Han 2013.
Methods | Double‐blind, placebo‐controlled trial 12 weeks duration |
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Participants | Inclusion criteria:
Exclusion criteria:
N = 119 |
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Interventions | Oral sildenafil (20 mg 3 times a day) (N=56) compared with placebo (N=63) | |
Outcomes | 6MWD
SGRQ SF‐36 EuroQol visual analogue scores |
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Notes | This was a substudy of the STEP‐IPF study which examined all participants with IPF and compared sildenafil with placebo This substudy examined only those with pulmonary hypertension and IPF Industry‐funded Trial conducted at 14 centres in the USA, dates of enrolment not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants meeting eligibility criteria were randomly assigned in a 1:1 ratio to receive sildenafil or matched placebo with the use of a permuted‐block design, with stratification according to clinical centre |
Allocation concealment (selection bias) | Low risk | Placebo‐controlled |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo‐controlled |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All echocardiograms were performed prior to randomisation and scored independently and in a blinded fashion by two cardiologists with advanced expertise in echocardiography. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "Sixty‐one echocardiograms could not be transferred to the study centre, thus ineligible for inclusion". |
Selective reporting (reporting bias) | High risk | This is a substudy |
Other bias | Low risk | Other bias is unlikely |