BackgroundPatient registries represent a well-established methodology for prospective data collection with a wide array of applications for clinical research and health care administration. An examination and synthesis of registry stakeholder perspectives has not been previously reported in the literature.MethodsTo inform the development of future neurological registries we examined stakeholder perspectives about such registries through a literature review followed by 3 focus groups comprised of a total of 15 neurological patients and 12 caregivers.Results(1) Literature review: We identified 6,435 abstracts after duplicates were removed. Of these, 410 articles underwent full text review with 24 deemed relevant to perspectives about neurological and non-neurological registries and were included in the final synthesis. From a patient perspective the literature supports altruism, responsible use of data and advancement of research, among others, as motivating factors for participating in a patient registry. Barriers to participation included concerns about privacy and participant burden (i.e. extra clinic visits and associated costs). (2) Focus groups: The focus groups identified factors that would encourage participation such as: having a clear purpose; low participant burden; and being well-managed among others.ConclusionsWe report the first examination and synthesis of stakeholder perspectives on registries broadly with a specific focus on neurological patient registries. The findings of the broad literature review were congruent with the neurological patient and caregiver focus groups. We report common themes across the literature and the focus groups performed. Stakeholder perspectives need to be considered when designing and operating patient registries. Emphasizing factors that promote participation and mitigating barriers may enhance patient recruitment.
This section summarizes the ethical and legal considerations that will impact the creation and operation of neurological disease registries in Canada. This document is not meant to provide legal or ethical advice. In order to ensure that applicable laws and organizational policies are adhered to in an appropriate manner, it is recommended that legal advisors and relevant organizational representatives be consulted. For registries to succeed, it is critical to proactively consider legal and ethical issues such as consent and privacy. Additional ethical and legal considerations include: the involvement of Aboriginal people and their communities, languages and communication; setting up of biobanks; data management; data ownership; and conducting transparent registry operations. The Belmont Report-Ethical Principles and Guidelines for the protection of human subjects of research 6 and the Government of Canada Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS-2) 7 should be referred to for the ethical principles that need to be considered during the creation of disease registries. In addition, Registries for Evaluating Patient Outcomes: A User's Guide 5 produced by The Agency for Healthcare Research and Quality provides useful information. However, this document presents perspectives and reviews legislation particularly relevant to the United States which differ in some respects from Canadian law and research policies and practice. In preparation of this guideline, we examined relevant Canadian and international literature as well as Canadian policy and legislation. We also consulted with Canadian privacy officers and specialists in research ethics. Finally, topic themes and issues were discussed with patients and families in project focus groups. BACKGROUND In Canada, Research Ethics Boards (REBs) are the equivalent of what is more commonly known as Institutional Review Boards (IRBs) in other jurisdictions. The TCPS-2 describes the authority, mandate and accountability of REBs. In some cases, provincial and federal legislation also applies. While Suppl. 2-S5
This section summarizes the considerations surrounding patient recruitment that Canadian neurological registries should address during planning and design. In preparation of this guideline, we examined relevant Canadian and international literature; Canadian policy and legislation. We also consulted with Canadian privacy officers and specialists in research ethics. BACKGROUNDClinical registries capture patient information contingent upon successful recruitment and retention of patients who will consent to participation. To accomplish this requires the elements that affect patient recruitment. For example, failure to adequately engage physicians or other healthcare professionals can have as much impact on recruitment success as failure to adequately identify the patients relevant to the purposes of the registry. A strategy for recruitment that is not properly targeted to relevant patients will fail to provide desired information. RELEVANT LITERATUREA literature review identified 96 abstracts describing registry recruitment. Full text reviews were performed on 37 articles and identified 23 articles for summarization. General OverviewRecruitment in a comprehensive manner can result in population-based registries that are highly generalizable and can be used for the identification of eligible participants for future research studies.
The purpose of this section of the document is to identify issues related to data collection and registry configuration. When designing a disease registry, it is important to consider the registry's purpose and target population as this will influence the type of data, source(s) of data, and the manner in which it is collected. A data dictionary defining the specific data elements to be collected is key to ensuring registry data quality. Compliance of physicians and patients who provide registry data is instrumental to data collection and should be addressed early. Additionally, it is important to consider if the registry will be linked to other databases. Finally, it is important to address procedures for making changes in the registry and to establish what types of documentation are necessary. In preparation of this section, we reviewed the literature, scholarly sources, and consulted with medical experts and registry/database specialists on the topics mentioned above. RELEVANT LITERATURE In preparing the information below 139 full text articles were reviewed. Conventional and Innovative Roles for Registries Most registries aimed to serve conventional registry roles. As examples, Byrne et al used a registry to examine the natural history of Pompe disease 68 ; three registries pursued quality improvement (stroke care, cardiac catheterization and management of childhood diabetes 69-71); disease subgroup characterization was facilitated for pituitary and lung tumors, 72,73 post-market device monitoring for cardiovascular stents, 74,75 as well as monitoring of treatment outcomes and safety follow up for cardiac transplant patients receiving everolimus, general cardiac care, biological agents for arthritis, giant intracranial aneurysms, and TPA for ischemic stroke. 76-80 Other registries aimed to serve innovative roles: • examining the impact of a diagnostic test on patient management (i.e. PET scanning on management of cancer patients), 81
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