TheJournal of Bone and Joint Surgery
American Volume

PAGE 1506  
October 2000, VOLUME 82-A, NUMBER 10

The Emerging Impact of the InformationAge on Orthopaedic Surgery*. The Value and Promise of PatientDatabases in Orthopaedic Surgery


American OrthopaedicAssociation

    *Presented at the Annual Meeting of theAmerican Orthopaedic Association, Sun Valley, Idaho, June 7,1999.Address for J. J. Harrast and R. Poss: Department of OrthopaedicSurgery, Brigham and Women's Hospital, 75 Francis Street, Boston, Massachusetts02115-6110. E-mail address for J. J. Harrast: E-mail addressfor R. Poss:

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The Total Joint Replacement Registry at Brighamand Women's Hospital
Lessons Learned
A Multicenter Database: The Hip SocietyRegistry
Future Applications

In the early 1980s,orthopaedic surgeons made the transition from reviewing patientcohorts on paper to storing patient data in computerized databases.These databases have proven to be useful tools for documentingpatient care, performing clinical research, and fostering continuingeducation. Patient databases will play an even more importantrole in the future as orthopaedic surgeons and softwaredevelopers further exploit the power of the Internet. In this paper,we review our experience with use of a patient database at asingle institution, the strides being taken to create aregistry that can be used by many centers, and the potential toaccelerate these efforts through the widespread use of theInternet.
Patient databases store information collected from instrumentsdesigned to measure components of patient care. We have useda system model (Fig. 1) to considerthese individual components. In the model, patient care comprisesthe continuous and recurring cycle of evaluation, decision, andintervention, and the interactions among these three elements. Eachof these components can be measured independently. Validity,reliability, and sensitivity are measures of evaluation.Appropriateness is a measure of the decision, and outcome is ameasure of the intervention. Satisfaction is a measure ofpatient care as a whole.
To demonstrate the use of one of these measures with apatient database, consider the example of a study that we conductedto determine the appropriateness of total hip replacement. Wemeasured the change in the physical scales of the ShortForm-36 (SF-36) from a point immediately before hipreplacement surgery to two years after surgery in aconsecutive group of 200 patients(1). Thepatient population was divided into three groups high, middle, and low on the basis of preoperative function (Fig. 2). The patientswho were in the low and middle-function groups preoperativelydemonstrated dramatic improvements in function after total hipreplacement; however, patients with relatively high preoperativefunction did not improve substantially. The frequency of patientswho reported dissatisfaction was also higher in this group.
These results suggest that patients who are relativelyhigh-functioning require more intensive preoperative educationalefforts to align their expectations with those of the surgeon.These patients in particular must understand the limits aswell as the promise of hip replacement surgery before decidingwhether to undergo it. This example demonstrates how measurement offunction and satisfaction as part of a patient database providesinsight that can lead to improved patient care.

The Total JointReplacement Registry at Brigham and Women'sHospital

The Total Joint Replacement Registry at Brigham and Women'sHospital in Boston has amassed a database with information onmore than 15,000 patients and more than 20,000 joint replacementprocedures performed in the last three decades. This databasecomprises patient demographics, histories, findings on physicalexamination, intraoperative findings, information on complications,patient outcomes, and patient-satisfaction data that were collectedprospectively with informed patient consent. The annual operatingbudget of the Registry is currently $350,000, with external grantsaccounting for $150,000 of the total.
The Registry has been a substantial resource for attendingsurgeons, residents, and fellows. Since 1990, the Registry hasaccommodated more than 1500 data requests for clinical researchprojects. These projects have generated 110 publications as well as140 presentations at the annual meeting of the American Academy ofOrthopaedic Surgeons. The Registry database also has been avaluable resource for collaboration with visiting scientists anda resource for collaborative studies with other departments atour institution, such as Rheumatology, the Multipurpose ArthritisCenter, and Internal Medicine(2-6,8). Wecould not have conducted these studies without this database ofprospectively collected information. In recent years, the databasehas made it possible for the Department of Orthopaedic Surgery to bea leader at Brigham and Women's Hospital in implementingnew patient-education programs, clinical pathways, and cost-efficiencyprograms.


Through the operation of the Registry, we have learnedmany lessons regarding the successful implementation of apatient database. Most importantly, the reason or reasons forconstructing a patient database must be clear and specific;otherwise, a great deal of energy and money may be expendedcollecting data that will never be used. Is the reason fordeveloping a patient database to perform retrospective and/orprospective studies, to assist in influencing patient care, orto document patient outcomes? The more reasons that there are, themore complex, time-consuming, expensive, and, in the end, difficultthe task.
There are practical limits to the quantity and frequencyof data collection. Our experience suggests that patientencounters for obtaining outcomes information should be limitedto ten minutes. The number of encounters during which thepatient is asked to provide information also must be limited. Wehave found that patient cooperation declines when the assessment ofoutcomes for the same condition occurs more than once ayear. The number of patients for whom substantial data are collectedmust be targeted to the research question being asked. It isimpractical to collect large amounts of data from allpatients visiting a busy orthopaedic clinic.

A MulticenterDatabase: The Hip Society Registry

Prospectively collected data from multiple centers offer thepromise of providing sufficiently large cohorts to serve asan early-warning system for implant failures and to formulateresearch questions far earlier than would be possible at anyindividual institution. The Hip Society has initiated a pilotproject, at ten participating centers, to begin to construct amulticenter clinical and radiographic database. The initial projectwould require only a limited data set.
The hypothesis of the first study to be conducted is thatthe impact of dislocation following total hip arthroplasty on thepatient's perception of outcome is greater than surgeons haveappreciated. With informed patient consent, participating centerswill collect data preoperatively, at surgery, and at follow-up, andthey will send digitized radiographs to the Hip SocietyRegistry to be electronically integrated with the clinicaldata. The study will enroll all patients undergoing primarytotal hip arthroplasty during a one-year period at the tenparticipating centers. We have projected that this cohort will besufficient to answer the research questions posed.
Simultaneously, the Hip Society Registry will perform a pilotaudit that records a limited data set to document the date ofimplantation and the types of components that are being removedduring revision total hip replacement(8) at thesefew centers over a period of one year.


The Internet affords the opportunity to outsource themanagement of patient databases by using the World WideWeb and ubiquitous Web-browser software. Off-site databases aregrowing rapidly in all fields. Now, a data-management companycan maintain the hardware, software, and data at its externallocation, while a personal computer and browser are all that theorthopaedic surgeon needs in order to enter and access hisor her data.
In 1999, we decided to transfer the management of theBrigham Total Joint Replacement Registry to an off-sitedata-management company. Reciprocal data transfers will be conductedthrough the World Wide Web. We realized immediate cost-savings byrelinquishing expensive rental space and reducing the number offull-time employees from 7.5 to three. We budgeted the total costfor the year 2000 to be the same as that for 1998, but weanticipate that, in succeeding years, the cost of maintaining theRegistry will be less because of outsourcing.
The Web provides a unique opportunity for multicenter registrydatabases to flourish. The Hip Society Registry will beavailable to participants online so that real-time interactions canoccur; these interactions would have been virtually impossiblewithout the Web. The Web also allows orthopaedic departments andpractices to participate more easily in multicenter "bestpractice" groups to study the effectiveness ofprograms.
In addition to single-center and multicenter registries andstudies, the Web is transforming the training and certificationprocesses in medicine through its influence on patientdatabases. For example, one requirement of the American Boardof Orthopaedic Surgery's examination process is that candidatessubmit to the Board a six-month case list of operative procedures.In previous years, this task has proven arduous for candidates usingpen and paper or a disk-based system. This year,candidates for the part-II certification examination were ableto electronically record their cases in an ongoing manner andthen to submit them to the Board through the Web. The resultingpatient database, consisting of more than 92,000 cases submittedby more than 700 candidates, provides a snapshot oforthopaedic surgery practice in the United States during thissix-month window of time.
Finally, patient databases and the World Wide Web nowoffer residency programs the possibility of automatically generatingthe information needed for the Residency Review Committee'sProgram Information Form. Residents tracking their cases withuse of online databases generate the statistics required forthe report, and program directors are able to follow, in real time,both the experience that their programs are providing to residentsand the performance of residents in their programs.
The World Wide Web is enabling patient databases to reachtheir full potential to provide timely and accurate information toorthopaedic surgeons. Its impact will continue to grow for years tocome.

NOTE: We are indebted to Maurice E.Müller, M.D., for his counsel and collaboration in thedevelopment and implementation of many of the conceptsexpressed in this paper. We also gratefully acknowledge theMaurice E. Müller Foundations of Switzerland and North Americafor their support of the Brigham Total Joint ReplacementRegistry; the contributions of Sonya van der Meer, JohnKwon, and Tad Bergman to the success of the Brigham TotalJoint Replacement Registry; and the contributions of Beth Imrem ofData Harbor, Incorporated, to the Hip Society Registry. Finally, weacknowledge and thank the Council on Research of theAmerican Academy of Orthopaedic Surgeons, the MusculoskeletalEvaluation and Research Institute, and the Orthopaedic Researchand Education Foundation for their support of the HipSociety Registry.


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