Data Sources for Medical Device Epidemiology
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1 Data Sources for Medical Device Epidemiology Kaiser Permanente Surgical Outcomes & Analysis Maria Inacio, PhD National Implant Registries
2 Today s Talk* I. Necessary data elements for device surveillance II. Types of data sources A. Examples *Focus is in orthopedic devices. 2 October 21, 2014 Kaiser Permanente All Rights Reserved.
3 Necessary Elements for Device Surveillance Population of Interest (sample, confounders/effect mod) Elements: 1. Denominator 2. Numerator 3. Who is the patient? 4. When/where is the procedure occurring? Device Information (exposure) Elements: 1. Reference numbers 2. Descriptions/names 3. Device attributes Performance (outcome) Elements: 1. Failure (when) 2. Death 3. Competing risks events 4. Attrition 3 October 21, 2014 Kaiser Permanente All Rights Reserved.
4 Medical Device Epidemiology Data Sources Primary Device registries- hybrid data collection Studies Implant retrieval databases Secondary Electronic medical records (EMR) Claims data (medical and pharmacy) Death records Boutique databases: specific disease registries Device manufacturers 4 October 21, 2014 Kaiser Permanente All Rights Reserved.
5 Medical Device Epidemiology Data Sources Population of Interest Device Information Performance Registries and studies capture all domains. 5 October 21, 2014 Kaiser Permanente All Rights Reserved.
6 Medical Device Epidemiology Data Sources Population of Interest Device Information Performance Data Sources: 1. Claims 2. EMR 3. Patient registries Data Sources: 1. EMR 2. Device manufacturers Data Sources: 1. Claims 2. EMR 3. Death records 4. Implant retrieval databases 6 October 21, 2014 Kaiser Permanente All Rights Reserved.
7 I. Primary Data Sources a. Device Registries 7 October 21, 2014 Kaiser Permanente All Rights Reserved.
8 Device Registries What is a registry? an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. AHRQ. Registries for Evaluating Patient Outcomes: A User s Guide. 2nd ed. (Prepared by Outcome DEcIDE Center [Outcome Sciences ) 8 October 21, 2014 Kaiser Permanente All Rights Reserved.
9 Example: Kaiser Permanente (KP) Anterior Cruciate Ligament Reconstruction (ACLR) Registry Goal: Monitor devices used to reconstruct an ACL Sampling Frame: KP membership, 9.5 million patients, 7 US regions Coverage: 1 integrated healthcare system, 52 hospitals, 330 surgeons Outcomes: revisions, re-operations, infections, thromoboembolic events Available to: registry participants Population of Interest Device Information Performance 9 October 21, 2014 Kaiser Permanente All Rights Reserved.
10 Example: Kaiser Permanente (KP) Anterior Cruciate Ligament Reconstruction (ACLR) Registry Goal: Monitor devices used to reconstruct an ACL Sampling Frame: KP membership, 9.5 million patients, 7 US regions Coverage: 1 integrated healthcare system, 52 hospitals, 330 surgeons Outcomes: revisions, re-operations, infections, thromoboembolic events Available to: registry participants Population of Interest Device Information Performance 10 October 21, 2014 Kaiser Permanente All Rights Reserved.
11 KP ACLR Registry Data Sources Extracted from EMR & Registry Forms Implant Components Company Name Catalog # Lot/Serial # Quantity Patient Demographics Medical Record # DOB Gender Race Registry Forms Electronic SmartForm/Paper Procedures Diagnoses Surgical Characteristics Fixation Types Outcomes Revisions Re-operations Infections VTE Catalog # Implant Reference Table Company Name Catalog # Description* Name* Attributes Registry SQL Database Other Data Sources Claims Diabetes Registries Membership Mortality GEMS *Obtained from device manufacturer catalogs. 11
12 KP ACLR Registry Data Sources Extracted from EMR & Registry Forms Implant Components Company Name Catalog # Lot/Serial # Quantity Patient Demographics Medical Record # DOB Gender Race Registry Forms Electronic SmartForm/Paper Procedures Diagnoses Surgical Characteristics Fixation Types Outcomes Revisions Re-operations Infections VTE Catalog # Implant Reference Table Company Name Catalog # Description* Name* Attributes Registry SQL Database Other Data Sources Claims Diabetes Registries Membership Mortality GEMS *Obtained from device manufacturer catalogs. 12
13 I. Primary Data Sources b. Studies 13 October 21, 2014 Kaiser Permanente All Rights Reserved.
14 Example: US FDA 522 Postmarket Surveillance Study Goal: evaluate specific device after introduction to the market because of: Possible serious adverse health consequences Pediatric use Intended to be implanted >1 year or be a life-sustaining/supporting device used outside a facility Sampling Frame: limited Coverage: limited Outcomes: study design/focus varies and information obtained from it varies Available to: investigators Population of Interest Device Information Performance 14 October 21, 2014 Kaiser Permanente All Rights Reserved.
15 Example: US FDA 522 Postmarket Surveillance Study Goal: evaluate specific device after introduction to the market because of: Possible serious adverse health consequences Pediatric use Intended to be implanted >1 year or be a life-sustaining/supporting device used outside a facility Sampling Frame: limited Coverage: limited Outcomes: study design/focus varies and information obtained from it varies Available to: investigators Population of Interest Device Information Performance 15 October 21, 2014 Kaiser Permanente All Rights Reserved.
16 Example: Postmarket study of Acell s MatriStem Pelvic Floor Matrix Goal: measure pain, quality of life, adverse events, long term need for retreatment Sampling Frame: 8 recruiting location s patient population Coverage: 162 women Timeframe: June Available to: investigators 16 October 21, 2014 Kaiser Permanente All Rights Reserved.
17 I. Primary Data Sources c. Implant retrieval databases 17 October 21, 2014 Kaiser Permanente All Rights Reserved.
18 Implant Retrieval Databases Population of Interest Device Information Performance Repositories of explanted implants and electronic information regarding implants Typically several institutions collaborating Typically smaller scale Biomechanical experts involved Passive surveillance Availability: institutions only Examples: London Implant Retrieval Centre Drextel University Implant Retrieval Research HSS Dept of Biomechanical Implant Retrieval 18 October 21, 2014 Kaiser Permanente All Rights Reserved.
19 II. Secondary Data Sources a. EMR 19 October 21, 2014 Kaiser Permanente All Rights Reserved.
20 EMR Computerized records of clinical information for providers and patients Can cover several areas, including: Medical history Encounter information (inpatient, outpatient, emergency) Laboratory data Imaging services Pharmacy data Operating room information Scheduling/reminder Billing Membership monitoring 20
21 Example: KP HealthConnect Structure 21 October 21, 2014 Kaiser Permanente All Rights Reserved.
22 KP HealthConnect Goal: monitor clinical activity Sampling Frame: US population in 8 geographical regions Modules that could contribute to device epidemiology: Patient information: demographics, characteristics, history of encounters for co-morbidity assessment, death information Optime: operating room module devices (bar codes), surgical characteristics (operative time, blood loss, etc) Encounters: inpatient, outpatient, and emergency/urgent encounters to identify reoperations, complications Available to: KP researchers and associated institutions Population of Interest Device Information Performance 22 October 21, 2014 Kaiser Permanente All Rights Reserved.
23 Example: KP HealthConnect Structure 23 October 21, 2014 Kaiser Permanente All Rights Reserved.
24 KP HealthConnect Goal: monitor clinical activity Sampling Frame: US population in 8 geographical regions Modules that could contribute to device epidemiology: Patient information: demographics, characteristics, history of encounters for co-morbidity assessment, death information Optime: operating room module devices (bar codes), surgical characteristics (operative time, blood loss, etc) Encounters: inpatient, outpatient, and emergency/urgent encounters to identify reoperations, complications Available to: KP researchers and associated institutions Population of Interest Device Information Performance 24 October 21, 2014 Kaiser Permanente All Rights Reserved.
25 II. Secondary Data Sources b. Claims 25 October 21, 2014 Kaiser Permanente All Rights Reserved.
26 Claims Health encounter (any) collected for administrative purposes Contains major reasons for encounter (diagnoses, procedures) or dispensing information Several available files: US Medicare claims US DVA claims Australia DVA Medicare claims US DHHS AHRQ Healthcare Cost and Utilization Project (ambulatory surgery, emergency dept visits, hospitalizations) Medical Expenditure Panel Survey (accessibility of care) Etc. 26 October 21, 2014 Kaiser Permanente All Rights Reserved.
27 Example Medical Claims: AHRQ Healthcare Cost and Utilization Project, National Inpatient Sample (NIS) Goal: National estimates of hospital inpatient stays Sampling Frame: US Files/variables that could contribute to device epidemiology: Patient: basic demographics, history of encounters for comorbidity assessment, inpatient death information Encounters: diagnoses for procedure, procedure type, and re-operations and/or complications Available to: Anyone Population of Interest Device Information Performance 27 October 21, 2014 Kaiser Permanente All Rights Reserved.
28 Example Medical Claims: AHRQ Healthcare Cost and Utilization Project, National Inpatient Sample (NIS) Goal: National estimates for hospital inpatient stays Sampling Frame: US Files/variables that could contribute to device epidemiology: Patient: basic demographics, history of encounters for comorbidity assessment, inpatient death information Encounters: diagnoses for procedure, procedure type, and re-operations and/or complications Available to: Anyone Population of Interest Device Information Performance 28 October 21, 2014 Kaiser Permanente All Rights Reserved.
29 Example Pharmacy Claims: Australian DVA dispensing records Goal: monitor all medication dispensed to eligible veterans Sampling Frame: Australian Veteran population and spouses Files/variables that could contribute to device epidemiology: Patient: history of medication for co-morbidity assessment Outcome: medications used to treat conditions (e.g. antibiotic prescription for infection monitoring) Available to: UniSA researchers Population of Interest Device Information Performance 29 October 21, 2014 Kaiser Permanente All Rights Reserved.
30 Example Pharmacy Claims: Australian DVA dispensing records Goal: monitor all medication dispensed to eligible veterans Sampling Frame: Australian Veteran population and spouses Files/variables that could contribute to device epidemiology: Patient: history of medication for co-morbidity assessment Outcome: medications used to treat conditions (e.g. antibiotic prescription for infection monitoring) Available to: UniSA researchers Population of Interest Device Information Performance 30 October 21, 2014 Kaiser Permanente All Rights Reserved.
31 II. Secondary Data Sources c. Others 31 October 21, 2014 Kaiser Permanente All Rights Reserved.
32 Death Records Population of Interest Device Information Performance Vital records, national registries, state records recording death of individuals and reasons for death Important to understand limitations and coverage of source Availability: mostly easily available, but will cost Examples in the US: National Archives: state specific death archives. Social Security Administration: Death Master File CDC/NCHS: National Death Index 32 October 21, 2014 Kaiser Permanente All Rights Reserved.
33 Infection Prevention and Control Surveillance Different organizations in several countries track hospital acquired (nosocomial) infections for the purpose of monitoring infection, assess effect of prophy interventions, and examine infection variation Nosocomial infection include surgical site infections Several procedures with medical devices are included in these datain the US over 40 procedures are monitored Availability: limited upon request Examples: ECDC- Hospitals in Europe Link for Infection Control through Surveillance (HELICS) CDC/NHSN- Healthcare associated infection tracking system Population of Interest Device Information Performance 33 October 21, 2014 Kaiser Permanente All Rights Reserved.
34 Implant Manufacturer Catalogs Descriptive information on devices: Implant name Short description Long description Attributes- sometimes Not standard, usually company specific Central repositories are difficult to find Some effort from certain groups to harmonize this information into one reference system- ICOR for orthopedics FDA UDI for all devices Population of Interest Device Information Performance Availability: upon request from manufacturers, larger repositories must be requested from owners 34 October 21, 2014 Kaiser Permanente All Rights Reserved.
35 Thank you Questions 35 October 21, 2014 Kaiser Permanente All Rights Reserved.
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