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PURPOSE: Sclerotic chronic graft-versus-host disease (cGVHD) represents a highly morbid and refractory form of cGVHD, and novel therapies for sclerotic cGVHD are critically needed. This study aimed to determine the efficacy of ruxolitinib in patients with corticosteroid refractory sclerotic cGVHD. PATIENTS AND METHODS: In a single-arm multicenter phase II trial (N = 47), adults with sclerotic cGVHD refractory to corticosteroids and ≥one additional line of systemic therapy for cGVHD received ruxolitinib for ≥six months (ClinicalTrials.gov identifier: NCT03616184). The primary end point was complete or partial response (PR) in skin and/or joint defined according to the 2014 National Institute of Health cGVHD Consensus Criteria. RESULTS: Following the use of ruxolitinib for a median of 11 months, PR in skin and/or joints was noted in 49% (95% CI, 34 to 64) at 6 months, with 45% having joint and fascia response and 19% having skin response. The duration of skin/joint response was 77% (95% CI, 48 to 91) at 12 months. Overall cGVHD PR was noted in 47% (95% CI, 32 to 61). Improvement in Lee Symptom Scale summary and skin subscale scores was noted in 38% of patients. With a cumulative incidence of treatment failure of 20.8% (95% CI, 10.0 to 34.1), nonrelapse mortality (NRM) of 2.2% (95% CI, 0.17 to 10.3), and no recurrent malignancy, failure-free survival (FFS) was 77.1% (95% CI, 61.3 to 87.0) at 12 months. Ruxolitinib was overall well tolerated with no new safety signals. CONCLUSION: The use of ruxolitinib was associated with relatively high rates of skin/joint responses and overall cGVHD responses, improvement in patient-reported outcomes, low NRM, and high FFS in patients with refractory sclerotic cGVHD. Ruxolitinib offers an effective treatment option for refractory sclerotic cGVHD.
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BACKGROUND: Metastatic triple-negative breast cancer (TNBC) is aggressive with poor median overall survival (OS) ranging from 8 to 13 months. There exists considerable heterogeneity in survival at the individual patient level. To better understand the survival heterogeneity and improve risk stratification, our study aims to identify the factors influencing survival, utilizing a large patient sample from the National Cancer Database (NCDB). METHODS: Women diagnosed with metastatic TNBC from 2010 to 2020 in the NCDB were included. Demographic, clinicopathological, and treatment data and overall survival (OS) outcomes were collected. Kaplan-Meier curves were used to estimate OS. The log-rank test was used to identify OS differences between groups for each variable in the univariate analysis. For the multivariate analysis, the Cox proportional hazard model with backward elimination was used to identify factors affecting OS. Adjusted hazard ratios and 95% confidence intervals are presented. RESULTS: In this sample, 2273 women had a median overall survival of 13.6 months. Factors associated with statistically significantly worse OS included older age, higher comorbidity scores, specific histologies, higher number of metastatic sites, presence of liver or other site metastases in those with only one metastatic site (excluding brain metastases), presence of cranial and extra-cranial metastases, lack of chemotherapy, lack of immunotherapy, lack of surgery to distant sites, lack of radiation to distant sites, and receipt of palliative treatment to alleviate symptoms. In the multivariate analysis, comorbidity score, histology, number of metastatic sites, immunotherapy, and chemotherapy had a statistically significant effect on OS. CONCLUSIONS: Through NCDB analysis, we have identified prognostic factors for metastatic TNBC. These findings will help individualize prognostication at diagnosis, optimize treatment strategies, and facilitate patient stratification in future clinical trials.
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BACKGROUND AND OBJECTIVE: Although guidelines call for the presence of pediatric ethics consultation services (PECS), their existence in children's hospitals remains unquantified. This study determined the prevalence of PECS in children's hospitals and compared the practice environments of those with versus without PECS. METHOD: The Children's Hospital Association Annual Benchmark Report survey from 2020 and PECS data were analyzed for the association of PECS with domains of care. RESULTS: Two hundred thirty-one hospitals received survey requests, with 148 submitted and 144 reachable to determine PECS (62% response rate), inclusive of 50 states. Ninety-nine (69%) reported having ethics consultation services. Freestanding children's hospitals (28% of all hospitals) were more likely to report the presence of PECS (P <.001), making up 41% of hospitals with a PECS. The median number of staffed beds was 203 (25th quartile 119, 75th quartile 326) for those with PECS compared with 80 for those without (25th quartile 40, 75th quartile 121). Facilities with palliative care, higher trauma ratio, intensive care, and comprehensive programs were more likely to have PECS. Academic affiliation was associated with PECS presence (P <.001). Settings associated with skilled nursing facilities or long-term care programs were not more likely to have PECS. Hospitals designated as federally qualified health centers (P = .04) and accountable care organizations (P = .001) were more likely to have PECS. CONCLUSION: Although PECS function as formal means to clarify values and mitigate conflict, one-third of children's hospitals lack PECS. Future research is needed to understand barriers to PECS and improve its presence.
Subject(s)
Ethics Consultation , Child , Humans , Surveys and Questionnaires , Hospitals, Pediatric , Palliative Care , Critical CareABSTRACT
BACKGROUNG AND OBJECTIVES: This study determined the prevalence of PPC programs in the United States and compared the environment of children's hospitals with and without PPC programs. METHODS: Analyses of the multicenter Children's Hospital Association Annual Benchmark Report 2020 survey for prevalence of PPC programs and association with operational, missional, educational, and financial domains. RESULTS: Two hundred thirty-one hospitals received Annual Benchmark Report survey requests with 148 submitted (64% response rate) inclusive of 50 states. One hundred nineteen (80%) reported having a PPC program and 29 (20%) reported not having a PPC program. Free-standing children's hospitals (n = 42 of 148, 28%) were more likely to report the presence of PPC (P = .004). For settings with PPC programs, the median number of staffed beds was 185 (25th quartile 119, 75th quartile 303) compared with 49 median number of staffed beds for those without PPC (25th quartile 30, 75th quartile 81). Facilities with higher ratio of trauma, intensive care, or acuity level were more likely to offer PPC. Although palliative care was associated with hospice (P <.001) and respite (P = .0098), over half of facilities reported not having access to hospice for children (n = 82 of 148, 55%) and 79% reported not having access to respite care (n = 117 of 148). CONCLUSIONS: PPC, hospice, and respite services remain unrealized for many children and families in the United States. Programmatic focus and advocacy efforts must emphasize creation and sustainability of quality PPC programs in smaller, lower resourced hospitals.
Subject(s)
Hospice Care , Hospices , Child , Hospitals, Pediatric , Humans , Palliative Care , Surveys and Questionnaires , United StatesABSTRACT
INTRODUCTION: Unintended perioperative hypothermia is associated with surgical site infection (SSI) in adults, prompting exhaustive efforts to maintain perioperative normothermia. Although these efforts are also made for pediatric patients, the association between hypothermia and SSI has not been demonstrated in children. We sought to determine whether perioperative hypothermia and other risk factors and clinical outcomes are associated with SSI in the pediatric population. MATERIALS AND METHODS: This case-control study took place from January 2014 through December 2016 and included patients at a National Surgical Quality Improvement Program-participant academic children's hospital. All surgical patients were included in this retrospective analysis. SSI rates were determined. A univariate analysis was performed to determine clinical factors associated with SSI. A multivariate regression analysis was then performed to determine the predictive effect of minimum perioperative temperature for SSI. RESULTS: This study included 3541 patients, of which 92 (2.6%) developed SSI. A univariate analysis showed associations among SSI and higher perioperative temperatures, surgical specialty of otolaryngology and general surgery, and wound classification (American Society of Anesthesiologists [ASA] classification III and IV). A multivariate analysis determined the odds of SSI increased by a factor of 1.6 for every 1°C increase in minimum perioperative temperature. CONCLUSIONS: Unintended perioperative hypothermia in our pediatric patients was inversely associated with SSI. This finding suggests that pediatric SSI prevention may not require the efforts made for adult patients to maintain normothermia.
Subject(s)
Hypothermia , Adult , Case-Control Studies , Child , Humans , Hypothermia/epidemiology , Hypothermia/etiology , Retrospective Studies , Risk Factors , Surgical Wound Infection/epidemiology , Surgical Wound Infection/etiology , Surgical Wound Infection/prevention & controlABSTRACT
Background: Medical interpreters are critical mediators in communication with pediatric subjects and families to include participation in difficult conversations. Objective: The objective of this pilot study was to provide suggestions from medical interpreters to palliative care teams as to how to effectively incorporate medical interpreters into end-of-life conversations. Methods: Participants included pediatric hospital-based medical interpreters who had interpreted for at least 1 end-of-life conversation in the pediatric hospital setting. A total of 11 surveys were completed by medical interpreters. The study consisted of a written 12-item survey with a follow-up focus group to further explore survey themes. Results: The translation of cultural contexts, awareness of the mixed messages the family received from health care teams, and the emotional intensity of the interactions were depicted as the most challenging aspects of the medical interpreter's role. Despite these challenges, 9 interpreters reported they would willingly be assigned for interpreting "bad news" conversations if given the opportunity (82%). Medical interpreters recognized their relationship with the family and their helping role for the family as meaningful aspects of interpreting even in difficult conversations. Medical interpreters shared 7 thematic suggestions for improved communication in language-discordant visits: content review, message clarity, advocacy role, cultural understanding, communication dynamics, professionalism, and emotional support. Conclusions: As experts in cultural dynamics and message transmission, the insights of medical interpreters can improve communication with families.
Subject(s)
Communication Barriers , Hospitals, Pediatric , Child , Communication , Death , Feedback , Humans , Pilot ProjectsABSTRACT
BACKGROUND: The optimal type of operative drainage following pancreaticoduodenectomy (PD) remains unclear. Our objective is to investigate risk associated with closed drainage techniques (passive [gravity] vs. suction) after PD. METHODS: We assessed operative drainage techniques utilized in patients undergoing PD in the ACS-NSQIP pancreas-targeted database from 2016 to 2018. Using multivariable logistic regression to adjust for characteristics of the patient, procedure, and pancreas, we examined the association between use of gravity drainage and postoperative outcomes. RESULTS: We identified 9665 patients with drains following PD from 2016 to 2018, of which 12.7% received gravity drainage. 61.0% had a diagnosis of adenocarcinoma or pancreatitis, 26.5% had a duct <3 mm, and 43.5% had a soft or intermediate gland. After multivariable adjustment, gravity drainage was associated with decreased rates of postoperative pancreatic fistula (odds ratio [OR] 0.779, 95% confidence interval [CI] 0.653-0.930, p=0.006), delayed gastric emptying (OR 0.830, 95% CI 0.693-0.988, p=0.036), superficial SSI (OR 0.741, 95% CI 0.572-0.959, p=0.023), organ space SSI (OR 0.791, 95% CI 0.658-0.951, p=0.012), and readmission (OR 0.807, 95% CI 0.679-0.958, p=0.014) following PD. CONCLUSIONS: Gravity drainage is independently associated with decreased rates of CR-POPF, DGE, SSI, and readmission following PD. Additional prospective research is necessary to better understand the preferred drainage technique following PD.
Subject(s)
Drainage , Pancreatic Fistula , Humans , Pancreatic Fistula/epidemiology , Pancreatic Fistula/etiology , Pancreaticoduodenectomy/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prognosis , Prospective Studies , Risk FactorsABSTRACT
BACKGROUND: Children with terminal cancer and their families describe a preference for home-based end-of-life care. Inadequate support outside of the hospital is a limiting factor in home location feasibility, particularly in rural regions lacking pediatric-trained hospice providers. METHODS: The purpose of this longitudinal palliative telehealth support pilot study was to explore physical and emotional symptom burden and family impact assessments for children with terminal cancer receiving home based-hospice care. Each child received standard of care home-based hospice care from an adult-trained rural hospice team with the inclusion of telehealth pediatric palliative care visits at a scheduled minimum of every 14 days. RESULTS: Eleven children (mean age 11.9 years) received pediatric palliative telehealth visits a minimum of every 14 days, with an average of 4.8 additional telehealth visits initiated by the family. Average time from enrollment to death was 21.6 days (range 4-95). Children self-reported higher physical symptom prevalence than parents or hospice nurses perceived the child was experiencing at time of hospice enrollment with underrecognition of the child's emotional burden. At the time of hospice enrollment, family impact was reported by family caregivers as 46.4/100 (SD 18.7), with noted trend of improved family function while receiving home hospice care with telehealth support. All children remained at home for end-of-life care. CONCLUSION: Pediatric palliative care telehealth combined with adult-trained rural hospice providers may be utilized to support pediatric oncology patients and their family caregivers as part of longitudinal home-based hospice care.
Subject(s)
Palliative Care , Telemedicine , Terminal Care , Adolescent , Child , Home Care Services , Humans , Infant , Infant, Newborn , Palliative Care/methods , Pilot Projects , Rural Population , Telemedicine/methods , Terminal Care/methodsSubject(s)
Bone Density/genetics , Fractures, Bone/genetics , Trisomy 13 Syndrome/genetics , Trisomy 18 Syndrome/genetics , Child , Female , Fractures, Bone/diagnostic imaging , Fractures, Bone/pathology , Humans , Male , Trisomy 13 Syndrome/diagnostic imaging , Trisomy 13 Syndrome/pathology , Trisomy 18 Syndrome/diagnosis , Trisomy 18 Syndrome/pathologyABSTRACT
Background: Children in rural geographies are not universally able to access pediatric-trained palliative or hospice providers. Objective: Determine whether telehealth inclusion of a familiar pediatric palliative care provider during the first two home-based hospice visits was acceptable to children, families, and adult-trained home hospice nurses in rural settings. Design: Case series. Setting: Home hospice in rural Midwest. Participants: Patients <18 years of age enrolling in home hospice for end-of-life care. Measurements: The acceptability of telehealth inclusion of a hospital-based pediatric palliative care provider in home hospice visits to the family caregiver and home hospice nurse was measured using the Technology Acceptance Model Questionnaires with the inclusion of the child perspective when possible. Results: Fifteen patients mean age of seven years enrolled. Family caregiver included 11 mothers (73%), 2 grandmothers (13%), and 2 fathers (13%). Fifteen nurses from nine hospice agencies participated. Twelve families (80%) included additional relatives by telehealth modality. Home distance averaged 172 miles with mean eight hours saved by accessing telehealth encounter. Visit content was primarily caregiver support, quality of life, goals of care, symptom management, and medication review. Telehealth acceptability improved between time points and was higher in family caregivers (4.3-4.9 on 5-point scale; p = 0.001) than hospice nurses (3.2-3.8 on 5-point scale; p = 0.05). All children able to self-report stated a "like" for telehealth, citing six reasons such as "being remembered" and "medical knowledge and care planning." Conclusions: Pediatric palliative telehealth visits partnered with in-person hospice nurse offer acceptable access to services, while extending support.
Subject(s)
Hospice Care , Hospices , Nurses , Telemedicine , Adult , Caregivers , Child , Humans , Inpatients , Palliative Care , Quality of LifeABSTRACT
PURPOSE: Data on the timeliness of emergent medication delivery for nonconvulsive status epilepticus (NCSE) are currently lacking. METHODS: Retrospective chart reviews (between 2015 and 2018) and analyses of all patients with NCSE were performed at the University of Nebraska Medical Center, a level 4 epilepsy center, to determine the latencies to order and administration of the first, second, and third antiepileptic drugs (AEDs). Recurrent NCSE cases were considered independently and classified as comatose and noncomatose. RESULTS: There were 77 occurrences of NCSE in 53 patients. The first, second, and third AEDs were delivered with substantial delays at median times of 80 (25%-75% interquartile range, 44-166), 126 (interquartile range, 67-239), and 158 minutes (interquartile range, 89-295), respectively, from seizure detection. The median times to the order of the first and second AEDs were 33 and 134.5 minutes longer in comatose NCSE patients compared with those with noncomatose forms, respectively (P = 0.001 and 0.004, respectively). The median times between the AED orders and their administration in these two groups were the same (P = 0.60 and 0.37, respectively). With bivariate analysis, the median latencies to administration of the first, second, and third AEDs were significantly increased by 33, 109.5, and 173 minutes, respectively, in patients who died within 30 days compared with those who survived (P = 0.047, P = 0.02, P = 0.0007, respectively). CONCLUSIONS: The administration of the first, second, and third AEDs for NCSE was delayed. Slow initiation of acute treatment in comatose patients was caused by delays in the placement of the medication order.
Subject(s)
Anticonvulsants/administration & dosage , Status Epilepticus/drug therapy , Time-to-Treatment/statistics & numerical data , Adult , Aged , Female , Humans , Male , Middle Aged , Retrospective Studies , Seizures/drug therapy , Status Epilepticus/diagnosis , Status Epilepticus/mortalityABSTRACT
BACKGROUND: Autologous hematopoietic stem cell transplant (HSCT) recipients are not uniformly considered as "high risk" enough to receive fluoroquinolone (FQ) prophylaxis. The risks versus benefits of FQ prophylaxis in autologous HSCT require further investigation. METHODS: A retrospective chart review of patients > 19 years old who received an autologous HSCT at Nebraska Medicine analyzed two time periods (period 1: no prophylaxis [2013-2015] versus period 2: levofloxacin prophylaxis [2015-2016]) to characterize the clinical impact of levofloxacin prophylaxis on autologous HSCT recipients. RESULTS: A total of 224 autologous HSCT were screened with 214 included. Febrile neutropenia (FN) developed in 101/113 (89%) versus 60/101 (59%) patients in the no prophylaxis (NPx) versus prophylaxis (Px) group (P < .01). Time to onset of FN was a median 6 versus 7 days (P = .01), and total bloodstream infections (BSI) were 33/113 (29%) versus 7/101 (7%) (P < .01) in NPx and Px groups, respectively. Gram-negative BSI were absent in the Px group. Viridans group streptococci were the most common Gram-positive BSI overall, with FQ-resistance more common in Px recipients. Rates of Clostridium difficile infections, length of hospital stay, or death at 100 days post-HSCT did not differ between the groups. CONCLUSION: Fluoroquinolone prophylaxis introduced into autologous HSCT care at our institution in 2015 resulted in prevention of Gram-negative BSI, decreased rates of FN, microbiologically documented infections, and a delay in time to onset of FN compared with the prior NPx. FQ prophylaxis in autologous HSCT recipients should be evaluated per individual institution.
Subject(s)
Anti-Bacterial Agents/administration & dosage , Antibiotic Prophylaxis , Febrile Neutropenia/etiology , Hematopoietic Stem Cell Transplantation/adverse effects , Levofloxacin/administration & dosage , Bacteremia/prevention & control , Clostridium Infections/prevention & control , Female , Humans , Incidence , Male , Middle Aged , Retrospective Studies , Transplant Recipients/statistics & numerical data , Transplantation, Autologous/adverse effects , Transplantation, Homologous/adverse effectsABSTRACT
BACKGROUND: Anastomotic leak is the most common major complication after esophagectomy. We investigated the 2016 American College of Surgeons National Surgical Quality Improvement Program esophagectomy targeted database to identify risk factors for anastomotic leak. METHODS: Patients who underwent esophagectomy for cancer were included. Patients experiencing an anstomotic leak were identified, and univariate and multivariable logistic regression was performed to identify variables independently associated with anastomotic leak. RESULTS: Of 915 patients included, 83% were male and the median age was 64 years. Patients with anastomotic leak more frequently had additional complications (87% vs 36%, P < .001). Rates of reoperation (64% vs 11%, P < .001) and mortality (8% vs 2%, P = .001) were higher in patients with anastomotic leak. After adjusting for patient and procedure characteristics, prolonged operative time (for each additional 30-minutes; adjusted odds ratios (AOR) 1.068, 95% CI, 1.022-1.115, P = .003), increased preoperative WBC count (for each 3000/µL increase; AOR 1.323, 95% CI, 1.048-1.670, P = .019), pre-existing diabetes (AOR 1.601, 95% CI, 1.012-2.534, P = .045), and perioperative transfusion (AOR 1.777, 95% CI, 1.064-2.965, P = .028) were independently associated with anastomotic leak. CONCLUSION: Both patient and procedure-related factors are associated with anastomotic leak. Though frequently non-modifiable, these findings could facilitate risk stratification and early detection of anastomotic leak to reduce associated morbidity.
Subject(s)
Adenocarcinoma/surgery , Anastomotic Leak/etiology , Carcinoma, Squamous Cell/surgery , Esophageal Neoplasms/surgery , Esophagectomy/adverse effects , Risk Assessment/methods , Adenocarcinoma/pathology , Aged , Anastomotic Leak/pathology , Carcinoma, Squamous Cell/pathology , Esophageal Neoplasms/pathology , Female , Follow-Up Studies , Humans , Male , Middle Aged , PrognosisABSTRACT
OBJECTIVES: Patients with chronic pancreatitis (CP) are at increased risk of low bone mineral density (BMD), although the prevalence of low BMD in patients with CP in the United States is lacking. We aimed to determine the prevalence of low BMD and identify potential risk factors, including hypogonadism and use of opioid medications, in subjects with CP in the United States. METHODS: This was a prospective, observational study. Subjects with CP underwent dual-energy x-ray absorptiometry scan. Blood was assayed for vitamin D, sex hormones, and a metabolic panel. History was obtained for fractures, menopause, hypogonadal symptoms, and opioid medication doses. Low BMD was defined by both World Health Organization and the International Society for Clinical Densitometry criteria. RESULTS: Depending on criteria used, 37% to 55% of our cohort had low BMD. Subjects with low and normal BMD had similar vitamin D levels. Hypogonadism was present in 27% of nonmenopausal subjects and was associated with reduced lumbar spine BMD in subjects 30 years or older. CONCLUSIONS: Patients with CP are at increased risk of low BMD, which is likely multifactorial. Hypogonadism, possibly related to opioid pain medications, may be an independent risk factor for low BMD in CP.
Subject(s)
Bone Density , Hypogonadism/epidemiology , Pancreatitis, Chronic/epidemiology , Vitamin D/blood , Absorptiometry, Photon , Adult , Comorbidity , Female , Humans , Male , Middle Aged , Prevalence , Prospective Studies , Risk Factors , United States/epidemiologyABSTRACT
PURPOSE: To describe the impact of fractionation scheme and tumor location on toxicities in stereotactic body radiation therapy (SBRT) for ≥5-cm non-small cell lung cancer (NSCLC), as part of a multi-institutional analysis. METHODS: Patients with primary ≥5-cm N0 M0 NSCLC who underwent ≤5-fraction SBRT were examined across multiple high-volume SBRT centers. Collected data included clinical/treatment parameters; toxicities were prospectively assessed at each institution according to the Common Terminology Criteria for Adverse Events. Patients treated daily were compared with those treated every other day (QOD)/other nondaily regimens. Stratification between central and peripheral tumors was also performed. RESULTS: Ninety-two patients from 12 institutions were evaluated (2004-2016), with median follow-up of 12 months. In total there were 23 (25%) and 6 (7%) grade ≥2 and grade ≥3 toxicities, respectively. Grades 2 and 3 pulmonary toxicities occurred in 9% and 4%, respectively; 1 patient treated daily experienced grade 5 radiation pneumonitis. Of the entire cohort, 46 patients underwent daily SBRT, and 46 received QOD (n=40)/other nondaily (n=6) regimens. Clinical/treatment parameters were similar between groups; the QOD/other group was more likely to receive 3-/4-fraction schemas. Patients treated QOD/other experienced significantly fewer grade ≥2 toxicities as compared with daily treatment (7% vs 43%, P<.001). Patients treated daily also had higher rates of grade ≥2 pulmonary toxicities (P=.014). Patients with peripheral tumors (n=66) were more likely to receive 3-/4-fraction regimens than those with central tumors (n=26). No significant differences in grade ≥2 toxicities were identified according to tumor location (P>.05). CONCLUSIONS: From this multi-institutional study, toxicity of SBRT for ≥5-cm lesions is acceptable, and daily treatment was associated with a higher rate of toxicities.
Subject(s)
Carcinoma, Non-Small-Cell Lung/mortality , Carcinoma, Non-Small-Cell Lung/radiotherapy , Dose Fractionation, Radiation , Lung Neoplasms/mortality , Lung Neoplasms/radiotherapy , Radiation Pneumonitis/mortality , Radiosurgery/mortality , Aged , Aged, 80 and over , Carcinoma, Non-Small-Cell Lung/pathology , Comorbidity , Dose-Response Relationship, Radiation , Female , Humans , Longitudinal Studies , Lung Neoplasms/pathology , Male , Middle Aged , Prevalence , Radiation Pneumonitis/pathology , Radiation Pneumonitis/prevention & control , Radiosurgery/methods , Retrospective Studies , Risk Factors , Survival Rate , Treatment Outcome , United States/epidemiologyABSTRACT
BACKGROUND: The assessment of cardiac risk in contemporary liver transplantation (LT) has required more sensitive testing for the detection of occult coronary artery disease as well as microvascular and functional cardiac abnormalities. Because dobutamine stress perfusion echocardiography provides an assessment of both regional systolic and diastolic function as well as microvascular perfusion (MVP), we sought to examine its incremental value in this setting. METHODS AND RESULTS: We evaluated the predictive value of dobutamine stress perfusion echocardiography in 296 adult patients with end-stage liver disease and preserved systolic function who underwent LT between 2008 and 2014. The primary outcome was cardiovascular death, nonfatal myocardial infarction, and/or sustained ventricular arrhythmias following LT. The main causes of liver failure were hepatitis C (25%) and nonalcoholic fatty liver disease (13%). Abnormal MVP during stress was observed in 18 patients (6%), whereas diastolic dysfunction was present in 109 patients (94 grade 1, 15 grade 2). Half of the patients (7 of 14) referred for angiography with abnormal MVP had significant epicardial disease by angiography, and these patients were revascularized prior to LT. Despite these interventions, the primary outcome still occurred in 9 patients (3%). Patients with abnormal MVP during dobutamine stress perfusion echocardiography had a 7-fold higher risk of a cardiovascular event following LT. Cox proportional hazards modeling examining clinical variables, left ventricular ejection fraction, diastolic function, and stress-induced wall motion abnormalities or MVP defects demonstrated that abnormal MVP was the only independent predictor of the primary outcome (P=0.004; hazard ratio 7.7). CONCLUSIONS: Stress MVP assessments are highly predictive of cardiovascular outcome in current LT candidates.
Subject(s)
Coronary Artery Disease/diagnosis , Dobutamine/pharmacology , Echocardiography, Stress/methods , End Stage Liver Disease/surgery , Liver Transplantation , Cardiotonic Agents/pharmacology , Coronary Angiography , Coronary Artery Disease/complications , End Stage Liver Disease/complications , Female , Follow-Up Studies , Humans , Male , Middle Aged , Predictive Value of Tests , Retrospective StudiesABSTRACT
BACKGROUND: Stereotactic body radiotherapy (SBRT) is the standard of care for patients with nonoperative, early-stage non-small cell lung cancer (NSCLC) measuring < 5 cm, but its use among patients with tumors measuring ≥5 cm is considerably less defined, with the existing literature limited to small, single-institution reports. The current multi-institutional study reported outcomes evaluating the largest such population reported to date. METHODS: Clinical/treatment characteristics, outcomes, toxicities, and patterns of failure were assessed in patients with primary NSCLC measuring ≥5 cm without evidence of distant/lymph node metastasis who underwent SBRT using ≤5 fractions. Statistics included Kaplan-Meier survival analyses and univariate/multivariate Cox proportional hazards models. RESULTS: A total of 92 patients treated from 2004 through 2016 were analyzed from 12 institutions. The median follow-up was 12 months (15 months in survivors). The median age and tumor size among the patients were 73 years (range, 50-95 years) and 5.4 cm (range, 5.0-7.5 cm), respectively. The median dose/fractionation was 50 Gray/5 fractions. The actuarial local control rates at 1 year and 2 years were 95.7% and 73.2%, respectively. The disease-free survival rate was 72.1% and 53.5%, respectively, at 1 year and 2 years. The 1-year and 2-year disease-specific survival rates were 95.5% and 78.6%, respectively. The median, 1-year, and 2-year overall survival rates were 21.4 months, 76.2%, and 46.4%, respectively. On multivariate analysis, lung cancer history and pre-SBRT positron emission tomography maximum standardized uptake value were found to be associated with overall survival. Posttreatment failures were most commonly distant (33% of all disease recurrences), followed by local (26%) and those occurring elsewhere in the lung (23%). Three patients had isolated local failures. Grade 3 to 4 toxicities included 1 case (1%) and 4 cases (4%) of grade 3 dermatitis and radiation pneumonitis, respectively (toxicities were graded according to the Common Terminology Criteria for Adverse Events [version 4.0]). Grades 2 to 5 radiation pneumonitis occurred in 11% of patients. One patient with a tumor measuring 7.5 cm and a smoking history of 150 pack-years died of radiation pneumonitis. CONCLUSIONS: The results of the current study, which is the largest study of patients with NSCLC measuring ≥5 cm reported to date, indicate that SBRT is a safe and efficacious option. Cancer 2017;123:688-696. © 2016 American Cancer Society.
Subject(s)
Carcinoma, Non-Small-Cell Lung/radiotherapy , Neoplasm Recurrence, Local/radiotherapy , Radiosurgery , Aged , Aged, 80 and over , Carcinoma, Non-Small-Cell Lung/epidemiology , Carcinoma, Non-Small-Cell Lung/pathology , Disease-Free Survival , Dose Fractionation, Radiation , Female , Follow-Up Studies , Humans , Kaplan-Meier Estimate , Lymphatic Metastasis , Male , Middle Aged , Neoplasm Recurrence, Local/epidemiology , Neoplasm Recurrence, Local/pathology , Treatment OutcomeABSTRACT
BACKGROUND: Recent studies have questioned the importance of the iliotibial band (ITB) in lateral knee pain. The Ober test or modified Ober test is the most commonly recommended physical examination tool for assessment of ITB tightness. No studies support the validity of either Ober test for measuring ITB tightness. PURPOSE/HYPOTHESIS: The purpose of this study was to assess the effects of progressive transection of the ITB, gluteus medius and minimus (med/min) muscles, and hip joint capsule of lightly embalmed cadavers on Ober test results and to compare them with assessment of all structures intact. In addition, thigh position change between gluteus med/min transection and hip capsule transection was also assessed for both versions of the Ober test. It was hypothesized that transection of the ITB would significantly increase thigh adduction range of motion as measured by an inclinometer when performing either Ober test and that subsequent structure transections (gluteus med/min muscles followed by the hip joint capsule) would cause additional increases in thigh adduction. STUDY DESIGN: Controlled laboratory study. METHODS: The lower limbs of lightly embalmed cadavers were assessed for midthigh ITB transection versus intact by use of the Ober (n = 28) and modified Ober (n = 34) tests; 18 lower limbs were assessed for all conditions (intact band, followed by sequential transections of the ITB midthigh, gluteus med/min muscles, hip joint capsule) by use of both Ober tests. Paired t tests were used to compare changes in Ober test results between conditions. RESULTS: No significant changes in thigh position (adduction) occurred in either version of the Ober test after ITB transection. Significant differences were noted for intact band versus gluteus med/min transection and intact band versus hip joint capsule transection (P < .0001) for all findings for both tests. Mean inclinometer measurements for the modified Ober were 4.28° (n = 34 for intact vs ITB transection comparisons), 3.33° (n = 18 for subsequent intact vs gluteus muscle and hip capsule transection comparisons), 5.00° (n = 34 for midthigh ITB transection), 11.20° (gluteus med/min transection), and 13.20° (hip capsule transection). For the Ober test, measures were -2.90° (n = 28 for intact vs ITB transection comparisons), -2.20° (n = 18 for subsequent intact vs gluteus muscle and hip capsule transection comparisons), -2.20° (n = 34 for midthigh ITB transection), 6.50° (gluteus med/min transection), and 9.53° (hip capsule transection). Statistically significant differences were also noted between test findings comparing gluteus med/min transection to hip capsule transection (Ober, P < .0001; modified Ober, P = .0036). CONCLUSION: The study findings refute the hypothesis that the ITB plays a role in limiting hip adduction during either version of the Ober test and question the validity of these tests for determining ITB tightness. The findings underscore the influence of the gluteus medius and minimus muscles as well as the hip joint capsule on Ober test findings. CLINICAL RELEVANCE: The results of this study suggest that the Ober test assesses tightness of structures proximal to the hip joint, such as the gluteus medius and minimus muscles and the hip joint capsule, rather than the ITB.