Greiner 2014.
Study characteristics | |||
Patient Sampling | Retrospective | ||
Patient characteristics and setting |
Study location: Germany Study periods: from July 1, 2007 through June 30, 2013 Care setting: Cardiology Department of the University Hospital of Heidelberg, Germany Participants enrolled: 3920: gender not reported Participants included in analysis: 1695: 1136 males and 559 females Age: mean age 63 ± 15 BMI: mean 26 ± 5 Classification of PH defined by WHO (diagnosis from right‐heart catheterisation): not reported Number of patients with asymptomatic or mild symptom: 85 (5%) Number of participants with COPD: not reported Number of intubated participants: 0 Inclusion criteria: All patients who had a cardiac ultrasound examination performed within 5 days before or after invasive examination Exclusion criteria: Patients whose pulmonary arterial pressure documents were not explicitly documented |
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Index tests |
Description of index test: Noninvasive assessment of systolic pulmonary arterial pressure was achieved by measurement of right ventricular systolic pressure and adding right atrial pressure. Right ventricular systolic pressure was derived from the peak systolic velocity of the tricuspid regurgitation obtained with continuous‐wave Doppler using the modified Bernoulli equation: pressure gradient = 49Vmax2. Description of method to estimate right atrial pressure: Right atrial pressure was estimated by the diameter of the inferior vena cava and its variability during inspiration. Cut‐off value to declare PH: 36 mmHg Estimated systolic pulmonary arterial pressure: mean 45.3 ± 15.5 mmHg Sonographer qualification: performed by two independent, experienced examiners How to handle the uninterpretable results: excluded from analysis |
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Target condition and reference standard(s) |
Target condition: pulmonary hypertension Description of reference standard: A femoral or jugular venous approach was used for right‐heart catheterisation. Cardiac output and cardiac index were calculated by saturation measurement according to Fick's method. Pulmonary arterial pressure, pulmonary capillary wedge pressure, and right ventricular and right atrial pressures were measured during breath hold in baseline over at least 3 heart cycles. Mean pulmonary artery pressure was calculated by integration of the pressure curve by Metek software (Metek GmbH, Roetgen, Germany). Mean pulmonary arterial pressure: mean 31.6 ± 10.9 mmHg |
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Flow and timing | The interval between the index test and reference standard: within five 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 |
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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? | 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? | Low concern | ||
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? | 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 |