A feasibility study of signed consent for the collection of patient identifiable information for a national paediatric clinical audit database.
OBJECTIVE
To investigate the feasibility of obtaining signed consent for submission of patient identifiable data to a national clinical audit database and to identify factors influencing the consent process and its success.


METHODS
Feasibility study.


METHODS
Seven paediatric intensive care units in England.


METHODS
Parents/guardians of patients, or patients aged 12-16 years old, approached consecutively over three months for signed consent for submission of patient identifiable data to the national clinical audit database the Paediatric Intensive Care Audit Network (PICANet).


METHODS
The numbers and proportions of admissions for which signed consent was given, refused, or not obtained (form not returned or form partially completed but not signed), by age, sex, level of deprivation, ethnicity (South Asian or not), paediatric index of mortality score, length of hospital stay (days in paediatric intensive care).


RESULTS
One unit did not start and one did not fully implement the protocol, so analysis excluded these two units. Consent was obtained for 182 of 422 admissions (43%) (range by unit 9% to 84%). Most (101/182; 55%) consents were taken by staff nurses. One refusal (0.2%) was received. Consent rates were significantly better for children who were more severely ill on admission and for hospital stays of six days or more, and significantly poorer for children aged 10-14 years. Long hospital stays and children aged 10-14 years remained significant in a stepwise regression model of the factors that were significant in the univariate model.


CONCLUSIONS
Systematically obtaining individual signed consent for sharing patient identifiable information with an externally located clinical audit database is difficult. Obtaining such consent is unlikely to be successful unless additional resources are specifically allocated to training, staff time, and administrative support.
McKinney
Patricia A
PA
Paediatric Epidemiology Group, University of Leeds, Leeds LS2 9LN. p.a.mckinney@leeds.ac.uk
Jones
Samantha
S
Parslow
Roger
R
Davey
Nicola
N
Darowski
Mark
M
Chaudhry
Bill
B
Stack
Charles
C
Parry
Gareth
G
Draper
Elizabeth S
ES
D000293:Adolescent; D000328:Adult; D002675:Child, Preschool; D032962:Consent Forms / Q000706:statistics & numerical data*; D003625:Data Collection / Q000379:methods*; D016208:Databases, Factual / Q000706:statistics & numerical data; D004739:England; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D015278:Intensive Care Units, Pediatric; D008297:Male; D010355:Patient Identification Systems / Q000706:statistics & numerical data; D020458:Third-Party Consent / Q000706:statistics & numerical data*