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.

Background:An urgent neurology assessment clinic was created at our institution to improve access to prompt neurological assessment, and has been in operation for over a decade. We assessed its timeliness and impact.Methods:The clinic database was examined retrospectively for trends in the volume and waiting time to assessments, neurologic diagnoses, and whether neurologic assessment changed patients’ diagnoses. Before and after implementation, the frequency of emergency department neurology assessments and hospital admissions for neurological investigation were compared.Results:In the first decade, 25145 referrals were received; 12460 patients were accepted and assessed within an average of 3.8 working days. The most common problems seen included headache and seizure (20.2% each). Overall, 44.6% of assessments resulted in a change to the referring diagnosis; this proportion varied by the type of problem seen (from 10.5% for seizures to 92.5% for psychiatric disturbances). From the pre- to post-opening periods, there were fewer emergency room neurological assessments (35.7% reduction) and fewer hospital admissions for neurological investigation (4.4/week to 2.2/week, 50% reduction).Conclusions:The urgent neurology clinic model at our institution has provided excellent service, including wait times of a few days, to a catchment of over two million Canadians for over a decade; clinic assessments have affected diagnoses and patient care.

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

At the outset of this project, one aim was to define a set of core data fields to include in all neurological registries in Canada. This project targeted neurological registries in Canada for all priority neurological conditions identified in the call for proposal including: Alzheimer's disease (AD) and other dementias, amyotrophic lateral sclerosis (ALS), brain tumours, cerebral palsy (CP), dystonia, epilepsy, Huntington's disease (HD), hydrocephalus, multiple sclerosis (MS), muscular dystrophy (MD), Parkinson's disease (PD), spina bifida, spinal cord injuries (SCI), Tourette syndrome and traumatic brain injury (TBI). The project team sought to identify all existing neurological condition registries in Canada to consult as stakeholders in this project. Disease experts from all of the above priority conditions were included in the process. Neurological registries represented in the project included: • The Canadian Cerebral Palsy Registry-a voluntary registry including children with CP across several jurisdictions in Canada. (Edmonton, Alberta). • The Canadian Neuromuscular Disease Registry (CNDR)-a voluntary registry which includes MD, ALS and all other adults and children with neuromuscular disease in Canada (Calgary, Alberta, www.cndr.org) • Hydrocephalus Registry (under development) • The North American Research Committee on Multiple Sclerosis (NARCOMS) Registry-a voluntary online registry for patients worldwide with MS (Birmingham, Alabama, www.narcoms.org) • The Ontario Stroke Registry-formerly known as the Registry of the Canadian Stroke Network, a mandatory registry under Ontario's Personal Health Information Protection Act (PHIPA) based at the Institute for Clinical Evaluative Sciences (ICES) in Toronto, Ontario. http://www.ices.on.ca/webpage .cfm?site_id=1&org_id=26&morg_id=0&gsec_id=7071&item_ id=7071 • The Quebec Myotonic Dystrophy Registry-a voluntary registry for Quebec patients with myotonic dystrophy (a form of MD) (Quebec, Quebec http://www.dystrophiemyotonique.chuq. qc.ca/ENG/registry-why.html) • The Rick Hansen Spinal Cord Injury Registry (RHSCIR)-a voluntary registry which includes individuals with SCI from across Canada (Vancouver, British Columbia, www.rickhansen registry.org) Suppl. 2-S62