ArticleBMJ (Clinical research ed.)2005
A feasibility study of signed consent for the collection of patient identifiable information for a national paediatric clinical audit database.
Article in BMJ (Clinical research ed.), 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed.
- End of life care for infants, children and young people (ENHANCE): Protocol for a mixed methods evaluation of current practice in the United Kingdom [version 1; peer review: 2 approved].NIHR open research · 2022Article
- Assessing the impact of the requirement for explicit consent in a hospital-based stroke study.QJM : monthly journal of the Association of Physicians · 2008Article
- The effect of privacy legislation on observational research.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2008Article
- Extracting information from hospital records: what patients think about consent.Quality & safety in health care · 2007Article
- Evaluating common de-identification heuristics for personal health information.Journal of medical Internet research · 2006Article
- National survey of British public's views on use of identifiable medical data by the National Cancer Registry.BMJ (Clinical research ed.) · 2006Article
- Research governance: regulating risk and reducing harm?Journal of the Royal Society of Medicine · 2006Review
- Many patients may not understand consent forms.BMJ (Clinical research ed.) · 2005Article
- Evaluating predictors of geographic area population size cut-offs to manage re-identification risk.Journal of the American Medical Informatics Association : JAMIAArticle
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo 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.
designFeasibility study.
settingSeven paediatric intensive care units in England.
participantsParents/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 measuresThe 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).
resultsOne 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.
conclusionSystematically 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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