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Should HFE p.C282Y homozygotes with moderately elevated serum ferritin be treated? A randomised controlled trial comparing iron reduction with sham treatment (Mi-iron).

Ong SY, Dolling L, Dixon JL, Nicoll AJ, Gurrin LC, Wolthuizen M, Wood EM, Anderson GJ, Ramm GA, Allen KJ, Olynyk JK, Crawford D, Kava J, Ramm LE, Gow P, Durrant S, Powell LW, Delatycki MB - BMJ Open (2015)

Bottom Line: Patients are blinded to all procedures.Patient reported outcome measures are the Modified Fatigue Impact Scale (MFIS-primary outcome), Hospital Anxiety and Depression Scale (HADS), Medical Outcomes Study 36-item short form V.2 (SF36v2) and Arthritis Impact Measurement Scale 2 short form (AIMS2-SF).This study has been approved by the Human Research Ethics Committees of Austin Health, Royal Melbourne Hospital and Royal Brisbane and Women's Hospital.

View Article: PubMed Central - PubMed

Affiliation: Bruce Lefroy Centre, Murdoch Childrens Research Institute, Parkville, Victoria, Australia Department of Medicine, The University of Melbourne, Parkville, Victoria, Australia.

No MeSH data available.


Related in: MedlinePlus

A black opaque curtain prevents the participant from seeing the apheresis machine and therefore the individual cannot see if red blood cells or plasma is removed. (A) View from the patient's perspective, (B) View from the apheresis machine side of the curtain.
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BMJOPEN2015008938F2: A black opaque curtain prevents the participant from seeing the apheresis machine and therefore the individual cannot see if red blood cells or plasma is removed. (A) View from the patient's perspective, (B) View from the apheresis machine side of the curtain.

Mentions: The participant is blinded as to which arm of the study he/she has been randomised by being connected to the apheresis machine with the machine and the tubing not visible to the individual. This is achieved by the participant's arm being passed through an opaque black curtain (figure 2). Thus participants are unaware of whether they are having red blood cells (RBCs) or plasma removed and are unaware of whether or not they are having their iron levels reduced. Staff performing the apheresis are trained to not inadvertently reveal the treatment arm of the participant through strict adherence to study protocol and careful use of language in describing what is being performed. A member of the research team is present during the intervention to ensure blinding is maintained by monitoring the procedure and conversation between apheresis staff with the participant.


Should HFE p.C282Y homozygotes with moderately elevated serum ferritin be treated? A randomised controlled trial comparing iron reduction with sham treatment (Mi-iron).

Ong SY, Dolling L, Dixon JL, Nicoll AJ, Gurrin LC, Wolthuizen M, Wood EM, Anderson GJ, Ramm GA, Allen KJ, Olynyk JK, Crawford D, Kava J, Ramm LE, Gow P, Durrant S, Powell LW, Delatycki MB - BMJ Open (2015)

A black opaque curtain prevents the participant from seeing the apheresis machine and therefore the individual cannot see if red blood cells or plasma is removed. (A) View from the patient's perspective, (B) View from the apheresis machine side of the curtain.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4538285&req=5

BMJOPEN2015008938F2: A black opaque curtain prevents the participant from seeing the apheresis machine and therefore the individual cannot see if red blood cells or plasma is removed. (A) View from the patient's perspective, (B) View from the apheresis machine side of the curtain.
Mentions: The participant is blinded as to which arm of the study he/she has been randomised by being connected to the apheresis machine with the machine and the tubing not visible to the individual. This is achieved by the participant's arm being passed through an opaque black curtain (figure 2). Thus participants are unaware of whether they are having red blood cells (RBCs) or plasma removed and are unaware of whether or not they are having their iron levels reduced. Staff performing the apheresis are trained to not inadvertently reveal the treatment arm of the participant through strict adherence to study protocol and careful use of language in describing what is being performed. A member of the research team is present during the intervention to ensure blinding is maintained by monitoring the procedure and conversation between apheresis staff with the participant.

Bottom Line: Patients are blinded to all procedures.Patient reported outcome measures are the Modified Fatigue Impact Scale (MFIS-primary outcome), Hospital Anxiety and Depression Scale (HADS), Medical Outcomes Study 36-item short form V.2 (SF36v2) and Arthritis Impact Measurement Scale 2 short form (AIMS2-SF).This study has been approved by the Human Research Ethics Committees of Austin Health, Royal Melbourne Hospital and Royal Brisbane and Women's Hospital.

View Article: PubMed Central - PubMed

Affiliation: Bruce Lefroy Centre, Murdoch Childrens Research Institute, Parkville, Victoria, Australia Department of Medicine, The University of Melbourne, Parkville, Victoria, Australia.

No MeSH data available.


Related in: MedlinePlus