American Volume

October 2000, VOLUME 82-A, NUMBER 10

PAGE 1506

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The Emerging Impact of the Information Age on Orthopaedic Surgery*. The Value and Promise of Patient Databases in Orthopaedic Surgery
BY JOHN J. HARRAST; ROBERT POSS, M.D.
American Orthopaedic Association

    *Presented at the Annual Meeting of the American Orthopaedic Association, Sun Valley, Idaho, June 7, 1999.Address for J. J. Harrast and R. Poss: Department of Orthopaedic Surgery, Brigham and Women's Hospital, 75 Francis Street, Boston, Massachusetts 02115-6110. E-mail address for J. J. Harrast: jjharrast@msn.com. E-mail address for R. Poss: rposs@partners.org.

Quick Access Outline Introduction The Total Joint Replacement Registry at Brigham and Women's Hospital Lessons Learned A Multicenter Database: The Hip Society Registry Future Applications References

In the early 1980s, orthopaedic surgeons made the transition from reviewing patient cohorts on paper to storing patient data in computerized databases. These databases have proven to be useful tools for documenting patient care, performing clinical research, and fostering continuing education. Patient databases will play an even more important role in the future as orthopaedic surgeons and software developers further exploit the power of the Internet. In this paper, we review our experience with use of a patient database at a single institution, the strides being taken to create a registry that can be used by many centers, and the potential to accelerate these efforts through the widespread use of the Internet.
Patient databases store information collected from instruments designed to measure components of patient care. We have used a system model (Fig. 1) to consider these individual components. In the model, patient care comprises the continuous and recurring cycle of evaluation, decision, and intervention, and the interactions among these three elements. Each of these components can be measured independently. Validity, reliability, and sensitivity are measures of evaluation. Appropriateness is a measure of the decision, and outcome is a measure of the intervention. Satisfaction is a measure of patient care as a whole.
To demonstrate the use of one of these measures with a patient database, consider the example of a study that we conducted to determine the appropriateness of total hip replacement. We measured the change in the physical scales of the Short Form-36 (SF-36) from a point immediately before hip replacement surgery to two years after surgery in a consecutive group of 200 patients(1). The patient population was divided into three groups high, middle, and low on the basis of preoperative function (Fig. 2). The patients who were in the low and middle-function groups preoperatively demonstrated dramatic improvements in function after total hip replacement; however, patients with relatively high preoperative function did not improve substantially. The frequency of patients who reported dissatisfaction was also higher in this group.
These results suggest that patients who are relatively high-functioning require more intensive preoperative educational efforts to align their expectations with those of the surgeon. These patients in particular must understand the limits as well as the promise of hip replacement surgery before deciding whether to undergo it. This example demonstrates how measurement of function and satisfaction as part of a patient database provides insight that can lead to improved patient care.

The Total Joint Replacement Registry at Brigham and Women's Hospital
The Total Joint Replacement Registry at Brigham and Women's Hospital in Boston has amassed a database with information on more than 15,000 patients and more than 20,000 joint replacement procedures performed in the last three decades. This database comprises patient demographics, histories, findings on physical examination, intraoperative findings, information on complications, patient outcomes, and patient-satisfaction data that were collected prospectively with informed patient consent. The annual operating budget of the Registry is currently $350,000, with external grants accounting for $150,000 of the total.
The Registry has been a substantial resource for attending surgeons, residents, and fellows. Since 1990, the Registry has accommodated more than 1500 data requests for clinical research projects. These projects have generated 110 publications as well as 140 presentations at the annual meeting of the American Academy of Orthopaedic Surgeons. The Registry database also has been a valuable resource for collaboration with visiting scientists and a resource for collaborative studies with other departments at our institution, such as Rheumatology, the Multipurpose Arthritis Center, and Internal Medicine(2-6,8). We could not have conducted these studies without this database of prospectively collected information. In recent years, the database has made it possible for the Department of Orthopaedic Surgery to be a leader at Brigham and Women's Hospital in implementing new patient-education programs, clinical pathways, and cost-efficiency programs.

Lessons Learned
Through the operation of the Registry, we have learned many lessons regarding the successful implementation of a patient database. Most importantly, the reason or reasons for constructing a patient database must be clear and specific; otherwise, a great deal of energy and money may be expended collecting data that will never be used. Is the reason for developing a patient database to perform retrospective and/or prospective studies, to assist in influencing patient care, or to document patient outcomes? The more reasons that there are, the more complex, time-consuming, expensive, and, in the end, difficult the task.
There are practical limits to the quantity and frequency of data collection. Our experience suggests that patient encounters for obtaining outcomes information should be limited to ten minutes. The number of encounters during which the patient is asked to provide information also must be limited. We have found that patient cooperation declines when the assessment of outcomes for the same condition occurs more than once a year. The number of patients for whom substantial data are collected must be targeted to the research question being asked. It is impractical to collect large amounts of data from all patients visiting a busy orthopaedic clinic.

A Multicenter Database: The Hip Society Registry
Prospectively collected data from multiple centers offer the promise of providing sufficiently large cohorts to serve as an early-warning system for implant failures and to formulate research questions far earlier than would be possible at any individual institution. The Hip Society has initiated a pilot project, at ten participating centers, to begin to construct a multicenter clinical and radiographic database. The initial project would require only a limited data set.
The hypothesis of the first study to be conducted is that the impact of dislocation following total hip arthroplasty on the patient's perception of outcome is greater than surgeons have appreciated. With informed patient consent, participating centers will collect data preoperatively, at surgery, and at follow-up, and they will send digitized radiographs to the Hip Society Registry to be electronically integrated with the clinical data. The study will enroll all patients undergoing primary total hip arthroplasty during a one-year period at the ten participating centers. We have projected that this cohort will be sufficient to answer the research questions posed.
Simultaneously, the Hip Society Registry will perform a pilot audit that records a limited data set to document the date of implantation and the types of components that are being removed during revision total hip replacement(8) at these few centers over a period of one year.

Future Applications
The Internet affords the opportunity to outsource the management of patient databases by using the World Wide Web and ubiquitous Web-browser software. Off-site databases are growing rapidly in all fields. Now, a data-management company can maintain the hardware, software, and data at its external location, while a personal computer and browser are all that the orthopaedic surgeon needs in order to enter and access his or her data.
In 1999, we decided to transfer the management of the Brigham Total Joint Replacement Registry to an off-site data-management company. Reciprocal data transfers will be conducted through the World Wide Web. We realized immediate cost-savings by relinquishing expensive rental space and reducing the number of full-time employees from 7.5 to three. We budgeted the total cost for the year 2000 to be the same as that for 1998, but we anticipate that, in succeeding years, the cost of maintaining the Registry will be less because of outsourcing.
The Web provides a unique opportunity for multicenter registry databases to flourish. The Hip Society Registry will be available to participants online so that real-time interactions can occur; these interactions would have been virtually impossible without the Web. The Web also allows orthopaedic departments and practices to participate more easily in multicenter "best practice" groups to study the effectiveness of programs.
In addition to single-center and multicenter registries and studies, the Web is transforming the training and certification processes in medicine through its influence on patient databases. For example, one requirement of the American Board of Orthopaedic Surgery's examination process is that candidates submit to the Board a six-month case list of operative procedures. In previous years, this task has proven arduous for candidates using pen and paper or a disk-based system. This year, candidates for the part-II certification examination were able to electronically record their cases in an ongoing manner and then to submit them to the Board through the Web. The resulting patient database, consisting of more than 92,000 cases submitted by more than 700 candidates, provides a snapshot of orthopaedic surgery practice in the United States during this six-month window of time.
Finally, patient databases and the World Wide Web now offer residency programs the possibility of automatically generating the information needed for the Residency Review Committee's Program Information Form. Residents tracking their cases with use of online databases generate the statistics required for the report, and program directors are able to follow, in real time, both the experience that their programs are providing to residents and the performance of residents in their programs.
The World Wide Web is enabling patient databases to reach their full potential to provide timely and accurate information to orthopaedic surgeons. Its impact will continue to grow for years to come.

NOTE: We are indebted to Maurice E. Müller, M.D., for his counsel and collaboration in the development and implementation of many of the concepts expressed in this paper. We also gratefully acknowledge the Maurice E. Müller Foundations of Switzerland and North America for their support of the Brigham Total Joint Replacement Registry; the contributions of Sonya van der Meer, John Kwon, and Tad Bergman to the success of the Brigham Total Joint Replacement Registry; and the contributions of Beth Imrem of Data Harbor, Incorporated, to the Hip Society Registry. Finally, we acknowledge and thank the Council on Research of the American Academy of Orthopaedic Surgeons, the Musculoskeletal Evaluation and Research Institute, and the Orthopaedic Research and Education Foundation for their support of the Hip Society Registry.

REFERENCES: 1-8

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