Lafitte 2013.
Study characteristics | |||
Patient Sampling | Retrospective | ||
Patient characteristics and setting |
Study location: France Study periods: between June 2011 and March 2012 Care setting: the cardiac catheterisation department, which performs approximately 4500 right‐heart catheterisation procedures every year, and from the echocardiography department, which conducts > 15,000 trans‐thoracic Doppler echocardiographic studies every year Participants enrolled: 310: 162 males and 148 females Participants included in analysis: 155: gender not reported Age: mean age 64.8 ± 15.9 years BMI: mean 26.3± 5.7 Classification of PH defined by WHO (diagnosis from right‐heart catheterisation): not reported Number of patients with asymptomatic or mild symptom: not reported Number of participants with COPD: not reported Number of intubated participants: 0 Inclusion criteria: The inclusion criterion for patient enrolment was having undergone both haemodynamic and echocardiographic investigations (with estimation of pulmonary pressures by Doppler on tricuspid regurgitant flow) between June 2011 and March 2012, irrespective of the causal disease, during a single hospitalisation period. Exclusion criteria: a lack of pulmonary pressures estimation on the basis of tricuspid regurgitant flow using Doppler echocardiography |
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Index tests |
Description of index test: All echocardiographic measurements were performed according to American Society of Echocardiography and European Association of Echocardiography recommendations in line with UERD standard operating procedure. Accordingly, tricuspid regurgitant maximum velocities were measured on the basis of adequate acquisitions, and estimated systolic pulmonary arterial pressure levels were determined using the modified Bernoulli equation when tricuspid regurgitant jets were analysable, in conjunction with echocardiographic estimation of right atrial pressure. Description of method to estimate right atrial pressure: Echocardiographic right atrial pressure estimation was performed on the basis of IVC size and collapsibility. Right atrial pressure was estimated to be 3 mmHg when the IVC diameter was < 21 mm with > 50% collapsibility, 8 mmHg when the IVC diameter was < 21 mm with < 50% collapsibility, and 15 mmHg when the IVC diameter was > 21 mm with < 50% collapsibility. Cut‐off value to declare PH: 38 mmHg Estimated systolic pulmonary arterial pressure: mean 49.6 ± 21.7 mmHg Sonographer qualification: underwent systematic validation by one of the senior cardiologists 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: Senior physicians specialising in invasive techniques performed the catheterisations according to standard procedures. Fluid‐filled catheters were used for patients not sedated. Systolic, diastolic, and mean PPs were averaged and calculated over five beats. Mean pulmonary arterial pressure: mean 32.7 ± 15.3 mmHg |
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Flow and timing | The interval between the index test and reference standard: mean interval 2 days ± 2.9 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? | 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? | Unclear | ||
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? | 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 |