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Database and Registry Research in Orthopaedic Surgery

Part 2: Clinical Registry Data

Pugely, Andrew J. MD1; Martin, Christopher T. MD1; Harwood, Jared MD2; Ong, Kevin L. PhD3; Bozic, Kevin J. MD, MBA4; Callaghan, John J. MD1

doi: 10.2106/JBJS.O.00134
Current Concepts Review
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Supplementary Content
Disclosures

➤ The use of large-scale national databases for observational research in orthopaedic surgery has grown substantially in the last decade, and the data sets can be categorized as either administrative claims or clinical registries.

➤ Clinical registries contain secondary data on patients with a specific diagnosis or procedure. The data are typically used for patient outcome surveillance to improve patient safety and health-care quality.

➤ Registries used in orthopaedic research exist at the regional, national, and international levels, and many were designed to specifically collect outcomes relevant to orthopaedics, such as short-term surgical complications, longer-term outcomes (implant survival or reoperations), and patient-reported outcomes.

➤ Although heterogeneous, clinical registries—in contrast to claims data—typically have a more robust list of variables, with relatively precise prospective data input, management infrastructure, and reporting systems.

➤ Some weaknesses of clinical registries include a smaller number of patients, inconstant follow-up duration, and use of sampling methods that may limit generalizability. Within the U.S., national joint registry adoption has lagged international joint registries.

➤ Given the changing health-care environment, it is likely that clinical registries will provide valuable information that has the potential to influence clinical practice improvement and health-care policy in the future.

1Department of Orthopaedic Surgery and Rehabilitation, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, 01008 JPP, Iowa City, IA 52242. E-mail address for A.J. Pugely: Andrew-pugely@uiowa.edu

2Department of Orthopaedics, Ohio State University Hospital, 376 West 10th Avenue Suite 725, Columbus, OH 43210

3Exponent, 3440 Market Street, Suite 600, Philadelphia, PA 19104

4Department of Orthopaedic Surgery, University of California, San Francisco, 3333 California Street, Suite 265, Box 0936, San Francisco, CA 94118

Peer Review: This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication. Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.

Over the last several decades, clinical registries have emerged worldwide as data repositories that allow for the aggregation and tracking of patients over time. Registries typically collect robust data related to particular disease states and/or track patients who undergo procedures or treatment with pharmaceuticals and medical devices. Patient data are typically collected prospectively using strict definitions and on the basis of an established informatics infrastructure. In general, these secondary data have been used as a tool for refining clinical understanding, resulting in improved patient safety, patient outcomes, and cost-effectiveness. In the simplest form, clinical registries exist at the local level and may contain patient information from a single surgeon or hospital, but also exist as multicenter international collaborations.

Within orthopaedic surgery, joint replacement registries represent the most common clinical registries and have been established decades prior in Europe. Several different clinical registries have been used in publications found within the most cited orthopaedic journals1 (Table I). Registry data have given researchers a powerful tool for answering a variety of clinical questions of international interest, including those regarding orthopaedic disease and treatment, volume, utilization, costs, and outcomes (Table II). In this two-part series, we describe the databases most commonly used for clinical orthopaedic research, which can be categorized as either administrative claims or clinical registries. In Part 1, we explored the commonly used administrative claims databases in the U.S.2. In Part 2, we explore the use of clinical registries at the state, national, and international level. Each database is described, helping the reader to interpret and understand appropriate data application through the exploration of the strengths and weaknesses.

TABLE I - List of Commonly Used Databases for Health Services Research in Orthopaedics
Database* Maintained by* Participating Sites Approximate Cost for Raw Data(USD) Web Site URL§
Regional clinical registries
 CJRR State of California 38 hospitals Not public http://www.caljrr.org
 MARCQI Michigan hospitals, Blue Cross Blue Shield 51 hospitals Not public http://marcqi.org
 SCOAP State of Washington hospitals and physicians >50 hospitals Not public http://www.scoap.org
National clinical registries
 AJRR AJRR >400 hospitals Not public https://teamwork.aaos.org/ajrr/default.aspx
 FORCE-TJR University of Massachusetts 150 surgeons Not public http://www.force-tjr.org
 Kaiser Kaiser Permanente 38 hospitals Not public http://www.kpimplantregistries.org
 NTDB ACS 900 hospitals $300 per year https://www.facs.org/quality-programs/trauma/ntdb
 NSQIP
  ACS NSQIP ACS >500 hospitals No charge to participating hospitals http://site.acsnsqip.org
  VASQIP VA All VA hospitals No charge to participating hospitals http://catalog.data.gov/dataset/veterans-affairs-surgical-quality-improvement-program-vasqip
National certification registry
 ABOS ABOS All with orthopaedic surgeons No charge, but requires research proposal and board approval https://www.abos.org
International registries Country-specific Variable Not typically public NA
*
CJRR = California Joint Replacement Registry, MARCQI = Michigan Arthroplasty Registry Collaborative Quality Initiative, SCOAP = Surgical Care and Outcomes Assessment Program, AJRR = American Joint Replacement Registry, FORCE-TJR = Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement, NTDB = National Trauma Data Bank, ACS = American College of Surgeons, NSQIP = National Surgical Quality Improvement Program, VASQIP = Veterans Affairs Surgical Quality Improvement Program, and ABOS = American Board of Orthopaedic Surgery.
Participating sites as of early 2015.
USD = U.S. dollars.
§
URL = uniform resource locator, and NA = not available.

TABLE II - Comparison of Database Characteristics
Database* Type Patients Included Payers* Coding Scheme Data Collector Comorbidities Laboratory Results Operative Variables Follow-up
Regional clinical registries
 CJRR Registry All (select hospitals) All Definitions Trained data abstractor Definitions Some Yes Continuous
 MARCQI Registry All (select hospitals) All Definitions Trained data abstractor Definitions Some Yes Continuous
 SCOAP Registry All (select hospitals) All Definitions Trained data abstractor Definitions Some Yes Continuous
National clinical registries
 AJRR Registry All (select hospitals) All Definitions Trained data abstractor Definitions Yes Yes Continuous
 FORCE-TJR Registry All (select hospitals) All Definitions Trained data abstractor Definitions Yes Yes Continuous
 KAISER Claims and registry All Kaiser ICD-9, CPT, and definitions Surgeon and coder ICD-9 and definitions Yes Yes Continuous
 NTDB Registry All (select hospitals) All ICD-9 and definitions Trained data abstractor ICD-9 and definitions No Yes Inpatient
 NSQIP Sample (select hospitals)
  ACS NSQIP Registry Sample All Definitions Trained data abstractor Definitions Yes Yes 30 day
  VASQIP Registry Sample VA Definitions Trained data abstractor Definitions Yes Yes 30 day
National certification registry
 ABOS Registry Part II, Board collection period All Definitions, less strict Surgeon Definitions Yes Yes 6 mo
International registries Registry All All Variable: surgeon and/or clinical team Definitions Variable Yes Continuous
*
CJRR = California Joint Replacement Registry, MARCQI = Michigan Arthroplasty Registry Collaborative Quality Initiative, SCOAP = Surgical Care and Outcomes Assessment Program, FORCE-TJR = Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement, AJRR = American Joint Replacement Registry, NTDB = National Trauma Data Bank, ACS = American College of Surgeons, NSQIP = National Surgical Quality Improvement Program, VASQIP = Veterans Affairs Surgical Quality Improvement Program, and ABOS = American Board of Orthopaedic Surgery.
ICD-9 = International Disease Classification, Ninth Revision, and CPT = Current Procedural Terminology.

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State Registries

At the state and regional level, multiple stakeholders have established clinical registries3. Within orthopaedics, these registries represent a heterogeneous group with a wide range of diseases captured, variable definitions, outcomes collected, and follow-up duration, which ultimately makes generalizations difficult. Most, however, allow for patient tracking beyond the index admission and thus provide a more robust opportunity for quality assessment and clinical research.

The State of California hospitals must report information about all hospitalized patients into a database that has been used to report short-term and long-term postoperative complications after total hip arthroplasty4, total knee arthroplasty5, and ankle fracture surgery6. In addition, the state also operates the California Joint Replacement Registry (CJRR), a separate voluntary registry designed specifically to monitor the safety and performance of hip and knee replacements. The CJRR, which collects level-III data1 (Table III), has sought to evaluate device safety and effectiveness by monitoring postoperative complication rates, revision rates, and patient-reported outcomes. Another state registry is the Michigan Arthroplasty Registry Collaborative Quality Initiative (MARCQI). Funded by Blue Cross Blue Shield, it was established as a consortium of Michigan hospitals and collects implant-related and adverse events. Washington State also maintains a mandatory clinical registry that captures a robust array of data and allows patient linkage across files. Researchers have used this database to analyze the morbidity, mortality, and reoperation rates after spine surgery7-9, or outlying surgeons with the highest revision rates after lumbar decompression10.

TABLE III - The Levels or Tiers of Data Collection Used in Joint Replacement Registries Worldwide*
Level I
 Patient, surgeon, and hospital identifiers
 Procedural and demographic information
Level II
 Patient factors, comorbidities, and ASA class
 Surgical factors and perioperative care data
 Complications and/or adverse events
Level III
 Patient-reported outcomes measures
 Disease-specific measures of health, symptoms, function, and satisfaction
Level IV
 Radiographic imaging
*
Data are from Hansen et al.1. Higher data levels are not necessarily inclusive of lower levels.
A
SA = American Society of Anesthesiologists.

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Strengths and Weaknesses

The advantages in using the state databases remain individual but include longitudinal outpatient follow-up, the ability to link with other state databases, and more robust variable definitions and collection mechanisms. While these state databases remain heterogeneous, some are subject to the same coding limitations as administrative claims data. Orthopaedic functional outcomes are not collected. Longitudinal follow-up, while not available in all states, will not typically capture events across state lines (Table IV).

TABLE IV - Strengths and Weaknesses of National Databases*
Database Time Trends Geographic Variation Patient Comorbidities Inpatient Complications Short-Term Complications Long-Term Complications Financial Analysis Accessibility
Regional registries
 CJRR – – + + + + + + + + +
 MARCQI – – + + + + + + + + +
 SCOAP – – + + + + + + + + +
National registries
 AJRR + + + + + + + + + – –
 FORCE-TJR + + + + + + + + – –
 KAISER + – – + + + + + + + + + – –
 NTDB + + + + + + + – – + + +
 NSQIP
  VASQIP – – + + + + + + – – – – +
  ACS NSQIP – – + + + + + + – – – – + +
Certification registry
 ABOS + + + + + – – – –
International registries + + + + + + – –
*
Values within the table correspond to how appropriately each database can evaluate various study questions. Two minus signs (– –) indicate that the database is unable to answer the question, i.e., a strong weakness; one minus sign (–) indicates that the database is poorly suited to answer the question but can in a limited fashion, i.e., a minor weakness; one plus sign (+) indicates that the database is able to answer the question but a better database exists, i.e., a minor strength; and two plus signs (+ +) indicate that the database is best suited to answer the question, i.e., a major strength. CJRR = California Joint Replacement Registry, MARCQI = Michigan Arthroplasty Registry Collaborative Quality Initiative, SCOAP = Surgical Care and Outcomes Assessment Program, FORCE-TJR = Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement, AJRR = American Joint Replacement Registry, NTDB = National Trauma Data Bank, ACS = American College of Surgeons, NSQIP = National Surgical Quality Improvement Program, VASQIP = Veterans Affairs Surgical Quality Improvement Program, and ABOS=American Board of Orthopaedic Surgery.

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National Clinical Registries

American Joint Replacement Registry (AJRR)

The AJRR is a multistakeholder, independent, nonprofit organization established by the American Academy of Orthopaedic Surgeons (AAOS) with wide support from the large orthopaedic community11. The registry currently uses collected total joint arthroplasty data to help participating institutions improve health-care quality and safety, while adding to the overall orthopaedic knowledge base. The Centers for Medicare & Medicaid Services has recognized the AJRR as a Qualified Clinical Data Registry that satisfies Physician Quality Reporting System requirements. In its current form, the AJRR is collecting data from >500 participating hospitals within the U.S. The AJRR is equipped to collect up to level-III data (Table III).

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Strengths and Weaknesses

The advantages of the AJRR as a clinical registry include specific definitions for collected data elements and expanded and clinically relevant variables, such as implant type, for risk-adjustment and disease severity assessment. Other advantages include the potential for long-term follow-up, with outcome measures relevant to orthopaedic surgeons. Relative to international registries, the AJRR is still in its infancy, with shorter patient follow-up and growing hospital participation. Mechanisms for level-III data collection are currently being validated as part of an ongoing AJRR trial. The data will be available to interested parties through the AJRR Annual Report (available online) and annual releases.

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Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR)

Within the last decade, several more regional clinical registries have emerged across the U.S. In 2010, the Agency for Healthcare Research and Quality (AHRQ) awarded the University of Massachusetts Medical School a $12 million grant to establish a registry termed the FORCE-TJR. Similar to the AJRR, this clinical registry collects detailed patient, surgical, and longitudinal postoperative outcomes data. The FORCE-TJR differentiates itself from administrative claims data and many other clinical registries with the collection of patient-reported outcomes. As of 2014, the database contains data on >20,000 patients from across the U.S.12.

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Strengths and Weaknesses

Some advantages of this registry include an emphasis on patient-reported outcomes collection, variables highly relevant to orthopaedics with strict definitions, and financial backing from large government grants. The database, however, is still relatively young with a smaller network of 136 surgeons. In addition, some important variables such as readmissions had not been added until 2014.

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Kaiser Permanente Joint Replacement Registry

Kaiser Permanente is one of the largest managed care organizations in the U.S. Based in California, it services millions of health plans. In 2001, orthopaedic surgeons at Kaiser developed the Total Joint Replacement Registry (TJRR), modeled after the Swedish Joint Register, to track and monitor short and long-term outcomes and complications. More recently, Kaiser has also implemented additional orthopaedic registries, such as for anterior cruciate ligament reconstructions, hip fractures, spine surgery, and other procedures. Some of the Kaiser TJRR organizational goals are to identify clinical best practices, evaluate and optimize patient risk factors, assess clinical effectiveness of implants, and alert surgeons to recall situations13. Patient data are collected through the electronic health record and specialized TJRR forms by surgeons and staff; completion and participation rates exceed 90%, with >98% accuracy13. As of 2012, >350 surgeons from fifty Kaiser medical centers had contributed data on >150,000 total joint arthroplasties14,15. Variables include standard level-I data, procedure information (surgical approach and implants used), and short and long-term patient outcomes. In addition to standard medical complications, data on patient satisfaction, pain levels, and radiographic assessment are also recorded. When the early metal-on-metal failures were identified with international registries16,17, the Kaiser TJRR allowed for the identification and notification of patients at risk18. Total hip arthroplasty and total knee arthroplasty survivorship and complication rates are known and tracked.

In addition to a quality improvement tool, the Kaiser orthopaedic registries are used for clinical research. Several publications have identified complication rates and patient risk factors19 after total joint arthroplasty20,21 and knee arthroscopy22. Other studies have assessed more longitudinal outcomes, such as a 2012 study comparing revision rates over an eight-year interval between mobile and fixed-bearing total knee arthroplasty23.

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Strengths and Weaknesses

Some of the notable advantages of the TJRR include large patient numbers and a robust variable list. Integration with a single electronic health record system fosters high rates of surgeon participation and high-quality data. Although an integrated health-care system (consisting of health plans, hospitals, and medical groups), the TJRR is not subject to many of the limitations seen in other administrative databases. Some weaknesses include the regional nature of the patient cohort, which may limit generalizability. The TJRR is young, with shorter patient follow-up relative to international registries14. The data set is also not accessible to the public for use in clinical research, but recent international collaboration will allow for outside analysis24.

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National Trauma Data Bank (NTDB)

The NTDB is a trauma registry created and maintained by the American College of Surgeons. Established in 1997, the registry currently contains over five million cases from >900 U.S. trauma centers. A subset of the NTDB includes the National Sample Program (NSP), which is a stratified sample of a portion of collection sites that can be extrapolated to represent a national sample. Data collected within the NTDB follow National Trauma Data Standards of standardized variable definitions. A broad inclusion criterion captures all injury victims (alive on arrival) with a hospital admission.

Using the 2008 NTDB-NSP, one study assessed the risk factors and complications for in-hospital complications following hip fractures in >40,000 patients25. Other studies have evaluated predictors of morbidity after spine26,27 and long-bone trauma28, and another looked at disparities in trauma care29.

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Strengths and Weaknesses

Strengths of the NTDB include a robust sample size with millions of records. Data are collected according to standardized and precise definitions. The NTDB also contains relevant trauma variables often not found in other registries such as mechanism of injury, injury severity scores, and blood pressure. Data are cleaned and standardized centrally to improve quality. The data can be purchased and manipulated at relatively low costs (Table I). One of the major weaknesses of the data set is follow-up limited to index hospitalization. Participating hospitals have not been systematically sampled and may not be representative. Minor sources of selection bias may occur from differences in site inclusion and/or exclusion criteria or from transfer of patients between hospitals.

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The Veterans Affairs (VA) and American College of Surgeons (ACS) National Surgical Quality Improvement Programs (NSQIPs)

The NSQIP is a surgical quality improvement program that prospectively collects and reports thirty-day morbidity and mortality data. Monthly risk-adjusted outcomes reports are provided to participating institutions. The NSQIP originated from a 1990s Veterans Affairs (VA) System30 pilot program to collect risk-adjusted outcomes31,32, and after five years, the program reported reductions of >40% in the rates of morbidity and mortality33. The NSQIP moved to the private sector in 1998, achieving funding by the AHRQ34, and was adopted by the ACS at the end of 2004. Through a multifaceted program, the NSQIP integrates quality improvement at the local level and has been shown to improve outcomes35,36. The NSQIP has achieved national recognition by the National Quality Forum for several of its quality measures37. Since the creation of the ACS NSQIP in 2005, participation in the program has grown to >500 institutions.

In late 2013, the AAOS began a joint venture with the ACS to expand the utility of the NSQIP within orthopaedic surgery. Through this collaboration, a pilot study for hip fractures was initiated and a variable module relevant to orthopaedic surgery was created. Data collection began in early 2015 at forty-nine pilot sites across the U.S. If successful, the AAOS plans to expand this collaboration to other orthopaedic conditions.

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Data Collection

While designed for general and vascular surgery, the NSQIP also collects subspecialty cases such as orthopaedics. Several reports specific to orthopaedics using NSQIP data have recently been published38-41. Each participating site has a surgical clinical reviewer, generally a registered nurse who is independently trained and audited. Strict variable definitions ensure consistent data collection. Not all cases are collected, and a systematic (eight-day) sampling process is used. The NSQIP collects data on >250 patient, operative, and outcomes variables. In terms of postoperative data, NSQIP reports on thirty-day, predefined complications contributing to morbidity and mortality regardless of inpatient status.

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Study Types and Examples

The ACS NSQIP database can be used to perform epidemiologic studies of short-term, thirty-day complications following surgical procedures. One study by Schoenfeld et al., examined the prevalence of short-term complications following cervical and lumbar spine procedures38. In addition to describing complications, recent studies have identified risk factors for morbidity and mortality following primary total knee arthroplasty, lumbar discectomy39,40, and hip fractures, while some studies have used these variables to create a risk calculator42-46. The NSQIP can also be used to perform observational comparison studies, as one study39 used propensity score adjustment to compare differences in short-term complications between spinal and general anesthesia among patients having total hip arthroplasty.

In the VASQIP system, similar, but not identical, predictor and outcomes variables are collected. Some additional variables include hemoglobin A1c and perioperative antibiotic usage. One study analyzed the relationships between prophylactic antibiotic choice and the occurrence of surgical site infections after total joint arthroplasty47.

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Strengths and Weaknesses

The real strength of the ACS NSQIP data collection lies in the power of the surgical clinical reviewer to obtain accurate thirty-day outcomes data—it is a true clinical registry. In this prospective collection, the surgical clinical reviewer collects data from multiple sources, including the medical record, surgeons, and patients. Most variables are collected dichotomously, as present or not present. Routine auditing also ensures high data reliability, with disagreement rates of <1.8%48.

Given the sampling process, the NSQIP does not reliably estimate disease prevalence and may not be the appropriate tool for studies examining trends. Another disadvantage is the short, thirty-day follow-up; several postoperative complications such as deep vein thrombosis or mortality often occur outside this time period. Since the NSQIP was designed as a tool for general surgeons, no functional outcomes specific to orthopaedics, such as pain or range of motion, are collected. Ultimately, understanding the advantages and drawbacks of the NSQIP data set allows for the design of relevant and feasible studies.

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Certification Registry: American Board of Orthopaedic Surgery (ABOS) Part-II Database

The ABOS was established in 1934 and has standardized orthopaedic surgical competency through the board certification process. The ABOS maintains a database of cases from board-eligible candidates (Part II of the certification process). For most surgeons, case collection for Part II generally occurs within twenty-two months after residency completion. The case information is self-reported by each candidate and is entered into an Internet-based web system.

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Data Collection

The database contains cases reported by candidates during their Part-II six-month board collection period. Information pertaining to patient demographics, comorbidities, procedures performed, length of follow-up, complications, and surgeon training has been captured electronically since 1999. Broadly, complications in the ABOS database are separated into medical (stroke, myocardial infarction, etc.) and surgical procedure-related (hemorrhage, implant failure, etc.) groups49.

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Study Types and Examples

The ABOS database lends itself well to studies evaluating temporal operative trends, geographic variation, and short-term surgical complications. A frequently cited ABOS study explored trends between the use of intramedullary nailing compared with plate fixation for intertrochanteric hip fractures49. Similarly designed studies have evaluated temporal trends in surgical treatment for distal radial fractures50, femoral neck fractures51, hip arthroscopy52,53, and rotator cuff surgery54. Other studies have evaluated geographic variation, such as in graft and instrumentation choice, for cervical spine fusions55 or changing patterns of fellowship training in candidates performing rotator cuff repairs54. Many of the mentioned studies have also analyzed short-term complications—typically either between alternative procedures (plate compared with pins) for one disease, or for one procedure performed for separate diagnoses (hip arthroscopy compared with labral repair for femoroacetabular impingement).

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Strengths and Weaknesses

Although the data are from a small subset of practicing orthopaedic surgeons, the data are fairly complete as 98% of U.S. trainees take Part II within five years after they have finished their residency or fellowship50. Detailed information regarding patient outcomes, including pain, deformity, function, and patient satisfaction, are reported by the operating surgeon. The onus of board collection encourages accurate and complete data collection. However, the data have not been independently validated or audited.

Arguably, the most important limitation of the ABOS database remains the narrow source of input data from a select, novice group of surgeons. Candidate behavior during board collection may also not be reflective after case collection. Certainly, conclusions derived from these studies may not reflect the orthopaedic community at large nor do they represent national practice trends. Additionally, the self-reported complication follow-up is limited and variable, ranging from a few weeks to six months. The database also does not contain nonoperative cases or clinical information such as certain patient demographics, medications, and comorbidity severity.

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International Registries and Databanks

International joint registries have become a powerful tool for implant surveillance and for improving clinical outcomes56. The first major joint replacement registry was developed in Sweden in the late 1970s to first follow total knee arthroplasty and then total hip arthroplasty57. While many of these registries originated for the collection of joint replacement registry data, most have expanded to include other orthopaedic procedures. In the modern era, these registries serve a powerful role in improving quality, clinical outcomes, and cost-effectiveness. Mechanisms that pervade registry design include timely surgeon feedback, tools to minimize potential complications, a warning system for early implant failure, real-time technique and implant performance, and techniques to maximize value56. Some well-known clinical registries have been established in the following countries: Sweden, Norway, Finland, Scotland, Denmark, England, New Zealand, Australia, and more1,58,59. Most of these registries are members of the International Society of Arthroplasty Registries, which requires participation of >80% of national hospitals, with local collection of data on >90% of procedures1. Within the last several years, each international registry has been a data source for a publication in a major U.S. orthopaedic journal60-75.

Successful joint registries have been built on a robust infrastructure. Stable and adequate funding is an essential foundation. Most international joint registries have full or partial government management and funding, and they are in single-payer systems, such as those in Sweden, Canada, England, and Finland. History has proven that long-term registry success depends heavily on these factors. Surgeon participation should be fostered and not forced, so as to ensure a high level of quality data. While most countries have voluntary participation, some have legal mandates requiring data submission. The successful registries have robust infrastructure required for accurate data collection, but also allow for flexibility and evolution. Data management strategies such as internal auditing, rapid data analysis, and usable feedback will establish legitimacy and dictate long-term success.

Aside from registries, international organizations such as the World Health Organization (WHO) and the World Bank have collected and analyzed worldwide epidemiologic health data from most countries. Over the last two decades, the WHO has released a series of reports detailing the Global Burden of Disease. The landmark study in The Lancet, in 2012, found that the burden of musculoskeletal disease is among the highest of the 291 disorders studied and is on the rise76. Data from that study have been used in part to estimate the global burden of specific orthopaedic conditions such as femoral fractures from road traffic collisions77.

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Data Collection

Most clinical registries collect patient demographics and include identifiers that allow for long-term tracking and follow-up. Preoperative variables such as comorbidity burden, previous operations, and disease severity are collected with less consistency among joint registries; these are important variables that can help to explain patient-specific outcomes. Unique to joint replacement registry collection, however, is detailed procedure information: implant type and manufacturer, surgical approach, fixation, laterality, surgical time, surgeon, anesthesia, and many more58. While not all registries collect data on short-term complications and readmissions, nearly all collect long-term revision arthroplasty and mortality data.

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Study Types and Examples

Clinical registries are well established for reporting on arthroplasty survivorship. Within this realm, some patient, surgeon, and procedural characteristics have been elucidated. Some of the most impactful recent studies have identified the mid-term failure of metal-on-metal total hip arthroplasty devices. High revision rates were reported using data from clinical joint replacement registries from England and Wales17, Australia, New Zealand, and others78. The Australian Orthopaedic Association National Joint Replacement Registry was one of the first to identify the high failure rates of the DePuy Articular Surface Replacement (ASR) XL and ASR Hip Resurfacing system16. In a review of the Swedish Total Hip Replacement Register data, investigators established several conclusions such as the most serious complications had declined by threefold, modern cementing techniques have substantially improved outcomes, and younger patients have increased failure rates59. We compiled a list of recent publications from international clinical registries (see Appendix).

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Strengths and Weaknesses

International clinical registries serve as a powerful tool for long-term outcomes and implant surveillance. Their large numbers, clinically relevant data elements, and proven history have set joint registries apart from the other databases discussed. While both a strength and limitation, participation within most joint registries is voluntary. Practice culture, government involvement, and economic viability of the registry infrastructure may all influence participation level. To prevent selection bias, however, participation should exceed 85%56. Joint registries are often criticized for the relatively narrow scope of their primary outcome, revision arthroplasty, as it may be inadequate. Although secondary analysis can be performed on shorter-term complications, critiques of registry data should be aware of each registry’s prospective data collection methods and variable definitions. Additionally, comparative studies only describe associative findings, and confounding variables may be difficult to control for, especially if they are not known. In addition, although the registries adjust for sex and age in their analyses, they often lack consideration of comorbidities and socioeconomic status, which are well known to be associated with worse outcomes. Finally, for U.S. researchers, international registry data files are not typically available for use.

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Future Directions and Overview

The use of large-scale databases in observational research has taken on an expanding and influential role within the orthopaedic surgery literature (Table V; see Appendix). We explored the use of clinical registries in observational research. The advantage of most registries includes well-defined criteria of certain variables, often collected by trained abstractors. Outcomes are typically defined, collected, and followed prospectively. As clinical registries within the U.S. become more mature, regulatory bodies will likely use these data sources to inform future health policy and payment. Understanding the nuances of each database will be useful for the clinical orthopaedic surgeon and researcher alike.

TABLE V - Number of Clinical Registry Studies Published in The Journal of Bone & Joint Surgery (American Volume) from January 1, 2012, to October 1, 2014, Separated by Type
Database* No. of Studies in JBJS
Regional clinical registries 0
 CJRR 0
 MARCQI 0
 SCOAP 0
Clinical registries
 AJRR 0
 FORCE-TJR 0
 KAISER 6
 NSQIP
  ACS NSQIP 8
  VASQIP 2
 ABOS 4
International registries
 Canada 3
 Japan 2
 Sweden 3
 U.K. 3
 Scotland 1
 Finland 2
 Netherlands 1
 New Zealand 1
*
CJRR = California Joint Replacement Registry, MARCQI = Michigan Arthroplasty Registry Collaborative Quality Initiative, SCOAP = Surgical Care and Outcomes Assessment Program, AJRR = American Joint Replacement Registry, FORCE-TJR = Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement, ACS = American College of Surgeons, NSQIP = National Surgical Quality Improvement Program, VASQIP = Veterans Affairs Surgical Quality Improvement Program, and ABOS = American Board of Orthopaedic Surgery.

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Appendix

A list of all database studies in JBJS from January 2012 to October 2014 is available with the online version of this article as a data supplement at jbjs.org.

Investigation performed at the Department of Orthopaedic Surgery and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, Iowa

Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, one or more of the authors has had another relationship, or has engaged in another activity, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

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