Patient-reported outcome measures for monitoring primary care patients with depression: the PROMDEP cluster RCT and economic evaluation
Authors: Kendrick Tony , Dowrick Christopher , Lewis Glyn , Moore Michael , Leydon Geraldine M , Geraghty Adam WA , Griffiths Gareth , Zhu Shihua , Yao Guiqing Lily , May Carl , Gabbay Mark , Dewar-Haggart Rachel , Williams Samantha , Bui Lien , Thompson Natalie , Bridewell Lauren , Trapasso Emilia , Patel Tasneem , McCarthy Molly , Khan Naila , Page Helen , Corcoran Emma , Hahn Jane Sungmin , Bird Molly , Logan Mekeda X , Ching Brian Chi Fung , Tiwari Riya , Hunt Anna , Stuart Beth 
Published: July 2023

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.