Myocarditis Following Coronavirus Disease 2019 mRNA Vaccine: A Case Series and Incidence Rate Determination.

BACKGROUND: Myocarditis following coronavirus disease 2019 (COVID-19) mRNA vaccines (Pfizer-BioNTech and Moderna) has been increasingly reported. Incidence rates in the general population are lacking, with pericarditis rather than myocarditis diagnostic codes being used to estimate background rates. This comparison is critical for balancing the risk of vaccination with the risk of no vaccination. METHODS: A retrospective case series was performed using the Mayo Clinic COVID-19 Vaccine Registry. We measured the incidence rate ratio (IRR) for myocarditis temporally related to COVID-19 mRNA vaccination compared with myocarditis in a comparable population from 2016 through 2020. Clinical characteristics and outcomes of the affected patients were collected. A total of 21 individuals were identified, but ultimately 7 patients met the inclusion criteria for vaccine-associated myocarditis. RESULTS: The overall IRR of COVID-19-related myocarditis was 4.18 (95% confidence interval [CI], 1.63-8.98), which was entirely attributable to an increased IRR among adult males (IRR, 6.69; 95% CI, 2.35-15.52) compared with females (IRR 1.41; 95% CI, .03-8.45). All cases occurred within 2 weeks of a dose of the COVID-19 mRNA vaccine, with the majority occurring within 3 days (range, 1-13) following the second dose (6 of 7 patients, 86%). Overall, cases were mild, and all patients survived. CONCLUSIONS: Myocarditis is a rare adverse event associated with COVID-19 mRNA vaccines. It occurs in adult males with significantly higher incidence than in the background population. Recurrence of myocarditis after a subsequent mRNA vaccine dose is not known at this time.

Individual-Level Digital Determinants of Health and Technology Acceptance of Patient Portals: Cross-Sectional Assessment.

BACKGROUND: Digital determinants of health (DDoH), including access to technological tools and digital health literacy, function independently as barriers to health. Assessment for DDoH is not routine within most health care systems, although addressing DDoH could help mitigate differential health outcomes and the digital divide. OBJECTIVE: This study aims to assess the role of individual-level DDoH factors on patient enrollment in and use of the patient portal. METHODS: We developed a multimodal, cross-sectional survey and deployed it to 11,424 individuals based on their preferred mode and language documented within the electronic medical record. Based on the Technology Acceptance Model, enrollment in and intent to use the patient portal were the outcomes of interest. Perceived usefulness and ease of use were assessed to determine construct validity, and exploratory investigations included individual-level DDoH, including internet and device access, availability of technological support, medical complexity, individual relationship with the health care system, and digital health literacy. Counts (n) and proportions (%) were used to describe response categories, and adjusted and unadjusted odds ratios are reported. RESULTS: This study included 1850 respondents (11,424 invited, 16.2% response rate), who were mostly female (1048/1850, 56.6%) and White (1240/1850, 67%), with an average age of 63 years. In the validation of the Technology Acceptance Model, measures of perceived ease of use (ie, using the patient portal will require a lot of mental effort; the patient portal will be very easy to use) and perceived usefulness (ie, the usefulness of the patient portal to send and receive messages with providers, schedule appointments, and refill medications) were positively associated with both enrollment in and intent to use the patient portal. Within adjusted models, perceived ease of use and perceived usefulness constructs, in addition to constructs of digital health literacy, knowing what health resources are available on the internet (adjusted odds ratio [aOR] 3.5, 95% CI 1.8-6.6), portal ease of use (aOR 2.8, 95% CI 1.6-5), and portal usefulness (aOR 2.4, 95% CI 1.4-4.2) were significantly associated with patient portal enrollment. Other factors associated with patient portal enrollment and intent to use included being comfortable reading and speaking English, reported use of the internet to surf the web or to send or receive emails, home internet access, and access to technology devices (computer, tablet, smartphone, etc). CONCLUSIONS: Assessing for and addressing individual-level DDoH, including digital health literacy, access to digital tools and technologies, and support of the relational aspects between patients, social support systems, and health care providers, could help mitigate disparities in health. By focusing efforts to assess for and address individual-level DDoH, an opportunity exists to improve digitally driven health care delivery outcomes like access and structural outcomes like bias built within algorithms created with incomplete representation across communities.

Safety of Triptans in Patients Who Have or Are at High Risk for Cardiovascular Disease: A Target Trial Emulation.

OBJECTIVE: To evaluate the safety of triptans in migraine patients with cardiovascular disease or elevated cardiovascular risk. PATIENTS AND METHODS: We retrieved data from a multistate US-based health system (January 2000 to August 2022) on adults with migraine and confirmed cardiovascular/cerebrovascular disease, or at least two cardiovascular risk factors. We compared the effect of triptans to nontriptan treatments on major adverse cardiovascular events (MACE) and its components at 60 days of starting treatments. We emulated a target trial and used propensity score matching for analysis. RESULTS: The 3518 patients in the triptan group were matched to the 3518 patients in the nontriptan group (median age, 55 years; 80.60% female). At 60 days, 52 patients (1.48%) in the triptan group had MACE, compared with 13 patients (0.37%) in the nontriptan group (relative risk [RR], 4.00; 95% CI, 2.24 to 7.14). Patients treated with triptans also had significantly higher risk of nonfatal myocardial infarction (15 patients (0.43%) vs 0 patients (0.00%)); heart failure (RR, 4.50; 95% CI, 1.91 to 10.61); and nonfatal stroke (RR, 8.00; 95% CI, 1.00 to 63.96). Five patients (0.14%) in each group died. The findings were consistent when analyses were restricted to sumatriptan, oral administration of triptan, patients with chronic migraine, history of cardiovascular disease, or history of cerebrovascular disease. CONCLUSION: Triptans likely increase the risk of MACE; however, the incidence of MACE remains low in migraine patients with cardiovascular disease or elevated cardiovascular risk. TRIAL REGISTRATION: Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk and in Pregnant Women. CLINICALTRIALS: gov Identifier: NCT05854992 (https://classic. CLINICALTRIALS: gov/ct2/show/NCT05854992).

Association of COVID-19 Vaccination With Risk of Medically Attended Postacute Sequelae of COVID-19 During the Ancestral, Alpha, Delta, and Omicron Variant Eras.

Background: Uncertainty exists regarding the effectiveness of COVID-19 vaccine to prevent postacute sequelae of COVID-19 (PASC) following a breakthrough infection. While most studies based on symptom surveys found an association between preinfection vaccination status and PASC symptoms, studies of medically attended PASC are less common and have reported conflicting findings. Methods: In this retrospective cohort of patients with an initial SARS-CoV-2 infection who were continually empaneled for primary care in a large US health system, the electronic health record was queried for preinfection vaccination status, demographics, comorbidity index, and diagnosed conditions. Multivariable logistic regression was used to model the outcome of a medically attended PASC diagnosis within 6 months of SARS-CoV-2 infection. Likelihood ratio tests were used to assess the interaction between vaccination status and prevalent variant at the time of infection and between vaccination status and hospitalization for SARS-CoV-2 infection. Results: During the observation period, 6.9% of patients experienced medically attended and diagnosed PASC. A diagnosis of PASC was associated with older age, female sex, hospitalization for the initial infection, and an increased severity-weighted comorbidity index and was inversely associated with infection during the Omicron period. No difference in the development of diagnosed PASC was observed between unvaccinated patients and those vaccinated with either 2 doses of an mRNA vaccine or >2 doses. Conclusions: We found no association between vaccination status at the time of infection and development of medically diagnosed PASC. Vaccine remains an important measure to prevent SARS-CoV-2 infection and severity. Further research is needed to identify effective measures to prevent and treat PASC.

Design, implementation, and impact of a cirrhosis-specific remote patient monitoring program.

BACKGROUND: Remote patient monitoring (RPM) is an emerging focus in health care, and specialized programs may reduce medical costs, supplement in-office visits, and improve patient satisfaction. In this study, we describe the development, feasibility, and early outcomes of an RPM program for patients with decompensated cirrhosis. METHODS: Forty-six patients were offered enrollment at the time of hospital discharge in the cirrhosis RPM program (CiRPM), of which 41 completed at least 30 days of monitoring. Participants were mailed remote monitoring equipment and a tablet to be used for patient-reported outcomes. Alerts were continuously monitored by virtual nursing staff who could perform targeted interventions. A cohort of historical controls (n = 74) was created for comparison using inverse probability of treatment weighting. RESULTS: Patients were enrolled in the program for a mean of 83.9 days, with 28 (68%) completing the full 90-day program. Participants uploaded vital signs and responded to symptom-based questionnaires on 93% of the monitored days. On end-of-program surveys, over 75% of patients expressed satisfaction with the program. Gender, age, and MELD-Na were similar between CiRPM and weighted control groups. The 90-day readmission rate was 34% in CiRPM and 47% in weighted controls. In the CiRPM group, 12% of subjects had 2 or more admissions, compared to 37% in the weighted control group. CONCLUSION: This study demonstrates the feasibility of a cirrhosis-specific RPM program. Overall, patient satisfaction and utilization of the CiRPM was high. Future studies are needed to confirm the impact of RPM on the reduction of hospital readmissions in decompensated cirrhosis.

Patient preferences for telehealth services in a large multispecialty practice.

INTRODUCTION: Telehealth service provision has accelerated during the Coronavirus disease 2019 (COVID-19) pandemic. As the pandemic continues, clinical practices have discovered ways to resume operations. Opportunities exist to understand patient preferences for telehealth clinical services and to tailor offerings to different demographic groups. METHODS: We conducted a survey of patients receiving telehealth services through our outpatient practice to understand the types of healthcare services for which patients report preferences for telehealth. RESULTS: We received 551 survey responses (response rate = 20.8%; 551/2650). More than half of patients indicated being 'very likely' to use telehealth services to refill medication(s) (67.3%), prepare for an upcoming visit (66.1%), review test results (60.3%), or receive education (54.2%). Males had lower odds of preferring telehealth services for reviewing test results (odds ratio (OR) = 0.57; 95% confidence interval (CI): 0.34-0.94) or mental health issues (OR = 0.54; 95% CI: 0.38-0.77). Respondents who received a video visit were significantly more likely than those who received a telephone visit to report preferences for using telehealth for education, care plan discussions, long-term health issues, and mental health. DISCUSSION: Patient preferences for telehealth services vary by services provided and respondent demographics. Experience with telehealth increases the likelihood for future use of these services.

Hybrid Immunity Provides Protective Advantage Over Vaccination or Prior Remote Coronavirus Disease 2019 Alone.

Background: The protective efficacy of prior coronavirus disease 2019 (COVID-19) with or without vaccination remains unknown. This study sought to understand if 2 or more messenger RNA (mRNA) vaccine doses provide additional protection in patients with prior infection, or if infection alone provides comparable protection. Methods: We conducted a retrospective cohort study of the risk of COVID-19 from 16 December 2020 through 15 March 2022, among vaccinated and unvaccinated patients of all ages with and without prior infection. A Simon-Makuch hazard plot illustrated the incidence of COVID-19 between groups. Multivariable Cox proportional hazards regression was used to examine the association of demographics, prior infection, and vaccination status with new infection. Results: Among 101 941 individuals with at least 1 COVID-19 polymerase chain reaction test prior to 15 March 2022, 72 361 (71.0%) received mRNA vaccination and 5957 (5.8%) were previously infected. The cumulative incidence of COVID-19 was substantially higher throughout the study period for those previously uninfected and unvaccinated, and lowest for those previously infected and vaccinated. After accounting for age, sex, and the interaction between vaccination and prior infection, a reduction in reinfection risk was noted during the Omicron and pre-Omicron phases of 26% (95% confidence interval [CI], 8%-41%; P = .0065) to 36% (95% CI, 10%-54%; P = .0108), respectively, among previously infected and vaccinated individuals, compared to previously infected subjects without vaccination. Conclusions: Vaccination was associated with lower risk of COVID-19, including in those with prior infection. Vaccination should be encouraged for all including those with prior infection, especially as new variants emerge and variant-specific booster vaccines become available.

Implementation of eLearning solutions for patients with chronic pain conditions.

Background: Digital and mobile (mHealth) solutions are online or application-based services intended to support individuals with health needs. Despite evidence supporting the use of mHealth for patients with chronic pain, and the increasing desire of these types of solutions by both patients and providers, adoption of mHealth solutions remains limited. Implementation mapping can serve as a practical method to facilitate implementation and adoption of mHealth solutions within healthcare settings. Methods: Implementation mapping was used to develop implementation strategies based on contextual determinants organized within the Consolidated Framework for Implementation Research (CFIR) for mHealth eLearning solutions across an integrated, multi-site healthcare system. We describe our experience identifying stakeholders, delineating implementation facilitators and barriers, defining implementation outcomes using RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, outlining initial implementation strategies, and iterating on implementation strategies. Results: A total of 30 implementation strategies were identified and implemented. Over the first year, primary and specialty care providers across all the clinical sites (n = 70) placed 2559 orders for the mHealth solution. Most patients reported receiving the mHealth eLearning module (74%), and most patients felt that the tool improved their knowledge regarding their condition (82%) and their ability to provide self-care related to the condition (73%). Conclusion: Practical applications of implementation science methods can help enable change within healthcare settings. Implementation mapping is an exercise that can engage stakeholders to facilitate the incorporation of new methods of care delivery, including mHealth solutions.

Association between value-based purchasing score and hospital characteristics.

BACKGROUND: Medicare hospital Value-based purchasing (VBP) program that links Medicare payments to quality of care will become effective from 2013. It is unclear whether specific hospital characteristics are associated with a hospital's VBP score, and consequently incentive payments.The objective of the study was to assess the association of hospital characteristics with (i) the mean VBP score, and (ii) specific percentiles of the VBP score distribution. The secondary objective was to quantify the associations of hospital characteristics with the VBP score components: clinical process of care (CPC) score and patient satisfaction score. METHODS: Observational analysis that used data from three sources: Medicare Hospital Compare Database, American Hospital Association 2010 Annual Survey and Medicare Impact File. The final study sample included 2,491 U.S. acute care hospitals eligible for the VBP program. The association of hospital characteristics with the mean VBP score and specific VBP score percentiles were assessed by ordinary least square (OLS) regression and quantile regression (QR), respectively. RESULTS: VBP score had substantial variations, with mean score of 30 and 60 in the first and fourth quartiles of the VBP score distribution. For-profit status (vs. non-profit), smaller bed size (vs. 100-199 beds), East South Central region (vs. New England region) and the report of specific CPC measures (discharge instructions, timely provision of antibiotics and beta blockers, and serum glucose controls in cardiac surgery patients) were positively associated with mean VBP scores (p<0.01 in all). Total number of CPC measures reported, bed size of 400-499 (vs. 100-199 beds), a few geographic regions (Mid-Atlantic, West North Central, Mountain and Pacific) compared to the New England region were negatively associated with mean VBP score (p<0.01 in all). Disproportionate share index, proportion of Medicare and Medicaid days to total inpatient days had significant (p<0.01) but small effects. QR results indicate evidence of differential effects of some of the hospital characteristics across low-, medium- and high-quality providers. CONCLUSIONS: Although hospitals serving the poor and the elderly are more likely to score lower under the VBP program, the correlation appears small. Profit status, geographic regions, number and type of CPC measures reported explain the most variation among scores.

Creation of a Multispecialty Clinic for Patients with Central Sensitization-Based Chronic Pain Conditions.

OBJECTIVE: To design and evaluate, through a human-centered design approach, a multispeciality clinic for patients with central sensitization syndromes that combined virtual previsit consultations, traditional face-to-face appointments, and technology-enabled educational programming. PATIENTS AND METHODS: Patients with suspected fibromyalgia and chronic abdominal pain were seen in a multispecialty practice, and the performance of the clinic was evaluated against a contemporary cohort. Quantitative and qualitative evaluation measures included team estimates of time spent on care-related tasks, physician rank of alignment of patient need with clinic design, major appointment changes, and nonvisit care tasks. Members of the care team also evaluated strengths, weaknesses, opportunities, and threats to the success of the clinic. RESULTS: The pilot clinic was operated from April 1, 2020, to April 30, 2021, and included 34 patients with suspected fibromyalgia/chronic abdominal pain. During the pilot period, physicians ranked the value of the virtual previsit consultations in providing care as 7.5 on a scale of 0 to 10 and reported an average of 50 minutes in preparation for the appointment, execution of the appointment, and postvisit documentation. We did not observe substantial differences in the number of added appointments or messages received within the patient portal when compared with a comparison cohort. Patients who participated in the combination nurse educator-led and digital education program provided positive feedback about their experience. CONCLUSION: Our clinic model provides a framework for the treatment of patients with debilitating centrally sensitized conditions and future expansion of virtual care delivery models to better meet patient care and educational needs.

Changes in social relationships during an initial "stay-at-home" phase of the COVID-19 pandemic: A longitudinal survey study in the U.S.

RATIONALE: Severe acute respiratory syndrome Coronavirus 2 (SARS CoV-2), the virus that causes COVID-19, and consequent social distancing directives have been observed to negatively impact social relationships but the impact of these changes on the quality of social relationships at a population level has not been explored. OBJECTIVE: To evaluate changes in social relationships in a U.S. population sample during a time of social distancing. METHODS: We deployed a matched, longitudinal survey design of the National Institutes of Health Adult Social Relationship Scales to assess the social aspects of emotional support, instrumental support, friendship, loneliness, perceived hostility, and perceived rejection from a time without social distancing (February 2018) to a time where social distancing directives were active (May 2020). Changes in social relationships were compared using paired t-tests, and generalized linear regression models were constructed to identify subpopulations experiencing differential changes in each subdomain of social relationships during social distancing. RESULTS: Within our sample population, individuals experienced an increased sense of emotional support, instrumental support, and loneliness, and decreased feelings of friendship and perceived hostility during a period of social distancing. Individuals with low self-rated health experienced a decreased sense of emotional support, and females experienced increased feelings of loneliness compared with males. CONCLUSIONS: Social distancing measurably impacts social relationships and may have a disproportionate impact on females and individuals with lower self-rated health. If novel emergent infectious diseases become more commonplace, social interventions may be needed to mitigate the potential adverse impact of social distancing on social relationships.

Use of a Computerized Algorithm to Evaluate the Proportion and Causes of Potentially Preventable Readmissions Among Patients Discharged to Skilled Nursing Facilities.

OBJECTIVES: Older patients discharged to skilled nursing facilities (SNFs) for post-acute care are at high risk for hospital readmission. Yet, as in the community setting, some readmissions may be preventable with optimal transitional care. This study examined the proportion of 30-day hospital readmissions from SNFs that could be considered potentially preventable readmissions (PPRs) and evaluated the reasons for these readmissions. DESIGN: Retrospective cohort study. SETTING AND PARTICIPANTS: Post-acute practice of an integrated health care delivery system serving 11 SNFs in the US Midwest. Patients discharged from the hospital to an SNF and subsequently readmitted to the hospital within 30 days from January 1, 2009, through November 31, 2016. METHODS: A computerized algorithm evaluated the relationship between initial and repeat hospitalizations to determine whether the repeat hospitalization was a PPR. We assessed for changes in PPR rates across the system over the study period and evaluated the readmission categories to identify the most prevalent PPR categories. RESULTS: Of 11,976 discharges to SNFs for post-acute care among 8041 patients over the study period, 16.6% resulted in rehospitalization within 30 days, and 64.8% of these rehospitalizations were considered PPRs. Annual proportion of PPRs ranged from 58.2% to 66.4% [mean (standard deviation) 0.65 (0.03); 95% confidence interval CI 0.63-0.67; P = .36], with no discernable trend. Nearly one-half (46.2%) of all 30-day readmissions were classified as potentially preventable medical readmissions related to recurrence or continuation of the reason for initial admission or to complications from the initial hospitalization. CONCLUSIONS AND IMPLICATIONS: For this cohort of patients discharged to SNFs, a computerized algorithm categorized a large proportion of 30-day hospital readmissions as potentially preventable, with nearly one-half of those linked to the reason for the initial hospitalization. These findings indicate the importance of improvement in postdischarge transitional care for patients discharged to SNFs.

Helpfulness of Clinical Visit Summary Content From Multi-Specialty Care: A Mixed-Methods Assessment.

OBJECTIVE: We surveyed patients who visited multiple outpatient specialty practices to understand what summary content was most helpful with the goal of optimizing meaningful outpatient clinical visit summary content. MATERIALS AND METHODS: We constructed a survey instrument to measure delivery, use, and contents of clinical visit summaries. We surveyed patients who visited with at least 2 different outpatient medical specialties to understand preferences. RESULTS: Most patients in our sample valued the summary information they received, and retained it as healthcare documentation (84%) and/or quick reference in supporting self-care (70%). Patients most commonly reported that information on results of completed tests (91%) and treatment plan instructions (89%) were very helpful. Additionally, patients expressed the importance of online access to clinical visit summary information. DISCUSSION: Most patients used the clinical visit summary as healthcare documentation, and valued online availability of their summary information. Patients most often reported that information on results of recently completed tests and specific instructions on treatment plan were very helpful. Patients who sought further information after their visit most often looked to a provider and/or online. CONCLUSIONS: Patients valued clinical visit summary accessibility and as a reference tool to summarize care and provide next steps. Optimal clinical visit summaries might collate and integrate assessments and recommendations from multiple specialties into coherent care plans for patients.

Analyses of the Complexity of Patients Undergoing Attended Polysomnography in the Era of Home Sleep Apnea Tests.

STUDY OBJECTIVES: Health care complexity includes dimensions of patient comorbidity and the level of services needed to meet patient demands. Home sleep apnea tests (HSAT) are increasingly used to test medically uncomplicated patients suspected of having moderate to severe obstructive sleep apnea (OSA). Patients with significant comorbidities or other sleep disorders are not candidates for HSAT and require attended in-center polysomnography. We hypothesized that this trend would result in increasingly complex patients being studied in sleep centers. METHODS: Our study had two parts. To ascertain trends in sleep patient comorbidity, we used administrative diagnostic codes from patients undergoing polysomnography at the Mayo Clinic Center for Sleep Medicine from 2005 to June 2015 to calculate the Charlson and the Elixhauser comorbidity indices. We measured the level of services provided in two ways: (1) in a subset of patients from the past 2 months of 2015, we evaluated correlation of these morbidity indices with an internally developed Polysomnogram Clinical Index (PSGCI) rating anticipated patient care needs from 0 to 3 and (2) we measured the sleep study complexity based on polysomnography protocol design. RESULTS: In 43,780 patients studied from 2005 to June 2015, the Charlson index increased from a mean of 1.38 to 1.88 (3.1% per year, P < .001) and the mean Elixhauser index increased from 2.61 to 3.35 (2.5% per year, P < .001). Both comorbidity indices were significantly higher at the highest (Level 3) level of the PSGCI (P < .001), and sleep study complexity increased over time. CONCLUSIONS: The complexity of patients undergoing attended polysomnography has increased by 28% to 36% over the past decade as measured by validated comorbidity indices, and these indices correlate with the complexity of rendered care during polysomnography. These findings have implications for increasing requirements for staffing, monitoring capabilities, and facility design of future sleep centers. COMMENTARY: A commentary on this article appears in this issue on page 499.

Utilizing Administrative Data to Focus Quality Improvement Efforts for Opioid Prescribing in an Integrated Health System.

This case study describes the use of multiple administrative data sources within a large, integrated health care delivery system to understand opioid prescribing patterns across practice settings. We describe the information needed to understand prescribing patterns and target interventions, the process for identifying relevant institutional data sources that could be linked to provide information on the settings for prescriptions, and the lessons learned in developing, testing, and implementing an algorithm to link the data sources in a useful manner.

Improving inpatient warfarin therapy safety using a pharmacist-managed protocol.

INTRODUCTION: Safe management of warfarin in the inpatient setting can be challenging. At the Mayo Clinic hospitals in Rochester, Minnesota, we set out to improve the safety of warfarin management among surgical and non-surgical inpatients. METHODS: A multidisciplinary team designed a pharmacist-managed warfarin protocol (PMWP) which designated warfarin dosing to inpatient pharmacists with guidance from computerised dosing algorithms. Ordering this protocol was ultimately designed as an 'opt out' practice. The primary improvement measure was frequency of international normalised ratio (INR) greater than 5; secondary measures included adoption rate of the protocol, a counterbalance INR metric (INR <1.7 three days after first inpatient warfarin dose), and complication rates, including bleeding and thrombosis events. An interrupted time series analysis was conducted to compare outcomes. RESULTS: Among over 50 000 inpatient warfarin recipients, the PMWP was adopted for the majority of both surgical and non-surgical inpatients during the study period (1 January 2005 to 31 December 2011). The primary improvement measure decreased from 5.6% to 3.4% for medical patients and from 5.2% to 2.4% for surgical patients during the preimplementation and postimplementation periods, respectively. The INR counterbalance measure did not change. Postoperative bleeding decreased from 13.5% to 11.1% among surgical patients, but bleeding was unchanged among medical patients. CONCLUSION: Our PMWP led to achievement of improved INR control for inpatient warfarin recipients and to less near-term bleeding among higher risk, surgical patients.

Going Beyond Administrative Data: Retrospective Evaluation of an Algorithm Using the Electronic Health Record to Help Identify Bleeding Events Among Hospitalized Medical Patients on Warfarin.

To reliably assess quality, a standardized electronic approach is needed to identify bleeding events. The study aims were the following: (1) clinically validate an electronic health record-based algorithm for bleeding and (2) assess interrater results to determine validity and reliability. Data were analyzed before and after implementation of a pharmacist-managed warfarin protocol. Bleeding was based on ≥2 of 3 criteria: (1) diagnosis indicating bleeding, (2) lab value decrease suggesting bleeding, and (3) blood product use. All suspected bleeds (234) and a sample (58) not meeting criteria were compared with clinical review. There were 234 bleeding cases identified electronically. Reviewer agreement was 78.2% (κ = 0.565). Algorithm sensitivity was 93.9% and positive predictive value 46.2%. Algorithm identification was least accurate for those with only 2 criteria but good for those with all criteria. This study supports using multiple electronic criteria to identify bleeding events. However, cases having exactly 2 criteria may require manual review for validation.