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1.
Vaccine ; 2021 Oct 13.
Artículo en Inglés | MEDLINE | ID: mdl-34656380

RESUMEN

BACKGROUND: The health and economic benefits of immunization may extend beyond the elements traditionally included in cost-effectiveness analyses (CEAs). This review investigated how broader impacts are considered in economic evaluations of vaccines and whether their inclusion would substantially change CEA findings. METHODS: We reviewed CEAs of vaccines associated with the largest global health burden, published from 2014 to 2019 using the Tufts CEA Registry and Tufts Global Health CEA Registry. We supplemented this with a systematic review of published and grey literature. We conducted descriptive analyses to examine the frequency of inclusion of specific social factors and study characteristics associated with their inclusion. We also conducted a case study of the human papilloma virus (HPV) vaccine to illustrate the potential change in CEA findings from selected social impacts. RESULTS: We identified 475 relevant health economic assessments. Overall, 40% of studies included at least one category of social impact. The most commonly included non-healthcare cost among cost-per-QALY studies was productivity (25%), while cost-per-DALY studies reported transportation costs most frequently (24%). Few studies examined the impact of vaccination on other sectors such as education and housing (<3%). Middle-income and North American settings were positively associated with social impact inclusion, while sub-Saharan African location was negatively associated. In the HPV case study, the addition of nonhealth costs improved cost-effectiveness by up to 90% or made the vaccine cost-saving, depending on geographic setting. The cost-saving scenario saved up to $30,000 in costs per case of cervical cancer averted. CONCLUSIONS: A minority of vaccine CEAs include social impacts, particularly for nonhealth sectors. The omission of these impacts may result in a systematic undervaluation of vaccines from a societal perspective. Further efforts are required to document the full benefits of vaccination for policymaker consideration.

2.
Vasc Endovascular Surg ; : 15385744211048310, 2021 Oct 02.
Artículo en Inglés | MEDLINE | ID: mdl-34601982

RESUMEN

Introduction: Completion imaging following carotid endarterectomy (CEA) remains controversial. We present our experience performing routine completion arteriography (CA). Methods: A retrospective review of our prospectively maintained institutional database was performed for patients undergoing isolated CEA. Results: 1439 isolated CEAs with CA were performed on 1297 patients. CEA was for asymptomatic lesions in 70% (1003) of cases. There were no complications related to arteriography. An abnormal arteriogram documented significant abnormalities in the internal carotid artery (ICA) and prompted revision in 1.7% (24/1439) of cases: 20 unsatisfactory distal endpoints of the endarterectomy (12 residual stenoses, 7 intimal flaps, and 1 dissection), 3 kinks or stenoses within the body of the patch, and 1 thrombus. Of the 20 distal endpoint lesions, stent deployment was used in 17 cases and patch revision in 3 cases. The other 4 cases were treated by patch angioplasty (3) or thrombectomy (1). None suffered a perioperative stroke. The overall 30-day stroke, death, and combined stroke/death rate for the 1439 patients in our series was 1.5% (22), .5% (7), and 1.9% (27), respectively. The combined stroke/death rate for asymptomatic lesions was 1.1% (11/1003) and for symptomatic lesions was 2.5% (11/436). Of the 22 strokes in the entire series (all with normal CA), 15 were non-hemorrhagic strokes ipsilateral to the CEA; 14 were confirmed to have widely patent endarterectomy sites by CT-A (13) or re-exploration and repeat arteriography (1). The occluded site was re-explored and underwent thrombectomy, but no technical problems were identified. The remaining strokes were hemorrhagic (4 reperfusion syndrome and 1 surgical site bleeding) or contralateral to the CEA (2). Conclusion: Although not all patients in this series who underwent intraoperative revision due to abnormal CA might have suffered a stroke, performing this simple and safe study may have halved our overall perioperative stroke rate from 3.2% to 1.5%.

3.
Artículo en Inglés | MEDLINE | ID: mdl-34606092

RESUMEN

PURPOSE: Enteral nutrition (EN) is considered as a cornerstone in the management of critically ill patients. However, its successful initiation is frequently hampered by various complications occurring in patients treated in the ICU. Successful placement of a nasojejunal tube by Cortrak enteral access system (CEAS) has been reported to be a simple bedside tool for placing the postpyloric (PP) feeding tube. PATIENTS AND METHODS: We evaluated the efficacy and side effects using CEAS to establish EN in critical ill, thrombocytopenic and/or anticoagulated patients. RESULTS: Fifty-six mechanically ventilated patients were analysed, 24 of them underwent prior haematopoietic stem cell transplantation (SCT). Sixteen patients received ECMO treatment due ARDS. The median platelet count at PP placement was 26 G/l (range: 4 - 106 G/l); 16 patients received therapeutic anticoagulation (aPTT 50-70 s.). CEAS assisted placement of a PP nasojejunal tube was performed successfully in all patients . The most frequent adverse event was epistaxis in 27 patients (48.2%) which was mostly mild (CTCAE grade 1, n = 21 (77.8%); grade 2, n = 6). A significant association between a low platelet count and bleeding complications was observed (p <0.001). CONCLUSIONS: Performed by an experienced operator, CEAS is a simple, rapid available and effective bedside tool for safely placing PP feeding tubes for enteral nutrition in thrombocytopenic patients, even when showing an otherwise caused coagulopathy in the ICU. Higher grade bleeding complications were not observed despite their obvious correlation to thrombocytopenia. A prospective study is in preparation. This article is protected by copyright. All rights reserved.

4.
Pharmacoeconomics ; 2021 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-34595671

RESUMEN

INTRODUCTION: The introduction of immuno-oncology (IO) therapies has changed the treatment landscape of non-small cell lung cancer (NSCLC). Numerous cost-effectiveness analyses (CEAs) and technology appraisals (TAs) evaluating IO therapies have been recently published. OBJECTIVE: We reviewed economic models of first-line (1L) IO therapies for previously untreated advanced or metastatic NSCLC to identify methodological challenges associated with modeling cost effectiveness from published literature and TAs and to make recommendations for future CEAs in this disease area. METHODS: A systematic literature review was conducted following Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. We searched MEDLINE, Embase, EconLit (January 2009-January 2020), and select conferences (since 2016) for CEAs of 1L IO treatments in patients with recurrent or metastatic, epidermal growth factor receptor (EGFR)/anaplastic lymphoma kinase (ALK) mutation-negative NSCLC, published in English. TAs from England, Scotland, Canada, Australia, Germany, and France were also examined. Two reviewers screened the results and extracted the data. The quality of the CEAs was described using the Drummond checklist. RESULTS: In total, 46 records reporting on 38 unique models met protocol-defined criteria and were included. Five models adjusted for treatment switching or crossover in base-case analyses, and the remainder considered treatment switching or crossover to represent clinical practice and made no adjustment. Seven models used external real-world data for survival modeling or extrapolation validation. Six models that assumed long-term treatment benefit stopped at 3 or 5 years after initiation. Seven models used the observed time-on-treatment distribution from the trial, and eight used progression-free survival for treatment duration. All models compared one or more IO monotherapies or combination therapies with chemotherapy. Only one study directly compared different IO agents but did not consider the concordance issue across programmed death-ligand 1 (PD-L1) testing methods. Utilities were modeled by health state in 12 models, four applied a time-to-death approach, and ten explored both. None applied cure models. CONCLUSION: Variations in methodological challenges were seen across studies. Previous models took approaches that were followed in subsequent models, such as a 2-year stopping rule of IO duration or treatment-effect waning. Challenges such as heterogeneity in PD-L1 testing and survival extrapolation and validation using real-world data should be further considered for future models in advanced or metastatic NSCLC.

5.
J Vasc Surg ; 2021 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-34606960

RESUMEN

OBJECTIVE: The aim of this study is to compare and to test the performance of all available risk scoring systems (RSSs) designed to predict long-term survival rate in asymptomatic candidate patients for carotid endarterectomy (CEA) for significant carotid artery stenosis. METHODS: Data on asymptomatic patients who underwent CEA in three high-volume centers were prospectively recorded. Through literature research using PRISMA recommendations, six RSSs were identified for the intent of the study. Primary endpoints were 3- and 5-year survival rate after CEA. All items used as variables to compose multiple RSSs were applied to every patient in the study population. The 3-year and 5-year mortality prediction rates for each score were assessed by sensitivity, specificity, predictive negative and positive value calculation, as well as univariable Cox proportional hazard models with the Harrell's C index. RESULTS: During the study period, 825 CEAs in 825 asymptomatic patients were analyzed. All items used in RSSs were available in the dataset, with some concerns regarding their definition and application among RSSs. The 3-year and 5-year survival rates of the study cohort were 94.5% and 90.3%, respectively. Among the six RSSs analyzed, no RSS demonstrated optimal results in terms of mortality rate prediction accuracy, although some scores had good diagnostic and risk of death precision. CONCLUSION: RSSs, when used alone, fail to optimally detect postoperative life-expectancy in asymptomatic CEA patient candidates. Further prospective controlled studies are needed to compose and validate RSSs with better calibration to predict outcomes.

6.
Ann Vasc Surg ; 2021 Oct 10.
Artículo en Inglés | MEDLINE | ID: mdl-34644636

RESUMEN

OBJECTIVE: To evaluate trends and differences in Near Infrared Spectroscopy (NIRS) monitoring during carotid endarterectomy (CEA) in patients affected by asymptomatic and symptomatic carotid artery stenosis, to predict postoperative neurological complications (PNCs). METHODS: NIRS data of CEAs performed in a University Hospital were retrospectively reviewed. All the interventions were performed under general anesthesia and patients with intraoperative complications were excluded. Mean regional Oxygen Saturation Index (rSO2), pre-clamp values (mean baseline value, MBv and Single Mark Baseline value, SMBv) were collected and compared to the lowest rSO2 values during carotid cross-clamp (LSO2v) calculated within 3 minutes (percentage drop, PD). ROC curve analysis with Youden's Test was performed to determine the best threshold value of PD, in order to identify PNCs in both asymptomatic and symptomatic groups. RESULTS: Between 2007 and 2015, a total of 399 CEAs were consecutively performed with NIRS monitoring. Three-hundred-seventy-two CEAs in 355 patients were reviewed. Asymptomatic stenoses were 291 (81.9%), eleven (2.9%) PNC were registered (5 in asymptomatic and 6 in symptomatic group). Asymptomatic and symptomatic diseases had different MBv (69.5±7.5 vs71.8±6.9, respectively; p=.011) and similar rSO2 value during carotid clamping (63.7±8.0vs63.7±6.7, respectively: p=.958). Asymptomatic patients experiencing PNCs had a greater PD than non-PNCs group (20.5±10.2% versus 12.5±7.6%, respectively using MBv as baseline value; p = .002), in contrast, in symptomatic patients, in which a low PD was associated with PNCs, it does not reach statistical significance (using MBv, 12.6±5.4% versus 14.8±6.7%, respectively; p = .476). In order to detect PNCs, ROC analysis revealed an optimal PD cut-off value of -17% in asymptomatic CEAs. (Sensibility (Se) 0.80, Specificity (Sp) 0.76, PPV 0.05, NPV 0.99, Youden's index 0.56; p=.020) In symptomatic a threshold value of -9% was found, without reaching statistical significance. CONCLUSIONS: NIRS as cerebral monitoring during CEA can predict PNCs in asymptomatic stenosis. Asymptomatic and symptomatic groups differ in baseline and intraprocedural cut-off values to detect an augmented PNCs risk.

7.
Cad Saude Publica ; 37(8): e00037221, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34495088

RESUMEN

The article describes methodological aspects in defining the study population, sampling plan, and sample weigthing and calibration of effective sample of the Brazilian National Survey on Child Nutrition (ENANI-2019). This population-based household survey assessed breastfeeding and dietary intake, anthropometric assessment of nutritional status, and micronutrient deficiencies by blood biomarkers in children under five years of age. The data were obtained with a probability sample, with stratification by the five geographic regions in the country and clustering by census enumeration areas (CEAs). The sample was calculated at 15,000 households distributed in 1,500 CEAs, with 300 allocated in each of Brazil's five major geographic regions and 10 eligible households per CEA, sampled using inverse sampling. The required population parameters were thus estimated to reach the study's objectives. The basic sampling design weights were calculated as the inverse probabilities of the households' inclusion in the study. Imputation was used to compensate for non-response to items in the target variables, except for data on the blood biomarkers. Finally, calibration used population totals of children in 60 post-strata, defined by cross-classification of the following variables: major geographic region, sex, and age. The final sample included 14,558 children residing in 12,524 households, distributed in 1,382 CEAs in the 26 states of Brazil and the Federal District. The data from the ENANI-2019 survey will support strategies for the promotion and implementation of public policies for children under five years of age.


Asunto(s)
Composición Familiar , Estado Nutricional , Brasil , Niño , Fenómenos Fisiológicos Nutricionales Infantiles , Preescolar , Humanos , Encuestas y Cuestionarios
8.
Artículo en Inglés | MEDLINE | ID: mdl-34472771

RESUMEN

BACKGROUND: When performing a conventional CEA it is recommended the use of patch angioplasty (PA), since previous meta-analyses have shown PA to be superior to primary closure (PRC) in terms of stroke and restenosis rates. Different materials patches can be employed although none of them has been proved to be superior. Although autologous veins are potentially more resistant to immediate thrombosis as well as infection, cons may be represented by patch rupture and late dilatation. Aim of this study is to evaluate immediate and long-term results of CEA with saphenous vein patch angioplasty (SVPA) in a single-centre experience. METHODS: A retrospective study was performed analyzing all patients undergoing CEA with SVPA at our institution from January 2012 to March 2020. CEA was performed in symptomatic patients with 50-99% carotid stenosis degree or asymptomatic patients with 70-99% stenosis degree. Exclusion criteria were critical limb ischemia, varicose disease, unavailability of saphenous veins, vein diameter <3,5mm. All CEAs were performed under general anesthaesia with routine shunting. Primary endpoints were perioperative stroke, death, carotid thrombosis and haematoma requiring surgery rates. Secondary endpoints included the rate of recurrent stenosis >70%, patch aneurysm/rupture/infection at follow-up. RESULTS: Four-hundred-eighty-eight interventions were performed on 461 patients. Most patients were male (77,8%) with a mean age of 71,2±8,3 years. 30-day mortality and stroke rates were 0,4% and 1,2% respectively. Carotid thrombosis occurred in 5 patients (1%). Five patients (1%) developed a surgical site hematoma requiring surgical drainage. At a mean follow-up of 34,4±25,8 months 12 restenoses (2,5%) were detected. Five-year freedom from restenosis rate was 96,7%. Restenosis at follow-up was more frequent in patients who had contralateral carotid stenosis (p=.019). Two patients (0,4%) developed carotid patch aneurysmal degeneration at a mean follow-up of 78,7 months. No infection nor patch disruption were detected. CONCLUSIONS: CEA with SVPA resulted safe end effective in terms of early and late results. The perioperative complications rates we recorded were quite similar to those reported by other larger reviews and meta-analyses.

9.
Risk Anal ; 2021 Sep 07.
Artículo en Inglés | MEDLINE | ID: mdl-34490933

RESUMEN

Regulatory agencies are required to evaluate the impacts of thousands of chemicals. Toxicological tests currently used in such evaluations are time-consuming and resource intensive; however, advances in toxicology and related fields are providing new testing methodologies that reduce the cost and time required for testing. The selection of a preferred methodology is challenging because the new methodologies vary in duration and cost, and the data they generate vary in the level of uncertainty. This article presents a framework for performing cost-effectiveness analyses (CEAs) of toxicity tests that account for cost, duration, and uncertainty. This is achieved by using an output metric-the cost per correct regulatory decision-that reflects the three elements. The framework is demonstrated in two example CEAs, one for a simple decision of risk acceptability and a second, more complex decision, involving the selection of regulatory actions. Each example CEA evaluates five hypothetical toxicity-testing methodologies which differ with respect to cost, time, and uncertainty. The results of the examples indicate that either a fivefold reduction in cost or duration can be a larger driver of the selection of an optimal toxicity-testing methodology than a fivefold reduction in uncertainty. Uncertainty becomes of similar importance to cost and duration when decisionmakers are required to make more complex decisions that require the determination of small differences in risk predictions. The framework presented in this article may provide a useful basis for the identification of cost-effective methods for toxicity testing of large numbers of chemicals.

10.
Artículo en Inglés | MEDLINE | ID: mdl-34511314

RESUMEN

OBJECTIVE: Ischaemic strokes can be caused by unstable carotid atherosclerosis, but methods for identification of high risk lesions are lacking. Carotid plaque morphology imaging using software for visualisation of plaque components in computed tomography angiography (CTA) may improve assessment of plaque phenotype and stroke risk, but it is unknown if such analyses also reflect the biological processes related to lesion stability. Here, we investigated how carotid plaque morphology by image analysis of CTA is associated with biological processes assessed by transcriptomic analyses of corresponding carotid endarterectomies (CEAs). METHODS: Carotid plaque morphology was assessed in patients undergoing CEA for symptomatic or asymptomatic carotid stenosis consecutively enrolled between 2006 and 2015. Computer based analyses of pre-operative CTA was performed to define calcification, lipid rich necrotic core (LRNC), intraplaque haemorrhage (IPH), matrix (MATX), and plaque burden. Plaque morphology was correlated with molecular profiles obtained from microarrays of corresponding CEAs and models were built to assess the ability of plaque morphology to predict symptomatology. RESULTS: Carotid plaques (n = 93) from symptomatic patients (n = 61) had significantly higher plaque burden and LRNC compared with plaques from asymptomatic patients (n = 32). Lesions selected from the transcriptomic cohort (n = 40) with high LRNC, IPH, MATX, or plaque burden were characterised by molecular signatures coupled with inflammation and extracellular matrix degradation, typically linked with instability. In contrast, highly calcified plaques had a molecular signature signifying stability with enrichment of profibrotic pathways and repressed inflammation. In a cross validated prediction model for symptoms, plaque morphology by CTA alone was superior to the degree of stenosis. CONCLUSION: The study demonstrates that CTA image analysis for evaluation of carotid plaque morphology, also reflects prevalent biological processes relevant for assessment of plaque phenotype. The results support the use of CTA image analysis of plaque morphology for risk stratification and management of patients with carotid stenosis.

11.
World Neurosurg ; 2021 Sep 26.
Artículo en Inglés | MEDLINE | ID: mdl-34587521

RESUMEN

OBJECTIVE: Nonfasting serum triglyceride (TG) level is attracting more and more attention as an atherosclerosis-promoting factor. However, no study has investigated the relationships between nonfasting TG levels and carotid restenosis after carotid endarterectomy (CEA) or carotid artery stenting (CAS). This study was conducted to investigate if nonfasting TG levels can be used to assess a risk for carotid restenosis after CEA or CAS. METHODS: This was a single-center retrospective study. We reviewed 201 consecutive primary carotid artery revascularization procedures (39 CEAs and 162 CASs), which were performed from 2008 to 2018 for 179 patients (163 men and 16 women) with atherosclerotic carotid stenosis, and were followed up for at least 1 year. Clinical variables including nonfasting lipid profiles and findings of magnetic resonance plaque imaging were compared between groups with and without postprocedural carotid restenosis (≥50% stenosis on ultrasonography). RESULTS: During a mean follow-up period of 1413 days, 24 of 201 carotid stenosis procedures (11.9%) suffered restenosis after successful revascularization procedures. Multivariate analyses demonstrated that nonfasting TG level was the only independent risk factor of postprocedural restenosis. The receiver operating characteristic curve analyses revealed that a cutoff value of nonfasting TG to discriminate postprocedural carotid restenosis was 127.5 mg/dL, which was much lower than the upper limit of normal. CONCLUSIONS: This study showed that nonfasting TG level may be a useful marker to predict carotid restenosis after CEA or CAS, and could be a new therapeutic target to prevent carotid restenosis after revascularization procedures.

12.
Ann Vasc Surg ; 2021 Aug 23.
Artículo en Inglés | MEDLINE | ID: mdl-34437970

RESUMEN

BACKGROUND: Patients who are obese or underweight are traditionally at higher risk for perioperative morbidity and mortality. The effect of body mass index (BMI) on outcomes after carotid endarterectomy (CEA) is unclear. Our goal was to analyze the association of BMI with perioperative and long-term outcomes after elective CEA. METHODS: The Vascular Quality Initiative (VQI) database was queried from 2003-2018 for patients undergoing elective CEAs. Patients were categorized into 5 BMI cohorts - underweight (UW, BMI < 18.5 kg/m2), normal weight (NW, BMI 18.5-24.9 kg/m2), overweight (OW, BMI 25-29.9 kg/m2), obese (OB, BMI 30-39.9 kg/m2), and morbidly obese (MO, BMI ≥ 40 kg/m2). Perioperative and long-term outcomes were assessed with univariable and multivariable analyses. RESULTS: There were 89,079 patients included: 2% UW, 26% NW, 38.4% OW, 29.9% OB, and 3.6% MO. Overall, the mean age was 70.6 years, 60% were male, and 91.8% were of white race. There were significant differences among the BMI cohorts in regards to age, sex, smoking status, and comorbidities (all P < 0.05). For perioperative outcomes, the BMI cohorts differed significantly in reoperation for bleeding and 30-day mortality. On multivariable analysis, BMI was not associated with stroke or perioperative mortality. MO was associated with perioperative cardiac complications (Odds Ratios [OR] 1.26, 95% CI 1-1.57, P = 0.05). UW status was associated with increased return to the operating room (OR 1.89, 95% confidence interval [95% CI] 1.28-2.78, P = 0.001), 30-day mortality (OR 1.68, 95% CI 1-2.86, P =0.05), 1-year mortality (Hazard ratio [HR] 1.37, 95% CI 1.08-1.74, P = 0.01), and 5-year mortality (HR 1.22, 95% CI 1.06-1.41, P =0.005). CONCLUSIONS: BMI status was not associated with perioperative stroke, cranial nerve injury, or surgical site infections. Patients with MO had higher perioperative cardiac complications. UW patients have lower short and long-term survival and should be a focus for long-term targeted risk factor stratification and modification.

13.
J Neurosurg ; : 1-8, 2021 Aug 27.
Artículo en Inglés | MEDLINE | ID: mdl-34450592

RESUMEN

OBJECTIVE: Postoperative internal carotid artery (ICA) intimal flap (IF) is a potential complication after carotid endarterectomy (CEA) for carotid artery stenosis. There are no clear recommendations in the current literature on the management of this condition due to sparse evidence. Some authors advocate carotid stent placement or reoperation, while others suggest watchful waiting. The aim of this study was to analyze incidence and management strategies of postoperative ICA-IF, and moreover, to put these findings into context with a systematic literature review. METHODS: The authors retrospectively reviewed all consecutive CEA cases performed at the University Hospital of Bern over a decade (January 2008 to December 2018). The incidence of postoperative ICA-IF, risk factors, management strategies, and outcomes were analyzed. These results were put into context with a systematic review following the PRISMA guidelines. RESULTS: A total of 725 CEAs were performed between January 2008 and December 2018. Postoperative ICA-IF was detected by routine duplex neurovascular ultrasound (NVUS) in 13 patients, corresponding to an incidence rate of 1.8% (95% CI 1.0%-3.1%). There were no associated intraluminal thrombi on the detected IF. Intraoperative shunt placement was used in 5.6% and one or more intima tack sutures were performed in 42.5% of the 725 cases. There was no significant association between intraoperative shunt placement and the occurrence of an IF (p > 0.99). Two patients (15.4%) with IF experienced a transient postoperative neurological deficit (transient ischemic attack). In these cases, the symptoms resolved spontaneously without any interventions or change in the antiplatelet regimen. All other cases (84.6%) with IF were asymptomatic. In 1 patient (7.7%) with IF, the antiplatelet treatment was switched from a mono- to a dual-antiaggregating regimen because the IF led to a stenosis > 70%; this patient remained asymptomatic. All cases of IFs were managed conservatively with close radiological follow-up evaluations, without reoperation or stenting of the ICA. All 13 IFs vanished spontaneously after a mean duration of 6.9 months (median 1.5 months, range 0.5-48 months). A systematic literature review revealed a postoperative ICA-IF incidence of 3.0% (95% CI 2.1%-4.1%) with relatively heterogenous management strategies. CONCLUSIONS: Postoperative ICA-IF is a rare finding after CEA. Conservative therapy with close NVUS follow-up evaluations appears to be an acceptable and safe management strategy for asymptomatic IFs without associated intraluminal thrombi.

14.
Pharmacoeconomics ; 39(11): 1225-1241, 2021 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-34368937

RESUMEN

Novel interventions for sickle cell disease (SCD) bring hope to patients, yet concern about the associated economic costs exists. Cost-effectiveness analysis (CEA) uses standardized methods, with robust underpinnings in health economics, to estimate the value of these interventions compared with usual care. However, because of the complexity and lifetime trajectory of SCD, CEAs are challenging to conduct. The objectives of this rapid review were to summarize the main characteristics, components, and results of published CEAs of existing interventions for SCD, identify research gaps, and provide directions for future analyses. We identified records through searches of bibliographic databases, from reference lists of relevant review articles, and through consultation with experts. A total of 13 CEAs met our inclusion criteria and were qualitatively synthesized. These evaluated blood transfusions (n = 2), hematopoietic stem cell transplantation (n = 1), pharmaceuticals (n = 2), hypothetical cell or genetic therapy (n = 1), screening programs (n = 4), and interventions for SCD treatment complications (n = 3). A limited number of potential SCD and treatment complications were evaluated. No study adopted a societal perspective in the base case, six studies examined lifetime cost-effectiveness, seven studies employed a Markov or discrete-event simulation model, and eight studies used an outcome metric that captured both quality and length of life. To better compare the value of emerging and current therapies, future CEAs should adopt a societal perspective incorporating both medical and nonmedical costs, comprehensively model SCD complexity using robust health economic simulation models over the patient's entire lifespan, and capture the intervention's effect on both survival and quality of life.

15.
Med Decis Making ; : 272989X211033287, 2021 Aug 11.
Artículo en Inglés | MEDLINE | ID: mdl-34378462

RESUMEN

BACKGROUND: Many cost-effectiveness analyses (CEAs) only consider outcomes for a single disease when comparing interventions that prevent or treat 1 disease (e.g., vaccination) to interventions that prevent or treat multiple diseases (e.g., vector control to prevent mosquito-borne diseases). An intervention targeted to a single disease may be preferred to a broader intervention in a single-disease model, but this conclusion might change if outcomes from the additional diseases were included. However, multidisease models are often complex and difficult to construct. METHODS: We present conditions for when multiple diseases should be considered in such a CEA. We propose methods for estimating health outcomes and costs associated with control of additional diseases using parallel single-disease models. Parallel modeling can incorporate competing mortality and coinfection from multiple diseases while maintaining model simplicity. We illustrate our approach with a CEA that compares a dengue vaccine, a chikungunya vaccine, and mosquito control via insecticide and mosquito nets, which can prevent dengue, chikungunya, Zika, and yellow fever. RESULTS: The parallel models and the multidisease model generated similar estimates of disease incidence and deaths with much less complexity. When using this method in our case study, considering only chikungunya and dengue, the preferred strategy was insecticide. A broader strategy-insecticide plus long-lasting insecticide-treated nets-was not preferred when Zika and yellow fever were included, suggesting the conclusion is robust even without the explicit inclusion of all affected diseases. LIMITATIONS: Parallel modeling assumes independent probabilities of infection for each disease. CONCLUSIONS: When multidisease effects are important, our parallel modeling method can be used to model multiple diseases accurately while avoiding additional complexity.

16.
Artículo en Inglés | MEDLINE | ID: mdl-34308613

RESUMEN

BACKGROUND: The role of shunting during carotid endarterectomy (CEA) in symptomatic patients is unclear. The aim was to evaluate early outcomes of CEA with routine "delayed" shunt insertion, for patients with symptomatic carotid stenosis. METHODS: we conducted a single-center retrospective review of symptomatic patients undergoing CEA (2009-2020). All CEAs were performed under general anesthesia using a standardized technique, based on delayed routine shunt insertion after plaque removal. Primary endpoints were 30-days mortality and stroke. A logistic regression was performed to identify clinical and procedural factors predictors of post-operative stroke. A literature systematic review was conducted using the terms "carotid endarterectomy" "stroke", "transient ischemic attack", "symptomatic carotid stenosis", and "shunt". RESULTS: two-hundred-sixty-three CEAs were performed for TIA (n=178, 47%) or acute ischemic stroke (n=85, 32%). Mean delay of surgery was 6±19 days, and early CEA (<48 hours) was performed in 98 cases (37%). Conventional CEA was performed in 171 patients (67%), eversion CEA in 83 (33%). Early (30-days) mortality was 0.3%. Stroke/death rate was 2.3%. Female sex (OR 5.14, 95%CI 1.32-24.93; P=.023), use of anticoagulants (OR 10.57, 95%CI 2.67-51.86; P=.001), preoperative stroke (OR 5.34, 95%CI 1.62-69.21; P=.006), and the presence of preoperative CT/MRI cerebral ischemic lesions (OR 5.96, 95%CI 1.52-28.59; P=.013) were associated with early neurological complications. Statin medication (OR 0.18, 95%CI 0.04-0.71; P=.019) and CEA timing <2 days (OR 0.14, 95%CI 0.03-0.55; P=.005) were protective from postoperative stroke. CEA outcomes were independent from time period (P=.201) and operator's volume (P=.768). Four studies described the CEA outcomes with routine shunting in symptomatic patients, with a large variability in the selection of patients, surgical technique, and description of the results. CONCLUSIONS: Routine delayed shunting after plaque removal seems to be a safe and effective technique, that contributed to maintain a low complication rate in neurologically symptomatic patients. Statin use and expedited timing were associated with improved outcomes using this technique.

17.
Arthroscopy ; 37(6): 2009-2010, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-34090578

RESUMEN

Health care systems globally, including in the United States, continue to undergo a much-needed transformation focused on optimizing value-or health outcomes per dollar spent across a full cycle of care-for patients. Given the traditionally high cost and use of orthopaedic surgery services, the field is ripe for in-depth assessment and comparison of interventions to ensure that evidence-based, high-value care is prioritized. Cost-effectiveness analyses (CEAs) provide an important framework from which to begin effective policy discussions, and a recent study suggests that current orthopaedic economic literature is of high quality. However, the same study demonstrated that no authors published CEAs that also provided commentary on how their work can actually guide policy decisions. Furthermore, the ethical implications of their research or insight into the larger consequences of their findings within and outside the health care sector was not discussed. We must be better at "connecting the dots" between CEAs and value-based health care research and practical policy initiatives while also considering how such proposals promote health equity and address systemic injustices currently found in our health care system.


Asunto(s)
Atención a la Salud , Promoción de la Salud , Análisis Costo-Beneficio , Investigación sobre Servicios de Salud , Humanos , Políticas , Estados Unidos
18.
Ann Vasc Surg ; 2021 Jun 19.
Artículo en Inglés | MEDLINE | ID: mdl-34153493

RESUMEN

OBJECTIVE: The use of radiographic evaluation of carotid disease may vary, and current guidelines do not strongly recommend the use of cross-sectional imaging (CSI) prior to surgical intervention. We sought to describe the trends in preoperative carotid imaging and evaluate the associated clinical outcomes and Medicare payments for patients undergoing carotid endarterectomy (CEA) for asymptomatic carotid disease. METHODS: We used a 20% Medicare sample from 2006 to 2014 identifying patients undergoing CEA for asymptomatic disease. We evaluated preoperative carotid ultrasound and CSI use: CT or MRI of the neck prior to CEA. We calculated average payments of each study from the carrier file and revenue center file. Imaging payments included both the professional component (PC) and the technical component (TC). Claims with a reimbursement of $0 and studies where payment for both the TC and PC could not be identified were excluded from the overall calculation to determine average payment per study. Inpatient reimbursements according to DRG 37-39 were calculated. We compared hospital length of stay (LOS), in hospital stroke, carotid re-exploration, and mortality according to CSI use. RESULTS: A total of 58,993 CEAs were identified with pre-operative carotid imaging. The average age was 74.8 ± 7.5 years, and 56.0% were men. A total of 19,678 (33%) patients had ultrasound alone with an average of (2.4 ± 1.9) exams prior to CEA. A total of 39,315 patients underwent CSI prior to CEA with 2.5 ± 2.1 ultrasounds, 0.95 ± 0.86 neck CTs and 0.47 ± 0.7 MRIs per patient. The average payment for ultrasound was $140 ± 40, $282 ± 94 for CT and $410 ± 146 for MRI. The average inpatient reimbursements were $7,413 ± 4,215 for patients without CSI compared with $7,792 ± 3,921 for patients with CSI, P < 0.001. The average LOS during CEA admission was 2.5 ± 3.7days. Patients with CSI had a slightly lower percentage of patients being discharged by postoperative day 2 compared with ultrasound alone (88.9% vs. 91.5%, respectively, P < 0.001). The overall in-hospital stroke rate was 0.38% and carotid re-exploration rate was 1.0% and there was no statistical significant difference between groups. Median follow-up was 3.9 years, and mortality at 8 years was 50% and did not statistically differ between groups. CONCLUSIONS: Our analysis found preoperative imaging to include CSI in nearly two-thirds of patients prior to CEA for asymptomatic disease. As imaging and inpatient payments were higher with patients with CSI further work is needed to understand when CSI is appropriate prior to surgical intervention to appropriately allocate healthcare resources.

19.
Artif Intell Med ; 117: 102064, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-34127243

RESUMEN

INTRODUCTION: Cost-effectiveness analysis (CEA) is used increasingly in medicine to determine whether the health benefit of an intervention is worth the economic cost. Decision trees, the standard decision modeling technique for non-temporal domains, can only perform CEAs for very small problems. Influence diagrams can model much larger problems, but only when the decisions are totally ordered. OBJECTIVE: To develop a CEA method for problems with unordered or partially ordered decisions, such as finding the optimal sequence of tests for diagnosing a disease. METHODS: We explain how to model those problems using decision analysis networks (DANs), a new type of probabilistic graphical model, somewhat similar to Bayesian networks and influence diagrams. We present an algorithm for evaluating DANs with two criteria, cost and effectiveness, and perform some experiments to study its computational efficiency. We illustrate the representation framework and the algorithm using a hypothetical example involving two therapies and several tests and then present a DAN for a real-world problem, the mediastinal staging of non-small cell lung cancer. RESULTS: The evaluation of a DAN with two criteria, cost and effectiveness, returns a set of intervals for the willingness to pay, separated by incremental cost-effectiveness ratios (ICERs). The cost, the effectiveness, and the optimal intervention are specific for each interval, i.e., they depend on the willingness to pay. CONCLUSION: Problems involving several unordered decisions can be modeled with DANs and evaluated in a reasonable amount of time. OpenMarkov, an open-source software tool developed by our research group, can be used to build the models and evaluate them using a graphical user interface.


Asunto(s)
Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Teorema de Bayes , Carcinoma de Pulmón de Células no Pequeñas/diagnóstico , Análisis Costo-Beneficio , Humanos , Neoplasias Pulmonares/diagnóstico , Modelos Estadísticos
20.
J Vasc Surg ; 2021 May 31.
Artículo en Inglés | MEDLINE | ID: mdl-34082003

RESUMEN

OBJECTIVE: Transfemoral carotid artery stenting (TFCAS) has higher combined stroke and death rates in elderly patients with carotid artery stenosis compared with carotid endarterectomy (CEA). However, transcarotid artery revascularization (TCAR) may have similar outcomes to CEA. This study compared outcomes after TCARs relative to those after CEAs and TFCAS, focusing on elderly patients. METHODS: We included all patients with carotid artery stenosis, and no prior endarterectomy or stenting, who underwent either a CEA, TFCAS, or TCAR in the Vascular Quality Initiative from September 2016 (TCAR commercially available) to December 2019. We categorized patients into age decades: 60-69 years, 70-79 years, and 80-90 years. Outcomes included 30-day and one-year composite rates of stroke or death. Cox-proportional hazards models evaluated both outcomes after adjusting for patient demographics, clinical factors, symptomatology, hospital CEA volume, and clustering. RESULTS: We identified 33,115 patients who underwent either a CEA, TFCAS, or TCAR for carotid artery stenosis (35% in their 60s, 44% in their 70s, and 21% in their 80s), where half (50%) were symptomatic. The majority of patients had CEAs (80%), followed by TFCAS (11%) and then TCARs (9.1%). The overall rate of 30-day stroke/death was 1.5% and of one-year stroke/death was 4.4%. Octogenarians had the highest 30-day and one-year stroke/death rates relative to their peers (2.3% and 6.3%, respectively). Among all patients, the adjusted hazards of TCARs relative to CEAs was similar for 30-day stroke/death (HR 1.10 [95%-CI 0.75-1.62]) and slightly higher for one-year stroke/death (HR 1.34 [1.02-1.76]). Among octogenarians, however, the adjusted hazards of TCARs relative to CEAs was similar for both 30-day stroke/death (HR 1.12 [0.59-2.13]) and one-year stroke/death (HR 1.28 [0.85-1.94]). TFCAS relative to CEAs had higher hazards of both 30-day stroke/death (HR 1.78 [1.10-2.89]) and one-year stroke/death (HR 1.85 [1.35-2.54]) in octogenarians. CONCLUSIONS: TCARs had similar outcomes relative to CEAs among octogenarians with respect to 30-day and one-year rates of stroke/death. TCAR may serve as a promising less-invasive treatment for carotid disease in older patients who are deemed high anatomic, surgical, or clinical risk for CEAs.

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