A feasibility study of signed consent for the collection of patient id
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《英国医生杂志》
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@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.
The paediatric intensive care audit network (PICANet) was established in 2001 in collaboration with the Paediatric Intensive Care Society. This prospective clinical audit database of all admissions to paediatric intensive care units in England and Wales aims to identify evidence based best practice, facilitate resource planning, and study the epidemiology of paediatric critical illness (see www.picanet.org.uk). The Data Protection Act requires that patients give their consent for the disclosure of patient identifiable information for purposes not directly related to treatment, including external clinical audit.
In 2002-3, under section 60 of the Health and Social Care Act 2001 for England and Wales1 the independent statutory Patient Information Advisory Group granted PICANet temporary support for the collection of patient identifiable data without consent, on the condition that the viability of taking consent was assessed. We studied the feasibility of obtaining signed consent for submission of patient identifiable information to a national clinical audit. We tried to identify the characteristics of patients that might influence the likelihood of consent being given.
Methods and participants
During May to July 2003 we collected the details of consecutive patients admitted to seven paediatric intensive care units in England that agreed to take part in the study. Staff in the units approached participants (parents or guardians) in a two stage process to obtain consent: first they provided a short oral explanation and an information sheet, then 24 hours later (or before discharge) they asked for signed consent. (For 12-16 year olds, the protocol allowed staff to approach either the parents/guardians or the children themselves, but none of the staff did approach the children.)
Numbers and proportions of patients for whom consent was obtained from parents or guardians of children admitted to five paediatric intensive care units in England in May and June 2003, by age, sex, level of deprivation, and illness severity
We linked the data from returned consent forms to the PICANet database so that we could assess the proportion of admissions for which signed consent was given, refused, or not obtained for some reason (form not returned or form partially completed but not signed). To estimate the likelihood of gaining consent according to characteristics of the patient, each of the following were considered separately in a univariate approach: age, sex, level of deprivation (Townsend score derived from residential postcode), ethnicity (South Asian or not), illness severity (score on the paediatric index of mortality), and length of hospital stay (days in paediatric intensive care). We calculated odds ratios with 95% confidence intervals using logistic regression.
Results
Owing to lack of staff resources, one unit did not start to implement and one did not fully implement the protocol. We excluded these two units from the analysis. All five remaining units reported that the process of gathering consent was labour intensive and they received no additional financial support for staff time. The table shows that consent was obtained for 182/422 admissions (43%) (range by unit 9% to 84%); of these, almost half (88) had some data missing but never the signature. Most (101/182; 55%) consents were taken by staff nurses. One refusal (0.2%) was received. For 239 admissions no approach for signature was made; 75 forms were returned unsigned and 164 forms were not returned. Consent rates were significantly better for children who were more severely ill on admission ( 1% on the paediatric index of mortality) 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.
Discussion
Stationery Office. Health and Social Care Act. 2001. www.legislation.hmso.gov.uk/acts/acts2001/20010015.htm (accessed 23 February 2005).
Willison DJ, Keshavjee K, Nair K, Goldsmith C, Holbrook AM, for the COMPETE investigators. Patients' consent preferences for research uses of information in electronic medical records: interview and survey data. BMJ 2003;326: 373-7.
Verity C, Nicholl A. Consent, confidentiality, and the threat to public health surveillance. BMJ 2002;324: 1210-3.
Coleman MP, Evans BG, Barrett G. Confidentiality and the public interest in medical research—will we ever get it right? Clin Med 2003;3: 219-28.(Patricia A McKinney, reader in paediatri)
Correspondence to: P A McKinney p.a.mckinney@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.
The paediatric intensive care audit network (PICANet) was established in 2001 in collaboration with the Paediatric Intensive Care Society. This prospective clinical audit database of all admissions to paediatric intensive care units in England and Wales aims to identify evidence based best practice, facilitate resource planning, and study the epidemiology of paediatric critical illness (see www.picanet.org.uk). The Data Protection Act requires that patients give their consent for the disclosure of patient identifiable information for purposes not directly related to treatment, including external clinical audit.
In 2002-3, under section 60 of the Health and Social Care Act 2001 for England and Wales1 the independent statutory Patient Information Advisory Group granted PICANet temporary support for the collection of patient identifiable data without consent, on the condition that the viability of taking consent was assessed. We studied the feasibility of obtaining signed consent for submission of patient identifiable information to a national clinical audit. We tried to identify the characteristics of patients that might influence the likelihood of consent being given.
Methods and participants
During May to July 2003 we collected the details of consecutive patients admitted to seven paediatric intensive care units in England that agreed to take part in the study. Staff in the units approached participants (parents or guardians) in a two stage process to obtain consent: first they provided a short oral explanation and an information sheet, then 24 hours later (or before discharge) they asked for signed consent. (For 12-16 year olds, the protocol allowed staff to approach either the parents/guardians or the children themselves, but none of the staff did approach the children.)
Numbers and proportions of patients for whom consent was obtained from parents or guardians of children admitted to five paediatric intensive care units in England in May and June 2003, by age, sex, level of deprivation, and illness severity
We linked the data from returned consent forms to the PICANet database so that we could assess the proportion of admissions for which signed consent was given, refused, or not obtained for some reason (form not returned or form partially completed but not signed). To estimate the likelihood of gaining consent according to characteristics of the patient, each of the following were considered separately in a univariate approach: age, sex, level of deprivation (Townsend score derived from residential postcode), ethnicity (South Asian or not), illness severity (score on the paediatric index of mortality), and length of hospital stay (days in paediatric intensive care). We calculated odds ratios with 95% confidence intervals using logistic regression.
Results
Owing to lack of staff resources, one unit did not start to implement and one did not fully implement the protocol. We excluded these two units from the analysis. All five remaining units reported that the process of gathering consent was labour intensive and they received no additional financial support for staff time. The table shows that consent was obtained for 182/422 admissions (43%) (range by unit 9% to 84%); of these, almost half (88) had some data missing but never the signature. Most (101/182; 55%) consents were taken by staff nurses. One refusal (0.2%) was received. For 239 admissions no approach for signature was made; 75 forms were returned unsigned and 164 forms were not returned. Consent rates were significantly better for children who were more severely ill on admission ( 1% on the paediatric index of mortality) 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.
Discussion
Stationery Office. Health and Social Care Act. 2001. www.legislation.hmso.gov.uk/acts/acts2001/20010015.htm (accessed 23 February 2005).
Willison DJ, Keshavjee K, Nair K, Goldsmith C, Holbrook AM, for the COMPETE investigators. Patients' consent preferences for research uses of information in electronic medical records: interview and survey data. BMJ 2003;326: 373-7.
Verity C, Nicholl A. Consent, confidentiality, and the threat to public health surveillance. BMJ 2002;324: 1210-3.
Coleman MP, Evans BG, Barrett G. Confidentiality and the public interest in medical research—will we ever get it right? Clin Med 2003;3: 219-28.(Patricia A McKinney, reader in paediatri)