Comparative analysis of real-world adherence and persistence patterns with vibegron, mirabegron, and anticholinergics in patients with overactive bladder: A retrospective claims study.

INTRODUCTION: Vibegron is a selective ß3-adrenergic receptor agonist that was approved by the US Food and Drug Administration in December 2020 for the treatment of overactive bladder in adults. This retrospective study assessed US pharmacy claims data to evaluate the real-world adherence and persistence of vibegron compared with mirabegron and with anticholinergics. MATERIALS AND METHODS: This analysis used the Optum Research Database to identify adults with ≥1 pharmacy claim for vibegron, mirabegron, or an anticholinergic from April 1, 2021, to August 31, 2022. Patients had ≥ 90 days of continuous commercial or Medicare medical and pharmacy coverage preindex and ≥ 60 days of continuous pharmacy coverage postindex. Two independent propensity-score models matched patients treated with (1) vibegron versus mirabegron and (2) vibegron versus anticholinergics on key variables such as demographics and clinical characteristics, index copay, days' supply, and time of entry into analysis (index quarter). Adherence was measured by proportion of days covered (PDC) from index to the end of follow-up and was defined as PDC ≥ 80%. Persistence was defined as days to discontinuation of index medication (first 30-day gap) or end of follow-up. RESULTS: The matched vibegron and mirabegron cohorts included 4921 and 9842 patients, respectively, and the matched vibegron and anticholinergic cohorts included 4676 and 9352 patients, respectively. Patients receiving vibegron had greater mean PDC versus patients receiving mirabegron (0.67 vs. 0.64, respectively; p < 0.001) or anticholinergics (0.67 vs. 0.58; p < 0.001). A greater percentage of patients receiving vibegron were adherent versus those receiving mirabegron (49.0% vs. 45.1%, respectively; p < 0.001) or anticholinergics (49.1% vs. 38.5%; p < 0.001). Persistence was longer with vibegron compared with both mirabegron (median [95% CI], 171 [159-182] vs. 128 [122-137] days, respectively; p < 0.001) and anticholinergics (172 [159-183] vs. 91 [91] days; p < 0.001). CONCLUSION: In this retrospective analysis of pharmacy claims data, patients receiving vibegron exhibited significantly higher adherence and demonstrated longer persistence in comparison to matched patient cohorts receiving either mirabegron or anticholinergics.

Real-World Adherence to and Persistence with Vibegron in Patients with Overactive Bladder: A Retrospective Claims Analysis.

INTRODUCTION: Vibegron is a ß3-adrenergic receptor agonist approved for overactive bladder (OAB). This analysis assessed real-world adherence and persistence with vibegron in patients with OAB, along with demographics and clinical characteristics associated with adherence and persistence. METHODS: This retrospective study used the Optum Research Database to identify patients treated with vibegron from April 2021 to August 2022 (identification period). Patients had ≥ 60 days of continuous pharmacy coverage in a commercial or Medicare Advantage plan following the index fill (follow-up). Adherence was assessed as proportion of days covered (PDC) from index to end of follow-up and was defined as PDC ≥ 80%. Persistence was measured as days to discontinuation of therapy (30-day gap) or end of follow-up. Data for adherence and persistence are presented descriptively. Characteristics associated with adherence and persistence were analyzed using multivariable models among patients with medical and pharmacy benefits during the 90 days before index (baseline). RESULTS: Overall, 9992 patients had a vibegron claim during the identification period; 9712 had ≥ 2 months of follow-up. Mean (SD) age was 74.2 (10.7) years; 68.2% were female. Mean (SD) PDC was 0.64 (0.34). Median (95% confidence interval) persistence was 142 (132-153) days. Of the 5073 patients who were ≥ 18 years old with continuous baseline pharmacy and medical benefits ≥ 90 days before index, 2497 (49.2%) were adherent. Patients were more likely to be adherent and persistent if they received a greater days' supply for the index fill and had baseline medication count ≥ 6. Patients were more likely to discontinue if their index copay was > $45. CONCLUSION: Nearly half of the patients initiating vibegron were adherent. Factors associated with adherence and persistence were more likely to be related to prescribing practices than patient characteristics. These results suggest it may be best to follow up with patients approximately 4 to 5 months after initiating treatment with vibegron.

Vibegron is a newer drug for treating overactive bladder. Vibegron was safe and worked well in clinical trials. However, there is no information on use of vibegron in a real-world population that is not a clinical trial. This study looked at how consistently and how long patients took vibegron after starting it. It also looked at what was common in patients who took vibegron consistently. To do this, the study used pharmacy prescription data from April 2021 to August 2022. It examined adherence to the study medication for each patient. Adherence is how many days patients had medication on hand compared to how long they were followed. The study also looked at persistence to the study medication. Persistence is how long a patient takes a medication before they stop taking it. Researchers then examined if there were reasons a patient may or may not take vibegron as prescribed. The study included prescription data for 9712 patients. The average age was 74 years and 68% of patients were female. Patients had their medication 64% of the time (adherence). On average, patients took their medication for 142 days before stopping (persistence). Patients had better adherence and persistence if they received a larger supply of medication at the pharmacy when first prescribed the medication and if they had more medications overall. Patients' age and gender did not affect adherence and persistence. Vibegron may be a good option for patients with overactive bladder. Follow-up with a provider may be considered 4 to 5 months after starting vibegron.

Patient-Reported Outcomes in Venous Thromboembolism: A Systematic Review of the Literature, Current Challenges, and Ways Forward.

BACKGROUND: Venous thromboembolism (VTE) affects >1.2 million Americans annually. Although the clinical outcomes and economic burdens of VTE have been well described, the impact of VTE on patients' health status has yet to be summarized. This systematic review summarizes how patient-reported outcome measures (PROMs) have been used in VTE to date. METHODS AND RESULTS: PubMed/MEDLINE was queried for literature published through March 2023 using PROMs in a population of patients with VTE. Studies were excluded if the reference was an editorial, review, or case report, or if the study included patients with conditions other than VTE. Qualitative analyses were performed. After screening and exclusion, 136 references were identified; 5 described PROM development, 20 focused on PROM validation, and 111 used PROMs in outcomes research. The most used generic PROMs were the 36-item Short-Form Health Survey and EuroQol 5-dimensional questionnaire, and the most common disease-specific PROMs were the Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms and the Pulmonary Embolism Quality of Life Questionnaire. PROMs were used to quantify the changes in health status after diagnosis, characterize the trajectory of subsequent improvement, and identify drivers of continued impairments in health status like postthrombotic syndrome and postpulmonary embolism syndrome. PROMs were also used to investigate the impact of novel treatment modalities on quality of life. CONCLUSIONS: This review demonstrates the many benefits of PROM use, including quantifying changes in health status with treatment, capturing patients' experiences with the treatment itself, and identifying complications of VTE. Incorporating PROMs into VTE care will be an essential component of evaluating the effectiveness of novel therapies and should lead to improved shared decision-making for patients with VTE.

Percutaneous Transluminal Angioplasty for Infrapopliteal Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-analysis of Primary Patency and Binary Restenosis Rates.

PURPOSE: Percutaneous transluminal angioplasty (PTA) remains the mainstay of endovascular therapy for infrapopliteal chronic limb-threatening ischemia (CLTI), but outcomes have not been well characterized using high-quality data. The aim of this meta-analysis was to provide an updated benchmark for rates of primary patency and binary restenosis after PTA using prospectively collected, predominantly core-lab adjudicated randomized controlled trial (RCT) data. MATERIALS AND METHODS: MEDLINE, EMBASE, Cochrane Central, and ClinicalTrials.gov were queried for RCTs published through November 2022 using PTA as a control arm and including patients with infrapopliteal CLTI. Studies were excluded if >25% of patients had intermittent claudication, other vessels were included, or primary patency or binary restenosis were not outcomes. Outcomes were analyzed using random effects models. This analysis was publicly registered (PROSPERO ID#394543). No funding was utilized. RESULTS: Seventeen RCTs were included (1048 patients, 1279 lesions). Pooled primary patency rates using data from 6 RCTs were 68% at 6 months (95% confidence interval [CI]=45%-84%) and 66% at 12 months (95% CI=51%-79%). Pooled binary restenosis rates using data from 11 RCTs were 54% at 6 months (95% CI=33%-73%) and 60% at 9 to 12 months (95% CI=39%-78%). Significant heterogeneity was present in all outcomes (I2>50%, p<0.0001). Publication bias was not observed (Egger's p>0.1). CONCLUSIONS: This meta-analysis provides estimates for binary restenosis and primary patency following PTA utilizing prospectively collected, predominantly core-lab adjudicated data. Results demonstrate 1-year primary patency rates that are 10% to 20% higher than what has been historically used in power calculations. These new estimates will help facilitate more accurate power analysis for future RCTs. CLINICAL IMPACT: Rates of primary patency and binary restenosis after percutaneous transluminal angioplasty (PTA) have not been well-described using high-quality data, and investigators have been utilizing estimates of 40% to 50% and 45% to 65%, respectively, when performing power calculations for trials. This meta-analysis demonstrates using high-quality, prospectively collected, and predominantly core-lab adjudicated randomized controlled trial data that actual rates of primary patency are closer to 60% up to 1 year following PTA and provides the first meta-analysis estimate of binary restenosis rates up to 1 year after PTA. These estimates will help facilitate more accurate power calculations for future RCTs in this space.

Gender Disparities in Presentation, Management, and Outcomes of Acute Pulmonary Embolism.

Pulmonary embolism (PE) is the third most common cause of cardiovascular death; however, gender disparities in PE remain understudied. All PE cases at a single institution between January 2013 and June 2019 were retrospectively reviewed. The clinical presentation, treatment modalities, and outcomes were compared between men and women using univariate and multivariate analyses adjusting for differences in baseline characteristics. A total of 1,345 patients were diagnosed with acute PE, of whom 56.3% were women (n = 757). Women had a significantly higher mean body mass index (29.4 vs 28.4) and a higher frequency of hypertension (53% vs 46%) and hormone use (6.6% vs 0%; all p <0.02). Men had a higher frequency of smoking (45% vs 33%, p <0.0001). Women had significantly lower PE severity index classifications (p = 0.0009). The rates of intensive care unit admission, vasopressor requirements, extracorporeal membrane oxygenation cannulation, and mechanical ventilation were similar between the genders. There was no significant difference in the treatment modality used between the genders. Although the risk factors and PE severity index class differed between the genders, there was no significant difference in resource utilization or treatment modality. Gender was also not a significant predictor of in-hospital mortality, moderate or severe bleeding, increased length of stay, or readmission in the study population.

Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder.

BACKGROUND: Overactive bladder (OAB) is defined as urinary urgency accompanied by frequency and nocturia, with or without urge urinary incontinence (UUI). Vibegron, a selective ß3-adrenergic receptor agonist approved in the US in December 2020, demonstrated efficacy in reducing symptoms of OAB and was safe and well tolerated in the 12-week EMPOWUR trial and its 40-week, double-blind extension trial. The goal of the COMPOSUR study is to evaluate vibegron in a real-world setting to assess patient treatment satisfaction, tolerability, safety, duration of treatment, and persistence. METHODS: This is a 12-month, prospective, observational, real-world study, with an optional 12-month extension to 24 months, in the US assessing adults ≥ 18 years old starting a new course of vibegron. Patients must be previously diagnosed with OAB with or without UUI, symptomatic for ≥ 3 months before enrollment, and receive prior treatment with an anticholinergic, with mirabegron, or with a combination of an anticholinergic and mirabegron. Enrollment is performed by the investigator following exclusion and inclusion criteria guided by US product labeling, reinforcing a real-world approach. Patients complete the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q) monthly and the OAB Questionnaire short form (OAB-q-SF) and Work Productivity and Activity Impairment Questionnaire (WPAI:US) at baseline and monthly for 12 months. Patients are followed up via phone call, in-person visits, or telehealth (ie, virtual) visits. The primary endpoint is patient treatment satisfaction as determined by the OAB-SAT-q satisfaction domain score. Secondary endpoints include percent positive responses to individual OAB-SAT-q questions, additional OAB-SAT-q domain scores, and safety. Exploratory endpoints include adherence and persistence. DISCUSSION: OAB leads to a significant decrease in quality of life, as well as impairment of work activities and productivity. Persistence with OAB treatments can be challenging, often due to lack of efficacy and adverse effects. COMPOSUR is the first study to provide long-term, prospective, pragmatic treatment data for vibegron in the US and the resultant effect on quality of life among patients with OAB in a real-world clinical setting. Trial registration ClinicalTrials.gov identifier: NCT05067478; registered: October 5, 2021.

Association between Hispanic or Latino ethnicity and pulmonary embolism severity, management, and in-hospital outcomes.

BACKGROUND: Hispanic and Latino patients are under-represented in existing healthcare disparities research in pulmonary embolism (PE). The goal of this study was to determine if differences in PE severity, treatment modality, or in-hospital outcomes exist for Hispanic or Latino patients with PE. METHODS: All PE cases from 2013 to 2019 at a single institution were reviewed. Clinical characteristics, imaging findings, intervention types, and in-hospital and 30-day outcomes were collected. Two cohorts were created based on patients' self-reported ethnicity. Outcomes were compared using univariate and multivariate analysis. RESULTS: A total of 1265 patients were identified with confirmed PE; 474 (37%) identified as Hispanic or Latino. Hispanic or Latino patients presented with high-risk PE significantly less often (19% vs 25%, p = 0.03). On univariate analysis, Hispanic or Latino patients had lower rates of PE-specific intervention (15% vs 19%, p = 0.03) and similar rates of inpatient mortality (6.8% vs 7.5%, p = 0.64). On ordinal regression analysis, Hispanic or Latino ethnicity was associated with lower PE severity (OR 0.69, 95% CI 0.54-0.89, p = 0.003). In subgroup analyses of intermediate and high-risk PEs, ethnicity was not a significant predictor of receipt of PE-specific intervention or in-hospital mortality. CONCLUSIONS: At this institution, Hispanic or Latino patients were less likely to present with high-risk PE but had similar rates of inpatient mortality. Future research is needed to identify if disparities in in-hospital care are driving perceived differences in PE severity and what addressable systematic factors are driving higher-than-expected in-hospital mortality for Hispanic or Latino patients.

The Overdose Crisis and Using Alone: Perspectives of People Who Use Drugs in Rural and Semi-Urban Areas of British Columbia.

Background: A significant rise in the rate of overdose deaths in British Columbia (BC), driven by fentanyl contamination of the illicit drug supply, led to the declaration of a public health emergency in 2016. Those at greatest risk of death are people who use alone. This community-based participatory action research study based in the Fraser East region of BC study aimed to overview underlying factors that contribute to unwitnessed overdoses in semi-urban and rural settings. Methods: This descriptive study used a community-based participatory action research model with peer research associates (PRAs) involved at various research stages. In total, 22 interviews were conducted with participants aged 19 and over who used illicit drugs in the Fraser East since the start of the public health emergency in 2016. A collaborative data analysis approach was taken for data interpretation, and content analysis was performed to explore themes surrounding using alone. Results: Among people who use drugs (PWUD), using alone was found to be influenced by (a) the availability of drugs and personal funds, (b) personal safety, (c) stigma and shame, (d) protecting privacy, (e) mental health conditions and addiction, and (f) the lack of engagement with harm reduction services. At times, using alone was due to unforeseen, episode-specific situations. Conclusion: A multi-dimentional and context-specific approach is needed in overdose prevention and response for people who use drugs alone. There is need for enhanced approaches that address or include support services for families to reduce stigma and isolation of those at risk of an overdose.

Genomic characterization of SARS-CoV-2 from vaccine breakthrough cases in Allegheny County, Pennsylvania.

We performed whole genome sequencing on SARS-CoV-2 from 59 vaccinated individuals from southwest Pennsylvania who tested positive between February and September, 2021. A comparison of mutations among vaccine breakthrough cases to a time-matched control group identified potential adaptive responses of SARS-CoV-2 to vaccination.

Surgical Scheduling Impacts Hospital Length of Stay and Associated Healthcare Costs for Patients Undergoing Total Hip and Knee Arthroplasty.

Background: Surgical scheduling, specifically the day of the week on which surgery is performed, has been associated with various postoperative outcomes in patients undergoing lower extremity joint arthroplasty. Purpose: We sought to investigate surgical scheduling as a potential modifiable factor for patient quality metrics and related costs. Methods: In a retrospective prognostic study, all total knee and total hip arthroplasty (TKA/THA) cases that took place in 2017 to 2018 at a multihospital academic health system were queried. Patients were separated by the day of the week the surgery was performed, with Monday/Tuesday compared to Thursday/Friday. Outcomes included length of stay (LOS) (extended LOS defined as 3 days or longer), cost, and complications. Multivariable regression models measured associations between scheduling of surgery and outcomes; odds ratios (OR) and 95% confidence intervals (CIs) are reported. Results: Overall, 1,571 TKA and 992 THA patients were included (65% and 35%, respectively, performed on Monday/Tuesday and 70% and 30%, respectively, performed on Thursday/Friday). Patients undergoing TKA on Monday/Tuesday versus Thursday/Friday had higher American Society of Anesthesiologists scores (42% vs 33% with score of 3 or higher) but less often an extended LOS (31% vs 54%; adjusted OR: 2.76, 95% CI: 2.22-3.46), lower skilled nursing facility costs (unadjusted mean, $12,515 vs $14,154) and lower home health aide costs (unadjusted mean, $3,793 vs $4,192). Similar patterns were observed in THA patients. Conclusion: These results from institutional data suggest that surgical scheduling is a modifiable factor possibly associated with postoperative outcomes. Furthermore, more rigorous study is warranted.

Genomic Diversity of Hospital-Acquired Infections Revealed through Prospective Whole-Genome Sequencing-Based Surveillance.

Healthcare-associated infections (HAIs) cause mortality, morbidity, and waste of health care resources. HAIs are also an important driver of antimicrobial resistance, which is increasing around the world. Beginning in November 2016, we instituted an initiative to detect outbreaks of HAIs using prospective whole-genome sequencing-based surveillance of bacterial pathogens collected from hospitalized patients. Here, we describe the diversity of bacteria sampled from hospitalized patients at a single center, as revealed through systematic analysis of bacterial isolate genomes. We sequenced the genomes of 3,004 bacterial isolates from hospitalized patients collected over a 25-month period. We identified bacteria belonging to 97 distinct species, which were distributed among 14 groups of related species. Within these groups, isolates could be distinguished from one another by both average nucleotide identity (ANI) and principal-component analysis of accessory genes (PCA-A). Core genome genetic distances and rates of evolution varied among species, which has practical implications for defining shared ancestry during outbreaks and for our broader understanding of the origins of bacterial strains and species. Finally, antimicrobial resistance genes and putative mobile genetic elements were frequently observed, and our systematic analysis revealed patterns of occurrence across the different species sampled from our hospital. Overall, this study shows how understanding the population structure of diverse pathogens circulating in a single health care setting can improve the discriminatory power of genomic epidemiology studies and can help define the processes leading to strain and species differentiation. IMPORTANCE Hospitalized patients are at increased risk of becoming infected with antibiotic-resistant organisms. We used whole-genome sequencing to survey and compare over 3,000 clinical bacterial isolates collected from hospitalized patients at a large medical center over a 2-year period. We identified nearly 100 different bacterial species, which we divided into 14 different groups of related species. When we examined how genetic relatedness differed between species, we found that different species were likely evolving at different rates within our hospital. This is significant because the identification of bacterial outbreaks in the hospital currently relies on genetic similarity cutoffs, which are often applied uniformly across organisms. Finally, we found that antibiotic resistance genes and mobile genetic elements were abundant and were shared among the bacterial isolates we sampled. Overall, this study provides an in-depth view of the genomic diversity and evolutionary processes of bacteria sampled from hospitalized patients, as well as genetic similarity estimates that can inform hospital outbreak detection and prevention efforts.

Development of metastatic Merkel cell carcinoma following the excision of same-sided recurrent auricular melanoma.

Merkel cell carcinoma (MCC) is a rare neuroendocrine malignancy of the skin that is highly aggressive and often metastasizes early. MCC is diagnosed based on histopathological findings and is most commonly treated with surgical resection, which may be accompanied by chemotherapy and/or radiation. This report describes a 55-year-old male patient with the history of recurrent malignant melanoma of the right pinna and subsequent excision. Three years following the excision of melanoma, he presented with a lesion to the right forehead as well as a right-sided neck mass that were found to be metastatic Merkel cell carcinoma.

Faith and resilience.

In this short essay, we sketch a theory of faith that features resilience in the face of challenges to relying on those in whom you have faith. We argue that it handles a variety of both religious and secular faith-data, e.g., the value of faith in relationships of mutual faith and faithfulness, how the Christian and Hebrew scriptures portray pístis and 'emûnah, and the character of faith as it is often expressed in popular secular venues.

Diabetes Is Predictive of Postoperative Outcomes and Readmission Following Posterior Lumbar Fusion.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: The present study analyzes complication rates and episode-based costs for patients with and without diabetes mellitus (DM) following posterior lumbar fusion (PLF). METHODS: PLF cases at a single institution from 2008 to 2016 were queried (n = 3226), and demographic and perioperative data were analyzed. Patients with and without the diagnosis of DM were compared using chi-square, Student's t test, and multivariable regression modeling. RESULTS: Patients with diabetes were older (63.10 vs 56.48 years, P < .001) and possessed a greater number of preoperative comorbidities (47.84% of patients had Elixhauser Comorbidity Index >0 vs 42.24%, P < .001) than did patients without diabetes. When controlling for preexisting differences, diabetes remained a significant risk factor for prolonged length of stay (OR = 1.59, 95% CI 1.26-2.01, P < .001), intensive care unit stay (OR = 1.52, 95% CI 1.07-2.17, P = .021), nonhome discharge (OR = 1.86, 95% CI 1.46-2.37, P < .001), 30-day readmission (OR = 2.15, 95% CI 1.28-3.60, P = .004), 90-day readmission (OR = 1.65, 95% CI 1.05-2.59, P = .031), 30-day emergency room visit (OR = 2.15, 95% CI 1.27-3.63, P = .004), and 90-day emergency room visit (OR = 2.27, 95% CI 1.41-3.65, P < .001). Cost modeling controlling for overall comorbidity burden demonstrated that diabetes was associated with a $1709 increase in PLF costs (CI $344-$3074, P = .014). CONCLUSIONS: The present findings indicate a correlation between diabetes and a multitude of postoperative adverse outcomes and increased costs, thus illustrating the substantial medical and financial burdens of diabetes for PLF patients. Future studies should explore preventive measures that may mitigate these downstream effects.

The Impact of Diabetes on Outcomes and Health Care Costs Following Anterior Cervical Discectomy and Fusion.

STUDY DESIGN: Retrospective cohort study. OBJECTIVES: Anterior cervical discectomy and fusion (ACDF) is commonly used to treat an array of cervical spine pathology and is associated with good outcomes and low complication rates. Diabetes mellitus (DM) is a common comorbidity for patients undergoing ACDF, but the literature is equivocal about the impact it has on outcomes. Because DM is a highly prevalent comorbidity, it is crucial to determine if it is an associated risk factor for outcomes after ACDF procedures. METHODS: Patients at a single institution from 2008 to 2016 undergoing ACDF were compared on the basis of having a prior diagnosis of DM versus no DM. The 2 cohorts were compared utilizing univariate tests and multivariate logistic and linear regressions. RESULTS: Data for 2470 patients was analyzed. Diabetic patients had significantly higher Elixhauser scores (P < .0001). Univariate testing showed diabetic patients were more likely to suffer from sepsis (0.82% vs 0.10%, P = .03) and bleeding complications (3.0% vs 1.5%, P = .04). In multivariate analyses, diabetic patients had higher rates of non-home discharge (odds ratio [OR] = 1.37, 95% confidence interval [CI] = 1.07-1.75, P = .013) and prolonged length of stay (OR = 1.95, 95% CI = 1.25-3.05, P = .003), but similar complication (OR = 1.46, 95% CI = 0.85-2.52, P = .17), reoperation (OR = 0.77, 95% CI = 0.33-1.81, P = .55), and 90-day readmission (OR = 1.53, 95% CI = 0.97-2.43) rates compared to nondiabetic patients. Direct cost was also shown to be similar between the cohorts after adjusting for patient, surgical, and hospital-related factors (estimate = -$30.25, 95% CI = -$515.69 to $455.18, P = .90). CONCLUSIONS: Diabetic patients undergoing ACDF had similar complication, reoperation, and readmission rates, as well as similar cost of care compared to nondiabetic patients.

Whole-Genome Sequencing Surveillance and Machine Learning of the Electronic Health Record for Enhanced Healthcare Outbreak Detection.

BACKGROUND: Most hospitals use traditional infection prevention (IP) methods for outbreak detection. We developed the Enhanced Detection System for Healthcare-Associated Transmission (EDS-HAT), which combines whole-genome sequencing (WGS) surveillance and machine learning (ML) of the electronic health record (EHR) to identify undetected outbreaks and the responsible transmission routes, respectively. METHODS: We performed WGS surveillance of healthcare-associated bacterial pathogens from November 2016 to November 2018. EHR ML was used to identify the transmission routes for WGS-detected outbreaks, which were investigated by an IP expert. Potential infections prevented were estimated and compared with traditional IP practice during the same period. RESULTS: Of 3165 isolates, there were 2752 unique patient isolates in 99 clusters involving 297 (10.8%) patient isolates identified by WGS; clusters ranged from 2-14 patients. At least 1 transmission route was detected for 65.7% of clusters. During the same time, traditional IP investigation prompted WGS for 15 suspected outbreaks involving 133 patients, for which transmission events were identified for 5 (3.8%). If EDS-HAT had been running in real time, 25-63 transmissions could have been prevented. EDS-HAT was found to be cost-saving and more effective than traditional IP practice, with overall savings of $192 408-$692 532. CONCLUSIONS: EDS-HAT detected multiple outbreaks not identified using traditional IP methods, correctly identified the transmission routes for most outbreaks, and would save the hospital substantial costs. Traditional IP practice misidentified outbreaks for which transmission did not occur. WGS surveillance combined with EHR ML has the potential to save costs and enhance patient safety.

Barriers to Collection and Use of Patient-Reported Outcomes A Multi-Institutional Survey of Surgeons and Care Teams.

BACKGROUND: Currently there is a lack of insight into what total joint replacement (TJR) surgeons and care teams perceive to be the greatest barriers to collection and use of patient reported outcomes (PROs). The goal of this study was to provide insight on this topic using a multi-institutional survey. METHODS: A thorough literature review on PROs adoption and utilization was conducted to generate a 26-question survey. This survey was disseminated to joint replacement surgeons, associate providers (e.g., nurse practitioners and physician assistants), and other non-clinical health care staff involved in PRO collection at three institutions. Data from all respondents were analyzed qualitatively and using chi-square tests. RESULTS: Of 37 responses, 24 (65%) were from orthopedic surgeons and 13 (35%) from other clinical and administrative staff. Seventy-one percent of surgeons thought that integration into clinical workflow was the greatest barrier to initial implementation of PROs, while the greatest long-term limitations were accessibility (50%), patient engagement and compliance (50%), ability to represent their health in PROs (54%), and consistency across providers (50%). For PROs to be clinically useful, surgeons required that they should be linked to the EMR interface (65%), immediately available (59%), and are trended over time (59%). Fifty-four percent of surgeons across institutions believed administrative leadership was ultimately responsible for successful PROs implementation, while 46% of other staff believed that responsibility fell to surgeons and clinical staff. CONCLUSION: Surgeons perceive that the greatest barriers to PRO collection are workflow integration initially, and patient engagement, compliance, and ability to represent their health in PROs over the long term. Stakeholders inconsistently report which group is responsible for successful implementation.

Orthopedic Surgeon and Care Team Perceptions and Use of Patient-Reported Outcomes in Total Joint Replacement Patients.

BACKGROUND: The recent shift toward value-based health care and bundled payments in orthopedic surgery has increased the use patient-reported outcomes (PROs) in standard clinical care. Such assessments of patient function and satisfaction are particularly important among total joint arthroplasty (TJA) patients to monitor postoperative health. PURPOSE: The purpose of this study was to assess orthopedic care team perceptions of current and future PRO usage and compare current rates and modes of PRO collection between three urban, academic health care systems. METHODS: A literature search was conducted on current PRO uses and barriers to their adoption to generate a 26-question survey. The survey was disseminated to orthopedic surgeons and care team members at three academic health care institutions (institutions A, B, and C). Responses were analyzed for qualitative and quantitative insights. RESULTS: Among institutions A, B, and C, PRO collection generally declined from baseline (60%, 90%, 89%) to 6 weeks (67%, 82%, 71%) and 3 months postoperatively (44%, 36%, 47%). However, there were large variations in reported PRO collection intervals among institutions. Respondents reported assessing patient baseline functional status as the most useful current application of PROs and cited the prediction of patient benefit from TJA as the most useful future application for PROs. Though respondents were largely optimistic about PRO utility in clinical care, a small minority remained skeptical. CONCLUSIONS: Perceptions of PRO utilization and collection intervals varied considerably among respondents. For PROs to be an accurate and useful clinical tool, standardization and thorough understanding of PRO collection among orthopedic care team members is essential.