Abstract
Background:
Guidelines on the management of depression recommend that practitioners use patient-reported outcome measures for the follow-up monitoring of symptoms, but there is a lack of evidence of benefit in terms of patient outcomes.
Objective:
To test using the Patient Health Questionnaire-9 questionnaire as a patient-reported outcome measure for monitoring depression, training practitioners in interpreting scores and giving patients feedback.
Design:
Parallel-group, cluster-randomised superiority trial; 1 : 1 allocation to intervention and control.
Setting:
UK primary care (141 group general practices in England and Wales).
Inclusion criteria:
Patients aged ≥ 18 years with a new episode of depressive disorder or symptoms, recruited mainly through medical record searches, plus opportunistically in consultations.
Exclusions:
Current depression treatment, dementia, psychosis, substance misuse and risk of suicide.
Intervention:
Administration of the Patient Health Questionnaire-9 questionnaire with patient feedback soon after diagnosis, and at follow-up 10–35 days later, compared with usual care.
Primary outcome:
Beck Depression Inventory, 2nd edition, symptom scores at 12 weeks.
Secondary outcomes:
Beck Depression Inventory, 2nd edition, scores at 26 weeks; antidepressant drug treatment and mental health service contacts; social functioning (Work and Social Adjustment Scale) and quality of life (EuroQol 5-Dimension, five-level) at 12 and 26 weeks; service use over 26 weeks to calculate NHS costs; patient satisfaction at 26 weeks (Medical Informant Satisfaction Scale); and adverse events.
Sample size:
The original target sample of 676 patients recruited was reduced to 554 due to finding a significant correlation between baseline and follow-up values for the primary outcome measure.
Randomisation:
Remote computerised randomisation with minimisation by recruiting university, small/large practice and urban/rural location.
Blinding:
Blinding of participants was impossible given the open cluster design, but self-report outcome measures prevented observer bias. Analysis was blind to allocation.
Analysis:
Linear mixed models were used, adjusted for baseline depression, baseline anxiety, sociodemographic factors, and clustering including practice as random effect. Quality of life and costs were analysed over 26 weeks.
Qualitative interviews:
Practitioner and patient interviews were conducted to reflect on trial processes and use of the Patient Health Questionnaire-9 using the Normalization Process Theory framework.
Results:
Three hundred and two patients were recruited in intervention arm practices and 227 patients were recruited in control practices. Primary outcome data were collected for 252 (83.4%) and 195 (85.9%), respectively. No significant difference in Beck Depression Inventory, 2nd edition, score was found at 12 weeks (adjusted mean difference –0.46, 95% confidence interval –2.16 to 1.26). Nor were significant differences found in Beck Depression Inventory, 2nd Edition, score at 26 weeks, social functioning, patient satisfaction or adverse events. EuroQol-5 Dimensions, five-level version, quality-of-life scores favoured the intervention arm at 26 weeks (adjusted mean difference 0.053, 95% confidence interval 0.013 to 0.093). However, quality-adjusted life-years over 26 weeks were not significantly greater (difference 0.0013, 95% confidence interval –0.0157 to 0.0182). Costs were lower in the intervention arm but, again, not significantly (–£163, 95% confidence interval –£349 to £28). Cost-effectiveness and cost–utility analyses, therefore, suggested that the intervention was dominant over usual care, but with considerable uncertainty around the point estimates. Patients valued using the Patient Health Questionnaire-9 to compare scores at baseline and follow-up, whereas practitioner views were more mixed, with some considering it too time-consuming.
Conclusions:
We found no evidence of improved depression management or outcome at 12 weeks from using the Patient Health Questionnaire-9, but patients’ quality of life was better at 26 weeks, perhaps because feedback of Patient Health Questionnaire-9 scores increased their awareness of improvement in their depression and reduced their anxiety. Further research in primary care should evaluate patient-reported outcome measures including anxiety symptoms, administered remotely, with algorithms delivering clear recommendations for changes in treatment.
Study registration:
This study is registered as IRAS250225 and ISRCTN17299295.
Funding:
This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/42/02) and is published in full in Health Technology Assessment; Vol. 28, No. 17. See the NIHR Funding and Awards website for further award information.
Plain language summary
Depression is common, can be disabling and costs the nation billions. The National Health Service recommends general practitioners who treat people with depression use symptom questionnaires to help assess whether those people are getting better over time. A symptom questionnaire is one type of patient-reported outcome measure. Patient-reported outcome measures appear to benefit people having therapy and mental health care, but this approach has not been tested thoroughly in general practice. Most people with depression are treated in general practice, so it is important to test patient-reported outcome measures there, too.
In this study, we tested whether using a patient-reported outcome measure helps people with depression get better more quickly. The study was a ‘randomised controlled trial’ in general practices, split into two groups. In one group, people with depression completed the Patient Health Questionnaire, or ‘PHQ-9’, patient-reported outcome measure, which measures nine symptoms of depression. In the other group, people with depression were treated as usual without the Patient Health Questionnaire-9. We fed the results of the Patient Health Questionnaire-9 back to the people with depression themselves to show them how severe their depression was and asked them to discuss the results with the practitioners looking after them.
We found no differences between the patient-reported outcome measure group and the control group in their level of depression; their work or social life; their satisfaction with care from their practice; or their use of medicines, therapy or specialist care for depression. However, we did find that their quality of life was improved at 6 months, and the costs of the National Health Service services they used were lower.
Using the Patient Health Questionnaire-9 can improve patients’ quality of life, perhaps by making them more aware of improvement in their depression symptoms, and less anxious as a result. Future research should test using a patient-reported outcome measure that includes anxiety and processing the answers through a computer to give practitioners clearer advice on possible changes to treatment for depression.
About the Series
Health Technology Assessment
ISSN (Electronic): 2046-4924
Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/PLRQ4216.
Primary conflicts of interest: Tony Kendrick, Christopher Dowrick, Glyn Lewis, Michael Moore, Geraldine Leydon, Adam WA 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 Care Research (NIHR) to carry out this study and other research. In addition, Glyn Lewis has received grant funding from the Medical Research Council and Wellcome. Gareth Griffiths has received funding from Janssen-Cilag (High Wycombe, UK), AstraZeneca (Cambridge, UK), Novartis (Basel, Switzerland), Astex (Cambridge, UK), Roche (Basel, Switzerland), HeartFlow (Mountain View, CA, USA), Celldex (Hampton, NJ, USA), BMS, BioNTech (Mainz, Germany), Cancer Research UK (London, UK), the NIHR, the British Lung Foundation (London, UK), Unitaid (Geneva, Switzerland) and GSK (Brentford, UK) for unrelated academic clinical trials and programme funding and has received personal payments from AstraZeneca for delivering Continuing Professional Development training courses. Mark Gabbay has received consultancy fees from Spectrum Learning and Development (Wakefield, UK) as a board member for substance misuse training courses. Tony Kendrick was a member of the NHS England Quality Outcomes Framework Advisory Committee 2009–14, NICE Quality Indicators Advisory Committee 2015–8 and NICE Depression Guideline Update Committee 2015–22 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 2016–21. Guiqing Lily Yao is a member of the National Institute for Health and Care Excellence Public Health Committee. Glyn Lewis is a member of the NIHR Efficacy and Mechanism Evaluation 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 NIHR Health Technology Assessment 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.
Disclaimer: This report contains transcripts of interviews conducted in the course of the research, which include language which may offend some readers.
Article history
The research reported in this issue of the journal was funded by the HTA programme as award number 17/42/02. The contractual start date was in November 2018. The draft report began editorial review in November 2022 and was accepted for publication in July 2023. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ manuscript and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this manuscript.
Last reviewed: November 2022; Accepted: July 2023.
