Food allergy is an important public health problem because it affects children and adults, can be severe and even life-threatening, and may be increasing in prevalence. Beginning in 2008, the ...National Institute of Allergy and Infectious Diseases, working with other organizations and advocacy groups, led the development of the first clinical guidelines for the diagnosis and management of food allergy. A recent landmark clinical trial and other emerging data suggest that peanut allergy can be prevented through introduction of peanut-containing foods beginning in infancy.
Prompted by these findings, along with 25 professional organizations, federal agencies, and patient advocacy groups, the National Institute of Allergy and Infectious Diseases facilitated development of addendum guidelines to specifically address the prevention of peanut allergy.
The addendum provides 3 separate guidelines for infants at various risk levels for the development of peanut allergy and is intended for use by a wide variety of health care providers. Topics addressed include the definition of risk categories, appropriate use of testing (specific IgE measurement, skin prick tests, and oral food challenges), and the timing and approaches for introduction of peanut-containing foods in the health care provider's office or at home. The addendum guidelines provide the background, rationale, and strength of evidence for each recommendation.
Guidelines have been developed for early introduction of peanut-containing foods into the diets of infants at various risk levels for peanut allergy.
Background Food allergy is an important public health problem because it affects children and adults, can be severe and even life-threatening, and may be increasing in prevalence. Beginning in 2008, ...the National Institute of Allergy and Infectious Diseases, working with other organizations and advocacy groups, led the development of the first clinical guidelines for the diagnosis and management of food allergy. A recent landmark clinical trial and other emerging data suggest that peanut allergy can be prevented through introduction of peanut-containing foods beginning in infancy. Objectives Prompted by these findings, along with 25 professional organizations, federal agencies, and patient advocacy groups, the National Institute of Allergy and Infectious Diseases facilitated development of addendum guidelines to specifically address the prevention of peanut allergy. Results The addendum provides 3 separate guidelines for infants at various risk levels for the development of peanut allergy and is intended for use by a wide variety of health care providers. Topics addressed include the definition of risk categories, appropriate use of testing (specific IgE measurement, skin prick tests, and oral food challenges), and the timing and approaches for introduction of peanut-containing foods in the health care provider's office or at home. The addendum guidelines provide the background, rationale, and strength of evidence for each recommendation. Conclusions Guidelines have been developed for early introduction of peanut-containing foods into the diets of infants at various risk levels for peanut allergy.
Background The management of Merkel cell carcinoma (MCC) has been complicated by a lack of detailed prognostic data and by the presence of conflicting staging systems. Objective We sought to ...determine the prognostic significance of tumor size, clinical versus pathologic nodal evaluation, and extent of disease at presentation and thereby derive the first consensus staging/prognostic system for MCC. Methods A total of 5823 prospectively enrolled MCC cases from the National Cancer Data Base had follow-up data (median 64 months) and were used for prognostic analyses. Results At 5 years, overall survival was 40% and relative survival (compared with age- and sex-matched population data) was 54%. Among all MCC cases, 66% presented with local, 27% with nodal, and 7% with distant metastatic disease. For cases presenting with local disease only, smaller tumor size was associated with better survival (stage I, ≤2 cm, 66% relative survival at 5 years; stage II, >2 cm, 51%; P < .0001). Patients with clinically local-only disease and pathologically proven negative nodes had better outcome (76% at 5 years) than those who only underwent clinical nodal evaluation (59%, P < .0001). Limitations The National Cancer Data Base does not capture disease-specific survival. Overall survival for patients with MCC was therefore used to calculate relative survival based on matched population data. Conclusion Although the majority (68%) of patients with MCC in this nationwide cohort did not undergo pathologic nodal evaluation, this procedure may be indicated in many cases as it improves prognostic accuracy and has important treatment implications for those found to have microscopic nodal involvement.
Summary Background Drug treatments for patients with high-risk myelodysplastic syndromes provide no survival advantage. In this trial, we aimed to assess the effect of azacitidine on overall survival ...compared with the three commonest conventional care regimens. Methods In a phase III, international, multicentre, controlled, parallel-group, open-label trial, patients with higher-risk myelodysplastic syndromes were randomly assigned one-to-one to receive azacitidine (75 mg/m2 per day for 7 days every 28 days) or conventional care (best supportive care, low-dose cytarabine, or intensive chemotherapy as selected by investigators before randomisation). Patients were stratified by French–American–British and international prognostic scoring system classifications; randomisation was done with a block size of four. The primary endpoint was overall survival. Efficacy analyses were by intention to treat for all patients assigned to receive treatment. This study is registered with ClinicalTrials.gov , number NCT00071799. Findings Between Feb 13, 2004, and Aug 7, 2006, 358 patients were randomly assigned to receive azacitidine (n=179) or conventional care regimens (n=179). Four patients in the azacitidine and 14 in the conventional care groups received no study drugs but were included in the intention-to-treat efficacy analysis. After a median follow-up of 21·1 months (IQR 15·1–26·9), median overall survival was 24·5 months (9·9–not reached) for the azacitidine group versus 15·0 months (5·6–24·1) for the conventional care group (hazard ratio 0·58; 95% CI 0·43–0·77; stratified log-rank p=0·0001). At last follow-up, 82 patients in the azacitidine group had died compared with 113 in the conventional care group. At 2 years, on the basis of Kaplan-Meier estimates, 50·8% (95% CI 42·1–58·8) of patients in the azacitidine group were alive compared with 26·2% (18·7–34·3) in the conventional care group (p<0·0001). Peripheral cytopenias were the most common grade 3–4 adverse events for all treatments. Interpretation Treatment with azacitidine increases overall survival in patients with higher-risk myelodysplastic syndromes relative to conventional care. Funding Celgene Corporation.
Background The incidence of cutaneous squamous cell carcinoma (cSCC) is increasing. Although most patients achieve complete remission with surgical treatment, those with advanced disease have a poor ...prognosis. The American Joint Committee on Cancer (AJCC) is responsible for the staging criteria for all cancers. For the past 20 years, the AJCC cancer staging manual has grouped all nonmelanoma skin cancers, including cSCC, together for the purposes of staging. However, based on new evidence, the AJCC has determined that cSCC should have a separate staging system in the 7th edition AJCC staging manual. Objective We sought to present the rationale for and characteristics of the new AJCC staging system specific to cSCC tumor characteristics (T). Methods The Nonmelanoma Skin Cancer Task Force of AJCC reviewed relevant data and reached expert consensus in creating the 7th edition AJCC staging system for cSCC. Emphasis was placed on prospectively accumulated data and multivariate analyses. Concordance with head and neck cancer staging system was also achieved. Results A new AJCC cSCC T classification is presented. The T classification is determined by tumor diameter, invasion into cranial bone, and high-risk features, including anatomic location, tumor thickness and level, differentiation, and perineural invasion. Limitations The data available for analysis are still suboptimal, with limited prospective outcomes trials and few multivariate analyses. Conclusions The new AJCC staging system for cSCC incorporates tumor-specific (T) staging features and will encourage coordinated, consistent collection of data that will be the basis of improved prognostic systems in the future.
The aim of this study was to determine the sonographic visibility of implanted collagen-based breast biopsy marker clips in the clinic and operating room.
Female patients aged > or =18 years who ...presented for preoperative surgical evaluation within 4 weeks of ultrasound-guided breast biopsy and collagen-based marker clip placement were eligible for this pilot study. The sonographic visibility of the marker clips was rated from 1 (not visible) to 5 (clearly visible) by surgeons at the preoperative appointment, by radiologists at wire localization, and by surgeons in the operating room. Visibility was considered inadequate for values of 1 or 2 and adequate for values of 3, 4, or 5. The data were compared using Wilcoxon's signed-rank test for paired differences across physician (radiologist vs surgeon), time (preoperative visit vs day of surgery), and target (lesion vs clip).
Twenty-five patients with 26 lesions were enrolled, and 19 patients returned for all imaging procedures. The mean lesion size was 12 mm (range, 5-24 mm). Adequate marker clip visibility assessed by the surgeons decreased from 80% (20 of 25) at the preoperative appointment to 65% (11 of 17) in the operating room, but the difference was not significant (P=.27). Visibilities of the lesions and clips were similar at the preoperative appointment (P=.61), but the clips were significantly less visible on the day of operation (P=.03).
The sonographic visibility of collagen-based marker clips is variable and likely decreases over time but may be adequate to guide intraoperative surgical excision in many cases.
Cardiac care team members included those with expertise in general cardiology and in specialty areas such as pediatric cardiology, geriatric cardiology, and healthcare disparities, as well as ...physicians and nurses in both private practice and academia, including those who work in rural, suburban, and urban areas. Content Reviewer--Clinical Quality Committee None None None None None None James W. Fasules Content Reviewer--ACCF Advocacy Steering Committee None None None None None None Eileen M. Handberg Content Reviewer--Patient-Centered Care Committee None None None None None None Wayne L. Miller Content Reviewer--ACCF Heart Failure Committee None None None None None None C. Venkata S. Ram Content Reviewer--ACCF Peripheral Vascular Disease Committee None Advanced Health Media None None None None Mark L. Sanz Content Reviewer--Clinical Quality Committee None None None None None None Peter P. Toth Content Reviewer--ACCF Peripheral Vascular Disease Committee None None None None None None Krishnaswami Vijayaraghavan Content Reviewer--ACCF Board of Governors None None None None None None Robert N. Vincent Content Reviewer--Adult Congenital/Pediatric Cardiology Council None None None None None None John R. Windle Content Reviewer--Clinical Quality Committee None None None None WebMD* None William A. Zoghbi Content Reviewer--Patient-Centered Care Committee None None None None None None * This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant. Names are listed in alphabetical order within each category of review.According to the ACCF, a person has a relevant relationship if: a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) The person, or a member of the person's household, has a reasonable potential for financial, professional, or other personal gain or loss as a result of the issues/content addressed in the document.
Background Patients with prolonged hospitalizations in the surgical intensive care unit often have ongoing medical needs that require further care at long-term, acute-care hospitals upon discharge. ...Setting expectations for patients and families after protracted operative intensive care unit hospitalization is challenging, and there are limited data to guide these conversations. The purpose of this study was to determine patient survival and readmission rates after discharge from the surgical intensive care unit directly to a long-term, acute-care hospital. Methods All patients who were admitted to the surgical intensive care unit at an academic, tertiary care medical center from 2009–2014 and discharged directly to long-term, acute-care hospitals were retrospectively reviewed. Patients represented all surgical subspecialties excluding cardiac and vascular surgery patients. Primary outcomes included 30-day readmission, and 1- and 3-year mortality rates following discharge. Results In total, 296 patients were discharged directly from the surgical intensive care unit to a long-term, acute-care hospital during the study period. There were 190 men (64%) and mean age was 61 ± 16 years. Mean duration of stay in the surgical intensive care unit was 27 ± 17 days. The most frequent complication was prolonged mechanical ventilation (277, 94%) followed by pneumonia (139, 47%), sepsis (78, 26%), and acute renal failure (32, 11%); 93% of patients required tracheostomy and enteral feeding access prior to discharge, and 19 patients (6%) were newly dependent on hemodialysis. The readmission rate was 20%. There were 86 deaths within 1 year from discharge (29%) with an overall 3-year mortality of 32%. In a multiple logistic regression analysis, a history of end-stage renal disease had a greater odds of readmission (odds ratio 6.07, P = .028). Patients with history of cancer had greater odds of 1- and 3-year mortality (odds ratio = 2.99, P = .028 and odds ratio 2.56, P = .053, respectively), and patients with a neurologic diagnosis had greater odds of 3-year mortality (odds ratio 4.69, P = .031). Readmission significantly increased the odds of 1- and 3-year mortality (odds ratio 3.12, P = .020 and odds ratio 2.90, P = .027, respectively). Patients who had both private insurance and Medicare had greater odds of 1- and 3-year mortality (odds ratio 10.39, P = .005 and odds ratio 10.65, P = .004, respectively). Conclusion Patients who are discharged to long-term, acute-care hospitals have prolonged hospitalizations with high complication rates. These patients have high readmission and 1-year mortality rates. Patients and families should be counseled regarding these outcomes related to post–intensive care unit recovery after discharge to a long-term, acute-care hospital to allow for realistic expectations of survival after prolonged intensive care unit hospitalization.