US / CANADA CHILD AMPUTEE REGISTRY
Hugh Watts, M.D.
Wouldn't it be great to know just how many children are born each year with a PFFD or congenital deletion of the left forearm? It would make planning easier. If we also knew the frequency that children loose their limbs due to farm implement accidents, we could better work to reduce the number. To those ends, the Board of ACPOC decided in 1998 to establish a registry.
The system to put this registry into place is ready to proceed as of the annual meeting in Houston. To make it effective, we will need your help. So let me tell you about it.
The members of ACPOC have always had an interest in getting reliable data on the children who are born with various types of limb deficiencies or who acquire amputations through other problems. Although several clinics have had a database for some time, a larger population encompassing all of the clinics would be more representative and therefore a great advantage.
The stumbling block has largely been that of differences concerning nomenclature. Because of the use of different names and the complexities seen in children (many of whom have combinations of limb deficiencies) it has not been easy to get a database entry form that was agreed to by all. Several years ago, after some discussion at ACPOC, Dr. Robert Fielden engaged the help of his son, (who was knowledgeable in the use of computers) to try to develop a graphic input so that the problems of nomenclature could be avoided. This progressed to a demonstration model but the program was not developed to a working version.
In 1997 at the Symposium on Limb Deficiency in Dallas, Dr. Mervin Letts of Ottawa, Canada, discussed various causes of traumatic amputation in children and expressed the deep concern that the lack of data made it impossible to go to any government body to try to formulate preventive policies. Dr. Newton McCollough urged me to take this issue to the ACPOC Board which then discussed the issue at the 1997 meeting in Dallas. Originally the idea was that the registry would be developed for traumatic amputees only since that would be much easier. Further discussion showed the wisdom of including children with congenital deficiencies. Three years ago this was agreed to by the Board of ACPOC. The plan is to proceed as of the annual meeting in Houston
To obtain the broadest possible numerical information concerning the number of children with a variety of limb deficiencies or acquired amputations in order to facilitate research projects and formulate policy goals to help prevent or decrease the incidents of such problems.
- Input Data input will be of three varieties.
Demographic: The demographic data includes the child's age, sex, and a number designated by the clinic entering the data. The child's name and address will not appear. There are entries to designate whether the child's problem is "Congenital" or "Acquired", and further sub-categories for "Acquired" (for example Tumor or Traumatic, and for the Traumatic whether it was acquired as a result of Farm equipment, Train accidents, or Recreational activities).
Anatomic: Limb deletions and amputations will be entered graphically. There is a schematic of a skeleton. (See Page 20) Each of the bones in the skeleton is marked with a box. Long bones have three boxes representing the proximal, middle and distal one third's. Missing areas will be entered by checking the appropriate boxes. As an alternative, there is an option of clicking on the "Transverse" mode. When that is done all the bones distal to what is checked are automatically deleted, thereby facilitating data entry.
The program will have a translator which will translate the boxes into one or more of the currently used nomenclature systems. These however can change with the times as nomenclature changes, however, but the actually anatomy will obviously not change.
At this time, there will not be an entry for the type of treatment, since with children especially, that is changes frequently.
The data which are entered will be e-mailed to a central terminal (Shriners Hospital, Los Angeles) where the entries will be checked by me for completeness, and to decrease the likelihood of aberrant entries. The collated data will be periodically transferred to the ACPOC web page (to be accessed by member password.
Storage. The server would be physically located with the Data Manager ( my home office computer) and backed up on a geographically separate site (the office computer of the software developer (i.e. Mr. Jan Koreska).
ACPOC owns the program and the data which are submitted. Submitted data will be under the supervision of the Child Amputee Registry Committee of ACPOC. Current members of this committee are: Hugh Watts, chairman, Donald Cummings, James Harder, Sheila Hubbard, Ramona Okumura and Dinah Stocker.
- Access to the Data.
Each individual clinic will have access to their own data, and will be able to ask for sorting and selection to facilitate their own reporting needs.
Individuals or clinics who wish to use the combined database for investigational purposes will make a formal application to the Child Amputee Registry Committee, via the Data Manager (currently me). The request would be reviewed by the Committee. If there is more than one clinic or individual who wishes to access the data for identical reasons the committee will favor the application which was received first.
When the application is satisfactorily reviewed by the committee, the Data Manager will sort the data to select out the appropriate categories of patients and transfer this information to the investigator giving the investigator the names of the clinics who have entered the data. The investigator will then contact the individual clinics if more information is needed than given on the registry. Such an investigator will not have access to the individual patient names or addresses. Each clinic has control over their own data. A copy of the final research will be sent to the Registry Committee. The Data Manager will keep a record of all applications for data access. These will be presented to the ACPOC Board at the time of the committee reports at the annual meeting.
Potential Problem Areas.
- Patient Confidentiality: Patients or their parents need to be aware that they are being entered on the Registry and would need to give permission to do so. However, their record cannot be accessed by outside investigators.
- "Ownership" of the information: Perhaps the biggest problem is that of the sense that individual clinic members may feel about who owns the information on their patients. If individuals do not feel that they are willing to share their information, they should not participate in the Registry.
- Reliability of Input: As with any data, the care with which data is entered defines the value of the output. But perhaps the biggest problem of input is whether those patients who are entered represent the entire group, (i.e. what is the denominator?)
- Costs: Since ACPOC has allocated money for the development of the graphic program and the maintenance of the Registry the cost does not appear to be a stumbling block. If there is a great demand for the data, there might need to be a small administrative cost requested of the applicants just for handling of paperwork and supplies, but I don't see that as a real issue at this point.
Where do we go from here?
This is a "work in progress". Most of you recognize that even the straight forward Word Processing program you use has gone through multiple versions and updates. That didn't keep you from using the initial version years ago. Presumably, the same will happen to this program will depend on the feedback which you as a user will provide.