Woods 2014.
Methods | RCT; parallel‐group (phase III). Study conducted in a single centre | |
Participants | Elite athletes with non‐anaemic iron deficiency (as determined by Hb > 120 g/L and serum ferritin between 30‐100 mcg/L). Patients taking oral iron therapy were excluded from the study. | |
Interventions | Patients randomised to receive dosing of IV iron (100 mg ferric carboxymaltose) or placebo (0.9% sodium chloride) every 2 weeks for 4 weeks (3 doses) | |
Outcomes | Primary outcome was improvement in tHb mass at the end of follow‐up. Additional secondary outcome measures included VO2 peak, Brunel Mood Scale and BFI as well as Hb, ferritin and TSAT. We could not extract data on QoL scores due to absence of baseline data and presentation of data not amenable to extraction. VO2 peak data for baseline measurement was obtained after the first dose of iron was given and hence we excluded this metric. | |
Study funding arrangements | Study funded by a University of Canberra grant for post‐doctoral fellowship research. The funder had no role in study design, data collection, data analysis, decision to publish or preparation of the manuscript. | |
Author conflicts of interest | No conflicts of interest declared | |
Sample size | 14 participants were randomised 1:1 to receive the intervention (n = 7) or control (n = 7) treatment | |
Notes | Study was not registered in a public trials registry | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: no reference made to the randomisation technique, beyond a statement that it was undertaken |
Allocation concealment (selection bias) | Unclear risk | Comment: given a random method was allegedly used, presumably the potential for allocation concealment existed. However, as study authors made no specific reference to methods used, the risk of bias is unclear |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Throughout each injection, the participant’s arm was shielded using a screen with the injection solution prepared out of sight. In addition to all athletes, all research staff associated with the testing and training sessions were blinded to the treatment groups and were unable to access blood results, nor preside over the injections. Thus, only the medical staff administering the injections had access to grouping allocation information." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Throughout each injection, the participant’s arm was shielded using a screen with the injection solution prepared out of sight. In addition to all athletes, all research staff associated with the testing and training sessions were blinded to the treatment groups and were unable to access blood results, nor preside over the injections. Thus, only the medical staff administering the injections had access to grouping allocation information." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: all participants completed follow‐up with no missing data. However, as we could not extract some data due to the style of presentation, and the lack of baseline data, we cannot give a judgement of low risk. |
Selective reporting (reporting bias) | Unclear risk | Comment: all stated outcomes in the article were reported, but as the study was not prospectively registered and we did not see the, the risk of bias remains unclear. |
Other bias | Low risk | Comment: only issue is the lack of information regarding prospective registration and lack of a protocol. This was addressed in previous domain. |
ADP: adenosine diphosphate; BFI: Brief Fatigue Inventory; BNP: B‐type natriuretic peptide; CABG: coronary artery bypass graft; CPET: cardiopulmonary exercise testing; EQ‐5D‐5L: Euroquol 5 dimension, 5 level quality‐of‐life measure; Hb: haemoglobin; HRQoL: health‐related quality of life; IQR: interquartile range; IRLS: International Restless Legs Syndrome Rating Scale; ITT: intention‐to‐treat; IV: intravenous; KCCQ: Kansas City Cardiomyopathy Questionnaire; LVEF: left ventricular ejection fraction; MLHFQ: Minnesota Living with Heart Failure Questionnaire; NAID: Non‐Anaemic Iron Deficiency; NYHA: New York Heart Association; PCR: polymerase chain reaction; QoL: quality of life; PHQ‐9: Patient Health Questionnaire (depression); RCT: randomised controlled trial; SD: standard deviation; SF‐12: 12‐item short form survey; tHb: total haemoglobin; TSAT: transferrin saturation; TTE: transthoracic echocardiogram; VO2 max: peak oxygen consumption; WHO: World Health Organization; 6MWT: 6‐metre walk test;