Heldal L et al. Donation of stem cells from blood or bone marrow: results of a randomised study of safety and complaints. Bone marrow transplantation (2002) 29: 479-86
Did the study ask a clearly focused question?
Set out to compare (a) biological consequences and (b) complaints (i.e. side effects) on donors who had donated stem cells via two different donation methods.
Was this a randomised controlled trial and was it appropriately so?
61 donors allocated to two groups: 31 to brain stem cell (BSC) donation, and 30 to bone marrow (BM) donation
Were participants appropriately allocated to intervention and control groups?
No details of randomisation or allocation procedure are included.
Were participants, staff and study personnel ‘blind’ to participants’ study group?
Neither group appears to have been blinded. Although different follow up procedures were undertaken on participants in the two groups, there was no reason why the researchers themselves could not have been blinded.
Were all of the participants who entered the trial accounted for at its conclusion?
Yes, they appear to be.Shows the advantage of conducting research on participants who have little to gain by dropping out!
Were the participants in all groups followed up and data collected in the same way?
Not all (58 of 61) donors completed the questionnaire. Of these, not allanswered all items on the questionnaire. Missing values were computed as an “average of the observed values”. Unclear what this means.
Did the study have enough participants to minimise the play of chance?
No details are provided about a power calculation. As a result (?) five of the ten individual discomfort scores which appear to indicate a difference between the two methods are not statistically significant.
How are the results presented, what do they show, and how precise are they?
On five of the ten discomfort measures, responses indicate that the BSC donors experienced significantly less discomfort than the BM donors.
In the first four days following donation, BSC donors reported fewer complaints than BM donors. Thereafter level of complaints was approximately equal.
BSC donors took a median two days sick leave following donation, compared with six days for the BM donors.
BSC donors took a median two analgesic tablets following donation compared with four tablets for BSC donors.
There was a greater total number of complaints reported by BSC donors than by BM donors, but the limitations on activity caused by the symptoms reported were rated as less severe.
Were all important outcomes considered so the results can be applied?
No description given of demographic characteristics of donors, other than their age, good health and suitability for donation. Would be useful to know whether willingness to enrol for BSC donation is related to age, ethnicity, education etc.
Glossary
leukapheresis a process by which blood is withdrawn from a vein, white blood cells are selectively removed, and the remaining blood is reinfused in the donor. It is a treatment or supportive care measure in patients with leukocytosis R/T leukemia. The white blood cells may be used for treating patients with blood deficiencies or for research.
Leukopenia: is a decrease in the number of white blood cells (leukocytes) found in the blood, which places individuals at increased risk of infection.
Leukocytes: Cells that help the body fight infections and other diseases. Also called white blood cells (WBCs).