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. 2019 Jan 31;2019(1):CD012621. doi: 10.1002/14651858.CD012621.pub2

Galiè 2016a.

Methods Randomised double‐blind controlled trial
Mean duration of follow‐up 4.7 months
Participants Inclusion criteria:
  • Consecutive naïve patients with operable and non‐operable chronic thromboembolic pulmonary hypertension (WHO Group 4)


n = 121
Interventions Sildenafil (20 mg 3 times ar day) (N=61) versus bosentan (125 mg bid) (N=60)
Outcomes 6MWD
RAP
Mean PAP
CI
PVR
Adverse events
Notes Abstract only
States the abstract is funded by "none"
Location of trial and dates of enrolment not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Random sequence generation was not reported, although information given was limited as this was an abstract only. We contacted the authors but there was no reply at the time of publication
Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Blinding of participants and personnel was not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinding of outcome assessment was not reported
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk It was not clear if there were issues with attrition bias
Selective reporting (reporting bias) Unclear risk It is not clear if there was selective reporting bias
Other bias Unclear risk Unclear if other bias is present ‐ abstract only from conference proceedings