Supplemental material: Additional File 1

1. Table S1: Registry characteristics – extended version.

Orthopedic Implant Registries

Authors Aim, Structure / Design and Reporting

Outcome

Arthroplasty Registries, several countries

Serra-Sutton, V.[1]

Aim: To describe the structure, functioning, and content of arthroplasty registers in Europe and other parts of the world.

Funding: Main funding source is the government (sometimes additional grants of taxes).

Data collection methods: Main source of information is a standardized clinical form completed by surgeons/other. Most registries are created as an initiative of an orthopedic society or of health authorities. Use of clinical administrative hospital data sets to complement the information from patients’ history. Additional data sources: e.g. data from mortality and health charge data or other registries. Participation is mostly voluntary (but there are exceptions). Clinical audits, periodical conferences, and training are strategies to reinforce an adequate completeness/coding of data to the register. Operational committees with different stakeholders and responsibility of defining the registry project strategies, supervising data, annual reports, stimulating hospitals’ and surgeons’ participation. Validation strategy: double entry and manual data revision or computer programming for the identification of missing values or systematic errors.

Data selection: Hospital characteristics, surgical technique and procedure characteristics, prosthesis characteristics, patient characteristics are reported.

Scientific or professional societies and the public health administration should collaborate in the development of arthroplasty registers. To adequately assess the results of observational data information on the structure, the process of arthroplasty interventions and patients characteristics should be collected.

Main outcome: the survival of the prosthesis

Dissemination of results via Internet Web sites, annual reports etc.

1

Worldwide arthorplasty registers, Sweden, Finland, Norway, New Zealand, Australia

Labek, G. [2] Aim: To collect valid data concerning total ankle Arthroplasty (TAA)

Funding: The Swedish Total Ankle Arthroplasty Register is organized as an independent project within a national network under the strategic management of the Swedish Association of Local Authorities and Regions (SALAR), which provides the major part of the funding.

Data collection methods: Special requirements on the methodology of data collection, evaluation, publication and assessment.

The results of TAA are promising, but the revision rate is higher than for total hip or knee arthroplasty. TAA outcome measurement by means of registers has several specific requirements necessitating additional documentation beyond the basic data set. For methodological reasons the evaluation of results is more complex than for hip or knee arthroplasty. It will therefore be essential to arthroplasty data collection and evaluation and develop a methodology addressing the specific needs of TAA.

Implant registry documentation System, USA

Barsoum, W. K.[3]

Aim: Compliance and accuracy of the collection of implant registry dataFunding: The Biomedical Research and Education FoundationData collection methods: Non-mandatory, inexpensive, low-burden pilot data collection systemData selection: Minimum essential data set: Patient (name, date of birth, gender medical record number), procedure (surgeon, date of surgery, laterality, procedure, primary diagnosis etc.), implants (components, manufacturer, etc.)

Even with relatively simple reporting systems, compliance was poor. Need for direct surgeon involvement, strict oversight, and a feedback system to ensure validity, particularly if a volunteer-based system is used.

The European Arthroplasty Register (EAR), Germany,

Labek, G.[4] Aim: International comparability of outcomes.Funding: Recommendations for financing a registry.Data collection methods: The registry has to be an integral component of the national health system: Central structure for data gathering and data assessment, task sharing of partners considering the individual focus, involvement of domain experts, involvement of respective professional societies, close cooperation between registry, physicians and health authorities.

Minimum of standardization of databases is useful to increase the value of registries for other countries.National registers reflect the prevailing national circumstances. Supranational evaluations yield additional findings, but they cannot replace a national register. EAR is a network of independent national registers.

2

The Australian OrthopaedicAssociation National Joint ReplacementRegistry

Jang, B.[5] Aim: improve the quality of care in patients undergoing joint replacement surgery; record and monitor the outcomes of implanted joint prostheses, determine failure rates, identify inferior implants

Data collection methods: supplying data to registry voluntary, compliance from hospitals almost 100%, data completed at time of surgery and submitted to registry every month, paper-based, responsible persons vary, data are validated externally and internally

Data selection: patient demographics, statistics for individual surgeons, record-keeping system on joint implants, statistics for primary and revision procedures

Outcomes: statistics about devices, device recalls, e.g. recall of the Corail AMT stems or the Articular Surface eReplacement hip system form the Australian market; publish concerns regarding implants in reports

European Federation of National Associations of Orthopaedics and Traumatology (I) European Arthroplasty Register (EAR)

Sadoghi, P.[6] Aim: To screen for complications or implant failures.Data collection methods: Minimal dataset for primary and revision joint arthroplasty: 25 different countries agreed to the dataset in a consensual meeting:Data selection: Date of operation, country, hospital ID-code, patient’s name, patient’s prename, birthday, identification code of the implant, gender, diagnosis, pre-operations, type of prosthesis (partial, total), side, cementation technique, use of antibiotics in the cement, surgical approach, and others specifically related to the hip, knee, ankle, elbow, and shoulder joint arthroplasty.

Using this minimal dataset will improve the chance for a worldwide comparison of arthroplasty registries and ask future countries for implementation.Data collection can be burdensome and expensive leading to weighting of each data element against the cost and burden of its collection.

The German Arthroplasty Registry, Germany

Heinz, B. C.[7] Aim: To assess long-term safety of devices, to identify concerned patientsFunding: Mainly government funds, sometimes fee on implantsData collection methods: Patient identification number with or without patient consent, data are pseudonomized for privacy reasons, involvement of the BQS (Bundesgeschäftsstelle Qualitätssicherung). An ideal solution would be scannable catalog or charge numbers to match patients and prostheses details. Use of a manufacturer reference databases.

Is it not sure if such a registry is also a valuable mean to detect short-term implant problems. Because of data protection it is not possible to identify patients at risk at the moment even if a registry is used.

3

Kaiser Permanente Implant Registries, USA

Paxton, E. W.[8]

Aim: To identify procedure incidence and implantable device utilization, evaluate patient outcomes, identify patients at risk, monitor devices, evaluate comparative effectiveness of devices, foundation for quality improvement.Data collection methods: Rigorous quality control and data validation processes for all registries (Total Joint Replacement: Knee, Hip, Total Shoulder Arthroplasty, ACL Reconstruction, Hip Fracture, Spine; Cardiac device: ICD, Pacemakers, Leads, Heart valve, Endovascular stent graft) by automated computer algorithms, reviewed by data quality personnel, quarterly logical and cross-validation checks. Analytic strategies to analyze the registry data: annual report with basic demographic of patients, surgical techniques etc.

The KP implant registries provide important information and affect several areas of organization, including patient safety, quality improvement, cost-effectiveness, and research.Quick identification of patients, recalls, risk factors, reports, changes in practice, cost-effectiveness, research.Development of real-time, proactive tracking of adverse trends.The Cardiac Device Registry detected an adverse trend in the performance of a particular defibrillator lead and alerted physicians in advance of a recall of that lead by the US Food and Drug Administration.

4

Kaiser Permanente National Total Joint Replacement Registry, USA

Paxton, E. W.[9]

Aims: Implant techniques and characteristics, characteristics of patients, relationship between patients and implants chosen, comparing incidence rates and variations in clinical care, relationship between variations in practice and short-term outcomes, risk factors, cost-effectiveness, patient-safety, benchmarking.Funding: Funding through integrated health plan.Data collection methods: Development supported by regional and national orthopedic chiefs groups, leading surgeons were identified to design the registry, surgeon champion at each center. Validation: use of different databases, for example to identify patients lost to follow-up. Use of comprehensive validation program for adverse events detection.Data selection: Core set of TJRR variables modeled after the Swedish THR registry, minimal data set with core data elements; Possibility to extend the documented variables for research projects TJRR Inputs: Standardized forms: preoperative, operative and postoperative form (piloted at different centers to identify key data elements). Staff: data entry specialists, biostatisticians, clinical project managers, surgeons. Patient (patient medical record number, name, age, gender etc.), procedure (procedure date, surgeon, laterality, anesthesia, etc.), hospital admission (hospital, discharge disposition, etc.), implant (fixation, implant characteristics) and outcomes (intra- or postoperative complications, revisions, death, etc.) information.

TJRR Outputs: best practice, ad hoc requests, implant performance, research, confidential surgeon practice profiles global navigation and static pages, dynamic web-based reports, trends reports, TJR risk calculator. 90% participation.Implant recalls and advisories, contract decision-making, and identification of patients at risk for revisions (e.g., younger patients having total knee arthroplasty). Tracking of overall survival of implants influenced clinical practice, with feedback resulting in the reduction of the number of unicompartmental and uncemented knee arthroplasties performed, usage of femoral head sizes\28 mm, and the number of minimally invasive surgical procedures performed.The registry has effectively aligned operations with information technology and leveraged that to enhance the ability to respond to recalls and advisories as well as improve quality of care, cost-effectiveness, and create research opportunities.

5

Total Joint Registry, USA

Berry, D. J.[10]

Aim: To systematically and prospectively collect clinical, surgical and radiographic data on all joint replacements, to use these data to communicate to the individual patient the success or failure of their procedure, to communicate to the orthopedic community, through peer reviewed literature etc.Data collection methods: The joint registry provides a systematic mechanism that triggers a request to the patient to be evaluated at regular intervals after surgery (return for an interview, physical examination, radiographs), letter questionnaire or telephone contact possible. Contacting patients who would be otherwise lost to follow-up: Social Security system (Thomas, Ramo, Woolridge), Switchboard, contacting relatives, a nursing home, and local postmaster. Patient data are kept indefinitely to provide more detailed information. Data retrieval by joint registry personnel skilled in programming. Search is performed by surgeons.Data selection: Preoperative clinical information relating to pain, function, and physical findings. Data about surgical approach, prosthesis model and design, prosthesis fixation, use of bone grafts, intraoperative and postoperative medical and surgical complications, and postoperative clinical results.

Hard endpoints: patient death, component revision, prosthetic infection, and dislocation.

Value of joint registry data is dependent on accuracy and completeness of data entered.

Tool for patient management, quality assurance, instrument for rigorous analysis of prospectively collected data.

EVEREST Registry, ankle implants, hardware-implants, soft-tissue procedures, USA

Heyer, C. F.[11]

Aim: To create a registry to assess the safety and efficacy of lower extremity implants and procedures.Data selection methods: Patient consent needed, Central Institutional Review Board. Patients are monitored at 6 weeks, 3, 6,12, 24, 36, 60 months, reporting of adverse events, personalized implant card, data collection via web-based remote data capture system. Quarterly reports, post market surveillance, support publications, presentations etc.Data selection: Demographics, baseline functional scores, intraoperative details, postoperative outcomes at defined intervals, preoperative diagnosis, operating room time, ease of surgery, length of stay in a health care facility.

Approach to the tracking, collecting, and sharing of data for total ankle replacements.Early outcomes suggest many surgeons are willing to assimilate a registry system into their practice. This registry supports the critical need for data collection in lower extremity medicine. While long-term follow-up is necessary, early outcomes of the INBONE Total Ankle Replacement are positive.

6

The Canadian Joint Replacement Registry (CJRR), Canada

Bohm, E. R.[12]

Aim: To assess the safety and efficacy of lower extremity implants and procedures.Funding: Through the CIHI by Health Canada.Data collection methods: Registry data collected by surgeon (appointee), patients are ask to sign a consent form, these core registry data are combined with additional CIHI data. Development of annual reports, analyses in brief and ad-hoc requests. Governance: leadership by an advisory committee (chairperson, e.g. an orthopedic surgeon, orthopedic representatives from each province, representatives from orthopedics societies, patients, nursing staff, members of CIHI.Data selection: Patient demographics, implant information, information on surgical technique.

Data capture with CJRR forms remains a challenge: only 41% of all TKAs and THAs had forms submitted to the CIHI in 2006–7. The CJRR is taking a multi-pronged approach to address this deficiency by focusing on several areas that have been identified as being problematic: consent, data collection form, and relevance.Reports are published describing for example the most commonly replaced componentsChanges were made to improve the registry outcome (new minimum data set)Reporting now is mandated increase of coverage.

7

The Swedish Knee Arthroplasty Register, Sweden

Robertsson, O.[13]

Aim: Safety of implant, outcome of knee arthroplasty, types and rates of failureFunding: The ownership of a national register must depend on the legal, financial and organizational circumstances in each country. In Sweden, the counties provide official health care and the registers are formally owned by the Federation of Swedish County Councils.Data collection methods: Most important variable to collect is a unique identifier for the patient, it is important to collect similar variables. Due to Publication bias, there are often better results for an intervention with an implant in studies published in the literature than the one for the analysis of registry data.Benefits of register studies: analysis of epidemiology, demography and outcome.Drawbacks: register may be biased by selection, be incomplete or erroneous. That is why there have to be protocols regarding how data are gathered, how these data are assessed, treated and saved.Ownership and control: must depend on the legal, financial and organizational circumstances in each country.Data selection: Details about prosthesis, patient, surgery, hospital, and surgeon.

Follow-up times of registries vary.

Measure of outcome: The principle of register studies is to establish a prospective follow-up of patients after surgery with no predefined control as to who is included or of the implants used. However, there is a lack of consensus on definitions.

The need for revision is the main outcome measure in registry studies as a measure of survival of the implant; in combination with a careful analysis of the reasons for revision.

8

The Swedish Knee Arthroplasty Register, Sweden

Knutson, K.[14]

Aim: Safety of implant, outcome of knee Arthroplasty, types and rates of failureComputer reporting and use of a minimal datasetFunding: The MFR supported the registry for the first 5 years, after which there was a 6-year period with intermittent financing by a variety of research grants. In the mid-1980s, the Board of Health and Welfare (Socialstyrelsen) started to provide regular financial means but in 2007 the support of quality registries was taken over by the Swedish Association of Local Authorities and Regions (SKL). In spite of this support by the central health authorities, the registry has been chronically under-financed, with Lund University Hospital indirectly bearing part of the cost and the rest being provided through individual research grants, e.g. from the Faculty of Medicine and Stiftelsen för bistånd åt rörelsehindrade i Skåne.Data collection: History of data collection in this registry.Data selection: Information about each procedure was coded to fill one printed line including identification number, hospital, diagnosis, date of surgery, side, type of surgery, implant type and brand, and early complications.

Findings presented at national and international meetings, published in peer-reviewed journals, annual report.Use of registry outcomes by authoritiesChronically underfinanced.

The Swedish Ankle Arthroplasty Register, Sweden

Henricson, A.[15]

Aim: Safety of implant, outcome of Knee Arthroplasty, types and rates of failure.

Data collection: Surgeons report all total ankle replacement via a paper form to a national register (database):

Data selection: Hospital, demographic data, date of index and revision surgery, operated side, diagnosis (primary or reason for revision), type of prosthesis, diagnosis, etc.

It is difficult for an individual surgeon to evaluate various designs and techniques. Use of a registry.Outcome: registry findings show that the low overall survival rate and high revision rate reflects the demanding surgical procedure and the long learning curve. Experience, strict indications, improved designs, and especially improved instrumentation will probably lead to better results in the future.

9

The Swedish Hip Registry, Sweden

Malchau, H.[16]

Aim: Monitoring surgical techniques and prophylactic measures to minimize complications, continuous feedback to all centers that provide access to the registry, warning system, to improve the value of the register by analyzing the patients’ own opinions of the results of THA.Data collection methods: 81 private and orthopedic units in Sweden participate voluntarily in the registry. Use of the patient’s social security number (Swedish PNR number) for data collection. Implant parts are registered separately (cup/liner and stem/head) as well as the method of fixation and type of cement Correct implant identification is ensured by the use of article bar codes.Follow up data are entered preoperatively using an Internet application either by a secretary or by the patient using a touch screenData selection: Number of primary operations and the type of implant used, age, gender, original diagnosis.

Endpoint: revisionThe preoperative routine has shown that a patient with osteoarthritis is suffering from severe pain and has low general quality of life.The retrospective 6-year results and prospective 1-year results show extremely good pain relief and very high patient satisfaction.Very good cost-utility result.

The Finnish Arthroplasty Registry, Finland

Puolaka, T. J.[17]

Aim: Ensure quality of prostheses for patient safety.Funding: The National Agency for Medicines meets all costs of the Implant Register.Data collection methods: Registration voluntary at first, later, since 1997 obligatory. With the aid of the civic registration number, data from the arthroplasty register are linked and matched with other national data registers.Data selection: Data about total hip (THA), total knee (TKA) and other joint replacements;the operating hospital, date, personal number, indication for the operation, implant design, method of fixation for each component and primary complications, date of the index operation, design of the revised prosthesis, indication for revision and the new prosthesis.

Endpoints: all kinds of revisionsData from the Finnish register indicate that the results of total hip replacements are improving in Finland. The 5-year survival of the cementless hip prosthesis has improved with time: it was 85 (82–87)% in 1985–1989, 89 (88–91)% in 1990–1994 and 92 (88–95)% in 1995–1999.

10

The Norwegian Joint Registry, Norway

Havelin, L. I.[18]

Aim: Detection of inferior results as early as possible.Endpoint: Revision.Funding: Norwegian medical association / Norwegian state.Data collection methods: The surgeon fills out a 1-page form after each operation. The form takes less than 1 minute to fill in. The name of the hospital is registered, but not the name of the surgeon.Team: orthopedic surgeons, secretary, statistician, research fellow.Data selection: Patient ID and date of birth, hospital details, previous operation in index hip, date, diagnosis, reasons for revisions, type of revision, approach, bone transplantation, operation theatre, duration of operation, preoperative complications, prosthesis type, etc. Acetabular, femoral and head components are registered separately.

Participation of surgeons practically 100%; reports of more than 95% of the performed joint replacements.Detection of inferior results of implants as early as after three years of use. Several brands on uncemented prostheses and two brands of cement have been withdrawn from the market mainly based on findings from this registry.Reports to the surgeons, annual reports, comparison between different hospitals possible, names of other institutions are masked, result of different implant brands are presented at conferences etc.

Registry for balloon kyphoplasty: SWISSspine registry, Switzerland

Diel, P.[19] Aim: To generate evidence about the safety and effectiveness of these technologies.Funding: Industry provided funding according to market share.Data collection methods: Ongoing, preliminary time frame was 3 years. Online and paper-based forms were used. The Institute for Evaluative Research in Orthopaedic Surgery at University of Bern serves as technology provider and organizer, working group with stakeholders; Certification of spine surgeons (withdrawing of certification possible if data show many complications. Primary intervention form, follow-up form, Euroqol-5D, co-morbidity questionnaire, two patient consent forms, one annotation form about the registry and its purpose.

Outcome: significant and clinically relevant reduction of back pain, improvement of quality of life, reduction of pain killer consumption.The registry proved to be an excellent tool for evaluation of this new technology and its results in combination with an elaborate HTA report led to a permanent coverage of BKP by the basic health insurance.

11

The Swiss Orthopaedic Registry

Röder, C.[20] Aim: To generate evidence about the safety and effectiveness of these technologies.Data collection methods: Technical set-up: Multi-tier client server electronic documentation system for data collection and storage, central database with patient demographics. Data collection instruments: Online interface, optical marker reader (OMR) paper questionnaires, barcode sheets, and use of the MEMdoc system since 2003. Use of hip (IDES) and knee questionnaires, core data set, admission, clinical evaluation, surgery, discharge; documentation of the description of components materials and sizes with the help of the secure data integration concept (SEDICO) Picture information possible (TIFF, JPEG)

Pilot program, positive feedback, basis for building the Swiss orthopaedic registry.

European spine registry: Spine Tango

Röder C.[21] Aim: To generate evidence about the safety and effectiveness of these technologies.Funding: While all costs for system and content development were covered by IEFO (Institute for Evaluative Research in Orthopaedic Surgery), the pilot study was co-sponsored by the most important implant suppliers in the Swiss marketplace.Data collection methods: Data collection took place on a voluntary basis, and was standardized according to the International Documentation and Evaluation System (IDES). Enormous human and financial resources are needed to read, correct and complete paper-based data sheets. An online tool for data collection is recommended. Online Interface, Paper-based OMR and Barcode reader transfer of data into the database real-time statistics, export and report tools.Data selection: Clinical, radiographic and implant data.

The growing number of Spine Tango participants indicates the success of the system that has always been a non-commercial academic project.

12

SWISSspine Schluessmann, E.[22, 23]

Aim: To generate evidence about safety and efficiency of Medtech innovations; to make reimbursement decisions based on registry data; the generation of evidence for a decision by the Swiss federal office of health about reimbursement of the concerned technologies and treatments by the basic health insurance of Switzerland.Funding: Industry partners provided funding according to market share.Data collection methods: surgeons complete Intervention and implant forms. Informed written consent of patients is necessary as well as completed life quality and co-morbidity questionnaires. Timeframe for registry, expert as technology provider and organizer of the registry, working group of stakeholders of industry, societies, etc. assigned tasks and duties, funding by industry partners and support of device-related questions, certification of surgeons, outsourcing of data entry possible.Data selection: Primary intervention form, implant form, follow-up form, Euroqol-5D, NASS (patient assessment), co-morbidity questionnaire, patient consent forms, annotation form.

The registry reports quality of life improvement, reduction of pain.The SWISSspine registry proofs to be an excellent tool for collection of observational data in a nationwide framework whereby advantages and deficits of its design must be considered. It can act as a model for similar projects in other health-care domains.Evaluation of the SWISSspine registry showed that TDA is efficient in short-term back and leg pain reduction. Along with it goes an improved quality of life and moderate rates of complications and revisions.

13

TMJ implant registry, USA

Myers, S.[24] Aim: To provide a national systematic program to collect removed TMJ implants and biological tissues, make them available to researchers, and study them in conjunction with long-term clinical follow-up, with the ultimate goal of stimulating research toward understanding the safety and outcomes of TMJ implants, to collect comprehensive clinical data and biological specimens from patients with TMJD and/or TMJ implants and to supply them to researchers.Funding: Temporomandibular joint (TMJ); “The NIH’s National Institute of Dental and Craniofacial Research (NIDCR) supported and funded the development of a new National TMJ Implant Registry and Repository at the University of Minnesota School of Dentistry.Data collection methods: NIDCR’s TIRR was structured to have two synchronized divisions: (1) a Registry to recruit clinicians and/or surgeons and patients and collect comprehensive clinical patient data over time, and (2) a Repository to procure and archive high quality, well characterized biological specimens and retrieved implants for dissemination. ”Recruited through personal contacts, displays, brochures, and presentations at professional meetings. Support is provided throughout the patient recruitment and consent processes, including obtaining Institutional Review Board (IRB) approval. Benefits of participation for clinicians and/or surgeons in NIDCR’s TIRR include: (1) a secure website for their individual patients to facilitate tracking and long-term follow-up, and (2) contributing to a national project to improve treatment outcomes for patients with TMJD and/or TMJ implants.“ Written consent is needed.“Benefits for patients include: (1) a personal portable electronic health database, and (2) contribution to a national effort to improve care for TMJD patients.“

Since October 2002, NIDCR’s TIRR has nationally recruited and registered 34 TMJ surgeons and 34 TMJ clinicians. 723 surgical/non-surgical TMJD patients and control subjects have been registered in the electronic database. 626 (86.6%) of the participants are female, and 97 (13.4%) are male.In July of 2005, NIDCR’s TIRR approved dissemination of archived data and biological materials for research use. To date, 19 projects at 17 different institutions are in progress using TIRR resources, and more than 60 publications and presentations at national and international meetings illustrate the value of NIDCR’s TIRR in TMJD and implant research.

Cardiovascular implant registries

Authors Aim, Structure / Design and Reporting Outcome

14

The Automaticity study (pacemakers), USA

Alings, M.[25]

Aim: To evaluate physician’s acceptance of automatic algorithms for ventricular capture, automatic sensing, and automatic optimization of sensor settings. To determine the percentage of patients who have any of the ‘Automaticity Algorithms’ reprogrammed within 12 months of pacemaker implant.Observational, prospective, multi-site, non-randomized registry.Funding: The study is entirely funded and sponsored by Boston Scientific International.Data collection methods: Patient’s data are collected based on the standard follow-up schedule of the enrolling institution. Both study questionnaires are completed by one physician associated directly with the study at each centre. Clinical decisions with respect to reprogramming of the automatic algorithms will be taken only by qualified study personnel. The sponsor’s representatives are not required to attend implants, nor follow-up procedures. Data are captured using a web-based electronic data capture system.Data selection: Percentage changes in programming, time to first reprogramming, and adverse events will be collected and prospectively evaluated.

Insight into physician’s perception and understanding of such automatic features, significant feedback as to the level of comfort and satisfaction when required to rely on such advanced technology. The data from this trial will directly impact the way automatic features are implemented in the next generation of pacemakers with a view to achieving a high level of physician’s satisfaction and confidence.

Kaiser Permanente Registries: Cardiac Devices; Heart Valves

http://www.kpimplantregistries.org/Registries/Cardiology.htm [26]

Aim: to identify and track patients with specified cardiac implants, identify patients during recalls, provide an active surveillance system, monitor trends and provide a framework for researchData collection methods: Implant data is obtained from cardiac device manufacturers, Paceart, Apollo, American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR) and internal administrative sources, such as KP HealthConnect (KPHC). KPHC serves as a primary data source for patient demographics, diagnosis and complications as well as for validation of data received from device manufacturers.Annual reports are developed.

Suspected complications are identified by queries run in the KPHC Clarity database using ICD-9 codes. Registry clinical staff validates identified complications through KPHC chart review to determine if they meet pre-established Registry criteria. Complications tracked are: Tamponade; Hematoma; Pneumothorax; Mechanical Complications of Pulse Generators and Leads; Infections: Superficial, Deep and Organ Space.

15

The Kaiser Permanente Endovascular Stent Graft Registry (KPSGR)

Hye, R.[27]

Aim: To create a prospectively entered registry using the EMR (electronic medical record), optimizing the ability to track device utilization and to appraise short- and long- term EVAR outcomes.Data collection methods: automated data extraction from EMR into registry, including patient demographics, comorbidities, diaginosis, procedure, hospital stay data. Implants are entered via barcode scanning. Use of templates for registry documentation.

Since implementation of the KPSGR, surgeon use of the preformatted templates has steadily increased over time, with participation varying between 60% and 90%, depending on the KP region.

German Aortic valve Registry (GARY), Germany

Beckmann, A.[28]

Aim: Variability in structural requirements, processes etc., indication criteria for various therapeutic options, quality and safety, changes of quality of life, health economic evaluation. Funding: Independent organizations, financial support by unrestricted grants by medical companies (they have no access to the data).Data collection methods: Prospective, controlled, multicenter registry study (2010-16). Data record of the German external quality assurance program (German Social Code), mandatory by law for all German hospitals. Data completeness verified by an electronic tool, data protection and Management. Strict rules in Germany (patient addresses are stored separate from medical data), only persons in charge have a limited access to the addresses. Personal data are anonymized. Responsible Body: nonprofit organization (members have to disclose possible conflicts of interest).Data selection: Pre-, intra-, and postoperative facts during hospital stay; Main variables of measurement (Event-free survival Eligibility criteria for obtainable procedures. Risk adjustment and QoLTechnical performance Etc.), patient information (administrative data, date of admission and discharge, QoL before and after intervention, outcome etc.), specific parameters (manufacturer and type of replacement, type of intervention and basis for decision, etc.), follow-up (events, symptomatic, adjuvant therapy, number of hospitalizations) and economic evaluation.

Since the launch of data acquisition in July 2010, almost all institutions performing aortic valve procedures in Germany joined the registry. By now, 91 sites which perform TAVI in Germany participate and more than 15,000 datasets are already in the registry.

16

RESTEM (REgistro delle PCI in era di STEnt Medicati)

Campolo, L. [29, 30]

Aim: a prospective multicenter registry collecting all percutaneous coronary interventions (PCIs) performed over 20 months and monitored up to 2 years; main goals of the registry were to evaluate SES utilization in a nationwide scenario and its outcome after 30 days, 1 and 2 years, in comparison with other techniques, primarily BMS

Data collection methods: Consecutive patients (5524) were enrolled over a 20- month period. Data collection was centralized through a VMG’s Intranet Service. A Central Task of Clinical Statistics, supervised by an independent advisory board, performed data processing and statistical analysis.

Data selection: Detailed demographic, clinical, angiographic and procedural information, immediate results and in-hospital complications were collected for each patient.

Results gathered from SES in the RESTEM Registry are positive only relating to TVR and only to the first year follow-up without any influence on global clinical outcomes; as a counterbalance, they do not appear to possess the long-term risks, described in recent meta-analyses, except a mild increase in late admissions for unstable angina.

RESTEM Registry (stents), Italy

Boswell olo, L.[31]

Aim: To evaluate SES utilization in a nationwide scenario and its outcome after 30 days, 1 and 2 years, in comparison with BMS.Funding: Financially supported by the Villa Maria Group and Foundation without any grant from pharmaceutical product/device companies.Data collection methods: Real world prospective, unsponsored, multicenter registry gathering all percutaneous coronary interventions (PCIs) 2002-2004 in 7 catheter laboratories. Follow-up: performed by a central call center, direct telephone contact. Data collection: centralized through a VMG’s Intranet Service (clinical statistics, supervised by an independent advisory board).Data selection: Patient details (gender, age, condition, diabetes, previous AMI or PCI etc.), procedure details (BMS, SES), vessel details, outcomes (death, major adverse cardiovascular and cerebrovascular event, stroke, revascularizations, etc.).

Primary endpoint: The combination of death, acute myocardial infarction (AMI), unstable angina and revascularizations. Secondary endpoints: combined clinical events, TVR revascularization etc. RESTEM results confirming SES’s capacity to reduce TVR without reduction of other clinical events, suggest that this advantage is limited to the first year after PCI, and show no evidence of excess of deaths, AMIs and late thrombosis following SES implantation described in recent meta-analyses.

17

Intranet-based AF (atrial fibrillation) registry, Germany

Dugas, M.[32]

Aim: To store prospectively all relevant data covering clinical information, quality of life and device parameters and by this means provide a platform for long-term follow-up.Funding: The pacing devices and the software ‘AF Discover’ are provided by Vitatron Medical BV, P.O. Box 76, 6950 AB Dieren, The Netherlands.Data collection methods: Hard and Software used is defined. Automatic generation of web programs is possible. To provide access to the AF registry from many locations within the hospital we applied state-of-the-art Intranet-technology. Integration of the AF registry into daily routine is necessary. Data mining methods and statistical evaluation. Use of database interfaces.Data selection: Anamnesis atrial fibrillation, symptoms, induction, termination.

Success factors are: Clinical integration, iterative software engineering, interfaces between data sources.

Italian BiodivYsio Open Registry (BiodivYsio PC-Coated Stent), Italy, Switzerland

Galli, M.[33]

Aim: Evaluation of safety and efficacy of the BiodivYsio stent (a stent coated with phosphorylcholine polymer), recording of major adverse cardiac events (MACE): recording was post-procedure, at 30 days and at 6-month follow-up.Data collection methods: Multicenter study, population of real world patients, data collection, verification etc. were carried out by an independent external center.Data selection: Clinical characteristics of the patient (demographics, clinical data), Morphology of coronary lesions treated.

Optimal results were reached in 97,2% of patients.This study evaluated the safety and efficacy of a third-generation stent.The results show a high procedural success rate, a low incidence of major adverse cardiac events at short- and medium- term follow-up. The BiodivYsio stent should be considered safe in clinical or anatomical situations with a high risk of complications.

(Balloon Angioplasty vs. Rotational Atherectomy for Intra-Stent Restenosis) BARASTER registry, USA

Goldberg, S.L.[34]

Aim: to evaluate rotational atherectomy in the management of in-stent restenosis, and to compare the results with stand-alone balloon angioplasty.Data collection methods: Two centers (Mayo Clinic, Rochester, MN and Beth Israel-Deaconess Hospital, Boston, MA) have maintained a database of lesions of in-stent restenosis treated with balloon angioplasty alone. The films of in-stent restenosis were sent to a core laboratory for quantitative coronary angiography (Artrek, ImageComm Systems, Inc., Santa Clara, CA).Data selection: A worksheet was filled out for each patient with in-stent restenosis encom- passing patient characteristics, details of the original stenting procedure, specifics of the management of in- stent restenosis and clinical follow-up.

The use of rotational atherectomy with adjunctive balloon angioplasty was associated with improved outcomes compared to either strategy used alone. Refinements in the optimal use of this device may further improve the clinical benefits achievable.

18

Canadian Registry of ICD Implant Testing Procedures, Canada

Healey, J. S.[35]

Aim: To document the details of Defibrillator Testing (DT), the reasons for not conducting DT, and the costs and complications associated with DT. Observational registry conducted at 13 ICD-implanting sites in Canada from 2006-2007, non-consecutive patients receiving a new or replacement ICD manufactured by Guidant (Boston Scientific Corporation, Minneapolis, MN, USA).Funding: Sponsored by Guidant Canada (the sponsor did not have any involvement in data management or patient selection etc.).Data collection methods: Protocol approved by ethic boards, patient provided written consent. Data collection via a web-based system, cost-analysis (perspective of healthcare payer, the Ontario Ministry of Health).Data selection: Baseline patient and device characteristics (single chamber, dual chamber etc.), precise details of the (defibrillation testing) DT performed, reasons for not conducting DT, complications up to 30 days after ICD insertion.

In the CREDIT registry, 36% of all ICDs were implanted without intraoperative DT, more frequently secondary to a perceived lack of need rather than a relative contraindication. This change in practice toward ICD implantation with- out DT has occurred in the absence of any high-quality data to support the safety of this approach. These observations support the need for a prospective, randomized trial of DT.

19

Ventricular Assist Devices, Germany

Hübler, S.[36]

Aim: To monitor and assess usability and safety of assist devices, to find a balance between sufficient comprehensiveness of the data collected from the huge amount of available information and practicability of database maintenance and data analysis at reasonable expenditure.Data collection methods: Written consent to non-anonymous data collection obtained on hospital admission. Entity/relationship model that contains 13 data tables, 3 temporary tables for data import, and 10 catalog tables (e.g., diagnosis, complication types) with 12 main relations between them. Medical records (results of examinations) are manually transferred into the Assist Database (with access for Windows) as well as laboratory data, OP data, blood bank data, electronic charts and admission database of the Hospital Electronic databases via interface. Inclusion of all patients treated with VAD; Collection of data relevant for outcome, complication, risk, stratification, and the decision making process; Comparability with other institutional scientific databases; and Online analysis of the data collected.Data selection: Part 1. Extended demographic data. This consists of name, address, date of birth, admission and discharge date, referring cardiologist, and diagnosis on admission. Part 2. Preoperative status and intra-operative data (proved diagnosis, pathologic evaluation, concomitant disease, VAD type, implantation technique, and goal of therapy at the time of implantation). Part 3. Postoperative status up to 30 days. Part 4. Follow-up period for the time on mechanical support. Part 5. Statistical evaluation.

The structure of the Assist Database facilitates comprehensive, time saving data collection, which allows different online data analyses. The Assist Database should include information relevant for the decision making process and for the prediction of outcome, data collection should be focused on patients’ preoperative condition and on postoperative organ function and quality of life. Different databases (for patients with congestive heart failure, assist device patients, and transplanted patients) should be unified to form a network to avoid the repeated collection of identical data, to save time, and to increase the quality of analysis. In the long term, multicenter use of the Assist Database could be considered.

International registry on PLV (Partial Left Ventriculectomy), Japan

Kawaguchi, A. T., [37]

Aim: An international registry of PLV was expanded, updated, and refined to include 287 non-ischemic cases voluntarily reported from 48 hospitals in 11 countries. Funding: This study was supported in part by The Research Grant for Cardiovascular Diseases (10A-l), and The Ministry of Health and Welfare, Tokyo, Japan.Data collection methods: Established through the Society for Cardiac Volume Reduction, a simple questionnaire regarding experience with PLV (Appendix 1) was mailed to hospitals where PLV was being performed.

Avoidance of risk factors appears to improve survival and might help stratify high- or low-risk patients. Although less symptomatic patients with preserved contractility had better results after PLV, change of indication requires prospective randomized comparison with medical therapies or other approaches.

20

Multicenter Interventional Cardiology Database (registry of percutaneous coronary interventions, PCIs), USA

Kline-Rogers, E.[38]

Aim: To develop a continuous quality improvement program, to prospectively evaluate appropriateness of percutaneous procedures, to develop and validate risk adjustment models for fatal and non- fatal outcomes of PCIs, and to apply these models in assessing the quality of care.Funding: Supported in part by a grant from the Blue Cross Blue Shield of Michigan Foundation, Detroit, Michigan.Data collection methods: One-page data form, physician representatives, standard definitions referring to the American College of Cardiology Guidelines, scannable data form, institutional Review Boards, approval prior to initiation, informed consent was waived by the institutions physician investigator, nurse coordinator, timeline to finish data forms, three-step data validation process: manual review for completeness and face validity, review of rejected data forms during the import process, review of forms that fail diagnostic inquiries. Data are reported into the Oracle database: series of diagnostic reports are run to identify potential errors. Site audits twice a year by a nurse practitioner from the coordinating center.Data selection: Demographic and procedural variables, past medical history, primary indication for PCI, priority, appropriateness, therapies, cardiac anatomy and function, outcome data.

The data from the registry show that outcome assessment does not end with the creation of a single center or a multicenter registry, but requires the institution of a process aimed toward the assurance of the quality of the data entered in the database, which is necessary to assure analytic rigor and credibility. Clinical inconsistencies and out of range data are common problems in the data collection process that can be easily resolved with automatic internal queries and reports. Database efforts that fail to undertake this level of data scrutiny will be significantly weakened by essential data that are missing or inaccurate.

Implantable Pacemakers, Cardioverter Defibrillators (ICD), cardiac resynchronization therapy (CRT), France

Lazarus, A.[39]

Aim: Daily, remote, wireless, patient- independent ambulatory monitoring of multiple medical and technical data.Funding: Biotronik GmbH, Berlin, Germany, supported this analysis.Data collection methods: Implanted devices are embedded with an antenna enabling the wireless, automatic, patient-independent transmission of diagnostic information stored in the device memory. Home MonitoringTM transmits data systematically on a daily basis. Email, SMS and/or facsimile single or combined alerts for physicians. Events classification (medical, system status-related, configuration monitoring). Rates of events reported, rates of follow-up visits.Data selection: General device status, lead function, rhythm monitoring, etc.

The database utilized for this analysis included no systematic clinical information. Therefore, no attempt was made to validate the clinical utility of home monitoring (HM) or measure the adverse event-free survival, and no conclusions could be drawn with respect to the effects of HM on patient outcomes.

21

The Ontario ICD database, Canada

Lee, D. S.[40]

Aim: Monitoring, outcomes, platform for evaluating patient risk.Funding: Ontario Ministry of Health and Long-Term Care is the sole payer of health care in Ontario.Data collection methods: Comprehensive, prospective clinical registry. All recipients of ICDs in Ontario must have their data entered into the database. Collaborative effort between the community of cardiac electrophysiologists, implanting centers, and health researchers in Ontario. Coordination at the Institute for Clinical Evaluative Sciences (ICES). No restrictions to ICD database participation, data collection occurs in real time.

Secure, webbased registry for monitoring a relatively new health technology, in conjunction with health care providers, researchers and policymakers. The majority of ICDs are being implanted for primary prevention indications. The majority of patients have ischemic heart disease, 4 of 5 are men.Ability to capture all defibrillator patients in a registry that has been mandated by a single payer health care system that provides health services to over 12 million persons of all ages.Ability to identify the occurrence of clinical and device related outcomes.The database will add substantially to current knowledge of defibrillator use and outcomes in the population.Possible to examine real world patient characteristics and treatment based on the indication for the ICD.

22

Cardiovascular Intervention Society Registry, United Kingdom

Ludman, P. F.[41]

Aim: Patient demographics, indications for PCI, details of the PCI operators, technical aspects of the PCI procedure, adverse outcomes, complications.Funding: Central government via the Department of Health (managed by the Healthcare Quality Improvement Partnership) is responsible for funding; costs for local data entry borne by hospitals.Data collection methods / data selection: British Cardiovascular Intervention Society (BCIS) is the leader of the data collection and analysis process (clinical and professional oversight provided), Central Cardiac Audit Database (CCAD) group. Information about every PCI procedure performed in all patients in the UK. A variety of database programs are used. Patient identification and tracking via national Health service number (pseudonymised).Data quality: 3 aspects of completeness are addressed: number of PCI centers, percentage of PCI performed by a unit, completeness of the fields in each record.Data quality check during upload of data, record rejected if serious inconsistencies occur. Use of data: to benchmark and improve the quality of the PCI, Life data analysis. 113 variables are collected (http://www.bcis.org.uk), programmed reports / automated reports / national annual reports.Indication weaknesses of data (e.g. balance between the size of the dataset and the willingness and ability to collect it accurately, duplicate data entry).

Very full participation has been achieved in recent years.The main purpose of the BCISeCCAD data collection is to help PCI units to benchmark and improve the quality of the PCI they provide for their patients. This involves a focus on three different but closely related areas: clinical audit against standards, outcomes analysis and research.

Asian Sudden Cardiac Death in Heart Failure (ASIAN-HF) registry, medical centre across Asia

Lam, C. S. P.[42]

Aim: The ASIAN-HF registry aims to fill the knowledge gaps regarding the mortality and morbidity burden of HF among Asian patients.Funding: The study is funded by the Investigator-Sponsored Research Program of Boston Scientific, via a grant for investigator- initiated studies awarded to the Cardiovascular Research Institute, Singapore after competitive application.Data collection methods: Prospective multinational Asian registry of patients with symptomatic HF. Data collection includes demographic variables, clinical symptoms, functional status, date of HF diagnosis and prior cardiovascular investigations, clinical risk factors, lifestyle factors, socio-economic status, and survey of cultural beliefs, health practices, and attitudes towards device therapy.Data selection: Demographics, clinical status, physical examination, medical history, lifestyle and socio-economic factors, device therapy.

Better understanding of the demographics, risk factors, and outcomes of such patients may provide opportunities to improve management and prognosis, guide healthcare resource allocation, and identify future areas of research in this large and growing population.

23

EFFORTLESS S-ICD Registry: Implantable cardioverter defibrillator

Pedersen, S.[43]

Aim: to evaluate the long-term performance of the S-ICD including patient quality of life and long-term resource utilizationData collection methods: A member of staff (e.g., electrophysiologist, research coordinator, etc.) at each participating center who has been approved by the center to take informed consent and do the enrollment will approach patients for participation in the Registry. Written informed consent of prospective patients will be obtained before the S-ICD implantation.Data selection: All complications, hospitalizations and clinical events that occur between annual follow-ups will be reported.

NA

ICD Registry, Italy

Proclemer, A[44]

Aim: The collection of epidemiological data and patient characteristics Data collection methods: Founded in 1997, member of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC). Data collection based on the official European Registry Implantable Defibrillator (EURID) form.

ICD implantation increased during the last years, number of implanting centers increased too. Prevalence of male patients significantly higher. Important increase in prophylactic ICD utilization during the last 3 years.

RELAY Endovascular Registry for Thoracic Disease (RESTORE) (Stents), Austria, France, Germany, Greece, Italy, The Netherlands, and Spain

Riambau, V.[45]

Aim: Evaluation of the RELAY stent.Data collection methods: Definition of inclusion criteria, description of patient selection and assessment (by medical history, physical examination, and diagnostic imaging). Definition of study outcomes. Ethical conduct of the study. All patients signed informed consent for their thoracic endovascular aortic repair procedure and collection of their data.Statistical analysis. Data were managed and analyzed with SAS 9.1.3 software (SAS Institute, Cary, NC). Descriptive statistics were used to summarize patient outcomes: counts, mean, standard deviation, minimum, median, and maximum values were calculated for continuous variables, and counts and percentages for categorical variables. RESTORE was submitted to a quality control procedure by an external company (Trial Form Support Co, Barcelona, Spain) using a random sample of 61 patients representing 20% of the series to ensure the authenticity of the data transferred from the clinical files to the case data forms.Data selection: Demographics (gender, age), co-morbidities (previous myocardial infarction, COPD, etc.), cardiovascular risk factors (diabetes, smoking), history of thoracic surgery (previous thoracotomy).

The results of RESTORE support the safety of thoracic endovascular aortic repair. Primary outcome was survival at 2 years. Secondary outcomes included procedural and hospital outcomes. The RELAY stent graft, even in acute and complicated situations. The device was highly efficient in angulated aortic anatomies, with acceptable mortality and a low rate of neurologic complications.This study has several limitations. The observational design does not allow us to establish causal relationships, and the lack of control patients hampers direct efficacy and safety comparisons between devices or even surgery.

24

TARIFF (ICD), Italy

Ricci, R. P.[46]

Aim: To enable remote follow-up of devices and collect diagnostic and device status information via programmed remote transmissions. To compare costs of on-site vs. remote follow-up.Funding: St.Jude Medical Italia, sponsor of the TARIFF Registry.Data collection methods: Merlin.NetTM: dedicated virtual data collection center, accessible via an Internet site (username, password). A transmitter communicates with the implanted devices, notifying every pre-defined clinical and technical issue at Merlin@home and Merlin.net.

Remote monitoring systems enable caregivers to better ensure patient safety and the healthcare to limit costs. TARIFF will allow defining the economic value of remote ICD follow-ups for Italian hospitals, third payers, and patients. The TARIFF study, based on a cost-minimization analysis, directly comparing remote follow-up with standard ambulatory visits, will validate the cost effectiveness of the Merlin.net technology, and define a proper reimbursement schedule applicable for the Italian healthcare system.

The Remote Active Monitoring in Patients with Heart Failure (RAPID-RF) study, USA

Saxon, L. A.[47]

Aim: To characterize type and frequency of alert notifications, time from alert notification to medical intervention, and type of intervention implemented for activated alerts; to assess NYHA class and quality of life changes over time, HF events, hospitalizations, mortality and device-collected data.Funding: Trial is sponsored in full by Boston Scientific Corporation.Data collection methods: „In addition to being implanted with an RF-enabled CRT-D device, each study patient will receive a Latitude communicator and home monitoring equipment including a weight scale and blood pressure monitor (Fig. 1). The communicator transmits information from the implanted CRT-D device, weight scale, blood pressure monitor, and the patient’s answers to weekly symptom self-report questions to a secure server through an analog telephone line. The secure server is a centralized computer database that stores patient and implanted device data. These data are also immediately available for viewing by the physician on the secure Latitude website.” Patient consent is necessary. For the purpose of this multi-centric registry study, each patient may be followed by both device- and health-following physicians.Data selection: Clinical history, current clinical information, current cardiovascular medications, etc.

The RAPID-RF study will provide important preliminary data on how remotely collected HF and arrhythmic surveillance data alter the management of HF patients with CRT-D devices.How physicians and other health care providers respond to the information is shown.

25

The PREHAMI (PREsillionTM in High-Risk Acute Myocardial Infarction) Registry (stents), Italy

Sciahbasi, A.[48]

Aim: To evaluate the efficacy of the new Cobalt–Chromium (Co-Cr) PresillionTMstent for the treatment of high-risk acute myocardial infarction (MI) patients.Data collection methods: Prospective, single center registry. The patients’ selection was performed in the catheterization laboratory by the nursing staff that had a checklist with the inclusion criteria. Definition of events etc. Data selection: Demographics, medical history, clinical features are reported.

Occurrence of major adverse cardiac events (MACE) in-hospital and at 1-year follow-up.In patients with high-risk ST-segment and non-ST-segment elevation acute MI, the use of the Co-Cr Presillion stent is safe and is associated with good in-hospital and long- term outcome.

Device Registries: Pacemaker and ICDs, several countries

Maisel, W. H.[49]

Aim: To determine pacemaker and ICD malfunction rates and to identify trends in these ratesData collection methods: Metaanalysis

Pacemaker reliability has improved markedly. After more than a decade of improving device reliability, the ICD malfunction rate transiently increased before experiencing substantial reductions in the latter 2 study years. Whether increasing device sophistication accounts for the observed decrease in reliability is not known. Continued monitoring of pacemaker and ICD performance is required. Active device registries can provide important insights into device performance trends.

26

Tabelle 3Other implant registriesCochlear Implant Registry

Authors Aim, Structure / Design and Reporting

Outcome

Cochlear Implant Registry, Italy

Berrettini, S.[50] Aim: To assess the impact of the use of cochlear implants on patient health, to ensure traceability of the devices currently used, monitoring their safety and reliability over time, to guarantee access of the technique in clinical and organizational conditions that can allow the best possible benefits.Data collection methods:Observational, prospective, multicenter, national or regional registries.Recruitment of structures interested in joining the registry (signing a participation form). Data analysis: clinical epidemiology, epidemiology of treatment, epidemiology of therapeutic-diagnostic protocols, compliance of centers to guidelines, post marketing surveillance, risk factors, sanitary and social costs, economic implications, new applications, best practices.Database: obligatory data, functional to the objectives of the registry, accessible to as many national centers as possible; Large amounts of non-obligatory data, alongside a minimum group of obligatory data, but only accessible to the few reference centers able to support the collection. Use of electronic case report form (eCRF). The patient should consent to treatment of his/her data, signing an informed consent form.Data selection: Patient details, technical information, clinical data.

The development of the technological part and the need to involve external technological partners is associated with high costs. That is why the project should be limited to the proposal of a paper registry to be implemented at a later stage, possibly within the framework of successive financed research projects.

27

The Cochlear Paediatric Implanted Recipient Observational Study (Cochlear P-IROS)

Sanderson, G.[51]

Aim: prospective, international, patient-outcome registry for children, collection of data on patient comorbidities, device use, auditory performance, quality of life

Funding: The Cochlear P-IROS Registry is commercially funded by Cochlear Limited.

Data collection methods: patients are evaluated with help of standardized as well as non-standardized questionnaires, web interface to electronic case reports. Implant clinics in Cuba, Israel, Japan, Malaysia, Singapore, South Africa, South Korea, Russia have been recruited until now. A secure web interface in different languages is established to ensure secure reporting to clinicians and families of implanted children. Reports translated into more than 22 local languages are available. Participation is investigator-driven and voluntary.

The Cochlear P-IROS will generate valuable data to support research interests of academics and clinicians around the globe. The data generated will be relevant for a wide range of stakeholders including regulators, payers, providers, policy makers, patients and their families, each with a different perspective for the acceptance and adoption of implantable hearing devices for the treatment of hearing loss.

Ophthalmic implant registries

Authors Aim, Structure / Design and Reporting

Outcome

28

NEON Cataract surgery registry, USA

Lum, F.[52, 53] Aim: To help ophthalmologists, networks etc. meet managed care plans, to educate payers how to evaluate the quality of eye care, to provide ophthalmologists with information, to assess changes in practice patterns over time.Funding: Study supported in part by the American Academy of Ophthalmology.Data collection methods: Registry was opened (in 1996) to participation by any ophthalmologist willing to pay a modest fee (200$ in 1998) to cover some of the costs for the maintenance of the registry. Software, paper data collection forms, data are submitted to a central database (7 data collection forms). Importance of maintaining the confidentiality of patient- and physician-specific data, unique identification number, no information about the patient’s name is submitted into the database.Data selection: Case mix, content of care, outcome of care data.Patient demographics, patient history, physical examination and test results, preoperative functional status and symptoms (cataract symptom score CSS), intra-operative procedure and events, postoperative findings, patient’s postoperative satisfaction with the outcome.

During the first 2 years of NEON, ophthalmologist participation was low and consisted of a self-selected and likely non-representative sample of ophthalmologists. The representativeness of patients for whom data were reported is unknown. Complete data were submitted on only a minority of patients who were enrolled.It is technically possible to collect clinical data from, and report aggregated results to, practicing clinicians’ offices. At least some practicing clinicians are willing to spend the time required to participate in the NEON registry. There is the potential to provide a practical means for tracking practice patterns and patient outcomes in real time.

Cosmetic Implant Registry

Authors Aim, Structure / Design and Reporting

Outcome

29

The International Breast Implant Registry (IBIR), several countries

Renner, C.[54] Aim: Safety and compatibility of implants.Data collection methods: Personal registration is required. All retrieval of data is strictly confidential and only through the web operator, a state health officer deducible to the surgeon, who is the only means to the patient. History of implant can be searched by serial number. Easy process. Data input time directly after operation rarely is longer than 2 minutes. The patients are identified by sex, date of birth, ZIP code and national ID only. The patients name cannot (and because of privacy concerns, obviously should not) be entered.Data selection: Frequency of short- and long-term complications, Frequency of capsular contraction, frequency of local complications, frequency of reoperations, frequency of implant rupture, durability of implants, implant defects for defining early proof of serial defects, safety of breast implants, implant-related data, shell material and type, filling materials, Implant shape, manufacturer, implant size, procedure-related data, Implant position, preoperative diagnosis, primary or secondary procedure, incision localization, general postoperative complications, connection of complications with general health risk factors (e.g., smoking, diabetes mellitus).

Internet based, can be accessible from any country in the world, much more economical solution than a multitude of national registries, free of charge.

30

European breast implant registry, several countries

Eisenmann-Klein, M.[55]

Aim: To define European standards in breast implants, to assess different kinds of breast implants, e.g. gel-filled-implants, their failure rates and stability, to get reliable numbers.Funding: Recommended that the registry is financed by government on a national level.Data collection methods: Questionnaire that covers all basic information and may also be expanded according to regional requirements. Patient information and consent form for quality assurance. Strategic coaching by international acknowledged plastic surgeons, accreditation of hospitals, special training courses, consensus conferences. The Quality Assurance Committee of the International Confederation of Plastic, Reconstructive and Aesthetic Surgery has been working on this issue for the past eight years. The European branch, EQUAM (European Committee on Quality Assurance and Medical Devices), has cooperated closely with the European Commission in the field of quality assurance in breast implants.

Evidence-based medicine will enable us to develop new techniques and have adequate safety controls.

The National Saline Breast Implant Registry (SaBIR), USA

PSEF Set Up Registry to Gather Breast Implant Datahttp://www.breastimplantsusa.com/plastic-surgery-articles/psef-set-up-registry-to-gather-breast-implant-data-425.ht

Aim: Set up by the Plastic Surgery Educational Foundation (PSEF) to gather scientific data on saline breast implants and to analyze and disseminate their findings to doctors, patients, and regulatory agencies.Funding: Funding aid from Silimed and The Doctors Company.Data collection methods: The information collected includes types of implants used, manufacturer, location of incision, placement of implants, deflation rates and causes and rates of reoperation. Augmentation, reconstruction, reoperation, and explantation procedures using saline implants are the focus of the study. Strictly voluntary.

34 sites are actively participating in collecting data. By the end of 2002, PSEF began to collect data on all types of breast implants used in the United States. SaBIR will be renamed the National Breast Implant Registry to reflect the increased scope of the project and will also welcome participation by non-plastic surgeons.

31

Plastic surgery of the breast, Denmark

Henriksen, T. F.[56]

Aim: To examine short-term and, eventually, long-term local complications and possible health effects, and to contribute to an ongoing evaluation of surgical results and surveillance of the products. The Registry will allow the identification of new areas for research into cosmetic and reconstructive breast surgery.

Funding: International Epidemiology Institute, Rockville, Maryland, through a support contract from the Dow Corning Corporation, Midland.

Data collection methods:Preoperatively: Information about registration, women who accept registration fill in a self-administered questionnaire and mail it directly to the DPB.Preoperatively: Blood sample prior to implantation/other surgery, Staff mails blood sample to State Serum Institute and the operation sheet to the DPB. Surgeon completes the operation sheet.Postoperatively: The follow up sheet is kept in the medical file and updated at clinical consultations. The surgeon registers date, objective etc. Mail to DPB when patient terminates at the clinic.

Data Handling: Access database for the registration of key data and an SAS library for analyses, sheets are reviewed and the validity of key data (clinic specific study number, operation date etc.) and the patient’s personal identification number are checked, patient name replaced by a patient sequence number (key file for matching).

Regulations for data access: Establishing of an Oversight Board to supervise the use of the data, permission to use data depends on the project, statistical report published annually.Error finding: Programs ensure that error corrections are performed on a weekly basis.Ethics: Approved by the Danish Ethical Committee System and the Danish Data Protection Agency.Organization: Copenhagen, Institute of Cancer Epidemiology, Danish Cancer Society, Oversight Board.

Recommendations for the handling of critical points in the registration process.

32

Full-time physician administrator, who is also secretary of the Oversight Board, is responsible for the organization of the registry, contact with physicians, nurses etc. Project nurse, data manager (Institute of Cancer Epidemiology), professionals (Scientific Advisory Panel).

Data selection:The questionnaire includes questions on demographic and lifestyle factors (including use of medication, alcohol consumption and smoking habits), previous breast surgery, symptoms and sickness within the past 3 months and reproductive history, perceived result satisfaction with the implant, adverse effects, breast-feeding capability. Operation sheet: Surgical technique, place of incision, location of implant etc., implant characteristics (manufacturer, size, filler material, etc.).

The UK breast implant registry (UKBIR), UK

Shakespeare, P. G.[57]

Aim: The initial aim of the Registry was to record the use in the UK of all types of breast implant on a prospective basis.

Funding: The Registry acknowledges the continued financial support of the then Medical Devices Agency (now the MHRA), our founding and funding body, which has ensured the stable environment in which to develop the concept and practicalities of the Registry and the registration process.

The number of procedures has risen steadily to some14,000 in the year 2001. The number of centers returning registrations increased, too. 3 Annual reports have been issued for each year of operation and the nature of the data analysis and reporting has been developed.The UKBIR now has some 80,000 patients registered. This involves in excess of 140,000 implants.The registry can be used to audit and feedback processes, to investigate implant procedure lifetime, in that repeat registrations can be identified and time intervals to secondary procedures recorded and analyzed.

33

Plastic surgery registries, USA

Hume, K. M.[58] Aim: To track procedures and assess 30-day post-operative outcomes, monitoring clinical outcomes and emerging trends, supporting research and educational programs, developing evidence- based practice parameters, and compilation of the National Clearinghouse of Annual Plastic Surgery Statistics.Funding: Medical Specialty Society–Sponsored Data Registries.Data collection methods: The Tracking Operations and Outcomes for Plastic Surgeons registry uses an electronic data capture interface to collect common demographic, risk factor, procedural, and 30-day outcome data elements. These data allow registry users to evaluate outcomes based on patient co-morbidities and risk factors, including body mass index, tobacco use, and diabetes, in addition to reporting and tracking the rate of surgical complications occurring postoperatively, such as types of infection (e.g., wound disruption, incisional surgery site), hematoma, deep vein thromboembolism/pulmonary embolism, or an unplanned return to the hospital/emergency department.

In the United States, the U.S. Food and Drug Administration has used data collected through registries to facilitate the drug and device regulatory process, for ongoing surveillance during the product life cycle, and for disease appraisals. Furthermore, the Centers for Medicare and Medicaid Services, in certain instances, bases registry participation and submitting data to registries as factors for reimbursement decisions.

Studies focusing on IT in registries

Authors Aim, Structure / Design and Reporting

Outcome

Medical device interface system: a framework for transforming data: outpatient EMR (Electronic Medical Record); at Samsung Medical Center (Hospital), Republic of Korea

Choi, J. S.[59] Aim: To transform data from medical devices, such as audiometers, intra-ocular pressure (IOP) devices, electro-cardiogram (ECG) recorders, trace masters, etc., and to automatically store the data in the EMR server.Data collection methods: A seamless and comprehensive integrated medical device interface system for outpatient electronic medical records, special Working group (physicians, nurses, mechanical engineers, information technology technicians).Structure: Device operation reporter, device observation filter, device observation consumer.

Most people are strongly satisfied (10%) or satisfied (66%) with the system, 20% neutral, only 4% not satisfied. easy access to patient data.

34

Medical Database Security, Greece

Pangalos, G.[60] Aim: Medical information systems: assurance of quality of care, support effective management of health care services institutions, monitor and contain cost of care, implement technology into care, ensure equity and availability of care, etc.:Data collection methods: Medical professional secrecy and confidentiality, protection of privacy of the patient. Confidentiality (information only disclosed to those users who are authorized to have access, integrity (information is modified only by those users who have the right to do so), availability (information and other IT resources can be accessed by authorized users when needed), Minimizing dangers. High availability, accuracy and consistency of stored data, the medical professional secrecy and confidentiality, and the protection of the privacy of the patient. Databases often are an amalgamation of data from many sources. Ethical and Legal Aspects or Protecting Medical Data and Databases.

Problems and requirements related to medical database security are reported in detail in this article. Problems concerning database security policies, secure design methodologies and implementation techniques are discussed. It also describes the current legal framework and regulatory requirements.

XML-based implant database, Semi-automated orthopedic implant management tool, Switzerland

Sagbo, S.[61, 62] Aim: To establish a virtual implant database containing geometrical as well as calibration information for orthopedic implants and instruments. Funding: This project is funded by AO/ASIF Foundation through CARIM (Computer Assisted Reduction and Imaging) project 1. Implant data was provided by Synthes-Stratec.Data collection methods: Virtual implant database for orthopedic implants and instruments with a focus on trauma. This should allow different surgical navigation applications to navigate any number of different types of implants from this database. Three main parts of the implant database system: implant data storage component, the core processing component, the interface.

This database has been successfully tested for various applications in the client/server mode.It makes it possible to fill the current gap that exists between the CAS system and implant manufacturers, hospitals, and surgeons.This tool allows addition of new implants, modification of existing ones, deletion of obsolete implants, export of a given implant, and also creation of backups.

35

Implant product library,Arthroplasty registry

Blömer, W.[63] Aim: To develop and evaluate an implant product library, registration of implants via barcode scanning, detaild description of implant specifications.

Data collection methods: data are submitted via barcode scanning at hospital site, the database has a direct interface with the implant manufacturers. The implant database serves as a reference database for the German Arthroplasty Registry, classification has been performed by the implant manufactures.

On-side barcode scanning for the registration; classification made by manufacturers as well as database maintenance and implementation (time saving for clinicians) potential to encourage harmonization between joint replacement registries; advantages for future research.

Studies analyzing device registries in general

Authors Aim, Structure / Design and Reporting

Outcome

Multicentre clinical databases, United Kingdom

Black, N.[64] Data collection methods: Geographical area covered, time frame for data collection, use of national approved codes, routinely linked to other databases, approval by clinical or professional body, composition of team, funding, data storage, back up data storage, paper forms, patients informed of data collection, patient consent for data collection.Quality criteria:Completeness of recruitment, Completeness of data, use of explicit definitions and variables, independence of observations of primary outcome, extent of data validation.

Limitation: may have missed some key data bases, self reported information by database custodians, lack of statistically significant associations between organizational characteristics and data quality may reflect the small sample size.

Considerable scope exists for improvements: greater use of nationally approved codes; more support from relevant professional organizations; greater involvement by nurses, allied health professionals, managers, and laypeople in database management teams; and more attention to data security and ensuring patient confidentiality (something that most database custodians are currently addressing in meeting the requirements of the Patient Information Advisory Group14). With some notable exceptions, the audit and research potential of most of the databases was not being realized.

36

Medical products, patient registries

Dreyer, N. A., Gliklich, R.E.[65]

Planning a registry: purpose, key stakeholders, registry team, governance and oversight plan, scope and rigor, core dataset, target population, outcomes, study/project plan, ending of registry.

Registry Design: choosing study design and patients for the study, registry size and duration, internal and external validity, generalizability of results, assessing the magnitude of bias.

Use of registries for product safety assessment, data elements and data sources, linking of registry data and technical and legal considerations, ethics, data ownership and privacy, recruitment (Hospitals, Physicians, Patients), partnerships, data collection, quality assurance, analysis of registry data.

N/A

General disease registries, USA

Patel[66] Aim: To track disease incidence, risk, trends, reviewing cost effectiveness, establishing protocols for interventions.Data collection methods: Disease registries often have no defined cutoff date. They may be sponsored by government agencies, nonprofit organizations, manufacturers. Disease registries appear to be widely underutilized by payers.

NA

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2. Conducting the systematic literature search:

Pubmed(registry OR registries OR register OR registers OR database OR databases) AND (structure OR design OR organisation OR implementation OR creation OR layout OR data collection) AND (quality criteria OR quality OR quality indicator OR minimal dataset OR standard OR standards OR quality standard) AND (medical device OR device OR product OR technology OR implant OR implants)= (Titel and Abstract) 1219

Medline((registry or registries or register or registers or database or databases) and (structure or design or organisation or implementation or creation or layout or data collection) and (quality criteria or quality or quality indicator or minimal dataset or standard or standards or quality standard) and (medical device or device or product or technology or implant or implants)).mp. [mp=title, abstract, original title, name of substance word, subject heading word, keyword heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]= without constraint = 1622

Scopus:TITLE-ABS-KEY(((registry OR registries OR register OR registers OR database OR databases) AND (structure OR design OR organisation OR implementation OR creation OR layout OR data COLLECTION) AND (quality criteria OR quality OR quality indicator OR minimal dataset OR standard OR standards OR quality standard) AND (medical device OR device OR product OR technology OR implant OR implants)))= 13

Cochrane Library(registry OR registries OR register OR registers OR database OR databases) AND (structure OR design OR organisation OR implementation OR creation OR layout OR data collection) AND (quality criteria OR quality OR quality indicator OR minimal dataset OR standard OR standards OR quality standard) AND (medical device OR device OR product OR technology OR implant OR implants)= (Title Abstract Keywords) 592

Science direct:With standard query more than 18.000 results adjusting search limits:(registry OR registries OR register OR registers OR database OR databases) AND (structure OR design OR organisation OR implementation OR creation OR layout OR data collection) AND (quality criteria OR quality OR quality indicator OR minimal dataset OR standard OR standards OR quality standard) AND (medical device OR device OR product OR technology OR implant OR implants)=1 result (Searching Title, Abstract, Keywords)

CRD York2113 results

Springerlink((registry OR registries OR register OR registers OR database OR databases) AND (structure OR design OR organisation OR implementation OR creation OR layout OR data collection) AND (quality criteria OR quality OR quality indicator OR minimal dataset OR standard OR standards OR quality standard) AND (medical device OR device OR product OR technology OR implant OR implants))=12113 (too many results)

38

(medical device registry OR medical device registries OR medical device register OR medical device registers OR implant registry OR implant registries OR implant registers OR implant register) AND (structure OR design OR creation) AND (quality criteria OR quality indicator OR minimal dataset OR quality standard)= too many results (2007-2013: 1252 reuslts)

Health affairsToo many results

Health policy0 results

Implementation Science(registry OR registries OR register OR registers OR database OR databases) AND (structure OR design OR organisation OR implementation OR creation OR layout OR data collection) AND (quality criteria OR quality OR quality indicator OR minimal dataset OR standard OR standards OR quality standard) AND (medical device OR device OR product OR technology OR implant OR implants)= 249 results

BMC Medical Research Methodology(registry OR registries OR register OR registers OR database OR databases) AND (structure OR design OR organisation OR implementation OR creation OR layout OR data collection) AND (quality criteria OR quality OR quality indicator OR minimal dataset OR standard OR standards OR quality standard) AND (medical device OR device OR product OR technology OR implant OR implants)= 188 results

Health Policy and Planning/

BMJ Quality and Safety/

Health Expectation= 171 results

Journal of Public Health Policy/

Search for details:Pubmed“Defining a patient registry”(Defining OR define OR definition) AND (medical device registry OR medical device registries OR medical device register OR medical device registers OR implant registry OR implant registries OR implant registers OR implant register)=161 results

“Planning a patient registry”(plan OR planning OR concept OR conception OR conduct OR conducting) AND (medical device registry OR medical device registries OR medical device register OR medical device registers OR implant registry OR implant registries OR implant registers OR implant register)= 477 results, 34 in title and abstract

“Designing a patient registry”

39

(design OR designing OR constitute OR constitution OR construct OR construction or structure OR layout) AND (medical device registry OR medical device registries OR medical device register OR medical device registers OR implant registry OR implant registries OR implant registers OR implant register)= 1625, in abstract or title 110 results

“Using a registry for product safety assessment”(product safety assessment OR product safety OR safety OR device safety OR safeness) AND (medical device registry OR medical device registries OR medical device register OR medical device registers OR implant registry OR implant registries OR implant registers OR implant register)= 1051, in title or abstract 127 results

“Selecting the data elements”(selecting data elements OR selection of data elements OR selecting data OR choosing data) AND (medical device registry OR medical device registries OR medical device register OR medical device registers OR implant registry OR implant registries OR implant registers OR implant register)= 42, im title/abstract 1 result, all 42 results

“Integrating different data sources”(integrating data sources OR integration of data sources OR data integration) AND (medical device registry OR medical device registries OR medical device register OR medical device registers OR implant registry OR implant registries OR implant registers OR implant register)= 19 Ergebnisse, 4 in title/abstract

“Linking registry data”(Linking registry data OR linkage of registry data OR linking data OR linkage of data OR combine data OR combination of data) AND (medical device registry OR medical device registries OR medical device register OR medical device registers OR implant registry OR implant registries OR implant registers OR implant register)=196, in title/abstract 19; all 196

“Determining ethical requirements, data ownership and privacy”(ethical requirements OR data ownership OR privacy) AND (medical device registry OR medical device registries OR medical device register OR medical device registers OR implant registry OR implant registries OR implant registers OR implant register)= 11, in title/abstract 1 result

Table S2: Search terms and number of resultsDatabase/ Searchterm Registry AND structure AND quality

criteria AND medical devicePubMed 1219Medline 1622Scopus 13Cochrane Library 592Science direct 1CRD York 2113Springerlink 1252Health Affairs >>Health Policy 0Implementation Science 249BMC Medical Research Methodology 188Health Policy and Planning /BMJ Quality and Safety /

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Health Exectation 171Journal of Public Health Policy /Searchterm/Database PubmedDefining a patient registry 161Planning a patient registry 477 results, after restriction to title and

abstract 34 resultsDesigning a patient registry 1625 results, after restriction to title and

abstract 110 resultsUsing a registry for product safety assessment

1051 results, after restriction to title and abstract 127 results

Selecting data elements 42Integrating different data sources 19Determining ethical requirements, data ownership and privacy

11

3. Update literature search in May 2016

An update literature search using the same search terms was conducted in May 2016 in the databases Pubmed for the time between 2014-2016 in title/abstract (675) as well as Ovid (restricted to abstracts) and timeframe between 2014-2016 (565).

4. References

1. Serra-Sutton V, Allepuz A, Espallargues M, et al. Arthroplasty registers: a review of international experiences. Int J Technol Assess Health Care. 2009;25:63-72. Epub 2009/01/08.

2. Labek G, Todorov S, Iovanescu L, et al. Outcome after total ankle arthroplasty-results and findings from worldwide arthroplasty registers. Int Orthop. 2013;37:1677-82. Epub 2013/07/09.

3. Barsoum WK, Higuera CA, Tellez A, et al. Design, implementation, and comparison of methods for collecting implant registry data at different hospital types. J Arthroplasty. 2012;27:842-50 e1. Epub 2012/01/31.

4. Labek G, Bohler N. [The European Arthroplasty Register (EAR), development and rationale for supranational cooperation of arthroplasty registers]. Zeitschrift fur Orthopadie & Unfallchirurgie. 2009;147:151-7.

5. Jang B, Walsh NA, Bruce WJ. Verification of the Australian Orthopaedic Association National Joint Replacement Registry using a surgeon's database. J Orthop Surg (Hong Kong). 2013;21:347-50. Epub 2013/12/25.

6. Sadoghi P, Leithner A, Labek G. Overcoming Boundaries of Worldwide Joint Arthroplasty Registers: The European Arthroplasty Register Minimal Dataset. J Arthroplasty. 2013;28:1327-8. Epub 2013/04/02.

7. Heinz BC. [Arthroplasty registries and their contribution to the safety of patient care in joint replacement]. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz. 2009;52:589-93.

8. Paxton EW, Inacio MC, Kiley ML. The Kaiser Permanente implant registries: effect on patient safety, quality improvement, cost effectiveness, and research opportunities. Perm J. 2012;16:36-44. Epub 2012/06/30.

41

9. Paxton EW, Inacio MC, Khatod M, et al. Kaiser Permanente National Total Joint Replacement Registry: aligning operations with information technology. Clin Orthop Relat Res. 2010;468:2646-63. Epub 2010/07/24.

10. Berry DJ, Kessler M, Morrey BF. Maintaining a hip registry for 25 years. Mayo Clinic experience. Clin Orthop Relat Res. 1997:61-8. Epub 1997/12/31.

11. Hyer CF, Portera WB, Haglund EM. Lower extremity implant registries: has the time come in the United States? Foot Ankle Spec. 2010;3:148-52. Epub 2010/04/22.

12. Bohm ER, Dunbar MJ, Bourne R. The Canadian Joint Replacement Registry-what have we learned? Acta Orthop. 2010;81:119-21. Epub 2010/02/23.

13. Robertsson O. Knee arthroplasty registers. J Bone Joint Surg Br. 2007;89:1-4. Epub 2007/01/30.

14. Knutson K, Robertsson O. The Swedish Knee Arthroplasty Register (www.knee.se). Acta Orthop. 2010;81:5-7. Epub 2010/02/23.

15. Henricson A, Skoog A, Carlsson A. The Swedish Ankle Arthroplasty Register: An analysis of 531 arthroplasties between 1993 and 2005. Acta Orthop. 2007;78:569-74. Epub 2007/10/30.

16. Malchau H, Garellick G, Eisler T, et al. Presidential guest address: the Swedish Hip Registry: increasing the sensitivity by patient outcome data. Clin Orthop Relat Res. 2005;441:19-29. Epub 2005/12/07.

17. Puolakka TJ, Pajamaki KJ, Halonen PJ, et al. The Finnish Arthroplasty Register: report of the hip register. Acta Orthop Scand. 2001;72:433-41. Epub 2001/12/01.

18. Havelin LI. The Norwegian Joint Registry. Bull Hosp Jt Dis. 1999;58:139-47. Epub 2000/01/22.

19. Diel P, Reuss W, Aghayev E, et al. SWISSspine-a nationwide health technology assessment registry for balloon kyphoplasty: methodology and first results. Spine J. 2010;10:961-71. Epub 2009/10/13.

20. Roder C, El-Kerdi A, Frigg A, et al. The Swiss Orthopaedic Registry. Bull Hosp Jt Dis. 2005;63:15-9. Epub 2006/03/16.

21. Roder C, El-Kerdi A, Grob D, et al. A European spine registry. European Spine Journal. 2002;11:303-7. Epub 2002/08/24.

22. Schluessmann E, Aghayev E, Staub L, et al. SWISSspine: the case of a governmentally required HTA-registry for total disc arthroplasty: results of cervical disc prostheses. Spine (Phila Pa 1976). 2010;35:E1397-405. Epub 2010/10/30.

23. Schluessmann E, Diel P, Aghayev E, et al. SWISSspine: a nationwide registry for health technology assessment of lumbar disc prostheses. Eur Spine J. 2009;18:851-61. Epub 2009/03/21.

24. Myers S, Kaimal S, Springsteen J, et al. Development of a National TMJ Implant Registry and Repository-- NIDCR's TIRR. Northwest Dent. 2007;86:13-8. Epub 2008/02/05.

25. Alings M, Vorstenbosch JM, Reeve H. Automaticity: design of a registry to assess long-term acceptance and clinical impact of Automatic Algorithms in Insignia pacemakers. Europace. 2009;11:370-3. Epub 2009/02/26.

26. Permanente K. Kaiser Permanente. Cardiac Device Registry: http://www.kpimplantregistries.org/Registries/Cardiology.htm [26.07.2015].

27. Hye RJ, Inui TS, Anthony FF, et al. A multiregional registry experience using an electronic medical record to optimize data capture for longitudinal outcomes in endovascular abdominal aortic aneurysm repair. Journal of Vascular Surgery. 2015;61:1160-6.

42

28. Beckmann A, Hamm C, Figulla HR, et al. The German Aortic Valve Registry (GARY): a nationwide registry for patients undergoing invasive therapy for severe aortic valve stenosis. Thorac Cardiovasc Surg. 2012;60:319-25. Epub 2012/08/04.

29. Campolo L, Pantaleo P, Barattoni MC, et al. [Coronary angioplasty in the real world: the RESTEM registry. Outcome of patients treated with sirolimus-eluting stents]. G Ital Cardiol (Rome). 2008;9:270-9. Epub 2008/06/12.

30. Campolo L, Pantaleo P, Barattoni MC, et al. RESTEM: a percutaneous coronary intervention 'real world' registry in the drug-eluting stent era. Coron Artery Dis. 2007;18:653-62. Epub 2007/11/16.

31. Boswell CCB, Y. YL. PSEF Set Up Registry to Gather Breast Implant Data. 2014.

32. Dugas M, Hoffmann E, Janko S, et al. Complexity of biomedical data models in cardiology: the Intranet-based AF registry. Comput Methods Programs Biomed. 2002;68:49-61. Epub 2002/03/12.

33. Galli M, Bartorelli A, Bedogni F, et al. Italian BiodivYsio open registry (BiodivYsio PC-coated stent): study of clinical outcomes of the implant of a PC-coated coronary stent. J Invasive Cardiol. 2000;12:452-8. Epub 2000/09/06.

34. Goldberg SL, Berger P, Cohen DJ, et al. Rotational atherectomy or balloon angioplasty in the treatment of intra-stent restenosis: BARASTER multicenter registry. Catheter Cardiovasc Interv. 2000;51:407-13. Epub 2000/12/07.

35. Healey JS, Dorian P, Mitchell LB, et al. Canadian Registry of ICD Implant Testing procedures (CREDIT): current practice, risks, and costs of intraoperative defibrillation testing. J Cardiovasc Electrophysiol. 2010;21:177-82. Epub 2009/10/07.

36. Hubler S, Potapov EV, Loebe M, et al. Development of a database of patients supported by ventricular assist devices. ASAIO Journal. 2003;49:340-4.

37. Kawaguchi AT, Suma H, Konertz W, et al. Partial left ventriculectomy: the 2nd International Registry Report 2000. J Card Surg. 2001;16:10-23. Epub 2001/11/21.

38. Kline-Rogers E, Share D, Bondie D, et al. Development of a multicenter interventional cardiology database: the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) experience. J Interv Cardiol. 2002;15:387-92. Epub 2002/11/21.

39. Lazarus A. Remote, wireless, ambulatory monitoring of implantable pacemakers, cardioverter defibrillators, and cardiac resynchronization therapy systems: analysis of a worldwide database.[Erratum appears in Pacing Clin Electrophysiol. 2007 Nov;30(11):1424]. Pacing & Clinical Electrophysiology. 2007;30 Suppl 1:S2-S12.

40. Lee DS, Birnie D, Cameron D, et al. Design and implementation of a population-based registry of Implantable Cardioverter Defibrillators (ICDs) in Ontario. Heart Rhythm. 2008;5:1250-6. Epub 2008/09/09.

41. Ludman PF. British Cardiovascular Intervention Society Registry for audit and quality assessment of percutaneous coronary interventions in the United Kingdom. Heart. 2011;97:1293-7. Epub 2011/07/02.

42. Lam CS, Anand I, Zhang S, et al. Asian Sudden Cardiac Death in Heart Failure (ASIAN-HF) registry. Eur J Heart Fail. 2013;15:928-36. Epub 2013/04/10.

43. Pedersen SS, Lambiase P, Boersma LV, et al. Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD: design and rationale of the EFFORTLESS S-ICD Registry. Pacing Clin Electrophysiol. 2012;35:574-9. Epub 2012/03/01.

44. Proclemer A, Ghidina M, Cicuttini G, et al. The Italian Implantable Cardioverter-Defibrillator Registry. A survey of the national activity during the years 2001-2003. Ital Heart J. 2005;6:272-80. Epub 2005/05/07.

43

45. Riambau V, Zipfel B, Coppi G, et al. Final operative and midterm results of the European experience in the RELAY Endovascular Registry for Thoracic Disease (RESTORE) study. J Vasc Surg. 2011;53:565-73. Epub 2010/11/30.

46. Ricci RP, D'Onofrio A, Padeletti L, et al. Rationale and design of the health economics evaluation registry for remote follow-up: TARIFF. Europace. 2012;14:1661-5. Epub 2012/05/01.

47. Saxon LA, Boehmer JP, Neuman S, et al. Remote Active Monitoring in Patients with Heart Failure (RAPID-RF): design and rationale. Journal of Cardiac Failure. 2007;13:241-6.

48. Sciahbasi A, Pendenza G, Romagnoli E, et al. The PREHAMI (PREsillion in high-risk acute myocardial infarction) registry: in-hospital and long-term outcomes. Catheter Cardiovasc Interv. 2011;77:608-14. Epub 2010/09/09.

49. Maisel WH. Pacemaker and ICD generator reliability: meta-analysis of device registries. JAMA. 2006;295:1929-34. Epub 2006/04/28.

50. Berrettini S, Arslan E, Baggiani A, et al. A registry for the collection of data in cochlear implant patients. Acta Otorhinolaryngol Ital. 2011;31:328-40. Epub 2012/01/31.

51. Sanderson G, Ariyaratne TV, Wyss J, et al. A global patient outcomes registry: Cochlear paediatric implanted recipient observational study (Cochlear() P-IROS). BMC Ear Nose Throat Disord. 2014;14:10. Epub 2014/10/16.

52. Lum F, Schachat AP, Jampel HD. The development and demise of a cataract surgery database. Joint Commission Journal on Quality Improvement. 2002;28:108-14.

53. Lum F, Schein O, Schachat AP, et al. Initial two years of experience with the AAO National Eyecare Outcomes Network (NEON) cataract surgery database. Ophthalmology. 2000;107:691-7. Epub 2000/04/18.

54. Renner C, Neuhann-Lorenz C. International Breast Implant Registry: a user report. Aesthetic Plastic Surgery. 2006;30:616-21.

55. Eisenmann-Klein M. European breast implant registry--plastic surgery center: European strategic coaching. J Cosmet Laser Ther. 2003;5:231. Epub 2004/01/27.

56. Henriksen TF, Holmich LR, Friis S, et al. The Danish Registry for Plastic Surgery of the Breast: establishment of a nationwide registry for prospective follow-up, quality assessment, and investigation of breast surgery. Plastic & Reconstructive Surgery. 2003;111:2182-9; discussion 90-1.

57. Shakespeare PG, Bazire N, Whitworth IH. The UK breast implant registry-ten years on. Br J Plast Surg. 2005;58:283-5. Epub 2005/03/23.

58. Hume KM, Crotty CA, Simmons CJ, et al. Medical specialty society-sponsored data registries: opportunities in plastic surgery. Plast Reconstr Surg. 2013;132:159e-67e. Epub 2013/06/29.

59. Choi JS, Lee JH, Park JH, et al. Design and implementation of a seamless and comprehensive integrated medical device interface system for outpatient electronic medical records in a general hospital. International Journal of Medical Informatics. 2011;80:274-85.

60. Pangalos G. Draft secure medical database standard. Studies in Health Technology & Informatics. 2002;69:49-110; discussion 229-37.

61. Sagbo S, Blochaou F, Langlotz F, et al. A semi-automatic orthopedic implant management tool for Computer Assisted planning, navigation and simulation: from XML implant database to unified implant access interface. Conf Proc IEEE Eng Med Biol Soc. 2005;1:890-3. Epub 2007/02/07.

62. Sagbo S, Blochaou F, Langlotz F, et al. New orthopaedic implant management tool for computer-assisted planning, navigation, and simulation: from implant CAD files to a standardized XML-based implant database. Computer Aided Surgery. 2005;10:311-9.

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63. Blomer W, Steinbruck A, Schroder C, et al. A new universal, standardized implant database for product identification: a unique tool for arthroplasty registries. Archives of Orthopaedic & Trauma Surgery. 2015;135:919-26.

64. Black N, Tan S. Use of national clinical databases for informing and for evaluating health care policies. Health Policy. 2013;109:131-6. Epub 2012/11/03.

65. Gliklich RE, Dreyer NA, eds. Registries for Evaluating Patient Outcomes: A User's Guide. Rockville MD2010.

66. Patel M, Haren MC. Disease registries and managed care. Managed Care Interface. 2007;20:52-6.

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