Sometimes the aims of industry and medicine mesh in a way that is productive for both, as well for the patients they serve. The new national Normal Pressure Hydrocephalus Registry of surgically treated adult patients with NPH represents such a beneficial collaboration.
The registry came about when the maker of products for the surgical treatment of central nervous system disorders, including cerebrospinal fluid shunt systems, recognized a need for reliable prospective data. The company, Codman & Shurtleff Inc., sought development of a registry of surgically treated adult patients with NPH as a source of data for presentations and publications, and as a source of real-time information that be used to direct clinical, marketing and engineering decisions. In addition to collecting reliable data, Codman wanted the registry to be overseen by a scientific advisory panel whose role would be to guide the scientific direction of the registry and generate regular submissions for abstract presentations and publications.
Codman Selects Neuro-Knowledge
With these goals in mind and with the understanding that such a registry would have value as a national data repository for scientific inquiry and for clinical information for individual surgeons, Codman turned to Neuro-Knowledge
Implicit in the choice of Neuro-Knowledge is Codman’s recognition that the program could offer not only the best Web-based information management services available but could also help recruit advisers and registry participants. Central to these services is a Web-based information platform that supports electronic practice and research tools including electronic data capture that is compliant with regulations set forth by the U.S. Food and Drug Administration and the Health Insurance Portability and Accountability Act. OSI, which currently manages programs in more than 30 disease areas, uses this unique platform to cost-effectively manage programs for a variety of healthcare clients including medical device and pharmaceutical companies, national medical associations and other healthcare organizations. Neuro-Knowledge brings together a unique blend of Web-based registry experience, neurosurgical expertise and the prestige and name recognition of the AANS.
How the NPH Registry Will Work
Neuro-Knowledge services for the Normal Pressure Hydrocephalus Registry were initiated by working collaboratively with Codman on ways to effectively develop and implement the best Web-based data collection program. In addition to developing appropriate electronic forms, Neuro-Knowledge evaluated workflow issues and user incentive opportunities to improve the value of the application to the user. Data from letters to referring physicians, procedure notes, and decision-support can be entered only once and accessed repeatedly depending on the one’s practice needs. Beyond the system itself, Neuro-Knowledge worked with Codman to develop and utilize advisory panels that will analyze data for strategic purposes and generate publishable manuscripts.
The registry will consist of standard case report forms encompassing procedural and hospital information and follow-up data. Individual patients will be followed through multiple admissions, procedures and follow-up visits, establishing reliable data over several years. The case report forms were developed to streamline and limit work while maximizing output for evaluation of clinical outcomes and benefits of treatment. Individual surgeons will be able to access data they have provided and will additionally be able to compare their data to the group’s aggregate information. The registry will track information such as patient symptoms, complications and shunt procedure revisions in patients with NPH with programmable valves as compared to other groups.
The Normal Pressure Hydrocephalus Registry is built on an information platform that provides many “value-added” features to the neurosurgeon. Surgeons will be able to access patient information securely through the Internet whenever a registry patient presents. Individual surgeons can customize data forms to include additional data elements of interest to them. The Neuro-Knowledge system can be further customized to allow data submission via personal digital assistants and to generate interactive practice guidelines that are displayed as “pop-ups” on the computer or PDA screen. When requested, the Neuro-Knowledge system can generate automatic notes and send letters based on completion of the case report forms.
The decision to use Neuro-Knowledge will give Codman the ability to cost-effectively perform additional clinical and market research studies among individuals or subgroups of the registry participants. The Normal Pressure Hydrocephalus Registry will be launched in September to a pilot group of up to 50 neurosurgeons with plans to expand to up to 250 neurosurgeons. AANS members who sign up for the registry will be compensated for their participation.
Robert E. Harbaugh, MD, is chair of the Department of Neurosurgery at The Pennsylvania State University College of Medicine, Hershey, Pa.
For Further Information
Normal Pressure Hydrocephalus Registry, www.AANS.org/nph_registry.asp
About Neuro-Knowledge, www.AANS.org/research/neuro.asp
Seaver, MJ. “Neuro-Knowledge Research Partnership.” AANS Bulletin. 2003 12(1), 12-13. www.AANS.org, article ID 9859