Applying the National Institute for Clinical Excellence criteria to patients treated with the Genous (TM) Bio-engineered R stent (TM): a sub-study of the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) worldwide registry

The National Institute for Clinical Excellence (NICE) guidelines recommend the use of bare-metal stents (BMS) in non-complex lesions with a low risk of restenosis (diameter a parts per thousand yen3 mm and lesion length a parts per thousand currency sign15 mm) and the use of drug-eluting stents (DES) in more complex lesions with a high risk of restenosis (diameter < 3.0 mm or lesion length > 15 mm). However, the guidelines were created based on studies evaluating BMS and DES only. We performed an analysis of patients undergoing non-urgent percutaneous coronary intervention with the novel endothelial cell capturing stent (ECS). The ECS is coated with CD34(+) antibodies that attract circulating endothelial progenitor cells to the stent surface, thereby accelerating the endothelialization of the stented area. We analyzed all patients enrolled in the worldwide e-HEALING registry that met the NICE criteria for either low-risk or high-risk lesions and were treated with a parts per thousand yen1 ECS. The main study outcome was target vessel failure (TVF) at 12-month follow-up, defined as the composite of cardiac death or MI and target vessel revascularization (TVR). A total of 4,241 patients were assessed in the current analysis. At 12-month follow-up, TVF occurred in 7.0% of the patients with low-risk lesions and in 8.8% of the patients with high-risk lesions (p = 0.045). When evaluating the diabetic patients versus the non-diabetic patients per risk group, no significant differences were found in TVF, MI or TVR in either risk group. The ECS shows good clinical outcomes in lesions carrying either a high or a low risk of restenosis according to the NICE guidelines with comparable rates of cardiac death, myocardial infarction, and stent thrombosis. The TVF rate with ECS was slightly higher in patients with high-risk lesions, driven by higher clinically driven TLR. The risk of restenosis with ECS in patients carrying high-risk lesions needs to be carefully considered relative to other risks associated with DES. Furthermore, the presence of diabetes mellitus did not influence the incidence of TVF in either risk group.

Indicações de tomografia de crânio em crianças com trauma cranioencefálico leve

A reunião de revista "Telemedicina Baseada em Evidência - Cirurgia do Trauma e Emergência" (TBE-CiTE) realizou uma revisão crítica da literatura e selecionou os três artigos mais relevantes e atuais sobre a indicação de tomografia de crânio em pacientes pediátricos com trauma craniencefálico leve (TCE). O primeiro trabalho identificou pacientes vítimas de TCE leve com fatores de alto e baixo risco de apresentarem lesões intracranianas vistas à tomografia computadorizada (TC) de crânio e com necessidade de intervenção neurocirúrgica. O segundo trabalho avaliou o uso das recomendações do "National Institute of Clinical Excellence" em pacientes pediátricos com TCE, e utilizou como variáveis de desfecho a realização de TC ou internação hospitalar. O último artigo analisou e identificou os pacientes onde a TC de crânio seria desnecessária e, portanto, não deve ser feita rotineiramente. Baseado nessa revisão crítica da literatura e a discussão com especialistas, o TBE-CiTE concluiu que é importante evitar a exposição desnecessária de crianças com TCE leve à radiação ionizante da TC de crânio. O grupo favoreceu a utilização do guideline do PECARN onde ECG de 14, alteração do nível de consciência ou fratura do crânio palpável são indicações de TC de crânio, ou quando a experiência do médico, achados múltiplos ou piora dos sintomas ocorrerem.

Lesiones abiertas del plexo braquial con compromiso vascular concomitante. Revisión sistemática de la literatura.

La presente investigación, intenta generar un impacto positivo dentro del ámbito médico-quirúrgico, ya que se espera que la revisión de la literatura genere mayor conocimiento sobre el manejo de las lesiones del plexo braquial con lesión vascular concomitante, ocasionada mediante un trauma abierto por herida causada por arma corto punzante, y con base en esto proponer una guía de manejo que se pueda aplicar en el día a día de todos aquellos especialistas quirúrgicos y no quirúrgicos para el tratamiento de dicha lesión. Es importante resaltar la dificultad metodológica presentada ante la poca validez de los estudios seleccionados, a pesar de que se aplicaron normas estrictas para la selección de los artículos. Las lesiones vasculares y nerviosas concomitantes del miembro superior no solo comprometen la viabilidad de la extremidad sino que además se constituyen en lesiones con secuelas severas desde el punto de vista funcional para el paciente. No se ha establecido un protocolo de manejo de estas lesiones. Los estudios realizados carecen de metodología adecuada de evaluación tanto en el momento de ingreso del paciente a urgencias como en su preoperatorio, postoperario y en las evaluaciones de los resultados funcionales de la extremidad una vez superada la lesión inicial. No hay una evolución consignada en la literatura con respecto al manejo integral de estos pacientes, que nos permita discernir con respecto al momento adecuado de la reparación nervios. El establecimiento de una guía clínica para cirujanos vasculares y cirujanos de mano para el manejo integral de este tipo de lesiones es apremiante. Los costos de tratamiento y rehabilitación de este tipo de pacientes son indiscutiblemente elevados desde todo punto de vista, pero es definitivo que el resultado funcional es mejor cuando se establece un manejo sistemático que incluya el manejo vascular y el manejo de la lesión neurológica de una forma integral.

Manejo de lesiones abiertas del plexo braquial con compromiso vascular concomitante. Revisión sistemática de la literatura

El manejo de las lesiones de plejo braquial ha sido ampliamente discutido e investigado, especialmente en las lesiones cerradas por tracción. Las lesiones abiertas con compromiso vascular, muchas veces comprometen la viabilidad de la extremidad o la vida del paciente; son de difícil manejo con prioridades distintas, tiempos de establecimiento de los procedimientos que varían respecto a los hallazgos con resultados funcionales pobres por el diagnostico tardío de la lesión nerviosa. Se plantean interrogantes desde el punto de vista vascular y de la lesión nerviosa. se realiza una revisión sistemática de la literatura, encontrando puntos importantes con respecto a la exploración, el momento de la reparación nerviosa pero sin establecer resultados funcionales claros ante la deficiencia metodológica de los estudios encontrados.

Practices and views on fetal heart monitoring:A structured observation and interview study

Objective: To assess and explain deviations from recommended practice in National Institute for Clinical Excellence (NICE) guidelines in relation to fetal heart monitoring. Design: Qualitative study. Setting: Large teaching hospital in the UK. Sample: Sixty-six hours of observation of 25 labours and interviews with 20 midwives of varying grades. Methods: Structured observations of labour and semistructured interviews with midwives. Interviews were undertaken using a prompt guide, audiotaped, and transcribed verbatim. Analysis was based on the constant comparative method, assisted by QSR N5 software. Main outcome measures: Deviations from recommended practice in relation to fetal monitoring and insights into why these occur. Results: All babies involved in the study were safely delivered, but 243 deviations from recommended practice in relation to NICE guidelines on fetal monitoring were identified, with the majority (80%) of these occurring in relation to documentation. Other deviations from recommended practice included indications for use of electronic fetal heart monitoring and conduct of fetal heart monitoring. There is evidence of difficulties with availability and maintenance of equipment, and some deficits in staff knowledge and skill. Differing orientations towards fetal monitoring were reported by midwives, which were likely to have impacts on practice. The initiation, management, and interpretation of fetal heart monitoring is complex and distributed across time, space, and professional boundaries, and practices in relation to fetal heart monitoring need to be understood within an organisational and social context. Conclusion: Some deviations from best practice guidelines may be rectified through straightforward interventions including improved systems for managing equipment and training. Other deviations from recommended practice need to be understood as the outcomes of complex processes that are likely to defy easy resolution. © RCOG 2006.

Photodynamic therapy with verteporfin for juxtafoveal choroidal neovascularisation secondary to pathological myopia

The treatment of choroidal neovascularisation (CNV) secondary to pathological myopia has presented a number of problems to ophthalmologists over the years, but the advent of photodynamic therapy (PDT) with verteporfin has changed how we manage these patients. Until PDT became available, the use of laser photocoagulation for extra and juxtafoveal lesions had been shown to be effective in the short term in preventing loss of vision, although the risk of regrowth of CNV and undertreatment were well recognised. However, even in apparent successful cases of photocoagulation, laser scar enlargement and creepage into the fovea in the mid-to-long term often occurred with resulting loss of central vision.1 Other options for treatment were very limited with little evidence that other modalities such as transpupillary thermotherapy or submacular surgery and macular transplantation surgery would be successful in highly myopic eyes. The evidence for the role of PDT and verteporfin CNV secondary to pathological myopia comes from the verteporfin in photodynamic therapy (VIP) study that has shown how effective this treatment is in eyes with subfoveal CNV.2, 3 Now in this publication, Lam et al4 from Hong Kong have shown that PDT is also effective in juxtafoveal CNV, with high myopia. They performed a small prospective study of 11 patients of mean age 44.8 years, with 12 months of follow-up. They found that there was a mean improvement of 1.8 lines of LogMAR best-corrected visual acuity (BCVA) at 12 months, with a mean number of 2.3 PDT treatments. The most rapid improvement occurred within the first 3 months of treatment and by 12 months none of the patients had suffered a deterioration in BCVA from baseline. There were no cases of adverse effects from the infusion or laser treatment. For ophthalmologists dealing with patients with CNV secondary to causes other than AMD, this is further evidence of the effectiveness of PDT with verteporfin in maintaining vision. These patients are likely to be younger than those with AMD and are likely to be in active employment and supporting families, and clearly the preservation of best vision possible is imperative in this group. It is therefore encouraging for ophthalmologists in the United Kingdom that the verteporfin in PDT Cohort Study (VPDT Study) includes the ability to treat patients with subfoveal CNV secondary to high myopia if they fulfill National Institute of Clinical Excellence guidelines, and will allow representations to be made on an individual basis for treatment of juxtafoveal lesions.5 For those ophthalmologists used to juggling increased patient expectations with scarce NHS resources, this is promising news and will allow us to offer a better standard of care to our patients.

Guideline-based decision support has a small, non-sustained effect on transthoracic echocardiography ordering frequency.

BACKGROUND: Guidance for appropriate utilisation of transthoracic echocardiograms (TTEs) can be incorporated into ordering prompts, potentially affecting the number of requests. METHODS: We incorporated data from the 2011 Appropriate Use Criteria for Echocardiography, the 2010 National Institute for Clinical Excellence Guideline on Chronic Heart Failure, and American College of Cardiology Choosing Wisely list on TTE use for dyspnoea, oedema and valvular disease into electronic ordering systems at Durham Veterans Affairs Medical Center. Our primary outcome was TTE orders per month. Secondary outcomes included rates of outpatient TTE ordering per 100 visits and frequency of brain natriuretic peptide (BNP) ordering prior to TTE. Outcomes were measured for 20 months before and 12 months after the intervention. RESULTS: The number of TTEs ordered did not decrease (338±32 TTEs/month prior vs 320±33 afterwards, p=0.12). Rates of outpatient TTE ordering decreased minimally post intervention (2.28 per 100 primary care/cardiology visits prior vs 1.99 afterwards, p<0.01). Effects on TTE ordering and ordering rate significantly interacted with time from intervention (p<0.02 for both), as the small initial effects waned after 6 months. The percentage of TTE orders with preceding BNP increased (36.5% prior vs 42.2% after for inpatients, p=0.01; 10.8% prior vs 14.5% after for outpatients, p<0.01). CONCLUSIONS: Ordering prompts for TTEs initially minimally reduced the number of TTEs ordered and increased BNP measurement at a single institution, but the effect on TTEs ordered was likely insignificant from a utilisation standpoint and decayed over time.

Diagnosis of Tinea pedis and onychomycosis in patients from Portuguese National Institute of Health: a four-year study

ABSTRACT - Tinea pedis and onychomycosis are two rather diverse clinical manifestations of superficial fungal infections, and their etiologic agents may be dermatophytes, non-dermatophyte moulds or yeasts. This study was designed to statistically describe the data obtained as results of analysis conducted during a four year period on the frequency of Tinea pedis and onychomycosis and their etiologic agents. A questionnaire was distributed from 2006 to 2010 and answered by 186 patients, who were subjected to skin and/or nail sampling. Frequencies of the isolated fungal species were cross-linked with the data obtained with the questionnaire, seeking associations and predisposing factors. One hundred and sixty three fungal isolates were obtained, 24.2% of which composed by more than one fungal species. Most studies report the two pathologies as caused primarily by dermatophytes, followed by yeasts and lastly by non-dermatophytic moulds. Our study does not challenge this trend. We found a frequency of 15.6% of infections caused by dermatophytes (with a total of 42 isolates) of which T. rubrum was the most frequent species (41.4%). There was no significant association (p >0.05) among visible injury and the independent variables tested, namely age, gender, owning pet, education, swimming pools attendance, sports activity and clinical information. Unlike other studies, the variables considered did not show the expected influence on dermatomycosis of the lower limbs. It is hence necessary to conduct further studies to specifically identify which variables do in fact influence such infections.

Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group.

BACKGROUND: Invasive fungal diseases are important causes of morbidity and mortality. Clarity and uniformity in defining these infections are important factors in improving the quality of clinical studies. A standard set of definitions strengthens the consistency and reproducibility of such studies. METHODS: After the introduction of the original European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group definitions, advances in diagnostic technology and the recognition of areas in need of improvement led to a revision of this document. The revision process started with a meeting of participants in 2003, to decide on the process and to draft the proposal. This was followed by several rounds of consultation until a final draft was approved in 2005. This was made available for 6 months to allow public comment, and then the manuscript was prepared and approved. RESULTS: The revised definitions retain the original classifications of "proven," "probable," and "possible" invasive fungal disease, but the definition of "probable" has been expanded, whereas the scope of the category "possible" has been diminished. The category of proven invasive fungal disease can apply to any patient, regardless of whether the patient is immunocompromised, whereas the probable and possible categories are proposed for immunocompromised patients only. CONCLUSIONS: These revised definitions of invasive fungal disease are intended to advance clinical and epidemiological research and may serve as a useful model for defining other infections in high-risk patients.

Pharmacogenomics of HIV Therapy: Summary of a Workshop Sponsored by the National Institute of Allergy and Infectious Diseases

Approximately 1 million people in the United States and over 30 million worldwide are living with human immunodeficiency virus type 1 (HIV-1). While mortality from untreated infection approaches 100%, survival improves markedly with use of contemporary antiretroviral therapies (ART). In the United States, 25 drugs are approved for treating HIV-1, and increasing numbers are available in resource-limited countries. Safe and effective ART is a cornerstone in the global struggle against the acquired immunodeficiency syndrome. Variable responses to ART are due at least in part to human genetic variants that affect drug metabolism, drug disposition, and off-site drug targets. Defining effects of human genetic variants on HIV treatment toxicity, efficacy, and pharmacokinetics has far-reaching implications. In 2010, the National Institute of Allergy and Infectious Diseases sponsored a workshop entitled, Pharmacogenomics A Path Towards Personalized HIV Care. This article summarizes workshop objectives, presentations, discussions, and recommendations derived from this meeting.

Using the National Institute of Health Stroke Scale to Predict Dysphagia in Acute Ischemic Stroke

Background and Purpose: Oropharyngeal dysphagia is a common manifestation in acute stroke. Aspiration resulting from difficulties in swallowing is a symptom that should be considered due to the frequent occurrence of aspiration pneumonia that could influence the patient's recovery as it causes clinical complications and could even lead to the patient's death. The early clinical evaluation of swallowing disorders can help define approaches and avoid oral feeding, which may be detrimental to the patient. This study aimed to create an algorithm to identify patients at risk of developing dysphagia following acute ischemic stroke in order to be able to decide on the safest way of feeding and minimize the complications of stroke using the National Institutes of Health Stroke Scale (NHISS). Methods: Clinical assessment of swallowing was performed in 50 patients admitted to the emergency unit of the University Hospital, Faculty of Medicine of Ribeirao Preto, Sao Paulo, Brazil, with a diagnosis of ischemic stroke, within 48 h after the beginning of symptoms. Patients, 25 females and 25 males with a mean age of 64.90 years (range 26-91 years), were evaluated consecutively. An anamnesis was taken before the patient's participation in the study in order to exclude a prior history of deglutition difficulties. For the functional assessment of swallowing, three food consistencies were used, i.e. pasty, liquid and solid. After clinical evaluation, we concluded whether there was dysphagia. For statistical analysis we used the Fisher exact test, verifying the association between the variables. To assess whether the NIHSS score characterizes a risk factor for dysphagia, a receiver operational characteristics curve was constructed to obtain characteristics for sensitivity and specificity. Results: Dysphagia was present in 32% of the patients. The clinical evaluation is a reliable method of detection of swallowing difficulties. However, the predictors of risk for the swallowing function must be balanced, and the level of consciousness and the presence of preexisting comorbidities should be considered. Gender, age and cerebral hemisphere involved were not significantly associated with the presence of dysphagia. NIHSS, Glasgow Coma Scale, and speech and language changes had a statistically significant predictive value for the presence of dysphagia. Conclusions: The NIHSS is highly sensitive (88%) and specific (85%) in detecting dysphagia; a score of 12 may be considered as the cutoff value. The creation of an algorithm to detect dysphagia in acute ischemic stroke appears to be useful in selecting the optimal feeding route while awaiting a specialized evaluation. Copyright (C) 2012 S. Karger AG, Basel

Report from the National Institute of Allergy and Infectious Diseases workshop on drug allergy

Allergic reactions to drugs are a serious public health concern. In 2013, the Division of Allergy, Immunology, and Transplantation of the National Institute of Allergy and Infectious Diseases sponsored a workshop on drug allergy. International experts in the field of drug allergy with backgrounds in allergy, immunology, infectious diseases, dermatology, clinical pharmacology, and pharmacogenomics discussed the current state of drug allergy research. These experts were joined by representatives from several National Institutes of Health institutes and the US Food and Drug Administration. The participants identified important advances that make new research directions feasible and made suggestions for research priorities and for development of infrastructure to advance our knowledge of the mechanisms, diagnosis, management, and prevention of drug allergy. The workshop summary and recommendations are presented herein.

Genetics and teratology : research programs of the National Institute of Child Health and Human Development.

"Prepared by the Genetics and Teratology Section of the Clinical Nutrition and Early Development Branch for presentation to the National Advisory Child Health and Human Development Council, May 1980"--P. 2 of cover.

New HPSS Clinical Excellence Awards Scheme (PDF 42 KB)

New HPSS Clinical Excellence Awards Scheme