Therapeutic drug monitoring in oncology: International Association of Therapeutic Drug Monitoring and Clinical Toxicology consensus guidelines for imatinib therapy.

Although therapeutic drug monitoring (TDM) is an important tool in guiding drug dosing for other areas of medicine including infectious diseases, cardiology, psychiatry and transplant medicine, it has not gained wide acceptance in oncology. For imatinib and other tyrosine kinase inhibitors, a flat dosing approach is utilised for management of oral chemotherapy. There are many published studies examining the correlation of blood concentrations with clinical effects of imatinib. The International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) determined that there was a need to examine the published literature regarding utility of TDM in imatinib therapy and to develop consensus guidelines for TDM based on the available data. This article summarises the scientific evidence regarding TDM of imatinib, as well as the consensus guidelines developed by the IATDMCT.

Approaches to rapid acting insulin intensification in patients with type 2 diabetes mellitus not achieving glycemic targets.

Type 2 diabetes mellitus (T2DM) is a growing problem in the USA, affecting 30.3 million Americans, or 9.4% of the US population. Given that T2DM is a progressive disease, intensification of rapid acting insulin (RAI) to address hyperglycaemia is often required. The American Diabetes Association and the European Association for the Study of Diabetes recommend individualizing the treatment approach to glucose control, considering factors such as age, health behaviours, comorbidities and life expectancy. There are several validated treatment algorithms in the literature, which can be helpful for providing guidance on initiation of RAI while simultaneously considering patient preferences and clinical needs during treatment intensification. This paper provides expert recommendations on prandial insulin regimens and how to use treatment algorithms to promote better glucose control through best practice guidelines. To help patients reach HbA1c targets through treatment intensification, the FullSTEP, SimpleSTEP, ExtraSTEP and AUTONOMY algorithms are discussed in this paper. KEY MESSAGES Clinical inertia should be prevented with timely intensification of therapy when HbA1c levels are greater than 7% (or rising above a patient's individual target) according to national guidelines. Increased personalization in the intensification of T2D treatment is necessary to improve HbA1c targets while addressing risk of hypoglycaemia, concern about weight gain, and overall health goals. Healthcare providers are encouraged to address glycaemic control with a variety of strategies, including prandial insulin, while developing evidence-based treatment plans on the basis of algorithms discussed in the literature.

Small papillary thyroid carcinoma with minimal extrathyroidal extension should be managed as ATA low-risk tumor.

PURPOSE: According to American Thyroid Association (ATA) guideline, papillary thyroid cancer (PTC) with minimal extrathyroidal extension (mETE) is classified at "intermediate risk" of persistent/recurrent disease. However, the impact of mETE per se on patients' outcome is not fully understood. The aim of our study was to evaluate the prognostic significance of mETE in patients with PTC not submitted to therapeutic or prophylactic lymph node dissection, according to tumor size and other prognostic factors. PATIENTS AND METHODS: We retrospectively evaluated a total of 514 PTC patients: 127 (24.7%) had mETE (pT3Nx) and 387 (75.3%) had negative margins (pT1-2Nx). At a median follow-up of 9.1 years, patients were divided in two groups: patients with "good outcome" (no evidence of disease) and patients with "poor outcome" (persistent structural disease or recurrent disease or tumor-related death). RESULTS: The rate of patients with "poor outcome" was significantly higher in patients with mETE compared with patients with negative margins (11.8 versus 5.1%; OR 2.4576, 95% CI 1.2178-4.9594, p = 0.01). However, mETE was significantly associated with poor outcome only in patients with tumors larger than 1.5 cm. CONCLUSIONS: mETE is an unfavorable prognostic factor in tumors larger than 1.5 cm, suggesting that, in the absence of other unfavorable characteristics, smaller tumors with mETE should be classified and managed as "low risk" tumors.

Mismatch between ADA and AGS recommendations for glycated hemoglobin targets for older adults.

In recent years, modified glycemic targets have been defined for older adults with diabetes mellitus. In a sample of elderly patients, we have identified several inconsistencies between the real life applicability of glycated hemoglobin goals recommended by the American Diabetes Association and the American Geriatrics Society.

Comment on: Martelletti et al. Refractory chronic migraine: a consensus statement on clinical definition from the European Headache Federation.

In this letter, we present the Austrian proposal for diagnostic criteria of refractory chronic migraine and we discuss the consensensus statement of the European Headache Feaderation. We focus in particular on the definition of adequate prophylactic treatment, the management of medication overuse and the requirement for CSF analyses in patients with refractory chronic migraine. In our proposal, the criteria for adequate treatment and recommendations for dealing with medication overuse are more explicit than in the EHF proposal, whereas the requirements for CSF analyses and measurement of CSF pressure are not as strict.

Refractory chronic migraine: a consensus statement on clinical definition from the European Headache Federation.

The debate on the clinical definition of refractory Chronic Migraine (rCM) is still far to be concluded. The importance to create a clinical framing of these rCM patients resides in the complete disability they show, in the high risk of serious adverse events from acute and preventative drugs and in the uncontrolled application of therapeutic techniques not yet validated.The European Headache Federation Expert Group on rCM presents hereby the updated definition criteria for this harmful subset of headache disorders. This attempt wants to be the first impulse towards the correct identification of these patients, the correct application of innovative therapeutic techniques and lastly aim to be acknowledged as clinical entity in the next definitive version of the International Classification of Headache Disorders 3 (ICHD-3 beta).

An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association.

Despite the global impact and advances in understanding the pathophysiology of cerebrovascular diseases, the term "stroke" is not consistently defined in clinical practice, in clinical research, or in assessments of the public health. The classic definition is mainly clinical and does not account for advances in science and technology. The Stroke Council of the American Heart Association/American Stroke Association convened a writing group to develop an expert consensus document for an updated definition of stroke for the 21st century. Central nervous system infarction is defined as brain, spinal cord, or retinal cell death attributable to ischemia, based on neuropathological, neuroimaging, and/or clinical evidence of permanent injury. Central nervous system infarction occurs over a clinical spectrum: Ischemic stroke specifically refers to central nervous system infarction accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage. The updated definition of stroke incorporates clinical and tissue criteria and can be incorporated into practice, research, and assessments of the public health.

O caminho para a certificação / Ministério da Saúde. Secretaria de Atenção à Saúde. Departamentode Certificação de Entidades Beneficentes de Assistência Social em Saúde / The path to certification / El camino a la certificación

O Sistema Único de Saúde (SUS), ao longo destes20 anos de existência, vem se consolidando de formacontinuada mediante inúmeras estratégias, com a finalidadede proporcionar assistência integral e qualificada com basenas necessidades da população. Neste cenário, as entidadesbeneficentes de assistência social constituem um importantesegmento na oferta de ações e serviços de saúde.Cabia ao Conselho Nacional de Assistência Social(CNAS), órgão do Ministério do Desenvolvimento Sociale Combate à Fome (MDS), a Certificação de EntidadeBeneficente de Assistência Social, processo pelo qual umapessoa jurídica de direito privado, sem fins lucrativos,com a finalidade de prestação de serviços na área deAssistência Social, Educação e Saúde, antes denominada“filantrópica”, é reconhecida como entidade beneficentede assistência social, com base em requisitos e critériosdefinidos em lei.A Lei nº 12.101, de 27 de novembro de 2009,criou novas regras e atribuiu ao Ministério da Saúde(MS), ao Ministério da Educação (MEC) e ao Ministériodo Desenvolvimento Social e Combate à Fome (MDS)a responsabilidade pela certificação das entidades emsuas respectivas áreas.A Secretaria de Atenção à Saúde (SAS) do Ministérioda Saúde (MS) é responsável pela condução da certificação.Na estrutura da SAS, o Departamento de Certificação de Entidades Beneficentes de Assistência Social em Saúde(DCEBAS) executa os procedimentos administrativoscom vistas ao efetivo processo de certificação, ou seja, aentidade é reconhecida e obtém o Certificado de EntidadeBeneficente de Assistência Social na Área de Saúde(Cebas-Saúde), que pode ser de concessão ou renovação.Neste contexto, o Ministério da Saúde, por meio doDCEBAS...