Patient-reported outcome measures for monitoring depression in primary care: cluster randomised controlled trial

Problem

Guidelines recommend practitioners consider using validated patient-reported outcome measures (PROMs) to inform treatment at diagnosis and follow-up of people with depression, but there is insufficient evidence that they improve depression management and outcomes for patients in primary care.The aim of the study was to answer the research question: What is the effectiveness and cost-effectiveness of assessing primary care patients with depression or low mood soon after diagnosis and again at follow-up 10-35 days later, using the PHQ-9 questionnaire combined with patient feedback and practitioner guidance on treatment?

Approach

Design: Prospective pragmatic cluster-randomised superiority trial using remote computerised randomisation with minimisation by recruiting university; small/large practice; and urban/rural location. Blinding of participants was not possible given the pragmatic design, but self-report outcome measures minimised observer bias and analysis was blind to allocation. Setting: UK primary care (141 group general practices in England and Wales). Participants: 529 patients aged 18 years or older with a new episode of depression, recruited through medical record searches and in consultations. Exclusions: dementia; psychosis; substance misuse; suicide risk. Intervention: Administration of the PHQ-9 questionnaire with patient feedback soon after diagnosis, and at follow-up 10-35 days later, compared to usual care. Practitioners were trained in interpreting PHQ-9 scores and giving patients feedback on the implications for treatment.Main outcome measures: Beck Depression Inventory (BDI-II) symptom scores at 12 weeks (primary outcome) and 26 weeks; social functioning (Work and Social Adjustment Scale) and quality of life (EuroQol EQ-5D-5L) at 12 and 26 weeks; antidepressant drug treatment, mental health service contacts, adverse events, and patient satisfaction (Medical Informant Satisfaction Scale) over 26 weeks.

Findings

Results: 302 patients were recruited in intervention arm practices and 227 in control practices. Primary outcome data were collected for 252 (83.4%) and 195 (85.9%) respectively. The study found no significant difference in BDI-II score at 12 weeks (mean difference -0.46; 95% CI -2.16 to 1.26; p=0.60, adjusted for baseline depression, baseline anxiety, sociodemographic factors, and clustering including practice as a random effect). No significant differences were found either in BDI-II score at 26 weeks, social functioning, antidepressant drug treatment, contact with mental health services, adverse events, or patient satisfaction. EQ-5D quality of life scores favoured the intervention arm at 26 weeks (adjusted mean difference 0.053; 95% CI 0.093 to 0.013; p=0.01), with more participants in the intervention arm reporting no problem on the Anxiety/Depression subscale (50/221 (22.6%) versus 25/185 (13.5%) in the control arm).

Consequences

Conclusions: This study found no evidence of improved depression management or outcome at 12 weeks from feedback monitoring with the PHQ-9 in primary care. A small benefit in the outcome of depression at 26 weeks could not be ruled out. Future research on feedback monitoring should include measures of anxiety as well as depression.