introduced bias?		High risk
Are there concerns that the index test, its conduct, or interpretation differ from the review question?			High
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?	Yes
Did all patients receive the same reference standard?	Yes
Were all patients included in the analysis?	No
Could the patient flow have introduced bias?		Low risk