Recommendations for defining treatment outcomes in major psychiatric disorders using real-world data

Elise Koch; Sophie Smart; Guðmundur Einarsson; Anders Kämpe; Lina Jonsson; Maris Alver; Matthew Iveson; Andreas Göteson; Antonio F. Pardiñas; Ida E. Sønderby; Kevin S. O'Connell; Qingqin Li; Yi Lu; Hreinn Stefánsson; Kári Stefánsson; Heather Whalley; Mikael Landén; Michael C. O'Donovan; Knut Smerud; Gerard R. Dawson; Thomas Werge; Alfonso Buil; Andreas Reif; Lili Milani; Espen Molden; Chiara Fabbri; Alessandro Serretti; James Walters; Cathryn M. Lewis; Ole A. Andreassen

doi:10.1016/S2215-0366(25)00061-6

Recommendations for defining treatment outcomes in major psychiatric disorders using real-world data

Elise Koch
, Sophie Smart
, Guðmundur Einarsson
, Anders Kämpe
, Lina Jonsson
, Maris Alver
, Matthew Iveson
, Andreas Göteson
, Antonio F. Pardiñas
, Ida E. Sønderby
, Kevin S. O'Connell
, Qingqin Li
, Yi Lu
, Hreinn Stefánsson
, Kári Stefánsson
, Heather Whalley
, Mikael Landén
, Michael C. O'Donovan
, Knut Smerud
, Gerard R. Dawson

Thomas Werge, Alfonso Buil, Andreas Reif, Lili Milani, Espen Molden, Chiara Fabbri, Alessandro Serretti, James Walters, Cathryn M. Lewis, Ole A. Andreassen

Faculty of Medicine

University of Iceland

Research output: Contribution to journal › Review article › peer-review

Abstract

Although information from real-world data can be used to identify factors that aid treatment choice, there are no guidelines for the use of such data. The aim of this Review is to summarise and evaluate definitions of treatment outcomes for antidepressants, antipsychotics, and mood stabilisers when using real-world data, and to suggest standards for the field. Given that no standards for the use of these data in estimating treatment outcomes exist, variability is high for treatment outcome definitions. We make recommendations for different scenarios of available data and highlight the importance of using other sources of information to validate proxy measures such as continued treatment, switching between medications, or polypharmacy of psychotropic medications. Well defined and validated treatment outcome measures that incorporate real-world data could facilitate the development of precision psychiatry approaches and support regulatory decision making regarding psychopharmacological agents.

Original language	English
Pages (from-to)	457-468
Number of pages	12
Journal	The Lancet Psychiatry
Volume	12
Issue number	6
DOIs	https://doi.org/10.1016/S2215-0366(25)00061-6
Publication status	Published - Jun 2025

Bibliographical note

Other keywords

Antidepressive Agents/therapeutic use
Antipsychotic Agents/therapeutic use
Humans
Mental Disorders/drug therapy
Outcome Assessment, Health Care
Psychotropic Drugs/therapeutic use
Treatment Outcome

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10.1016/S2215-0366(25)00061-6

Cite this

Koch, E., Smart, S., Einarsson, G., Kämpe, A., Jonsson, L., Alver, M., Iveson, M., Göteson, A., Pardiñas, A. F., Sønderby, I. E., O'Connell, K. S., Li, Q., Lu, Y., Stefánsson, H., Stefánsson, K., Whalley, H., Landén, M., O'Donovan, M. C., Smerud, K., ... Andreassen, O. A. (2025). Recommendations for defining treatment outcomes in major psychiatric disorders using real-world data. The Lancet Psychiatry, 12(6), 457-468. https://doi.org/10.1016/S2215-0366(25)00061-6

@article{52df4707c08a46b9bc953f0e4545d9a0,

title = "Recommendations for defining treatment outcomes in major psychiatric disorders using real-world data",

abstract = "Although information from real-world data can be used to identify factors that aid treatment choice, there are no guidelines for the use of such data. The aim of this Review is to summarise and evaluate definitions of treatment outcomes for antidepressants, antipsychotics, and mood stabilisers when using real-world data, and to suggest standards for the field. Given that no standards for the use of these data in estimating treatment outcomes exist, variability is high for treatment outcome definitions. We make recommendations for different scenarios of available data and highlight the importance of using other sources of information to validate proxy measures such as continued treatment, switching between medications, or polypharmacy of psychotropic medications. Well defined and validated treatment outcome measures that incorporate real-world data could facilitate the development of precision psychiatry approaches and support regulatory decision making regarding psychopharmacological agents.",

keywords = "Antidepressive Agents/therapeutic use, Antipsychotic Agents/therapeutic use, Humans, Mental Disorders/drug therapy, Outcome Assessment, Health Care, Psychotropic Drugs/therapeutic use, Treatment Outcome",

author = "Elise Koch and Sophie Smart and Gu{\dh}mundur Einarsson and Anders K{\"a}mpe and Lina Jonsson and Maris Alver and Matthew Iveson and Andreas G{\"o}teson and Pardi{\~n}as, \{Antonio F.\} and S{\o}nderby, \{Ida E.\} and O'Connell, \{Kevin S.\} and Qingqin Li and Yi Lu and Hreinn Stef{\'a}nsson and K{\'a}ri Stef{\'a}nsson and Heather Whalley and Mikael Land{\'e}n and O'Donovan, \{Michael C.\} and Knut Smerud and Dawson, \{Gerard R.\} and Thomas Werge and Alfonso Buil and Andreas Reif and Lili Milani and Espen Molden and Chiara Fabbri and Alessandro Serretti and James Walters and Lewis, \{Cathryn M.\} and Andreassen, \{Ole A.\}",

note = "Publisher Copyright: {\textcopyright} 2025 Elsevier Ltd",

year = "2025",

month = jun,

doi = "10.1016/S2215-0366(25)00061-6",

language = "English",

volume = "12",

pages = "457--468",

journal = "The Lancet Psychiatry",

issn = "2215-0366",

publisher = "Elsevier Ltd.",

number = "6",

}

Koch, E, Smart, S, Einarsson, G, Kämpe, A, Jonsson, L, Alver, M, Iveson, M, Göteson, A, Pardiñas, AF, Sønderby, IE, O'Connell, KS, Li, Q, Lu, Y, Stefánsson, H, Stefánsson, K, Whalley, H, Landén, M, O'Donovan, MC, Smerud, K, Dawson, GR, Werge, T, Buil, A, Reif, A, Milani, L, Molden, E, Fabbri, C, Serretti, A, Walters, J, Lewis, CM & Andreassen, OA 2025, 'Recommendations for defining treatment outcomes in major psychiatric disorders using real-world data', The Lancet Psychiatry, vol. 12, no. 6, pp. 457-468. https://doi.org/10.1016/S2215-0366(25)00061-6

TY - JOUR

T1 - Recommendations for defining treatment outcomes in major psychiatric disorders using real-world data

AU - Koch, Elise

AU - Smart, Sophie

AU - Einarsson, Guðmundur

AU - Kämpe, Anders

AU - Jonsson, Lina

AU - Alver, Maris

AU - Iveson, Matthew

AU - Göteson, Andreas

AU - Pardiñas, Antonio F.

AU - Sønderby, Ida E.

AU - O'Connell, Kevin S.

AU - Li, Qingqin

AU - Lu, Yi

AU - Stefánsson, Hreinn

AU - Stefánsson, Kári

AU - Whalley, Heather

AU - Landén, Mikael

AU - O'Donovan, Michael C.

AU - Smerud, Knut

AU - Dawson, Gerard R.

AU - Werge, Thomas

AU - Buil, Alfonso

AU - Reif, Andreas

AU - Milani, Lili

AU - Molden, Espen

AU - Fabbri, Chiara

AU - Serretti, Alessandro

AU - Walters, James

AU - Lewis, Cathryn M.

AU - Andreassen, Ole A.

PY - 2025/6

Y1 - 2025/6

N2 - Although information from real-world data can be used to identify factors that aid treatment choice, there are no guidelines for the use of such data. The aim of this Review is to summarise and evaluate definitions of treatment outcomes for antidepressants, antipsychotics, and mood stabilisers when using real-world data, and to suggest standards for the field. Given that no standards for the use of these data in estimating treatment outcomes exist, variability is high for treatment outcome definitions. We make recommendations for different scenarios of available data and highlight the importance of using other sources of information to validate proxy measures such as continued treatment, switching between medications, or polypharmacy of psychotropic medications. Well defined and validated treatment outcome measures that incorporate real-world data could facilitate the development of precision psychiatry approaches and support regulatory decision making regarding psychopharmacological agents.

AB - Although information from real-world data can be used to identify factors that aid treatment choice, there are no guidelines for the use of such data. The aim of this Review is to summarise and evaluate definitions of treatment outcomes for antidepressants, antipsychotics, and mood stabilisers when using real-world data, and to suggest standards for the field. Given that no standards for the use of these data in estimating treatment outcomes exist, variability is high for treatment outcome definitions. We make recommendations for different scenarios of available data and highlight the importance of using other sources of information to validate proxy measures such as continued treatment, switching between medications, or polypharmacy of psychotropic medications. Well defined and validated treatment outcome measures that incorporate real-world data could facilitate the development of precision psychiatry approaches and support regulatory decision making regarding psychopharmacological agents.

KW - Antidepressive Agents/therapeutic use

KW - Antipsychotic Agents/therapeutic use

KW - Humans

KW - Mental Disorders/drug therapy

KW - Outcome Assessment, Health Care

KW - Psychotropic Drugs/therapeutic use

KW - Treatment Outcome

UR - https://www.scopus.com/pages/publications/105002751797

U2 - 10.1016/S2215-0366(25)00061-6

DO - 10.1016/S2215-0366(25)00061-6

M3 - Review article

C2 - 40222385

SN - 2215-0366

VL - 12

SP - 457

EP - 468

JO - The Lancet Psychiatry

JF - The Lancet Psychiatry

IS - 6

ER -

Recommendations for defining treatment outcomes in major psychiatric disorders using real-world data

Abstract

Bibliographical note

Other keywords

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