A Medical Records Review Study Assessing Safety of Zoster Vaccine Recombinant, Adjuvanted in Patients With Rheumatic Disease.

OBJECTIVE: Patients with rheumatic disease are at increased risk for herpes zoster infection. Because of limited safety data in this population and concerns over vaccine-precipitated flares, there are no guidelines for vaccination with the zoster vaccine recombinant, adjuvanted (ZRA). We evaluated self-reported adverse events (AEs) and disease activity after ZRA administration in adults with rheumatic disease. METHODS: In this medical records review study at our large academic center, patients who had received at least 1 dose of ZRA from January 1, 2018 to March 11, 2020 were assessed. Self-reported AEs and disease activity were monitored 3 months after each ZRA administration. Measures of disease activity were reviewed 6 months before ZRA in those who received both doses, or 3 months before ZRA in those who received 1 dose. RESULTS: We identified 65 patients, of whom 34 (52.3%) received both doses of ZRA. Four patients (6.2%) self-reported AEs after receiving ZRA, all of which were minor and systemic. Three patients (9.2%) developed a flare after receiving ZRA, compared with 8 (12.3%) who experienced a flare in the baseline period. There was no significant change in flare incidence or disease activity after vaccination. Subgroup analysis of those on biologic and nonbiologic disease-modifying antirheumatic drugs revealed no differences in frequency of postvaccination AEs, flares, or disease activity. CONCLUSIONS: In our cohort, disease activity seemed stable when comparing disease markers before and after ZRA administration. In addition, ZRA was well-tolerated with minor AEs. Further studies are needed to guide formal vaccination recommendations.

Improving Diabetes Control Using Lean Six Sigma Quality Improvement in an Endocrine Clinic in a Large Accountable Care Organization.

This article describes a quality improvement project to reduce the number of patients with diabetes who have poor glycemic control in a large tertiary care endocrinology clinic. The project used the Lean Six Sigma Define-Measure-Analyze-Improve-Control process improvement methodology to develop clinic workflow processes for obtaining A1C measurements in a timely manner to facilitate interventions to improve glycemic control. The percentage of patients with poorly controlled diabetes (A1C >9.0% or missing value in the past 12 months) significantly improved from 26.4% at baseline to 16% (P <0.001), and the proportion of patients with an A1C test within 3-6 months of an appointment improved from 76 to 92%.

Long-term assessment of aspirin desensitization shows successful bridging with non-aspirin nonsteroidal anti-inflammatory drugs for procedures.

Background: Aspirin (ASA) desensitization and continuous daily ASA therapy is the criterion standard treatment for ASA-exacerbated respiratory disease (AERD). However, the optimal maintenance dosage of ASA and safety of "bridging" patients with AERD and with alternative cyclooxygenase-1 inhibitors for surgery have not been determined and require further investigation. Objective: This study was designed to compare the long-term effects of different maintenance doses of ASA and to assess the success of bridging subjects with AERD for surgery without losing desensitization. Methods: We retrospectively assessed 36 subjects with AERD who successfully underwent ASA desensitization from 2011 to 2017. We performed comprehensive medical record reviews and subsequent telephone interviews with a questionnaire. Results: Of 36 subjects, the average age was 52.8 years, with an average of 3.2 years since desensitization, and 65% were women. The subjects reported a decrease in frequency of nasal symptoms (p < 0.001), asthma symptoms (p = 0.016), and sinus infections (p < 0.001) after desensitization. Improvements were reported in sense of smell, taste, quality of sleep, and quality of life (p < 0.001) in all dosage groups. Thirteen subjects required stopping of ASA for surgeries. Six subjects (46%) were bridged with ibuprofen on an average of 5.9 days before surgery and restarted ASA on an average of 1.3 days after surgery, with no incidence of major adverse events or loss of desensitization. Seven subjects (54%) were not bridged, with three subjects restarting ASA after surgery without symptoms and four subjects losing desensitization. Conclusion: There did not seem to be a difference of benefits between 325 mg once or twice a day compared with 650 mg once or twice a day, but our small subject numbers made this conclusion difficult to prove. Desensitization improved subjective reporting on sleep quality as well as quality of life. Bridging the subjects with AERD who required surgery by using ibuprofen seemed to be safe and effective in maintaining ASA desensitization.

Assessment of American College of Rheumatology-Endorsed Quality Indicators in Rheumatoid Arthritis Patients: A Quality Improvement Initiative.

BACKGROUND: The American College of Rheumatology endorses 7 rheumatoid arthritis (RA) quality indicators (QIs), which we used to access quality of care at our institution. OBJECTIVE: The aim of this study was to assess the quality of care provided to RA patients at our outpatient rheumatology practice based on adherence to 7 QIs. METHODS: We performed a retrospective paper chart review and included 356 RA patients to determine adherence to each QI. A χ test analyzed trends in the assessment of disease activity and functional status. RESULTS: There was excellent adherence to disease-modifying antirheumatic drug therapy (99.4%) and managing worsening disease (100%). Assessment of disease activity and functional status increased over the study period (72.8% to 94.2% and 70.8% to 93.4%, respectively). Despite this, none of our patients had disease prognosis classified and documented. Tuberculosis screening was done in 87.9%. Only a small percentage (1.4%) of patients met criteria for a glucocorticoid management plan, thus limiting our assessment of this QI. CONCLUSIONS: Excellent adherence to disease-modifying antirheumatic drug therapy and management is likely due to targeting clinical remission. Assessment of disease activity and functional status not only rose each year, but also is higher compared with similar studies. This may be due to an increased awareness of QIs and the utility of objective measures of disease activity. Deficient documentation of prognosis may be due to a lack of awareness of its importance. Suboptimal tuberculosis screening may be an artifact of poor documentation. We propose interventions to improve adherence.

High-grade fever and pancytopenia in an adult patient with common variable immune deficiency.

Fever of unknown origin in patients with common variable immune deficiency (CVID) can be caused by variety of infectious, autoimmune, or malignancy-related etiologies. We present a 52-year-old man with history of CVID, who presented with 3 weeks of persistent high-grade fevers. During admission, he developed severe pancytopenia with shock and multiorgan failure. An extensive workup was performed for typical and atypical infections, autoimmune pathologies, and malignancy. His peripheral blood smear showed marked anisocytosis and poikilocytosis with elevated atypical lymphocytes. Flow cytometry showed markedly elevated CD8 counts, with abnormal CD4/CD8 ratio. Monospot test was negative but real-time polymerase chain reaction showed high Epstein-Barr virus load. Initial clinical suspicion was high for bacterial infections including pneumonia and acute sinusitis complicated by bacteremia and sepsis. Hematologic malignancy was also high on the differentials because of presence of rapidly progressive pancytopenia. The final diagnosis in this case illustrates a rare but potentially fatal disease that can present in CVID patients with persistent fevers and pancytopenia and can be refractory to standard treatment regimen. Because allergy and immunology physicians commonly treat CVID patients, they should be aware of this disease condition including pathophysiology, clinical presentation, laboratory workup, and treatment options.

Impact of pharmacist-driven referral to increase specialty pharmacy prescription capture.

PURPOSE: To assess the impact of a clinical pharmacy specialist (CPS) embedded within a rheumatology clinic at a large academic medical center on the prescription capture rate at the health-system specialty pharmacy. METHODS: Initially low prescription capture rates for the health-system specialty pharmacy led to the integration of a CPS in the main campus rheumatology clinic. Benchmarking was completed by assessing the prior prescription capture rate using electronic medical record analytics and Loopback Analytics (a database of prescription capture for the health-system specialty pharmacy). The existing workflows for both the rheumatology clinic and specialty pharmacy were observed with regard to biologic medication ordering and processing. Strategies for an updated workflow for biologic ordering with the incorporation of an embedded CPS in the rheumatology clinic were designed. This new workflow was established with key stakeholders, including the CPS, rheumatology providers, clinic staff, and pharmacy technicians. Once the workflow was established, all parties were educated and updated, including rheumatology providers, nursing staff, and specialty pharmacy staff. Prescription capture rate was monitored on a monthly basis. RESULTS: Prescription capture increased from 13.16% before pharmacist implementation (October to December 2021) to 35.42% after pharmacist implementation (October to December 2022) (P = 0.019). During the same periods, the revenue generated increased from $43,222.89 to $135,198.70 (P = 0.224) and the proportion of prescriptions initially sent to the health-system specialty pharmacy compared to other specialty pharmacies increased from 37% to 79% (P < 0.001) with CPS implementation. CONCLUSION: Expansion and implementation of pharmacy services by integrating a CPS in a rheumatology ambulatory clinic increased prescription capture and pharmacy revenue while optimizing patient care. We hope to expand similar CPS services to other clinics within the health system.

Implementing a Nurse-Driven Protocol for Pneumococcal Vaccination in an Academic Rheumatology Clinic.

OBJECTIVE: Rheumatology patients are at high risk for complications from pneumococcal infections. The goal of this study was to assess the feasibility of implementing a nurse-driven pneumococcal vaccination protocol based on the 2012 Advisory Committee on Immunization Practices (ACIP) guidelines within an academic rheumatology clinic. Our aims were to increase (1) pneumococcal conjugate vaccine (PCV13) and pneumococcal polysaccharide vaccine (PPSV23) monthly vaccination rates in immunosuppressed patients aged 19 to 64 years, and (2) the overall proportion of immunosuppressed patients aged 19 to 64 years who have received both PCV13 and PPSV23 vaccinations by ≥ 10% over a 2-year period. METHODS: We identified eligible adults in the electronic medical record using a search protocol based on preset medication group. We obtained baseline pneumococcal vaccination rates in 2019, calculating the proportion of patients who were unvaccinated, partially vaccinated (received either PCV13 or PPSV23), or fully vaccinated. We created a pneumococcal vaccination protocol based on 2012 ACIP guidelines and converted it into a standing medical order to be implemented by the nursing staff. Postintervention vaccination rates were calculated monthly and at the end of the study period. Multiple comparison testing was performed to assess for significant postintervention changes. RESULTS: The average rate of monthly vaccination with either PCV13 or PPSV23 increased from 4.3% in 2019 to 12.6% in 2021. The proportion of patients who were fully vaccinated increased from 14.6% in 2019 to 26.2% in 2021. Both changes were statistically significant. CONCLUSION: It is feasible to employ a nurse-driven protocol for improving pneumococcal vaccination rates in immunosuppressed patients, despite difficulties posed by coronavirus disease 2019 (COVID-19) pandemic disruptions.

Enhancing Care Partnerships Using a Rheumatology Dashboard: Bringing Together What Matters Most to Both Patients and Clinicians.

OBJECTIVE: Dashboards can support person-centered care by helping people partner with their clinicians to coproduce care based on preferences, shared decision-making, and evidence-based treatments. We engaged caregivers of children with juvenile idiopathic arthritis (JIA), adults with rheumatoid arthritis (RA), and clinicians in a pilot study to assess their experiences and the utility and impact of an electronic previsit questionnaire and point-of-care dashboard to support coproduction of rheumatology care. METHODS: We employed a mixed-methods design to assess users' perceptions of a customized electronic health record rheumatology module at four pediatric rheumatology practices and two adult rheumatology practices. We surveyed a convenience sample of caregivers of children with JIA (n = 113), adults with RA (n = 116), and clinicians (n = 12). We conducted semistructured interviews with 13 caregivers and patients and six care teams. Experiences were evaluated using descriptive statistics and thematic analyses. RESULTS: Caregivers of children with JIA and adults with RA reported the dashboards were useful during discussions (88%) and helped them talk about what mattered most (82%), make health care decisions (83%), and create a treatment plan (77%). Clinicians provided similar feedback. Two-thirds (67%) of caregivers and adults and 55% of clinicians would recommend the dashboard to peers. System usability scores (77.1 ± 15.6) were above average. Dashboards helped users make sense of health information, communicate more effectively, and make decisions. Improvements to the dashboards and workflows could enhance patient self-management and clinician efficiency. CONCLUSION: Visual point-of-care dashboards can support caregivers, patients, and clinicians to coproduce rheumatology care. Findings demonstrate a need to spread and scale for broader benefit and impact.

Seronegative immune-mediated necrotising myopathy complicated by fulminant myocarditis resulting in cardiogenic shock and cardiac arrest.

A woman in her late 30s recently diagnosed with viral myopericarditis presented with 1 month of worsening fatigue, diffuse myalgias and chest pain radiating to her back. While undergoing work-up for chest wall myositis, she rapidly decompensated, developing heart failure and acute hypoxaemic respiratory failure. Her clinical course was complicated by cardiac arrest and severe cardiogenic shock requiring intra-aortic balloon pump support.

A sixty-five-year-old man with rash, fever, and generalized weakness.

Diffuse erythematous rash accompanied by high-grade fever, eosinophilia, and facial edema can be caused by a variety of infective, allergic, or systemic etiologies. We present a case of 65-year-old man with septic arthritis, who had a vancomycin antibiotic spacer placed in his infected knee and was also started on intravenous (i.v.) vancomycin. After 2 weeks he presented with sudden onset of fever and generalized weakness. Physical examination was significant for tachycardia and hypotension, facial edema, diffuse erythematous rash, and bilateral wheezing. Laboratory values indicated acute renal insufficiency associated with eosinophiluria and significant peripheral eosinophilia. Septic shock was highly suspected and he was treated with i.v. fluids and broad-spectrum antibiotics. Despite aggressive management his condition rapidly deteriorated with persistent of shock state, increase in facial edema, and rash. Other suspected etiologies included hypersensitivity reactions to i.v. antibiotics (piperacillin/tazobactam) or vancomycin, systemic vasculitis, or idiosyncratic reactions to medications such as Stevens-Johnson syndrome. The patient was started on high-dose i.v. steroids, which led to improvement of his clinical condition. Clinical presentation of adverse drug reactions is highly variable and may present as potentially life-threatening multiorgan failure. Early recognition of the etiology and removing the offending agent is important to improve the outcome.

Coupled Effect of Electronic Medical Record Modifications and Lean Six Sigma Methodology on Rheumatoid Arthritis Disease Activity Measurement and Treat-to-Target Outcomes.

OBJECTIVE: Rheumatoid arthritis (RA) disease activity assessment is critical for treatment decisions and treat to target (T2T) outcomes. Utilization of the electronic medical record (EMR) and techniques to improve the routine capture of disease activity measures in clinical practice are not well described. We leveraged a Lean Six Sigma (LSS) approach, a data-driven five-step process improvement and problem-solving methodology, coupled with EMR modifications to evaluate improvement in disease activity documentation and patient outcomes. METHODS: A RA registry was established, and structured fields for Routine Assessment of Patient Index Data (RAPID3) and Clinical Disease Activity Index (CDAI) were built in the EMR, along with a dashboard to display provider performance rates. An initial rapid-cycle improvement intervention was launched, and subsequent LSS improvement cycles helped in standardization of clinic workflow, modifying provider behaviors, and motivating better documentation practices. Trends related to CDAI score categories were compared over time using run charts. RESULTS: Our project included 1322 patients with RA and 10 241 encounters between April 2016 and December 2019. Initially, RAPID3 completion rates increased from 16% to 50%, and CDAI from 15% to 44% from the RCI intervention. Post LSS intervention, the RAPID3 rate increased to more than 90% (sustained at 85%), and CDAI rate increased to more than 80% (sustained at 72%). The patients in the low disease/remission category increased from 54% to 66% (p < 0.001), and those in the high disease category decreased from 15% to 7% (p < 0.001), demonstrating improved T2T outcomes. CONCLUSION: Combining EMR modifications with systems redesign utilizing LSS approach led to impressive and sustained improvement in disease activity documentation and T2T outcomes.

Improving Diabetic Retinopathy Screening Among Patients With Diabetes Mellitus Using the Define, Measure, Analyze, Improve, and Control Process Improvement Methodology.

ABSTRACT: Diabetic retinopathy, a complication of diabetes mellitus (DM), is the leading cause of blindness in the United States. Early detection and appropriate timely treatment would result in 50-70% reduction in blindness due to DM, with a positive economic impact on patients and the healthcare system. The purpose of our project is to improve screening rates for retinopathy among patients with DM seen in a large endocrinology clinic applying the Lean Six Sigma Define, Measure, Analyze, Improve, and Control project framework and clinical decision support tools embedded in the electronic health record (EHR). Retinopathy screening rates improved from 49% to 72% by the end of the project. Interventions included identifying care gaps using a population registry, patient outreach through the electronic medical record patient portal, placing referrals to ophthalmology, improving documentation in health maintenance, and tracking improvement for sustainability. Our results demonstrate that process improvement methodologies and EHR tools can be successfully applied to improve care and clinical outcomes in patients with DM.

Applying Lean Six Sigma to Improve Depression Screening and Follow-Up in Oncology Clinics.

ABSTRACT: Depression is a common and serious illness that impairs the health of individuals and societies globally. It is associated with a significant economic burden, with productivity losses exceeding $40 billion dollars annually in the United States (U.S.) alone. This project focused on the use of a systematic, data-driven approach to improve the screening rate for depression in an academic, metropolitan cancer center located in North Texas. A multidisciplinary team collaboratively applied Lean Six Sigma education, methods, and tools within oncology and psychiatry clinics to address the increased risk of depression among oncology patients. Improving the standardization of screening and follow-up processes, resulted in a 44% sustained increase in the depression screening and follow-up performance rate. This improvement was verified to be statistically significant through the use of control charts toward the end of the project.

The Development of the Rheumatology Informatics System for Effectiveness Learning Collaborative for Improving Patient-Reported Outcome Collection and Patient-Centered Communication in Adult Rheumatology.

OBJECTIVE: Patient-reported outcomes (PROs) are an integral part of treat-to-target approaches in managing rheumatoid arthritis (RA). In clinical practice, however, routine collection, documentation, and discussion of PROs with patients are highly variable. The RISE LC (Rheumatology Informatics System for Effectiveness Learning Collaborative) was established to develop and share best practices in PRO collection and use across adult rheumatology practices in the United States METHODS: The goals of the RISE LC were developed through site surveys and in-person meetings. Participants completed a baseline survey on PRO collection and use in their practices. RISE LC learning sessions focused on improving communication around PROs with patients and enhancing shared decision-making in treatment plans. During the coronavirus disease 2019 (COVID-19) pandemic, the RISE LC pivoted to adapt PRO tools for telehealth. RESULTS: At baseline, all responding sites (n = 15) had established workflows for collecting PROs. Most sites used paper forms alone. PRO documentation in electronic health records was variable, with only half of the sites using structured data fields. To standardize and improve the use of PROs, participants iteratively developed a Clinical Disease Activity Index-based RA Disease Activity Communication Tool to solicit treatment goals and improve shared decision-making across sites. The COVID-19 pandemic necessitated developing a tool to gauge PROs via telehealth. CONCLUSION: The RISE LC is a continuous, structured method for implementing strategies to improve PRO collection and use in rheumatological care, initially adapting from the Learning Collaborative model and extending to include features of a learning network. Future directions include measuring the impact of standardized PRO collection and discussion on shared decision-making and RA outcomes.

User stories as lightweight requirements for agile clinical decision support development.

OBJECTIVE: We sought to demonstrate applicability of user stories, progressively elaborated by testable acceptance criteria, as lightweight requirements for agile development of clinical decision support (CDS). MATERIALS AND METHODS: User stories employed the template: As a [type of user], I want [some goal] so that [some reason]. From the "so that" section, CDS benefit measures were derived. Detailed acceptance criteria were elaborated through ensuing conversations. We estimated user story size with "story points," and depicted multiple user stories with a use case diagram or feature breakdown structure. Large user stories were split to fit into 2-week iterations. RESULTS: One example user story was: As a rheumatologist, I want to be advised if my patient with rheumatoid arthritis is not on a disease-modifying anti-rheumatic drug (DMARD), so that they receive optimal therapy and can experience symptom improvement. This yielded a process measure (DMARD use), and an outcome measure (Clinical Disease Activity Index). Following implementation, the DMARD nonuse rate decreased from 3.7% to 1.4%. Patients with a high Clinical Disease Activity Index improved from 13.7% to 7%. For a thromboembolism prevention CDS project, diagrams organized multiple user stories. DISCUSSION: User stories written in the clinician's voice aid CDS governance and lead naturally to measures of CDS effectiveness. Estimation of relative story size helps plan CDS delivery dates. User stories prove to be practical even on larger projects. CONCLUSIONS: User stories concisely communicate the who, what, and why of a CDS request, and serve as lightweight requirements for agile development to meet the demand for increasingly diverse CDS.

Objective measurement of shade color in age estimation.

INTRODUCTION: Age estimation is an important subspecialty of forensic medicine. Dental hard tissues are highly resistant to degradation and putrefaction. Enamel is translucent and varies in color from light yellow to grey white. The color of the teeth has been reported to be affected by chronological age. Enamel color may also depend on environmental factors viz. diet, occupational habits, vitamin deficiencies, fluoride level in drinking water etc., It has been found that color changes in dentin vary from white to yellow. Studies have been done to measure the dentin color for age estimation. AIM: To find a correlation between the enamel color and chronological age and secondly to estimate the age of an individual from enamel color. MATERIAL AND METHODS: A total of 300 patients visiting the outpatient department of oral medicine and radiology were selected. Out of those, 150 were men and 150 women. The patients were divided into V groups based on the age. A thorough case history was taken for all the patients. Maxillary Central and Lateral incisor was used for the estimation of shade. The enamel color was evaluated using a VITA classical shade guide. STATISTICAL ANALYSIS: Data were exported to an Excel spread sheet and statistical analysis was performed using the SPSS. Linear regression analysis was used to find correlations between age and enamel shade. RESULTS: In the group 1 and 2 i.e. from 15 to 36 years, the shades A 2 and B 2 (reddish hue) was found to be most common. While in the group 3 and 4, shades ranged from A 3 to B 3 (brownish to yellowish hue). In the patients above 59 years i.e. group 5 the enamel shade with greyish hue was found to be most common. CONCLUSION: Age determination using enamel color can be tried in forensic cases in the identification of individuals with no birth records.