Objectives: 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.
Design: Feasibility study.
Setting: Seven paediatric intensive care units in England.
Participants: 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).
Main outcome measures: 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.
Conclusion: 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
