Implementation, efficacy, costs and processes of inpatient equivalent home-treatment in German mental health care (AKtiV): protocol of a mixed-method, participatory, quasi-experimental trial.
Collaborative research
Community mental health care
Coproduction
Crisis resolution teams
Home treatment
Inpatient-equivalent treatment
Mixed methods
Multi-center study
User involvement
Journal
BMC psychiatry
ISSN: 1471-244X
Titre abrégé: BMC Psychiatry
Pays: England
ID NLM: 100968559
Informations de publication
Date de publication:
30 03 2021
30 03 2021
Historique:
received:
23
02
2021
accepted:
11
03
2021
entrez:
30
3
2021
pubmed:
31
3
2021
medline:
27
4
2021
Statut:
epublish
Résumé
Over the last decades, many high-income countries have successfully implemented assertive outreach mental health services for acute care. Despite evidence that these services entail several benefits for service users, Germany has lagged behind and has been slow in implementing outreach services. In 2018, a new law enabled national mental health care providers to implement team-based crisis intervention services on a regular basis, allowing for different forms of Inpatient Equivalent Home Treatment (IEHT). IEHT is similar to the internationally known Home Treatment or Crisis Resolution Teams. It provides acute psychiatric treatment at the user's home, similar to inpatient hospital treatment in terms of content, flexibility, and complexity. The presented naturalistic, quasi-experimental cohort study will evaluate IEHT in ten hospitals running IEHT services in different German regions. Within a multi-method research approach, it will evaluate stakeholders' experiences of care, service use, efficacy, costs, treatment processes and implementation processes of IEHT from different perspectives. Quantitative surveys will be used to recruit 360 service users. Subsequently, 180 service users receiving IEHT will be compared with 180 matched statistical 'twins' receiving standard inpatient treatment. Assessments will take place at baseline as well as after 6 and 12 months. The primary outcome is the hospital re-admission rate within 12 months. Secondary outcomes include the combined readmission rate, total number of inpatient hospital days, treatment discontinuation rate, quality of life, psycho-social functioning, job integration, recovery, satisfaction with care, shared decision-making, and treatment costs. Additionally, the study will assess the burden of care and satisfaction with care among relatives or informal caregivers. A collaborative research team made up of researchers with and without lived experience of mental distress will conduct qualitative investigations with service users, caregivers and IEHT staff teams to explore critical ingredients and interactions between implementation processes, treatment processes, and outcomes from a stakeholder perspective. By integrating outcome, process and implementation research as well as different stakeholder perspectives and experiences in one study, this trial captures the various facets of IEHT as a special form of home treatment. Therefore, it allows for an adequate, comprehensive evaluation on different levels of this complex intervention. Trial registrations: 1) German Clinical Trials Register (DRKS), DRKS000224769. Registered December 3rd 2020, https://www.drks.de/drks_web/setLocale_EN.do ; 2) ClinicalTrials.gov, Identifier: NCT0474550 . Registered February 9th 2021.
Sections du résumé
BACKGROUND
Over the last decades, many high-income countries have successfully implemented assertive outreach mental health services for acute care. Despite evidence that these services entail several benefits for service users, Germany has lagged behind and has been slow in implementing outreach services. In 2018, a new law enabled national mental health care providers to implement team-based crisis intervention services on a regular basis, allowing for different forms of Inpatient Equivalent Home Treatment (IEHT). IEHT is similar to the internationally known Home Treatment or Crisis Resolution Teams. It provides acute psychiatric treatment at the user's home, similar to inpatient hospital treatment in terms of content, flexibility, and complexity.
METHODS/DESIGN
The presented naturalistic, quasi-experimental cohort study will evaluate IEHT in ten hospitals running IEHT services in different German regions. Within a multi-method research approach, it will evaluate stakeholders' experiences of care, service use, efficacy, costs, treatment processes and implementation processes of IEHT from different perspectives. Quantitative surveys will be used to recruit 360 service users. Subsequently, 180 service users receiving IEHT will be compared with 180 matched statistical 'twins' receiving standard inpatient treatment. Assessments will take place at baseline as well as after 6 and 12 months. The primary outcome is the hospital re-admission rate within 12 months. Secondary outcomes include the combined readmission rate, total number of inpatient hospital days, treatment discontinuation rate, quality of life, psycho-social functioning, job integration, recovery, satisfaction with care, shared decision-making, and treatment costs. Additionally, the study will assess the burden of care and satisfaction with care among relatives or informal caregivers. A collaborative research team made up of researchers with and without lived experience of mental distress will conduct qualitative investigations with service users, caregivers and IEHT staff teams to explore critical ingredients and interactions between implementation processes, treatment processes, and outcomes from a stakeholder perspective.
DISCUSSION
By integrating outcome, process and implementation research as well as different stakeholder perspectives and experiences in one study, this trial captures the various facets of IEHT as a special form of home treatment. Therefore, it allows for an adequate, comprehensive evaluation on different levels of this complex intervention.
TRIAL REGISTRATION
Trial registrations: 1) German Clinical Trials Register (DRKS), DRKS000224769. Registered December 3rd 2020, https://www.drks.de/drks_web/setLocale_EN.do ; 2) ClinicalTrials.gov, Identifier: NCT0474550 . Registered February 9th 2021.
Identifiants
pubmed: 33781237
doi: 10.1186/s12888-021-03163-9
pii: 10.1186/s12888-021-03163-9
pmc: PMC8008509
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
173Subventions
Organisme : Federal Joint Committee/Gemeinsamer Bundesausschuss (G-BA)
ID : VSF2_2019-108
Commentaires et corrections
Type : ErratumIn
Références
Dean C, Phillips J, Gadd EM, Joseph M, England S. Comparison of community based service with hospital based service for people with acute, severe psychiatric illness. Br Med J. 1993;307(6902):473–6. https://doi.org/10.1136/bmj.307.6902.473 .
doi: 10.1136/bmj.307.6902.473
Winness MG, Borg M, Kim HS. Service users' experiences with help and support from crisis resolution teams. A literature review. J Ment Health. 2010;19(1):75–87. https://doi.org/10.3109/09638230903469178 .
doi: 10.3109/09638230903469178
pubmed: 20380500
Lu W, Mueser KT, Rosenberg SD, Yanos PT, Mahmoud N. Posttraumatic reactions to psychosis: a qualitative analysis. Front Psychiatry. 2017;8(129). https://doi.org/10.3389/fpsyt.2017.00129 .
Wittchen HU, Jacobi F, Rehm J, Gustavsson A, Svensson M, Jönsson B, et al. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011;21(9):655–79. https://doi.org/10.1016/j.euroneuro.2011.07.018 .
OECD, Union E. Health at a Glance: Europe 2018 2018.
doi: 10.1787/health_glance_eur-2018-en
NICE. In: Health NCCfM, editor. Psychosis and Schizophrenia in Adults: prevention and management [CG178]. London: National Institute for Health and Care Excellence (UK); 2014.
Murphy S, Irving CB, Adams CE, Driver R. Crisis intervention for people with severe mental illnesses. In: Collaboration TC, editor. Cochrane Database of Systematic Reviews. Chichester: Wiley; 2012. p. CD001087.pub4.
DGPPN. S3-Leitlinie Psychosoziale Therapien bei schweren psychischen Erkrankungen. Berlin, Heidelberg: Springer; 2019.
Bechdolf A, Skutta M, Horn A. Psychiatrische Akutbehandlung ohne Krankenhausbett – Klinische Wirksamkeit von “Home Treatment” am Beispiel der “Integrativen Psychiatrischen Behandlung (IPB)” am Alexianer-Krankenhaus Krefeld. Fortschr Neurol Psychiatr. 2011;79(01):26–31.
doi: 10.1055/s-0029-1245595
Gühne U, Weinmann S, Arnold K, Atav E-S, Becker T, Riedel-Heller S. Akutbehandlung im häuslichen Umfeld: Systematische Übersicht und Implementierungsstand in Deutschland. Psychiatr Prax. 2011;38(03):114–22. https://doi.org/10.1055/s-0030-1248598 .
doi: 10.1055/s-0030-1248598
pubmed: 21207350
Bechdolf A, Baumgardt J, Weinmann S. Wirksamkeit aufsuchender Behandlung – Aktuelle Evidenz aus dem deutschsprachigen Raum. In: Weinmann S, Bechdolf A, Greve N, editors. Psychiatrische Krisenintervention zuhause Das Praxisbuch zu StäB & Co. Köln: Psychiatrie-Verlag; 2020. p. 35–73.
Schwarz J, Galbusera L, Bechdolf A, Birker T, Deister A, Duve A, et al. Changes in German mental health care by implementing a global treatment budget—a mixed-method process evaluation study. Front Psychiatry. 2020;11:426. https://doi.org/10.3389/fpsyt.2020.00426 .
Längle G, Holzke M, Gottlob M, GmbH WK. Psychisch Kranke zu Hause versorgen – Handbuch zur Stationsäquivalenten Behandlung. Stuttgart: Kohlhammer; 2018.
Vereinbarung zur Stationsäquivalenten psychiatrischen Behandlung nach § 115d Abs. 2 SGB V vom 01.08.2017, 2020 (2017).
Gesetz zur Weiterentwicklung der Versorgung und der Vergütung für psychiatrische und psychosomatische Leistungen (PsychVVG), (2016).
Statistisches Bundesamt. Einrichtungen, Betten und Patientenbewegung 2017 2019 [Available from: https://www.destatis.de/DE/Themen/Gesellschaft-Umwelt/Gesundheit/Krankenhaeuser/Tabellen/gd-krankenhaeuser-jahre.html ].
Holzke M, Gottlob M, Längle G. Stationsäquivalente Behandlung: Umsetzungserfahrungen der ersten zwei Jahre. Psychiatrische Pflege. 2020;5(3):11–6. https://doi.org/10.1024/2297-6965/a000298 .
doi: 10.1024/2297-6965/a000298
Gottlob M, Holzke M, Längle G. Rechtliche Anforderungen und organisatorische Herausforderungen: Die Besonderheiten der stationsäquivalenten Behandlung. Psychiatrische Pflege. 2020;5(3):7–10. https://doi.org/10.1024/2297-6965/a000297 .
doi: 10.1024/2297-6965/a000297
Schwarz J, Bechdolf A, Hirschmeyer C, Hochwarter S, Holthoff-Detto V, Mühlensiepen F, et al. “Ich sehe es tatsächlich als Zwischenschritt” – eine qualitative Analyse der Implementierungsbedingungen und -hürden von Stationsäquivalenter Behandlung in Berlin und Brandenburg [“I Indeed Consider it to be a Temporary Solution” – A Qualitative Analysis of the Conditions and Obstacles to Implementation of Psychiatric Home-Treatment in Berlin and Brandenburg"]. Psychiatrische Praxis (efirst). https://doi.org/10.1055/a-1274-3662 .
Boyens J, Hamann J, Ketisch E, Brieger P. Vom Reißbrett in die Praxis - Wie funktioniert stationsäquivalente Behandlung in München? (From Theory into Practice – Early Experiences with Home Treatment in Munich, Germany). Psychiatr Prax. 2020; e-first. https://doi.org/10.1055/a-1276-6637 .
Nugter MA, Engelsbel F, Bähler M, Keet R, van Veldhuizen R. Outcomes of FLEXIBLE assertive community treatment (FACT) implementation: a prospective real life study. Community Ment Health J. 2016;52(8):898–907. https://doi.org/10.1007/s10597-015-9831-2 .
Wheeler C, Lloyd-Evans B, Churchard A, Fitzgerald C, Fullarton K, Mosse L, et al. Implementation of the crisis resolution team model in adult mental health settings: a systematic review. BMC Psychiatry. 2015;15(1):74. https://doi.org/10.1186/s12888-015-0441-x .
Weinmann S, Wiedmann S, Breidert T, Bohe M, Pfeiffer J, Rosenberger E, et al. Klinische Wirksamkeit von “FlexiTeam” (Home Treatment und intensivierte ambulante Behandlung) – Vergleich einer Behandlung in einem Modellprojekt nach § 64b in Berlin mit der stationären Behandlung. Psychiatr Prax. 2019;46(05):249–55.
doi: 10.1055/a-0881-1124
Stulz N, Wyder L, Maeck L, Hilpert M, Lerzer H, Zander E, et al. Home treatment for acute mental healthcare: randomised controlled trial. Br J Psychiatry. 2019;2016(6):323–30.
doi: 10.1192/bjp.2019.31
Weinmann S, Gühne U, Kösters M, Gaebel W, Becker T. Teambasierte Gemeindepsychiatrie: Bedeutung von Kontextfaktoren und Übertragbarkeit der Studienevidenz. Nervenarzt. 2012;83(7):825–31. https://doi.org/10.1007/s00115-011-3468-3 .
doi: 10.1007/s00115-011-3468-3
pubmed: 22688090
Kilian R, Becker T, Frasch K. Effectiveness and cost-effectiveness of home treatment compared with inpatient care for patients with acute mental disorders in a rural catchment area in Germany. Neurol Psychiatry Brain Res. 2016;22(2):81–6. https://doi.org/10.1016/j.npbr.2016.01.005 .
doi: 10.1016/j.npbr.2016.01.005
McCrone P, Johnson S, Nolan F, Pilling S, Sandor A, Hoult J, et al. Economic evaluation of a crisis resolution service: a randomised controlled trial. Epidemiol Psichiatr Soc. 2009;18(1):54–8. https://doi.org/10.1017/S1121189X00001469 .
Paton F, Wright K, Ayre N, Dare C, Johnson S, Lloyd-Evans B, et al. Improving outcomes for people in mental health crisis: a rapid synthesis of the evidence for available models of care. Health Technol Assess. 2016;20(3):1–162. https://doi.org/10.3310/hta20030 .
Icks A, Chernyak N, Bestehorn K, Brüggenjürgen B, Bruns J, Damm O, et al. Methoden der gesundheitsökonomischen Evaluation in der Versorgungsforschung. Das Gesundheitswesen. 2010;72(12):917–33. https://doi.org/10.1055/s-0030-1262859 .
von Peter S. Partizipative und kollaborative Forschungsansätze in der Psychiatrie. Psychiatr Prax. 2017;44(08):431–3.
doi: 10.1055/s-0043-120241
Flick U. Triangulation. Eine Einführung. Wiesbaden: VS Verlag für Sozialwissenschaften; 2011.
doi: 10.1007/978-3-531-92864-7
DGPPN. S3-Leitlinie Schizophrenie. Berlin: DGPPN; 2019.
Durbin J, Lin E, Layne C, Teed M. Is readmission a valid Indicator of the quality of inpatient psychiatric care? J Behav Health Serv Res. 2007;34(2):137–50. https://doi.org/10.1007/s11414-007-9055-5 .
doi: 10.1007/s11414-007-9055-5
pubmed: 17437186
Byrne SL, Hooke GR, Page AC. Readmission: a useful indicator of the quality of inpatient psychiatric care. J Affect Disord. 2010;126(1–2):206–13. https://doi.org/10.1016/j.jad.2010.02.135 .
doi: 10.1016/j.jad.2010.02.135
pubmed: 20334927
Roick C, Kilian R, Matschinger H, Bernert S, Mory C, Angermeyer MC. Die deutsche Version des Client Sociodemographic and Service Receipt Inventory - Ein Instrument zur Erfassung psychiatrischer Versorgungskosten. Psychiatr Prax. 2001;28:84–90. https://doi.org/10.1055/s-2001-17790 .
doi: 10.1055/s-2001-17790
Leidl R, Reitmeir P. An experience-based value set for the EQ-5D-5L in Germany. Value Health. 2017;20(8):1150–6. https://doi.org/10.1016/j.jval.2017.04.019 .
doi: 10.1016/j.jval.2017.04.019
pubmed: 28964448
Fankhauser S, Hochstrasser B, Sievers M, Soyka M. Die Eignung der HoNOS (Health of the Nation Outcome Scales) zur Erfassung des Verlaufs und des Schweregrads depressiver Symptomatik im stationären Setting. PPmP – Psychother Psychosom Med Psychol. 2017;67(09/10):391–400.
doi: 10.1055/s-0043-105482
Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R. Development, reliability and acceptability of a new version of the DSM?IV social and occupational functioning assessment scale (SOFAS) to assess routine social funtioning. Acta Psychiatr Scand. 2000;101(4):323–9. https://doi.org/10.1111/j.1600-0447.2000.tb10933.x .
doi: 10.1111/j.1600-0447.2000.tb10933.x
pubmed: 10782554
Cavelti M, Wirtz M, Corrigan P, Vauth R. Recovery assessment scale: examining the factor structure of the German version (RAS-G) in people with schizophrenia spectrum disorders. Eur Psychiatry. 2017;41(1):60–7. https://doi.org/10.1016/j.eurpsy.2016.10.006 .
doi: 10.1016/j.eurpsy.2016.10.006
pubmed: 28049083
Kriston L, Scholl I, Hölzel L, Simon D, Loh A, Härter M. The 9-item shared decision making questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010;80(1):94–9. https://doi.org/10.1016/j.pec.2009.09.034 .
doi: 10.1016/j.pec.2009.09.034
pubmed: 19879711
Bernert S, Kilian R, Matschinger H, Mory C, Roick C, Angermeyer MC. Die Erfassung der Belastung der Angehörigen psychisch erkrankter Menschen - Die deutsche Version des Involvement Evaluation Questionnaires (IEQ-EU). Psychiatr Prax. 2001;28:97–101. https://doi.org/10.1055/s-2001-17792 .
doi: 10.1055/s-2001-17792
Hoult J, Reynolds I, Charbonneau-Powis M, Weekes P, Briggs J. Psychiatric hospital versus community treatment: the results of a randomised trial. Aust N Z J Psychiatry. 1983;17(2):160–7. https://doi.org/10.3109/00048678309160000 .
doi: 10.3109/00048678309160000
pubmed: 6578788
Fenton WS, Mosher LR, Herrell JM, Blyler CR. Randomized trial of general hospital and residential alternative care for patients with severe and persistent mental illness. Am J Psychiatr. 1998;155(4):516–22. https://doi.org/10.1176/ajp.155.4.516 .
doi: 10.1176/ajp.155.4.516
pubmed: 9545998
Johnson S, Nolan F, Pilling S, Sandor A, Hoult J, McKenzie N, et al. Randomised controlled trial of acute mental health care by a crisis resolution team: the north Islington crisis study. BMJ (Clinical research ed). 2005;331(7517):599.
doi: 10.1136/bmj.38519.678148.8F
Weinmann S, Spiegel J, Baumgardt J, Bühling-Schindowski F, Pfeiffer J, Kleinschmidt K, et al. Stationsäquivalente Behandlung (StäB) im Vergleich mit der vollstationärern Behandlung: 12 Monats- Follow-Up einer gematchten Kohortenstudie. Psychiatr Prax. 2021; submitted.
Götz E. Umsetzung der stationsäquivalenten Behandlung im städtischen Raum, Pilotstudie zur Implementierung einer neuen Versorgungsform in der Psychiatrie (Dissertation in Ausarbeitung) [Dissertation]: Eberhard Karls Universität Tübingen; 2020.
Hirschek D. Umsetzung der stationsäquivalenten Behandlung im ländlichen Raum, Pilotstudie zur Implementierung einer neuen Versorgungsform in der Psychiatrie (Dissertation in Ausarbeitung) [Dissertation]: Eberhard Karls Universität Tübingen; 2020.
Kusenbach M. Street phenomenology: the go-along as ethnographic research tool. Ethnography. 2003;4(3):455–85. https://doi.org/10.1177/146613810343007 .
doi: 10.1177/146613810343007
Charmaz K. Constructing grounded theory. 2nd ed. Los Angeles ; London ; New Delhi, SAGE; 2014.
Male L, Noble A, Atkinson J, Marson T. Measuring patient experience: a systematic review to evaluate psychometric properties of patient reported experience measures (PREMs) for emergency care service provision. Int J Qual Health Care. 2017;29(3):314–26. https://doi.org/10.1093/intqhc/mzx027 .
doi: 10.1093/intqhc/mzx027
pubmed: 5890873
pmcid: 5890873
Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350(mar19 6):h1258. https://doi.org/10.1136/bmj.h1258 .
Borgatti SP, Everett MG, Johnson JC. Analyzing social networks. 2nd ed. Los Angeles ; London ; New Delhi ; Singapore ; Washington DC ; Melbourne: Sage; 2018.
Nicaise P, Tulloch S, Dubois V, Matanov A, Priebe S, Lorant V. Using social network analysis for assessing mental health and social services inter-organisational collaboration: findings in deprived areas in Brussels and London. Adm Policy Ment Health Ment Health Serv Res. 2013;40(4):331–9. https://doi.org/10.1007/s10488-012-0423-y .
doi: 10.1007/s10488-012-0423-y
Mayring P. Qualitative content analysis: theoretical foundation, basic procedures and software solution. AUT Klagenfurt; 2014. p. 143.
Psychosis and schizophrenia in adults: prevention and management. Clinical guideline [CG178]. 2014. Available from: https://www.nice.org.uk/guidance/cg178/resources .
McCrone P, Johnson S, Nolan F, Sandor A, Hoult J, Pilling S, et al. Impact of a crisis resolution team on service costs in the UK. Psychiatr Bull. 2009;33(1):17–9. https://doi.org/10.1192/pb.bp.107.018648 .
Widmann F, Bachhuber G, Riedelsheimer A, Schiele A, Ullrich S, Kilian R, et al. Home treatment. Fortschr Neurol Psychiatr. 2016;84(01):42–9.
doi: 10.1055/s-0041-110887
Drummond F, Sculpher MJ, Torrance GW. Methods for the economic evaluation of health care programmes. 3rd ed. New York: Oxford University Press; 2005.
Glick HA, Doshi JA, Sonnad SS, Polsky D. Economic evaluation in clinical trials, vol. 2014: Oxford University Press; 2014.
Salize HJ, Kilian R. Gesundheitsökonomie in der Psychiatrie: Konzepte, Methoden, Analysen. Stuttgart: Kohlhammer; 2010.
Bernert S, Fernández A, Haro JM, König H-H, Alonso J, Vilagut G, et al. Comparison of different valuation methods for population health status measured by the EQ-5D in three European countries. Value Health. 2009;12(5):750–8. https://doi.org/10.1111/j.1524-4733.2009.00509.x .
Brooks R, Rabin R, de Charro F. The measurement and valuation of health status using EQ-5D: a European perspective. Dordrecht: Springer Netherlands; 2003. https://doi.org/10.1007/978-94-017-0233-1 .
doi: 10.1007/978-94-017-0233-1
Beecham J, Knapp M. Costing psychiatric interventions. In: Thornicroft G, editor. Measuring mental health needs London: Gaskell; 2001. p. 200–24.
Chisholm D, Knapp MRJ, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B, et al. Client socio-demographic and service receipt inventory – European version: development of an instrument for international research: EPSILON study 5. Br J Psychiatry. 2000;177(S39):s28–33. https://doi.org/10.1192/bjp.177.39.s28 .
Bock JO, Brettschneider C, Seidl H, Bowles D, Holle R, Greiner W, et al. Ermittlung standardisierter Bewertungssätze aus gesellschaftlicher Perspektive für die gesundheitsökonomische Evaluation. Gesundheitswesen. 2015;77(01):53–61.
Grupp H, König H-H, Konnopka A. Kostensätze zur monetären Bewertung von Versorgungsleistungen bei psychischen Erkrankungen. Gesundheitswesen. 2017;79(01):48–57.
pubmed: 26402381
Buchholz I, Janssen MF, Kohlmann T, Feng Y-S. A systematic review of studies comparing the measurement properties of the three-level and five-level versions of the EQ-5D. PharmacoEconomics. 2018;36(6):645–61. https://doi.org/10.1007/s40273-018-0642-5 .
Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, et al. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013;22(7):1717–27. https://doi.org/10.1007/s11136-012-0322-4 .
Ludwig K, von der Schulenburg JM G, Greiner W. German value set for the EQ-5D-5L. PharmacoEconomics. 2018;36(6):663–74. https://doi.org/10.1007/s40273-018-0615-8 .
doi: 10.1007/s40273-018-0615-8
pubmed: 29460066
pmcid: 5954069
Marseille E, Larson B, Kazi DS, Kahn JG, Rosen S. Thresholds for the cost–effectiveness of interventions: alternative approaches. Bull World Health Organ. 2015;93(2):118–24. https://doi.org/10.2471/BLT.14.138206 .
Fisher LD, Dixon DO, Herson J, Frankowski RF, Hearron MS, Peace KE. Intention-to-treat in clinical trials. In: Peace KE, editor. Statistical issues in drug research and development. New York: Macrel Dekker; 1990.
Razali N, Wah Y. Power comparisons of Shapiro-Wilk, Kolmogorov-Smirnov, Lilliefors and Anderson-Darling tests. J Stat Model Anal. 2011;2:21–33.
Benchimol EI, Smeeth L, Guttmann A, Harron K, Moher D, Petersen I, et al. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement. PLoS Med. 2015;12(10):e1001885. https://doi.org/10.1371/journal.pmed.1001885 .
Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health Ment Health Serv Res. 2011;38(2):65–76. https://doi.org/10.1007/s10488-010-0319-7 .
Richards DA. Complex Interventions in Health: An overview of research methods. 1st ed: Routledge; 2015.
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA relevance), 2016/679 (2016).
“Bundesdatenschutzgesetz vom 30. Juni 2017 (BGBl. I S. 2097), das durch Artikel 12 des Gesetzes vom 20. November 2019 (BGBl. I S. 1626) geändert worden ist”, Art. 12 (2019).