An Electronic Database for Outcome Studies That Includes Digital Radiographs

Transcription

1 The Journal of Arthroplasty Vol. 16 No. 8 Suppl An Electronic Database for Outcome Studies That Includes Digital Radiographs Diana L. Hauser PhD,* Sara Jane Wessinger, RN,* Robert T. Condon, MS, Greg J. Golladay, MD,* Daniel P. Hoeffel, MD,* Dennis J. Gillis, BS, David R. Merrill, David Chaisson, BS, Andrew A. Freiberg, MD,* Daniel M. Estok, MD, Harry E. Rubash, MD,* Henrik Malchau, MD, PHD, and William H. Harris, MD Abstract: We report on acquisition of key data from the clinical medical record, surgical data, radiologic studies, and patient surveys for a novel digital total hip arthroplasty (THA) registry that includes electronic capture of digital radiographic images into a database on an internet platform for query. We now have the ability to collect demographic and operative data, including the operative note, discharge summary, surgery data, and Digital Imaging Communications in Medicine (DICOM) radiology images. Steps are being completed to assemble office encounters, hospital procedural codes, and implant bar codes. Two examples include a THA surgery record and a THA outcome study with plain radiograph set. Analysis of such data could suggest ways to improve clinical practice. Key words: outcomes, total hip arthroplasty, registry, digital radiology, internet. From the *Department of Orthopaedic Surgery, Massachusetts General Hospital, Boston, Massachusetts; RCCS Systems, Asheville, North Carolina; Computing Systems, Massachusetts General Hospital, Boston, Massachusetts; Department of Orthopaedic Surgery, Brigham and Women s Hospital, Boston, Massachusetts; Department of Orthopaedic Surgery, Sahlgrenska Universitetssjukhuset, Göteborg, Sweden; Department of Orthopaedic Surgery, Harvard Medical School, and Adult Reconstructive Unit, Massachusetts General Hospital, Boston, Massachusetts. Funds were received in support of the research material described in this article from the William H. Harris Foundation, Boston, Massachusetts. Reprint requests: William H. Harris, MD, Orthopaedic Biomechanics Laboratory GRJ 1126, Massachusetts General Hospital, 55 Fruit Street, Boston, MA Copyright 2001 by Churchill Livingstone /01/ $35.00/0 doi: /arth Local, regional, and national registries for total joint arthroplasty have made major contributions to advance the field. Outstanding data have come from local registries such as that of the Mayo Clinic [1], which has shaped clinical practice worldwide. The Scandinavian registries (Swedish [2], Norwegian [3], and Finnish [4]) have contributed remarkably to improvements in regional and worldwide standards of practice. Single surgeon outcome studies, including (Iowa [5], Massachusetts General Hospital (MGH) [6], and many others [7 14]) have contributed to similar progress. The building of these databases has been pivotal to research. Outcome findings have affected the development of new techniques, led to the abandonment of faulty procedures, helped to define correct follow-up protocols, channeled information into decisions for techniques, provided for higher quality products sooner, and increased the quality of care for patients. Several features could enhance the impact and reach of these data banks, including: 1. acquisition of key data with further minimizing of the physician s efforts 2. inclusion of patient satisfaction measures (eg, some registries do not include the MOS 36-item short-form health survey (SF-36) [15], the Western Ontario and McMaster Universities Arthritis Index (WOMAC) [16], and Harris hip score (HHS) [17]) 71

2 72 The Journal of Arthroplasty Vol. 16 No. 8 Suppl. 1 December addition of all related digital radiology data to the physician s data for each patient 4. increased storage capacity for different forms of digital information, including image, voice, and video stream 5. greater ease of data manipulation 6. high standards of confidentiality 7. compliance and facilitation of collection procedures Our efforts in designing and establishing an intranet, contemporary, relational, scalable registry for total hip arthroplasty (THA) and potentially total knee arthroplasty include the following: 1. digital submission and retrieval of content from the medical record, surgical procedure, radiologic studies, and patient surveys 2. an internet platform application that runs in a Web browser (eg, Microsoft Internet Explorer, Microsoft, Inc., Seattle, WA) supporting a variety of physician and patient data exchange methods, including Web-based forms and potentially scanned forms, wireless hand-helds, and touch-screens 3. database searching, which includes relational direct search, text screening with proximity and potentially intelligence searching, and ad hoc queries Methods and Materials We divided the surgical data to be acquired into preoperative data, operative data, and follow-up data. The preoperative data encompass the following: 1. demographics with medical record number, name, date of birth, next of kin, address, telephone number, billing data, and referring physician 2. clinical office encounters, including chief complaint (CC), history of present illness (HPI), family history, social history (SH), physical examination, diagnosis (Dx), and management plan 3. baseline SF-36, WOMAC, and HHS 4. Digital Imaging Communications in Medicine (DICOM) digital radiology files The operative data encompass the following: 1. operative note 2. discharge summary 3. procedure-specific data about the operation for research purposes 4. package bar code of the implant 5. DICOM digital radiology files Key words including hardware specifications from the operative note and specific data about the procedure (eg, osteotomy, graft incorporation, or surgical approach) are used from these data. The follow-up data parallel the preoperative data. To date, our emphasis has been on the operative data with emerging steps to complete the preoperative and follow-up data. For the operative data we import from the hospital database electronically the patient s data, including the following: 1. demographic data 2. operative note 3. discharge summary 4. DICOM digital radiology files These data are assembled into the Web-based, internet server secured, practice-based Picture Archival Communication System (PACS) 400 MHz Pentium; Intel Inc, Santa Clara, CA; NT 4.0; Internet Explorer 4.7.2; Microsoft Inc, Seattle, WA), which has been integrated with a Structured Query Language (SQL) server (MS SQL 7.0; ColdFusion 4.0.1; Allaire Inc, Santa Clara, CA) with the hospital PACS for unifying the digital radiology (computerized radiography [CR], dual-energy x-ray absorptiometry [DEXA], computed tomography [CT], and magnetic resonance imaging [MRI]; DICOM 3.0) with text-based reports, questionnaires, and study data in a relational database (4th Dimension; PatientStudy 1.0, RCCS, Asheville, NC). Access to the central database is provided through the internet with wireless and Web-enabled devices. All digital radiology DICOM files are identified automatically from patient registration and from patient operation listings and treating physician. Security of the database is provided by the following: 1. All patient data are kept within the hospital intranet on secured servers. 2. Data access are provided only to authorized medical staff with appropriate training and institutional approved clearances. 3. Patient data are collected under the supervision and consent of the Institutional Review Board with informed consent required from the patient. 4. System institute and provider network patient confidentiality obligations are honored in compliance with the National Health Insurance Portability and Accountability Act (HIPAA) standards. Demonstration Two examples, a THA surgery record and a THA outcome study with plain radiograph set, illus-

3 THA Outcomes Registry With Digital Radiographs Hauser et al. 73 trate the functionality of the orthopaedic outcomes documentation vehicle. Operative data for a THA patient include radiologic assessment of the pelvis with documentation of the hardware, reconstructive technique, and medical factors pertinent to the outcome (Fig. 1). A radiologybased study jacket can be constructed to facilitate grouping of cases for review (Fig. 2). A typical full DICOM set of THA x-ray images includes the following: Fig. 1. THA surgery documents for outcome study. Selected documents from each of the 3 divisions of care interval, including operative note (part 1), operative data (part 2), and discharge summary (screen 2), are shown in the Web browser pages with a hierarchical folder system for efficient and comprehensive organization of the data.

4 74 The Journal of Arthroplasty Vol. 16 No. 8 Suppl. 1 December 2001 Fig. 2. THA outcome study jacket with digital radiology images. A study jacket is created for pulling all images relative to a special subset for examination in a freestanding, readily available folder. The thumbnail images can be viewed for a rapid assessment. 1. anteroposterior images of both hips 2. frog view images of both hips 3. true lateral images of both hips 4. Judet views of the pelvis The DICOM set of images requires 650 Mb of storage. The full x-ray image can be retrieved for detailed assessment using the physician s viewer of choice (eg, NIH Image, National Institutes of Health, Bethesda, MD; or Adobe Photoshop, Adobe, Inc., San Jose, CA). The image-based nature of the outcomes documentation vehicle provides a platform for the sharing and archiving of digital-based THA teaching files. Web content (eg, digital image, voice, and video) can be combined in the flexible Web browser platform. Research documents (eg, MS Excel spreadsheets, study participation governing forms, grants, abstracts, and manuscripts) also can be stored and retrieved to complement the outcomes study documents. Discussion Building an in-depth database to collect diversified and multisource digital information represents a considerable undertaking in orthopaedic science; information collection and exchange standards; information systems technology; and extensive reliable information storage, mining, and structure. The MGH instituted digital radiology in Several other university hospitals (e.g., Johns Hopkins University School of Medicine) also have instituted digital radiology. For the practices with nondigital radiology, films can be scanned externally at a service center or internally with a film scanner. Improvements in wireless technology and digital information processing show promise for rapid access to several terabytes of orthopaedic data. The value of this in-depth registry includes not only the rich digital radiology data for outcomes study, but also flexibility in the number of documents that may be reviewed and studied. Digital radiology data collection and access are valuable because images can be catalogued and shared to discuss interpretation and analytical assessment, such as the grading of loosening or the measurement of polyethylene wear using digital computerized techniques. As analysis techniques mature, the digital images can be reassessed efficiently. An electronic record has the additional intrinsic value in that it provides for complete data archiving and provides the approved physician/scientist with the flexibility for his or her own individual view and interaction with the orthopaedic data. Work in progress includes the following: 1. Patient entry of SF-36, WOMAC, and HHS via Web-based forms and scanned forms

5 THA Outcomes Registry With Digital Radiographs Hauser et al Physician entry of a dictated CC, HPI, digital radiology information, and Rx plan 3. Physician entry of operative note via Webbased form 4. Implant bar code scanning for database entry This comprehensive orthopaedic database will help facilitate evidence-based assessment to study the multifactorial nature of primary and revision THA surgery. Conclusion The documentation vehicle provides for a new way to explore orthopaedic digital radiology and clinical data for the purposes of collecting information regarding the hardware and body tissues to relate to surgical factors, instrumentation, and technique for completion of outcome studies. Fast bidirectional submission, review, and retrieval of data can start to provide a forum for investigation that easily incorporates more in-depth data, and provides for the possibility for research study investigation with greater numbers of radiographs and the ability to link together investigators with communication through the internet for multicenter study. The aims of this specific type of data collection are simplicity from the surgeon s point of view, comprehensive data collection including radiographic images, completeness of data collection, and ease of recall and manipulation of data with massive storage capacity. Such use of data could suggest ways to improve practice. References 1. Berry DJ, Kessler M, Morrey BF: Maintaining a hip registry for 25 years: Mayo Clinic experience. Clin Orthop 344:61, Herberts P, Malchau H: Long-term registration has improved the quality of hip replacement: a review of the Swedish THR Register comparing 160,000 cases. Acta Orthop Scand 71:111, Havelin LI: The Norwegian Joint Registry. Bull Hosp Joint Dis 58:139, Puolakka TJ, Pajamaki KJ, Pulkkinen PO, et al: Poor survival of cementless Biomet total hip: a report of 1,047 hips from the Finnish Arthroplasty Register. Acta Orthop Scand 70:425, Callaghan JJ, Albright JC, Goetz DD, et al: Charnley total hip arthroplasty with cement: minimum twentyfive-year follow-up. J Bone Joint Surg Am 82:487, Smith SE, Estok II DM, Harris WH: 20-Year experience with cemented primary and conversion total hip arthroplasty using so-called second-generation cementing techniques in patients aged 50 years or younger. J Arthroplasty 15:263, Simmons BP, Swiontkowski MF, Evans RW, et al: Outcome assessment in the information age: available instruments, data collection, and utilization of data. Instr Course Lect 48:667, Wixted JJ, Grover NK, Adnerson FA Jr, et al: Clinical outcomes in orthopaedic surgery: the collaborative efforts of orthopaedic surgeons with industry. Bull Hosp Joint Dis 58:161, Bourne RB: The planning and implementation of the Canadian Joint Replacement Registry. Bull Hosp Joint Dis 58:128, Baron JA, Barrett J, Katz JN, et al: Total hip arthroplasty: use and select complications in the US Medicare population. Am J Public Health 86:70, Brand DA, Krag MH, Hausman MR, et al: A patient registry for orthopaedic surgery. Clin Orthop 252: 262, Wall A, Dragan S: Some aspects of revisional hip arthroplasty on the basis of register of removed orthopaedic implants: one year data. Chir Narzadow Ruchu Ortop Pol 64:627, Rothwell AG: Development of the New Zealand Joint Register. Bull Hosp Joint Dis 58:148, Fender D, Harper WM, Gregg PJ: The Trent regional arthroplasty study: experiences with a hip register. J Bone Joint Surg Br 82:944, Ware JE, Sherbourne CD: The MOS 36-item shortform health survey (SF-36). Med Care 30:473, Bellamy N, Buchanan W, Goldsmith CH, et al: Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip and the knee. J Rheumatol 15:1833, Harris WH: Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty: an end-result study using a new method of result evaluation. J Bone Joint Surg Am 51:737, 1976