
Preprints with The Lancet is a collaboration between The Lancet Group of journals and SSRN to facilitate the open sharing of preprints for early engagement, community comment, and collaboration. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early-stage research papers that have not been peer-reviewed. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. The findings should not be used for clinical or public health decision-making or presented without highlighting these facts. For more information, please see the FAQs.
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
More...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: Suggested Citation