Mothers' attitudes to the randomized controlled trial (RCT): the case of acute lymphoblastic leukaemia (ALL) in children.
OBJECTIVE
Survival rates for childhood cancer have improved substantially partly as a result of national and international randomized clinical trials (RCT). However, the decision for families is complex and emotional. Our aim was to describe the views of mothers of children newly diagnosed with ALL regarding consent to randomized controlled trials.


METHODS
Qualitative interview to explore mothers knowledge, and reasons for involving their child in RCTs. Interviews took place in mothers' homes.


METHODS
Fifty mothers of children with newly diagnosed ALL (age 4-16 years; mean = 7.4) recruited through research nurses at outpatient appointments.


RESULTS
All but three families had consented for their child to be treated in the RCT, although there was wide variation in their understanding of the aims, costs and benefits. Most mothers reported the aim of the trial to compare 'old' and 'new' treatments.


CONCLUSIONS
Despite detailed verbal and written information, mothers were poorly informed about the purpose of the trial, and possibility of side effects. Individual preferences for either standard or new treatment were routinely reported. The data raise questions about the extent to which families give truly informed consent to recruitment of their child to an RCT.
Eiser
C
C
Cancer Research UK Professor of Child Health Psychology, Child and Family Research Group, Department of Psychology, University of Sheffield, Western Bank, UK. c.eiser@shef.ac.uk
Davies
H
H
Jenney
M
M
Glaser
A
A
D000293:Adolescent; D001294:Attitude to Health; D002648:Child; D002675:Child, Preschool; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent / Q000523:psychology; D008137:Longitudinal Studies; D009035:Mothers / Q000523:psychology*; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D045808:Refusal to Participate; D015203:Reproducibility of Results