Nowak 2018.
Study characteristics | |||
Patient Sampling | Retrospective | ||
Patient characteristics and setting |
Study location: Poland Study periods: between April 2007 and December 2011 Care setting: the Silesian Center of Heart Disease Participants enrolled: 65: 49 males and 16 females Participants included in analysis: 37: males and females Age: mean age 53.3 ± 9.5 years BMI: mean 24.1 ± 4.3 Classification of PH defined by WHO (diagnosis from right‐heart catheterisation): not reported Number of patients with asymptomatic or mild symptom: 2 (3%) Number of participants with COPD: 31 Number of intubated participants: 0 Inclusion criteria: patients with advanced lung disease who underwent right‐heart catheterisation Exclusion criteria: patients with IPH were excluded. |
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Index tests |
Description of index test: All patients underwent transthoracic echocardiography, including M‐mode, 2‐dimensional, pulsed, continuous‐wave, and colour‐flow Doppler imaging using the GE VIVID 5 system and a transducer array of 2.5 MHz, according to the guidelines of the American Society of Cardiology. Description of method to estimate right atrial pressure: not reported Cut‐off value to declare PH: 43 mmHg Estimated systolic pulmonary arterial pressure: mean 54.2 ± 21.5 mmHg Sonographer qualification: not reported 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: All patients were clinically stable with no changes in medical therapy. This procedure was performed at rest in supine position, using a Swan‐ganz catheter. Measurements were performed using supplemental oxygen, if needed, to achieve saturation over 90%. Mean pulmonary arterial pressure: mean 28.8 ± 11.5 mmHg |
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Flow and timing | The interval between the index test and reference standard: mean interval 3 days ± 1.7 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? | 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? | 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? | Unclear | ||
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? | No | ||
Could the patient flow have introduced bias? | High risk |