The Safety of Outpatient Health Care : Review of Electronic Health Records.

BACKGROUND: Despite considerable emphasis on delivering safe care, substantial patient harm occurs. Although most care occurs in the outpatient setting, knowledge of outpatient adverse events (AEs) remains limited. OBJECTIVE: To measure AEs in the outpatient setting. DESIGN: Retrospective review of the electronic health record (EHR). SETTING: 11 outpatient sites in Massachusetts in 2018. PATIENTS: 3103 patients who received outpatient care. MEASUREMENTS: Using a trigger method, nurse reviewers identified possible AEs and physicians adjudicated them, ranked severity, and assessed preventability. Generalized estimating equations were used to assess the association of having at least 1 AE with age, sex, race, and primary insurance. Variation in AE rates was analyzed across sites. RESULTS: The 3103 patients (mean age, 52 years) were more often female (59.8%), White (75.1%), English speakers (90.8%), and privately insured (70.4%) and had a mean of 4 outpatient encounters in 2018. Overall, 7.0% (95% CI, 4.6% to 9.3%) of patients had at least 1 AE (8.6 events per 100 patients annually). Adverse drug events were the most common AE (63.8%), followed by health care-associated infections (14.8%) and surgical or procedural events (14.2%). Severity was serious in 17.4% of AEs, life-threatening in 2.1%, and never fatal. Overall, 23.2% of AEs were preventable. Having at least 1 AE was less often associated with ages 18 to 44 years than with ages 65 to 84 years (standardized risk difference, -0.05 [CI, -0.09 to -0.02]) and more often associated with Black race than with Asian race (standardized risk difference, 0.09 [CI, 0.01 to 0.17]). Across study sites, 1.8% to 23.6% of patients had at least 1 AE and clinical category of AEs varied substantially. LIMITATION: Retrospective EHR review may miss AEs. CONCLUSION: Outpatient harm was relatively common and often serious. Adverse drug events were most frequent. Rates were higher among older adults. Interventions to curtail outpatient harm are urgently needed. PRIMARY FUNDING SOURCE: Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.

What Went Right? A Mixed-Methods Study of Positive Feedback Data in a Hospital-Wide Mortality Review Survey.

BACKGROUND: Toxic work culture contributes to healthcare worker burnout and attrition, but little is known about how healthcare organizations can systematically create and promote a culture of civility and collegiality. OBJECTIVE: To analyze peer-to-peer positive feedback collected as part of a systematized mortality review survey to identify themes and recognition dynamics that can inform positive organizational culture change. DESIGN: Convergent mixed-methods study design. PARTICIPANTS: A total of 388 physicians, 212 registered nurses, 64 advanced practice providers, and 1 respiratory therapist at four non-profit hospitals (2 academic and 2 community). INTERVENTION: Providing optional positive feedback in the mortality review survey. MAIN MEASURES: Key themes and subthemes that emerged from positive feedback data, associations between key themes and positive feedback respondent characteristics, and recognition dynamics between positive feedback respondents and recipients. KEY RESULTS: Approximately 20% of healthcare workers provided positive feedback. Three key themes emerged among responses with free text comments: (1) providing extraordinary patient and family-centered care; (2) demonstrating self-possession and mastery; and (3) exhibiting empathic peer support and effective team collaboration. Compared to other specialties, most positive feedback from medicine (70.2%), neurology (65.2%), hospice and palliative medicine (64.3%), and surgery (58.8%) focused on providing extraordinary patient and family-centered care (p = 0.02), whereas emergency medicine (59.1%) comments predominantly focused on demonstrating self-possession and mastery (p = 0.06). Registered nurses (40.2%) provided multidirectional positive feedback more often than other clinician types in the hospital hierarchy (p < 0.001). CONCLUSIONS: Analysis of positive feedback from a mortality review survey provided meaningful insights into a health system's culture of teamwork and values related to civility and collegiality when providing end-of-life care. Systematic collection and sharing of positive feedback is feasible and has the potential to promote positive culture change and improve healthcare worker well-being.

Effect of Automated Real-Time Feedback on Early-Sepsis Care: A Pragmatic Clinical Trial.

OBJECTIVES: To determine if a real-time monitoring system with automated clinician alerts improves 3-hour sepsis bundle adherence. DESIGN: Prospective, pragmatic clinical trial. Allocation alternated every 7 days. SETTING: Quaternary hospital from December 1, 2020 to November 30, 2021. PATIENTS: Adult emergency department or inpatients meeting objective sepsis criteria triggered an electronic medical record (EMR)-embedded best practice advisory. Enrollment occurred when clinicians acknowledged the advisory indicating they felt sepsis was likely. INTERVENTION: Real-time automated EMR monitoring identified suspected sepsis patients with incomplete bundle measures within 1-hour of completion deadlines and generated reminder pages. Clinicians responsible for intervention group patients received reminder pages; no pages were sent for controls. The primary analysis cohort was the subset of enrolled patients at risk of bundle nonadherent care that had reminder pages generated. MEASUREMENTS AND MAIN RESULTS: The primary outcome was orders for all 3-hour bundle elements within guideline time limits. Secondary outcomes included guideline-adherent delivery of all 3-hour bundle elements, 28-day mortality, antibiotic discontinuation within 48-hours, and pathogen recovery from any culture within 7 days of time-zero. Among 3,269 enrolled patients, 1,377 had reminder pages generated and were included in the primary analysis. There were 670 (48.7%) at-risk patients randomized to paging alerts and 707 (51.3%) to control. Bundle-adherent orders were placed for 198 intervention patients (29.6%) versus 149 (21.1%) controls (difference: 8.5%; 95% CI, 3.9-13.1%; p = 0.0003). Bundle-adherent care was delivered for 152 (22.7%) intervention versus 121 (17.1%) control patients (difference: 5.6%; 95% CI, 1.4-9.8%; p = 0.0095). Mortality was similar between groups (8.4% vs 8.3%), as were early antibiotic discontinuation (35.1% vs 33.4%) and pan-culture negativity (69.0% vs 68.2%). CONCLUSIONS: Real-time monitoring and paging alerts significantly increased orders for and delivery of guideline-adherent care for suspected sepsis patients at risk of 3-hour bundle nonadherence. The trial was underpowered to determine whether adherence affected mortality. Despite enrolling patients with clinically suspected sepsis, early antibiotic discontinuation and pan-culture negativity were common, highlighting challenges in identifying appropriate patients for sepsis bundle application.

Long-Term Sustainability and Adaptation of I-PASS Handovers.

BACKGROUND: Inadequate communication during transitions of care is a major health care quality and safety vulnerability. In 2013 Massachusetts General Hospital (MGH) embarked on a comprehensive training program using a standardized handover system (I-PASS) that had been shown to reduce adverse events by 30% even when not completely executed on each patient. In this cross-sectional study, the authors sought to characterize handover practices six years later. METHODS: Using a standardized interview tool, the researchers evaluated handovers between responding clinicians in 10 departments and then validated these findings through direct observations, allowing for flexibility and customization in the I-PASS elements. The study qualitatively compared I-PASS element use in verbal handovers to MGH early postintervention data, as well as verbal and written handovers with the I-PASS Study Group's postintervention results. RESULTS: The authors observed 156 verbal and reviewed 182 written patient handovers. Ninety percent of departments adhered at least partially to the I-PASS system. Average handover duration ranged from 0.6 to 2.1 minutes per established patient. The service with best I-PASS adherence also consistently included the most information per unit of time. Acknowledging substantial differences in study technique, MGH adherence was, on average, comparable or better on all I-PASS elements in verbal handovers and on three of four elements of written handovers compared with the I-PASS Study Group's postintervention results. CONCLUSION: Although uptake has varied across services, six years after hospitalwide implementation of I-PASS, the majority of services are performing structured and sequenced handovers, most of which include some elements of the I-PASS system. Those services with the best I-PASS adherence conducted the most efficient handovers.

Development and Implementation of a Practical Onboarding Curriculum for Physician Quality and Safety Leaders.

Physicians are increasingly asked to assume quality and safety (Q&S) leadership roles; prior experience varies, and onboarding training is limited. Semistructured interviews were completed with physician Q&S leaders; interview responses were analyzed using 2-step rapid analysis. Interview learnings informed development of a 2-day onboarding training and complementary digital resource repository. Attendees were surveyed to evaluate the training. Thirteen semistructured interviews with physician leaders from 6 academic medical centers demonstrated 61.5% had no formal Q&S training before assuming their role. Respondents identified a range of knowledge gaps. A 2-day virtual onboarding training and complementary digital repository were created. Attendee surveys demonstrated 96% (73/76) believed the training would be "extremely" or "moderately" helpful to others. Subject-matter familiarity across all content areas improved after the training. Using front-line stakeholder input, a pilot onboarding curriculum for Q&S leaders was created. Future work includes ongoing implementation and iterative improvement.

The Safety of Inpatient Health Care.

BACKGROUND: Adverse events during hospitalization are a major cause of patient harm, as documented in the 1991 Harvard Medical Practice Study. Patient safety has changed substantially in the decades since that study was conducted, and a more current assessment of harm during hospitalization is warranted. METHODS: We conducted a retrospective cohort study to assess the frequency, preventability, and severity of patient harm in a random sample of admissions from 11 Massachusetts hospitals during the 2018 calendar year. The occurrence of adverse events was assessed with the use of a trigger method (identification of information in a medical record that was previously shown to be associated with adverse events) and from review of medical records. Trained nurses reviewed records and identified admissions with possible adverse events that were then adjudicated by physicians, who confirmed the presence and characteristics of the adverse events. RESULTS: In a random sample of 2809 admissions, we identified at least one adverse event in 23.6%. Among 978 adverse events, 222 (22.7%) were judged to be preventable and 316 (32.3%) had a severity level of serious (i.e., caused harm that resulted in substantial intervention or prolonged recovery) or higher. A preventable adverse event occurred in 191 (6.8%) of all admissions, and a preventable adverse event with a severity level of serious or higher occurred in 29 (1.0%). There were seven deaths, one of which was deemed to be preventable. Adverse drug events were the most common adverse events (accounting for 39.0% of all events), followed by surgical or other procedural events (30.4%), patient-care events (which were defined as events associated with nursing care, including falls and pressure ulcers) (15.0%), and health care-associated infections (11.9%). CONCLUSIONS: Adverse events were identified in nearly one in four admissions, and approximately one fourth of the events were preventable. These findings underscore the importance of patient safety and the need for continuing improvement. (Funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.).

Allergy Safety Events in Health Care: Development and Application of a Classification Schema Based on Retrospective Review.

BACKGROUND: Allergy safety requires understanding the operational processes that expose patients to their known allergens, including how and when such processes fail. OBJECTIVE: To improve health care safety for patients with allergies, we developed and assessed an allergy safety event classification schema to describe failures resulting in allergy-related safety events. METHODS: Using keyword searches followed by expert manual review of 299,031 voluntarily-filed safety event reports at 2 large academic medical centers, we identified and classified allergy-related safety events from 5 years of safety reports. We used driver diagrams to elucidate root causes for commonly observed allergy safety events in health care settings. RESULTS: From 299,031 safety reports, 1922 (0.6%) were extracted with keywords and 744 (0.2%) were manually confirmed as allergy-related safety events. Safety failures were due to incomplete/inaccurate electronic health record documentation (n = 375, 50.4%), human factors (n = 175, 23.5%), allergy alert limitation and/or malfunction (n = 127, 17.1%), data exchange and interoperability failures (n = 92, 12.4%), and electronic health record system default options (n = 30, 4.0%). Safety failures resulted in known allergen exposures to drugs (n = 537), including heparin (n = 27) and topical anesthetics such as lidocaine (n = 8); latex (n = 114); food allergens (n = 73); and adhesive (n = 23). CONCLUSIONS: We identified 744 allergy-related safety events to inform a novel safety failure classification schema as an important step toward a safer health care environment for patients with allergies. Improved systems are required to address safety issues with certain food and drug allergens.

The association of hospital research publications and clinical quality.

OBJECTIVE: To assess the quantity and impact of research publications among US acute care hospitals; to identify hospital characteristics associated with publication volumes; and to estimate the independent association of bibliometric indicators with Hospital Compare quality measures. DATA SOURCES: Hospital Compare; American Hospital Association Survey; Magnet Recognition Program; Science Citation Index Expanded. STUDY DESIGN: In cross-sectional studies using a 40% random sample of US Medicare-participating hospitals, we estimated associations of hospital characteristics with publication volumes and associations of hospital-linked bibliometric indicators with 19 Hospital Compare quality metrics. DATA COLLECTION/EXTRACTION METHODS: Using standardized search strategies, we identified all publications attributed to authors from these institutions from January 1, 2015 to December 31, 2016 and their subsequent citations through July 2020. PRINCIPAL FINDINGS: Only 647 of 1604 study hospitals (40.3%) had ≥1 publication. Council of Teaching Hospitals and Health Systems (COTH) hospitals had significantly more publications (average 599 vs. 11 for non-COTH teaching and 0.6 for nonteaching hospitals), and their publications were cited more frequently (average 22.6/publication) than those from non-COTH teaching (18.2 citations) or nonteaching hospitals (12.8 citations). In multivariable regression, teaching intensity, hospital beds, New England or Pacific region, and not-for-profit or government ownership were significant predictors of higher publication volumes; the percentage of Medicaid admissions was inversely associated. In multivariable linear regression, hospital publications were associated with significantly lower risk-adjusted mortality rates for acute myocardial infarction (coefficient -0.52, p = 0.01), heart failure (coefficient -0.74, p = 0.004), pneumonia (coefficient -1.02, p = 0.001), chronic obstructive pulmonary disease (coefficient -0.48, p = 0.005), and coronary artery bypass surgery (coefficient -0.73, p < 0.0001); higher overall Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) ratings (coefficient 2.37, p = 0.04); and greater patient willingness to recommend (coefficient 3.38, p = 0.01). CONCLUSIONS: A minority of US hospitals published in the biomedical literature. Publication quantity and impact indicators are independently associated with lower risk-adjusted mortality and higher HCAHPS scores.

Improving Allergy Documentation: A Retrospective Electronic Health Record System-Wide Patient Safety Initiative.

OBJECTIVES: Documentation of allergies in a coded, non-free-text format in the electronic health record (EHR) triggers clinical decision support to prevent adverse events. Health system-wide patient safety initiatives to improve EHR allergy documentation by specifically decreasing free-text allergy entries have not been reported. The goal of this initiative was to systematically reduce free-text allergen entries in the EHR allergy module. METHODS: We assessed free-text allergy entries in a commercial EHR used at a multihospital integrated health care system in the greater Boston area. Using both manual and automated methods, a multidisciplinary consensus group prioritized high-risk and frequently used free-text allergens for conversion to coded entries, added new allergen entries, and deleted duplicate allergen entries. Environmental allergies were moved to the patient problem list. RESULTS: We identified 242,330 free-text entries, which included a variety of environmental allergies (42%), food allergies (18%), contrast media allergies (13%), "no known allergy" (12%), drug allergies (2%), and "no contrast allergy" (2%). Most free-text entries were entered by medical assistants in ambulatory settings (34%) and registered nurses in perioperative settings (20%). We remediated a total of 52,206 free-text entries with automated methods and 79,578 free-text entries with manual methods. CONCLUSIONS: Through this multidisciplinary intervention, we identified and remediated 131,784 free-text entries in our EHR to improve clinical decision support and patient safety. Additional strategies are required to completely eliminate free-text allergy entry, and establish systematic, consistent, and safe guidelines for documenting allergies.

An analysis of the structure and content of dashboards used to monitor patient safety in the inpatient setting.

The objective of this study is to review and compare patient safety dashboards used by hospitals and identify similarities and differences in their design, format, and scope. We reviewed design features of electronic copies of patient safety dashboards from a representative sample of 10 hospitals. The results show great heterogeneity in the format, presentation, and scope of patient safety dashboards. Hospitals varied in their use of performance indicators (targets, trends, and benchmarks), style of color coding, and timeframe for the displayed metrics. The average number of metrics per dashboard display was 28, with a wide range from 7 to 84. Given the large variation in dashboard design, there is a need for future work to assess which approaches are associated with the best outcomes, and how specific elements contribute to usability, to help customize dashboards to meet the needs of different clinical, and operational stakeholders.

Design and Implementation of a Real-time Monitoring Platform for Optimal Sepsis Care in an Emergency Department: Observational Cohort Study.

BACKGROUND: Sepsis is the leading cause of death in US hospitals. Compliance with bundled care, specifically serial lactates, blood cultures, and antibiotics, improves outcomes but is often delayed or missed altogether in a busy practice environment. OBJECTIVE: This study aims to design, implement, and validate a novel monitoring and alerting platform that provides real-time feedback to frontline emergency department (ED) providers regarding adherence to bundled care. METHODS: This single-center, prospective, observational study was conducted in three phases: the design and technical development phase to build an initial version of the platform; the pilot phase to test and refine the platform in the clinical setting; and the postpilot rollout phase to fully implement the study intervention. RESULTS: During the design and technical development, study team members and stakeholders identified the criteria for patient inclusion, selected bundle measures from the Center for Medicare and Medicaid Sepsis Core Measure for alerting, and defined alert thresholds, message content, delivery mechanisms, and recipients. Additional refinements were made based on 70 provider survey results during the pilot phase, including removing alerts for vasopressor initiation and modifying text in the pages to facilitate patient identification. During the 48 days of the postpilot rollout phase, 15,770 ED encounters were tracked and 711 patient encounters were included in the active monitoring cohort. In total, 634 pages were sent at a rate of 0.98 per attending physician shift. Overall, 38.3% (272/711) patients had at least one page. The missing bundle elements that triggered alerts included: antibiotics 41.6% (136/327), repeat lactate 32.4% (106/327), blood cultures 20.8% (68/327), and initial lactate 5.2% (17/327). Of the missing Sepsis Core Measures elements for which a page was sent, 38.2% (125/327) were successfully completed on time. CONCLUSIONS: A real-time sepsis care monitoring and alerting platform was created for the ED environment. The high proportion of patients with at least one alert suggested the significant potential for such a platform to improve care, whereas the overall number of alerts per clinician suggested a low risk of alarm fatigue. The study intervention warrants a more rigorous evaluation to ensure that the added alerts lead to better outcomes for patients with sepsis.

Allergic Reactions Captured by Voluntary Reporting.

BACKGROUND: The epidemiology of hospital adverse reactions (ARs), particularly allergic reactions, or hypersensitivity reactions (HSRs), is poorly defined. To determine priorities for allergy safety in healthcare, we identified and described safety reports of allergic reactions. METHODS: We searched the safety report database of a large academic medical center from April 2006 to March 2016 using 101 complete, truncated, and/or misspelled key words related to allergic symptoms, treatments, and culprits (e.g., medications, foods). Patient and event data were summarized for ARs and two types of ARs, HSRs and side effects/toxicities. RESULTS: Among 9111 key word search-identified events, 876 (10%) were ARs, of which 436 (5%) were HSRs and the remaining 440 (5%) were side effect reactions or toxicities. Whereas the most common HSRs were simple cutaneous reactions (83%), the following severe immediate HSRs were also identified: shortness of breath (16%), anaphylaxis (14%), and angioedema (12%). Most HSRs were caused by drugs (81%), with antibiotics (26%), particularly ß-lactams (11%), and vancomycin (8%), commonly implicated. Other causes of drug HSRs included contrast agents (24%), chemotherapeutics (7%), and opioids (6%). Nondrug HSRs were from blood products (8%), latex (3%), and devices (3%). Food reactions were rarely identified (1%). CONCLUSIONS: We identified ARs, HSRs, and side effects/toxicities, contained in a decade of safety reports at an academic medical center. Allergy safety in the healthcare setting should target approaches to common and severe reactions, with a focus on the safe administration of ß-lactams, vancomycin, contrast agents, chemotherapeutics, and opioids. Priority nondrug HSR culprits include blood products, latex, and devices.

Interdisciplinary Patient Tracers: Routine, Systematic Safety Surveillance.

Patient tracers and leadership WalkRounds proactively identify quality and safety issues. However, these programs have been inconsistent in application, results, and sustainability. The goal was to identify a more consistent and efficient approach to survey health care facilities. The authors developed a Peer-to-Peer Interdisciplinary Patient Tracer program to assess compliance with National Patient Safety Goals and to proactively identify areas of inpatient, ambulatory, and procedural risk. The program has been operational for more than 5 years, with continued expansion annually. In all, 96% of frontline leadership reported satisfaction; 100% reported that they would recommend the program to others (Kirkpatrick level 1 results). Mean absolute change in performance scores from 2014 to 2018 was 15%. All survey findings triggered the development of an improvement project. This novel integrated program advanced institutional improvement by strengthening internal peer-to-peer surveillance, engaging leadership, and creating an accountability structure for internal improvement efforts.

A description of medical malpractice claims involving advanced practice providers.

BACKGROUND: The number of physician assistants (PAs) and advanced practice registered nurses (APRNs), together known as advanced practice providers (APPs), has risen dramatically. The goal is identifying characteristics of paid medical malpractice claims, in which APPs are defendants. METHODS: Retrospective cohort study using Harvard's malpractice insurer's national database. Closed claims (2007-2016) with PAs, APRNs, or physicians as defendants. The primary analysis compared claims by role group by patient-, provider-, and claim-level characteristics. Supplemental analyses compared claims naming APPs with and without physicians. Multivariable logistic regression identified variables associated with claim payment. RESULTS: Of 54,772 claims, PAs were defendants without APRNs or physicians in 26 claims; APRNs were defendants without PAs or physicians in 63; physicians were defendants without PAs or APRNs in 37,354. Approximately 75% of claims naming APPs co-named physicians. More claims naming PAs and APRNs were paid on behalf of the hospital/practice (38% and 32%, respectively) compared with physicians (8%, P < 0.001). Payment was less likely for inpatient care (OR 0.89, 95% CI 0.85-0.93, P < 0.001) but higher when APRNs were defendants (1.82, 1.09-3.03), when procedure-related (1.31, 1.25-1.38, P < 0.001) or patients died (1.09, 1.03-1.16, P = 0.003). CONCLUSIONS: These results can inform patient safety initiatives to prevent future harms. The target is outpatient airway procedures performed by APRNs.

Body of Evidence: Do Autopsy Findings Impact Medical Malpractice Claim Outcomes?

OBJECTIVE: Clinicians may hesitate to advocate for autopsies out of concern for increased malpractice risk if the pathological findings at time of death differ from the clinical findings. We aimed to understand the impact of autopsy findings on malpractice claim outcomes. METHODS: Closed malpractice claims with loss dates between 1995 and 2015 involving death related to inpatient care at 3 Harvard Medical School hospitals were extracted from a captive malpractice insurer's database. These claims were linked to patients' electronic health records and their autopsy reports. Using the Goldman classification system, 2 physician reviewers blinded to claim outcome determined whether there was major, minor, or no discordance between the final clinical diagnoses and pathologic diagnoses. Claims were compared depending on whether an autopsy was performed and whether there was major versus minor/no clinical-pathologic discordance. Primary outcomes included percentage of claims paid through settlement or plaintiff verdict and the amount of indemnity paid, inflation adjusted. RESULTS: Of 293 malpractice claims related to an inpatient death that could be linked to patients' electronic health records, 89 claims (30%) had an autopsy performed by either the hospital or medical examiner. The most common claim allegation was an issue with clinician diagnosis, which was statistically less common in the autopsy group (18% versus 38%, P = 0.001). There was no difference in percentage of claims paid whether an autopsy was performed or not (42% versus 41%, P = 0.90) and no difference in median indemnity of paid claims after adjusting for number of defendants ($1,180,537 versus $906,518, P = 0.15). Thirty-one percent of claims with hospital autopsies performed demonstrated major discordance between autopsy and clinical findings. Claims with major clinical-pathologic discordance also did not have a statistically significant difference in percentage paid (44% versus 41%, P > 0.99) or amount paid ($895,954 versus $1,494,120, P = 0.10) compared with claims with minor or no discordance. CONCLUSIONS: Although multiple factors determine malpractice claim outcome, in this cohort, claims in which an autopsy was performed did not result in more paid outcomes, even when there was major discordance between clinical and pathologic diagnoses.

Expert Consensus on Currently Accepted Measures of Harm.

BACKGROUND: Twenty-five years after the seminal work of the Harvard Medical Practice Study, the numbers and specific types of health care measures of harm have evolved and expanded. Using the World Café method to derive expert consensus, we sought to generate a contemporary list of triggers and adverse event measures that could be used for chart review to determine the current incidence of inpatient and outpatient adverse events. METHODS: We held a modified World Café event in March 2018, during which content experts were divided into 10 tables by clinical domain. After a focused discussion of a prepopulated list of literature-based triggers and measures relevant to that domain, they were asked to rate each measure on clinical importance and suitability for chart review and electronic extraction (very low, low, medium, high, very high). RESULTS: Seventy-one experts from 9 diverse institutions attended (primary acceptance rate, 72%). Of 525 total triggers and measures, 67% of 391 measures and 46% of 134 triggers were deemed to have high or very high clinical importance. For those triggers and measures with high or very high clinical importance, 218 overall were deemed to be highly amenable to chart review and 198 overall were deemed to be suitable for electronic surveillance. CONCLUSIONS: The World Café method effectively prioritized measures/triggers of high clinical importance including those that can be used in chart review, which is considered the gold standard. A future goal is to validate these measures using electronic surveillance mechanisms to decrease the need for chart review.

Conducting Safety Research Safely: A Policy-Based Approach for Conducting Research with Peer Review Protected Material.

A multidisciplinary team developed a policy-based approach that provides guidance for using peer review protected information for safety research while maintaining peer review privilege. The approach includes project approval by an ad hoc review committee, signed confidentiality agreements by investigators and study staff, early removal of case identification numbers, standards for maintaining data security, and publication of aggregate data without data set sharing. By describing this procedure and embedding into an institutional policy on Data for Performance Improvement, the team encourages other institutions to develop similar policies consistent with their state regulations.