Schneider 2017.
Study characteristics | |||
Patient Sampling | Prospective | ||
Patient characteristics and setting |
Study location: Austria Study periods: between July 2015 and July 2016 Care setting: Medical University of Vienna Participants enrolled: 65: 28 males and 37 females Participants included in analysis: 65: 28 males and 37 females Age: mean age 67.2 years (range: 19‐89 years) BMI: not reported Classification of PH defined by WHO (diagnosis from right‐heart catheterisation): Class I: 8, Class II: 23, Class III: 10, Class IV: 13, 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 prospectively included all adult patients with clinically indicated right‐heart catheterisation between July 2015 and July 2016. Exclusion criteria: Patients less than 18 years old were excluded. |
||
Index tests |
Description of index test: Transthoracic echocardiograms (2D, Doppler) were performed with echocardiography systems equipped with 3.5 MHz transducers (Vivid E9, Vivid S70; General Electric Healthcare) according to the recommendations and guidelines by the American Society of Echocardiography and the European Association of Cardiovascular Imaging. In all patients, peak continuous wave Doppler velocity of the tricuspid regurgitation jet was systematically measured in the parasternal long‐axis view of the right ventricular inflow, the parasternal short axis view of the basal right ventricular, the right ventricular modified apical four chamber view, the apical long axis view of right ventricular inflow, and the subcostal four chamber view. Description of method to estimate right atrial pressure: none Cut‐off value to declare PH: 34 mmHg Estimated systolic pulmonary arterial pressure: not reported Sonographer qualification: performed by experienced physician How to handle the uninterpretable results: not applicable |
||
Target condition and reference standard(s) |
Target condition: pulmonary hypertension Description of reference standard: Haemodynamic measurements were performed using a 7F Swan‐Ganz catheter (Edwards Lifesciences GmbH, Austria) via a femoral access. Pressures were documented as average of eight measurements over eight consecutive heart cycles using CathCorLX (Siemens AG, Berlin and Munich, Germany). Mean pulmonary arterial pressure: mean 37.6 ± 14.9 mmHg |
||
Flow and timing | The interval between the index test and reference standard: within 1 day 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? | Low concern | ||
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? | Yes | ||
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? | 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? | Yes | ||
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? | Yes | ||
Could the patient flow have introduced bias? | Low risk |