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With an increasing prevalence of diabetes, there is a need to risk stratify arthroplasty patients preoperatively and characterize postoperative infections. This study sought to determine if perioperative markers of diabetic control were associated with infection and to further characterize diabetic periprosthetic joint infections (PJI). A retrospective analysis of 506 diabetic patients and 900 nondiabetic patients who underwent primary total hip and knee arthroplasty was performed. In this cohort, an infection rate of 4.7% and 2.0% for diabetic and nondiabetic patients, respectively, was observed. There was no association between infection at 1 year and preoperative hemoglobin A1C or postoperative blood glucose; however, diabetic infections were significantly more likely to be deep (HR = 4.6; p < .001) and present >6 weeks postoperatively (HR = 8.0; p = .001). This study concluded that common markers of glycemic control are not predictive of the increased risk of diabetic PJI and alternative markers should be investigated. (Journal of Surgical Orthopaedic Advances 28(2):127-131, 2019).
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Artroplastia de Reemplazo de Cadera , Glucemia , Diabetes Mellitus , Infecciones Relacionadas con Prótesis , Complicaciones de la Diabetes , Humanos , Estudios RetrospectivosRESUMEN
BACKGROUND: In the United States, race and socioeconomic status are well known predictors of adverse outcomes in several different cancers. Existing evidence suggests that race and socioeconomic status may impact survival in soft tissue sarcoma (STS). We investigated the National Cancer Database (NCDB), which contains several socioeconomic and medical variables and contains the largest sarcoma patient registry to date. Our goal was to determine the impact of race, ethnicity and socioeconomic status on patient survival in patients with soft tissue sarcoma of the extremities (STS-E). METHODS: We retrospectively analyzed 14,067 STS-E patients in the NCDB from 1998 through 2012. Patients were stratified based on race, ethnicity and socioeconomic status. Univariate and multivariate analyses were used to correlate specific outcomes and survival measures with these factors. Then, long-term survival between groups was evaluated using the Kaplan-Meier (KM) method with comparisons based on the log-rank test. Multiple variables were analyzed between two groups. RESULTS: Of the 14,067 patients analyzed, 84.9% were white, 11% were black and 4.1% were Asian. Black patients were significantly more likely (7.18% vs 5.65% vs 4.47%) than white or Asian patients to receive amputation (p = 0.027). Black patients were also less likely to have either an above-median education level or an above-median income level (p < 0.001). In addition, black patients were more likely to be uninsured (p < 0.001) and more likely to have a higher Charleson Comorbidity Score than white or Asian patients. Tumors were larger in size upon presentation in black patients than in white or Asian patients (p < 0.001). Black patients had significantly poorer overall survival than did white or Asian patients (p < 0.001) with a KM 5-year survival of 61.4% vs 66.9% and 69.9% respectively, and a 24% higher independent likelihood of dying in a multivariate analysis. CONCLUSION: This large database review reveals concerning trends in black patients with STS-E. These include larger tumors, poorer resources, a greater likelihood of amputation, and poorer survival than white and Asian patients. Future studies are warranted to help ensure adequate access to effective treatment for all patients.
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Extremidades/patología , Grupos de Población , Sarcoma/epidemiología , Adulto , Anciano , Comorbilidad , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Pronóstico , Estudios Retrospectivos , Sarcoma/etnología , Sarcoma/mortalidad , Sarcoma/patología , Factores Socioeconómicos , Tasa de SupervivenciaRESUMEN
BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) are implementing changes in hospital reimbursement models for total joint arthroplasty (TJA), moving to value-based bundled payments from the fee-for-service model. The purpose of this study is to identify consults and complications during the perioperative period that increase financial burden. METHODS: We combined CMS payment data for inpatient, professional, and postoperative with retrospective review of patients undergoing primary TJA and developed profiles of patients included in the Comprehensive Care for Joint Replacement bundle undergoing TJA. Statistical comparison of episode inpatient events and payments was conducted. Multiple regression analysis was adjusted for length of stay, disposition, and Charlson-Deyo comorbidity profile. RESULTS: Median total payment was $21,577.36, which exceeded the median bundle target payment of $20,625.00. Adjusted analyses showed that psychiatry consults (increase of $73,123.32; P < .001), internal medicine consults ($5789.38; P ≤ .001), pulmonary embolism ($35,273.68; P < .001), intensive care unit admission ($14,078.37; P < .001), and deep vein thrombosis ($9471.26; P = .019) resulted in increased payments using multivariate analysis adjusted for length of stay, Charlson-Deyo comorbidities, and discharge disposition. CONCLUSION: Patients with inpatient complications such as pulmonary embolism and/or deep vein thrombosis, intensive care unit admission, and medical/psychiatric consultation exceeded the CMS target. Although study results showed typical complication rates, acute inpatient consultation significantly increased utilization beyond the CMS target even when adjusted for length of stay, patient comorbidities, and discharge. Needed medical care should continue to be a priority for inpatients, and allowance for individual outliers should be considered in policy discussions.
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Artroplastia de Reemplazo de Cadera/efectos adversos , Artroplastia de Reemplazo de Cadera/economía , Artroplastia de Reemplazo de Rodilla/efectos adversos , Artroplastia de Reemplazo de Rodilla/economía , Gastos en Salud , Pacientes Internos , Paquetes de Atención al Paciente/economía , Anciano , Centers for Medicare and Medicaid Services, U.S. , Comorbilidad , Planes de Aranceles por Servicios , Femenino , Hospitales , Humanos , Unidades de Cuidados Intensivos , Masculino , Persona de Mediana Edad , Alta del Paciente , Embolia Pulmonar/etiología , Derivación y Consulta , Estudios Retrospectivos , Estados Unidos , Trombosis de la Vena/etiologíaRESUMEN
AIMS: ST-segment recovery (STR) is a strong mechanistic correlate of infarct size (IS) and outcome in ST-segment elevation myocardial infarction (STEMI). Characterizing measures of speed, amplitude, and completeness of STR may extend the use of this noninvasive biomarker. METHODS AND RESULTS: Core laboratory continuous 24-h 12-lead Holter ECG monitoring, IS by single-photon emission computed tomography (SPECT), and 30-day mortality of 2 clinical trials of primary percutaneous coronary intervention in STEMI were combined. Multiple ST measures (STR at last contrast injection (LC) measured from peak value; 30, 60, 90, 120, and 240min, residual deviation; time to steady ST recovery; and the 3-h area under the time trend curve [ST-AUC] from LC) were univariably correlated with IS and predictive of mortality. After multivariable adjustment for ST-parameters and GRACE risk factors, STR at 240min remained an additive predictor of mortality. Early STR, residual deviation, and ST-AUC remained associated with IS. CONCLUSIONS: Multiple parameters that quantify the speed, amplitude, and completeness of STR predict mortality and correlate with IS.
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Intervención Coronaria Percutánea/métodos , Infarto del Miocardio con Elevación del ST/fisiopatología , Infarto del Miocardio con Elevación del ST/cirugía , Medios de Contraste , Electrocardiografía Ambulatoria , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Factores de Riesgo , Infarto del Miocardio con Elevación del ST/diagnóstico por imagen , Tomografía Computarizada de Emisión de Fotón Único , Resultado del TratamientoRESUMEN
BACKGROUND: Controversy exists over optimal timing of tracheostomy in patients with respiratory failure after blunt trauma. The study aimed to determine whether the timing of tracheostomy affects mortality in this population. METHODS: The 2008-2011 National Trauma Data Bank was queried to identify blunt trauma patients without concomitant head injury who required tracheostomy for respiratory failure between hospital days 4 and 21. Restricted cubic spline analysis was performed to evaluate the relationship between tracheostomy timing and the odds of inhospital mortality. The cohort was stratified based on this analysis. Unadjusted characteristics and outcomes were compared. Multivariable logistic regression was used to evaluate the effect of tracheostomy timing on mortality after adjustment for age, gender, race, payor status, level of trauma center, injury severity score, presentation Glasgow coma scale, and thoracic and abdominal abbreviated injury score. RESULTS: There were 9662 patients included in the study. Restricted cubic spline analysis demonstrated a nonlinear relationship between timing of tracheostomy and mortality, with higher odds of mortality occurring with tracheostomy placement within 10 d of admission compared with later time points. The cohort was therefore stratified into early and delayed tracheostomy groups relative to this time point. The resulting groups contained 5402 (55.9%) and 4260 (44.1%) patients, respectively. After multivariable adjustment, the delayed tracheostomy group continued to have significantly reduced odds of mortality (Adjusted odds ratio, 0.82, 95% confidence interval, 0.71-0.95, C-statistic, 0.700). CONCLUSIONS: Among non-head injured blunt trauma patients with prolonged respiratory failure, tracheostomy placement within 10 d of admission may result in increased mortality compared with later time points.
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Insuficiencia Respiratoria/terapia , Traqueostomía/mortalidad , Heridas y Lesiones/complicaciones , Adulto , Anciano , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Tiempo , Estados Unidos/epidemiología , Heridas y Lesiones/mortalidadRESUMEN
The purpose of this study was to identify the preoperative predictors of hospital length of stay after primary total knee arthroplasty in a patient population reflecting current trends toward shorter hospitalization and using readily obtainable factors that do not require scoring systems. A single-center, multi-surgeon retrospective chart review of two hundred and sixty consecutive patients who underwent primary total knee arthroplasty was performed. The mean length of stay was 3.0 days. Among the different variables studied, increasing comorbidities, lack of adequate assistance at home, and bilateral surgery were the only multivariable significant predictors of longer length of stay. The study was adequately powered for statistical analyses and the concordance index of the multivariable logistic regression model was 0.815.
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Artroplastia de Reemplazo de Rodilla/estadística & datos numéricos , Tiempo de Internación/estadística & datos numéricos , Adulto , Anciano , Anciano de 80 o más Años , Artroplastia de Reemplazo de Rodilla/métodos , Comorbilidad , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Periodo Preoperatorio , Estudios Retrospectivos , Factores de Riesgo , Apoyo SocialRESUMEN
The purpose of this study was to identify preoperative predictors of discharge destination after total joint arthroplasty. A retrospective study of three hundred and seventy-two consecutive patients who underwent primary total hip and knee arthroplasty was performed. The mean length of stay was 2.9 days and 29.0% of patients were discharged to extended care facilities. Age, caregiver support at home, and patient expectation of discharge destination were the only significant multivariable predictors regardless of the type of surgery (total knee versus total hip arthroplasty). Among those variables, patient expectation was the most important predictor (P < 0.001; OR 169.53). The study was adequately powered to analyze the variables in the multivariable logistic regression model, which had a high concordance index of 0.969.
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Artroplastia de Reemplazo de Cadera/rehabilitación , Artroplastia de Reemplazo de Rodilla/rehabilitación , Alta del Paciente , Instituciones de Cuidados Especializados de Enfermería , Adulto , Anciano , Anciano de 80 o más Años , Artroplastia de Reemplazo de Cadera/psicología , Artroplastia de Reemplazo de Rodilla/psicología , Femenino , Humanos , Tiempo de Internación , Modelos Logísticos , Masculino , Persona de Mediana Edad , Estudios RetrospectivosRESUMEN
The purpose of this study was to identify preoperative predictors of length of stay after primary total hip arthroplasty in a patient population reflecting current trends toward shorter hospitalization and using readily obtainable factors that do not require scoring systems. A retrospective review of 112 consecutive patients was performed. High preoperative pain level and patient expectation of discharge to extended care facilities (ECFs) were the only significant multivariable predictors of hospitalization extending beyond 2 days (P=0.001 and P<0.001 respectively). Patient expectation remained significant after adjusting for Medicare's 3-day requirement for discharge to ECFs (P<0.001). The study was adequately powered to analyze the variables in the multivariable logistic regression model, which had a concordance index of 0.857.
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Artroplastia de Reemplazo de Cadera/métodos , Tiempo de Internación , Dimensión del Dolor , Dolor Postoperatorio/diagnóstico , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Hospitalización , Hospitales , Humanos , Masculino , Medicare , Persona de Mediana Edad , Análisis Multivariante , Alta del Paciente , Estudios Retrospectivos , Instituciones de Cuidados Especializados de Enfermería , Estados UnidosRESUMEN
A pilot study was undertaken to examine the impact of Medicare's 3-day rule on length of stay (LOS). One hundred consecutive patients who underwent primary total joint arthroplasty and were discharged to extended care facilities were retrospectively reviewed. Based on readiness for discharge criteria, delaying discharge until the third postoperative day increased LOS by 1.1 days (P<0.001). 60.6% of patients were ready for discharge by the second postoperative day, none of whom required re-admission within 30 days of discharge. There were no rehabilitation gains by staying an additional hospital day beyond readiness for discharge (P=0.092). This pilot study calls into question the value of Medicare's 3-day rule and demonstrates the feasibility and need for further research to address this seemingly antiquated policy.
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Tiempo de Internación/legislación & jurisprudencia , Medicare/legislación & jurisprudencia , Alta del Paciente/legislación & jurisprudencia , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Política de Salud , Humanos , Tiempo de Internación/economía , Masculino , Medicare/economía , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Alta del Paciente/economía , Proyectos Piloto , Periodo Posoperatorio , Estudios Retrospectivos , Instituciones de Cuidados Especializados de Enfermería , Factores de Tiempo , Estados UnidosRESUMEN
The objective of this study was to characterize the impact of opioid-based analgesia in total joint arthroplasty. The primary outcomes were incidence of in-hospital complications, length of stay, and discharge destination. Six hundred and seventy-three primary total hip and knee arthroplasties were retrospectively reviewed. The incidence of opioid-related adverse drug events was 8.5%, which accounted for 58.2% of all postoperative complications. Age, anesthesia technique, ASA score, and surgery type were significant risk factors for complications. After adjusting for these confounders, opioid-related adverse drug events were significantly associated with increased length of stay (P < 0.001) and discharge to extended care facilities (P = 0.014).
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Analgésicos Opioides/efectos adversos , Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Dolor Postoperatorio/tratamiento farmacológico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Analgésicos Opioides/uso terapéutico , Femenino , Humanos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Alta del Paciente , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Adulto JovenAsunto(s)
Bloqueo Nervioso Autónomo/métodos , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/terapia , Nervios Esplácnicos/fisiopatología , Anciano , Enfermedad Crónica , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Nervios Esplácnicos/efectos de los fármacos , Resultado del TratamientoRESUMEN
BACKGROUND: Graft tears and contralateral anterior cruciate ligament (ACL) tears are common in pediatric athletes after ACL reconstruction. Use of objective return-to-sports (RTS) criteria, in particular physical performance tests (PPTs), is believed to reduce the incidence of secondary injury; however, pediatric norms for these tests are unknown. PURPOSE: To establish a proof of concept for the creation of age- and sex-based norms for commonly used RTS PPTs in healthy pediatric athletes, allowing the creation of growth curves for clinical referencing. STUDY DESIGN: Cross-sectional study; Level of evidence, 3. METHODS: A total of 100 healthy people who were between the ages of 6 and 18 years and involved in organized sports were enrolled, with even distributions of age and sex. All participants underwent 9 common RTS PPTs: stork test, stork test on Bosu, single-leg squat, single-leg squat on Bosu, clockwise and counterclockwise quadrant hops, single-leg hop for distance, 6-m timed hop, and triple crossover hop for distance. Mean performance across limbs was calculated for each individual. Chronological age, height, weight, sex, and self-reported Pubertal Maturational Observational Scale (PMOS) score were recorded. Univariable and multivariable models were created for each PPT, assessing the importance of the recorded descriptive variables. Quantile regression was used to create growth curves for each PPT. RESULTS: The cohort was 52% female, and the mean ± standard deviation age was 11.7 ± 3.6 years. PMOS was highly correlated with age (r = 0.86) and was excluded from the regressions. In univariable regression, age, height, and weight were strong predictors of performance for all PPTs, whereas sex was a predictor of performance on the single-leg and triple crossover hops for distance (with males outperforming females). Height and weight were excluded from multivariable regression because of multicollinearity with age. Multivariable regression showed predictive patterns for age and sex that were identical to those shown in the univariable analysis. Given ceiling effects, quantile regression for the stork tests was not possible, but quantile regression growth curves were successfully created for the 7 remaining PPTs. CONCLUSION: Chronological age and sex accurately predicted performance on common RTS PPTs in pediatric patients. The growth curves presented herein could assist clinicians with benchmarking pediatric patients postoperatively against a healthy athletic cohort.
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BACKGROUND: Return to sport (RTS) after anterior cruciate ligament (ACL) reconstruction in children is associated with a much higher risk (â¼30%) of subsequent ACL injury than in adults. Most RTS testing protocols use a limb symmetry index (LSI) ≥90% on physical performance tests (PPTs) to assess an athlete's readiness for sport. This assumes that, in a healthy state, the physical performances across both lower extremities are and should be equal. PURPOSE: To determine the prevalence of limb asymmetries >10% in the uninjured pediatric population on common PPTs as well as to explore the relationship between athlete variables, limb preference, and LSI values. STUDY DESIGN: Cross-sectional study; Level of evidence, 3. METHODS: This study included healthy volunteers (N = 100) evenly distributed between the ages of 6 and 18 years (mean age, 11.7 ± 3.6 years; 52% female). Participants performed 9 common PPTs. For analysis, we developed a composite score for each limb by averaging trials. We then calculated the LSI for each test. Univariable and multivariable linear regression analyses were performed to assess the relationship between athlete variables (age, sex, height, and weight) and LSI for each PPT. RESULTS: Instances of poor baseline limb symmetry (<90% LSI) were common across all PPTs. The single-leg timed hop had the highest percentage of participants, with LSI ≥90% at 73%, while the stork on a Bosu ball had the lowest percentage at 23%. After adjusting for age, female sex showed a significant association with LSI for the stork test (P = .010) and the quadrant hop-counterclockwise (P = .021). Additionally, after adjusting for sex, increasing age showed a significant association with LSI for the stork test (P < .001), single-leg squat on a Bosu ball (P = .010), quadrant hop-clockwise (P = .016), and quadrant hop-counterclockwise (P = .009). CONCLUSION: The majority of healthy athletes 18 years and younger demonstrated significant (<90%) limb asymmetries. Limb symmetry was not consistently affected by participant age or sex, and the effect sizes of these relationships were small. These findings should encourage clinicians and coaches to exercise caution in using the LSI as an isolated measure of RTS readiness after injury in pediatric athletes.
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Existing characterizations of coronavirus disease 2019 (COVID-19) admissions have occurred primarily in urban settings. This report describes demographic and clinical characteristics of the first COVID-19 patients presenting to a 6-hospital integrated health care system in rural/suburban southcentral Pennsylvania. Medical records of adult patients admitted with COVID-19 between March and May of 2020 were retrospectively reviewed for demographics, symptomatology, imaging, and lab values. Results were largely consistent with previous studies, although gastrointestinal manifestations were more prevalent, with diarrhea reported in 25.4% of patients hospitalized due to COVID-19. Nursing home patients represented 10.1% of admissions but accounted for 35.5% of total deaths in our sample. Patients self-identifying as Hispanic were disproportionately affected. Although Hispanic ethnicity was self-reported in only 9% of the community population, Hispanic patients accounted for 34% of admissions. Our data provide a unique focused review of hospitalized COVID-19 patients in a rural/suburban setting.
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We reviewed 354 cases of malignant diffuse mesothelioma (MM) in women from a database of 2858 histologically confirmed MM cases. There was a pleural predominance with 78% pleural MM and 22% peritoneal MM. The pleural tumors consisted of 72% epithelioid, 19% biphasic, and 9% sarcomatoid variant. The peritoneal tumors consisted of 82% epithelioid, 13% biphasic, and 5% sarcomatoid. The immunohistochemical profile was typical of what is well-accepted and previously described for MM. When examining tumor subtype and location, there was a trend toward epithelioid subtype and peritoneal location; however, this did not reach statistical significance. Age at the time of diagnosis ranged from 19 to 93 years with a mean of 60 years. The median age at time of diagnosis for pleural MM was 65 years and for peritoneal MM was 52 years. A further look at age and histologic subtype showed no statistically significant difference in age between MM subtypes. Survival was greatest for epithelioid variant, and this was magnified in the peritoneum. A majority of our cases were exposed to asbestos through a household contact. Asbestosis and parietal pleural plaque were present in 5% and 50% of cases with data, respectively. Fiber analysis data was available in 67 cases; 38 cases had elevated asbestos fiber burden, and tremolite was the most common asbestos fiber type detected. Commercial and noncommercial amphibole asbestos fibers were elevated in nearly equal numbers of cases.
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Neoplasias Pulmonares/patología , Mesotelioma/patología , Adulto , Anciano , Anciano de 80 o más Años , Amianto/toxicidad , Carcinógenos/toxicidad , Bases de Datos Factuales , Exposición a Riesgos Ambientales/efectos adversos , Femenino , Humanos , Neoplasias Pulmonares/inducido químicamente , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/mortalidad , Mesotelioma/inducido químicamente , Mesotelioma/diagnóstico , Mesotelioma/mortalidad , Mesotelioma Maligno , Persona de Mediana Edad , Pronóstico , Análisis de Supervivencia , Estados Unidos/epidemiologíaRESUMEN
STUDY DESIGN: Retrospective review. OBJECTIVE: To determine if adjuvant radiation therapy (RT) improves overall survival (OS) following surgical resection of chordomas. SUMMARY OF BACKGROUND DATA: The role of RT for the treatment of chordomas remains incompletely described. Previous studies have not found adjuvant RT to improve OS, but these studies did not group patients based on surgical margin status or radiation dose or modality. We used the National Cancer Database to investigate the role of RT in chordomas following surgical resection. METHODS: Patients were stratified based on surgical margin status (positive vs. negative). Utilizing the Kaplan-Meier method, OS was compared between treatment modalities (surgical resection alone, therapeutic RT alone, and surgical resection plus therapeutic RT). OS was subsequently compared between patients treated with palliative dose (<40âGy), low dose (40-65âGy), and high dose (>65âGy) RT. Similarly, OS was compared between advanced RT modalities including proton beam therapy (PBT) and intensity-modulated radiation therapy (IMRT), stereotactic radiosurgery (SRS), and external beam radiation therapy (EBRT). A multivariable model was used to determine adjusted variables predictive of mortality. RESULTS: One thousand four hundred seventy eight chordoma patients were identified; skull base (nâ=â567), sacral (nâ=â551), and mobile spine (nâ=â360). Surgical resection and therapeutic adjuvant RT improved 5-year survival in patients with positive surgical margins (82% vs. 71%, Pâ=â0.03). No clear survival benefit was observed with the addition of adjuvant RT in patients with negative surgical margins. High dose RT was associated with improved OS compared with palliative and low dose RT (Pâ<â0.001). Advanced RT techniques and SRS were associated with improved OS compared with EBRT. In the multivariate analysis high dose advanced RT (>65âGy) was superior to EBRT. CONCLUSION: Patients with positive surgical margins benefit from adjuvant RT. Optimal OS is associated with adjuvant RT administered with advanced techniques and cumulative dose more than 65âGy. LEVEL OF EVIDENCE: 4.
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Cordoma/radioterapia , Cordoma/cirugía , Adulto , Anciano , Bases de Datos Factuales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Terapia de Protones , Dosificación Radioterapéutica , Radioterapia Adyuvante , Radioterapia de Intensidad Modulada , Estudios Retrospectivos , Sacro , Base del CráneoRESUMEN
RATIONALE: The relationship between clinical and biomarker characteristics of asthma and its severity in Africa is not well known. METHODS: Using the Expert Panel Report 3, we assessed for asthma severity and its relationship with key phenotypic characteristics in Uganda, Kenya and Ethiopia. The characteristics included adult onset asthma, family history of asthma, exposures (smoking and biomass), comorbidities (HIV, hypertension, obesity, tuberculosis (TB), rhinosinusitis, gastro-oesophageal disease (GERD) and biomarkers (fractional exhaled nitric oxide (FeNO), skin prick test (SPT) and blood eosinophils). We compared these characteristics on the basis of severity and fitted a multivariable logistic regression model to assess the independent association of these characteristics with asthma severity. RESULTS: A total of 1671 patients were enrolled, 70.7% women, with median age of 40 years. The prevalence of intermittent, mild persistent, moderate persistent and severe persistent asthma was 2.9%, 19.9%, 42.6% and 34.6%, respectively. Only 14% were on inhaled corticosteroids (ICS). Patients with severe persistent asthma had a higher rate of adult onset asthma, smoking, HIV, history of TB, FeNO and absolute eosinophil count but lower rates of GERD, rhinosinusitis and SPT positivity. In the multivariate model, Ethiopian site and a history of GERD remained associated with asthma severity. DISCUSSION: The majority of patients in this cohort presented with moderate to severe persistent asthma and the use of ICS was very low. Improving access to ICS and other inhaled therapies could greatly reduce asthma morbidity in Africa.
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Asma/epidemiología , Fenotipo , Índice de Severidad de la Enfermedad , Administración por Inhalación , Adolescente , Corticoesteroides/administración & dosificación , Adulto , Antiasmáticos/administración & dosificación , Asma/tratamiento farmacológico , Biomarcadores , Estudios de Cohortes , Comorbilidad , Estudios Transversales , Etiopía/epidemiología , Femenino , Reflujo Gastroesofágico/epidemiología , Humanos , Kenia/epidemiología , Recuento de Leucocitos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Óxido Nítrico/análisis , Fumar/epidemiología , Uganda/epidemiología , Adulto JovenRESUMEN
BACKGROUND: KAI-9803, a delta-protein kinase C inhibitor, has been shown to ameliorate injury associated with ischemia and reperfusion in animal models of acute myocardial infarction (MI). METHODS AND RESULTS: Direct Inhibition of delta-Protein Kinase C Enzyme to Limit Total Infarct Size in Acute Myocardial Infarction (DELTA MI) was a "first-in-human," dose-escalation study that evaluated the safety, tolerability, and activity of KAI-9803 for patients with acute anterior ST-segment elevation MI undergoing primary percutaneous coronary intervention. Patients who presented within 6 hours of symptom onset and had an occluded left anterior descending infarct artery on angiography were randomized in a 2:1 fashion to receive 1 of 4 doses of KAI-9803 (cohort 1, 0.05 mg; cohort 2, 0.5 mg; cohort 3, 1.25 mg; cohort 4, 5.0 mg) versus blinded concurrent placebo delivered in 2 divided doses via intracoronary injection before and after reestablishment of antegrade epicardial flow with percutaneous coronary intervention. Safety and biomarker end points were assessed. Overall, 154 patients were randomized and treated with study drug (37 in cohort 1, 38 in cohort 2, 38 in cohort 3, 41 in cohort 4). The incidence of serious adverse events was similar between patients treated with KAI-9803 versus placebo. Other safety end points, including changes in QT intervals and standard laboratory values after study drug administration, were similar between treatment groups. Although the study was not powered to demonstrate efficacy with the biomarker end points assessed, signs of drug activity with KAI-9803 were suggested by trends for consistent, nonsignificant reductions in creatine kinase-MB area under the curve and ST-recovery area under the curve values across all dosing cohorts with KAI-9803 compared with concurrent placebo, and similar trends were demonstrated for improvements in (99m)technetium sestamibi infarct size values with active study drug in cohorts 1, 2, and 3. CONCLUSIONS: KAI-9803 had an acceptable safety and tolerability profile when delivered via intracoronary injection during primary percutaneous coronary intervention for ST-segment elevation MI. Signs of potential drug activity were demonstrated with biomarker end points in this small exploratory study, indicating that further testing of KAI-9803 as an adjunctive therapy for ST-segment elevation MI is warranted.
Asunto(s)
Angioplastia Coronaria con Balón , Fármacos Cardiovasculares/administración & dosificación , Quimioterapia Adyuvante , Infarto del Miocardio/tratamiento farmacológico , Péptidos/administración & dosificación , Proteína Quinasa C-delta/antagonistas & inhibidores , Inhibidores de Proteínas Quinasas/administración & dosificación , Biomarcadores , Fármacos Cardiovasculares/efectos adversos , Fármacos Cardiovasculares/uso terapéutico , Estudios de Cohortes , Terapia Combinada , Angiografía Coronaria , Vasos Coronarios , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Electrocardiografía , Femenino , Humanos , Inyecciones Intraarteriales , Masculino , Persona de Mediana Edad , Infarto del Miocardio/sangre , Infarto del Miocardio/diagnóstico por imagen , Infarto del Miocardio/patología , Infarto del Miocardio/cirugía , Reperfusión Miocárdica , Péptidos/efectos adversos , Péptidos/uso terapéutico , Inhibidores de Proteínas Quinasas/efectos adversos , Inhibidores de Proteínas Quinasas/uso terapéuticoRESUMEN
BACKGROUND: Legacy hip outcome measures may be burdensome to patients and sometimes yield floor or ceiling effects. Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive tests (CATs) allow for low-burden data capture and limited ceiling and floor effects. PURPOSE/HYPOTHESIS: The purpose of this study was to determine whether the PROMIS CAT domains demonstrate correlation against commonly used legacy patient-reported outcome measures in a population of patients presenting to a tertiary care hip preservation center. The authors hypothesized the following: (1) PROMIS CAT scores based on physical function (PF), pain interference (PIF), pain behavior, and pain intensity would show strong correlation with the following legacy scores: modified Harris Hip Score (mHHS), International Hip Outcome Tool-12 (iHOT-12), Hip Outcome Score (HOS) Sports and Activities of Daily Living subscales, and Veterans RAND-6D (VR-6D) utility measure. (2) The mental and physical health portions of the VR-6D legacy measure would show weak correlation with mental- and psychosocial-specific PROMIS elements-depression, anxiety, fatigue, sleep, and ability to participate in social roles and activities. (3) All PROMIS measures would exhibit fewer floor and ceiling effects than legacy scores. STUDY DESIGN: Cohort study (diagnosis); Level of evidence, 3. METHODS: Prospective data were collected on 125 patients in the hip preservation clinics. Enrollees completed legacy scores (visual analog scale for pain, mHHS, iHOT-12, HOS, and VR-6D) and PROMIS CAT questionnaires (PF, PIF, pain behavior, anxiety, depression, sleep, social roles and activities, pain intensity, fatigue). Spearman rank correlations were calculated, with rs values of 0 to 0.3 indicating negligible correlation; 0.3 to 0.5, weak correlation; 0.5 to 0.7, moderately strong correlation; and >0.7, strong correlation. Floor and ceiling effects were evaluated. RESULTS: As anticipated, the PF-CAT yielded strong correlations with the iHOT-12, mHHS, HOS-Sports, HOS-Activities of Daily Living, and VR-6D, with rs values of 0.76, 0.71, 0.81, 0.87, and 0.71, respectively. The PIF-CAT was the only pain score to show moderately strong to strong correlation with all 14 patient-reported outcome measures. A strong correlation was observed between the VR-6D and the social roles and activities CAT ( rs = 0.73). The depression CAT had a significant floor effect at 19%. No additional floor or ceiling effect was present for any other legacy or PROMIS measure. CONCLUSION: The PF-CAT shows strong correlation with legacy patient-reported outcome scores among patients presenting to a tertiary care hip preservation center. The PIF-CAT also correlates strongly with legacy and PROMIS measures evaluating physical and mental well-being. PROMIS measures are less burdensome and demonstrate no floor or ceiling effects, making them a potential alternative to legacy patient-reported outcome measures for the hip.
Asunto(s)
Cadera/cirugía , Artropatías/cirugía , Medición de Resultados Informados por el Paciente , Actividades Cotidianas , Adulto , Anciano , Ansiedad/etiología , Artralgia/etiología , Artralgia/prevención & control , Artroscopía/efectos adversos , Depresión/etiología , Femenino , Lesiones de la Cadera/complicaciones , Lesiones de la Cadera/psicología , Lesiones de la Cadera/cirugía , Humanos , Artropatías/complicaciones , Artropatías/psicología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Atención Terciaria de Salud , Adulto JovenRESUMEN
Importance: Cutaneous chronic graft-vs-host disease (cGVHD) is common after allogeneic hematopoietic stem cell transplant and is often associated with poor patient outcomes. A reliable and practical method for assessing disease severity and response to therapy among these patients is urgently needed. Objective: To evaluate the interrater agreement and reliability of skin-specific and range of motion (ROM) variables of the 2014 National Institutes of Health (NIH) response criteria for cGVHD and a skin sclerosis grading scale (SSG). Design, Setting, and Participants: In this observational study performed at a single tertiary academic center, 6 academic blood and marrow transplant specialists and 4 medical dermatologists examined 8 patients with diagnosed cutaneous cGVHD on July 10, 2015. The patient cohort was enriched for patients with sclerotic features. Each patient was evaluated by using the skin-specific and ROM criteria of the 2014 NIH response criteria for cGVHD and an SSG ranging from 0 to 3. Each patient was also asked to complete quality-of-life scoring instruments. Interrater agreement and reliability were estimated by calculating the Krippendorff α and Cohen κ statistics. Data were analyzed from September 29, 2015, through November 22, 2018. Main Outcomes and Measures: Estimation of interrater agreement by interclass coefficient (Krippendorff α and Cohen κ statistics) for the skin-specific and ROM components of the 2014 NIH Response Criteria for Chronic GVHD and for the SSG. Results: The median age of the patients evaluated was 54 years (range, 46-58 years). Patients were predominantly male (6 [75%]). Six of the 8 patients had a predominantly sclerotic cutaneous phenotype. Interrater agreement among our experts was acceptable for NIH skin feature score (0.68; 95% CI, 0.30-0.86) and good for NIH ROM scoring (0.80; 95% CI, 0.68-0.86). Dermatologists had acceptable agreement for NIH skin GVHD score (0.69; 95% CI, 0.25-0.82) and skin feature score (0.78; 95% CI, 0.17-0.98), good agreement in ROM grading (0.85; 95% CI, 0.69-0.90), and near perfect agreement in identifying sclerosis (0.82; 95% CI, 0.27-0.97). Conclusions and Relevance: Although dermatologists had acceptable agreement in NIH skin GVHD score and skin features score, near perfect agreement in identifying cutaneous sclerosis, better agreement in grading severity of cutaneous cGVHD, especially in the intermediate grades, appears to be needed.