ThemenCheck Medizin (IQWIG): Depression in children and adolescents - Does psychotherapy lead to better results compared to other therapies? (HT19-04) (Health Economics and Ethics)

Duration: January 2020 – September 2020
Language: German
In co-operation with: Department for Evidence Based Medicine / DUK

Background: Across Germany, children and adolescents with mental health problems rarely seek psychological help (11.8% of children and adolescents classified as borderline symptomatic and 18.6% of those classified as symptomatic seek mental health help [1]). Even when parents explicitly stated that their child had been diagnosed with mental illness, psychological, psychotherapeutic or psychiatric treatment was only sought in about half of the cases [2].

The criteria for the diagnosis of a depressive episode are met if at least 2 of the following 3 core symptoms are present for at least 2 weeks: a clear and persistent depressive mood, a limited sense of joy, desire and interests (anhedonia) and listlessness (according to ICD-10-GM, version 2020 [3]). Other symptoms of depression include low self-confidence and self-esteem, self-reproach and guilt, suicidal thoughts and behaviour, difficulty concentrating and making decisions, psychomotoric restlessness or inhibitions, sleeping problems and reduced or increased appetite [4]. The manifestation of depressive disorder in adolescence has been well researched; its symptoms are similar to those already cited for depression in general. In children, on the other hand, somatic symptoms, such as headaches and abdominal pain, are the most common. They often overlap with anxiety disorders and social insecurity [5].

In the course of the ThemenCheck Medizin, IQWiG collects inquiries on health topics from German citizens every year. Subsequently, a selection of proposed topics is put out to tender for processing as a HTA (Health Technology Assessment). This present HTA is to investigate whether psychotherapy is more effective than other interventions in children and adolescents with depression. In addition to an assessment of the effectiveness and safety of psychotherapy, health economic, ethical, legal, social and organisational aspects related to this intervention will be investigated.

Project objectives (Health Economics and Ethics):

• determining the costs (intervention costs) incurred by a (i) treatment with psychotherapy or (ii) treatment with psychotherapy as an "add-on" compared to (iii) active wait-and-see support, (iv) treatment with antidepressants, (v) treatment with other non-drug therapies, and (vi) no treatment in children and adolescents (? 18 years) with depression
• evaluating the cost-effectiveness of (i) treatment with psychotherapy or (ii) treatment with psychotherapy as an "add-on" compared to (iii) active wait-and-see support, (iv) treatment with antidepressants, (v) treatment with other non-drug therapy, and (vi) no treatment in children and adolescents (? 18 years) with depression, and
• the processing of ethical aspects associated with (i) treatment with psychotherapy or (ii) treatment with psychotherapy as an "add-on

Research question (full report):

• Does psychotherapy in children and adolescents with depression lead to better results compared to other therapies?

Methods:

Health Economics

To determine the intervention costs, the average consumption of resources is determined, which is directly necessary when applying the investigative and comparison intervention. In addition to the trial and comparison intervention, the services directly associated with the application are also taken into account. As far as possible, the relevant regulated or negotiated prices - for example from the database of the Information Agency for Medical Specialities (IFA), the Uniform Valuation Standard (EBM), the Diagnosis-Related Groups Catalogue (DRG Catalogue) - or similarly suitable lists from the pension insurance scheme or the Federal Statistical Office (DESTATIS) are used for the services incurred. In the case of services that are not subject to clear regulation or price negotiations and that cannot be identified by database searches, inquiries are made to service providers. In case of ambiguities in the treatment plan and procedure, the clinical expert who is involved in this HTA is consulted. If a therapy lasts longer than 1 year, the average costs per patient and year are given. Reimbursable and non-reimbursable costs are shown separately. If the prices and costs collected do not relate to the year under review (2020), they are adjusted for inflation using the Harmonized Consumer Price Index of the German Federal Statistical Office [6].

In the systematic review of health economic studies, comparative cost-effectiveness studies are included [7], i.e. cost-effectiveness/effectiveness analyses, cost-utility analyses or cost-benefit analyses (in the narrower sense). Primary sources of information are the bibliographic databases Medline, Embase and HTA Database. Further sources of information: Views of reference lists of identified systematic reviews, consultation on the preliminary HTA report and author inquiries. All information necessary for the evaluation is extracted from the documents of the included publications into standardized tables. One person extracts the data, a second person reviews them. The evaluation of the reporting quality of the health economic studies considered is based on the criteria of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS statement) [8]. The assessment of the methodological quality of health economic studies based on decision-analytical models is based on the ISPOR checklist ("Assessing the Evidence for Health Care Decision Makers") [9]. The evaluation of the transferability/generalisability of results is based on the criteria of the European network for Health Technology Assessment (EUnetHTA) HTA Adaptation Toolkit [10].

Ethics:

In a first step, a collection of possible ethically relevant arguments and aspects is compiled in the Hofman questionnaire [11]. Subsequently, a systematic literature search for primary literature is carried out in the databases CINAHL, EthiscWeb, EthxWeb, PsychInfo, and Medline. The following documents are checked for possible ethical arguments: studies included in the benefit assessment studies included in the health economic evaluation, protocol to document the discussion with the interviewed stakeholders.

Information from all information sources of the systematic searches are screened by 1 person for statements on ethical arguments and aspects of the technology under investigation. The result is quality assured by a 2nd person. All arguments and aspects necessary for the information processing are extracted in tables and processed with the help of Hofmann's questionnaire.

PICO (Basis report incl. Health Economics and Ethics):

Schedule/Milestones:

References:

[1]           Wölfle S, Jost D, Oades R, Schlack R, Hölling H, Hebebrand J. Somatic and mental health service use of children and adolescents in Germany (KiGGS-study). European Child & Adolescent Psychiatry 2014; 23(9): 753-764.

[2]           Ravens-Sieberer U, Wille N, Bettge S, Erhart M. Psychische Gesundheit von Kindern und Jugendlichen in Deutschland. Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz. 2007; 50(5): 871-878.

[3]           Deutsches Institut für Medizinische Dokumentation und Information (DIMDI). Internationale statistische Klassifikation der Krankheiten und verwandter Gesundheitsprobleme, 10. Revision (ICD-10-GM Version 2020) [online]. [Zugriff: 30.01.2020]. URL: https://www.dimdi.de/static/de/klassifikationen/icd/icd-10-gm/kode- suche/htmlgm2020/.

[4]          Petermann F. Depressive Kinder und Jugendliche. Monatsschr Kinderheilkd 2011; 159(10): 985-994.

[5]           Petermann F. Depressive Störungen im Kindes- und Jugendalter. Gesundheitswesen 2012; 74(08/09): 533-540. 533.

[6]           Statistisches Bundesamt (DE-Statis). Harmonisierter Verbraucherpreisindex (inkl. Veränderungsraten) [online]. [Zugriff: 06.02.2020]. URL: https://www-genesis.destatis.de/genesis//online/data?operation=table&code=61121-0001&levelindex=0&levelid=1580977447721

 [7]           Drummond MF, Sculpher MJ, Claxton K, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes. Oxford: Oxford University Press; 2015.

[8]           Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. Int J Technol Assess Health Care 2013; 29(2): 117-122.

[9]          International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Assessing the Evidence for Health Care Decision Makers [online]. [Zugriff: 06.02.2020]. URL: https://www.healthstudyassessment.org/.

[10]           European Network for Health Technology Assessment. EUnetHTA HTA adaptation toolkit: work package 5; version 5 [online]. 10.2011 [Zugriff: 29.10.2019]. URL: https://www.eunethta.eu/wp- content/uploads/2011/01/EUnetHTA_adptation_toolkit_2011_version_5.pdf.

[11]           Hofmann B, Droste S, Oortwijn W, Cleemput I, Sacchini D. Harmonization of ethics in health technology assessment: a revision of the Socratic approach. Int J Technol Assess Health Care 2014; 30(1): 3-9