Wong 2016.
Methods | RCT; parallel‐group (phase III). Single‐centre study | |
Participants | Chronic heart failure patients being managed in an outpatient setting. Patients had stable disease, but were judged to be iron deficient as per a serum ferritin < 100 mcg/L or < 300 mcg/L where TSAT was < 20%. Anaemic participants were not excluded, and so only data from non‐anaemic participants were extracted in association with the study authors. | |
Interventions | Single dose of intervention (ferric carboxymaltose, 1000 mg) or an equivalent volume of placebo (250 mL 0.9% sodium chloride) | |
Outcomes | Primary outcome was change in mean KCCQ score at 2 weeks post‐intervention. Secondary end points were 6MWT distance, PHQ‐9, grip strength, NT‐proBNP, Hb, ferritin and TSAT | |
Study funding arrangements | No information available on study funding arrangements | |
Author conflicts of interest | No information available on study funding arrangements | |
Sample size | 24 non‐anaemic participants were randomised 1:1 to receive the intervention (n = 12) or control (n = 12) treatment | |
Notes | Study was retrospectively registered on a public trials register (ACTRN 12615000952549) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The allocation sequence was generated randomly by computer software performed at the clinical trials pharmacy. Randomization was stratified by NYHA class (I vs II + III)." |
Allocation concealment (selection bias) | Low risk | Comment: no suggestion that using the technique described that allocation would have been known by the researchers ahead of time. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Clinician was blinded as infusion was administered by a research nurse not involved in data collection/analysis. Subjects were blinded as infusion pump was set up behind a curtain to shield their view." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Clinician was blinded as infusion was administered by a research nurse not involved in data collection/analysis. Subjects were blinded as infusion pump was set up behind a curtain to shield their view." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "[single participant] refused to attend follow‐up on day 7 and refused to perform 6 minute walk test. Data from the walk test and data from day 7 were excluded from analysis." Comment: single participant lost to follow‐up and accounted for in analysis |
Selective reporting (reporting bias) | High risk | Comment: despite data on haematinic markers and PHQ‐9 being collected, formal results were not available in the data provided by researchers. However, reference is made in the conference abstract notes to there being no difference between groups with respect to these metrics. |
Other bias | Unclear risk | Comment: no pharmaceutical company involvement implied, but conference abstract lacks an explicit statement indicating independent study. |