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1.
Ann Intern Med ; 2019 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-31711094

RESUMO

The PATH (Predictive Approaches to Treatment effect Heterogeneity) Statement was developed to promote the conduct of, and provide guidance for, predictive analyses of heterogeneity of treatment effects (HTE) in clinical trials. The goal of predictive HTE analysis is to provide patient-centered estimates of outcome risk with versus without the intervention, taking into account all relevant patient attributes simultaneously, to support more personalized clinical decision making than can be made on the basis of only an overall average treatment effect. The authors distinguished 2 categories of predictive HTE approaches (a "risk-modeling" and an "effect-modeling" approach) and developed 4 sets of guidance statements: criteria to determine when risk-modeling approaches are likely to identify clinically meaningful HTE, methodological aspects of risk-modeling methods, considerations for translation to clinical practice, and considerations and caveats in the use of effect-modeling approaches. They discuss limitations of these methods and enumerate research priorities for advancing methods designed to generate more personalized evidence. This explanation and elaboration document describes the intent and rationale of each recommendation and discusses related analytic considerations, caveats, and reservations.

2.
Ann Intern Med ; 2019 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-31711134

RESUMO

Heterogeneity of treatment effect (HTE) refers to the nonrandom variation in the magnitude or direction of a treatment effect across levels of a covariate, as measured on a selected scale, against a clinical outcome. In randomized controlled trials (RCTs), HTE is typically examined through a subgroup analysis that contrasts effects in groups of patients defined "1 variable at a time" (for example, male vs. female or old vs. young). The authors of this statement present guidance on an alternative approach to HTE analysis, "predictive HTE analysis." The goal of predictive HTE analysis is to provide patient-centered estimates of outcome risks with versus without the intervention, taking into account all relevant patient attributes simultaneously. The PATH (Predictive Approaches to Treatment effect Heterogeneity) Statement was developed using a multidisciplinary technical expert panel, targeted literature reviews, simulations to characterize potential problems with predictive approaches, and a deliberative process engaging the expert panel. The authors distinguish 2 categories of predictive HTE approaches: a "risk-modeling" approach, wherein a multivariable model predicts the risk for an outcome and is applied to disaggregate patients within RCTs to define risk-based variation in benefit, and an "effect-modeling" approach, wherein a model is developed on RCT data by incorporating a term for treatment assignment and interactions between treatment and baseline covariates. Both approaches can be used to predict differential absolute treatment effects, the most relevant scale for clinical decision making. The authors developed 4 sets of guidance: criteria to determine when risk-modeling approaches are likely to identify clinically important HTE, methodological aspects of risk-modeling methods, considerations for translation to clinical practice, and considerations and caveats in the use of effect-modeling approaches. The PATH Statement, together with its explanation and elaboration document, may guide future analyses and reporting of RCTs.

3.
J Am Heart Assoc ; 8(20): e011972, 2019 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-31583938

RESUMO

Background While many clinical prediction models (CPMs) exist to guide valvular heart disease treatment decisions, the relative performance of these CPMs is largely unknown. We systematically describe the CPMs available for patients with valvular heart disease with specific attention to performance in external validations. Methods and Results A systematic review identified 49 CPMs for patients with valvular heart disease treated with surgery (n=34), percutaneous interventions (n=12), or no intervention (n=3). There were 204 external validations of these CPMs. Only 35 (71%) CPMs have been externally validated. Sixty-five percent (n=133) of the external validations were performed on distantly related populations. There was substantial heterogeneity in model performance and a median percentage change in discrimination of -27.1% (interquartile range, -49.4%--5.7%). Nearly two-thirds of validations (n=129) demonstrate at least a 10% relative decline in discrimination. Discriminatory performance of EuroSCORE II and Society of Thoracic Surgeons (2009) models (accounting for 73% of external validations) varied widely: EuroSCORE II validation c-statistic range 0.50 to 0.95; Society of Thoracic Surgeons (2009) Models validation c-statistic range 0.50 to 0.86. These models performed well when tested on related populations (median related validation c-statistics: EuroSCORE II, 0.82 [0.76, 0.85]; Society of Thoracic Surgeons [2009], 0.72 [0.67, 0.79]). There remain few (n=9) external validations of transcatheter aortic valve replacement CPMs. Conclusions Many CPMs for patients with valvular heart disease have never been externally validated and isolated external validations appear insufficient to assess the trustworthiness of predictions. For surgical valve interventions, there are existing predictive models that perform reasonably well on related populations. For transcatheter aortic valve replacement (CPMs additional external validations are needed to broadly understand the trustworthiness of predictions.

4.
Pediatr Surg Int ; 35(7): 793-801, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31076868

RESUMO

PURPOSE: Distribution and outcomes of traumatic injury of the esophagus (TIE) in pediatric versus adult populations are unknown. Our study sought to perform a descriptive analysis of TIE in children and adults. METHODS: We reviewed the National Trauma Data Bank (NTDB) for the years 2010-2015. Demographics, characteristics, and outcomes of pediatric (age < 16 years) and adult TIE patients were described and compared. RESULTS: Among 526,850 pediatric and 3,838,895 adult trauma patients, 90 pediatric (0.02%) and 1,411 (0.04%) adult TIE patients were identified. Demographics and esophageal injury severity did not differ. Children were more likely to sustain blunt trauma (63% versus 37%), with the most common mechanism being transportation-related accidents, were less-severely injured (median ISS 14 versus 22), and had fewer associated injuries (79% versus 95%) and complications (30% versus 51%) (all p < 0.001). Children had shorter hospitalizations (median 5 versus 10 days) and were more likely to be discharged home (84% versus 64%) (both p = 0.01). In-hospital mortality did not differ significantly between children and adults (10% versus 19%, p = 0.09). CONCLUSION: TIE in the pediatric population has unique characteristics compared to adults: it is more likely to be a result of blunt trauma, has lower injury burden, and has more favorable clinical outcomes.


Assuntos
Traumatismos Abdominais/epidemiologia , Esôfago/lesões , Traumatismo Múltiplo , Sistema de Registros , Traumatismos Torácicos/epidemiologia , Centros de Traumatologia/estatística & dados numéricos , Ferimentos não Penetrantes/epidemiologia , Traumatismos Abdominais/diagnóstico , Adolescente , Adulto , Criança , Pré-Escolar , Feminino , Mortalidade Hospitalar/tendências , Humanos , Incidência , Lactente , Recém-Nascido , Escala de Gravidade do Ferimento , Tempo de Internação/tendências , Masculino , Traumatismos Torácicos/diagnóstico , Estados Unidos/epidemiologia , Ferimentos não Penetrantes/diagnóstico , Adulto Jovem
5.
Am Surg ; 85(4): 342-349, 2019 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-31043192

RESUMO

Existing literature on traumatic injury of the esophagus (TIE) is limited. We aimed to describe the clinical characteristics and outcomes of TIE. We reviewed the National Trauma Data Bank for the years 2010-2015. We described the demographics, characteristics, and outcomes of adult (age ≥16 years) TIE patients and also compared those factors in blunt versus penetrating TIE. The association between TIE and mortality was analyzed using multivariable logistic regression. Thousand four hundred eleven adult TIE patients were identified (37 per 100,000 trauma patients, 95% confidence intervals (CI): 35, 39). TIE patients were younger (38 vs 52 years), more likely to be male (81% vs 62%), and more severely injured (Injury Severity Score ≥ 25: 45% vs 7%) than patients without TIE (all P < 0.001). TIE was observed 16 times more frequently with penetrating injuries (257 per 100,000, 95% CI: 240, 270) than with blunt injuries (16 per 100,000, 95% CI: 15, 18). Inhospital TIE mortality was 19 per cent. TIE patients had greater risk of mortality than other trauma patients, after adjusting for age, gender, and Injury Severity Score (odds ratio = 1.4, 95% CI: 1.1, 1.7). Mortality in blunt and penetrating TIE did not differ. Although extremely rare, TIE is independently associated with a marked increase in mortality, even after adjusting for other risk factors.


Assuntos
Esôfago/lesões , Ferimentos não Penetrantes/epidemiologia , Ferimentos Penetrantes/epidemiologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Bases de Dados Factuais , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Prognóstico , Sistema de Registros , Estados Unidos/epidemiologia , Ferimentos não Penetrantes/diagnóstico , Ferimentos Penetrantes/diagnóstico , Adulto Jovem
6.
Cancer Chemother Pharmacol ; 84(1): 213-216, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31011815

RESUMO

PURPOSE: The liver is critically involved in drug metabolism pathways and the potential for hepatic toxicity is significant with specific cancer therapeutics. Variations in the definition of liver function thresholds that may generate heterogeneity of toxicity and efficacy outcomes across therapeutics trials in cancer require assessment. METHODS: A random sample of therapeutic trials in cancer (n = 500, general category), trials using hepatotoxic drugs (abiraterone, pazopanib: n = 181), trials using drugs metabolized by the liver (doxorubicin, vincristine: n = 606), and therapeutic trials in hepatic dysfunction (n = 49) were each identified on clinicaltrials.gov. Definitions of liver function thresholds and their distribution were collated and categorized in each group. RESULTS: A third of all trials listed on clinicaltrials.gov across the four categories failed to provide an explicit definition of liver function. Among trials with an explicit definition, a combination of bilirubin and transaminase levels was used in 33-64%, whereas a miscellaneous combination of definitions (in the general category consisting of 11 unique liver function parameters creating 17 unique combinations) was used 29-58% of the time across the four categories of studies. The Child-Pugh or National Cancer Institute Organ Dysfunction Working Group (NCI-ODWG) criteria were rarely employed (0-12% studies). Allowance for Gilbert's disease in bilirubin thresholds was identified in only 6-23% studies and for liver metastases in 2-15% of studies. CONCLUSIONS: There is a marked heterogeneity in the liver function definitions used across cancer clinical trials even when the potential for drug toxicity and altered drug metabolism is significant. Harmonization of criteria will streamline eligibility and mitigate variations in key outcomes across trials.

7.
Circ Cardiovasc Qual Outcomes ; 12(2): e004666, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30764652

RESUMO

Background Current strategies for ensuring the postmarket safety of medical devices are limited by small sample size and reliance on voluntary reporting of adverse events. Prospective, active surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety but has not been demonstrated in national clinical data registries. Methods and Results The CathPCI DELTA (Data Extraction and Longitudinal Trend Analysis) study was designed to assess the feasibility of prospective, active safety surveillance of medical devices within a national cardiovascular registry. We sought to assess the ability of our surveillance strategy to avoid false safety alerts by conducting an active safety surveillance study of aspiration thrombectomy catheters using data within the National Cardiovascular Data Registry CathPCI registry, where no difference in safety outcomes were anticipated for the primary in-hospital safety outcome of death and major adverse cardiovascular events (MACE). We performed a propensity-matched analysis of 5 aspiration thrombectomy catheter devices used during percutaneous coronary intervention among 95 925 patients presenting with ST-segment-elevation myocardial infarction between January 1, 2011 and September 30, 2013. After 33 months of surveillance, no safety alerts were triggered for the primary safety endpoints of death or MACE, with no between-catheter differences observed. The absolute risk of death during acute hospitalization ranged from 5.11% to 5.32% among the most commonly used aspiration thrombectomy catheter devices, with relative risks for death ranging from 0.96 to 1.03. The absolute risk of MACE ranged from 9.78% to 10.18%, with relative risks for MACE ranging from 0.99 to 1.02. There were no statistically significant differences in the rates of death or MACE between any of the aspiration thrombectomy catheter devices analyzed. Conclusions The CathPCI DELTA study demonstrates that prospective, active safety surveillance of national clinical registries is feasible to provide near-real-time safety assessments of new medical devices.


Assuntos
Cateterismo Cardíaco/instrumentação , Cateteres Cardíacos , Intervenção Coronária Percutânea/instrumentação , Vigilância de Produtos Comercializados , Trombectomia/instrumentação , Idoso , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/mortalidade , Desenho de Equipamento , Falha de Equipamento , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Segurança do Paciente , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Estudos Prospectivos , Sistema de Registros , Medição de Risco , Trombectomia/efeitos adversos , Trombectomia/mortalidade , Resultado do Tratamento
8.
Patient Educ Couns ; 102(5): 932-936, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30573296

RESUMO

OBJECTIVE: Identify inhaler use characteristics among English (ESP) and non-English speaking patients (NSP) to develop quality improvement efforts. METHODS: Outpatients were surveyed for technique confidence, education, preferences and disease control. We compared characteristics between ESP and NSP. RESULTS: Of 197 respondents, 75% were ESP, 25% were NSP. Compared to NSP, ESP responders were more likely female (57% vs 31%, p = 0.001), used inhalers for a longer time (10 vs 6 years, p = 0.008) and had higher rates of metered dose inhaler use (85% vs. 60%, p < 0.001). Both language groups had similar confidence in inhaler use, after adjustment for age, gender and duration of use. Similar rates of inhaler technique education were reported by ESP and NSP at the initial visit. More NSP reported receiving education at subsequent visits (54% vs. 72%, p = 0.03). Education for both groups was mostly performed by a clinician. Both language groups reported low internet use for learning proper technique, low interest in a separate education session, preferred an active learning method. CONCLUSIONS: These findings will be used to further develop quality inhaler education efforts at our institution. PRACTICAL IMPLICATIONS: Local patient preferences should be considered when designing inhaler education programs.


Assuntos
Asma/tratamento farmacológico , Conhecimentos, Atitudes e Prática em Saúde , Inaladores Dosimetrados , Educação de Pacientes como Assunto/métodos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração por Inalação , Adulto , Feminino , Humanos , Linguagem , Masculino , Pessoa de Meia-Idade , Determinação de Necessidades de Cuidados de Saúde , Educação de Pacientes como Assunto/normas , Melhoria de Qualidade
10.
Transl Psychiatry ; 8(1): 101, 2018 05 23.
Artigo em Inglês | MEDLINE | ID: mdl-29795112

RESUMO

Exposure of male mice to early life stress alters the levels of specific sperm miRNAs that promote stress-associated behaviors in their offspring. To begin to evaluate whether similar phenomena occur in men, we searched for sperm miRNA changes that occur in both mice and men exposed to early life stressors that have long-lasting effects. For men, we used the Adverse Childhood Experience (ACE) questionnaire. It reveals the degree of abusive and/or dysfunctional family experiences when young, which increases risks of developing future psychological and physical disorders. For male mice, we used adolescent chronic social instability (CSI) stress, which not only enhances sociability defects for >1 year, but also anxiety and defective sociability in female offspring for multiple generations through the male lineage. Here we found a statistically significant inverse correlation between levels of multiple miRNAs of the miR-449/34 family and ACE scores of Caucasian males. Remarkably, we found members of the same sperm miRNA family are also reduced in mice exposed to CSI stress. Thus, future studies should be designed to directly test whether reduced levels of these miRNAs could be used as unbiased indicators of current and/or early life exposure to severe stress. Moreover, after mating stressed male mice, these sperm miRNA reductions persist in both early embryos through at least the morula stage and in sperm of males derived from them, suggesting these miRNA changes contribute to transmission of stress phenotypes across generations. Since offspring of men exposed to early life trauma have elevated risks for psychological disorders, these findings raise the possibility that a portion of this risk may be derived from epigenetic regulation of these sperm miRNAs.


Assuntos
MicroRNAs/metabolismo , Espermatozoides/metabolismo , Estresse Psicológico/metabolismo , Adulto , Adultos Sobreviventes de Eventos Adversos na Infância , Animais , Grupo com Ancestrais do Continente Europeu , Humanos , Masculino , Camundongos
12.
JNCI Cancer Spectr ; 2(4): pky060, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31360878

RESUMO

Current guidance for evaluation of kidney function and drug dosing emphasize using measured or estimated glomerular filtration rate (GFR) rather than measured or estimated creatinine clearance or serum creatinine (Scr) alone. We assessed the definitions of kidney function thresholds for eligibility in cancer clinical trials. A random sample of active Phase I-III trials with cisplatin (n = 465) and studies in cancer with decreased kidney function (n = 74) were identified from clinicaltrials.gov. Among cisplatin trials, kidney function thresholds were defined by Scr alone or a composite of Scr or creatinine clearance in 46% (212/465) of studies. Only 2% (n = 11) used GFR. Among trials in participants with decreased kidney function, the proportion utilizing GFR (14%, 10/74) was modestly higher. Imprecise and logically inconsistent kidney function thresholds are in frequent use in clinical trials in cancer and may cause harm from either toxicity or impaired efficacy. We recommend the adoption and harmonization of recommended standards.

13.
Pulm Circ ; 7(4): 793-796, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28849992

RESUMO

This study explores the racial and ethnic differences in presentation, severity, and treatment of patients with pulmonary arterial hypertension (PAH) in a large multicenter registry. African American and Hispanic patients are more likely to present with associated PAH compared to non-Hispanic whites. Hispanic patients with PAH were less likely to be treated with PAH-specific medications compared to non-Hispanic whites.

15.
J Diabetes Complications ; 31(10): 1515-1520, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28739267

RESUMO

OBJECTIVE: To determine the association between H. pylori infection and risk of incident diabetes in adults at high risk for diabetes who participated in the Diabetes Prevention Program (DPP) study. METHODS: In a nested case-control study conducted among 421 adults with newly diagnosed diabetes and 421 matched controls, we examined the association between serological status of H. pylori at baseline and risk of incident diabetes over a mean follow-up period of 2.6years. Using data from the baseline visit of the DPP, we also examined the cross-sectional association between presence of H. pylori antibodies and insulin sensitivity, insulin secretion and the disposition index-like measure after a 75-g oral glucose tolerance test (OGTT). RESULTS: At baseline, H. pylori antibodies were present in 40% of participants who developed diabetes and 39% of controls. After adjusting for matching factors, there was no association between exposure to H. pylori and incident diabetes (odds ratio [OR] of 1.04 (95% CI, 0.77 to 1.40). In cross-sectional analyses, H. pylori status was not significantly associated with insulin sensitivity and disposition index-like measure from OGTT. CONCLUSIONS: In adults at high risk for diabetes, H. pylori seropositivity was not associated with risk of developing diabetes.


Assuntos
Diabetes Mellitus Tipo 2/etiologia , Infecções por Helicobacter/fisiopatologia , Helicobacter pylori/isolamento & purificação , Adulto , Anticorpos Antibacterianos/análise , Estudos de Casos e Controles , Estudos de Coortes , Estudos Transversais , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/imunologia , Diabetes Mellitus Tipo 2/microbiologia , Feminino , Infecções por Helicobacter/sangue , Infecções por Helicobacter/imunologia , Infecções por Helicobacter/microbiologia , Helicobacter pylori/imunologia , Humanos , Incidência , Resistência à Insulina , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Prospectivos , Fatores de Risco , Estudos Soroepidemiológicos , Estados Unidos/epidemiologia
16.
J Public Health Manag Pract ; 23(6): 684-689, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28628582

RESUMO

OBJECTIVE: The aim of this study was to assess the impact of a revolving loan fund (RLF) on timing of device insertion and long-acting reversible contraception (LARC) access among a high-risk urban population at 3 Boston community health centers. DESIGN: Three health centers were identified to implement a RLF. Each clinic received $5000 from the RLF to purchase LARC devices. Data collected through medical record review retrospectively 1 year prior to start of the RLF and prospectively for 1 year thereafter included patient demographics, type of LARC selected, patient's date of documented interest in a LARC device, and date of insertion. The effect of a RLF on delay to LARC insertion was tested using negative binomial regression, controlling for site and potential confounding variables between the pre- and post-RLF periods. SETTING: Three urban community health centers. PARTICIPANTS: Reproductive-aged women who received family planning services at the 3 participating health centers. MAIN OUTCOME MEASURES: Increasing access to LARC and decreasing wait times to LARC insertion after implementation of the RLF. RESULTS: Data on 133 patients in the pre-RLF group and 205 in the post-RLF group were collected. There were no statistically significant differences in demographic or clinical characteristics between the 2 time periods. LARC uptake increased significantly from the pre- to post-RLF period, specifically among implant users. There was a statistically significant decrease in the mean number of days in delay from interest to insertion from the pre- to post-RLF period (pre-RLF: 31.3 ± 50.6 days; post-RLF: 13.6 ± 16.7 days, adjusted P < .001). The reasons for the delay did not differ significantly between the 2 time periods. CONCLUSION: The RLF decreased wait time for the devices and increased overall insertion rates. This may serve as a promising solution to improve LARC access in community health centers. This project could be expanded to include more health centers, creating a city wide RLF. This expansion could allow for further data analysis, including unintended pregnancy rates with LARC delay, LARC continuation rates, and sustainability of a RLF.


Assuntos
Centros Comunitários de Saúde/economia , Acesso aos Serviços de Saúde/normas , Contracepção Reversível de Longo Prazo/estatística & dados numéricos , Adulto , Boston , Centros Comunitários de Saúde/tendências , Serviços de Planejamento Familiar/economia , Serviços de Planejamento Familiar/métodos , Serviços de Planejamento Familiar/organização & administração , Feminino , Apoio ao Planejamento em Saúde/tendências , Humanos , Contracepção Reversível de Longo Prazo/economia , Contracepção Reversível de Longo Prazo/métodos , Estudos Prospectivos , Estudos Retrospectivos , População Urbana/estatística & dados numéricos
18.
J Surg Res ; 206(1): 231-234, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27916367

RESUMO

BACKGROUND: Foregut duplication cysts are rare congenital anomalies that require surgical intervention with approximately 10%-15% of all gastrointestinal duplication cysts originating from the esophagus. Consensus is lacking among surgeons regarding closure of the esophageal muscle layer after resection of an esophageal duplication cyst and long-term outcomes are poorly documented. Therefore, we conducted the first study comparing complication rates in patients undergoing closure versus nonclosure of the esophageal muscle layer after esophageal duplication cyst resection. MATERIALS AND METHODS: A retrospective cohort study at Boston Children's Hospital, Massachusetts General Hospital, Brigham and Women's Hospital, and the Floating Hospital for Children at Tufts Medical Center was conducted. Patients undergoing resection of esophageal duplication cysts between 1990 and 2012 were classified according to whether the esophageal muscle layer was closed or left open. Demographic data, surgical technique, preoperative symptoms, and both short-term (<30 d) and long-term (≥30 d) complication rates were abstracted from patient medical records. RESULTS: Twenty-five patients were identified with a median age of 15-y old (range, 2 mo to 68-y old) and an average follow-up of 1 y. Eleven patients had the esophageal muscle layer closed after surgical resection (44%). Of those 11 patients, one developed a short-term complication, dysphagia (9%, 95% CI: 2%, 38%). Only one patient returned to the operating room, after 30 d, for an upper endoscopy after developing symptoms of gastroesophageal reflux disease. Of the 14 patients who had their muscle layer left open, three patients (21%, 95% CI: 8%, 48%) developed short-term complications, two of whom required surgical intervention within 30 d. Furthermore, two additional patients required surgical intervention after 30 d for a long-term complication (diverticulum and cyst recurrence). CONCLUSIONS: Surgical complications occurred more frequently in patients who had the muscle layer left open after resection of an esophageal duplication cyst. In addition, most patients requiring reoperation for both short-term and long-term complications occurred in this group. Though small, this study is the first to evaluate the complications after resecting esophageal duplication cysts. Our results suggest that closing the esophageal muscle layer after removal of an esophageal duplication cyst may be indicated to prevent both complications and the need for reoperations.


Assuntos
Cisto Esofágico/congênito , Cisto Esofágico/cirurgia , Esofagoplastia/métodos , Esôfago/anormalidades , Esôfago/cirurgia , Adolescente , Adulto , Idoso , Criança , Pré-Escolar , Feminino , Seguimentos , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
19.
Chiropr Man Therap ; 24: 42, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27822362

RESUMO

BACKGROUND: For patients and health care providers who are considering spinal manipulative therapy of the neck, it is crucial to establish if it is a trigger for cervical artery dissection and/or stroke, and if it is, the magnitude of the risk. DISCUSSION: We discuss the biological plausibility of how neck manipulation could cause cervical artery dissection. We also discuss how case misclassification threatens the validity of influential published studies that have investigated the relationship between neck manipulation and dissection. Our position is supported by the fact that the largest epidemiologic studies of neck manipulation safety with respect to neurological outcomes have relied on International Classification of Diseases-9 codes for case identification. However, the application of these codes in prior studies failed to identify dissections (rather than strokes in general) and so conclusions from those studies are invalid. CONCLUSION: There are several methodological challenges to understanding the association between neck manipulation and vertebral artery dissection. Addressing these issues is critical because even a modest association between neck manipulation and cervical artery dissection could translate into a significant number of avoidable dissections given the widespread use of neck manipulation by providers from various backgrounds. We believe that valid case classification, accurate measurement of manipulative procedures, and addressing reverse causation bias should be top priorities for future research.

20.
J Am Heart Assoc ; 5(12)2016 11 23.
Artigo em Inglês | MEDLINE | ID: mdl-27881423

RESUMO

BACKGROUND: Systemic arterial stiffness is recognized as a major contributor to development of left ventricular dysfunction and failure; however, the relationship of systemic arterial properties and the right ventricle (RV) is unknown. METHODS AND RESULTS: The associations between systemic arterial measures (total arterial compliance [TAC], systemic vascular resistance [SVR], and aortic augmentation index [AI]) and RV morphology (mass, end-systolic [RVESV] and end-diastolic volume [RVEDV], and ejection fraction [RVEF]) were examined using data from the Multi-Ethnic Study of Atherosclerosis. All analyses were adjusted for anthropometric, demographic, and clinical variables and the corresponding left ventricular parameter. A total of 3842 subjects without clinical cardiovascular disease were included with a mean age of 61 years, 48% male, 39% non-Hispanic white, 25% Chinese-American, 23% Hispanic, and 13% black. RV measures were within normal range for age and sex. A 1-mL/mm Hg decrease in TAC was associated with 3.9-mL smaller RVESV, 7.6-mL smaller RVEDV, and 2.4-g lower RV mass. A 5-Wood-unit increase in SVR was associated with 0.6-mL decrease in RVESV, 1.7-mL decrease in RVEDV, and 0.4-g decrease in RV mass. A 1% increase in AI was associated with 0.2-mL decrease in RVEDV. We found significant effect modification by age, sex, and race for some of these relationships, with males, whites, and younger individuals having greater decreases in RV volumes and mass. CONCLUSIONS: Markers of increased systemic arterial load were associated with smaller RV volumes and lower RV mass in a population of adults without clinical cardiovascular disease.


Assuntos
Aterosclerose/fisiopatologia , Doenças Cardiovasculares/diagnóstico , Grupos Étnicos , Ventrículos do Coração/diagnóstico por imagem , Rigidez Vascular/fisiologia , Função Ventricular Direita/fisiologia , Idoso , Idoso de 80 Anos ou mais , Aterosclerose/diagnóstico , Aterosclerose/etnologia , Doenças Cardiovasculares/etnologia , Doenças Cardiovasculares/fisiopatologia , Feminino , Seguimentos , Ventrículos do Coração/fisiopatologia , Humanos , Incidência , Imagem Cinética por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Volume Sistólico , Estados Unidos/epidemiologia
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