Database Collection System
The NYSMSC collection system was developed through a centralized patient registry and standardized data collection instrument used by all 15 participating centers. The 5-page registry questionnaire and follow-up forms consist of two sections: (1) Three pages of demographic data and self-report assessments are completed by the patient (with assistance from a family member, study nurse, or office personnel if required), and (2) two pages of clinical data are completed by the examining neurologist and the study nurse.
The purpose of the Consortium is explained to all potential registry and follow-up patients during a one-on-one session with site personnel, which includes a review of the informed consent according to local Health Insurance Portability and Accountability Act (HIPAA) regulations.
After consent has been obtained, the self-report section of the form is completed. This session generally occurs during a regularly scheduled office visit. Some NYSMSC sites choose to mail the self-report section of the data collection form to their MS patients prior to their office visit in order to give them additional time to complete the form to the best of their ability and obtain assistance from support persons who may not be able to accompany them to their scheduled neurology appointment.
The clinical section of the form contains information concerning the physical examination, exacerbation history, MS type, clinical and instrumental outcomes, laboratory findings and use of disease-modifying and symptomatic therapies. On a monthly basis, sites mail completed registration and follow-up questionnaires along with a transmittal form to the Consortiumís Data Management Center (DMC), which is Uniform Data System for Medical Rehabilitation (UDSMR) in Buffalo, NY. The DMC maintains the grouped data from all enrolled patients. A copy of the transmittal forms is retained at the submitting site.
The DMC is inventorying the forms together with the accompanying transmittal form. Transmittal forms are marked as received and either accurate or erroneous, as applicable, and transmitted to the submitting site via fax for the sitesí retention. For each record, a portion of the social security number, patient's initials and birth date are used to uniquely identify the patient as well as preserve confidentiality.
Sites reply to data clarification requests by either email or fax and the DMC maintains all data clarification documents. Original forms (with data clarification form, if produced) are stored by the DMC for a maximum of 6 months. Every 6 months, the original forms are moved to the NYSMSC storage system.
Since standard follow-up visits are performed on a yearly basis within 3 months of the anniversary of the original registration date, a system was created to make tracking easier. On a regular basis (every 3 months), the DMC generates a list containing the NYSMSC code of the patients and initials for each site, providing a 3-month window of patients due for follow-up. Recently, the lists became available on-line using the NYSMSC website calendar. The DMC also generates a list of patients for each site who have not been actively followed within the past 18 months and the sites respond as to the reason for no follow-up (i.e., deceased, refused to participate, lost to follow-up, etc.). This is done on a regular basis, in order to assess the reasons for failed follow-up in active/non-active patients.
The NYSMSC questionnaire was first developed in 1995 and revised in 1999. This year, the NYSMSC developed a new questionnaire integrating the new diagnostic McDonald criteria, including comprehensive cognitive screening and collection of digital MRI data, as well as new therapeutic options. A list of various revisions proposed in recent months includes race, disease course, concomitant diseases, changes in therapeutic options, etc.
Development of the new questionnaire is in the final stage, awaiting approval. In addition, changes to the questionnaire will require modification of the NYSMSC Registry Guide for Completion of Registration and Follow-up Forms. Once revisions to the new questionnaire and registry are completed by the Consortium Scientific Review Committee, final approval will then be necessary both by the Executive-Financial Committee and the individual sites. The new questionnaire and teleforms are planned to become available at the end of 2004.