Downloaded from http://jme.bmj.com/ on November 15, 2015 - Published by group.bmj.com
Brief report
Implementation of a consent for chart review and contact and its impact in one clinical centre Irena Druce,1 T C Ooi,1,2 Debbie McGuire,1 Alexander Sorisky,1,2 Janine Malcolm1,2 1
Division of Endocrinology and Metabolism, Department of Medicine, The Ottawa Hospital, University of Ottawa, The Ottawa Hospital, Riverside Campus, Ottawa, Ontario, Canada 2 Chronic Disease Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada Correspondence to Dr T C Ooi, Division of Endocrinology and Metabolism, The Ottawa Hospital, Riverside Campus, 1967 Riverside Drive, Ottawa, Ontario, Canada K1H 7W9; [email protected] Received 13 August 2013 Revised 18 August 2014 Accepted 2 September 2014 Published Online First 19 September 2014
ABSTRACT Objective Informed consent and protection of patient confidentiality are central to the conduction of clinical research. Consent for chart review and contact (CCRC) allows a patient chart to be screened for research by persons outside the direct circle-of-care and for the patient to be contacted regarding potential studies. This study describes the process of implementation and benefits of such a consent. Design We present a descriptive report of a CCRC document that was created and presented to patients over a 3.5-year period at a tertiary care Endocrinology and Metabolism centre. To assess the potential impact of such a document on patient recruitment, the basic demographics of patients who did and did not consent were compared. In addition, we compared the recruitment rate at our centre, using our novel approach, with that at other centres for an ongoing study of patients with type 1 diabetes. Results A large proportion (6501/8025, or 81%) of patients gave their consent for chart review. Patients who denied consent were more likely to be women and older. Compared with other centres, our centre recruited at the highest rate for a known study of patients with type 1 diabetes. The majority (46/60, or 76.7%) of patients were recruited via the novel approach. Conclusions Consent for chart review and contact addresses several important ethical issues regarding the use of patient clinical information for research purposes. Our study demonstrated how such a process can be implemented. INTRODUCTION
To cite: Druce I, Ooi TC, McGuire D, et al. J Med Ethics 2015;41:425–428.
Informed consent and protection of personal health information are central to the conduct of clinical research. The use of personal health information is guided by law and local regulations at individual research institutions. At The Ottawa Hospital, patient confidentiality is maintained by following the requirements set out in the Personal Health Information Protection Act and personal health information is subject to security measures, including the use of locked cabinets, passwords and encryption. Furthermore, The Ottawa Health Science Network Research Ethics Board (OHSN-REB) has a document entitled ‘Guidance for Researchers on Privacy, Confidentiality and Security in Research’, which dictates that personal health information cannot be accessed by anyone except the designated custodian of the information, nor can a patient be contacted to discuss potential research projects, without the expressed consent of the subject. Such mandates pose a challenge for research recruitment, as only the patient’s primary physician, and those directly in the circle-of-care,
can access clinical information and approach patients. In response to this, the Division of Endocrinology and Metabolism, The Ottawa Hospital, University of Ottawa, developed and implemented a consent for chart review and contact (CCRC). Habiba and Evans introduced the concept of CCRC in 2002.1 The CCRC is presented to patients on their first meeting with a physician. Patients either give or deny consent for their charts to be reviewed by research staff and to be contacted should they meet the criteria for a study. Despite the potential merits of CCRC, there is no literature on the implementation and use of this approach in clinical research. This study describes the process involved in the implementation of such a consent and its benefit of increasing research recruitment.
METHODS Creation of CCRC A working group in the Division of Endocrinology and Metabolism, The Ottawa Hospital, the University of Ottawa, prepared a preliminary CCRC document based on literature and existing local documents. OHSN-REB approval was sought and obtained. The document is entitled ‘Consent to Review Your Chart for Clinical Research Eligibility’, referred from here as the consent for chart review and contact (CCRC; figure 1). The document explains the consent’s voluntary nature and gives contact information in case a person wishes to withdraw. In providing consent, a patient is allowing their entire medical record, which includes physical chart notes and an electronic medical record, to be screened to determine eligibility for potential future studies and gives permission for the patient to be contacted by research staff.
Implementation of CCRC The CCRC was implemented on 12 May 2009. It was the role of the treating physician to explain the purpose of the CCRC. A copy of the signed CCRC was provided to the patient, a copy was left in the patient’s chart and a third copy was retained by administrative personnel.
Data analysis Patients were grouped according to whether they agreed, or did not agree, to the CCRC. Both data sets were analysed for duplicates and these were excluded (59 out of 6560 and 20 out of 1544, respectively). For each group, the mean age was calculated as well as the number of men and women.
Druce I, et al. J Med Ethics 2015;41:425–428. doi:10.1136/medethics-2013-101765
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Downloaded from http://jme.bmj.com/ on November 15, 2015 - Published by group.bmj.com
Brief report
Figure 1 Division of Endocrinology and Metabolism prepared a document entitled ‘Consent to Review Your Chart for Research Eligibility’. Mean ages were compared using Student’s t test, and the gender distribution was compared using a Fisher’s exact test. All statistics were performed using Microsoft Excel Software (Microsoft Office Excel 2007). The above-described analysis was authorised by the OHSN-REB as an extension of the original CCRC document ethics approval, as it represented an examination of the outcome of implementing the consent.
recruitment team. At the meeting, the study was explained and each patient had the opportunity to sign a trial-specific consent.
RESULTS
Enrolment for an ongoing international trial involving patients with type 1 diabetes was analysed. Patients having type 1 diabetes who gave their consent to the CCRC were identified. Those deemed eligible were asked whether they would be willing to meet with a member of the
Between 12 May 2009 and 31 December 2012, a total of 8025 patients signed the CCRC; 6501 patients (81%) gave their consent and 1524 patients (19%) did not. The basic demographics (age and gender) of the patients in each group are summarised in table 1. The mean age of patients who gave consent was significantly lower than those who did not (54.25±16.24 vs 56.91±17.3 years; p
Brief report
Implementation of a consent for chart review and contact and its impact in one clinical centre Irena Druce,1 T C Ooi,1,2 Debbie McGuire,1 Alexander Sorisky,1,2 Janine Malcolm1,2 1
Division of Endocrinology and Metabolism, Department of Medicine, The Ottawa Hospital, University of Ottawa, The Ottawa Hospital, Riverside Campus, Ottawa, Ontario, Canada 2 Chronic Disease Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada Correspondence to Dr T C Ooi, Division of Endocrinology and Metabolism, The Ottawa Hospital, Riverside Campus, 1967 Riverside Drive, Ottawa, Ontario, Canada K1H 7W9; [email protected] Received 13 August 2013 Revised 18 August 2014 Accepted 2 September 2014 Published Online First 19 September 2014
ABSTRACT Objective Informed consent and protection of patient confidentiality are central to the conduction of clinical research. Consent for chart review and contact (CCRC) allows a patient chart to be screened for research by persons outside the direct circle-of-care and for the patient to be contacted regarding potential studies. This study describes the process of implementation and benefits of such a consent. Design We present a descriptive report of a CCRC document that was created and presented to patients over a 3.5-year period at a tertiary care Endocrinology and Metabolism centre. To assess the potential impact of such a document on patient recruitment, the basic demographics of patients who did and did not consent were compared. In addition, we compared the recruitment rate at our centre, using our novel approach, with that at other centres for an ongoing study of patients with type 1 diabetes. Results A large proportion (6501/8025, or 81%) of patients gave their consent for chart review. Patients who denied consent were more likely to be women and older. Compared with other centres, our centre recruited at the highest rate for a known study of patients with type 1 diabetes. The majority (46/60, or 76.7%) of patients were recruited via the novel approach. Conclusions Consent for chart review and contact addresses several important ethical issues regarding the use of patient clinical information for research purposes. Our study demonstrated how such a process can be implemented. INTRODUCTION
To cite: Druce I, Ooi TC, McGuire D, et al. J Med Ethics 2015;41:425–428.
Informed consent and protection of personal health information are central to the conduct of clinical research. The use of personal health information is guided by law and local regulations at individual research institutions. At The Ottawa Hospital, patient confidentiality is maintained by following the requirements set out in the Personal Health Information Protection Act and personal health information is subject to security measures, including the use of locked cabinets, passwords and encryption. Furthermore, The Ottawa Health Science Network Research Ethics Board (OHSN-REB) has a document entitled ‘Guidance for Researchers on Privacy, Confidentiality and Security in Research’, which dictates that personal health information cannot be accessed by anyone except the designated custodian of the information, nor can a patient be contacted to discuss potential research projects, without the expressed consent of the subject. Such mandates pose a challenge for research recruitment, as only the patient’s primary physician, and those directly in the circle-of-care,
can access clinical information and approach patients. In response to this, the Division of Endocrinology and Metabolism, The Ottawa Hospital, University of Ottawa, developed and implemented a consent for chart review and contact (CCRC). Habiba and Evans introduced the concept of CCRC in 2002.1 The CCRC is presented to patients on their first meeting with a physician. Patients either give or deny consent for their charts to be reviewed by research staff and to be contacted should they meet the criteria for a study. Despite the potential merits of CCRC, there is no literature on the implementation and use of this approach in clinical research. This study describes the process involved in the implementation of such a consent and its benefit of increasing research recruitment.
METHODS Creation of CCRC A working group in the Division of Endocrinology and Metabolism, The Ottawa Hospital, the University of Ottawa, prepared a preliminary CCRC document based on literature and existing local documents. OHSN-REB approval was sought and obtained. The document is entitled ‘Consent to Review Your Chart for Clinical Research Eligibility’, referred from here as the consent for chart review and contact (CCRC; figure 1). The document explains the consent’s voluntary nature and gives contact information in case a person wishes to withdraw. In providing consent, a patient is allowing their entire medical record, which includes physical chart notes and an electronic medical record, to be screened to determine eligibility for potential future studies and gives permission for the patient to be contacted by research staff.
Implementation of CCRC The CCRC was implemented on 12 May 2009. It was the role of the treating physician to explain the purpose of the CCRC. A copy of the signed CCRC was provided to the patient, a copy was left in the patient’s chart and a third copy was retained by administrative personnel.
Data analysis Patients were grouped according to whether they agreed, or did not agree, to the CCRC. Both data sets were analysed for duplicates and these were excluded (59 out of 6560 and 20 out of 1544, respectively). For each group, the mean age was calculated as well as the number of men and women.
Druce I, et al. J Med Ethics 2015;41:425–428. doi:10.1136/medethics-2013-101765
425
Downloaded from http://jme.bmj.com/ on November 15, 2015 - Published by group.bmj.com
Brief report
Figure 1 Division of Endocrinology and Metabolism prepared a document entitled ‘Consent to Review Your Chart for Research Eligibility’. Mean ages were compared using Student’s t test, and the gender distribution was compared using a Fisher’s exact test. All statistics were performed using Microsoft Excel Software (Microsoft Office Excel 2007). The above-described analysis was authorised by the OHSN-REB as an extension of the original CCRC document ethics approval, as it represented an examination of the outcome of implementing the consent.
recruitment team. At the meeting, the study was explained and each patient had the opportunity to sign a trial-specific consent.
RESULTS
Enrolment for an ongoing international trial involving patients with type 1 diabetes was analysed. Patients having type 1 diabetes who gave their consent to the CCRC were identified. Those deemed eligible were asked whether they would be willing to meet with a member of the
Between 12 May 2009 and 31 December 2012, a total of 8025 patients signed the CCRC; 6501 patients (81%) gave their consent and 1524 patients (19%) did not. The basic demographics (age and gender) of the patients in each group are summarised in table 1. The mean age of patients who gave consent was significantly lower than those who did not (54.25±16.24 vs 56.91±17.3 years; p
