ThemenCheck Medizin: Winter Depression – Do non-pharmaceutical procedures such as light therapy and vitamin therapy lead to superior outcomes? (Health Economics and Ethics)

Duration: October 2018 – March 2020
Suggested by (resp. Principal): Co-operation with Donau-Universität Krems (DUK) (Institute for Quality and Efficiency in Health Care/IQWiG, Cologne)
Language: German

Publication: IQWiG ThemenCheck Medizin (HTA Report)

Background:
Seasonal affective disorder is a form of depression that occurs mainly in autumn/winter and completely remits in the spring/summer time [1]. According to the international classification of diseases ICD-10, seasonal affective disorder (F33) is a subtype of the major depressive disorder with recurrent episode with a seasonal pattern [2]. The US-American classification DSM-5 defines the SAD as follows: SAD occurs when depressive episodes emerge at least in 2 consecutive months in the same year and the same period, and cannot be explained by other incidents and events, such as job loss of seasonal labour [3]. The winter type is the most common type of SAD when affected people develop symptoms in autumn/winter and completely remit in spring/summer. In rare cases, a summer type is documented where depressive symptoms emerge only during the summer time [3]. This report focusses on the SAD winter type – commonly known as autumn/winter depression.

Project Aim (Health Economics and Ethics)

• the determination and description of the costs (intervention costs) that accrue by a treatment with light (light therapy) or vitamin D therapy in comparison with no treatment, treatment with a second-generation antidepressant (A2G), or psychotherapy in order to deal with an autumn-winter depression
• the evaluation of cost-effectiveness of light therapy that result by the treatment with light (light therapy) or vitamin D in comparison with no treatment, treatment with a second-generation antidepressant (A2G), or psychotherapy in order to deal with an autumn-winter depression
• the appraisal of ethical aspects that are associated with the treatment alternatives

Research Question:
Do non-pharmaceutical procedures such as light therapy and vitamin therapy lead to superior outcomes?

Methods:
Health Economics

To quantify the intervention costs – as far as the data of the quantities and prices in the German context is available and no further costs arise – the average resource use is determined that directly arises when conducting the interventions in question. In doing so, the directly associated services of the interventions and comparators are considered. The relevant contracted and negotiated prices of databases such as the information agency of pharmaceutical specialities (IFA), the uniform remuneration system in Germany (EBM), the catalogue of diagnosis related groups (DRG-Katalog) or similar adequate data sources such as the pension insurance system or the Federal Statistical Office of Germany are utilised. If a therapy lasts longer than a year, then the average costs per patient and year will be provided. Refundable and non-refundable costs are listed separately.

The systematic review of the health economic studies comprises of comparative health economic studies [4], i.e. cost-effectiveness, cost-utility, or cost-benefit-analyses (in a narrower sense). The final inclusion of the studies is conducted in an iterative process with the Donau-Universität Krems (DUK). The Evaluation of the report quality of the included health economic studies is based on the Consolidated Health Economic Evaluation Reporting Standards (CHEERS-Statement) [5]. In addition, the quality of methods is evaluated with the aid of the recent Drummond checklist [4].

Ethics

For the appraisal of the ethical aspects, as a first step a collection of possibly relevant ethical arguments facilitated by a revised Socratic approach/Hofman approach [6] is conducted. Subsequently a systematic literature review is carried out to search for primary literature in the databases of MEDLINE, CINAHL, Scopus, PsychInfo, BELIT, Ethicsweb, EthxWeb. Additionally, interest dependent information resources, such as web pages of interest representatives, are searched. The target population of the ethical appraisal is extended to patients generally affected by depression. The reason is that ethics related challenges affecting patients with a major depressive disorder (according to DSM-V and ICD-10) are similar to the challenges affecting patients with SAD. The interventions include treatment with light therapy/vitamin D3/combination light therapy + vitamin D3 in different dosage forms (light lamp, light room, vitamin D3 drops, pills).

The information compiled from all sources of all systematic searches is screened for statements associated with ethical arguments of the respective technology by one person. The results are quality assured by a second person. All necessary arguments are listed in extraction tables. The tables include of 1) superordinate questions, 2) specific ethical aspects, and 3) explanations/citations/reference

PICO-Analysis (Base Report incl. Health Economics and Ethics):

Schedule/Milestones:

Literatur:

1. Rosenthal NE, Sack DA, Gillin J, et al. Seasonal affective disorder: A description of the syndrome and preliminary findings with light therapy. Arch Gen Psychiatry 1984; 41(1): 72-80.
2. World Health Organization. The ICD-10 Classification of Mental and Behavioural Disorders. Diagnostic criteria for research. Geneva, Switzerland: World Health Organization; 1993.
3. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Washington, DC: American Psychiatric Association; 2013.
4. Drummond MF, Sculpher MJ, Claxton K, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes. Oxford: Oxford University Press; 2015.
5. 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.
6. 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.