An innovative partnership launched in 2001 brought clinical research into the 21st century by means of a Web-based data network. Neuro-KnowledgeTM, a collaboration of the American Association of Neurological Surgeons (AANS) and Outcome Sciences Inc., provides a convenient means for both private practice and academic neurosurgeons across the United States to participate in a variety of clinical research opportunities. Neuro-Knowledge additionally offers its clients in industry, academia and government a time- and cost-efficient method for generating reliable data.
“For neurosurgeons, Neuro-Knowledge offers the opportunity to take part in many types of clinical research while enjoying generous compensation, while vendors and others need access to neurosurgical expertise and a wide range of types of data, as well as first rate data,” said Robert E. Harbaugh, MD, chair of the AANS Neuro-Knowledge Committee. “Neuro-Knowledge is the link that facilitates cost-effective, quality clinical research, in the end resulting in improved neurosurgical care.”
The first Neuro-Knowledge project, an opinion survey for a product used in lumbar disc procedures, illustrates how the network functions for the benefit of neurosurgeons, clients, and patients. A manufacturer wanted feedback from the marketplace regarding the efficacy of its lumbar disc product. It had surveyed its own client database and received positive feedback, but realizing that the information could be skewed toward a false positive, was looking for a broader range of expert opinion. The manufacturer hired a private market research firm to conduct a survey, but over a six-week period the firm experienced difficulty achieving the required number of respondents.
Then Neuro-Knowledge was engaged to recruit respondents for a telephone survey. Neuro-Knowledge contacted its registry of neurosurgeons via e-mail asking if they would participate in the survey. The recruitment goal was met within 48 hours, shaving eight days off of the 10-day recruitment period that had been allotted. Participating neurosurgeons were reimbursed for their time, and the client was pleased with both the remarkable speed and rate of response. The product was not rated highly by neurosurgeons, refuting the client’s prior internal research and providing valuable information for improving the product in the future.
“While we are as pleased as the client at the success of this survey, it really represents the tip of the iceberg as to what Neuro-Knowledge can accomplish,” said Richard E. Gliklich, MD, president of Outcome Sciences. “Our innovative data collection system can power clinical trials, including recruitment of investigators and data management, and observational studies such as registries and outcomes studies, in addition to opinion research.”
He explained that Outcome Sciences brings to the partnership the infrastructure for conducting research today. Based upon a state-of-the-art, Internet-based data capture system, data management is automated and compliant with all provisions of the Health Insurance Portability and Accountability Act. It additionally offers expertise in study design and management, opinion research and survey methodology, biostatistics, data analysis and reporting.
The AANS offers the concentrated experience of the world’s largest neurosurgical society, counting among its membership nearly 92 percent of all neurosurgeons certified by the American Board of Neurological Surgery, the Royal College of Physicians and Surgeons (Neurosurgery) of Canada, or the Mexican Council of Neurological Surgery, AC. These private practice and academic neurosurgeons contribute their proficiency in all areas of neurosurgery and neurosurgical trial design.
The expertise represented by Neuro-Knowledge ensures a high level of confidence in the quality of research. By continually inspiring this level of confidence in potential clients and researchers, Dr. Gliklich and Dr. Harbaugh hope to meet the Neuro-Knowledge mission: to improve the understanding of neurosurgical disease and its treatment by providing the highest quality research services to its clients.
Neuro-Knowledge Services
In addition to conducting relatively rapid and low-cost surveys, Neuro-Knowledge can recruit neurosurgeons, epidemiologists and statisticians to create a clinical trial design “from concept to protocol,” or simply to consult on a client’s project design. It also can completely manage a clinical trial for a client, including identifying and recruiting investigators, contracting with trial sites, creating procedures and developing appropriate oversight panels.
Neuro-Knowledge’s “real time” data management tools can produce randomization and audit trails, facilitate communication among investigators and manage group documents, and generate e-mail reminders prompting data submission. Data can be submitted and captured online, speeding statistical data analysis. Once the analysis is complete, Neuro-Knowledge can prepare the final report for internal or external release.
All services are offered in an articulated package, or they can be contracted independently of one another.
“Neuro-Knowledge really can be thought of as a full service provider for neurosurgical research,” said Dr. Gliklich. “We can put an entire study together, manage it and all the data, including creating any necessary forms, put together an oversight group, perform data analysis, and produce a report, or we can support any part of a study with our expertise.”
Six Flags Commission: “Roller Coaster” Study
In 2002 Neuro-Knowledge accepted a commission from Six Flags Inc. to evaluate whether fixed site theme park rides pose a risk of neurological injury to riders.
“If Six Flags had put together its own study, the credibility of the findings would have been questioned,” Dr. Harbaugh said.
Dr. Gliklich agreed, “Third party research puts them at arm’s length.”
Six Flags released results of the study at a January press conference in Washington, D.C. In a prepared statement, Dr. Harbaugh noted: “All parts of our work were completely independent of Six Flags. There were no restrictions on the scope of our inquiries. Our mandate was to thoroughly evaluate the question and to find the truth, whatever that might be.”
Study methodology involved convening a panel of neurosurgeons and others with expertise in cerebrovascular disease, neurological trauma, medical neurology, emergency medicine, clinical epidemiology, biostatistics, and roller coaster engineering to review all available data. The data sources included a national survey of neurosurgeons, medical literature and case reports selected by an experienced medical librarian conducting a Medline search, and the U.S. Consumer Product Safety Commission.
As Dr. Harbaugh reported, “The panel concluded that there are no data available establishing a causal link between g-forces on amusement park rides and neurological injury.” However, the panel also determined that the literature and other data sources reviewed were “clearly inadequate as a basis for conclusions and recommendations” and proposed that additional study, based on yet-to-be-collected, reliable data, be undertaken.
In light of this finding, Six Flags said that it would support prospective, ongoing research into any connection between neurological injury and fixed site theme park rides through an ongoing relationship with Neuro-Knowledge. Gary Story, president and chief operating officer of Six Flags Inc., announced: “Six Flags [will] report any head injury data from all Six Flags properties to a monitoring board assembled by Neuro-Knowledge and the AANS. In addition, this board will develop and implement a national hospital and physician-based surveillance program to identify and track the occurrence of non-traumatic brain injuries.” In addition to providing an evidence-based analysis of the relationship between neurological injury and fixed site theme park rides and inspiring addittiioonnal investigation of the subject, the study generated intense media coverage, with related articles reaching an estimated audience of 20 million people.
Getting Involved in Neuro-Knowledge
“As a neurosurgeon, I see incredible value for our specialty and for our communities in conducting clinical research,” said Dr. Harbaugh. “As a member of AANS, I appreciate that Neuro-Knowledge not only provides an avenue for neurosurgeons to serve as investigators, regardless of the type of practice they are involved in, but also that they are compensated for their time. I also recognize that developing revenue sources like the Neuro-Knowledge program can keep our membership dues from increasing and contribute to the ongoing health of the AANS.”
Neurosurgeons can register for Neuro-Knowledge online at https://www.outcomesciences.com by selecting Partner Programs from the menu and choosing Neuro-Knowledge.
“Registering with Neuro-Knowledge carries no obligation,” said Dr. Gliklich. “When we are recruiting for a new study, we contact appropriate registrants with a proposal and approximate compensation, so they always have the opportunity to consider whether or not they are able to participate.”
Additional information about Neuro-Knowledge is available online, or from Dr. Harbaugh or Dr. Gliklich, (888) 526-6700 within the United States only, or [email protected].
Manda J. Seaver is staff editor of the Bulletin
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