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1. One of the Great Books of Emergency Medicine Just Published: Extraordinary Cases in Emergency Medicine

One of the Great Books of Emergency Medicine Just Published: Extraordinary Cases in Emergency Medicine Dr. Smith's ECG Blog: One of the Great Books of Emergency Medicine Just Published: Extraordinary Cases in Emergency Medicine Tuesday, January 8, 2019 Doug Brunette is one of the finest Emergency Physicians, if not the finest, whom I have ever known. He was one of the early Hennepin greats, and one of my first and best teachers. He has always been passionate about teaching and practicing (...) for a cardiologist was to wait too long. Doug and Hennepin (Ernie Ruiz, Joe Clinton, Dave Plummer, and more) taught me long ago that we Emergency Physicians must be the deciders. And that is just one of his countless contributions to EM over a 37 year career. Doug has collected images in EM since 1983 and they are incredible images, classics in EM. Now he has put 500 of these images (344 cases) together in an amazing new book: The Most Fascinating Book in Emergency Medicine History Posted by Steve Smith

2019 Dr Smith's ECG Blog

2. Larotrectinib (solid tumours) - Benefit assessment according to §35a Social Code Book V

next generation sequencing NSCLC non-small cell lung cancer NTRK neurotrophic tyrosine receptor kinase PedsQL Pediatric Quality of Life Inventory RCT randomized controlled trial RECIST Response Evaluation Criteria in Solid Tumours RT-PCR reverse transcriptase polymerase chain reaction SAE serious adverse event SAP statistical analysis plan SGB Sozialgesetzbuch (Social Code Book) SPC Summary of Product Characteristics VAS visual analogue scale Extract of dossier assessment A19-90 Version 1.0 (...) analysis, the following methods for detection of NTRK gene fusion were accepted: next generation sequencing (NGS), fluorescence in situ hybridization (FISH) or reverse transcriptase polymerase chain reaction (RT-PCR). The testing methods used cover the methods recommended by the European Society for Medical Oncology (ESMO) to detect NTRK gene fusions [4]. If NGS was used for detection, it had to be clear from the pathology report that fusion between one of the NTRK genes (NTRK1, NTRK2, NTRK3

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

3. Atezolizumab (non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V

be continued after disease progression if the following criteria were met: clinical benefit from the treatment, no deterioration of the general condition due to disease progression, no disease progression that cannot be treated with permitted concomitant medication (e.g. leptomeningeal disease), patient consent. b. Toxicity-related dose adjustments up to treatment discontinuation were made without relevant deviations from the requirements of the SPC. c. Bisphosphonates were not excluded. Patients who had (...) Atezolizumab (non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Atezolizumab (kleinzelliges Lungenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 January 2020). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

4. Belimumab (SLE) - Benefit assessment according to §35a Social Code Book V

Belimumab (SLE) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Belimumab (systemischer Lupus erythematodes bei Kindern und Jugendlichen) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 February 2020). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports (...) – Commission No. A19-94 Belimumab (systemic lupus erythematosus in children and adolescents) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-94 Version 1.0 Belimumab (systemic lupus erythematosus in children and adolescents) 13 February 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Belimumab (systemic lupus erythematosus in children and adolescents

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Niraparib (ovarian cancer) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Niraparib (Ovarialkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 January 2020). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. A19-88 Niraparib (ovarian (...) cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-88 Version 1.0 Niraparib (ovarian cancer) 13 January 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Niraparib (ovarian cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency Federal Joint Committee Commission awarded on 15 October 2019 Internal Commission

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

6. Ibrutinib (new therapeutic indication, chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V

und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) IRC independent review committee IWCLL International Workshop on Chronic Lymphocytic Leukemia MedDRA Medical Dictionary for Regulatory Activities PFS progression-free survival PRAC Pharmacovigilance Risk Assessment Committee RAI radioactive iodine RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SLL small-cell lymphocytic lymphoma SMQ Standardized MedDRA (...) Ibrutinib (new therapeutic indication, chronic lymphocytic leukaemia) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ibrutinib (chronische lymphatische Leukämie) – Nutzenbewertung gemäß § 35a SGB V (Version 2.0; Status: 14 January 2020). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

7. Elotuzumab (multiple myeloma) - Benefit assessment according to §35a Social Code Book V

Elotuzumab (multiple myeloma) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Elotuzumab (multiples Myelom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 20 December 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. A19-80 Elotuzumab (...) (multiple myeloma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-80 Version 1.0 Elotuzumab (multiple myeloma) 20 December 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Elotuzumab (multiple myeloma) – Benefit assessment according to §35a Social Code Book V Commissioning agency Federal Joint Committee Commission awarded on 20 September 2019

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

8. Atezolizumab (NSCLC, combination chemotherapy with paclitaxel) - Benefit assessment according to §35a Social Code Book V

Atezolizumab (NSCLC, combination chemotherapy with paclitaxel) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Atezolizumab (NSCLC; Kombination mit Bevacizumab, Carboplatin und Paclitaxel) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 20 December 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely (...) authoritative and legally binding. Extract IQWiG Reports – Commission No. A19-83 Atezolizumab (NSCLC; combination with bevacizumab, carboplatin and paclitaxel) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-83 Version 1.0 Atezolizumab (NSCLC; combination with bevacizumab, carboplatin and paclitaxel) 20 December 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Cares

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Atezolizumab (breast cancer) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Atezolizumab (Mammakarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 20 December 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. 19-81 Atezolizumab (...) (breast cancer) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-81 Version 1.0 Atezolizumab (breast cancer) 20 December 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Atezolizumab (breast cancer) – Benefit assessment according to §35a Social Code Book V Commissioning agency Federal Joint Committee Commission awarded on 20 September 2019 Internal

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

10. Asfotase alfa (hypophosphatasia) - Benefit assessment according to §35a Social Code Book V

Asfotase alfa (hypophosphatasia) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Asfotase alfa (Hypophosphatasie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 January 2020). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. A19-89 (...) Asfotase alfa (hypophosphatasia) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-89 Version 1.0 Asfotase alfa (hypophosphatasia) 13 January 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Asfotase alfa (hypophosphatasia) – Benefit assessment according to §35a Social Code Book V Commissioning agency Federal Joint Committee Commission awarded on 15

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

11. Dolutegravir/lamivudine (HIV infection) - Benefit assessment according to §35a Social Code Book V

Dolutegravir/lamivudine (HIV infection) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dolutegravir/Lamivudin (HIV-Infektion) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 October 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission (...) No. A19-55 Dolutegravir/lamivudine (HIV infection) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-55 Version 1.0 Dolutegravir/lamivudine (HIV infection) 30 October 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dolutegravir/lamivudine (HIV infection) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

12. Ramucirumab (hepatocellular carcinoma) - Benefit assessment according to §35a Social Code Book V

Ramucirumab (hepatocellular carcinoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ramucirumab (hepatozelluläres Karzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission (...) No. A19-73 Ramucirumab (hepatocellular carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-73 Version 1.0 Ramucirumab (hepatocellular carcinoma) 28 November 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ramucirumab (hepatocellular carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

13. Ivacaftor (combination with ivacaftor/tezacaftor, cystic fibrosis, 12 years and older, with F508del mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V

Ivacaftor (combination with ivacaftor/tezacaftor, cystic fibrosis, 12 years and older, with F508del mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ivacaftor (Kombination mit Tezacaftor/Ivacaftor; zystische Fibrose, ab 12 Jahre, F508del-Mutation, heterozygot) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2019). Please note: This translation is provided as a service (...) by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A19-71 Ivacaftor (combination with tezacaftor/ivacaftor, cystic fibrosis, 12 years and older, F508del mutation, heterozygous) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-71 Version 1.0 Ivacaftor (with TEZA/IVA; CF, from 12 years, F508del mutation, heterozygous) 28 Nov 2019 Institute for Quality

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

14. Ivacaftor (combination with ivacaftor/tezacaftor, cystic fibrosis, 12 years and older, with F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V

Ivacaftor (combination with ivacaftor/tezacaftor, cystic fibrosis, 12 years and older, with F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ivacaftor (Kombination mit Tezacaftor/Ivacaftor; zystische Fibrose, ab 12 Jahre, F508del-Mutation, homozygot) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2019). Please note: This translation is provided as a service (...) by IQWiG to English- language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A19-70 Ivacaftor (combination with tezacaftor/ ivacaftor; cystic fibrosis, 12 years and older, with F508del mutation, homozygous) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-70 Version 1.0 Ivacaftor (with tezacaftor/ivacaftor; CF, 12 years and older, F508del mutation, homozygous) 28 November 2019

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

15. Ibrutinib (new therapeutic indication, Waldenström macroglobulinaemia) - Benefit assessment according to §35a Social Code Book V

Ibrutinib (new therapeutic indication, Waldenström macroglobulinaemia) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ibrutinib (Morbus Waldenström) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG (...) Reports – Commission No. A19-78 Ibrutinib (Waldenström macroglobulinaemia) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-78 Version 1.0 Ibrutinib (Waldenström macroglobulinaemia) 28 November 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ibrutinib (Waldenström macroglobulinaemia) – Benefit assessment according to §35a Social Code Book V

2020 Institute for Quality and Efficiency in Healthcare (IQWiG)

16. Development of scientific concepts for the generation of routine practice data and their analysis for the benefit assessment of drugs according to §35a Social Code Book V – rapid report

Development of scientific concepts for the generation of routine practice data and their analysis for the benefit assessment of drugs according to §35a Social Code Book V – rapid report 1 Translation of the executive summary of the rapid report A19-43 Konzepte zur Generierung versorgungsnaher Daten und deren Auswertung zum Zwecke der Nutzenbewertung von Arzneimitteln nach §35a SGB V (Version 1.0; Status: 10 January 2020). Please note: This translation is provided as a service by IQWiG (...) to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. A19-43 Concepts for the generation of routine practice data and their analysis for the benefit assessment of drugs according to §35a Social Code Book V (SGB V) 1 Extract of rapid report A19-43 Version 1.0 Routine practice data for the benefit assessment of drugs 10 January 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i

2020 Plant signaling & behavior

17. Patient safety and the annulment of medical clearance exams for hearing aids: Are we "closing the book" too soon? (Abstract)

Patient safety and the annulment of medical clearance exams for hearing aids: Are we "closing the book" too soon? To determine the utility of medical clearance exams by otolaryngologists prior to the distribution of hearing aids to patients with hearing loss.Medical records of 313 consecutive hearing-impaired individuals seeking financial assistance for hearing aids from the Lions Hearing Center of Michigan and who presented for medical clearance exams between January 2014 and May 2017 were (...) of patients with hearing loss prior to receiving hearing aids. With the impending arrival of over-the-counter hearing aids in the United States, special consideration should be placed on educating the general public about the importance of the medical evaluation prior to purchasing any type of hearing aid.Copyright © 2020 Elsevier Inc. All rights reserved.

2020 American Journal of Otolaryngology

18. The use of comic books, graphic novels, and fotonovelas as a health promotion tool

P, Rengifo J, Valverde I, et al. Effectiveness of a fotonovela for reducing depression and stress in Latino dementia family caregivers. Alzheimer Disease & Associated Disorders. 2015;29(2):146–53. Towey F. Conference: Comics and medicine. Lancet Oncology. 2014;15(9):927–8. Waite M. Writing medical comics. Journal of Visual Communication in Medicine. 2019;42(3):144–50. Suggested citation Rapid Response Service. The use of comic books, graphic novels, and fotonovelas as a health promotion tool (...) , and fotonovelas as health promotion tools (including HIV and STIs)? Key take-home messages Comics — including graphic novels, comic books, and fotonovelas — are one way to learn and teach about illness (1) as the reader can relate words and images to personal experience (2, 3). Generally, comics focused on health can fall into two different categories: memoirs about personal health or an experience of illness, and comics that consist of instructional content designed for education (4). The Undetectables

2020 Ontario HIV Treatment Network

19. Ipilimumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V

Abbreviation Meaning ACT appropriate comparator therapy AE adverse event AJCC American Joint Committee on Cancer CI confidence interval CTCAE Common Terminology Criteria for Adverse Events G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) EMA European Medicines Agency EQ-5D European Quality of Life-5 Dimensions FACT-G Functional Assessment of Cancer Therapy-General FKSI-DRS Functional Assessment of Cancer Therapy – Kidney Symptom Index – Disease-Related Symptoms IMDC International Metastatic Renal (...) Ipilimumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ipilimumab (Nierenzellkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 May 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A19-12 Ipilimumab

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

20. Melatonin (sleep disorders) - Benefit assessment according to §35a Social Code Book V

Melatonin (sleep disorders) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Melatonin (Schlafstörungen bei Kindern und Jugendlichen mit Autismus-Spektrum-Störung und/oder Smith-Magenis-Syndrom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 April 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely (...) authoritative and legally binding. IQWiG Reports – Commission No. A19-04 Melatonin (Insomnia in children and adolescents with autism spectrum disorder and/or Smith-Magenis syndrome) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-04 Version 1.0 Melatonin (Insomnia in children and adolescents with ASD and/or SMS) 11 April 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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