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  • The Auckland Breast Cancer Registry

    2022-07-25

    The Auckland Breast Cancer Registry was established in June 2000 by a voluntary group led by clinicians to collect demographic, clinical and pathological data on all newly diagnosed patients with breast cancer in the Auckland region (population around 1.4 million in 2016), and to document follow-up and outcomes [1,2]. The registry is popu-lation-based, including all newly diagnosed patients with primary breast cancer resident in the defined region, and is regularly linked to the statutory national cancer registry, and to national mortality data to ascertain deaths [1,2]. From 2000–2012, individual written consent was required for patients to be included in the registry. Clinicians were requested to present the project to potential participants when seen in a clinic, and patients were asked to sign the consent form with a sup-porting signature by a witness. The consent form assured patients that
    their demographic information and data on their cancer data, treatment and follow-up would be collected using a key-coded technique suitable for potentially identifiable data, and only anonymized/unidentifiable data would be used for research and audit activities and for presenta-tion or publication. The consent form provided assurances that Cycloheximide there was a strict protocol to ensure confidentiality, and that participation was voluntary and would not affect the patient’s care. Patients were usually approached for consent at their first visit to the specialist clinic. For some patients the process was delayed but the consent process was completed by first therapy, within 90 days of diagnosis.
    By 2010, the registry management group was aware that consent was not being obtained from approximately 10% of patients. To achieve greater completeness, the group requested a review by the national statutory Health and Disability Ethics Committee, operated by the Ministry of Health, on whether the requirement for consent was
    Abbreviations: C, consented; NC, non-consented; DCIS, ductal carcinoma in situ; LCIS, lobular carcinoma in situ; NHI, National Health Index number
    Corresponding author.
    E-mail address: [email protected] (J.M. Elwood).
    Table 1
    Disease specific survival up to 10 years in consented and non-consented patients, for invasive cancer and for DCI.
    Group and numbers
    Number Survival % 95% CI
    Number Survival % 95% CI
    Number Survival % 95% CI
    followed
    followed
    followed
    Difference consented to not consented
    Difference consented to total
    Difference consented to not consented
    Difference consented to total
    required. As a result of the review, the ethics committee in July 2011 allowed the registry a dispensation to research and analyse ‘non-con-sented data’ (NC) and to compare enzymes with ‘consented data’ (C). This temporary access aimed at checking whether the NC data was com-promising or skewing the conclusions in the overall data. A short report comparing the consented and non-consented groups was prepared. (We will refer to patients as ‘consented’ rather than ‘consenting’, as consent requires the patient to be invited as well to give their consent.) Further ethical review following this report resulted in changes in the consent process: approval to use an opt-out approach in November 2012, and the grant of a waiver of consent in March 2013 allowing the previously non-consented data to be analysed and kept in the registry.
    For this study, information on all patients diagnosed from 2000 to 2012 was accessed, including data from patients not giving active consent (‘NC data’). The NC data came from those patients had not returned their consent form for any reason.