Consent and newborn screening

“To me it was just one thing that happened”: parental consent and newborn bloodspot screening. : 

“To me it was just one thing that happened”: parental consent and newborn bloodspot screening. Stuart Nicholls Dept. Mathematics and Statistics, Lancaster University 3 September 2009 BSA Medsoc conference

Overview : 

Overview Newborn bloodspot screening: what is it? Screening and consent Existing knowledge Methodological approach Results Discussion

Newborn bloodspot screening : 

Newborn bloodspot screening 5-8 days post-birth National programme of screening for PKU (1969)‏ Increase in number of conditions Interest as a gateway to genetic profiling

Screening and consent : 

Screening and consent Consent requires a voluntary decision by a competent person who has been adequately informed (Beauchamp & Childress 2001, Del Carmen & Joffe 2005, Dixon-Woods et al. 2007)‏ Midwife is to: “Explain fully to parents and then record in the maternity record that newborn blood spot screening has been discussed and recommended, booklet given and consent sought. (UK Newborn Screening Programme Centre 2008, p.2).

Existing evidence : 

Existing evidence Routinisation (Hargreaves et al., 2005; Parsons et al., 2007)‏ Lack of knowledge (Faden et al., 1982; Statham et al., 1993; Davey et al., 2005; Davis et al., 2006; )‏ But: The nature of a routine offer? Knowledge assessment; sample sizes and analyses; capacity/competence

Methodological approach : 

Methodological approach Semi-structured Interviews Interviews audio-recorded and transcribed verbatim Transcribed interviews analysed using Atlas.ti software Thematic analysis (Boyatzis, 1998)‏ Open coding followed by data reduction through pattern coding into themes and concepts (Miles & Huberman 1994, p.69)‏

Voluntariness of screening : 

Voluntariness of screening Routine `And all the different things and you just think oh if it's like a procedure then it must be, it must be normal and have it done.'' KS Dualistic representation ``[...] the way it's offered can throw people a little bit. If it's offered in a way that they're almost expecting the results to be negative, [...] so as a result there's a very low risk of your child having this disorder, then you're going to go along with it.'' LH

Perceived & constrained choice : 

Perceived & constrained choice Lack of choice “...the heelprick test was just one thing amongst lots of other things really, [...] it was only when I was reading your stuff, I didn’t really think of it as being optional...”HP Competency “[...]well for me it was quite traumatic really [...] I think just my emotions kicked in, hormones or something like that. So I was, I felt more of a sound mind when I was going to antenatal” SB Time to research

Knowledge and understanding : 

Knowledge and understanding Recall Demonstrable understanding of process and implications Risk/benefit analyses Experiential knowledge (not just knowledge of heel prick)‏ e.g. Condition specific

Implications and further questions : 

Implications and further questions What counts as knowledge? Calls for improved education. What constitutes `informed' in the context of consent? How could one assess consent? Are parents providing an informed consent to newborn bloodspot screening?

Acknowledgements : 

Acknowledgements Supervisors Dr Mairi Levitt & Prof Paul Fearnhead (Lancaster University)‏ Dr Kevin Southern & Mrs Elaine Hanmer (Alder Hey)‏ Mrs Liz Eccleston (Macclesfield)‏ All the parents who took part NCT & Sure start schemes ESRC

References : 

References Beauchamp, T. & Childress, J. Principles of Biomedical Ethics Oxford University Press, 2001, 5th edn del Carmen, M. & Joffe, S. Informed consent for medical treatment and research: a review. The Oncologist, 2005, 10, 636-641 Dixon-Woods, M.; Ashcroft, R.; Jackson, C.; et al. Beyond `misunderstanding': Written information and decisions about taking part in a genetic epidemiology study. Social Science & Medicine, 2007, 65, 2212-2222 Hargreaves, K.; Stewart, R. & Oliver, S. Informed choice and public health screening for children: the case of blood spot screening. Health Expectations, 2005, 8, 161-171 Parsons, E.; King, J.; Israel, J. & Bradley, D. Mothers' accounts of screening newborn babies in Wales (UK). Midwifery, 2007, 23, 59-65

References : 

References Faden, R.; Chwalow, A.; Holtzman, N. & Horn, S. A survey to evaluate parental consent as public policy for neonatal screening. American Journal of Public Health, 1982, 72, 1347-1352 Statham, H.; Green, J. & Snowden, C. Mothers' consent to screening newborn babies for disease. British Medical Journal, 1993, 306, 858 Davey, A.; French, D.; Dawkins, H. & O'Leary, P. New mothers' awareness of newborn screening, and their attitudes to the retention and use of samples for research purposes. Genomics, Society and Policy, 2005, 1, 41-51 Davis, T.; Humiston, S.; Arnold, C.; et al.. Recommendations for effective newborn screening communication: results of focus groups with parents, providers, and experts Pediatrics, 2006, 117, S326-S340

References : 

References Campbell, E. & Ross, L. Incorporating newborn screening into prenatal care American Journal of Obstetrics and Gynecology, 2004, 190, 876-877 Clayton, E. Talking with parents before newborn screening. Journal of Pediatrics, 2005, 147, S26-S29 Kemper, A.; Fant, K. & Clark, S. Informing parents about newborn screening. Public Health Nursing, 2005, 22, 332-338