Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation

Background: Psoriasis is a chronic inflammatory disease that predominantly affects the skin. Adalimumab (HUMIRA®, AbbVie, Maidenhead, UK), etanercept (Enbrel®, Pfizer, New York, NY, USA) and ustekinumab (STELARA®, Janssen Biotech, Inc., Titusville, NJ, USA) are the three biological treatments currently licensed for psoriasis in children. Objective: To determine the clinical effectiveness and cost-effectiveness of adalimumab, etanercept and ustekinumab within their respective licensed indications for the treatment of plaque psoriasis in children and young people. Data sources: Searches of the literature and regulatory sources, contact with European psoriasis registries, company submissions and clinical study reports from manufacturers, and previous National Institute for Health and Care Excellence (NICE) technology appraisal documentation. Review methods: Included studies were summarised and subjected to detailed critical appraisal. A network meta-analysis incorporating adult data was developed to connect the effectiveness data in children and young people and populate a de novo decision-analytic model. The model estimated the cost-effectiveness of adalimumab, etanercept and ustekinumab compared with each other and with either methotrexate or best supportive care (BSC), depending on the position of the intervention in the management pathway. Results: Of the 2386 non-duplicate records identified, nine studies (one randomised controlled trial for each drug plus six observational studies) were included in the review of clinical effectiveness and safety. Etanercept and ustekinumab resulted in significantly greater improvements in psoriasis symptoms than placebo at 12 weeks’ follow-up. The magnitude and persistence of the effects beyond 12 weeks is less certain. Adalimumab resulted in significantly greater improvements in psoriasis symptoms than methotrexate for some but not all measures at 16 weeks. Quality-of-life benefits were inconsistent across different measures. There was limited evidence of excess short-term adverse events; however, the possibility of rare events cannot be excluded. The majority of the incremental cost-effectiveness ratios for the use of biologics in children and young people exceeded NICE’s usual threshold for cost-effectiveness and were reduced significantly only when combined assumptions that align with those made in the management of psoriasis in adults were adopted. Limitations: The clinical evidence base for short- and long-term outcomes was limited in terms of total participant numbers, length of follow-up and the absence of young children. Conclusions: The paucity of clinical and economic evidence to inform the cost-effectiveness of biological treatments in children and young people imposed a number of strong assumptions and uncertainties. Health-related quality-of-life (HRQoL) gains associated with treatment and the number of hospitalisations in children and young people are areas of considerable uncertainty. The findings suggest that biological treatments may not be cost-effective for the management of psoriasis in children and young people at a willingness-to-pay threshold of £30,000 per quality-adjusted life-year, unless a number of strong assumptions about HRQoL and the costs of BSC are combined. Registry data on biological treatments would help determine safety, patterns of treatment switching, impact on comorbidities and long-term withdrawal rates. Further research is also needed into the resource use and costs associated with BSC. Adequately powered randomised controlled trials (including comparisons against placebo) could substantially reduce the uncertainty surrounding the effectiveness of biological treatments in biologic-experienced populations of children and young people, particularly in younger children. Such trials should establish the impact of biological therapies on HRQoL in this population, ideally by collecting direct estimates of EuroQol-5 Dimensions for Youth (EQ-5D-Y) utilities. Study registration: This study is registered as PROSPERO CRD42016039494. Funding: The National Institute for Health Research Health Technology Assessment programme

Assessment or referral tool: the unintended consequences of a dual purpose common assessment framework form

The Common Assessment Framework (CAF) was designed to facilitate early intervention through multi-agency working and the active involvement of families. The underlying principle was to move away from a risk-focused, needs-led or service-led culture to assess need and match needs to identified services. It was anticipated that services and assessments would become more evidence-based, and a common language between professionals and agencies would evolve. Taking a social constructionist approach this study explored professionals’ experiences of the use of the Common Assessment Framework form. Forty-one professionals from four different local authorities and a variety of agencies took part in semi-structured interviews. Data were analyzed utilizing thematic analysis. Findings suggest the unintended consequences of the use of the CAF were influenced by local authority policy. As the local authorities adopted the policy of utilizing the CAF as a referral mechanism, rather than to assess needs, profes-sionals unintentionally perceived the CAF form as a referral tool, to refer families to existing service provision. Further to this, professionals referred to the CAF form itself, as a ‘means to an end’, implying that this was a step that had to be overcome in order to access services

A Comparative Analysis of Competency Frameworks for Youth Workers in the Out-of-School Time Field

Research suggests that the quality of out-of-school time (OST) programs is related to positive youth outcomes and skilled staff are a critical component of high quality programming. This descriptive case study of competency frameworks for youth workers in the OST field demonstrates how experts and practitioners characterize a skilled youth worker. A comparative analysis of 11 competency frameworks is conducted to identify a set of common core competencies. A set of 12 competency areas that are shared by existing frameworks used in the OST field are identified. The age of youth being served, descriptions of mastery for each competency area, an emphasis on developing mid-level managers, and incorporating research emerge as factors that should be addressed in future competency frameworks

24 Groups to Secretary Austin: Make Amends for Civilian Harm in Somalia

The undersigned Somali and international human rights and protection of civilians organizations write to request that you take immediate steps to address the requests of families whose loved ones were killed or injured by US airstrikes in Somalia. New reporting illustrates how in multiple cases of civilian harm in Somalia confirmed by the US government, civilian victims, survivors, and their families have yet to receive answers, acknowledgement, and amends despite their sustained efforts to reach authorities over several years

National Survey of Children

A detailed determination of the situation of children by means of 5 questionnaires. 1. Survey of parents about their background and the surroundings in which their child is growing up. 2. Survey of parents on their educational goals, supervision of the child and the child-parent relationship. 3. The situation and conduct of the child from the view of the parents. 4. Survey of the child about his situation, social contacts, self-image, family relations, school questions and personal attitudes. 5. Survey of the teacher on school achievement as well as characterization of the child. Topics: 1. Parent survey about their personal background and description of the social surroundings in which the child is growing up: number of marriages up to now; duration and reason for dissolution of earlier marriages; number of children and ages of the children; regional and social origins; city size of place of birth; condition of health, primary occupation, employment intents and time of last employment of mother; characterization of job; these questions were also answered for the father. 2. Questions on upbringing and supervision of the children: primary person raising or supervising the child; place of upbringing and supervision; costs for supervision and satisfaction with current supervision; importance of religious instruction of children; regional mobility and number of changes of residence in the last 5 years; length of current local residency; the significance of environmental stress and crime in the neighborhood as reason to move; judgement on the neighborhood as surroundings for child-raising; judgement on local infrastructure facilities in view of the child; preferred institutions for sick care; housing situation and size of residence; monthly housing costs; most important source of income; frequency of money difficulties; manner of organization of leisure time and activities together with the child; educational goals; sanction practices; marriage conflicts and judgement on one´s own marriage; frequency of expressions of affection to the child as well as reasons for refusal; frequency of phases of nervousness and sadness of child; frequency of being fed up with the family and personal uncontrolled conduct regarding the child; perceptions of stress or boredom; significance of children for personal life up to now; judgement on the importance of upbringing as help in life for the child; general contentment with life. 3. Parent information about current situation of the child: serious injuries or accidents of the child; current condition of health; number of visits to the doctor; information on development in school; number of classes repeated and times of absence; discipline or behavior problems in school; desired educational level; number of playmates and familiarity of the friends with parents; assessment of sociability; satisfaction with general conduct of child in comparison to others; independence and learning ability; frequency of running away; psychological characterization of child (scale); medical treatments due to behavior disturbances and use of psychiatric drugs; athletic and artistic activities; time budget of child for television, homework, playing and contact with parents; most difficult child-raising period; current psychological closeness to child and expected changes; general judgement on the being of the child; number of pregnancies up to now; problems during pregnancy; desired pregnancy. 4. Survey of the child: leisure behavior and duties in household; boredom afternoons; preferred hobbies and leisure activities; frequency of playing without supervision; number of friends and characterization of them according to race and sex; trouble with friends; assessment of personal popularity among playmates; playing alone and feeling of loneliness; possession of a ´best friend´ and desire for more friends; judgement on the neighborhood and surroundings; information on ´current mother´ or reference person; detailed judgement on the upbringing style of mother as well as the upbringing style of father; relation to siblings; judgement on one´s own health; relationship with doctor; pretending illness; assessment of personal appearance and strength in comparison with other children; self-assessment of personal advantages and disadvantages; occupation desire; famous model; knowledge about current US president and preferred president; attitude to a woman or a Black as US president; frequency of concerns and fears; fear situations; ability to interpret correctly facial expressions in the form of sample pictures presented; conditions of great anxiety; modesty; conditions of great pleasure; general contentment with life; attitude to school; judgement on one´s own strength of achievement; favorite subjects; number of teachers and relation to home-room teacher; fights with classmates; difficulties with teachers due to such fights; interest in homework and help with homework; desire for change of school. Interviewer rating: for this part of the survey extensive information was recorded by the interviewer: presence of other persons and their relationship with the child; assessment of the intensity of listening during the interview and intervention by this person; physical appearance of respondent; assessment of intelligence and spontaneity of respondent; problems in communication; attention and willingness of respondent to cooperate; judgement on reliability of responses; assessment of shyness of the child; general atmosphere in household; place of stay during the interview; judgement on residence furnishings; equipped with books, media, pictures and games; type of building; description of residential surroundings; assessment of social class of family. 5. Teacher survey: judgement on strength of achievement and learning progress of the child; most important improvement measures; number of days absent and reasons for this; discipline and behavior problems; assessment of relationship of child to teachers and classmates; judgement on physical and psychological condition of health; characterization of child (scale); available background information about the child; achievements of the child on standardized reading, mathematics and intelligence tests; school grades and most important support measures for the child; general judgement on the child; length of knowing the child; place of education and education degree as well as duration of occupation of the teacher; assessment of the primary cultural background of the teacher.Eine detaillierte Ermittlung der Situation der Kinder mittels 5 Fragebögen. 1. Befragung der Eltern über ihren Hintergrund und das Umfeld, in dem ihr Kind aufwächst. 2. Befragung der Eltern zu ihren Erziehungszielen, der Beaufsichtigung des Kindes und dem Kind-Eltern-Verhältnis. 3. Die Situation und das Verhalten des Kindes in der Sicht der Eltern. 4. Befragung des Kindes über seine Situation, seine sozialen Kontakte, sein Selbstbild, die Familienbeziehungen, schulische Fragen und persönliche Einstellungen. 5. Befragung des Lehrers zu den schulischen Leistungen sowie zur Charakterisierung des Kindes. Themen: 1.) Elternbefragung über ihren eigenen Hintergrund und Beschreibung des sozialen Umfelds, in dem das Kind aufwächst: Anzahl bisheriger Ehen; Dauer und Auflösungsgrund für frühere Ehen; Kinderzahl und Alter der Kinder; regionale und soziale Herkunft; Ortsgröße des Geburtsortes; Gesundheitszustand, Hauptbeschäftigung, Berufsabsichten und Zeitpunkt der letzten Beschäftigung der Mutter; Charakterisierung der Arbeit; die bisherigen Fragen wurden auch für den Vater beantwortet. 2.) Fragen zur Erziehung und Beaufsichtigung der Kinder: Hauptsächliche Erziehungs- bzw. Beaufsichtigungsperson des Kindes; Ort der Erziehung und Beaufsichtigung; Kosten für die Beaufsichtigung und Zufriedenheit mit der derzeitigen Beaufsichtigung; Wichtigkeit religiöser Unterweisung der Kinder; regionale Mobilität und Anzahl der Wohnungswechsel in den letzten 5 Jahren; Dauer der jetzigen Ortsansässigkeit; die Bedeutung von Umweltbelästigungen und Kriminalität in der Nachbarschaft als Umzugsgründe; Beurteilung der Nachbarschaft als Erziehungsumfeld; Beurteilung der örtlichen Infrastruktureinrichtungen im Hinblick auf das Kind; präferierte Institutionen für die Krankenbehandlung; Wohnsituation und Wohnungsgröße; monatliche Wohnkosten; wichtigste Einkommensquellen; Häufigkeit von Geldschwierigkeiten; Art der Freizeitgestaltung und der gemeinsamen Aktivitäten mit dem Kind; Erziehungsziele; Sanktionsverhalten; Ehekonflikte und Beurteilung der eigenen Ehe; Häufigkeit von Liebeszuwendungen gegenüber dem Kind sowie Gründe für eine Verweigerung; Häufigkeit von Phasen der Nervosität und Traurigkeit des Kindes; Häufigkeit von Familienüberdrüssigkeit und eigenem unkontrollierten Verhalten gegenüber dem Kind; Streßempfindungen oder Langeweile; Bedeutung der Kinder für das bisherige eigene Leben; Beurteilung der Wichtigkeit von Erziehung als Lebenshilfe für das Kind; allgemeine Lebenszufriedenheit. 3.) Elternangaben über die derzeitige Situation des Kindes: Schwere Verletzungen bzw. Unfälle des Kindes; derzeitiger Gesundheitszustand; Anzahl der Arztbesuche; Angaben über die Entwicklung in der Schule; Anzahl der Klassenwiederholungen und Abwesenheitszeiten; Disziplin- oder Verhaltensprobleme in der Schule; gewünschter Ausbildungsabschluß; Anzahl der Spielkameraden und Bekanntheit der Freunde bei den Eltern; Einschätzung der Kontaktfreudigkeit; Zufriedenheit mit dem allgemeinen Verhalten des Kindes im Vergleich zu anderen; Selbständigkeit und Lernfähigkeit; Ausreißhäufigkeit; psychologische Charakterisierung des Kindes (Skala); ärztliche Behandlungen wegen Verhaltensstörungen und Anwendung von Psychopharmaka; sportliche und künstlerische Aktivitäten; Zeitbudget des Kindes für Fernsehen, Hausaufgaben, Spielen und Elternkontakte; schwierigste Erziehungsperiode; derzeitige psychologische Nähe zum Kind und erwartete Änderungen; allgemeine Beurteilung des Wesens des Kindes; Anzahl der bisherigen Schwangerschaften; Probleme während der Schwangerschaft; gewünschte Schwangerschaft. 4.) Befragung des Kindes: Freizeitverhalten und Pflichten im Haushalt; Langeweile an Nachmittagen; präferierte Hobbies und Freizeitbeschäftigungen; Häufigkeit des Spielens ohne Aufsicht; Anzahl der Freunde und Charakterisierung dieser nach Rasse und Geschlecht; Ärger mit den Freunden; Einschätzung der eigenen Beliebtheit bei den Spielkameraden; Spielen alleine und Gefühl der Einsamkeit; Besitz eines "besten Freundes" und Wunsch nach mehr Freunden; Beurteilung der Nachbarschaft und Umgebung; Angabe der "derzeitigen Mutter" bzw. Bezugsperson; detaillierte Beurteilung des Erziehungsstils der Mutter sowie des Erziehungsstils des Vaters; Beziehung zu den Geschwistern; Beurteilung der eigenen Gesundheit; Verhältnis zum Arzt; Vortäuschen von Krankheiten; Einschätzung des eigenen Aussehens und der Stärke im Vergleich zu anderen Kindern; Selbsteinschätzung der eigenen Vorteile und Nachteile; Berufswunsch; berühmtes Vorbild; Kenntnis des derzeitigen US-Präsidenten und präferierter Präsident; Einstellung zu einer Frau oder zu einem Schwarzen als US-Präsident; Häufigkeit von Sorgen und Ängsten; Angstsituationen; Fähigkeit, Gesichtsausdrücke in Form von vorgelegten Bildvorlagen richtig zu deuten; Zustände großer Ängstlichkeit; Schamhaftigkeit; Zustände großer Freude; allgemeine Lebenszufriedenheit; Einstellung zur Schule; Beurteilung der eigenen Leistungsstärke; Lieblingsfächer; Anzahl der Lehrer und Beziehung zum Klassenlehrer; Prügeleien mit Klassenkameraden; Schwierigkeiten mit den Lehrern wegen solcher Prügeleien; Interesse an den Hausaufgaben und Hilfe bei der Erstellung der Hausaufgaben; Wunsch nach Schulwechsel. Interviewerrating: Zu diesem Befragungsteil wurde eine umfangreiche Feststellung durch den Interviewer vorgenommen: Anwesenheit anderer Personen und ihr Verwandtschaftsgrad zum Kind; Einschätzung der Intensität des Zuhörers beim Interview und Eingriffe durch diese Person; physische Erscheinung des Befragten; Einschätzung der Intelligenz und der Spontanität des Befragten; Probleme bei der Verständigung; Kooperationsbereitschaft und Aufmerksamkeit des Befragten; Beurteilung der Zuverlässigkeit der Antworten; Einschätzung der Schüchternheit des Kindes; allgemeine Atmosphäre im Haushalt; Aufenthaltsort während des Interviews; Beurteilung der Wohnungseinrichtung; Ausstattung mit Büchern, Medien, Bildern und Spielen; Haustyp; Beschreibung des Wohnumfelds; Einschätzung der Schichtzugehörigkeit der Familie. 5.) Lehrerbefragung: Beurteilung der Leistungsstärke und Lernfortschritte des Kindes; wichtigste Verbesserungsmaßnahmen; Anzahl der Fehltage und Gründe dafür; Disziplin- und Verhaltensprobleme; Einschätzung des Verhältnisses des Kindes zu den Lehrern und Mitschülern; Beurteilung des physischen und psychischen Gesundheitszustands; Charakterisierung des Kindes (Skala); vorhandene Hintergrundinformationen über das Kind; Leistungen des Kindes in standardisierten Lese-, Mathematik- und Intelligenztests; Schulnoten und wichtigste Förderungsmaßnahmen für das Kind; allgemeine Beurteilung des Kindes; Dauer des Kennens des Kindes; Ausbildungsstätte und Ausbildungsabschlüsse sowie Tätigkeitsdauer des Lehrers; Einschätzung des hauptsächlichen kulturellen Hintergrunds des Lehrers