The Multicenter Perioperative Outcomes Group: Using Automated Data Sources for Outcomes Research and Quality Improvement Sachin Kheterpal, MD MBA sachinkh@med.umich.edu Introduction: Adverse events following surgery are a major source of mortality, morbidity, and health care expenditures in the United States. Over 40 million surgical procedures are performed annually, associated with over 100,000 postoperative deaths and more than $100 billion in unnecessary costs. The wide variation in risk-adjusted morbidity and mortality across centers and providers suggests opportunities for quality improvement. Historically, anesthesiology has focused its research efforts on preventing rare, catastrophic intraoperative mishaps. However, a growing body of animal studies and case series demonstrate that anesthesiologists may influence common perioperative adverse outcomes by modulating the surgical injury, perioperative stress, and inflammatory responses. Difficulties in blinding, ethical randomization, and recruitment challenge the use of randomized controlled trials in surgical patients, resulting in a paucity of large, multicenter perioperative trials. As a result, basic perioperative decisions such as the choice of anesthesia technique, hemodynamic thresholds, or transfusion triggers lack compelling data. Attempts to correlate intraoperative management with postoperative outcomes in observational studies are hampered by the absence of structured patient outcome data in perioperative clinical information systems. We sought to develop a scalable, multicenter infrastructure for automatically aggregating observational data across disparate anesthesia information management systems (AIMS). In addition, the infrastructure must enable research using de-identified, HIPAA compliant patient datasets, while maintaining the ability to link the data to national data sources. The Multicenter Perioperative Outcomes Group (MPOG http://mpog.med.umich.edu) was formed to develop the necessary policies, procedures, and technical infrastructure required for multicenter perioperative outcomes research. It has already aggregated 2 million operative encounters across 14 medical centers across the US and Europe with detailed risk adjustment, process of care, and outcome data for observational outcomes research. Current State: The Multicenter Perioperative Outcomes Group (MPOG) is a consortium of 37 anesthesiology and surgical departments. Each uses a commercially available Anesthesia Information Management System (AIMS) – a structured electronic medical record that replaces the paper pre-, intra-, and post-operative anesthesia records. The MPOG consortium has already obtained performance site, coordinating center, and analysis of data IRB approvals. A configurable interface that abstracts data from multiple vendors and institutions into the standardized MPOG content and database has been developed. Disparate data sources are translated into standardized MPOG data structures: AIMS: Anesthesia information management system data are extracted into eleven distinct data structures o Patient: stores a single record for each unique patient in a given institution’s database. Static information about the patient that cannot change over time is stored in this structure: race, sex, and hashed codes based upon patient identifiers o PreoperativeCaseInfo: Multiple records for each preoperative attribute, including preoperative history and physical information. This includes ASA physical status, home medications, height, weight, allergies, baseline antibiotic resistance precautions, baseline vital signs (heart rate, blood pressure, SpO2), and all comorbidities. Key elements from the surgical scheduling or nursing 1 documentation system, such as primary CPT code or wound classification, are also stored in this table. Because date of birth is removed from the extract to limit PHI, the patient’s age on the date of the operation is stored with each operation. This age is HIPAA compliant at extremes (old or young) o IntraoperativeCaseHeader: a single record for each operative case which summarizes basic information about the structure of care: surgical center type (free standing ambulatory, ambulatory associated with acute care hospital, acute care hospital, offsite procedure area), procedure area type (offsite, main operative room, etc), and admission type o IntraoperativeMedicationDetails: many records per operation, with each dose of each medication and infusion rate change documented. Rather than free text documentation, this table is based upon structured data elements, with each medication and infusion mapped to an MPOG medication system number which is then referenced to RxNorm. o IntraoperativeFluidDetails many records per operation, with each fluid administration or output (urine, estimated blood loss) stored as a distinct record. o IntraoperativePhysiologic: thousands of records per operation, with each vital sign (from the physiologic monitors) and device parameter (from the ventilator and anesthesia machine) recorded every sixty seconds. Structured data elements map each record to a specific clinical concept rather than free text. Where applicable, SNOMED codes are used to define physiologic concepts. o IntraoperativeEvents: contains dozens to hundreds of records per operation, depending upon the duration of the operation. All non-pharmacologic interventions, such as intubation, placement of a forced-air warmer, nasogastric suctioning, peripheral nerve blockade, etc are stored as discrete rows in this table. In addition, process times (in hospital, in room, anesthesia start, etc), anesthetic technique performed, airway management technique, associated minor procedures (peripheral nerve block, arterial line, epidural), and free text documentation is stored. o IntraoperativeStaffing: contains a record for each anesthesia care team provider participating during the anesthesia services. Includes the provider’s role (CRNA, attending, resident), experience level for residents, and care-handoffs. In addition, a surgical attending identifier is also recorded for each case. o PerioperativeLaboratoryValues: contains a record for each laboratory value of interest within 365 days. Specific laboratory values are extracted from the AIMS or hospital laboratory system: hemoglobin, hematocrit, platelets, white blood cell count, prothrombin time, partial thromboplastin time, creatinine, troponin, etc. In addition, all intraoperative point of care testing such as hemoglobin, coagulation studies, and pH is stored. o VenousAccess: contains a record for each venous access site used or documented during the intraoperative anesthetic o ProfessionalCharge: For each operative episode, the primary surgical CPT, anesthesia CPT, and operative ICD codes are stored. Anesthesiology modifiers and flat-fee CPT (for line placement, TEE interpretation, etc) are also stored. These elements allow structured analysis of the primary surgical procedure performed, an essential component of outcomes research risk adjustment. No actual financial charges (dollar amounts) are collected or analyzed. o HospitalCharge: For each inpatient or outpatient stay, the ICD discharge diagnoses and procedures used for hospital billing are also collected. These diagnoses are an important source of risk adjustment and outcome data. Surgical registries: The ACS-NSQIP database at participating sites is incorporated into the MPOG schema. o Preoperative: One record for each operation, and stores all 44 preoperative comorbidity elements tracked by ACS-NSQIP methodology, ranging from coronary artery disease to cancer status o PreoperativeLab: One record for each operation with 13 preoperative lab variables and the date the value was observed. Includes elements such as creatinine, albumin, hematocrit, platelet count, prothrombin time, partial thromboplastin time, etc o IntraoperativeSummary: Contains 6 clinical elements, the most important of which is the preoperative wound classification, and basic process variables such as seniority of the surgery assistant and a unique surgeon ID 2 o AdverseEvents: If a patient experiences any of 3 intraoperative or 26 postoperative events within 30 days of the operation, each event and descriptive information regarding it is recorded. Outcomes range from SSI to myocardial infarction and renal failure o DischargeOutcome: one record for each operation and indicates the patients status at postoperative day 30. The discharge location, needed for reoperation, and vital status are recorded. Administrative sources: The reliable 30-day outcomes collected using ACS-NSQIP are of great interest. However, access to longer-term outcomes currently requires the use of administrative data sources. Using the Blinded Record Index technology, we are able to connect detailed perioperative clinical data with the following administrative data elements o All cause-mortality: Integration of the social security death master file using the Blinded National Death Service™ (BliNDS) allows each institution to identify all-cause mortality beyond the 30 day time period for all of its perioperative patients. Although all-cause mortality and the social security death master file have limitations, data for patients from 2003 and beyond demonstrate a 95% sensitivity and 98% specificity using BliNDS. o Discharge ICD9 Through the use of administrative data linked with EHR, we are able to provide highly specific complication data for outcome analyses. Fourteen institutions – The University of Michigan, Columbia University, Oregon Health & Science University, University Medical Center of Utrecht, Netherlands, University of Colorado, University of Florida, University of Oklahoma, University of Tennessee, University of Vermont, University of Virginia, University of Utah, University of Washington, Vanderbilt University, and Washington University (St Louis) have successfully deployed the MPOG data interfaces and were able to extracts vital signs, physiologic parameters, procedures, interventions, and medications from the intraoperative period. Five leading vendors of AIMS have been successfully integrated into the MPOG schema: Epic (Optime) General Electric (Centricity), Philips (Compurecord), Picis (Anesthesia Manager), and iMDSoft (Metavision). Across these fourteen institutions, more than 2 million operative records have been extracted into a single database with detailed, structured minute-to-minute vital signs, medication administration, anesthesia technique, laboratory records, and procedural intervention data. These detailed, structured AIMS data can be combined with complementary data sources to enable outcomes research to address critical perioperative interventions. These data have already been integrated with preoperative and postoperative laboratory data, national all-cause mortality data, and ACS-NSQIP. The use of secure hashing algorithms combined with the social security death master file allows the derivation of all-cause mortality without the communication of protected health information. This novel record-linking strategy allows us to merge patient-specific data without using patient identifiers, minimizing privacy risk. In addition, a “de-identification” algorithm that is used to remove protected health information from free-text entry fields is used to reduce the risk of protected health information transmission. Using US Census Bureau data regarding common names and institution-specific provider and patient data, identifiers are removed using automated routines. Finally, we have mapped intraoperative medications and physiologic vital signs to internationally accepted lexicons such as RxNorm and SNOMED-CT to allow comparison of data from multiple institutions in a single repository. The MPOG database is also supported by the leading EHR vendor in the US – Epic Systems. Epic systems developed, supports, and distributes an MPOG interface that allows any EPIC customer to submit their data to the MPOG research consortium. Other leading vendors, such as GE and SIS, are now developing support structures as well. Next steps With the successful deployment of the AIMS interfaces at these fourteen initial institutions, two major initiatives are the focus of MPOG efforts: performing specific hypothesis-driven research projects using the 2 million operations already collected, and deploying the interfaces to other MPOG members. The deep observational research expertise of the MPOG members enables rigorous analyses focused on important patient-centric outcomes. These analyses are focused on healthcare associated infections, perioperative myocardial infarction, acute kidney injury, stroke, airway management, and optimal anesthesia techniques. 3 Each contributing institution has equal access to the centralized repository of data stored at the MPOG coordinating center, The University of Michigan. Proposals are reviewed and refined by a multicenter Perioperative Clinical Research Committee (PCRC) that ensures that scientifically valid analyses are performed on sound underlying observational data. Nineteen proposals have already been reviewed, improved, and are now in the process of data extraction or statistical analysis. Four manuscripts using MPOG data or describing the MPOG methodology have already been published. Second, the MPOG consortium is ready to accelerate adoption at other MPOG member institutions that use the same AIMS and surgical outcome registries. Because each of these interfaces was designed to be configurable and reusable at subsequent sites, minimal incremental effort is needed to unlock the outcomes research potential of remaining MPOG members. There are no monetary fees associated with MPOG membership, lowering the hurdle for participation from a broad range of institutions. Finally, the MPOG consortium is now spreading from a US-focused effort to inclusion of medical centers around the world. We are actively receiving data from Academic Medical Center (AMC), Amsterdam and University Medical Center of Utrecht, Netherlands. Our next goal is to have active software development in place from centers in Germany, Israel, and Canada. The variant care patterns in these other countries will be a fertile ground for observational research. 4