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1.
J Clin Lipidol ; 2024 Jul 22.
Article in English | MEDLINE | ID: mdl-39289124

ABSTRACT

BACKGROUND AND OBJECTIVE: High Lp(a) levels are a risk factor for ASCVD, however Lp(a) ordering in clinical practice is low. This study examines how race/ethnicity and socioeconomic status influence Lp(a) ordering. METHODS: This is a single center, retrospective study (2/1/2020-6/30/2023) using electronic medical records of adults with at least one personal ICD-10 diagnosis of ASCVD, aortic valve stenosis, resistant hypercholesterolemia (LDL-C >160 mg/dL on statin therapy), and family history of ASCVD or high Lp(a). We evaluated Lp(a) level differences among racial/ethnic groups and sexes. We also assessed associations between diagnosis type, diagnosis number, age at diagnosis, race/ethnicity, socioeconomic score (based on zip codes), public health coverage and the presence of Lp(a) orders. RESULTS: 4 % of our cohort (N=2,249 in 56,833) had an Lp(a) order (17.3 % of whom identified as Hispanic, 8.7 % non-Hispanic Black, 47.5 % non-Hispanic White, and 27 % Asian/other). Non-Hispanic Black and Hispanic patients had lower rates of Lp(a) orders (0.17 % and 0.28 %, respectively) when compared to non-Hispanic White patients (2.35 %), p < 0.001, however, their median Lp(a) levels were higher, p < 0.001. Individuals on Medicaid or belonging to deprived socioeconomic groups were less likely to have an Lp(a) order (IRR = 0.40, p < 0.001 and IRR = 0.39, p < 0.001 respectively). Certain diagnosis (carotid stenosis, family history of ASCVD and FH) and multiple diagnoses (>2) resulted in more Lp(a) orders compared to only one diagnosis (p < 0.001). CONCLUSIONS: Lp(a) ordering is low in patients with or at risk for ASCVD. Non-Hispanic Black and Hispanic patients are less likely to have an Lp(a) order. Individuals on Medicaid and residing in socioeconomically deprived neighborhoods are less like have an Lp(a) order. Lp(a) orders depend on the type and number of patients' diagnoses.

2.
J Am Coll Cardiol ; 83(24): 2440-2454, 2024 Jun 18.
Article in English | MEDLINE | ID: mdl-38866447

ABSTRACT

BACKGROUND: Despite documented associations between social determinants of health and outcomes post-congenital heart surgery, clinical risk models typically exclude these factors. OBJECTIVES: The study sought to characterize associations between social determinants and operative and longitudinal mortality as well as assess impacts on risk model performance. METHODS: Demographic and clinical data were obtained for all congenital heart surgeries (2006-2021) from locally held Congenital Heart Surgery Collaborative for Longitudinal Outcomes and Utilization of Resources Society of Thoracic Surgeons Congenital Heart Surgery Database data. Neighborhood-level American Community Survey and composite sociodemographic measures were linked by zip code. Model prediction, discrimination, and impact on quality assessment were assessed before and after inclusion of social determinants in models based on the 2020 Society of Thoracic Surgeons Congenital Heart Surgery Database Mortality Risk Model. RESULTS: Of 14,173 total index operations across New York State, 12,321 cases, representing 10,271 patients at 8 centers, had zip codes for linkage. A total of 327 (2.7%) patients died in the hospital or before 30 days, and 314 children died by December 31, 2021 (total n = 641; 6.2%). Multiple measures of social determinants of health explained as much or more variability in operative and longitudinal mortality than clinical comorbidities or prior cardiac surgery. Inclusion of social determinants minimally improved models' predictive performance (operative: 0.834-0.844; longitudinal 0.808-0.811), but significantly improved model discrimination; 10.0% more survivors and 4.8% more mortalities were appropriately risk classified with inclusion. Wide variation in reclassification was observed by site, resulting in changes in the center performance classification category for 2 of 8 centers. CONCLUSIONS: Although indiscriminate inclusion of social determinants in clinical risk modeling can conceal inequities, thoughtful consideration can help centers understand their performance across populations and guide efforts to improve health equity.


Subject(s)
Cardiac Surgical Procedures , Heart Defects, Congenital , Social Determinants of Health , Humans , Heart Defects, Congenital/surgery , Heart Defects, Congenital/mortality , Male , Female , Cardiac Surgical Procedures/mortality , Infant , Child, Preschool , Risk Assessment/methods , Child , Infant, Newborn , New York/epidemiology
3.
BMC Med Educ ; 24(1): 657, 2024 Jun 12.
Article in English | MEDLINE | ID: mdl-38867188

ABSTRACT

BACKGROUND: Staff shortages limit access to health services. The bidirectional benefits of allied health clinical placements are understood in the domains of student learning, health service delivery, and future workforce development. Still, the benefits to current workforce outcomes remain unknown. This review provides insights into the effects of allied health student placements in acute and primary care settings, particularly on healthcare staff's knowledge and procedural skills. METHODS: This search was based on the integrative review process established by Whittemore and Knafl in 2005. In October 2023, the first author (MH) searched five major electronic databases: Medline-EBSCO, PubMed, CINAHL, Embase, and Scopus. The CLUSTER model was used to track additional references. The first three authors (MH, SM, and SC) were involved in screening, quality appraisal, and synthesis of the studies. Data were thematically synthesised and analysed. RESULTS: MeSH headings and keywords were used in key search areas: health education, health professional training, clinical placements, and allied health professions. The systematic search yielded 12 papers on allied health student placements across various healthcare settings in rural and metropolitan areas, with no high-quality methodologies measuring student placements' impact on staff knowledge and skills. Four main themes were identified from the analysis: meaningful student integration in service delivery, targeted educational support to healthcare staff, development of staff procedural skills and confidence, and the mechanisms of why student placements work in this aspect. CONCLUSIONS: This review suggests that offering allied health student placement could be a promising approach to supporting rural healthcare staff in performing patient assessments and treatments proficiently and collaboratively. However, this requires further investigation to confirm.


Subject(s)
Allied Health Personnel , Clinical Competence , Primary Health Care , Humans , Allied Health Personnel/education
4.
medRxiv ; 2024 May 14.
Article in English | MEDLINE | ID: mdl-38798532

ABSTRACT

Background and Objective: High Lp(a) levels are a risk factor for ASCVD, however Lp(a) ordering in clinical practice is low. This study examines how race/ethnicity and socioeconomic status influence Lp(a) ordering. Methods: This is a single center, retrospective study (2/1/2020-6/30/2023) using electronic medical records of adults with at least one ICD-10 diagnosis of ASCVD or resistant hyperlipidemia (LDL-C >160 mg/dL on statin therapy). We evaluated Lp(a) level differences among racial/ethnic groups and sexes. We also assessed associations between diagnosis type, diagnosis number, age at diagnosis, race, socioeconomic score (based on zip codes), public health coverage and presence of Lp(a) orders. Results: 4% of our cohort (N=56,833) had an Lp(a) order (17.3% Hispanic, 8.7% non-Hispanic Black, 47.5% non-Hispanic White and, 27% Asian/others). Non-Hispanic Black and Hispanic patients had lower rates of Lp(a) orders (0.17%, 0.28%, respectively) when compared to non-Hispanic White patients (2.35%), p<0.001, however, their median Lp(a) levels were higher. Individuals belonging to deprived socioeconomic groups or on Medicaid, were less likely to have an Lp(a) order (RR=0.39, p<0.001 and RR=0.40, p<0.001 respectively). Certain diagnoses (carotid stenosis, family history of ASCVD and FH) and multiple diagnoses (>2) resulted in more Lp(a) orders compared to those with only one diagnosis (p<0.001). Conclusions: Lp(a) ordering is low in patients with ASCVD. Non-Hispanic Black and Hispanic patients at risk are less likely to have an Lp(a) order. Individuals residing in socioeconomically deprived neighborhoods and on Medicaid are also less like have Lp(a) order. Lp(a) orders depend on the type and number of patients' diagnoses.

5.
ERJ Open Res ; 9(6)2023 Nov.
Article in English | MEDLINE | ID: mdl-37936899

ABSTRACT

Background: Repair of systemic to pulmonary shunts is timed to prevent the development of irreversible pulmonary vascular disease, including in patients with other factors contributing to pulmonary hypertension. This study assessed outcomes of an individualised strategy for managing patients with mild-moderately elevated pulmonary vascular resistance (PVR) deemed borderline eligible for repair. Methods: A retrospective chart review was conducted of patients with systemic to pulmonary shunts and baseline indexed PVR (PVRi) ≥3 WU·m2 treated at a single centre from 1 January 2005 to 30 September 2019. Data included demographics, World Health Organization functional class (WHO FC), medications and haemodynamic data at baseline and serial follow-up. Results: 30 patients (18 females) met criteria for inclusion. Median age at diagnosis of pulmonary arterial hypertension was 1.3 years (range 0.03-54 years) and at surgery was 4.1 years (range 0.73-56 years). Median follow-up time was 5.8 years (range 0.2-14.6 years) after repair. Most patients received at least one targeted pulmonary arterial therapy prior to repair and the majority (80%) underwent fenestrated shunt closure. There was a significant decrease in mean pulmonary arterial pressure (mPAP) (p<0.01), PVRi (p=0.0001) and PVR/systemic vascular resistance (p<0.01) between baseline and preoperative catheterisation and a decrease in PVRi (p<0.005), mPAP (p=0.0001) and pulmonary to systemic flow ratio (p<0.03) from baseline to most recent catheterisation. WHO FC improved from FC II-III at baseline to FC I post repair in most patients (p<0.003). Conclusions: In carefully selected patients with systemic to pulmonary shunts and elevated PVR considered borderline for operability, the use of preoperative targeted therapy in conjunction with fenestrated or partial closure of intracardiac shunts is associated with improvement in WHO FC and clinical outcomes.

6.
J Am Coll Cardiol ; 82(23): 2212-2221, 2023 12 05.
Article in English | MEDLINE | ID: mdl-38030351

ABSTRACT

BACKGROUND: Congenital heart surgery (CHS) encompasses a heterogeneous population of patients and surgeries. Risk standardization models that adjust for patient and procedural characteristics can allow for collective study of these disparate patients and procedures. OBJECTIVES: We sought to develop a risk-adjustment model for CHS using the newly developed Risk Stratification for Congenital Heart Surgery for ICD-10 Administrative Data (RACHS-2) methodology. METHODS: Within the Kids' Inpatient Database 2019, we identified all CHSs that could be assigned a RACHS-2 score. Hierarchical logistic regression (clustered on hospital) was used to identify patient and procedural characteristics associated with in-hospital mortality. Model validation was performed using data from 24 State Inpatient Databases during 2017. RESULTS: Of 5,902,538 total weighted hospital discharges in the Kids' Inpatient Database 2019, 22,310 pediatric cardiac surgeries were identified and assigned a RACHS-2 score. In-hospital mortality occurred in 543 (2.4%) of cases. Using only RACHS-2, the mortality mode had a C-statistic of 0.81 that improved to 0.83 with the addition of age. A final multivariable model inclusive of RACHS-2, age, payer, and presence of a complex chronic condition outside of congenital heart disease further improved model discrimination to 0.87 (P < 0.001). Discrimination in the validation cohort was also very good with a C-statistic of 0.83. CONCLUSIONS: We created and validated a risk-adjustment model for CHS that accounts for patient and procedural characteristics associated with in-hospital mortality available in administrative data, including the newly developed RACHS-2. Our risk model will be critical for use in health services research and quality improvement initiatives.


Subject(s)
Cardiac Surgical Procedures , Heart Defects, Congenital , Child , Humans , Infant , Cardiac Surgical Procedures/methods , Heart Defects, Congenital/surgery , Risk Adjustment , Hospital Mortality , Logistic Models , Risk Factors , Retrospective Studies
7.
Tex Heart Inst J ; 50(5)2023 10 17.
Article in English | MEDLINE | ID: mdl-37853911

ABSTRACT

BACKGROUND: Patients with pulmonary arterial hypertension have quality-of-life limitations, decreased exercise capacity, and poor prognosis if the condition is left untreated. Standard exercise testing is routinely performed to evaluate patients with pulmonary arterial hypertension but may be limited in its ability to monitor activity levels in daily living. OBJECTIVE: To evaluate the validity of the commercial Fitbit Charge HR as a tool to assess real-time exercise capacity as compared with standard exercise testing. METHODS: Ambulatory pediatric and adult patients were enrolled and given a Fitbit with instructions to continuously wear the device during waking hours. Patients underwent a 6-minute walk test, cardiopulmonary exercise test, and a 36-Item Short Form Health Survey on the day of enrollment and follow-up. Twenty-seven ambulatory patients with pulmonary arterial hypertension were enrolled, and 21 had sufficient data for analyses (median age, 25 years [range, 13-59 years]; 14 female participants). RESULTS: Daily steps measured by the Fitbit had a positive correlation with 6-minute walk distance (r = 0.72, P = .03) and an inverse trend with World Health Organization functional class. On the 36-Item Short Form Health Survey, 77% of patients reported improvement in vitality (P = .055). At follow-up, there was a strong correlation between number of steps recorded by Fitbit and role limitations because of physical problems (r = 0.88, P = .02) and weaker correlations with other quality-of-life markers. CONCLUSION: The findings of this pilot study suggest activity monitors may have potential as a simple and novel method of assessing longitudinal exercise capacity and activity levels in patients with pulmonary hypertension. Further study in larger cohorts of patients is warranted to determine which accelerometer measures correlate best with outcomes.


Subject(s)
Hypertension, Pulmonary , Pulmonary Arterial Hypertension , Adult , Humans , Female , Child , Hypertension, Pulmonary/diagnosis , Pilot Projects , Exercise , Walking
8.
J Am Coll Cardiol ; 82(13): 1331-1340, 2023 09 26.
Article in English | MEDLINE | ID: mdl-37730290

ABSTRACT

BACKGROUND: Congenital heart defects are the most common and resource-intensive birth defects. As children with congenital heart defects increasingly survive beyond early childhood, it is imperative to understand longitudinal disease burden. OBJECTIVES: The purpose of this study was to examine chronic outpatient prescription medication use and expenditures for New York State pediatric Medicaid enrollees, comparing children who undergo cardiac surgery (cardiac enrollees) and the general pediatric population. METHODS: This was a retrospective cohort study of all Medicaid enrollees age <18 years using the New York State Congenital Heart Surgery Collaborative for Longitudinal Outcomes and Utilization of Resources database (2006-2019). Primary outcomes were total chronic medications per person-year, enrollees per 100 person-years using ≥1 and ≥3 medications, and medication expenditures per person-year. We described and compared outcomes between cardiac enrollees and the general pediatric population. Among cardiac enrollees, multivariable regression examined associations between outcomes and clinical characteristics. RESULTS: We included 5,459 unique children (32,131 person-years) who underwent cardiac surgery and 4.5 million children (22 million person-years) who did not. More than 4 in 10 children who underwent cardiac surgery used ≥1 chronic medication compared with approximately 1 in 10 children who did not have cardiac surgery. Medication expenditures were 10 times higher per person-year for cardiac compared with noncardiac enrollees. Among cardiac enrollees, disease severity was associated with chronic medication use; use was highest among infants; however, nearly one-half of adolescents used ≥1 chronic medication. CONCLUSIONS: Children who undergo cardiac surgery experience high medication burden that persists throughout childhood. Understanding chronic medication use can inform clinicians (both pediatricians and subspecialists) and policymakers, and ultimately the value of care for this medically complex population.


Subject(s)
Cardiac Surgical Procedures , Medicaid , Adolescent , Infant , United States/epidemiology , Child , Child, Preschool , Humans , Retrospective Studies , Heart , Cost of Illness
9.
J Am Coll Cardiol ; 81(16): 1605-1617, 2023 04 25.
Article in English | MEDLINE | ID: mdl-37076215

ABSTRACT

BACKGROUND: Understanding the longitudinal burden of health care expenditures and utilization after pediatric cardiac surgery is needed to counsel families, improve care, and reduce outcome inequities. OBJECTIVES: The purpose of this study was to describe and identify predictors of health care expenditures and utilization for Medicaid-insured pediatric cardiac surgical patients. METHODS: All Medicaid enrolled children age <18 years undergoing cardiac surgery in the New York State CHS-COLOUR database, from 2006 to 2019, were followed in Medicaid claims data through 2019. A matched cohort of children without cardiac surgical disease was identified as comparators. Expenditures and inpatient, primary care, subspecialist, and emergency department utilization were modeled using log-linear and Poisson regression models to assess associations between patient characteristics and outcomes. RESULTS: In 5,241 New York Medicaid-enrolled children, longitudinal health care expenditures and utilization for cardiac surgical patients exceeded noncardiac surgical comparators (cardiac surgical children: $15,500 ± $62,000 per month in year 1 and $1,600 ± $9,100 per month in year 5 vs noncardiac surgical children: $700 ± $6,600 per month in year 1 and $300 ± $2,200 per month in year 5). Children after cardiac surgery spent 52.9 days in hospitals and doctors' offices in the first postoperative year and 90.5 days over 5 years. Being Hispanic, compared with non-Hispanic White, was associated with having more emergency department visits, inpatient admissions, and subspecialist visits in years 2 to 5, but fewer primary care visits and greater 5-year mortality. CONCLUSIONS: Children after cardiac surgery have significant longitudinal health care needs, even among those with less severe cardiac disease. Health care utilization differed by race/ethnicity, although mechanisms driving disparities should be investigated further.


Subject(s)
Cardiac Surgical Procedures , Medicaid , United States/epidemiology , Child , Humans , Adolescent , Patient Acceptance of Health Care , Health Expenditures , New York
10.
J Am Soc Echocardiogr ; 36(6): 654-665, 2023 06.
Article in English | MEDLINE | ID: mdl-36933850

ABSTRACT

BACKGROUND: Right ventricular (RV) dysfunction is an independent predictor of poor outcomes in patients with tetralogy of Fallot (TOF), and global longitudinal strain (GLS) is a well-validated echocardiographic technique to measure RV function. Although trends in RV GLS have been examined in patients with TOF, they have not been studied specifically in those with ductal-dependent TOF, a group in which there is not a clear consensus on the best surgical strategy. The aim of this study was to assess the midterm trajectory of RV GLS in patients with ductal-dependent TOF, drivers of this trajectory, and differences in RV GLS between repair strategies. METHODS: This was a retrospective two-center cohort study of patients with ductal-dependent TOF who underwent repair. Ductal dependence was defined as being initiated on prostaglandin therapy and/or undergoing surgical intervention on or before 30 days of life. RV GLS was measured on echocardiography preoperatively, early after complete repair, and at 1 and 2 years of age. RV GLS was trended over time and compared between surgical strategies and with control subjects. Mixed-effects linear regression models were used to evaluate the factors associated with changes in RV GLS over time. RESULTS: Forty-four patients with ductal-dependent TOF were included in the study, of whom 33 (75%) underwent primary complete repair and 11 (25%) underwent staged repair. Complete TOF repair was performed at a median of 7 days in the primary-repair group and 178 days in the staged-repair group. RV GLS improved over time from post-complete repair echocardiography through 2 years of age (-17.4% [interquartile range, -15.5% to -18.9%] vs -21.5% [interquartile range, -18.0% to -23.3%], P < .001). However, compared with age-matched control subjects, patients had worse RV GLS at all time points. There was no difference in RV GLS between the staged and primary complete repair groups at 2-year follow-up. Shorter intensive care unit length of stay after complete repair was independently associated with improvement in RV GLS over time. Strain improved by 0.07% (95% CI, 0.01 to 0.12) for each fewer day in the intensive care unit (P = .03). CONCLUSIONS: RV GLS improves over time among patients with ductal-dependent TOF, though it is consistently reduced compared with control subjects, suggesting an altered deformation pattern in patients with ductal-dependent TOF. There was no difference in RV GLS between the primary- and staged-repair groups at midterm follow-up, suggesting that repair strategy is not a risk factor for worse RV strain in the mid postoperative period. A shorter complete-repair intensive care unit length of stay is associated with an improved trajectory of RV GLS.


Subject(s)
Tetralogy of Fallot , Ventricular Dysfunction, Right , Humans , Retrospective Studies , Cohort Studies , Heart Ventricles/diagnostic imaging , Echocardiography/methods , Ventricular Function, Right
11.
J Am Coll Cardiol ; 79(5): 465-478, 2022 02 08.
Article in English | MEDLINE | ID: mdl-35115103

ABSTRACT

BACKGROUND: As the cardiac community strives to improve outcomes, accurate methods of risk stratification are imperative. Since adoption of International Classification of Disease-10th Revision (ICD-10) in 2015, there is no published method for congenital heart surgery risk stratification for administrative data. OBJECTIVES: This study sought to develop an empirically derived, publicly available Risk Stratification for Congenital Heart Surgery (RACHS-2) tool for ICD-10 administrative data. METHODS: The RACHS-2 stratification system was iteratively and empirically refined in a training dataset of Pediatric Health Information Systems claims to optimize sensitivity and specificity compared with corresponding locally held Society of Thoracic Surgeons-Congenital Heart Surgery (STS-CHS) clinical registry data. The tool was validated in a second administrative data source: New York State Medicaid claims. Logistic regression was used to compare the ability of RACHS-2 in administrative data to predict operative mortality vs STAT Mortality Categories in registry data. RESULTS: The RACHS-2 system captured 99.6% of total congenital heart surgery registry cases, with 1.0% false positives. RACHS-2 predicted operative mortality in both training and validation administrative datasets similarly to STAT Mortality Categories in registry data. C-statistics for models for operative mortality in training and validation administrative datasets-adjusted for RACHS-2-were 0.76 and 0.84 (95% CI: 0.72-0.80 and 0.80-0.89); C-statistics for models for operative mortality-adjusted for STAT Mortality Categories-in corresponding clinical registry data were 0.75 and 0.84 (95% CI: 0.71-0.79 and 0.79-0.89). CONCLUSIONS: RACHS-2 is a risk stratification system for pediatric cardiac surgery for ICD-10 administrative data, validated in 2 administrative-registry-linked datasets. Statistical code is publicly available upon request.


Subject(s)
Cardiac Surgical Procedures/methods , Heart Defects, Congenital/classification , Registries , Risk Assessment/methods , Child , Databases, Factual , Female , Heart Defects, Congenital/epidemiology , Heart Defects, Congenital/surgery , Hospital Mortality/trends , Humans , Incidence , Infant , Male , ROC Curve , Retrospective Studies
12.
J Thorac Cardiovasc Surg ; 163(5): 1630-1641.e2, 2022 05.
Article in English | MEDLINE | ID: mdl-34583843

ABSTRACT

OBJECTIVE: Postoperative chylothorax causes significant morbidities in pediatric patients with cardiac disease. New treatment approaches based on evolving understanding of underlying lymphatic dysfunction are being developed. We hypothesized that propranolol reduces morbidities and duration of chest tube requirement in high-output chylous effusion. METHODS: The postoperative courses of 50 pediatric patients with cardiac disease and high-output chylous effusion (control, n = 25; propranolol-treated, n = 25) were reviewed, including morbidities, length of hospitalization, and duration of chest tube requirement. Statistical analysis was performed using Welch's t test, Kruskal-Wallis tests for continuous variables, and chi-square and Fisher exact tests for categorical variables. Univariable logistic regression was used to determine predictors of response. RESULTS: Propranolol response was defined as 80% or more drainage reduction in 9 days or less. Treated patients were grouped into responders (<9 days) and nonresponders (>10 days). Neither initial amount of drainage (P = .12) nor day of propranolol initiation (P = .17) correlated with response. When compared with controls and nonresponders, responders had significantly fewer days with chest tube requirement (P < .01), infection (P < .0002), and thrombus (P = .005), and shorter hospitalization (P < .05). All patients had low serum albumin, although nonresponders had significantly decreased serum albumin when compared with responders and control patients (P < .002), and were more likely to receive albumin replacement (P < .01). Malnutrition was prevalent in all patient groups. CONCLUSIONS: Responders to propranolol had significantly less morbidity and duration of chest tube requirement when compared with control patients and nonresponders. Nonresponders did not have worse outcomes than control patients. We conclude that propranolol may be an effective treatment of patients with refractory chylothorax.


Subject(s)
Cardiac Surgical Procedures , Chylothorax , Heart Diseases , Cardiac Surgical Procedures/adverse effects , Child , Chylothorax/drug therapy , Chylothorax/etiology , Heart Diseases/complications , Humans , Postoperative Complications/drug therapy , Postoperative Complications/etiology , Propranolol/therapeutic use , Retrospective Studies , Serum Albumin
13.
Pediatr Pulmonol ; 57(3): 724-733, 2022 03.
Article in English | MEDLINE | ID: mdl-34921523

ABSTRACT

OBJECTIVE: To describe the safety and tolerability of treatment with ambrisentan and tadalafil in pediatric pulmonary hypertension (PH). STUDY DESIGN: This retrospective observational two-center study included subjects (≤18 years of age) with PH receiving combination therapy with ambrisentan and tadalafil. Before initiating this therapy, many patients were on other therapies for PH. At baseline, patients either received no therapy or monotherapy with a phosphodiesterase 5 inhibitor (PDE5i) or endothelin receptor antagonist (ERA) (Group A), switched from a different PDE5i and ERA (Group B), or were on prostanoid therapy with or without a PDE5i and/or ERA (Group C and D). Demographics, symptoms, and adverse effects were collected. Pre- and postvalues for exercise capacity, hemodynamics, and biomarkers were compared. RESULTS: There were 43 subjects (26 F, 17 M) ages 4-17.5 years (median 9.3) with World Symposium of PH group 1, 3, and 5. Significant improvements were seen in change scores at follow-up in the entire sample and Group A for 6-min walk distance: +37.0 (6.5-71.0) [p = 0.022], mean pulmonary artery pressure: -6.0 (-14.0 to -3.5) [p = .002], pulmonary vascular resistance: -1.7 (-6.2 to -1.0) [p = .003], NT-proBNP -32.9 (-148.9 to -6.7) [p = .025]. WHO functional class improved in 39.5% and was unchanged in 53.5%; PH risk scores improved in 16%; were unchanged in 56%; and declined in 14%. Three patients discontinued therapy (two headaches, one peripheral edema). Seven patients were hospitalized for worsening disease (2/7 had a Potts shunt placed, 2/7 had an atrial septostomy). There were no deaths or lung transplantation. CONCLUSIONS: Combination therapy with ambrisentan and tadalafil was well-tolerated, with an acceptable safety profile in a select group of children. This therapy was associated with improved exercise capacity and hemodynamics in children who were treatment naïve or on monotherapy with a PH medication before the initiation of ambrisentan and tadalafil. Based on these early data, further study of combination therapy in pediatric PH is warranted.


Subject(s)
Hypertension, Pulmonary , Phenylpropionates , Pulmonary Arterial Hypertension , Pyridazines , Adolescent , Antihypertensive Agents/therapeutic use , Child , Child, Preschool , Drug Therapy, Combination , Familial Primary Pulmonary Hypertension/drug therapy , Humans , Hypertension, Pulmonary/drug therapy , Phenylpropionates/adverse effects , Phosphodiesterase 5 Inhibitors/therapeutic use , Pyridazines/therapeutic use , Retrospective Studies , Tadalafil/therapeutic use , Treatment Outcome
14.
J Am Coll Cardiol ; 78(17): 1703-1713, 2021 10 26.
Article in English | MEDLINE | ID: mdl-34674815

ABSTRACT

BACKGROUND: Longitudinal follow-up, resource utilization, and health disparities are top congenital heart research and care priorities. Medicaid claims include longitudinal data on inpatient, outpatient, emergency, pharmacy, rehabilitation, home health utilization, and social determinants of health-including mother-infant pairs. OBJECTIVES: The New York Congenital Heart Surgeons Collaborative for Longitudinal Outcomes and Utilization of Resources linked robust clinical details from locally held state and national registries from 10 of 11 New York congenital heart centers to Medicaid claims, building a novel, statewide mechanism for longitudinal assessment of outcomes, expenditures, and health inequities. METHODS: The authors included all children <18 years of age undergoing cardiac surgery in The Society of Thoracic Surgeons Congenital Heart Surgery Database or the New York State Pediatric Congenital Cardiac Surgery Registry from 10 of 11 New York centers, 2006 to 2019. Data were linked via iterative, ranked deterministic matching on direct identifiers. Match rates were calculated and compared. Proportions of the linked cohort trackable over 3, 5, and 10 years were described. RESULTS: Of 14,097 registry cases, 59% (n = 8,322) reported Medicaid use. Of these, 7,414 were linked to New York claims, at an 89% match rate. Of matched cases, the authors tracked 79%, 74%, and 65% of children over 3, 5, and 10 years when requiring near-continuous Medicaid enrollment. Allowing more lenient enrollment criteria, the authors tracked 86%, 82%, and 76%, respectively. Mortality over this time was 7.7%, 8.4%, and 10.0%, respectively. Manual validation revealed ∼100% true matches. CONCLUSIONS: This establishes a novel statewide data resource for assessment of longitudinal outcome, health expenditure, and disparities for children with congenital heart disease.


Subject(s)
Health Equity , Heart Defects, Congenital/physiopathology , Adolescent , Algorithms , Child , Child, Preschool , Efficiency , Follow-Up Studies , Health Services Accessibility , Healthcare Disparities , Heart Defects, Congenital/complications , Humans , Infant , Infant, Newborn , Insurance Claim Review , Longitudinal Studies , Medicaid , New York , Outpatients , Registries , Severity of Illness Index , Social Determinants of Health , Treatment Outcome , United States
15.
Pediatr Cardiol ; 41(8): 1623-1631, 2020 Dec.
Article in English | MEDLINE | ID: mdl-32729052

ABSTRACT

The aims of this study were (1) to describe the additive risk of performing cardiac surgery in neonates born ≤ 2.0 kg, after accounting for the baseline risks of low birth weight, and (2) to describe the additive risk of being born ≤ 2.0 kg in neonates undergoing cardiac surgery. We used a risk difference analysis in a retrospective cohort, 2006-2016. Neonates born ≤ 2.0 kg undergoing congenital heart surgery during initial postnatal admission were included. Data were standardized alternatingly for birth weight and cardiac surgical risk using national population data to estimate the number of deaths expected had they not required cardiac surgery or were they of normal weight. Of 105 neonates ≤ 2 kg, median birth weight was 1.6 kg (IQR 1.3-1.8 kg). Median gestational age was 33 weeks (IQR 31-35 weeks). Observed operative mortality was 14.3%; 0% for neonates ≤ 1.0 kg (CI 0-33.6%), 20.6% for neonates > 1.0-1.5 kg (CI 8.7-37.9%), and 12.9% for neonates > 1.5-2.0 kg (CI 5.7-23.9%). Among neonates ≤ 2.0 kg not undergoing cardiac surgery, expected mortality was 4.8% (CI 1.6-10.8); cardiac surgery increased the risk of mortality 9.5% (CI 1.7-17.4%). Conversely, the expected risk for normal birth weight neonates undergoing cardiac surgery was 5.7% (CI 2.1-12.0%); low birth weight increased the risk of mortality 8.6% (CI 0.5-16.6%). To continue making advancements in cardiac surgery, we must understand that the rate of mortality observed in normal weight infants is not a realistic target and that, despite advances, the risk attributable to the surgery remains higher among low birth weight patients.


Subject(s)
Cardiac Surgical Procedures/statistics & numerical data , Heart Defects, Congenital/surgery , Infant, Low Birth Weight , Birth Weight , Cardiac Surgical Procedures/mortality , Female , Gestational Age , Humans , Infant , Infant, Newborn , Male , Retrospective Studies , Risk Factors , Treatment Outcome
16.
J Hist Med Allied Sci ; 75(2): 193-220, 2020 Apr 01.
Article in English | MEDLINE | ID: mdl-31913482

ABSTRACT

This article explores how and why student mental health became an issue of concern in British universities between 1944 and 1968. It argues that two factors drew student mental health to the attention of medical professionals across this period: first, it argues that the post-war interest in mental illness drew attention to students, who were seen to be the luminaries of the future, investing their wellbeing with particular social importance. Second, it argues that the development of university health services made students increasingly visible, endorsing the view that higher education posed distinctive yet shared mental challenges to young people. The article charts the expansion of services and maps the implications of the visibility of student mental distress for post-war British universities. It suggests that claims that British higher education is currently in the midst of an unprecedented mental health "crisis" should be seen within this broader historical context, for while the contours of the debates around student mental health have shifted substantially, evidence that there was anxiety around student mental wellbeing in the immediate post-war years undermines accusations that contemporary students constitute a unique "snowflake generation."


Subject(s)
Mental Disorders/history , Mental Health/history , Students , Universities , Adolescent , History, 20th Century , Humans , Mental Disorders/diagnosis , Mental Disorders/therapy , United Kingdom , Young Adult
17.
Med Humanit ; 46(2): 124-134, 2020 Jun.
Article in English | MEDLINE | ID: mdl-31147447

ABSTRACT

The Second World War lent impetus to the creation of new models and explanatory frameworks of risk, encouraging a closer reading of the relationship between individual psychiatric disorder and social disarray. This article interrogates how conceptions of psychiatric risk were animated in debates around abortion reform to forge new connections between social conditions and psychiatric vulnerability in post-war Britain. Drawing upon the arguments that played out between medical practitioners, I suggest that abortion reform, culminating in the 1967 Abortion Act, was both a response to and a stimulus for new ideas about the interaction between social aetiologies and medical pathologies; indeed, it became a site in which the medical and social domains were recognised as mutually constitutive. Positioned in a landscape in which medical professionals were seeking to assert their authority and to defend their areas of practice, abortion reform offered new opportunities for medical professionals to intervene in the social sphere under the guise of risk to women's mental health. The debate in medical journals around the status of issues that were seen to bridge the social and the medical were entangled with increasing anxiety about patient agency and responsibility. These concerns were further underscored as conversations about psychiatric risk extended towards considerations of the potential impact on women's existing families, bringing domestic conditions and the perceived psychosocial importance of family life into relief within medical journals. This article, then, argues that conceptions of psychiatric risk, as refracted through the creation of new synapses connecting the social and the medical domains, were critical to medical debates over abortion reform in post-war Britain.


Subject(s)
Abortion, Legal/history , Health Care Reform/history , Mental Health/history , Social Conditions/history , Women's Health/history , Abortion, Legal/psychology , Female , History, 20th Century , Humans , Pregnancy , United Kingdom
18.
Eur Respir Rev ; 28(154)2019 Dec 31.
Article in English | MEDLINE | ID: mdl-31852745

ABSTRACT

The objective of this document was to standardise published cardiopulmonary exercise testing (CPET) protocols for improved interpretation in clinical settings and multicentre research projects. This document: 1) summarises the protocols and procedures used in published studies focusing on incremental CPET in chronic lung conditions; 2) presents standard incremental protocols for CPET on a stationary cycle ergometer and a treadmill; and 3) provides patients' perspectives on CPET obtained through an online survey supported by the European Lung Foundation. We systematically reviewed published studies obtained from EMBASE, Medline, Scopus, Web of Science and the Cochrane Library from inception to January 2017. Of 7914 identified studies, 595 studies with 26 523 subjects were included. The literature supports a test protocol with a resting phase lasting at least 3 min, a 3-min unloaded phase, and an 8- to 12-min incremental phase with work rate increased linearly at least every minute, followed by a recovery phase of at least 2-3 min. Patients responding to the survey (n=295) perceived CPET as highly beneficial for their diagnostic assessment and informed the Task Force consensus. Future research should focus on the individualised estimation of optimal work rate increments across different lung diseases, and the collection of robust normative data.


Subject(s)
Exercise Test , Lung Diseases/diagnosis , Chronic Disease , Clinical Protocols , Europe , Humans
19.
Rural Remote Health ; 19(3): 5358, 2019 09.
Article in English | MEDLINE | ID: mdl-31474113

ABSTRACT

Context and issues: The introduction of individualised funding under the National Disability Insurance Scheme in Australia aimed to increase individual choice and control over how people received disability supports. An increase in the allied health disability workforce was anticipated; however, disability workforce sector reports have consistently indicated difficulties in attracting and retaining sufficient allied health staff to satisfy current and future demand. Autism spectrum disorder is the most prevalent primary diagnosis of participants receiving individualised funding to date and requires support staff to have specialised skills and experience. Given that overall staff attraction and retention issues are reported to be exacerbated in regional and remote areas of Australia, it is important to seek innovative ways of supporting individuals on the autism spectrum in their local communities. Technology has the potential to provide a timely and low-cost alternative that extends access to specialist services for people in remote locations. The current project aimed to identify the feasibility, essential requirements and potential barriers in delivering therapy support to regional and remote participants on the autism spectrum via video-conferencing technology. Lessons learned: A multidisciplinary team (speech pathologist, occupational therapist, psychologist and a special educator) were recruited and trained to deliver tele-therapy services to 16 participants on the autism spectrum, in collaboration with their families and local support teams. Participants resided in two northern, nine western and one southern regional area in New South Wales (NSW), Australia. There were three sets of siblings. One participant resided on remote Lord Howe Island off the coast of northern NSW. Researchers used semi-structured telephone interviews to gain insight into the program from key stakeholder groups including parents, education staff, allied health professionals and tele-therapists. A general inductive approach to data analysis was used under five project evaluation areas. The evaluation focused on five areas including: development of the tele-health delivery team, understanding the role of collaboration, examining the need for autism-specific support, establishing the need for in-person contact and identifying barriers to success. The project evaluation found that investment in staff training and support was key to building a competent tele-therapy team and delivering successful tele-therapy services under a sustainable model. For many families and support team members, collaboration was reported as an important part of the tele-therapy program, with families and teachers finding it helpful to work together with the same information. The evaluation confirmed that access to autism-specific knowledge and support was novel and regarded as beneficial for families and support teams living in regional and remote areas. There were mixed responses to the inclusion of in-person support as part of a tele-therapy service. While some families felt a tele-therapy service was no different to in-person services, other families and tele-therapists indicated that the addition of at least one in-person session would help to increase rapport. Barriers within the tele-therapy model included scheduling and local staff changes, as well as the delivery of intervention requiring physical support. Technology was not seen as a barrier in the current study. This research adds to the growing body of information supporting the use of tele-practice for geographically isolated regions. Ideally, tele-therapy should not replace in-person services; however, it is necessary when no other comparable service option is available locally. Larger scale research is needed to compare blended, online and in-person models so that an optimal ratio can be established.


Subject(s)
Activities of Daily Living/psychology , Allied Health Personnel , Autism Spectrum Disorder/therapy , Rural Health Services/organization & administration , Videoconferencing/organization & administration , Autism Spectrum Disorder/psychology , Female , Health Services Accessibility , Humans , Male , New South Wales , Program Evaluation , Qualitative Research , Residence Characteristics
20.
Pharmaceut Med ; 33(4): 331-339, 2019 08.
Article in English | MEDLINE | ID: mdl-31933187

ABSTRACT

BACKGROUND: Most drug regulatory agencies and pharmaceutical companies hold databases of spontaneous reports of suspected adverse drug reactions (ADRs). Detection systems for ADR signals have been created by specialists to analyse such reports, based on the concept of disproportionality, in order to support safety decision making. However, these measures are often misinterpreted by non-specialists in pharmacovigilance. OBJECTIVES: Our aim was to assess agreement between estimates of risk from spontaneous reports of suspected ADRs and estimates of risks of ADRs from randomised controlled trials (RCTs). METHODS: From 150 drugs randomly selected from the US Food and Drug Administration's Adverse Event Reporting System (FAERS), we identified drugs where FAERS provided reporting odds ratios (RORs) and corresponding systematic reviews from the Cochrane database gave (pooled) odds ratios (ORs) for the same drugs and adverse reactions. We assessed agreement between (ln) RORs and (ln) ORs using the Pearson correlation coefficient and the Bland-Altman agreement method, and performed sensitivity analyses. RESULTS: We identified 6 drugs and 125 ADRs. Overall, there was a weak correlation (r = 0.20) between RORs (FAERS) and ORs (RCTs). However, we observed a stronger correlation (r = 0.78) between RORs and ORs for one drug (roflumilast) that received market approval relatively recently (2011). CONCLUSIONS: Spontaneous reporting of suspected ADRs is an important tool for regulatory agencies and pharmaceutical companies in making decisions and detecting drug safety signals. Although there was moderate-to-strong agreement between ADR risk estimates from drug surveillance and RCTs for one drug, this study illustrates the current recommendations not to use disproportionality measures as valid proxies for risk estimates.


Subject(s)
Drug-Related Side Effects and Adverse Reactions/epidemiology , Pharmacovigilance , Randomized Controlled Trials as Topic/statistics & numerical data , Databases, Factual , Humans , Systematic Reviews as Topic , United States , United States Food and Drug Administration
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