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61. Standardisation of immunosuppressive and anti-infective drug regimens in UK Paediatric Renal transplantation: The Harmonisation programme

controlled trials (RCT), non-randomised studies if adjusted for key confounders (age, health at baseline, co-morbidities). Clinicians on the guideline committee critically appraised any eligible papers using critical appraisal skills programme tools 1 . Where evidence was lacking, formal Delphi consensus methodology was employed. A Delphi panel was constituted, comprising representation from each specialist area covered by the guideline: Nephrology services (panelists representing 4 adult and all 13 (...) receive IL-2 receptor antagonist, tacrolimus (Adoport®/Modigraf®) and MMF (mycophenolate mofetil) as routine therapy. 1 No recommendations were made for prednisolone or azathioprine, however, some CYP have more adverse events with MMF compared with azathioprine, particularly gastro-intestinal symptoms and bone marrow suppression. Furthermore, recent studies have reported an increased incidence of acute rejection in adults and children receiving steroid avoidance and withdrawal drug regimens after

2020 Renal Association

62. Dolutegravir/rilpivirine (Juluca) for the treatment of human immunodeficiency virus type 1 (HIV-1)

inhibitor), age group (over or under 50 years), and planned participation in a bone mineral density sub-study 11 . Dolutegravir/rilpivirine (Juluca ® ). Reference number 2850. Page 5 of 14 This assessment report will be considered for review three years from the date of the Final Appraisal Recommendation. Patients were assessed at screening, day 1, weeks 4, 8, 12, 24, 36, 48 and week 52 (current antiretroviral therapy only) or withdrawal 11 . At week 52, patients assigned to current antiretroviral (...) Dolutegravir/rilpivirine (Juluca) for the treatment of human immunodeficiency virus type 1 (HIV-1) AWMSG SECRETARIAT ASSESSMENT REPORT Dolutegravir/rilpivirine (Juluca ® ) 50 mg/25 mg film-coated tablet Reference number: 2850 FULL SUBMISSION This report has been prepared by the All Wales Therapeutics & Toxicology Centre (AWTTC). Please direct any queries to AWTTC: All Wales Therapeutics & Toxicology Centre (AWTTC) University Hospital Llandough Penlan Road Llandough Vale of Glamorgan CF64 2XX

2019 All Wales Medicines Strategy Group

63. Optimisation of RIZIV – INAMI lump sums for incontinence

or drugs) 120 4.4 ESTIMATING THE NUMBER OF PEOPLE WITH UNTREATED INCONTINENCE 130 5 INTERNATIONAL PERSPECTIVE 131 5.1 INTRODUCTION 131 5.2 METHODS 131 5.3 SELECTION OF COUNTRIES 131 5.4 CROSS-COUNTRY ANALYSIS 132 5.4.1 Absorbent materials: included or excluded from the health benefit basket 132 5.4.2 Absorbent materials: eligible indications and age groups 134 5.4.3 Reimbursement method 140 5.4.4 Strengths and weaknesses of different reimbursement methods 144 5.4.5 Patient classification (...) FORM WITH KATZ SCALE 199 APPENDIX 2. REQUEST FORM FOR “SMALL LUMP SUM” FOR INCONTINENCE 200 ? APPENDIX TO CHAPTER 4 201 APPENDIX 1. NUMBER AND TYPE OF ADMISSIONS, AGE AND SEX PER APR-DRG (2014) 201 APPENDIX 2. TEN MOST FREQUENT PROCEDURE PERFORMED PER MDC (2014) 202 APPENDIX 3. SELECTION CRITERIA TO EXTRACT EPS DATA 2008-2015 204 APPENDIX 4. VARIABLES DERIVED FROM EPS VARIABLES (2015) 214 APPENDIX 5. VOLUME (DDD), REIMBURSEMENTS (€) AND NUMBER OF PATIENTS FOR URINARY FREQUENCY AND INCONTINENCE

2020 Belgian Health Care Knowledge Centre

64. Olaparib (breast cancer) - Benefit assessment according to §35a Social Code Book V

chemotherapy using capecitabine or vinorelbine or eribulin Study Intervention Comparison OlympiAD ? Twice daily 300 mg olaparib (each dose consisting of 2x150 mg film-coated tablets), orally, at 12 hour intervals; total daily dose: 600 mg ? Recommended treatment interruptions and dose reductions due to side effects comply with the specifications of the SPC. Re-escalation after dose reduction was not allowed. ? One of the following chemotherapeutic regimens chosen by the physician for the individual patient (...) therapy. ? no more than 2 lines of cytotoxic chemotherapy for metastatic disease b Non-permitted pretreatment ? cytotoxic chemotherapy or non-hormonal targeted therapy within 21 days before start of treatment ? endocrine therapy had to be discontinued = 7 days before start of treatment ? palliative radiotherapy had to be discontinued = 14 days before start of treatment ? prior treatment with PARP inhibitors (including olaparib) ? prior allogeneic bone marrow transplantation Concomitant treatment ? any

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

65. Olaparib (ovarian cancer) - Benefit assessment according to §35a Social Code Book V

7: Characteristics of the intervention – RCT, direct comparison: olaparib vs. watchful waiting Study Intervention Comparison SOLO1 Olaparib 300 mg, orally, twice daily as film- coated tablet (total daily dose: 600 mg), at the same time of the day, at 12-hour intervals Placebo, orally, twice daily as film-coated tablet, at the same time of the day, at 12-hour intervals Dose adjustments, treatment interruption and treatment discontinuation due to toxicity are possible a Pretreatment Required (...) : ? corticosteroids for symptom control in brain metastases as well as bisphosphonates or denosumab for bone disorders, each in a stable dose at the start of the administration at least 4 weeks before start of the study ? palliative radiotherapy for pain treatment of bone metastases already existing before the start of the study as long as there are no indications of disease progression ? antiemetics, antidiarrhoeal drugs ? G-CSF in grade = 3 febrile neutropenia ? warfarin, subcutaneous heparin Not allowed

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

66. Spondyloarthritis in over 16s: diagnosis and management

infection). 1.1.4 Be aware that axial spondyloarthritis: affects a similar number of women as men can occur in people who are human leukocyte antigen B27 (HLA-B27) negative may be present despite no evidence of sacroiliitis on a plain film X-ray. Referr Referral for suspected axial spondyloarthritis al for suspected axial spondyloarthritis 1.1.5 If a person has low back pain that started before the age of 45 years and has lasted for longer than 3 months, refer the person to a rheumatologist (...) for a spondyloarthritis assessment if 4 4 or more or more of the following additional criteria are also present: low back pain that started before the age of 35 years (this further increases the likelihood that back pain is due to spondyloarthritis compared with low back pain that started between 35 and 44 years) waking during the second half of the night because of symptoms buttock pain improvement with movement improvement within 48 hours of taking non-steroidal anti-inflammatory drugs (NSAIDs) Spondyloarthritis

2017 National Institute for Health and Clinical Excellence - Clinical Guidelines

67. Lorlatinib (Lorviqua) - non-small cell lung cancer (NSCLC)

Lorlatinib (Lorviqua) - non-small cell lung cancer (NSCLC) 1 Published 9 March 2020 1 SMC2239 lorlatinib 25mg and 100mg film-coated tablets (Lorviqua®) Pfizer Limited 7 February 2020 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission assessed under the end of life process lorlatinib (...) , single-arm and included adults with metastatic, stage IV, NSCLC (histologically or cytologically confirmed) that carried a locally determined ALK or ROS1 gene rearrangement. Patients were required to have =1 measurable target extracranial lesion as per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Patients with asymptomatic central nervous system (CNS) metastases, with or without prior treatment, were permitted in the study. Patients were required to have adequate bone marrow

2020 Scottish Medicines Consortium

68. Clostridioides difficile Infection in Adults and Children

in Adults and Children 12/2019 Key Points for Patients =18 Years of Age: Diagnosis The decision to test children for CDI is complicated given a high rate of asymptomatic carriage, especially in infants 15,000 cells/mm 3 ]) ? Abdominal pain with radiographic evidence of bowel thickening ? Radiographic evidence of toxic megacolon OR 2. Colonoscopic or histopathologic evidence of pseudomembranous colitis. 6 UMHS C. difficile Infection in Adults and Children 12/2019 Table 3A. Classification and Treatment (...) . difficile Infection in Patients =18 Years of Age Disease Severity Initial Episode 1 First Recurrence 1 Second Recurrence 1 Mild-Moderate (Disease is considered Mild-Moderate when the criteria for severe or fulminant disease are not met) Metronidazole 7.5 mg/kg/dose PO QID for 10 days 2 , maximum 500 mg/dose OR Patients with metronidazole allergy, pregnant, nursing, on warfarin therapy, or who fail to improve after 3-5 days of PO metronidazole: Vancomycin 10 mg/kg/dose PO QID, up to maximum 125 mg PO QID

2020 University of Michigan Health System

69. Encorafenib (Braftovi) - unresectable or metastatic melanoma with a BRAF V600 mutation

violet (UV) light exposure (both natural and artificial sunlight) is considered to be the main risk factor for cutaneous melanoma. It has a relatively young age distribution and often affects people of working age. About 90% of melanoma cases are diagnosed as primary tumours, with no evidence of metastasis. 12 These cases can be cured if recognised and treated with surgery at an early stage. However, for patients with advanced melanoma, prognosis is poor, with 5-year survival rates ranging between 40 (...) to complex and severe symptoms as secondary tumours can spread to the brain, lung, and bones. It can also have a psychological toll, causing stress, anxiety and depression. Advanced melanoma affects a disproportionate number of 9 younger patients, who may be parents and/or providing care for older members of their family. The diagnosis can therefore have a considerable emotional, psychological, and financial impact on the family. ? Treatment options are limited in advanced melanoma. Encorafenib plus

2020 Scottish Medicines Consortium

70. Diagnosis and Treatment of Low Back Pain

and the needs and resources particular to the locality or institution. Diagnosis & Treatment of Low Back Pain | Glossary & Acronyms 13 Red Flag Conditions 4,6-7 History ? Cancer ? Unexplained weight loss ? Immunosuppression ? Intravenous drug use ? Urinary tract infection ? Fever ? Significant trauma relative to age ? Bladder or bowel incontinence ? Urinary retention (with overflow incontinence) Ph y sical Ex amina tion ? Saddle anesthesia ? Loss of anal sphincter tone ? Major motor weakness in lower (...) BMI Body mass index BMP Bone morphogenetic protein BPI Brief Pain Inventory CBA Cognitive behavioral approach CBT Cognitive behavioral therapy CCBT Contextual cognitive-behavioral therapy CEQ Cognitive Error Questionnaire CLBP Chronic low back pain CMDQ Common Mental Disorders Questionnaire COX-2 Cyclooxygenase-2 CPAQ Chronic Pain Acceptance Questionnaire CPR Clinical Prediction Rule CT Computed tomography DPQ Dallas Pain Questionnaire DD Disc degeneration DDS Descriptor Differential Scale DIS

2020 North American Spine Society

71. Abiraterone acetate (Zytiga) - for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer

Abiraterone acetate (Zytiga) - for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer 1 Published 13 January 2020 1 SMC2215 abiraterone acetate 500mg film-coated tablets (Zytiga®) Janssen-Cilag Ltd 6 December 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following (...) two of the following prognostic factors: a Gleason score =8 (scale ranges from 2 to 10 with higher scores indicating more aggressive disease), the presence of =3 lesions on a bone scan, and the presence of measurable visceral (excluding lymph node disease) metastasis on computerised tomography (CT) or magnetic resonance imaging (MRI) scan (according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1 criteria). 2-4 Patients were randomised equally to receive abiraterone 1,000mg

2020 Scottish Medicines Consortium

72. Evaluation of the Thoracic and Lumbar Spine in Blunt Trauma

hip, you are planning to get plain films of the lumbar spine. Again, you wonder if this is sufficient, or if you need to get more advanced imaging (such as a CT) to evaluate for fracture. The first patient gets a “pan-scan” and is found to have isolated facial bone fractures, for which he is evaluated by ENT and eventually discharged home. The second patient is found to have no fractures on plain films, feels much better after ibuprofen, and also goes home. You still have questions about your (...) of pain, tenderness to palpation, deformity, or neurologic deficit 3.Age ≥ 60 Future research will be needed to validate this rule in multiple settings, and should be aimed at determining the impact of the rule to ensure it improves outcomes or reduces unnecessary imaging without worsening outcomes. Until then, it seems reasonable to continue using clinical acumen to determine who needs imaging of the thoracic or lumbar spine following blunt trauma, with a lower threshold to at least get plain films

2019 Washington University Emergency Medicine Journal Club

73. Trastuzumab (Ogivri) - breast cancer or stomach cancer

carried out. In a population pharmacokinetic analysis, age and renal impairment were not shown to affect trastuzumab disposition. Paediatric population There is no relevant use of trastuzumab in the paediatric population. Method of administration Trastuzumab loading dose should be administered as a 90-minute intravenous infusion. Do not administer as an intravenous push or bolus. Trastuzumab intravenous infusion should be administered by a healthcare provider prepared to manage anaphylaxis (...) 2 ). The incidence of symptomatic cardiac dysfunction was 1.7 % in the trastuzumab arm. Clinical experience is limited in patients above 65 years of age. Infusion-related reactions (IRRs) and hypersensitivity Serious IRRs to trastuzumab infusion including dyspnoea, hypotension, wheezing, hypertension, bronchospasm, supraventricular tachyarrhythmia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria and angioedema have been reported (see section 4.8). Pre-medication may

2019 European Medicines Agency - EPARs

74. Istradefylline (Nourianz) - Parkinson's disease

of top 3 TEAEs Related to Dizziness, Hypotension or Orthostatic Table 44. Incidence of A Subject Experiencing at Least One TEAE Belonging to the Cardiac SOC Table 47. Treatment-Emergent Adverse Events, Grouped Occurring by Age Group = 65 49.0 (75) 51.3 (446) 47.3 (424) 52.9 (82) 46.6 (471) 48.3 (1564) = 75 8.5 (13) 13.6 (118) 10.2 (91) 12.9 (20) 11.4 (115) 11.4 (369) Race American Indian or Alaska Native 0 0.4 (3) 0.1 (1) 0 0.1 (1) 0.2 (5) Asian 2.6 (4) 29.1 (253) 32.8 (294) 1.9 (3) 28.7 (290) 27.1 (...) : September 6, 2017 for all NDAs and BLAs Reference ID: 4482736 Reference ID: 4484018 21 Clinical Review Natalie Branagan, MD NDA 022075 Nourianz/istradefylline of North America (77%). Pool 8 was similar to Pool 1 with respect to gender and age but was different with respect to race and region. Males made up 50.5% of the population and the median age of the population was 65 years. Asians made up a higher percentage of the population (64.1%). A higher percentage of the population was located outside

2019 FDA - Drug Approval Package

75. Acute Kidney Injury (AKI)

sample ? systolic BP 15 years old) population [7]. There appears to be an increasing incidence of AKI with age [8]. In addition, AKI appears to be becoming more common when assessed over even short periods of time; Hsu et al, for instance, showed the incidence of non-dialysis requiring AKI amongst a large population of hospitalised patients to have increased from 323 to 522 per 100 000 person-years between 1996 and 2003, alone [8]. These changes may be explained by more aggressive medical (...) and surgical interventions in an aging and increasingly co-morbid population who are more vulnerable to AKI as a complication of such treatments[9, 10]. When corrected for disease acuity there is at least some evidence that hospital survival from AKI is increasing [11] although longer term mortality rates appear to be unchanged and may, Renal Association Clinical Practice Guideline Acute Kidney Injury (AKI) - August 2019 22 it has been speculated, actually represent increased use of early discharge

2019 Renal Association

77. Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain

infection ? Fever ? Significant trauma relative to age ? Bladder or bowel incontinence ? Urinary retention (with overflow incontinence) Ph y sical Ex amina tion ? Saddle anesthesia ? Loss of anal sphincter tone ? Major motor weakness in lower extremities ? Fever ? Neurologic findings persisting beyond one month or progressively worsening References 1. Frymoyer JW. Back pain and sciatica. N Engl J Med. 1988;318(5):291-300. 2. Von Korff M. Studying the natural history of back pain. Spine. 1994;19(18 Suppl (...) of Low Back Pain | Glossary & Acronyms 14 Acronyms AAQ-II Acceptance and Action Questionnaire ADS Allgemeine Depressions-Skala ALIF Anterior lumbar interbody fusion AM Active management BDI Beck Depression Inventory BDI-II Beck Depression inventory-II BMI Body mass index BMP Bone morphogenetic protein BPI Brief Pain Inventory CBA Cognitive behavioral approach CBT Cognitive behavioral therapy CCBT Contextual cognitive-behavioral therapy CEQ Cognitive Error Questionnaire CLBP Chronic low back pain CMDQ

2020 American Academy of Pain Medicine

78. Opioid Treatments for Chronic Pain

mortality. 44 It was not possible to determine a causal association between opioid discontinuation and overdose mortality because most patients had a safety reason for discontinuation, the study did not attempt to control for potential confounders other than age and race, most patients received opioids from another provider after discontinuation, and there was no information about time to discontinuation. Rather, the findings may indicate that patients with indications for opioid discontinuation

2020 Effective Health Care Program (AHRQ)

79. Abdominal and pelvic imaging

that the prior intervention was never administered. Imaging of the Abdomen and Pelvis Copyright © 2020 AIM Specialty Health ® All Rights Reserved. 8 Imaging of the Abdomen and Pelvis General Information/Overview Scope These guidelines address advanced imaging of the abdomen and pelvis in both adult and pediatric populations. For interpretation of the Guidelines, and where not otherwise noted, “adult” refers to persons age 19 and older, and “pediatric” refers to persons age 18 and younger. Where separate (...) indications exist, they are specified as Adult or Pediatric. Where not specified, indications and prerequisite information apply to persons of all ages. See the Coding section for a list of modalities included in these guidelines. Technology Considerations Advanced imaging is an umbrella term that refers to anatomy-based (structural), physiology-based (functional), and hybrid imaging methods that offer greater spatial and/or contrast resolution relative to conventional imaging methods in radiology

2020 AIM Specialty Health

80. Adhesive capsulitis

shoulder instability) negative relocation test (to further exclude anterior shoulder instability) negative Kim test (to exclude posteroinferior labral lesion of the shoulder) age 40 to 70 years diabetes mellitus prior hx of adhesive capsulitis shoulder pain and immobilisation previous shoulder surgery female sex thyroid disease Diagnostic investigations plain film radiographs MRI/MR arthrogram shoulder CT arthrogram Treatment algorithm ACUTE Contributors Authors Complex Shoulder Knee and Sports Surgery (...) Adhesive capsulitis Adhesive capsulitis - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Adhesive capsulitis Last reviewed: February 2019 Last updated: April 2018 Summary Affects 2% to 5% of the population, slightly more common in women than in men, and most common in people between 40 and 70 years of age. Recent history of traumatic shoulder injury, prior surgery to affected shoulder, diabetes mellitus, thyroid

2018 BMJ Best Practice

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