Click on above image for
example of registry
patient data screen

Courtesy: RHSCI Registry.

Registry Roll-out!
Progress of the Rick Hansen Spinal Cord Injury Registry

By Garry Angus

Just two years after the formalization of the team and the project, the Rick Hansen Spinal Cord Injury Registry is in its pilot phase at Vancouver General Hospital and G.F. Strong, and at Foothills Hospital in Calgary, Alberta. Remarkable speed for a remarkable project.

"So far the momentum has been wonderful, and the commitment of the team, the steering committee and everybody, all the stakeholders across the country has been quite something," says Monique Echols, Project Director.

The development of registry -- a unique database project capable of international scope - is, as the Project Director says, a "fundamental piece" in the Rick Hansen Man in Motion Foundation's Spinal Cord Injury Network strategy: "developing a Canada-wide network of clinicians and scientists collaborating to improve functional recovery and quality of life" for people living with spinal cord injuries (SCI)."

"The sort of overall mission of the registry," says Echols, "is to collect extensive wide data nationally at this point for the purpose of improving SCI care and clinical outcomes."

Echols is quick to point out that a unique feature of registry is that it is "first and foremost, consumer orientated."

"We want to make sure that the needs and issues of the consumers are heard so research is focused appropriately, not just on the clinical," she says. "We are interested in their [people with spinal cord injuries] quality of life, and what kinds of things clinically and in the community they need."

What the Registry Project team set out to do was to create and develop an efficient, effective national SCI data retrieval and management system, which could be used as a clinical and epidemiological based information service for provincial, national, and international data exchange and collaboration between scientists and clinicians to help partners achieve their SCI information goals.

Echols, who joined on as Project Director in 2002, relates that the "whole process" began three years ago where the Rick Hansen Man in Motion Foundation in partnership with various sites across the country and key stakeholders in clinical research and industry started talking about the concept and "a small internal team started to look at exploring the possibility of developing this nationally."

"Before my time there was a lot of work done as preamble to get stakeholder buy-in and involvement. And then roughly about two years ago, I came on board, where they had finally developed their mission statement and some preliminary strategic direction. Then we built the team to start the [Registry] project," Echols said.

Initiated under the leadership of Dr. Marcel Dvorak, the RH SCI Registry Project consists of three key teams. Responsible for overall accountability is the Project Steering Committee with representatives from the Rick Hansen Man In Motion Foundation (RHMIMF), International Collaboration on Repair Discoveries (ICORD), Ontario Neurotrauma Foundation (ONF), Vancouver Coastal Health Authority (VCHA) and other interested organizations.

Expert clinical input is provided by a Project Advisory Committee made up of representatives from various stakeholders with an interest in the development and use of the registry. The third component is the Project Team under the leadership of Echols.

"We have developed the infrastructure for a program ... it's not just a database," says Echols. "We have a central staff; we have the ability to support technically and in terms of processes and operational stuff at participating sites. So we have nursing, medical, physiotherapy, health records and information system staff on board at a central level and we have a physical location with physical security. The infrastructure is there."

An important feature of the project team is the inclusion of a "designated and trained privacy officer" who, according to Echols, "is responsible for ensuring that all consent issues, the privacy and security and data quality are as they should be" -- a significant consideration for the people providing information to registry and for the project's national and international scope.

"One of the most unique things about registry is that we have direct patient contact," Echols says. "We are not pulling information just from their clinical records. And that is different and requires a lot more attention and detail to the consent process and the privacy and security issues around that."

The registry project abides by all provincial and federal legislation with respect to privacy and security. Data sharing agreements are in place with participating local and provincial health authorities. Echols points out, "We are stewards of the data. We do not own the data. The only person that owns the data is the individual themselves."

Client interviews and the generated "data sets" that organize information about their SCI experience are the building blocks of the Registry.

According to Echols, the project recognizes the importance of information, "and is capable of being used in a 'phase-staggered process,' where participating sites collect 'core' data sets, and have the option of collecting 'expanded' sets."

Core data sets consist of: basic client demographics; injury mechanisms and descriptive data; treatment parameters; complications; morbidity and mortality data; and standardized outcome assessment. Echols says the optional expanded data sets include a variety of research modules. For example, she said, "there's pain, bowel and bladder, sexual health, more detailed clinical information, so (researchers and clinicians) can pick."

She notes, "The scope of the database is such that we collect, at the acute care level, the rehabilitation level, and we follow and track the individual through the course of their life at various intervals, so our consent process incorporates all of that."

The registry pilot -- which began collecting data at Vancouver General Hospital and GF Strong Rehabilitation Hospital on June 29, 2004, and will start at Foothills Hospital in Calgary in January 2005--is making good use of the "phase-staggered" process.

"I've done a number of registries before and they take time and buy-in, and initially they can be a little cumbersome and expensive.... so what we did is design the system in a flexible manner," says Echols. "For example in our B.C. pilot in Vancouver with V.G.H. and G.F. Strong (in addition to core data set collection), we are doing the expanded (data sets) and in Calgary Foothills Hospital, they are starting with the core under the guise that eventually once the processes are really well established and people are comfortable, then you can move on into the expanded."

She says "the individuals have options for their level of participation" with the Registry and the data sets.

"If a person wanted to withdraw, we would be aware that they are an SCI individual, but we would not have their data. It would be removed from the system. If an individual was expanded and just wanted to go to the core, we can accommodate that. If an individual wanted to stop after the rehabilitation phase or stop at the acute phase and didn't want to be involved at the community follow-up level, that can be accommodated as well, because the core focuses mostly on the acute phase. It identifies there has been an injury and there is an individual out there. Aligned with privacy and security, of course, goes the whole premise that patient-identifying information is not available.

"During their SCI acute phase," says Echols, "in Vancouver, a clinical nurse specialist and /or trained research nurses will approach patients and leave them with some materials and explain to them what we are about and how it works, and then come back at time that is convenient for the patient.

"And there is an interview process that takes place and we check off on this questionnaire a lot of the information for the core and the expanded. And of course, there are also significant pieces that are pulled from the charts, but because everything has been standardized at an international level, all our questions are based on accepted standardized and used questionnaires. So it's not open-ended stuff for interpretation. Everything has been graded and accepted as a benchmark."

The registry pilot has to date collected approximately 60 cases in record at the acute care level and is now starting to import at the rehabilitation level, according to Echols.

"We have yet to start tracking at the community level because individuals are not there yet. The first encounter is at one year following discharge, and then one year, two years, five years, and on."

Echols explains that BC, Alberta and Ontario are targeted for national roll-out in 2006 and that the registry Team is working in partnership with the Ontario Neurotrauma Foundation to pilot select sites in Ontario.

Echols says the pilot process will take about one year to complete. "Then we will be prepared to roll-out nationally. The pilot process involves us learning how to implement this system properly and to find out where the bugs are and the problems so we are actively modifying and changing and adapting the system and our program as the pilot progresses. We are almost ready for version two."

With approximately 40,000 people in Canada living with SCI – a relatively small incidence compared to other studied conditions such as cancer - the registry team designed the database and data collection procedures "thinking," as Echols says, "eventually it is going to have to be international. The registry is standardized and completely aligned with international standards, so that in the bigger picture it will fit in nicely."

"One of our team members sits on the international committee and keeps them updated regularly and we also have ongoing communication contact to make sure everything is aligned, so we are right on board there," she says.

Echols says that future planning will examine how to capture retrospective data for patients long past their injuries.

"Interestingly enough," she says, "we have four requests so far, via our website (www.rickhansenregistry.org), from SCI individuals who are interested in participating. So it's really neat."

Echols notes that collecting retrospective data will be a slow process. "We will be working with the Rick Hansen Man in Motion Foundation, who are our key champions, and their connections to also identify individuals," She says. "So far the momentum has been wonderful."

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