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21. Brivaracetam (epilepsy) - Benefit assessment in accordance with §35a Social Code Book V

and legally binding. IQWiG Reports – Commission No. A18-48 Brivaracetam (epilepsy in children and adolescents) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-48 Version 1.0 Brivaracetam (epilepsy in children and adolescents) 30 October 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Brivaracetam (epilepsy in children and adolescents) – Benefit (...) assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 30 July 2018 Internal Commission No.: A18-48 Address of publisher: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Im Mediapark 8 50670 Köln Germany Phone: +49 221 35685-0 Fax: +49 221 35685-1 E-mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A18-48 Version 1.0 Brivaracetam (epilepsy in children and adolescents) 30 October 2018 Institute

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Lenvatinib (hepatocellular carcinoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Lenvatinib (hepatozelluläres Karzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 13 February 2019). Please note: This document was translated by an external translator and 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. A18-57 Lenvatinib (hepatocellular carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-57 Version 1.1 Lenvatinib (hepatocellular carcinoma) 13 February 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Lenvatinib (hepatocellular carcinoma) – Benefit assessment according to §35a Social Code Book

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

23. Mepolizumab (asthma) - Benefit assessment according to §35a Social Code Book V

and legally binding. IQWiG Reports – Commission No. A18-58 Mepolizumab (asthma in adolescents and children aged 6 years and older) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-58 Version 1.0 Mepolizumab (asthma in adolescents and children aged 6 years and older) 20 December 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Mepolizumab (asthma (...) in adolescents and children aged 6 years and older) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 24 September 2018 Internal Commission No.: A18-58 Address of publisher: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Im Mediapark 8 50670 Köln Germany Phone: +49 221 35685-0 Fax: +49 221 35685-1 E-mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A18-58 Version 1.0 Mepolizumab (asthma

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

24. Ivacaftor (cystic fibrosis, 6 years and older, with gating mutations) - Benefit assessment according to §35a Social Code Book V

Ivacaftor (cystic fibrosis, 6 years and older, with gating mutations) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ivacaftor (zystische Fibrose, ab 6 Jahre, non- G551D Gating-Mutation) – 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. A19-66 Ivacaftor (cystic fibrosis, 6 years and older, non-G551D gating mutation) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-66 Version 1.0 Ivacaftor (cystic fibrosis, 6 years and older, non-G551D gating mutation) 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: Ivacaftor

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

25. The Influence of Presentation Format of Story on Narrative Production in Chinese Children Learning English-as-a-Second-Language: A Comparison Between Graphic Novel, Illustration Book and Text. (Abstract)

The Influence of Presentation Format of Story on Narrative Production in Chinese Children Learning English-as-a-Second-Language: A Comparison Between Graphic Novel, Illustration Book and Text. Past studies have shown that multimodal presentation of story can improve story-retelling performance in the first language. The purpose of the present study was to investigate whether similar multimedia effects can be observed in second language learning and graphic novel reading. A total of 51 Chinese (...) elementary school children, aged 7-8, who were learning English as a second language were recruited. They were randomly assigned to one of the three experimental conditions that differed in the format of story presentation: English text, English text with pictorial illustrations or graphic novel. After reading the same story, the children retold the story in English. The narratives produced were then rated by two independent raters. The results of group comparison showed that children from the three

2019 Journal of psycholinguistic research

26. Best practice for managing outpatient bookings

Best practice for managing outpatient bookings 1 Rapid Literature Review Best practice for managing outpatient bookings Citation Fiona Clay, Corey Joseph & Angela Melder. 2018. Best practice for managing outpatient bookings: Evidence Review. Centre for Clinical Effectiveness, Monash Health, Melbourne, Australia. Contact CCE@monashhealth.org Background Transformation of care at Monash Health is an organisation-wide program of work aiming to improve the efficiency of delivery and operations (...) of outpatient service delivery. The purpose of this is to inform the potential redesign of specialist outpatient services. To achieve this objective the review covered the following areas: ? Overview of approaches to outpatient services ? Referral management ? Appointment scheduling and booking ? Alternatives to Outpatient Appointments ? Management of waiting times ? Failure to attend ? Implementing patient-focused booking ? Follow-up ? Barriers to appointment booking ? Patient experience with specialist

2019 Monash Health Evidence Reviews

27. Ledipasvir/sofosbuvir (hepatitis C) ? Benefit assessment according to §35a Social Code Book V

Ledipasvir/sofosbuvir (hepatitis C) ? Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Ledipasvir/Sofosbuvir (chronische Hepatitis C bei Jugendlichen) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 November 2017). 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. A17-41 Ledipasvir/sofosbuvir (chronic hepatitis C in adolescents) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-41 Version 1.0 Ledipasvir/sofosbuvir (chronic hepatitis C in adolescents) 13 November 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ledipasvir/sofosbuvir (chronic hepatitis C in adolescents) – Benefit

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

28. Sofosbuvir (hepatitis C in adolescents) - Benefit assessment according to §35a Social Code Book V

viral hepatitis C in children and adolescents: UK experience. Arch Dis Child 2014; 99(6): 505-510. 21. Bortolotti F, Indolfi G, Zancan L, Giacchino R, Verucchi G, Camma C et al. Management of chronic hepatitis C in childhood: the impact of therapy in the clinical practice during the first 2 decades. Dig Liver Dis 2011; 43(4): 325-329. 22. Jonas MM, Balistreri W, Gonzalez-Peralta RP, Haber B, Lobritto S, Mohan P et al. Pegylated interferon for chronic hepatitis C in children affects growth and body (...) therapy in children with chronic hepatitis C infection. Pediatr Infect Dis J 2008; 27(2): 142-148. 17. Sokal EM, Bourgois A, Stephenne X, Silveira T, Porta G, Gardovska D et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection in children and adolescents. J Hepatol 2010; 52(6): 827-831. Extract of dossier assessment A17-55 Version 1.0 Sofosbuvir (chronic hepatitis C in adolescents) 11 January 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - 23 - 18. Wirth

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

29. Glycopyrronium bromide (sialorrhoea) - Benefit assessment according to §35a Social Code Book V

? Carolin Weigel ? Beate Wieseler Keywords: glycopyrrolate, sialorrhoea, child, adolescent, benefit assessment Extract of dossier assessment A18-22 Version 1.0 Glycopyrronium bromide (sialorrhoea) 27 June 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - 1 - Executive summary of the benefit assessment Background In accordance with §36a Social Code Book (SBG) V, the Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to assess (...) Glycopyrronium bromide (sialorrhoea) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Glycopyrroniumbromid (Sialorrhö) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 June 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

30. Emicizumab (haemophilia A) - Benefit assessment according to §35a Social Code Book V

; cohort B: n = 10) and continued their treatment from before the start of the study. HAVEN 2 is a single-arm, multicentre approval study of emicizumab for paediatric patients. The study included children (< 12 years of age) and adolescents (12 to 17 years of age, < 40 kg body weight) previously treated with bypassing agents who had congenital haemophilia A and high-titre factor VIII inhibitors (= 5 BU) in their medical history (N = 63). The company states that the before-and-after comparisons (...) Emicizumab (haemophilia A) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Emicizumab (Hämophilie A) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 June 2018). Please note: This document was translated by an external translator and 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

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

31. Hydrocortisone (adrenal insufficiency) - Benefit assessment according to §35a Social Code Book V

Balg ? Gertrud Egger ? Tatjana Hermanns ? Katharina Hirsch ? Vjollcë Olluri ? Ulrike Seay ? Volker Vervölgyi Keywords: hydrocortisone, adrenal insufficiency, child, adolescent, benefit assessment Extract of dossier assessment A18-29 Version 1.0 Hydrocortisone (adrenal insufficiency in children) 10 August 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - 1 - Executive summary of the benefit assessment Background In accordance with §35a Social Code Book (SBG) V, the Federal Joint (...) authoritative and legally binding. IQWiG Reports – Commission No. A18-29 Hydrocortisone (adrenal insufficiency in children) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-29 Version 1.0 Hydrocortisone (adrenal insufficiency in children) 10 August 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Hydrocortisone (adrenal insufficiency in children

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

32. The Effect of e-Book Vocabulary Instruction on Spanish-English Speaking Children. Full Text available with Trip Pro

The Effect of e-Book Vocabulary Instruction on Spanish-English Speaking Children. This study aimed to examine the effect of an intensive vocabulary intervention embedded in e-books on the vocabulary skills of young Spanish-English speaking English learners (ELs) from low-socioeconomic status backgrounds.Children (N = 288) in kindergarten and 1st grade were randomly assigned to treatment and read-only conditions. All children received e-book readings approximately 3 times a week for 10-20 weeks (...) using the same books. Children in the treatment condition received e-books supplemented with vocabulary instruction that included scaffolding through explanations in Spanish, repetition in English, checks for understanding, and highlighted morphology.There was a main effect of the intervention on expressive labeling (g = 0.38) and vocabulary on the Peabody Picture Vocabulary Test-Fourth Edition (g = 0.14; Dunn & Dunn, 2007), with no significant moderation effect of initial Peabody Picture Vocabulary

2018 Journal of speech, language, and hearing research : JSLHR Controlled trial quality: uncertain

33. Parental Book Reading and Social-Emotional Outcomes for Head Start Children in Foster Care. (Abstract)

Parental Book Reading and Social-Emotional Outcomes for Head Start Children in Foster Care. This study examines the associations between parental book reading and social-emotional outcomes for Head Start children in foster care. Despite no main Head Start impact on parental book reading, subgroup effects were found. Foster parents in Head Start provided more book reading for children with disabilities but less for children with low preacademic scores. Head Start enhanced social-emotional (...) outcomes for children in foster care. The positive impacts of Head Start on children's social-emotional outcomes were greater when parents read books frequently. Head Start should include more foster families and provided parenting skills to enhance social-emotional outcomes for children in foster care.

2018 Social work in public health Controlled trial quality: uncertain

34. Don't Judge a Book by Its Cover: Factitious Disorder Imposed on Children-Report on 2 Cases Full Text available with Trip Pro

Don't Judge a Book by Its Cover: Factitious Disorder Imposed on Children-Report on 2 Cases Factitious Disorder Imposed on Another (FDIA), also known as Munchausen Syndrome by Proxy (MSbP) is a very serious form of child abuse. The perpetrator, usually the mother, invents symptoms or causes real ones in order to make her child appear sick. Usually this is due to a maladaptive disorder or to an excessive of attention-seeking on her part. We report here two new cases of FDIA. The first one is a 9

2018 Frontiers in pediatrics

35. A didactic approach to presenting verbal and visual information to children participating in research protocols: the comic book informed assent Full Text available with Trip Pro

A didactic approach to presenting verbal and visual information to children participating in research protocols: the comic book informed assent When children participate in research protocols, consent (by a parent or legal guardian) and assent (by the children) must be given. Understanding research protocols can be challenging for an adult and even more difficult for a child. The aim of this study was to describe the development of a comic book created to facilitate children's understanding (...) of informed assent with clear and simple language.Five researchers with scores above seven according to the Fehring criteria developed the comic book, avoiding the use of technical terminology. Twenty children between 7 and 12 years old, and enrolled in a larger study, responded using a Likert scale and questions about the clarity of texts and illustrations. The final version met National Health System Resolutions (Resoluções do Conselho Nacional da Saúde - CNS n° 196/1996 and 466/2012).The comic book

2018 Clinics

36. Association between availability of children’s book and the literacy-numeracy skills of children aged 36 to 59 months: secondary analysis of the UNICEF Multiple-Indicator Cluster Surveys covering 35 countries Full Text available with Trip Pro

Association between availability of children’s book and the literacy-numeracy skills of children aged 36 to 59 months: secondary analysis of the UNICEF Multiple-Indicator Cluster Surveys covering 35 countries Stimulating home environments that have children's books, pictures and play toys facilitate caregiver-child interactions and enhance children's development. Although this has been demonstrated in small-scale intervention studies, it is important to document whether book ownership (...) . The main exposure was availability of children's book to the child within household. Analysis considered the survey design, assessed and ranked risk ratios of being on track, adjusting for potential confounders such as child's age (in months), maternal education, household wealth index quintile and area of residence (rural/urban). Ecological analysis was performed using meta-regression after grouping countries by World Bank income groups (low- to high-income).Only half (51.8%) of children from all

2018 Journal of global health

37. Effect of Augmented Reality Books on Cortisol Levels in Hospitalized Pediatric Patients

in hospitalized children. Condition or disease Intervention/treatment Phase Hospitalized Child Other: Augmented Reality Other: Non Augmented Reality Not Applicable Detailed Description: Background: Acute stress produced by hospitalization has a direct impact on the patient's recovery. Increased cortisol levels, the biomarker of stress, have been associated to poor health outcomes, especially on pediatric patients. Stress management in the hospital environment is essential to lower the effects (...) Pediatric Patients: a Cross-over Study. Actual Study Start Date : June 5, 2018 Estimated Primary Completion Date : August 2018 Estimated Study Completion Date : December 2018 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Augmented Reality (AR) Books with augmented reality plus an electronic tablet. Other: Augmented Reality Augmented reality children books. The books will have special

2018 Clinical Trials

38. Randomized Trial of a Children's Book Versus Brochures for Safe Sleep Knowledge and Adherence in a High-Risk Population. (Abstract)

Randomized Trial of a Children's Book Versus Brochures for Safe Sleep Knowledge and Adherence in a High-Risk Population. Sleep-related infant deaths have plateaued in the past decade, disproportionately affecting low socioeconomic status (SES) families. Printed materials are widely used for anticipatory guidance, yet none for safe sleep has been studied. We tested the efficacy of a specially designed children's book compared to brochures for safe sleep knowledge and adherence, which we (...) hypothesized would be greater due to superior readability and engagement.This randomized controlled trial involved low-SES mothers (n = 282) enrolled in a home visiting program. Home visitors (n = 56) were randomly assigned to perform safe sleep teaching and assessments during 3 visits: third trimester, 1 week old, and 2 months old, exclusively utilizing a specially designed children's book or brochures, and surveys incorporating the American Academy of Pediatrics' safe sleep recommendations. Outcomes were

2018 Academic pediatrics Controlled trial quality: uncertain

39. Rilpivirine (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V

Rilpivirine (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Rilpivirin (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 March 2016). 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. A15 (...) -55 Rilpivirine (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-55 Version 1.0 Rilpivirine (new TI) – Benefit assessment acc. to §35a Social Code Book V 30 March 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Rilpivirine (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

40. Insulin degludec (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Grouven ? Thomas Kaiser ? Marco Knelangen ? Sarah Mostardt ? Ulrike Seay 1 Due to legal data protection regulations, employees have the right not to be named. Keywords: insulin degludec, diabetes mellitus – type 1, child, adolescent, benefit assessment Extract of dossier assessment A15-10 – Benefit assessment acc. to §35a SGB V Version 1.0 Insulin degludec – type 1 diabetes mellitus (children and adolescents) 28 May 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - I.iii - Table (...) diabetes mellitus (children and adolescents) 28 May 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - I.1 - I 2 Benefit assessment I 2.1 Executive summary of the benefit assessment Background In accordance with §35a Social Code Book (SGB) V, the Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to assess the benefit of the drug insulin degludec. The assessment was based on a dossier compiled by the pharmaceutical company

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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