An observational study to understand burden and cost of care in adults diagnosed with refractory chronic cough (RCC) or unexplained chronic cough (UCC).

BACKGROUND: Refractory and unexplained chronic cough (RCC and UCC) necessitate frequent referral for specialist evaluations, but data on healthcare resource utilisation and costs are lacking. METHODS: This observational study enrolled adults with RCC or UCC attending a specialist cough clinic and included a control cohort, both from North West England, matched 1:5 for age, gender and smoking history. Primary and secondary care data were obtained for the 5 years prior to and 2 years post initial clinic visit (index). The primary endpoint was the total 5-year healthcare cost to the UK NHS pre-RCC or UCC diagnosis compared to the control cohort. RESULTS: Mean age at index for the 200 RCC or UCC consented patients was 62.2 ± 11.4 years; 71% were female, and 68% had never smoked. Mean duration of symptoms pre-diagnosis was 8.0 ± 9.4 years. Mean cough severity score was 63.7 ± 23.2 mm at index on a Visual Analog Scale, and Leicester Cough Questionnaire total score was 10.9 ± 4.1. GP data were available for 80 patients and mean total cost over the 5 years pre-diagnosis (index date) was 3.0-fold higher (95% CI 2.3, 3.9) than in the control cohort (p < 0.001). Most excess costs were related to visits and procedures carried out in secondary care. RCC- or UCC-associated costs decreased post-diagnosis, but remained higher than those of controls. CONCLUSION: Diagnosis of RCC or UCC requires significant health resource utilisation in the 5 years prior to a specialist clinic diagnosis. Resource utilisation was less after diagnosis, but remained higher than in a matched control cohort.

Prevalence, clinical characteristics, and disease burden of chronic cough in Italy: a cross-sectional study.

BACKGROUND: Chronic cough has been associated with reduced health-related quality of life, negative impacts on sleep, work, and other daily activities, and increased use of health care resources. Little is known about the prevalence of chronic cough in Italy. In the present study we sought to estimate the prevalence of chronic cough in Italy, describe sociodemographic and clinical characteristics associated with chronic cough, and characterize the impact of chronic cough on overall health and wellness, work and other daily activities, and health care resource use. METHODS: We conducted a cross-sectional study to collect sociodemographic and health-related data from Italian residents who participated in the 2020 National Health and Wellness Survey (N = 10,026). To assess the characteristics and burden of chronic cough, adults who indicated that they had experienced chronic cough during the prior 12 months were compared with propensity score-matched controls without chronic cough. RESULTS: The estimated weighted lifetime and 12-month prevalence of chronic cough were estimated as 9.2% and 6.3%, respectively. Compared with matched controls, respondents with chronic cough had significantly lower measures of overall physical and mental health (P < .001 for both comparisons), and significantly higher rates of anxiety, depression, and sleep disorders (P < .001 for all comparisons). Chronic cough was significantly associated with higher rates of impairment of work and other activities (P < .001 for all comparisons) in the past 7 days, any-cause emergency department visits and hospitalizations in the prior 6 months (P < .001 for both comparisons), and more visits to general and specialist health care providers (P < .001 for both comparisons) in the prior 6 months. CONCLUSIONS: In Italy, chronic cough affects an estimated 3.3 million adults annually and represents a significant burden to individuals and the health care system. TAKE HOME MESSAGE: Little is known about the prevalence of chronic cough in Italy. We found that, in Italy chronic cough represents a significant burden to individuals and the health care system, affecting an estimated 3.3 million adults annually.

Prevalence and burden of chronic cough in France.

Background: Chronic cough is a common condition that is associated with lower health-related quality of life and greater healthcare resource use. There are limited data on the prevalence, population characteristics and burden of chronic cough in France. Methods: This was a cross-sectional study based on responses from French adult residents to the 2020 National Health and Wellness Survey. Respondents with chronic cough were compared to 1:3 propensity score-matched controls without chronic cough. Results: The weighted lifetime and 12-month prevalence of chronic cough were estimated as 7.5% and 4.8%, respectively. Respondents with chronic cough reported significantly worse perceived health than matched controls, with lower mean±sd scores of 46.68±9.28 versus 50.42±8.26 on the physical health component and 40.32±9.87 versus 44.32± 9.69 on the mental health component of the Medical Outcomes Study 12-item Short Form Survey Version 2 survey (p<0.001 for both comparisons). Respondents with chronic cough also had higher rates of moderate-to-severe forms of anxiety (24.4% versus 12.4%) and depression (36.4% versus 20.2%); higher rates of multiple forms of sleep disturbance; greater impairment of work productivity (38.2% versus 25.5%) and other activities (41.8% versus 28.2%; p<0.001 for all comparisons). Respondents with chronic cough also had higher rates of all-cause healthcare resource use including emergency room visits, hospitalisation, and overall and specialist healthcare provider visits compared to controls (p<0.001 for all comparisons). Conclusion: Chronic cough is a common condition in France that is associated with lower health-related quality of life and greater healthcare resource utilisation.

Hospitalization Among Patients Treated With Molnupiravir: A Retrospective Study of Administrative Data.

PURPOSE: Molnupiravir is an oral antiviral agent authorized for emergency use to treat mild to moderate cases of coronavirus disease 2019 (COVID-19) in adults at high risk for progression to severe clinical outcomes. This study aimed to describe patient characteristics and health outcomes in a cohort of adult patients treated with molnupiravir in an outpatient setting in the United States. METHODS: This was a retrospective cohort study of adults identified in the HealthVerity database with a pharmacy claim for molnupiravir between December 24, 2021, and April 14, 2022. Hospitalization and health care use were assessed over the 28 days after the molnupiravir pharmacy claim. FINDINGS: Among 26,554 patients identified, 71.1% were aged ≥50 years and 58.9% were female. A total of 8794 patients (33.1%) had received at least 1 dose of the COVID-19 vaccine. The most prevalent risk factors for severe COVID-19 identified were hypertension (45.1%), steroid and/or immunosuppressant use (39.6%), and being obese or overweight (24.6%), with 79.1% of patients having ≥1 risk factor. The majority (61.0%) of patients were prescribed comedications contraindicated with or had the potential for major drug-drug interactions with ritonavir-containing regimens. Within 28 days after initiating molnupiravir, 3.3% of patients were hospitalized for any cause and 1.7% for COVID-19-related reasons. Among all hospitalized patients, 9.2% were admitted to an intensive care unit, 3.9% received oxygen, and 3.8% required mechanical ventilation. IMPLICATIONS: The majority of patients treated with molnupiravir in early 2022 had at least one risk factor for severe COVID-19 and had comedications that could require treatment modification or monitoring if given a ritonavir-containing regimen. Hospitalization was uncommon after treatment with molnupiravir, with COVID-19-related inpatient admission in <2% of patients. Among those hospitalized, patient use of intensive care and oxygen-based resources was infrequent. The study design, however, does not permit any conclusions regarding the effectiveness of molnupiravir.

Burden of chronic cough in the UK: results from the 2018 National Health and Wellness Survey.

Background: Chronic cough, defined as daily cough for at least 8 weeks, negatively affects quality of life and work productivity and increases healthcare resource utilisation. We aimed to determine the prevalence and burden of chronic cough in the UK. Methods: Study participants were general population respondents to the 2018 UK National Health and Wellness Survey (NHWS). Respondents completed survey questions relating to health, quality of life, work productivity and activity impairment, and use of healthcare resources. Prevalence estimates were projected to the UK population using post-stratification sampling weights to adjust for sampling bias. The population with chronic cough was matched 1:3 with a group without chronic cough, using propensity score matchingon age, sex and the modified Charlson Comorbidity Index. Results: Of 15 000 NHWS respondents, 715 reported chronic cough in the previous 12 months and 918 during their lifetime. Weighted to the UK adult population, the 12-month prevalence of chronic cough was 4.9% and lifetime prevalence was 6.2%. Prevalence of chronic cough was higher among older respondents and those with smoking histories. Chronic cough respondents experienced higher rates of severe anxiety and depression in the past 2 weeks than matched controls. Poor sleep quality and loss of work productivity were also observed. More chronic cough respondents visited a healthcare provider in the past 6 months than respondents without chronic cough with a mean of 5.8 and 3.7 visits per respondent, respectively. Conclusion: Adults with chronic cough report lower quality of life, reduced work productivity and greater healthcare resource utilisation than matched controls without chronic cough.

Prevalence of chronic cough and patient characteristics in adults in Spain: A population-based cross-sectional survey.

BACKGROUND: Chronic cough (CC) represents a significant health burden. This study assessed the prevalence of CC (defined as per international guidelines as cough duration >8 weeks) in Spanish adults and compared characteristics between CC and non-CC cohorts. METHODS: CC cohorts were compiled using data from adult respondents to the 2020 Spanish cross-sectional online National Health and Wellness Survey (NHWS). Using propensity scores, respondents experiencing CC during their lifetime and the previous 12 months were matched 3:1 to respondents without CC and their health characteristics were compared. The number of Spanish adults affected with CC was estimated using weighted CC prevalence. RESULTS: CC during their lifetime or the previous 12 months was experienced by 579 (8.2%) and 389 (5.5%) of 7074 NHWS respondents, of whom 233 (38.5%) and 171 (44.0%), respectively, had physician-diagnosed CC. Based on weighted prevalence rates, lifetime and 12-month CC were estimated to affect ≈3.3 million and ≈2.2 million Spanish adults, respectively. Relative to the non-CC cohort, the 12-month CC cohort consistently demonstrated poorer health status, poorer mental health, greater healthcare utilization, and lower productivity at work and home. CONCLUSION: This study contributes novel data regarding the prevalence of CC in Spain, suggests that CC is underdiagnosed, and reflects that CC and related comorbidities inflict a significant health burden in the affected population.

Chronic cough in Germany: results from a general-population survey.

BACKGROUND: Chronic cough (CC) which is defined ≥8 weeks is a common condition in clinical practice. However, estimates of prevalence and associated comorbidities in German adults and key subgroups of age and gender are lacking. METHODS: Cross-sectional study based on a representative panel of 15 020 adult subjects of the general population who completed the German National Health and Wellness Survey, reporting CC and questions about comorbidities. Lifetime and 12-month prevalence are presented as unweighted estimates. RESULTS: The lifetime CC prevalence was 6.5% (range across age groups 5.1%-8.3%) and the 12-month prevalence was 4.9% (range 3.7-5.7%). The prevalence of diagnosed CC was 2.8% (range 0.9-4.1%) and the prevalence of persons currently on any prescription to treat CC was 0.6% (range 0.2-1.4%). Respondents who experienced CC were 52.0±17.0 years old, with a higher prevalence in those aged 50 years and older. Persons with CC had higher morbidity scores and were diagnosed with an increased number of comorbidities, most frequently diagnoses of the respiratory system (71.0%), followed by digestive tract disorders (34.0%) and sleep disorders (37.6%). CONCLUSIONS: In a broadly representative sample of German adults, lifetime and 12-month prevalence of CC was greatest in current and former smokers and those older ≥50 years of age. Comorbidities are frequent and may complicate management of these patients.

[Identification of epithelial-mesenchymal transition markers (EMT) by immunohistochemistry in pediatric osteosarcoma and association with clinical outcomes]. / Identificación de marcadores de transición epitelio-mesénquima (TEM) por inmunohistoquímica en osteosarcoma pediátrico y asociación con desenlaces clínicos.

The epithelial-mesenchymal transition (EMT) is the ability of epithelial and mesenchymal cells to exchange phenotypes transiently. Its identification in carcinomatous cells has been associated with aggressive clinical phenotypes. In sarcomas, this ability is under study. OBJECTIVE: to evaluate the expression of two transcription factors involved in EMT by immunohistochemistry in pediatric osteosarcoma and its association with clinical outcomes. PATIENTS AND METHOD: A retrospective cohort study in children under 18 years of age with osteosarcoma diagnosis. Immunohistochemistry was performed for Snail and Twist-1 expressions from samples collected at the time of diagnosis. Correlations between immunohistochemistry and the clinical outcomes and overall survival were performed. RESULTS: 53 patients were included. There were 26 positive cytoplasmic cases (49.1%) in Snail expression and were correlated with the presence of multiple metastases (p = 0.02) and distant bone metastases (p = 0.01). On the other hand, 45 cases (84.9%) were positive in Twist-1 expression in the nuclear location, showing no association with the analyzed clinical variables. CONCLUSIONS: Snail and Twist-1 were frequently expressed in pediatric cases of osteosarcoma. Cytoplasmic Snail was correlated with the presence of multiple metastatic disease and distant bone metastases. The positivity of both markers suggests the activation of these proteins as regulators of EMT events in this tumor, suggesting a role in the phenomena related to the clinical presentation of the disease.

Prevalence and Burden of Chronic Cough in the United States.

BACKGROUND: Chronic cough is a common complaint but there are little population-based data on its burden in the United States. OBJECTIVE: To determine the prevalence of chronic cough and its burden on individuals and the health care system. METHODS: This was a survey of respondents who completed the 2018 National Health and Wellness Survey and questions about sleep and health care resource use. Chronic cough was defined as having a daily cough for 8 or more weeks. Respondents without chronic cough were selected through propensity score matching. Chronic cough prevalence was estimated using poststratification sampling weights calculated using U.S. Census data and post-data Horvitz-Thompson sampling weights to adjust for sampling bias. RESULTS: Of 74,977 National Health and Wellness Survey respondents, 3,654 had experienced chronic cough in the previous 12 months, for a weighted prevalence of 5.0%. Respondents with chronic cough were older and more predominantly female than respondents without chronic cough (both P < .001). Compared with matched respondents without chronic cough, those with chronic cough had lower mean scores on the Medical Outcomes Study 36-item Short Form Survey v2 physical (P < .001) and mental (P < .001) component summary scores. More respondents with chronic cough than matched controls experienced severe anxiety and severe depression in the past 2 weeks, work productivity impairment, impaired sleep quality and daytime sleepiness, as well as more emergency department visits and hospitalizations in the past 6 months (P < .001 for all comparisons). CONCLUSIONS: The burden of chronic cough manifests itself as reduced health-related quality of life, increased anxiety and depression, impaired sleep and work productivity, and greater health care utilization.

New Heart Failure After Myocardial Infarction (From the National Cardiovascular Data Registries [NCDR] Linked With All-Payer Claims).

Heart failure (HF) is common in patients presenting with acute myocardial infarction (MI), but incidence and predictors of new onset HF after hospitalization for MI are less well characterized. We evaluated patients hospitalized for acute MI without preceding or concurrent HF in the National Cardiovascular Data Registry (NCDR) CathPCI and Chest Pain-MI registries linked with claims data between April 2010 and March 2017. Cumulative incidence and independent predictors of HF after discharge were determined, and a simplified risk score was developed to predict incident HF following MI. In 337,274 patients with acute MI and no history of HF, 8.0% developed incident HF within 1 year after discharge and 18.8% developed HF within 5 years. Significant predictors of HF after MI included advanced chronic kidney disease (CKD) (HR 2.34, 95% confidence interval [CI] 2.23-2.46 for Stage IV vs Stage I, and HR 2.18, 95% CI 2.07-2.29 for Stage V vs. Stage I), recurrent MI following index MI (HR 2.24, 95% CI 2.19-2.28), African-American race (HR 1.44, 95% CI 1.40-1.48), and diabetes (HR 1.39, 95% CI 1.37-1.42). A risk score of 8 variables predicted HF with modest discrimination (optimism-corrected c-statistic 0.64) and good calibration. In conclusion, nearly 1 in 5 patients in a large nationally representative cohort without preceding or concurrent heart failure at time of MI developed incident HF within 5 years after discharge. Advanced CKD and recurrent MI were the strongest predictors of future HF. Increased recognition of specific risk factors for HF may help inform care strategies following MI.

Clinical Characteristics and Outcomes of a Cohort of Pediatric Oncohematologic Patients With COVID-19 Infection in the City of Bogotá, Colombia.

BACKGROUND: In children, the complications of severe acute respiratory syndrome coronavirus 2 infection occur less frequently than in adults but the characteristics of this disease in oncology patients are not well characterized. METHODS: This was a retrospective study in patients younger than 18 years of age with coronavirus disease 2019 (COVID-19) and cancer diagnoses between April and September 2020. Demographic variables, laboratory, and radiologic findings and complications of each case were identified. A descriptive analysis was performed. RESULTS: A total of 33 patients were identified; the median age was 10 years. Fifteen patients (42%) were in chemotherapy at the time of the infection diagnosis, in two patients the chemotherapy protocol was permanently suspended. The most common symptom was fever in 20 patients (60%). Seven patients (21.2%) showed mild pneumonia, four patients (12.1%) severe pneumonia, and three cases (9.0%) were classified as critical. In the evaluated cohort, five patients (15.1%) died, and in two of those, death was caused by COVID-19 infection. CONCLUSIONS: Children with an oncologic disease, the search for COVID cases should be oriented to patients with fever, including febrile neutropenia, the presence of respiratory symptoms, and the search for epidemiologic contact. A higher frequency of complications and mortality attributed to COVID-19, two in pediatric oncohematologic patients was found. Institutional strategies to detect the infection early and lower institutional infection are indicated.

Difference in Medication Adherence Between Patients Prescribed a 30-Day Versus 90-Day Supply After Acute Myocardial Infarction.

Background Evidence-based medication adherence rates after a myocardial infarction are low. We hypothesized that 90-day prescriptions are underused and may lead to higher evidence-based medication adherence compared with 30-day fills. Methods and Results We examined patients with myocardial infarction treated with percutaneous coronary intervention between 2011 and 2015 in the National Cardiovascular Data Registry. Linking to Symphony Health pharmacy data, we described the prevalence of patients filling 30-day versus 90-day prescriptions of statins, ß-blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and P2Y12 inhibitors after discharge. We compared 12-month medication adherence rates by evidence-based medication class and prescription days' supply and rates of medication switches and dosing changes. Among 353 259 patients with myocardial infarction treated with percutaneous coronary intervention, 90-day evidence-based medication fill rates were low: 13.0% (statins), 12.3% (ß-blockers), 14.6% (angiotensin-converting enzyme inhibitors/angiotensin receptor blockers), and 9.7% (P2Y12 inhibitors). Patients filling 90-day prescriptions were more likely older (median 69 versus 62 years) with a history of prior myocardial infarction (25.0% versus 17.9%) or percutaneous coronary intervention (30.3% versus 19.5%; P<0.01 for all) than patients filling 30-day prescriptions. The 12-month adherence rates were higher for patients who filled 90-day versus 30-day supplies: statins, 83.1% versus 75.3%; ß-blockers, 72.7% versus 62.9%; angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, 71.1% versus 60.9%; and P2Y12 inhibitors, 78.5% versus 66.6% (P<0.01 for all). Medication switches and dosing changes within 12 months were infrequent for patients filling 30-day prescriptions-14.7% and 0.3% for 30-day P2Y12 inhibitor fills versus 6.3% and 0.2% for 90-day fills, respectively. Conclusions Patients who filled 90-day prescriptions had higher adherence and infrequent medication changes within 1 year after discharge. Ninety-day prescription strategies should be encouraged to improve post-myocardial infarction medication adherence.

Impact of a Copayment Reduction Intervention on Medication Persistence and Cardiovascular Events in Hospitals With and Without Prior Medication Financial Assistance Programs.

Background Hospitals commonly provide a short-term supply of free P2Y12 inhibitors at discharge after myocardial infarction, but it is unclear if these programs improve medication persistence and outcomes. The ARTEMIS (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) trial randomized hospitals to usual care versus waived P2Y12 inhibitor copayment costs for 1-year post-myocardial infarction. Whether the impact of this intervention differed between hospitals with and without pre-existing medication assistance programs is unknown. Methods and Results In this post hoc analysis of the ARTEMIS trial, we examined the associations of pre-study free medication programs and the randomized copayment voucher intervention with P2Y12 inhibitor persistence (measured by pharmacy fills and patient report) and major adverse cardiovascular events using logistic regression models including a propensity score. Among 262 hospitals, 129 (49%) offered pre-study free medication assistance. One-year P2Y12 inhibitor persistence and major adverse cardiovascular events risks were similar between patients treated at hospitals with and without free medication programs (adjusted odds ratio 0.93, 95% CI, 0.82-1.05 and hazard ratio 0.92, 95% CI, 0.80-1.07, respectively). The randomized copayment voucher intervention improved persistence, assessed by pharmacy fills, in both hospitals with (53.6% versus 44.0%, adjusted odds ratio 1.45, 95% CI, 1.20-1.75) and without (59.0% versus 48.3%, adjusted odds ratio 1.46, 95% CI, 1.25-1.70) free medication programs (Pinteraction=0.71). Differences in patient-reported persistence were not significant after adjustment. Conclusions While hospitals commonly report the ability to provide free short-term P2Y12 inhibitors, we did not find association of this with medication persistence or major adverse cardiovascular events among patients with insurance coverage for prescription medication enrolled in the ARTEMIS trial. An intervention that provided copayment assistance vouchers for 1 year was successful in improving medication persistence in hospitals with and without pre-existing short-term medication programs. Registration URL: https://www.clini​caltr​ials.gov/. Unique identifier: NCT02406677.

Agreement and Accuracy of Medication Persistence Identified by Patient Self-report vs Pharmacy Fill: A Secondary Analysis of the Cluster Randomized ARTEMIS Trial.

Importance: Pharmacy fill data are increasingly accessible to clinicians and researchers to evaluate longitudinal medication persistence beyond patient self-report. Objective: To assess the agreement and accuracy of patient-reported and pharmacy fill-based medication persistence. Design, Setting, and Participants: This post hoc analysis of the cluster randomized clinical trial ARTEMIS (Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) enrolled patients at 287 US hospitals (131 randomized to intervention and 156 to usual care) from June 5, 2015, to September 30, 2016, with 1-year follow-up and blinded adjudication of major adverse cardiovascular events. In total, 8373 patients with myocardial infarction and measurement of P2Y12 inhibitor persistence by both patient self-report and pharmacy data were included. Serum P2Y12 inhibitor drug levels were measured for 944 randomly selected patients. Data were analyzed from May 2018 to November 2019. Interventions: Patients treated at intervention-arm hospitals received study vouchers to offset copayments at each P2Y12 inhibitor fill for 1 year after myocardial infarction. Main Outcomes and Measures: Nonpersistence was defined as a gap of 30 days or more in P2Y12 inhibitor use (patient report) or supply (pharmacy fill) and as serum P2Y12 inhibitor levels below the lower limit of quantification (drug level). Among patients in the intervention arm, a "criterion standard" definition of nonpersistence was a gap of 30 days or more in P2Y12 inhibitor use by both voucher use and pharmacy fill. Major adverse cardiovascular events were defined as adjudicated death, recurrent myocardial infarction, or stroke. Results: Of 8373 patients included in this analysis, the median age was 62 years (interquartile range, 54-70 years), 5664 were men (67.7%), and 990 (11.8%) self-reported as nonwhite race/ethnicity. One-year estimates of medication nonpersistence rates were higher using pharmacy fills (4042 patients [48.3%]) compared with patient self-report (1277 patients [15.3%]). Overall, 4185 patients (50.0%) were persistent by both pharmacy fill data and patient report, 1131 patients (13.5%) were nonpersistent by both, and 3057 patients (36.5%) were discordant. By application of the criterion standard definition, the 1-year nonpersistence rate was 1184 of 3703 patients (32.0%); 892 of 3318 patients (26.9%) in the intervention arm who self-reported persistence were found to be nonpersistent, and 303 of 1487 patients (20.4%) classified as nonpersistent by pharmacy fill data were actually persistent. Agreement between serum P2Y12 inhibitor drug levels and either patient-reported (κ = 0.11-0.23) or fill-based (κ = 0.00-0.19) persistence was poor. Patients who were nonpersistent by both pharmacy fill data and self-report had the highest 1-year major adverse cardiac event rate (18.3%; 95% CI, 16.0%-20.6%) compared with that for discordant patients (9.7%; 8.7%-10.8%) or concordantly persistent patients (8.2%; 95% CI, 7.4%-9.0%). Conclusions and Relevance: Patient report overestimated medication persistence rates, and pharmacy fill data underestimated medication persistence rates. Patients who are nonpersistent by both methods have the worst clinical outcomes and should be prioritized for interventions that improve medication-taking behavior. Trial Registration: ClinicalTrials.gov Identifier: NCT02406677.

Association of a P2Y12 Inhibitor Copayment Reduction Intervention With Persistence and Adherence With Other Secondary Prevention Medications: A Post Hoc Analysis of the ARTEMIS Cluster-Randomized Clinical Trial.

Importance: The Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS) cluster-randomized trial found that copayment reduction for P2Y12 inhibitors improved 1-year patient persistence in taking that medication. Objective: To assess whether providing copayment reduction for P2Y12 inhibitors increases patient persistence in taking other secondary prevention cardiovascular medications. Design, Setting, and Participants: This post hoc analysis of the ARTEMIS trial includes data from 287 hospitals that enrolled patients between June 2015 and September 2016. Patients hospitalized with acute myocardial infarction were included. Data analysis occurred from May 2018 through August 2019. Interventions: Hospitals randomized to the intervention provided patients vouchers that waived copayments for P2Y12 inhibitors fills for 1 year. Hospitals randomized to usual care did not provide study vouchers. Main Outcomes and Measures: Persistence in taking ß-blocker, statin, and angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker medications at 1 year, defined as the absence of a gap in medication supply of 30 or more days by pharmacy fill data in the intervention-arm (intent-to-treat) population. Results: A total of 131 hospitals (with 5109 patients) were randomized to the intervention, and 156 hospitals (with 3264 patients) randomized to the control group. Patients discharged from intervention hospitals had higher persistence in taking statins (2247 [46.1%] vs 1300 [41.9%]; adjusted odds ratio, 1.11 [95% CI, 1.00-1.24]), and ß-blockers (2235 [47.6%] vs 1277 [42.5%]; odds ratio, 1.23 [95% CI, 1.10-1.38]), although the association was smaller than that seen for P2Y12 inhibitors (odds ratio, 1.47 [95% CI, 1.29-1.66]). Persistence in taking angiotensin-converting enzyme inhibitors or angiotensin II-receptor blockers were also numerically higher among patients in the intervention arm than in the usual-care arm, but this was not significant after risk adjustment (1520 [43.9%] vs 847 [40.5%]; adjusted odds ratio, 1.10 [95% CI, 0.97-1.24]). Patients in the intervention arm reported greater financial burden associated with medication cost than the patients in the usual-care arm at baseline, but these differences were no longer significant at 1 year. Conclusions and Relevance: Reducing patient copayments for 1 medication class increased persistence not only to that therapy class but may also have modestly increased persistence to other post-myocardial infarction secondary prevention medications. These findings have important implications for the clinical utility and cost-effectiveness of medication cost-assistance programs. Trial Registration: ClinicalTrials.gov identifier: NCT02406677.

Multivariate Model for the Prediction of Severity of Acute Pancreatitis in Children.

This study aimed to develop a severity prediction system for pediatric patients with acute pancreatitis (AP) based on clinical and laboratory parameters recorded at disease onset. A retrospective cohort study including 130 patients with AP, aged 0 to 18 years, was conducted. Correlations between severe AP (SAP) and clinical and laboratory data were established. Parameters with a significant statistical correlation (P ≤ 0.05) were incorporated in logistic regression models, and receiver operating characteristic curves were generated. The best-performance cutoff points were calculated to propose a severity prediction score, for which sensitivity and specificity were determined. Thirty-eight cases (29.2%) were consistent with SAP. A value of ≥1 point yielded a sensitivity of 81.5% and specificity of 64.1% for SAP prediction, when using a score including blood urea nitrogen ≥12.5 mg/dL (1 point) or hemoglobin <13 mg/dL (1 point) as variables. The proposed severity score showed good performance in predicting SAP.

Utility of CT classifications to predict unfavorable outcomes in children with acute pancreatitis.

BACKGROUND: Computed tomography (CT) is useful for the diagnosis of local complications in children with acute pancreatitis but its role as a prognostic tool remains controversial. OBJECTIVE: To establish the correlation between the CT Severity Index and the Revised Atlanta Classification regarding unfavorable outcomes such as severe acute pancreatitis and need for Pediatric Special Care Unit attention in children with acute pancreatitis. MATERIALS AND METHODS: We conducted a retrospective and concordance cohort study in which we obtained abdominal CT scans from 30 patients ages 0 to 18 years with acute pancreatitis. Two pediatric radiologists interpreted the results using the CT Severity Index and the Revised Atlanta Classification. The kappa coefficient was determined for each scale. The association among severe acute pancreatitis, need for admission to the Pediatric Special Care Unit and CT systems were established using chi-square or Mann-Whitney U tests. The best CT Severity Index value to predict the need for admission to the Pediatric Special Care Unit was estimated through a receiver operating characteristic (ROC) curve. RESULTS: Mean CT Severity Index was 5.1±2.8 (mean ± standard deviation on a scale of 0 to 10) for the severe acute pancreatitis group vs. 3.8±2.7 for the mild acute pancreatitis group (P=0.230). The CT Severity Index for the children who were not hospitalized at the Pediatric Special Care Unit was 2.2±2.2 vs. 5.6±2.4 for the group hospitalized at the Pediatric Special Care Unit (P=0.001). Only parenchymal necrosis >30% was associated with severe acute pancreatitis (P=0.021). A CT Severity Index ≥3 has a sensitivity of 89% and specificity of 72% to predict need for admission to the Pediatric Special Care Unit. None of the Revised Atlanta Classification categories was associated with severe acute pancreatitis or admission to the Pediatric Special Care Unit. CONCLUSION: A CT Severity Index ≥3 in children with acute pancreatitis who require CT assessment based on clinical criteria is associated with the need for admission to the Pediatric Special Care Unit. We found that pancreatic necrosis greater than 30% is the only tomographic parameter related to severe acute pancreatitis. New studies with a greater sample size are necessary to confirm this result.

Hospital Admissions, Costs, and 30-Day Readmissions Among Newly Diagnosed Nonvalvular Atrial Fibrillation Patients Treated with Dabigatran Etexilate or Warfarin.

BACKGROUND: Oral anticoagulation such as warfarin and dabigatran is indicated for atrial fibrillation (AF) patients at risk of ischemic stroke. Dabigatran etexilate was developed to address the limitations of warfarin, including the need for regular blood monitoring, which has the potential to lead to higher health care resource use, particularly in hospitalized patients. OBJECTIVE: To evaluate whether hospitalization cost, length of hospital stay (LOS), likelihood of readmission within 30 days, and cost of readmissions differed across inpatient encounters among nonvalvular atrial fibrillation (NVAF) patients that were newly diagnosed and newly treated with either dabigatran or warfarin. METHODS: A retrospective cohort study was conducted using IMS Health's Charge Detail Master (CDM) database. Hospitalizations were identified based on a primary or secondary AF diagnosis, dabigatran or warfarin use, and a discharge date from January 2011 through March 2012. The identified patients without valvular procedures and transient AF were required to have a minimum of 12 months of pharmacy and private practitioner records prior to the inpatient encounter to ensure that they were newly treated on dabigatran or warfarin. Propensity score matching was used to balance baseline characteristics between treatment cohorts. Outcomes assessed were LOS, 30-day readmissions, and costs. Because individual patients could have more than 1 hospital observation, generalized estimating equations (GEE) with a gamma distribution (log link) were used for the analysis of continuous outcome measures (e.g., LOS and costs) and a binominal distribution for dichotomous outcomes (hospital readmissions). RESULTS: Two cohorts were propensity score matched (1:2) on demographic and clinical characteristics. The dabigatran cohort included 646 hospitalizations, and the warfarin cohort included 1,292 hospitalizations. Hospitalizations were on average 13% shorter (4.8 vs. 5.5 days, P less than 0.001) and cost 12% less ($14,794 vs. $16,826, P = 0.007) when dabigatran was used versus warfarin. No differences in 30-day readmissions were observed. CONCLUSIONS: Hospital encounters among newly diagnosed NVAF patients during which warfarin was initiated had longer lengths of stay and incurred higher costs than those during which dabigatran was initiated.

Pharmacogenomic and pharmacogenetic-guided therapy as a tool in precision medicine: current state and factors impacting acceptance by stakeholders.

Pharmacogenetic/pharmacogenomic (PGx) testing is currently available for a wide range of health problems including cardiovascular disease, cancer, diabetes, autoimmune disorders, mental health disorders and infectious diseases. PGx contributes important information to the field of precision medicine by clarifying appropriate treatments for specific disease subtypes. Tangible benefits to patients including improved outcomes and reduced total health care costs have been observed. However, PGx-guided therapy faces many barriers to full integration into clinical practice and acceptance by stakeholders, whether practitioner, patient or payer. Each stakeholder has a unique perspective on the role of PGx testing, although all are similarly challenged with demonstrating or appraising its cost-to-benefit value. Coverage by insurers is a critical step in achieving widespread adoption of PGx testing. The acceleration of adoption of precision medicine in general and for PGx testing in particular will be determined by how quickly robust evidence can be accumulated that shows a return on investment for payers in terms of real dollars, for clinicians in terms of patient clinical responses, and for patients in terms of economic, health and quality of life outcomes. Trends in PGx testing utilization and uptake by payers in real-world practice are discussed; the role of pharmacoeconomics in assessing cost-effectiveness is highlighted using a case study in psychiatric care, and several issues that will affect adoption of PGx testing in the United States (US) over the next few years are reviewed.

Pharmacogenetic-guided psychiatric intervention associated with increased adherence and cost savings.

OBJECTIVES: Pharmacogenetic testing as a means of guiding treatment decisions is beginning to see wider clinical use in psychiatry. The utility of this genetic information as it pertains to clinical decision making, treatment effectiveness, cost savings, and patient perception has not been fully characterized. STUDY DESIGN: In this retrospective study, we examined health claims data in order to assess medication adherence rates and healthcare costs for psychiatric patients. METHODS: Individuals for whom pharmacogenetic testing was ordered (cases) were contrasted with those who did not undergo such testing (controls). Cases and controls were propensity score matched in order to minimize risk of confounding in this nonrandomized study. An initial analysis of 111 cases and 222 controls examined both adherence and healthcare costs. A replication study of 116 cases and 232 controls examined adherence alone, as cost data was not available for this latter cohort. RESULTS: Overall, individuals with assay-guided treatment were significantly more medication adherent (P = 1.56 3 10­3; Cohen's d = 0.511) than patients with standard treatment and demonstrated a relative cost savings of 9.5% in outpatient costs over a 4-month follow-up period, or $562 in total savings. CONCLUSIONS: The data show the utility of pharmacogenetic testing in everyday psychiatric clinical practice, as it can lead to improved patient adherence and decreased healthcare costs.