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Use of the Patient Health Questionnaire as a Patient-Reported Outcome Measure for Monitoring Depression in Primary Care: The PROMDEP Cluster Randomised Controlled Trial

25 Pages Posted: 31 Jul 2023

See all articles by Tony Kendrick

Tony Kendrick

University of Southampton - School of Primary Care, Population Sciences and Medical Education

Christopher Dowrick

University of Liverpool - Department of Primary Care and Mental Health

Glyn Lewis

University College London - Division of Psychiatry

Micheal Moore

University of Southampton - Primary Care and Population Science

Geraldine M. Leydon

University of Southampton - School of Primary Care, Population Sciences and Medical Education

Adam WA Geraghty

University of Southampton - School of Primary Care, Population Sciences and Medical Education

Gareth Griffiths

University of Southampton - Southampton Clinical Trials Unit

Shihua Zhu

University of Southampton - School of Primary Care, Population Sciences and Medical Education

Guiqing Lily Yao

University of Leicester - Leicester Clinical Trials Unit

Carl May

London School of Hygiene & Tropical Medicine - Faculty of Public Health and Policy

Mark Gabbay

University of Liverpool - Department of Primary Care and Mental Health

Rachel Dewar-Haggart

University of Southampton - School of Primary Care, Population Sciences and Medical Education

Samantha Williams

University of Southampton - School of Primary Care, Population Sciences and Medical Education

Lien Bui

University of Southampton - School of Primary Care, Population Sciences and Medical Education

Natalie Thompson

University of Southampton - School of Primary Care, Population Sciences and Medical Education

Lauren Bridewell

University of Southampton - School of Primary Care, Population Sciences and Medical Education

Emilia Trapasso

University of Liverpool - Department of Primary Care and Mental Health

Tasneem Patel

University of Liverpool - Department of Primary Care and Mental Health

Molly McCarthy

University of Liverpool - Department of Primary Care and Mental Health

Naila Khan

University of Liverpool - Department of Primary Care and Mental Health

Helen Page

University of Liverpool - Department of Primary Care and Mental Health

Emma Corcoran

University College London - Division of Psychiatry

Jane Sungmin Hahn

University College London - Division of Psychiatry

Molly Bird

University College London - Division of Psychiatry

Mekeda X. Logan

University College London - Division of Psychiatry

Brian Chi Fung Ching

University College London - Division of Psychiatry

Riya Tiwari

University of Southampton - School of Primary Care, Population Sciences and Medical Education

Anna Hunt

University of Southampton - School of Primary Care, Population Sciences and Medical Education

Beth Stuart

Queen Mary University of London - Wolfson Institute of Population Health

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Abstract

Background: Outcome monitoring of depression is widely recommended but lacks evidence of patient benefit.

Methods: Cluster-randomised trial in 141 general practices. Self-report measures minimised observer bias. Analysis was blind. Participants: 529 adult patients with new depressive episodes, recruited through record searches and in consultations. Exclusions: dementia, psychosis, substance misuse, suicide risk. Intervention: Administration of PHQ-9 questionnaires with feedback after diagnosis, and 10-35 days later. Outcome measures: Beck Depression Inventory (BDI-II) scores at 12 weeks (primary outcome) and 26 weeks; Work and Social Adjustment Scale and EuroQol EQ-5D-5L quality of life at 12 and 26 weeks; antidepressant treatment, mental health service use, adverse events, and Medical Informant Satisfaction Scale over 26 weeks.

Outcomes: 302 intervention arm patients were recruited and 227 controls; at 12 weeks 252 (83.4%) and 195 (85.9%) were followed-up respectively. There was no significant difference in BDI-II score at 12 weeks (mean difference -0.46;95%CI -2.16,1.26, adjusted for baseline differences). No significant differences were found either in social functioning, antidepressant or mental health service use, adverse events or satisfaction. A clinically significant benefit in BDI-II scores at 26 weeks could not be excluded (adjusted mean difference -1.20;95%CI -3.07,0.67). EQ-5D-5L scores were higher in the intervention arm at 26 weeks (adjusted mean difference 0.053;95%CI 0.093,0.013).

Interpretation: There was no evidence of improved depression management or outcome at 12 weeks, although a benefit at 26 weeks could not be excluded. Outcome monitoring of depression in primary care should be discretionary rather than mandatory.

Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN) no: 17299295.

Funding: This project was funded by the National Institute for Health and Social Care Research (NIHR) Health Technology Assessment programme (grant reference no. HTA 17/42/02). The views expressed in this publication are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

Declaration of Interest: Tony Kendrick, Christopher Dowrick, Glyn Lewis, Michael Moore, Geraldine Leydon, Adam Geraghty, Gareth Griffiths, Shihua Zhu, Guiqing Lily Yao, Carl May, Mark Gabbay and Beth Stuart have received grant funding to their employer universities from the National Institute for Health and Social Care Research (NIHR) to carry out this study and other research. In addition Glyn Lewis has received grant funding from the MRC and Wellcome. Gareth Griffiths has received funding from Janssen-Cilag, AstraZeneca, Novartis, Astex, Roche, Heartflow, Celldex, BMS, BioNTech, Cancer Research UK, the NIHR, the British Lung Foundation, Unitaid, and GSK for unrelated academic clinical trials and programme funding, and has received personal payments from AZ for delivering CPD training courses. Mark Gabbay has received consultancy fees from Spectrum Learning and Development as a board member for substance misuse training courses. Tony Kendrick was a member of the NHS England Quality Outcomes Framework (QOF) Advisory Committee 2009-2014, NICE Quality Indicators Advisory Committee 2015-2018, and NICE Depression Guideline Update Committee 2015- 2022, and has been a member of the NHS England Improving Access to Psychological Therapies Expert Advisory Committee since 2020. Christopher Dowrick chaired the WONCA Working Party on Mental Health 2016-2021. Guiqing Lily Yao is a member of the NICE Public Health Committee. Glyn Lewis is a member of the NIHR EME Funding Committee. Gareth Griffiths is Director of the Southampton Clinical trials Unit which is part-funded by the NIHR. Beth Stuart is a member of the HTA Commissioning Committee. Tony Kendrick, Glyn Lewis, Michael Moore, Gareth Griffiths, Guiqing Lily Yao, and Beth Stuart have been members of trial steering committees for other NIHR funded studies. All the other authors declared no relevant interests.

Ethical Approval: The study was approved by the West of Scotland NHS Research Ethics Committee 5, on 21st September 2018 (ref: 18/WS/0144).

Keywords: Primary Health Care, Mental health, Mood Disorders

Suggested Citation

Kendrick, Tony and Dowrick, Christopher and Lewis, Glyn and Moore, Micheal and Leydon, Geraldine M. and Geraghty, Adam WA and Griffiths, Gareth and Zhu, Shihua and Yao, Guiqing Lily and May, Carl and Gabbay, Mark and Dewar-Haggart, Rachel and Williams, Samantha and Bui, Lien and Thompson, Natalie and Bridewell, Lauren and Trapasso, Emilia and Patel, Tasneem and McCarthy, Molly and Khan, Naila and Page, Helen and Corcoran, Emma and Sungmin Hahn, Jane and Bird, Molly and Logan, Mekeda X. and Ching, Brian Chi Fung and Tiwari, Riya and Hunt, Anna and Stuart, Beth, Use of the Patient Health Questionnaire as a Patient-Reported Outcome Measure for Monitoring Depression in Primary Care: The PROMDEP Cluster Randomised Controlled Trial. Available at SSRN: https://ssrn.com/abstract=4522402 or http://dx.doi.org/10.2139/ssrn.4522402

Tony Kendrick (Contact Author)

University of Southampton - School of Primary Care, Population Sciences and Medical Education ( email )

Christopher Dowrick

University of Liverpool - Department of Primary Care and Mental Health ( email )

Glyn Lewis

University College London - Division of Psychiatry ( email )

Micheal Moore

University of Southampton - Primary Care and Population Science ( email )

Southampton, SO16 5ST
United Kingdom

Geraldine M. Leydon

University of Southampton - School of Primary Care, Population Sciences and Medical Education ( email )

Adam WA Geraghty

University of Southampton - School of Primary Care, Population Sciences and Medical Education ( email )

Gareth Griffiths

University of Southampton - Southampton Clinical Trials Unit ( email )

Shihua Zhu

University of Southampton - School of Primary Care, Population Sciences and Medical Education ( email )

Guiqing Lily Yao

University of Leicester - Leicester Clinical Trials Unit ( email )

Carl May

London School of Hygiene & Tropical Medicine - Faculty of Public Health and Policy ( email )

Mark Gabbay

University of Liverpool - Department of Primary Care and Mental Health ( email )

Rachel Dewar-Haggart

University of Southampton - School of Primary Care, Population Sciences and Medical Education ( email )

Samantha Williams

University of Southampton - School of Primary Care, Population Sciences and Medical Education ( email )

Lien Bui

University of Southampton - School of Primary Care, Population Sciences and Medical Education ( email )

Natalie Thompson

University of Southampton - School of Primary Care, Population Sciences and Medical Education ( email )

Lauren Bridewell

University of Southampton - School of Primary Care, Population Sciences and Medical Education ( email )

Emilia Trapasso

University of Liverpool - Department of Primary Care and Mental Health ( email )

Tasneem Patel

University of Liverpool - Department of Primary Care and Mental Health ( email )

Molly McCarthy

University of Liverpool - Department of Primary Care and Mental Health ( email )

Naila Khan

University of Liverpool - Department of Primary Care and Mental Health ( email )

Helen Page

University of Liverpool - Department of Primary Care and Mental Health ( email )

Emma Corcoran

University College London - Division of Psychiatry ( email )

Jane Sungmin Hahn

University College London - Division of Psychiatry ( email )

Molly Bird

University College London - Division of Psychiatry ( email )

Mekeda X. Logan

University College London - Division of Psychiatry ( email )

Brian Chi Fung Ching

University College London - Division of Psychiatry ( email )

Riya Tiwari

University of Southampton - School of Primary Care, Population Sciences and Medical Education ( email )

Anna Hunt

University of Southampton - School of Primary Care, Population Sciences and Medical Education ( email )

Beth Stuart

Queen Mary University of London - Wolfson Institute of Population Health ( email )