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1.
Am J Surg ; 2021 Jan 30.
Artigo em Inglês | MEDLINE | ID: mdl-33551115

RESUMO

BACKGROUND: Parathyroidectomy is the only curative treatment for primary hyperparathyroidism (pHPT) and is associated with low morbidity. This study examined the severity of disease and outcomes of parathyroidectomy based on patient age at a high-volume institution. METHODS: This is a retrospective review of sporadic pHPT patients who underwent initial parathyroidectomy. To study disease severity over time, patients were divided into timeframes: 1999-2007, 2007-2012, and 2013-2018. Elderly was defined as age ≥75 years. RESULTS: Over time, the elderly had progressively lower preoperative calcium (11.0, 10.7, 10.7; p = 0.05) and PTH (150.4, 111.9, 107.9; p < 0.001) levels. By age, there was no difference in preoperative calcium (10.8, 10.9; p = 0.91) or in rates of recurrent laryngeal nerve injury, hypoparathyroidism, or persistent/recurrent pHPT. CONCLUSIONS: Over the 3 time periods of the study, elderly patients had progressively lower calcium and PTH levels. There was no difference in endocrine-specific complications between the age groups, suggesting that parathyroidectomy in the elderly is safe and therefore, age-associated morbidity should not preclude parathyroidectomy.

2.
Ann Surg Oncol ; 2021 Feb 14.
Artigo em Inglês | MEDLINE | ID: mdl-33586069

RESUMO

BACKGROUND: Adrenocortical carcinoma (ACC) is a rare but aggressive malignancy, and many prognostic factors that influence survival remain undefined. Individually, the GRAS (Grade, Resection status, Age, and Symptoms of hormone hypersecretion) parameters have demonstrated their prognostic value in ACC. This study aimed to assess the value of a cumulative GRAS score as a prognostic indicator after ACC resection. METHODS: A retrospective cohort study of adult patients who underwent surgical resection for ACC between 1993 and 2014 was performed using the United States Adrenocortical Carcinoma Group (US-ACCG) database. A sum GRAS score was calculated for each patient by adding one point each when the criteria were met for tumor grade (Weiss criteria ≥ 3 or Ki67 ≥ 20%), resection status (micro- or macroscopically positive margin), age (≥ 50 years), and preoperative symptoms of hormone hypersecretion (present). Overall survival (OS) and disease-free survival (DFS) by cumulative GRAS score were analyzed by the Kaplan-Meier method and log-rank test. RESULTS: Of the 265 patients in the US-ACCG database, 243 (92%) had sufficient data available to calculate a cumulative GRAS score and were included in this analysis. The 265 patients comprised 23 patients (10%) with a GRAS of 0, 52 patients (21%) with a GRAS of 1, 92 patients (38%) with a GRAS of 2, 63 patients (26%) with a GRAS of 3, and 13 patients (5%) with a GRAS of 4. An increasing GRAS score was associated with shortened OS (p < 0.01) and DFS (p < 0.01) after index resection. CONCLUSION: In this retrospective analysis, the cumulative GRAS score effectively stratified OS and DFS after index resection for ACC. Further prospective analysis is required to validate the cumulative GRAS score as a prognostic indicator for clinical use.

3.
Circ Cardiovasc Qual Outcomes ; 14(1): e006548, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33435730

RESUMO

BACKGROUND: Cardiovascular prevention guidelines use estimated 10-year atherosclerotic cardiovascular disease (CVD) risk based on the pooled cohort equations to guide treatment decisions and engage patients in shared decision-making. We sought to determine patient perceived versus actual risk of atherosclerotic CVD and associations with willingness for preventive therapy. METHODS: We evaluated calculated and perceived CVD risk among 4187 patients across 124 sites in the Patient and Provider Assessment of Lipid Management Registry. Ten-year risk was assessed using the pooled cohort equations; risk relative-to-peers was determined based on age-, sex-, and race-based percentiles; and patient estimates of risk were assessed using patient surveys. Poisson regression models evaluated associations between risk estimates, statin use, and willingness to take prevention therapy. RESULTS: Overall, there was no correlation between patients' estimates of their 10-year CVD risk and calculated 10-year risk (ρ=-0.01, Pcorrelation=0.46), regardless of age, sex, race, or socioeconomic status. The majority (72.2%) overestimated their 10-year CVD risk relative to the pooled cohorts equation (mean perceived 33.3% versus mean calculated 17.1%, Pdifference<0.01). Patients' perceptions of their risk relative-to-peers were slightly correlated with standardized risk percentiles (ρ=0.19, P<0.01), although most had overly optimistic views of how risk compared with their peers. Increasing perceived risk was not associated with current statin use (P=0.18) but was associated with willingness to consider future prevention therapy (P<0.01). Perceived risk relative-to-peers was associated with increased prevalent statin use (risk ratio 1.04 per category increase [95% CI, 1.02-1.06]) and reported willingness for prevention therapy (risk ratio 1.11 [95% CI, 1.07-1.16]). CONCLUSIONS: When asked, most patients overestimate their 10-year risk but hold an optimistic bias of their risk relative to age-, race-, and sex-matched peers. Providing accurate absolute risk assessments to patients without proper context may paradoxically decrease many patients' perceived risk of CVD, thereby disincentivizing initiation of CVD risk reduction therapy.

4.
JAMA Intern Med ; 181(3): 309-310, 2021 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-33427866
5.
J Am Heart Assoc ; 10(1): e016215, 2021 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-33342227

RESUMO

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.

6.
Circulation ; 2020 Nov 17.
Artigo em Inglês | MEDLINE | ID: mdl-33200953

RESUMO

Background: The COVID-19 pandemic has exposed longstanding racial/ethnic inequities in health risks and outcomes in the U.S.. We sought to identify racial/ethnic differences in presentation and outcomes for patients hospitalized with COVID-19. Methods: The American Heart Association COVID-19 Cardiovascular Disease Registry is a retrospective observational registry capturing consecutive patients hospitalized with COVID-19. We present data on the first 7,868 patients by race/ethnicity treated at 88 hospitals across the US between 01/17/2020 and 7/22/2020. The primary outcome was in-hospital mortality; secondary outcomes included major adverse cardiovascular events (MACE: death, myocardial infarction, stroke, heart failure) and COVID-19 cardiorespiratory ordinal severity score (worst to best: death, cardiac arrest, mechanical ventilation with mechanical circulatory support, mechanical ventilation with vasopressors/inotrope support, mechanical ventilation without hemodynamic support, and hospitalization without any of the above). Multivariable logistic regression analyses were performed to assess the relationship between race/ethnicity and each outcome adjusting for differences in sociodemographic, clinical, and presentation features, and accounting for clustering by hospital. Results: Among 7,868 patients hospitalized with COVID-19, 33.0% were Hispanic, 25.5% were non-Hispanic Black, 6.3% were Asian, and 35.2% were non-Hispanic White. Hispanic and Black patients were younger than non-Hispanic White and Asian patients and were more likely to be uninsured. Black patients had the highest prevalence of obesity, hypertension, and diabetes. Black patients also had the highest rates of mechanical ventilation (23.2%) and renal replacement therapy (6.6%) but the lowest rates of remdesivir use (6.1%). Overall mortality was 18.4% with 53% of all deaths occurring in Black and Hispanic patients. The adjusted odds ratios (ORs) for mortality were 0.93 (95% confidence interval [CI] 0.76-1.14) for Black patients, 0.90 (95% CI 0.73-1.11) for Hispanic patients, and 1.31 (95% CI 0.96-1.80) for Asian patients compared with non-Hispanic White patients. The median OR across hospitals was 1.99 (95% CI 1.74-2.48). Results were similar for MACE. Asian patients had the highest COVID-19 cardiorespiratory severity at presentation (adjusted OR 1.48, 95% CI 1.16-1.90). Conclusions: Although in-hospital mortality and MACE did not differ by race/ethnicity after adjustment, Black and Hispanic patients bore a greater burden of mortality and morbidity due to their disproportionate representation among COVID-19 hospitalizations.

7.
Surgery ; 2020 Oct 30.
Artigo em Inglês | MEDLINE | ID: mdl-33139065

RESUMO

BACKGROUND: Finding and preserving normal parathyroid glands or localizing and removing diseased parathyroid glands are crucial steps to successful thyroid and parathyroid operations. Using near-infrared fluorescence detection to identify parathyroid glands during thyroid and parathyroid operations has lately gained widespread recognition, with 2 Food and Drug Administration-cleared devices currently in the market. We aim to update the endocrine surgery community on how near-infrared fluorescence detection can be most optimally used for rapid intraoperative parathyroid gland identification or preservation. METHODS: A literature review was performed using the key terms: "parathyroid," "near infrared," and "fluorescence" in relevant search engines. Based on the reviewed literature and expert surgeons' opinions, recommendations were formulated for applying near-infrared fluorescence detection to identify or preserve parathyroid glands during cervical endocrine surgery. RESULTS: The scope of near-infrared fluorescence detection can be broadly categorized into (1) using near-infrared auto-fluorescence to identify or locate both healthy and diseased parathyroid glands, and (2) using contrast-enhanced near-infrared fluorescence to evaluate parathyroid gland perfusion. The benefits and pitfalls for both near-infrared-based approaches are described herein. CONCLUSION: Near-infrared fluorescence detection appears helpful for identification and likely preservation of parathyroid glands. We hope these recommendations will be valuable to the practicing endocrine surgeon as they consider incorporating these intraoperative adjuncts in their surgical practice.

8.
Am J Cardiol ; 2020 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-33068540

RESUMO

The purpose of this analysis was to assess implantable cardioverter-defibrillator (ICD) utilization and its association with mortality among patients ≥65 years of age after coronary revascularization. Patients in the National Cardiovascular Database Registry Chest Pain-Myocardial Infarction (MI) Registry who presented with MI from January 2, 2009 to December 31, 2016, had a left ventricular ejection fraction ≤35% and underwent in-hospital revascularization (10,014 percutaneous coronary intervention (PCI) and 1,647 coronary artery bypass grafting (CABG)) were linked with Medicare claims to determine rates of 1-year ICD implantation. The association between ICD implantation and 2-year mortality was assessed. Of 11,661 included patients, an ICD was implanted in 1,234 (10.6%) within 1 year of revascularization (1,063 (10.6%) PCI and 171 (10.4%) CABG). Among PCI-treated patients, in-hospital ventricular arrhythmia (adjusted hazard ratio [aHR] 1.60, 95% confidence interval [CI] 1.34 to 1.92), 2-week cardiology follow-up (aHR 1.48, 95% CI 1.29 to 1.70), readmission for heart failure (aHR 3.21, 95% CI 2.73 to 3.79), and readmission for MI (aHR 2.18, 95% CI 1.66 to 2.85) were positively associated with ICD implantation. Among CABG-treated patients, in-hospital ventricular arrhythmia (aHR 2.33, 95% CI 1.39 to 3.91), and heart failure readmission (aHR 3.14, 95% CI 1.96 to 5.04) were positively associated with ICD implantation. Women were less likely to receive an ICD, regardless of the revascularization strategy. ICD implantation was associated with lower 2-year all-cause mortality (aHR 0.74, 95% CI 0.63 to 0.86). In conclusion, only 1 in 10 Medicare patients with low ejection fraction received an ICD within 1 year after revascularization. Contact with the healthcare system after discharge was associated with higher likelihood of ICD implantation. ICD implantation was associated with lower mortality following revascularization for MI.

9.
Am Heart J ; 231: 32-35, 2020 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-33045223

RESUMO

Routine intensive care unit (ICU) utilization for patients with initially stable non-ST segment elevation myocardial infarction is not associated with improved short- or long-term patient outcomes; however, the association with patient experience has not been reported. Using Hospital Consumer Assessment of Healthcare Providers and Systems patient survey data linked to ICU use data from the National Cardiovascular Data Registry, we found no association between hospital-level ICU utilization and metrics of patient experience, including communication, staff responsiveness, and overall satisfaction.

10.
JAMA Intern Med ; 180(10): 1383-1384, 2020 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-32865542
11.
Am J Surg ; 2020 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-32933747

RESUMO

BACKGROUND: Patients with low-risk-PTC who undergo thyroid lobectomy (TL) have comparable disease-specific survival with lower morbidity than total thyroidectomy (TT). We aim to describe the surgical management of low-risk-PTC using the Collaborative Endocrine Surgery Quality Improvement Program (CESQIP). METHOD: CESQIP thyroidectomies of PTC tumors <4 cm were analyzed from 2014 to 2019 (n = 740). Postoperative outcomes were compared. Subgroup analysis examined temporal and institutional trends, and stratified for tumor size. Statistics utilized t-test, ANOVA, and Chi-squared. RESULTS: TT patients had greater hypoparathyroidism, operative time, and length-of-stay (all p < 0.001). Incidence of TL decreased with increasing tumor size (24.2% for <1 cm, 15.8% for 1-2 cm, 6.1% for 2-4 cm). TL rates increased from 2.0% in 2014 to 21.2% in 2018-19. Completion thyroidectomy was recommended in 12.0% of TL subjects. There was significant variation in TL rate by institution (p < .001). CONCLUSIONS: For low-risk-PTC, TT remained the most commonly utilized operation. TL rates increased following release of the new ATA guidelines. TT was associated with higher perioperative morbidity. Further insight is needed to understand factors influencing operative approach.

12.
J Am Coll Cardiol ; 76(11): 1328-1340, 2020 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-32912447

RESUMO

BACKGROUND: Adoption of the results of large-scale randomized controlled trials in percutaneous coronary intervention (PCI) may differ internationally, yet few studies have described the potential variations in PCI practice patterns. OBJECTIVES: Using representative national registries, we compared temporal trends in procedural volume, patient characteristics, pre-procedural testing, procedural characteristics, and quality metrics in the United States and Japan. METHODS: The National Cardiovascular Data Registry CathPCI was used to describe care in the United States, and the J-PCI was used to assess practice patterns in Japan (numbers of participating hospitals: 1,752 in the United States and 1,108 in Japan). Both registries were summarized between 2013 and 2017. RESULTS: PCI volume increased by 15.8% in the United States from 550,872 in 2013 to 637,650 in 2017, primarily because of an increase in nonelective PCIs (p for trend <0.001). In Japan, the volume of PCIs increased by 36%, from 181,750 in 2013 to 247,274 in 2017, primarily because of an increase in elective PCIs (p for trend <0.001). The proportion of PCI cases for elective conditions was >2-fold greater in Japan (72.7%) than in the United States (33.8%; p < 0.001). Overall, the ratio of nonelective PCI (vs. elective PCI; 27.3% vs. 66.2%; p < 0.001) and the performance of noninvasive stress testing in patients with stable disease (15.2% vs. 55.3%; p < 0.001) was lower in Japan than in the United States. Computed tomography angiography was more commonly used in Japan (22.3% vs. 2.0%; p < 0.001). CONCLUSIONS: Elective PCI is more than twice as common in Japan as in the United States in contemporary practice. Computed tomography angiography is much more frequently used pre-procedurally in Japan than in the United States.

13.
J Am Heart Assoc ; 9(16): e015879, 2020 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-32777969

RESUMO

Background Aortic valve replacement (AVR) is a life-saving treatment for patients with symptomatic severe aortic valve stenosis. We sought to determine whether transcatheter AVR has resulted in a more equitable treatment rate by race in the United States. Methods and Results A total of 32 853 patients with symptomatic severe aortic valve stenosis were retrospectively identified via Optum's deidentified electronic health records database (2007-2017). AVR rates in non-Hispanic Black and White patients were assessed in the year after diagnosis. Multivariate Fine-Gray hazards models were used to evaluate the likelihood of AVR by race, with adjustment for patient factors and the managing cardiologist. Time-trend and 1-year symptomatic severe aortic valve stenosis survival analyses were also performed. From 2011 to 2016, the rate of AVR increased from 20.1% to 37.1%. Overall, Black individuals were less likely than Whites to receive AVR (22.9% versus 31.0%; unadjusted hazard ratio [HR], 0.70; 95% CI, 0.62-0.79; fully adjusted HR, 0.76; 95% CI, 0.67-0.85). Yet, during 2015 to 2016, AVR racial differences were attenuated (29.5% versus 35.2%; adjusted HR, 0.86; 95% CI, 0.74-1.02) because of greater uptake of transcatheter AVR in Blacks than Whites (53.4% of AVRs versus 47.3%; P=0.128). Untreated patients had significantly higher 1-year mortality than those treated (adjusted HR, 0.57; 95% CI, 0.53-0.61), which was consistent by race (interaction P value=0.52). Conclusions Although transcatheter AVR has increased the use of AVR in the United States, treatment rates remain low. Black patients with symptomatic severe aortic valve stenosis were less likely than White patients to receive AVR, yet these differences have recently narrowed.

14.
Surgery ; 2020 Aug 25.
Artigo em Inglês | MEDLINE | ID: mdl-32854969

RESUMO

BACKGROUND: Approximately 80% of general surgery residents undertake some form of fellowship training. Our objective was to characterize goals and burdens of the interview process among applicants to Comprehensive Endocrine Surgery Fellowship programs. METHODS: Participants included trainees from 2013 to 2019. Results for ranking questions are presented as a mean rank reported out of the total number of selections. RESULTS: Response rate was 54% (n = 75). The most important goal for interviews was meeting the faculty (mean rank 2.4/9), followed by "behind the scenes information" and "make a good impression" (mean rank 3.6 and 3.7, respectively). The most substantial burden for the applicant was expense (mean rank 2.1/7), followed by time away from residency (mean rank 3.1/7). The economic burden of 51% of the applicants was $2,500 to $7,500. Geographic location and expense were the top 2 reasons applicants declined offers of interviews. Despite the process, 76% of respondents indicated that no improvements to the interview process are necessary. Alternative strategies such as videoconferencing or centralized interviews received little support (<10%). CONCLUSION: Despite identifying several burdens, survey respondents believed that in-person interviews are an integral component of the fellowship application process. Indeed, 70% of applicants do not have a first-choice program before interviews, and meeting the faculty is ranked as the greatest priority goal. Our data illustrate the importance of individual specialties evaluating and optimizing their own processes for fellowship interviews.

16.
Am Heart J ; 227: 91-99, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32693197

RESUMO

Vitamin K antagonists are the only approved oral anticoagulants for long-term prophylaxis against valve thrombosis and thromboembolism in patients with a mechanical heart valve. Despite the proven efficacy and safety of anticoagulation with the oral direct factor Xa inhibitor apixaban compared with warfarin in high-risk populations including subjects with atrial fibrillation or with venous thromboembolism, it remains unknown whether patients with a mechanical heart valve can be safely managed with apixaban. The On-X Aortic Heart Valve and On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft may have lower rates of valve thrombosis and thromboembolism than conventional bileaflet and tilting disc valves due its unique pyrolytic carbon composition and flared inlet design. DESIGN: PROACT Xa is a randomized, multicenter, open-label, active-controlled trial comparing apixaban with warfarin in patients with an On-X Aortic Heart Valve or On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft. The study will randomize approximately 1,000 patients from approximately 60 sites in North America who underwent aortic valve replacement at least 3 months prior. Patients will be randomized 1:1 to receiving apixaban 5 mg twice daily or warfarin with a target international normalized ratio of 2.0-3.0. The last randomized participant will be followed for at least 2 years. The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding. Assuming the primary outcome occurs in warfarin-anticoagulated patients at a rate of 1.75%/patient-year, the study has more than 90% power to assess noninferiority of apixaban treatment with an absolute noninferiority margin of 1.75%/patient-year. A second co-primary analysis is to compare the hazard rate for the apixaban arm to twice the objective performance criterion for thromboembolism and valve thrombosis, that is, 3.4%/patient-year. SUMMARY: PROACT Xa will determine whether patients with an On-X Aortic Heart Valve can be anticoagulated with apixaban as an alternative to warfarin.


Assuntos
Anticoagulantes/uso terapêutico , Valva Aórtica/cirurgia , Inibidores do Fator Xa/uso terapêutico , Próteses Valvulares Cardíacas , Complicações Pós-Operatórias/prevenção & controle , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Tromboembolia/prevenção & controle , Trombose/prevenção & controle , Varfarina/uso terapêutico , Anticoagulantes/efeitos adversos , Inibidores do Fator Xa/efeitos adversos , Humanos , Estudos Multicêntricos como Assunto , Desenho de Prótese , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Resultado do Tratamento , Varfarina/efeitos adversos
17.
Circ Cardiovasc Qual Outcomes ; 13(7): e006564, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32683983

RESUMO

Utilization management strategies, including prior authorization, are commonly used to facilitate safe and guideline-adherent provision of new, individualized, and potentially costly cardiovascular therapies. However, as currently deployed, these approaches encumber multiple stakeholders. Patients are discouraged by barriers to appropriate access; clinicians are frustrated by the time, money, and resources required for prior authorizations, the frequent rejections, and the perception of being excluded from the decision-making process; and payers are weary of the intensive effort to design and administer increasingly complex prior authorization systems to balance value and appropriate use of these treatments. These issues highlight an opportunity to collectively reimagine utilization management as a transparent and collaborative system. This would benefit the entire healthcare ecosystem, especially in light of the shift to value-based payment. This article describes the efforts and vision of the multistakeholder Prior Authorization Learning Collaborative of the Value in Healthcare Initiative, a partnership between the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University. We outline how healthcare organizations can take greater utilization management responsibility under value-based contracting, especially under different state policies and local contexts. Even with reduced payer-mandated prior authorization in these arrangements, payers and healthcare organizations will have a continued shared need for utilization management. We present options for streamlining these programs, such as gold carding and electronic and automated prior authorization processes. Throughout the article, we weave in examples from cardiovascular care when possible. Although reimagining prior authorization requires collective action by all stakeholders, it may significantly reduce administrative burden for clinicians and payers while improving outcomes for patients.

18.
Circ Cardiovasc Qual Outcomes ; 13(7): e006606, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32683985

RESUMO

The pipeline of new cardiovascular drugs is relatively limited compared with many other clinical areas. Challenges causing lagging drug innovation include the duration and expense of cardiovascular clinical trials needed for regulatory evaluation and approvals, which generally must demonstrate noninferiority to existing standards of care and measure longer-term outcomes. By comparison, there has been substantial progress in cardiovascular device innovation. There has also been progress in cardiovascular trial participation equity in recent years, especially among women, due in part to important efforts by Food and Drug Administration, National Institutes of Health, American Heart Association, and others. Yet women and especially racial and ethnic minority populations remain underrepresented in cardiovascular trials, indicating much work ahead to continue recent success. Given these challenges and opportunities, the multistakeholder Partnering with Regulators Learning Collaborative of the Value in Healthcare Initiative, a collaboration of the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University, identified how to improve the evidence generation process for cardiovascular drugs and devices. Drawing on a series of meetings, literature reviews, and analyses of regulatory options, the Collaborative makes recommendations across four identified areas for improvement. First, we offer strategies to enhance patient engagement in trial design, convenient participation, and meaningful end points and outcomes to improve patient recruitment and retention (major expenses in clinical trials). Second, new digital technologies expand the potential for real-world evidence to streamline data collection and reduce cost and time of trials. However, technical challenges must be overcome to routinely leverage real-world data, including standardizing data, managing data quality, understanding data comparability, and ensuring real-world evidence does not worsen inequities. Third, as trials are driven by evidence needs of regulators and payers, we recommend ways to improve their collaboration in trial design to streamline and standardize efficient and innovative trials, reducing costs and delays. Finally, we discuss creative ways to expand the minuscule proportion of sites involved in cardiovascular evidence generation and medical product development. These actions, paired with continued policy research into better ways to pay for and equitably develop therapies, will help reduce the cost and complexity of drug and device research, development, and trials.

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