Safety of the Zoster Vaccine Recombinant Adjuvanted in Rheumatoid Arthritis and Other Systemic Rheumatic Disease Patients: A Single Center's Experience With 400 Patients.

OBJECTIVE: Patients with rheumatoid arthritis (RA) and other systemic rheumatic diseases (SRDs) are at increased risk of developing herpes zoster (HZ). Zoster recombinant adjuvanted (ZRA) is a recombinant vaccine approved by the Food and Drug Administration in 2018. Concern has been raised that the ZRA may trigger disease flares in rheumatology patients who are immunocompromised. We investigated the impact of the ZRA vaccine in patients with RA and SRD and measured the incidence of flares and side effects. METHODS: A flare was defined as occurring within 12 weeks of vaccine administration by either 1) documentation of RA flare in office notes, telephone encounter, or patient portal communication or 2) new or increased dose of corticosteroids. RESULTS: We identified 403 patients (239 patients with RA and 164 patients with SRD) who received the ZRA vaccine from February 1, 2018, to February 1, 2019. We measured a 6.7% (n = 27) incidence of flare. Side effects occurred in 12.7% (n = 51) of patients. All flares and side effects were regarded as mild. Three cases of HZ were reported as occurring 2, 10, and 11 months after the vaccination. CONCLUSION: In 403 patients who received the ZRA vaccine, the incidence of disease flares was 7% or less and that of side effects was 13% or less, both of which are less than the incidence rates observed in the pivotal trials.

Is inter-rater reliability of Global Trigger Tool results altered when members of the review team are replaced?

OBJECTIVE: To evaluate the inter-rater reliability of results from Global Trigger Tool (GTT) reviews when one of the three reviewers remains consistent, while one or two reviewers rotate. DESIGN: Comparison of results from retrospective record review performed as a cross-sectional study with three review teams each consisting of two non-physicians and one physician; Team I (three consistent reviewers), Team II (one of the two non-physician reviewers or/and the physician from Team I are replaced for different review periods) and Team III (three consistent reviewers different from reviewers in Team I and Team II). SETTING: Medium-sized hospital trust in Northern Norway. PARTICIPANTS: A total of 120 records were selected as biweekly samples of 10 from discharge lists between 1 July and 31 December 2010 for a 3-fold review. INTERVENTION: Replacement of review team members was tested to assess impact on inter-rater reliability and adverse events measurment. MAIN OUTCOME MEASURES: Inter-rater reliability assessed with the Cohen kappa coefficient between different teams regarding the presence and severity level of adverse events. RESULTS: Substantial inter-rater reliability regarding the presence and severity level of adverse events was obtained between Teams I and II, while moderate inter-rater reliability was obtained between Teams I and III. CONCLUSIONS: Replacement of reviewers did not influence the results provided that one of the non-physician reviewers remains consistent. The experience of the consistent reviewer can result in continued consistency in interpretation with the new reviewer through discussion of events. These findings could encourage more hospital to rotate reviewers in order to optimize resources when using the GTT.

Does increasing the size of bi-weekly samples of records influence results when using the Global Trigger Tool? An observational study of retrospective record reviews of two different sample sizes.

OBJECTIVES: To investigate the impact of increasing sample of records reviewed bi-weekly with the Global Trigger Tool method to identify adverse events in hospitalised patients. DESIGN: Retrospective observational study. SETTING: A Norwegian 524-bed general hospital trust. PARTICIPANTS: 1920 medical records selected from 1 January to 31 December 2010. PRIMARY OUTCOMES: Rate, type and severity of adverse events identified in two different samples sizes of records selected as 10 and 70 records, bi-weekly. RESULTS: In the large sample, 1.45 (95% CI 1.07 to 1.97) times more adverse events per 1000 patient days (39.3 adverse events/1000 patient days) were identified than in the small sample (27.2 adverse events/1000 patient days). Hospital-acquired infections were the most common category of adverse events in both the samples, and the distributions of the other categories of adverse events did not differ significantly between the samples. The distribution of severity level of adverse events did not differ between the samples. CONCLUSIONS: The findings suggest that while the distribution of categories and severity are not dependent on the sample size, the rate of adverse events is. Further studies are needed to conclude if the optimal sample size may need to be adjusted based on the hospital size in order to detect a more accurate rate of adverse events.

'Global trigger tool' shows that adverse events in hospitals may be ten times greater than previously measured.

Identification and measurement of adverse medical events is central to patient safety, forming a foundation for accountability, prioritizing problems to work on, generating ideas for safer care, and testing which interventions work. We compared three methods to detect adverse events in hospitalized patients, using the same patient sample set from three leading hospitals. We found that the adverse event detection methods commonly used to track patient safety in the United States today-voluntary reporting and the Agency for Healthcare Research and Quality's Patient Safety Indicators-fared very poorly compared to other methods and missed 90 percent of the adverse events. The Institute for Healthcare Improvement's Global Trigger Tool found at least ten times more confirmed, serious events than these other methods. Overall, adverse events occurred in one-third of hospital admissions. Reliance on voluntary reporting and the Patient Safety Indicators could produce misleading conclusions about the current safety of care in the US health care system and misdirect efforts to improve patient safety.

Performance characteristics of a methodology to quantify adverse events over time in hospitalized patients.

OBJECTIVE: To assess the performance characteristics of the Institute for Healthcare Improvement Global Trigger Tool (GTT) to determine its reliability for tracking local and national adverse event rates. DATA SOURCES: Primary data from 2008 chart reviews. STUDY DESIGN: A retrospective study in a stratified random sample of 10 North Carolina hospitals. Hospital-based (internal) and contract research organization-hired (external) reviewers used the GTT to identify adverse events in the same 10 randomly selected medical records per hospital in each quarter from January 2002 through December 2007. DATA COLLECTION/EXTRACTION: Interrater and intrarater reliability was assessed using κ statistics on 10 percent and 5 percent, respectively, of selected medical records. Additionally, experienced GTT users reviewed 10 percent of records to calculate internal and external teams' sensitivity and specificity. PRINCIPAL FINDINGS: Eighty-eight to 98 percent of the targeted 2,400 medical records were reviewed. The reliability of the GTT to detect the presence, number, and severity of adverse events varied from κ=0.40 to 0.60. When compared with a team of experienced reviewers, the internal teams' sensitivity (49 percent) and specificity (94 percent) exceeded the external teams' (34 and 93 percent), as did their performance on all other metrics. CONCLUSIONS: The high specificity, moderate sensitivity, and favorable interrater and intrarater reliability of the GTT make it appropriate for tracking local and national adverse event rates. The strong performance of hospital-based reviewers supports their use in future studies.

Making inpatient medication reconciliation patient centered, clinically relevant, and implementable: a consensus statement on key principles and necessary first steps.

This white paper identifies potential solutions to help ensure the utility and sustainability of this critical patient safety issue.

Making inpatient medication reconciliation patient centered, clinically relevant and implementable: a consensus statement on key principles and necessary first steps.

Medication errors and adverse events caused by them are common during and after a hospitalization. The impact of these events on patient welfare and the financial burden, both to the patient and the healthcare system, are significant. In 2005, The Joint Commission put forth medication reconciliation as National Patient Safety Goal (NPSG) No. 8 in an effort to minimize adverse events caused during these types of care transitions. However, the meaningful and systematic implementation of medication reconciliation, as expressed through NPSG No. 8, proved to be extraordinarily difficult for healthcare institutions around the country. Given the importance of accurate and complete medication reconciliation for patient safety occurring across the continuum of care, the Society of Hospital Medicine convened a stakeholder conference in 2009 to begin to identify and address: (1) barriers to implementation; (2) opportunities to identify best practices surrounding medication reconciliation; (3) the role of partnerships among traditional healthcare sites and nonclinical and other community-based organizations; and (4) metrics for measuring the processes involved in medication reconciliation and their impact on preventing harm to patients. The focus of the conference was oriented toward medication reconciliation for a hospitalized patient population; however, many of the themes and concepts derived would also apply to other care settings. This paper highlights the key domains needing to be addressed and suggests first steps toward doing so. An overarching principle derived at the conference is that medication reconciliation should not be viewed as an accreditation function. It must, first and foremost, be recognized as an important element of patient safety. From this principle, the participants identified ten key areas requiring further attention in order to move medication reconciliation toward this focus. 1 There is need for a uniformly acceptable and accepted definition of what constitutes a medication and what processes are encompassed by reconciliation. Clarifying these terms is critical to ensuring more uniform impact of medication reconciliation. 2 The varying roles of the multidisciplinary participants in the reconciliation process must be clearly defined. These role definitions should include those of the patient and family/caregiver and must occur locally, taking into account the need for flexibility in design given the varying structures and resources at healthcare sites. 3 Measures of the reconciliation processes must be clinically meaningful (i.e., of defined benefit to the patient) and derived through consultation with stakeholder groups. Those measures to be reported for national benchmarking and accreditation should be limited in number and clinically meaningful. 4 While a comprehensive reconciliation system is needed across the continuum of care, a phased approach to implementation, allowing it to start slowly and be tailored to local organizational structures and work flows, will increase the chances of successful organizational uptake. 5 Developing mechanisms for prospectively and proactively identifying patients at risk for medication-related adverse events and failed reconciliation is needed. Such an alert system would help maintain vigilance toward these patient safety issues and help focus additional resources on high risk patients. 6 Given the diversity in medication reconciliation practices, research aimed at identifying effective processes is important and should be funded with national resources. Funding should include varying sites of care (e.g., urban and rural, academic and nonacademic, etc.). 7 Strategies for medication reconciliation-both successes and key lessons learned from unsuccessful efforts-should be widely disseminated. 8 A personal health record that is integrated and easily transferable between sites of care is needed to facilitate successful medication reconciliation. 9 Partnerships between healthcare organizations and community-based organizations create opportunities to reinforce medication safety principles outside the traditional clinician-patient relationship. Leveraging the influence of these organizations and other social networking platforms may augment population-based understanding of their importance and role in medication safety. 10 Aligning healthcare payment structures with medication safety goals is critical to ensure allocation of adequate resources to design and implement effective medication reconciliation processes. Medication reconciliation is complex and made more complicated by the disjointed nature of the American healthcare system. Addressing these ten points with an overarching goal of focusing on patient safety rather than accreditation should result in improvements in medication reconciliation and the health of patients.

Rethinking emergency department visits.

Efforts to date have been unable to reverse the trend of increased emergency department utilization. The Institute for Healthcare Improvement has developed a framework for reducing avoidable emergency department visits on the basis of the formation of local coalitions. These coalitions include interested partners approaching improvement by integrating community resources and nonmedical solutions. Targeted patient populations are identified via homogeneous characteristics. Open-ended interview questions are used to identify possible community and nonmedical solutions to complement medical strategies. This article describes the framework and process of testing. If validated, this approach will have significant policy implications.

A compendium of strategies to prevent healthcare-associated infections in acute care hospitals.

Preventable healthcare-associated infections (HAIs) occur in US hospitals. Preventing these infections is a national priority, with initiatives led by healthcare organizations, professional associations, government and accrediting agencies, legislators, regulators, payers, and consumer advocacy groups. To assist acute care hospitals in focusing and prioritizing efforts to implement evidence-based practices for prevention of HAIs, the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America Standards and Practice Guidelines Committee appointed a task force to create a concise compendium of recommendations for the prevention of common HAIs. This compendium is implementation focused and differs from most previously published guidelines in that it highlights a set of basic HAI prevention strategies plus special approaches for use in locations and/or populations within the hospital when infections are not controlled by use of basic practices, recommends that accountability for implementing infection prevention practices be assigned to specific groups and individuals, and includes proposed performance measures for internal quality improvement efforts.

Reducing surgical complications.

BACKGROUND: One of the 12 interventions that the Institute for Healthcare Improvement (IHI) recommends for its 5 Million Lives Campaign is "Reduce Surgical Complications...by reliably implementing all the changes in care recommended by the Surgical Care Improvement Project (SCIP)." Many surgical patients experience complications from surgery, some of which are preventable with the reliable application of evidence-based medicine. Despite promotion and dissemination of recommendations and practices, overall national compliance remains less than optimal. METHODS: IHI's 5 Million Lives Campaign is supporting the recommended practices in the SCIP to accelerate adoption for reduction in surgical complications by 25% by December 2008. Practices relate to surgical site infection prevention, prophylaxis for venousthromboembolism, continuation of beta blockers, and prevention of postoperative pneumonia. Strategies used in hospitals that have achieved improvement in the recommended SCIP measures include practices that increase reliability and minimize practice variation. These changes, along with efforts to improve teamwork and communication, are essential to reduce surgical complications. CONCLUSION: Organizations that strive for high reliability in their processes should see improvement in the associated outcomes and a reduction in harm to patients.

Miles to go: an introduction to the 5 Million Lives Campaign.

BACKGROUND: The Institute for Healthcare Improvement (IHI)'s 5 Million Lives Campaign targets a reduction of five million instances of harm from December 2006 through December 2008. The campaign continues the six interventions of the 100,000 Lives Campaign and adds six more. DEFINITION OF MEDICAL HARM AND SETTING THE GOAL: The campaign's aim is to support the reduction of medical harm, so defined: "Unintended physical injury resulting from or contributed to by medical care (including the absence of indicated medical treatment), that requires additional monitoring, treatment, or hospitalization, or that results in death." The goal of a reduction of five million incidents of harm in two years is based on an estimate that 40 to 50 incidents occur per 100 admissions, for a total of 15 million incidents of medical harm each year in the United States. THE 5 MILLION LIVES CAMPAIGN'S "PLATFORM": This campaign's six new interventions address the prevention of pressure ulcers, reduction of methicillin-resistant Staphylococcus aureus (MRSA) infection, prevention of harm from high-alert medications, reduction of surgical complications, delivery of reliable and evidence-based care for congestive heart failure, and getting hospitals' boards of directors on board. CONCLUSION: Together with complementary partner initiatives, the 5 Million Lives Campaign is intended to act as a major driver of national improvement.

5 Million Lives Campaign. Reducing methicillin-resistant Staphylococcus aureus (MRSA) infections.

BACKGROUND: Hospital-acquired infections from methicillin-resistant Staphylococcus aureus (MRSA) now account for more than 60% of S. aureus infections in intensive care patients reported to the Centers for Disease Control and Prevention (CDC). Media stories have raised the profile of this problem, and several states have moved toward legislative action regarding screening of hospital patients or mandatory reporting of infections. Guidelines from clinical expert organizations, including the CDC, the Association for Professionals in Infection Control and Epidemiology (APIC), and the Society for Healthcare Epidemiology of America (SHEA), recommend the use of basic prevention practices to avoid transmission in the hospital setting, yet concerns persist that compliance with these practices is neither consistent nor reliable. INTERVENTION: The campaign's MRSA intervention recommends five key components of care. These are not intended to be an all-inclusive list but rather have been recommended by experts as the minimum necessary components: (1) hand hygiene, (2) decontamination of the environment and equipment, (3) active surveillance, (4) contact precautions for infected and colonized patients, and (5) device bundles (central line bundle and ventilator bundle). CONCLUSION: The IHI's 5 Million Lives Campaign considers all hospital-acquired infections as harm to patients, and reduction of MRSA is one of the areas of focus.