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161. Guidelines for the Investigation and Management of Transient Leukaemia of Down Syndrome

for the persistence of the GATA1 mutation and/or of quantitative assessment of the size of any residual GATA1-mutant clone in TL-DS or silent TL-DS has yet been demonstrated. (Grade 2B). • All children with previous TL-DS or silent TL-DS should be monitored for progression to ML-DS with 3 monthly clinical review and FBC and film until the age of 2 years. If the FBC and film are normal and there are no clinical features of ML-DS, monitoring should continue 6 monthly until the age of 4 years. Abnormal blood counts (...) is driven by mutations in the haematopoietic transcription factor gene GATA1 and is only seen in conjunction with trisomy 21, either constitutional or acquired. TL- DS may present with overt clinical features but some cases are only identified through examination of the blood film and/or by GATA1 mutation analysis (Klusmann et al, 2008; Roberts et al, 2013). Although many cases resolve without treatment, TL-DS results in early death in 15? 23% cases and 20?23% of survivors will develop acute myeloid

2018 British Association of Perinatal Medicine

162. Regorafenib (Stivarga) indicated as monotherapy for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib treatment

and treatment of physical, psychological, social, and spiritual dimensions of suffering [5]. Table 3.1 provides an overview of the technology. Table 3.1: Features of the intervention and comparators Technology Comparator Non-proprietary name Regorafenib No active comparator is available Proprietary name STIVARGA ® Active substance Regorafenib Galenic Form 40 mg film-coated tablets ATC code L01XE21 Abbreviations: ATC=anatomical therapeutic chemical; EMA=European Medicines Agency. Source: EMA 2013 (...) of coffee or tea (520 calories, 2 g fat). No active comparator is available Description of packaging 28 film-coated tablets in bottle 84 film-coated tablets (3 x 28) in bottle Total volume contained in packaging for sale 28-tablet package of 40 mg regorafenib formulation 112-tablet package of 40 mg regorafenib formulation Dosing Recommended daily dose is 160 mg (4 tablets of 40 mg) taken once daily. Dose interruptions and/or dose reductions may be required based on individual safety and tolerability

2018 EUnetHTA

163. Diagnosis and management of polycythaemia vera Full Text available with Trip Pro

, mutation, JAK 2, MPL , CALR , bone marrow, red cell mass, erythropoietin, risk, management, treatment, cytoreduction, venesection, hydroxyurea, interferon, busulfan, pipobroman, radioactive phosphorus, aspirin, anagrelide, ruxolitinib, thrombosis, haemorrhage, pregnancy, pruritus, surgery and management. The search covered the period from 2005, the date of last version of the guideline (McMullin et al , ), to February week 3 2017. Exclusions included articles not in English, studies not in humans (...) Recommended diagnostic criteria for PV JAK2‐positive polycythaemia vera (requires both criteria) A1 High haematocrit (>0·52 in men, >0·48 in women) OR raised red cell mass (>25% above predicted) A2 Mutation in JAK 2 JAK2‐negative polycythaemia vera (requires A1‐A4 plus another A or two B criteria) a This is a very rare clinical entity. A1 Raised red cell mass (>25% above predicted) OR haematocrit ≥0·60 in men, ≥0·56 in women A2 Absence of mutation in JAK 2 A3 No cause of secondary erythrocytosis A4 Bone

2018 British Committee for Standards in Haematology

164. Tadalafil - Pulmonary Hypertension

Area Under the plasma Concentration-time curve from time zero to t hours BA BioAvailability BCT Blinded combination therapy BE Bioequivalence BID Bis in die (twice daily) BMI Body Mass Index BMPR2 Bone morphogenetic protein receptor type 2 BNFc British National Formulary for Children BNP Brain natriuretic peptide BP Blood pressure BPH Benign prostatic hyperplasia BPI Brief Pain Inventory BUN Blood urea nitrogen cGMP Cyclic guanosine monophosphate CI Confidence interval CI Cardiac index CIOMS (...) similarity with authorised orphan medicinal products. The chosen reference product is: Medicinal product which is or has been authorised in accordance with Community provisions in force for not less than 6/10 years in the EEA: • Product name, strength, pharmaceutical form: Cialis, 20 mg, film-coated tablet • Marketing authorisation holder: Eli Lilly Nederland B.V. • Date of authorisation: 12/11/2002 • Marketing authorisation granted by: - Community • Community Marketing authorisation number: EU/1/02/237

2017 European Medicines Agency - EPARs

165. Venetoclax (Venclyxto) - Chronic, B-Cell Lymphocytic Leukemia

/100,000 person years. The median age of diagnosis in the EU is 72 years and only 10% of patients are less than 55 years old. The current WHO classification system recognizes and groups CLL and small lymphocytic lymphoma (SLL) as the same biological entity, with CLL clinically manifesting primarily in bone marrow and peripheral blood, and SLL primarily manifesting in the lymph nodes. Current treatments for CLL are not curative. Fewer patients obtain responses with each subsequent regimen, and subjects (...) time ASO PCR allele specific oligonucleotide polymerase chain reaction AST aspartate aminotransferase Bcl B cell lymphoma BCRi B Cell receptor inhibitor BMI body mass index BR bendamustine rituximab CD cluster of differentiation CI confidence interval CLL chronic lymphocytic leukaemia CPP Critical process parameter CQA Critical Quality Attribute CR complete remission CRi complete remission with incomplete bone marrow recovery CSR clinical study report CT computed tomography CTLS clinical tumour

2017 European Medicines Agency - EPARs

166. Obeticholic acid (Ocaliva) - Liver Cirrhosis, Biliary

Code): bile therapy, bile acid preparations (A05AA04) Therapeutic indication(s): OCALIVA is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Pharmaceutical form(s): Film-coated tablet Strength(s): 5 mg and 10 mg Route(s) of administration: Oral use Packaging: bottle (HDPE) Package size(s): 30 tablets (...) /2016 Page 5/129 List of abbreviations AASLD American Association for the Study of Liver Diseases AE adverse event AMA antimitochondrial antibody ALT alanine aminotransferase ALP alkaline phosphatase AMA antimitochondrial antibodies ANCOVA analysis of covariance aPTT activated partial thromboplastin time AST aspartate aminotransferase ATC Anatomical/Therapeutic/Chemical AUC area under the curve BA bioavailability BAS bile acid sequestrants BE bioequivalence BMD bone mineral density BMI body mass

2017 European Medicines Agency - EPARs

167. Baricitinib (Olumiant) - rheumatoid arthritis

with mild, limited RA usually have minimal joint destruction. Patients with moderately to severely active disease have persistent systemic inflammation with elevated acute phase proteins and pro-inflammatory cytokines contributing to symptoms of fatigue, pain, joint stiffness, and associated comorbidities of cardiovascular disease, infections, mental health disorders, and malignancies (CDC 2015). Within the joint, inflammation directly affects the synovial membrane and bone resulting in damage (...) to the bone and articular cartilage. Importantly, while signs and symptoms are reversible with appropriate treatment, joint damage and the associated disability are permanent. 2.1.4. Management Pharmaceutical treatment options in moderate-severe RA include conventional small molecule Disease Modifying Anti-Rheumatic Drugs (cDMARDs), and biologic DMARDs (bDMARDs). In addition, symptomatic treatment with conventional NSAIDs or selective COX-2 inhibitors is often required. EMA/13493/2017 Page 12/132

2017 European Medicines Agency - EPARs

168. Tofacitinib (Xeljanz) - Rheumatoid arthritis

, and excretion AEs Adverse events Ag Antigen AIA Adjuvant induced arthritis ALT Alanine aminotransferase APA Action potential amplitude APD Action potential duration APD50 Action potential duration at 50% repolarization APD90 Action potential duration at 90% repolarization AST Asparate aminotransferase AUC Area under concentration-time curve AUC24 AUC from time 0 to 24 hours postdose AUCt AUC from 0 to time t last postdose BAT Brown adipose tissue BCRP Breast cancer resistant protein BID Twice a day BP Blood (...) is a common disease with a prevalence of 0.5 – 1.0% and occurs 2 -3 times more commonly in women than men although the gender difference becomes less pronounced, the later the age of onset. The incidence rises with age and peaks between 65 and 74 years of age. The underlying cause is still unknown but is thought to result from a complex interplay of genetic and environmental factors. The disease is characterised by structural joint damage accompanied by pain and swelling, causes progressive disability

2017 European Medicines Agency - EPARs

169. Perinatal Mortality Guideline

Perinatal Mortality Guideline Definitions Clinical Note: For the purposes of review of Perinatal Mortality, “Perinatal” will be defined as from greater than or equal to 20 weeks gestational age and less than 28 days of life. There has been variation in the definition of perinatal mortality, both internationally and within North America. For consistency of data collection, PSBC promotes the use of definitions as outlined by the British Columbia Vital Statistics Act. 1 www.bclaws.ca/civix/document/id (...) of the pregnancy, of a product of conception in which, after the expulsion or extraction, there is any of: breathing, beating of the heart, pulsation of the umbilical cord or unmistakable movement of voluntary muscle, whether or not the umbilical cord has been cut or the placenta is attached. Abortus – a fetus weighing less than or equal to 500 grams or having completed less than 20 weeks gestational age at the time of expulsion or removal from the uterus regardless of whether signs of life are present

2017 British Columbia Perinatal Health Program

170. Intravenous Regional Anaesthesia for Distal Forearm Fractures (Bier's Block)

intravenous regional anaesthesia (Bier’s Block) for adults in the Emergency Department requiring manipulation for distal forearm fractures. Reason for development To help the clinician in performing an intravenous regional anaesthesia (IVRA), standardise and improve patient care. Introduction Fracture of the distal forearm fractures is a frequent presentation to every Emergency Department with a prevalence of 9/10,000 in men and 37/10,000 in women aged more than 35 years and above. A proportion (...) which require systemic drug administration • IV access, distal to the cuff, with small bore cannulae (22G) on the side to be anaesthetised. Proximal vein can be used but injection should be slow and wait 13 mins for effect • Radiographer informed about the requirement of post reduction film • There is some evidence to support use of ultrasound guidance to aid reduction Intravenous Regional Anaesthesia for Distal Forearm Fractures (Bier’s Block) (revised Nov 2017) 5 Procedure: • Place double cuff

2017 Royal College of Emergency Medicine

171. Fractures (non-complex): assessment and management

, standards and laws (including on consent and mental capacity), and safeguarding. Recommendations apply to both children (under 16s) and adults (16 or over) unless otherwise specified. Some recommendations on management depend on whether the growth plate of the injured bone has closed (skeletal maturity). The age at which this happens varies. In practice, healthcare professionals use clinical judgement to determine whether a bone is skeletally mature. When a recommendation depends on skeletal maturity (...) (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 14 of 18Conte Context xt The annual incidence of fractures in Britain is about 3.6% and the lifetime prevalence nearly 40%. Most of the 1.8 million fractures that occur in England each year are non-complex, and include a wide range of injuries over the complete age range from infancy to old age. Many different bones can be involved and the mechanisms of injury are many and varied. The range of treatment options is also wide

2016 National Institute for Health and Clinical Excellence - Clinical Guidelines

172. Sunlight exposure: risks and benefits

for children and young people oung people Children under 6 months of age should be kept out of direct strong sunlight. Between March and October in the UK, children and young people need their skin protecting. They should cover up with suitable clothing, be encouraged to spend time in the shade (particularly between 11am and 3pm) and wear sunscreen. The parents and carers of children younger than 5 should be given advice on vitamin D supplements (see NICE's guideline on vitamin D: increasing supplement use (...) days absence because of sunburn or other adverse effects (Sun protection: advice for employers of outdoor workers Health and Safety Executive). Cover the needs of all at-risk groups (see recommendation 1.1.1). T ailor advice according to skin type and age. T ailor advice according to needs and circumstances. This includes people for whom English is not a first language, from lower socioeconomic groups, with specific cultural needs, or with a disability. Encourage people to manage their own risk

2016 National Institute for Health and Clinical Excellence - Clinical Guidelines

173. Haematological cancers: improving outcomes

malignancy if patients with an established or previous malignancy have suspected relapse or disease progression. [new 2016] [new 2016] 1.1.7 If an urgent treatment decision is needed and local diagnostic workup will not reduce the speed or quality of the SIHMDS assessment and integrated reporting, local diagnostic laboratories should process and report on blood film, bone marrow aspirate and cerebrospinal fluid cytology specimens. [new 2016] [new 2016] 1.1.8 SIHMDS should release individual laboratory (...) quality management system be formally accredited as a SIHMDS by a recognised independent organisation be managed by a single trust/organisation assess the clinical benefit and the financial and resource impact of new diagnostic and therapeutic technologies before introducing them have a central reception point for all specimens have a full range of age-appropriate specialist haematology and haematopathology input for diagnosis and the authorisation of integrated reports Haematological cancers

2016 National Institute for Health and Clinical Excellence - Clinical Guidelines

174. Melanoma: assessment and management

people. More than 900 adults aged under 35 are now diagnosed with melanoma annually in the UK, and it is the second most common cancer in adults aged between 25 and 49. Melanoma therefore leads to more years of life lost overall than many more common cancers. Most melanomas occur in people with pale skin. The risk factors are skin that tends to burn in the sun, having many moles, intermittent sun exposure and sunburn. This guideline addresses areas where there is uncertainty or variation in practice (...) -specific MDTs (such as an MDT for the brain or for bones). Melanoma: assessment and management (NG14) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 22 of 61Br Brain metastases ain metastases 1.8.3 Discuss the care of people with melanoma and brain metastases with the SSMDT. 1.8.4 Refer people with melanoma and brain metastases that might be suitable for surgery or stereotactic radiotherapy to the brain and other

2015 National Institute for Health and Clinical Excellence - Clinical Guidelines

175. Conductor-Assisted Nasal Sonography: An Innovative Technique for Rapid and Accurate Detection of Nasal Bone Fracture. (Abstract)

), and negative predictive value (NPV) of nasal bone fracture identified by CANS and other plain films versus nasal bone fracture evidenced by CT scan, taken as the gold standard, were measured.Of these patients (52 males and 19 females; mean age, 40 years ± 19.8 years), 52 of 71 were diagnosed with nasal fractures by facial CT scans. No demographic difference was found in fracture and nonfracture groups. In addition to nasal sonography and facial CT scan, 23 patients also received nasal X-ray examination, 17 (...) Conductor-Assisted Nasal Sonography: An Innovative Technique for Rapid and Accurate Detection of Nasal Bone Fracture. Nasal bone is frequently involved in craniofacial trauma. We sought to investigate the role of conductor-assisted nasal sonography (CANS) in patients with nasal trauma.In all, 71 patients sustaining midfacial trauma who underwent CANS examination with simultaneous facial computed tomography (CT) scans were reviewed. Sensitivity, specificity, positive predictive value (PPV

2011 Journal of Trauma

176. Protective Stabilization for Pediatric Dental Patients

Background Pediatric dentists receive formal education and training to gain the knowledge and skills required to manage the various phys- ical challenges, cognitive capacities, and age-defining traits of their patients. A dentist who treats children should be able to assess each child’s developmental level, dental attitude, and temperament and also be able to recognize potential barriers to delivery of care (e.g., previous unpleasant and/or painful medical or dental experiences) to help predict (...) ) immobilization requires use of restraints. When mechanical immobilization is indicated, the least restrictive alternative or technique should be used. 28,29 An accurate, comprehensive, and up-to-date medical history is necessary for effective treatment. This would include careful review of the patient’s medical history to ascertain if there are any conditions (e.g., asthma) which may compromise respiratory function or neuromuscular or bone/skeletal dis- orders which may require additional positioning aids

2017 American Academy of Pediatric Dentistry

177. Required hospital capacity in 2025 and criteria for rationalisation of complex cancer surgery, radiotherapy and maternity services

and foreign patients 112 1.7.4 Summary of baseline forecast results 116 1.8 PROJECTION RESULTS SCENARIO WITH ACCELERATED SUBSTITUTION TO DAY CARE ... 124 1.8.1 Methodology 125 1.8.2 Results 130 1.9 PROJECTION RESULTS SCENARIO WITH ACCELERATED POPULATION AGEING 135 1.9.1 Methodology 135 1.9.2 Results 137 2 HOSPITAL USE BY PATIENTS WITH DEMENTIA 145 2.1 BACKGROUND AND AIM OF THE STUDY 145 2.2 METHOD 147 2.2.1 Literature review 147 2.2.2 Analysis of Belgian hospital registry data 148 2.3 RESULTS (...) 445 8.5.2 Costs savings 445 8.5.3 Occupancy rate 448 8.5.4 Volume and outcome 448 8.5.5 Access / Distance 449 DISCUSSION AND CONCLUSION 450 ? APPENDICES 451 ? REFERENCES 503 KCE Report 289 Required hospital capacity and criteria for rationalisation 9 LIST OF FIGURES Figure 1 – Population projections for Belgium 38 Figure 2 – Overview of projection model in the report Cannoodt 43 Figure 3 – Projected and observed Belgian population by age, 2005-2015 47 Figure 4 – Projected and observed number

2017 Belgian Health Care Knowledge Centre

178. CRACKCast E027 – Abdominal Pain

abdominal aneurysm Increases with advanced age, men, or HTN, DM, smoking, COPD, CAD, connective tissue disease, trauma Symptoms: usually asymptomatic until rupture ACUTE onset epigastric, back pain WITH syncope and shock. May radiate to back, groin, testes. May have normal vital signs with normal exam and normal femoral pulses. Abdominal plain films – abnormal in 80% of cases; can do FAST CT abdomen is test of choice. Mesenteric ischemia Peak: elders, CV disease, CHF, arrhythmias, sepsis, dehydration 70 (...) be serious Epidemiology Groups that require special consideration in the work up: Elderly Commonly missed diagnoses Diverticulitis Ruptured AAA Mesenteric ischemia Immunocompromised (uncontrolled DM, HIV, liver disease, chemo) Presentation can be misleading due to lack of an inflammatory response Women of reproductive age Pelvic organs can lead to more missed pathologies Ectopic pregnancy Pathophysiology Pain is derived from three pathways: Visceral Somatic Referred Visceral pain: Stimulation from

2017 CandiEM

179. Clinical Practice Guideline on the Management of Osteoarthritis of the Hip

a single study for recommending for or against the intervention or diagnostic test or the evidence is insufficient or conflicting and does not allow a recommendation for or against the intervention. AGE AS A RISK FACTOR a) Moderate strength evidence supports that increased age is associated with lower functional and quality of life outcomes in patients with symptomatic osteoarthritis of the hip undergoing total hip arthroplasty. Strength of Recommendation: Moderate Evidence Description: Evidence from (...) two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. b) Limited strength evidence supports that increased age may be associated with a higher risk of mortality in patients with symptomatic osteoarthritis of the hip undergoing total hip arthroplasty. Strength of Recommendation: Limited Evidence Description: Evidence from two or more “Low” strength studies with consistent findings

2017 American Academy of Orthopaedic Surgeons

180. Therapeutic monitoring of TNF-alpha inhibitors in Crohn's disease (LISA-TRACKER ELISA kits, IDKmonitor ELISA kits, and Promonitor ELISA kits)

(Steed et al. 2010). The condition can affect people of all ages, but most develop it between the ages of 16 and 30 years. Many also develop it between the ages of 60 and 80 years. Although the cause of Crohn's disease is unknown, it is likely that a genetic predisposition, smoking and intercurrent infection increase the risk of it developing. 3.7 The clinical course of Crohn's disease is marked by relapses (when the disease flares up) and remission (when there are few or no signs or symptoms (...) can deepen over time and become a channel to another hollow organ or the skin, known as a fistula. Cancer: Crohn's disease is associated with a small increase in the risk of developing colorectal cancer in later life. Osteoporosis: weakening of the bones because of poor absorption of nutrients from food and the use of steroid medication. Problems with growth and development in children with Crohn's disease, because their bodies are not absorbing enough nutrients. The diagnostic and care pathways

2016 National Institute for Health and Clinical Excellence - Diagnostics Guidance

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