BMJ  2005;330:877-879 (16 April), doi:10.1136/bmj.38404.650208.AE (published 18 March 2005)

Paper

A feasibility study of signed consent for the collection of patient identifiable information for a national paediatric clinical audit database

Patricia A McKinney, reader in paediatric epidemiology1, Samantha Jones, research fellow2, Roger Parslow, senior research fellow1, Nicola Davey, research nurse3, Mark Darowski, clinical director of paediatric critical care4, Bill Chaudhry, consultant paediatric intensivist6, Charles Stack, consultant in paediatric intensive care5, Gareth Parry, reader in health services research2, Elizabeth S Draper, senior research fellow in perinatal and paediatric epidemiology3, for the PICANet Consent Study Group

1 Paediatric Epidemiology Group, University of Leeds, Leeds LS2 9LN, 2 Critical Care Group, School of Health and Related Research, University of Sheffield, Sheffield S1 4DA, 3 Department of Health Sciences, University of Leicester, Leicester LE1 6TP, 4 Leeds Teaching Hospitals Trust, Leeds General Infirmary, Leeds LS1 3EX, 5 Sheffield Children's NHS Trust, Sheffield S10 2TH, 6 Newcastle General Hospital, Newcastle upon Tyne NE4 6BE

Correspondence to: P A McKinney p.a.mckinney{at}leeds.ac.uk

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.


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Rapid Responses:

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Data Protection Act does not require consent for medical research
Peter D Singleton
bmj.com, 3 Apr 2005 [Full text]
Re: Data Protection Act does not require consent for medical research
susanne mccabe
bmj.com, 6 Apr 2005 [Full text]
Re: Re: Data Protection Act does not require consent for medical research
susanne mccabe
bmj.com, 15 Apr 2005 [Full text]
Can patients understand our consent forms?
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