Standardization of health outcomes assessment for depression and anxiety: recommendations from the ICHOM Depression and Anxiety Working Group

Alexander Obbarius¹, Lisa van Maasakkers², Lee Baer^{3

4}, David M Clark⁵, Anne G Crocker^{6

7}, Edwin de Beurs^{8

9}, Paul M G Emmelkamp^{10

11}, Toshi A Furukawa¹², Erik Hedman-Lagerlöf^{13

14}, Maria Kangas¹⁵, Lucie Langford¹⁶, Alain Lesage^{7

17}, Doris M Mwesigire¹⁸, Sandra Nolte^{19

20}, Vikram Patel²¹, Paul A Pilkonis²², Harold A Pincus^{23

24}, Roberta A Reis²⁵, Graciela Rojas²⁶, Cathy Sherbourne²⁴, Dave Smithson²⁷, Caleb Stowell², Kelly Woolaway-Bickel²⁸, Matthias Rose^{19

29}

Affiliations

¹ Department of Psychosomatic Medicine, Center for Internal Medicine and Dermatology, Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany. alexander.obbarius@charite.de.
² International Consortium for Health Outcomes Measurement (ICHOM), 14 Arrow St., Ste. #11, Cambridge, MA, 02138, USA.
³ Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA.
⁴ Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
⁵ Department of Experimental Psychology, University of Oxford, Tinbergen Building, South Parks Road, Oxford, OX1 3UD, UK.
⁶ Institut Philippe-Pinel de Montréal, 10905 Henri-Bourassa Est, Montréal, QC, H1C 1H1, Canada.
⁷ Department of Psychiatry, University of Montréal, Pavillon Roger-Gaudry, C.P., 6128 succursale Centre-ville, Montréal, QC, H3C 3J, Canada.
⁸ Stichting Benchmark GGZ, Rembrandtlaan 46, 3723 BK, Bilthoven, The Netherlands.
⁹ Department of Clinical Psychology, Leiden University, Rapenburg 70, 2311 EZ, Leiden, The Netherlands.
¹⁰ Netherlands Institute for Advanced Study, Meijboomlaan 1, 2242 PR, Wassenaar, The Netherlands.
¹¹ The Center for Social and Humanities Research, King Abdulaziz University, Jeddah, 21589, Saudi Arabia.
¹² School of Public Health, Kyoto University Graduate School of Medicine, Yoshida Konoecho, Sakyo-ku, Kyoto, 606-8501, Japan.
¹³ Department of Clinical Neuroscience, Karolinska Institutet, Nobels väg 9, 17177, Stockholm, Sweden.
¹⁴ Gustavsberg Primary Care Clinic, Stockholm County Council, Odelbergs väg 19, 13440, Gustavsberg, Sweden.
¹⁵ Centre for Emotional Health, Department of Psychology, Macquarie University, Building C3A, Level 7, Sydney, NSW, 2109, Australia.
¹⁶ , Ottawa, ON, Canada.
¹⁷ Research centre, Institut universitaire en santé mentale de Montréal, 7401 rue Hochelaga, Montréal, QC, H1N 3M5, Canada.
¹⁸ Makerere College of Health Sciences, Makerere University, P.O. Box 7072, Kampala, Uganda.
¹⁹ Department of Psychosomatic Medicine, Center for Internal Medicine and Dermatology, Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.
²⁰ Population Health Strategic Research Centre, School of Health and Social Development, Deakin University, 221 Burwood Highway, Burwood, VIC, 3125, Australia.
²¹ Department of Global Health and Social Medicine, Harvard Medical School, 641 Huntington Avenue, Boston, 02115, MA, USA.
²² Department of Psychiatry, University of Pittsburgh School of Medicine, Thomas Detre Hall, 3811 O'Hara Street, Pittsburgh, PA, 15213, USA.
²³ Department of Psychiatry, Columbia University, New York Presbyterian Hospital, 630 West 168th Street, New York, NY, 10032, USA.
²⁴ The RAND Corporation, 1776 Main Street, Santa Monica, CA, 90407-2138, USA.
²⁵ Federal University of Rio Grande do Sul, Grupo CNPq - GPEMSA - USP/São Paulo, Av. Paulo Gama, 110 - Bairro Farroupilha, Porto Alegre, Rio Grande do Sul, Brazil.
²⁶ Clinical Hospital, Department of Psychiatry and Mental Health, University of Chile, Av. Libertador Bernardo O'Higgins 1058, Santiago de Chile, Chile.
²⁷ Anxiety UK, Zion Community Centre, 339 Stretford Road, Hulme, Manchester, M15 4ZY, UK.
²⁸ Office of the U.S. Army Surgeon General, 7700 Arlington Blvd., Room 3SW116A, Falls Church, VA, 22042, USA.
²⁹ Department of Quantitative Health Sciences, Medical School, University of Massachusetts, 368 Plantation Street, Worcester, MA, 01605, USA.

PMID: 28786017
PMCID: PMC5681977
DOI: 10.1007/s11136-017-1659-5

Standardization of health outcomes assessment for depression and anxiety: recommendations from the ICHOM Depression and Anxiety Working Group

Alexander Obbarius et al. Qual Life Res. 2017 Dec.

. 2017 Dec;26(12):3211-3225.

doi: 10.1007/s11136-017-1659-5. Epub 2017 Aug 7.

Authors

Affiliations

¹ Department of Psychosomatic Medicine, Center for Internal Medicine and Dermatology, Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany. alexander.obbarius@charite.de.
² International Consortium for Health Outcomes Measurement (ICHOM), 14 Arrow St., Ste. #11, Cambridge, MA, 02138, USA.
³ Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA.
⁴ Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
⁵ Department of Experimental Psychology, University of Oxford, Tinbergen Building, South Parks Road, Oxford, OX1 3UD, UK.
⁶ Institut Philippe-Pinel de Montréal, 10905 Henri-Bourassa Est, Montréal, QC, H1C 1H1, Canada.
⁷ Department of Psychiatry, University of Montréal, Pavillon Roger-Gaudry, C.P., 6128 succursale Centre-ville, Montréal, QC, H3C 3J, Canada.
⁸ Stichting Benchmark GGZ, Rembrandtlaan 46, 3723 BK, Bilthoven, The Netherlands.
⁹ Department of Clinical Psychology, Leiden University, Rapenburg 70, 2311 EZ, Leiden, The Netherlands.
¹⁰ Netherlands Institute for Advanced Study, Meijboomlaan 1, 2242 PR, Wassenaar, The Netherlands.
¹¹ The Center for Social and Humanities Research, King Abdulaziz University, Jeddah, 21589, Saudi Arabia.
¹² School of Public Health, Kyoto University Graduate School of Medicine, Yoshida Konoecho, Sakyo-ku, Kyoto, 606-8501, Japan.
¹³ Department of Clinical Neuroscience, Karolinska Institutet, Nobels väg 9, 17177, Stockholm, Sweden.
¹⁴ Gustavsberg Primary Care Clinic, Stockholm County Council, Odelbergs väg 19, 13440, Gustavsberg, Sweden.
¹⁵ Centre for Emotional Health, Department of Psychology, Macquarie University, Building C3A, Level 7, Sydney, NSW, 2109, Australia.
¹⁶ , Ottawa, ON, Canada.
¹⁷ Research centre, Institut universitaire en santé mentale de Montréal, 7401 rue Hochelaga, Montréal, QC, H1N 3M5, Canada.
¹⁸ Makerere College of Health Sciences, Makerere University, P.O. Box 7072, Kampala, Uganda.
¹⁹ Department of Psychosomatic Medicine, Center for Internal Medicine and Dermatology, Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.
²⁰ Population Health Strategic Research Centre, School of Health and Social Development, Deakin University, 221 Burwood Highway, Burwood, VIC, 3125, Australia.
²¹ Department of Global Health and Social Medicine, Harvard Medical School, 641 Huntington Avenue, Boston, 02115, MA, USA.
²² Department of Psychiatry, University of Pittsburgh School of Medicine, Thomas Detre Hall, 3811 O'Hara Street, Pittsburgh, PA, 15213, USA.
²³ Department of Psychiatry, Columbia University, New York Presbyterian Hospital, 630 West 168th Street, New York, NY, 10032, USA.
²⁴ The RAND Corporation, 1776 Main Street, Santa Monica, CA, 90407-2138, USA.
²⁵ Federal University of Rio Grande do Sul, Grupo CNPq - GPEMSA - USP/São Paulo, Av. Paulo Gama, 110 - Bairro Farroupilha, Porto Alegre, Rio Grande do Sul, Brazil.
²⁶ Clinical Hospital, Department of Psychiatry and Mental Health, University of Chile, Av. Libertador Bernardo O'Higgins 1058, Santiago de Chile, Chile.
²⁷ Anxiety UK, Zion Community Centre, 339 Stretford Road, Hulme, Manchester, M15 4ZY, UK.
²⁸ Office of the U.S. Army Surgeon General, 7700 Arlington Blvd., Room 3SW116A, Falls Church, VA, 22042, USA.
²⁹ Department of Quantitative Health Sciences, Medical School, University of Massachusetts, 368 Plantation Street, Worcester, MA, 01605, USA.

PMID: 28786017
PMCID: PMC5681977
DOI: 10.1007/s11136-017-1659-5

Abstract

Purpose: National initiatives, such as the UK Improving Access to Psychological Therapies program (IAPT), demonstrate the feasibility of conducting empirical mental health assessments on a large scale, and similar initiatives exist in other countries. However, there is a lack of international consensus on which outcome domains are most salient to monitor treatment progress and how they should be measured. The aim of this project was to propose (1) an essential set of outcome domains relevant across countries and cultures, (2) a set of easily accessible patient-reported instruments, and (3) a psychometric approach to make scores from different instruments comparable.

Methods: Twenty-four experts, including ten health outcomes researchers, ten clinical experts from all continents, two patient advocates, and two ICHOM coordinators worked for seven months in a consensus building exercise to develop recommendations based on existing evidence using a structured consensus-driven modified Delphi technique.

Results: The group proposes to combine an assessment of potential outcome predictors at baseline (47 items: demographics, functional, clinical status, etc.), with repeated assessments of disease-specific symptoms during the treatment process (19 items: symptoms, side effects, etc.), and a comprehensive annual assessment of broader treatment outcomes (45 items: remission, absenteeism, etc.). Further, it is suggested reporting disease-specific symptoms for depression and anxiety on a standardized metric to increase comparability with other legacy instruments. All recommended instruments are provided online ( www.ichom.org ).

Conclusion: An international standard of health outcomes assessment has the potential to improve clinical decision making, enhance health care for the benefit of patients, and facilitate scientific knowledge.

Keywords: Anxiety; Depression; Health-related quality of life; Outcome Set; Patient-reported outcomes; Standardization.

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Conflict of interest statement

Conflict of interest

Edwin de Beurs and Anne Crocker are currently working for institutions that financially contributed to the present project. And as they were both members of the Working Group, they were also involved in analysis and interpretation of data and revision of the manuscript. Paul A. Pilkonis holds “founders’ shares” in Psychiatric Assessment, Inc. (PAI); however, no measures developed by PAI were considered for inclusion in the ICHOM Standard Set. Toshi A. Furukawa has received lecture fees from Eli Lilly, Meiji, Mochida, MSD, Otsuka, Pfizer and Tanabe-Mitsubishi, and consultancy fees from Sekisui Chemicals and Takeda Science Foundation. He has received royalties from Igaku-Shoin, Seiwa-Shoten and Nihon Bunka Kagaku-sha publishers. He has received grant or research support from the Japanese Ministry of Education, Science, and Technology, the Japanese Ministry of Health, Labour and Welfare, the Japan Society for the Promotion of Science, the Japan Foundation for Neuroscience and Mental Health, Mochida and Tanabe-Mitsubishi. He is diplomate of the Academy of Cognitive Therapy. Erik Hedman-Lagerlöf is a shareholder of Dahlia, a company specializing in psychiatric symptom assessment. Lucie Langford is currently employed by the Canadian Institutes of Health Research (CIHR) as a student. Sandra Nolte has no commercial or financial interest in promoting any of the instruments mentioned in this paper. She has received several research grants from the German Research Foundation and the European Organisation for Research and Treatment of Cancer (EORTC) and is Co-Chair of the PROMIS International Initiative. Harold A. Pincus has no commercial relationships or funding. He has received grants from the Commonwealth Fund and National Institutes of Health/National Center for Advancing Translational Sciences,/National Institute of Mental Health/National Institute on Drug Abuse/National Institute on Alcohol Abuse and Alcoholism/National Institute on Nursing Research, the US Department of Health and Human Services/Substance Abuse and Mental Health Services Administration/Assistant Secretary for Planning and Evaluation, Atlantic Philanthropies, John A. Hartford Foundation, the governments of Australia, Canada, England, Germany, Ireland, Netherlands, New Zealand, Norway, and Scotland, New York State Health Foundation, Patient-Centered Outcomes Research Institute, Department of Veterans Affairs, and the Department of Defense. He is employed by Columbia University/New York Presbyterian and RAND. He has consulted for Mathematica Policy Research and Manila Consulting. He serves on committees for (and received travel support but no compensation) from the National Quality Forum, National Committee for Quality Assurance, and American Psychiatric Association. Matthias Rose has no commercial, or financial interest promoting any of the instruments mentioned in this paper. He has received several grants from the U.S. National Institutes of Health, including one RO1 grant where he has worked together with Kurt Kroenke, one of the developers of the PHQ questionnaire. He was also one of the Co-Investigators of the NIH cross-funded initiative to develop a comprehensive Patient-Reported Measurement Information System (PROMIS), and is one of the Co-Chairs of the PROMIS International Initiative. The other authors declare that they have no conflict of interest.

Ethical approval

This article does not contain any studies with human participants or animals performed by any of the authors.

Figures

**Fig. 1**
Search strategy and selection process for instruments considered for the D+A standard set (modified PRISMA flow diagram). Stepwise selection based on literature review, monthly teleconference calls, and subsequent online surveys. Initial search term for scientific databases: “(depress* [TITLE] OR anxiety [TITLE] OR PTSD [TITLE] OR post-traumatic stress disorder [TITLE] OR dysthymia [TITLE] OR GAD [TITLE] OR SAD [TITLE] OR agoraphobia [TITLE] OR panic [TITLE] OR obsessive compulsive [TITLE] OR OCD [TITLE]) AND (instrument [TITLE] OR patient-reported outcome [TITLE] OR questionnaire [TITLE])”. IAPT UK = Improving Access to Psychological Therapies program by the National Institute of Health in the United Kingdom; PHQ-9 = Patient Health Questionnaire 9-item version; GAD-7 = PHQ module for assessment of General anxiety disorder, 7-items; WHODAS = WHO Disability Assessment Schedule

**Fig. 2**
Follow-up timeline for the depression and anxiety standard set. Proposed and optional assessment time points for subsets included in the ICHOM depression and anxiety standard set. BL baseline assessment, TM treatment monitoring, AA annual assessment

See this image and copyright information in PMC

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Standardization of health outcomes assessment for depression and anxiety: recommendations from the ICHOM Depression and Anxiety Working Group

Affiliations

Standardization of health outcomes assessment for depression and anxiety: recommendations from the ICHOM Depression and Anxiety Working Group

Authors

Affiliations

Abstract

Conflict of interest statement

Conflict of interest

Ethical approval

Figures

References

MeSH terms

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical