title: Patient-reported outcome measures for monitoring primary care patients with depression: PROMDEP feasibility randomised trial.
abstract: To determine the feasibility of a trial of patient-reported outcome measures (PROMs) for monitoring primary care patients with depression.
  
  
  
  Partly individually randomised, partly cluster-randomised controlled trial.
  
  
  
  Nine general practices in Southern England.
  
  
  
  47 adults with new episodes of depression: 22 intervention, 25 control.
  
  
  
  Remote computerised sequence generation and allocation.
  
  
  
  Patient Health Questionnaire, Distress Thermometer Analogue Scale and PSYCHLOPS problem profile for monitoring depression, following diagnosis and at 10-35 days later. Feedback of scores to patients was determined by practitioners.
  
  
  
  Non-blinded, using self-completed measures.
  
  
  
  Beck Depression Inventory (BDI-II).
  
  
  
  Work and Social Adjustment Scale (WSAS), EuroQol Five-item, Five-level (EQ-5D-5L) Scale for quality of life, modified Client Service Receipt Inventory for costs, Medical Informant Satisfaction Scale (MISS), qualitative interviews with 14 patients and 13 practice staff about feasibility and acceptability of trial design.
  
  
  
  Three practices failed to recruit the target of six patients in 12 months. Follow-up rates were intervention patients: 18 (82%) at 12 weeks and 15 (68%) at 26 weeks; controls: 18 (72%) and 15 (60%), respectively. At 12 weeks, mean BDI-II score was lower among intervention group patients than controls by 5.8 points (95% CI -11.1 to -0.5), adjusted for baseline differences and clustering. WSAS scores were not significantly different. At 26 weeks, there were no significant differences in symptoms, social functioning, quality of life or costs, but mean satisfaction score was higher among controls by 22.0 points (95% CI -40.7 to -3.29). Intervention patients liked completing PROMs, but were disappointed when practitioners did not use the results to inform management.
  
  
  
  PROMs may improve depression outcome in the short term, even if PROM scores do not inform practitioners' management. Challenges in recruiting and following up patients need addressing for a definitive trial of relatively brief measures which can potentially inform management. https://www.isrctn.com/search?q=97492541 TRIAL REGISTRATION NUMBER: ISRCTN 97492541; Pre-results.
authors.affiliation: Primary Care and Population Sciences, University of Southampton, Southampton, UK.
authors.forename: Tony
authors.initials: T
authors.lastname: Kendrick
authors.affiliation: Primary Care and Population Sciences, University of Southampton, Southampton, UK.
authors.forename: Beth
authors.initials: B
authors.lastname: Stuart
authors.affiliation: Primary Care and Population Sciences, University of Southampton, Southampton, UK.
authors.forename: Geraldine M
authors.initials: GM
authors.lastname: Leydon
authors.affiliation: Primary Care and Population Sciences, University of Southampton, Southampton, UK.
authors.forename: Adam W A
authors.initials: AW
authors.lastname: Geraghty
authors.affiliation: Primary Care and Population Sciences, University of Southampton, Southampton, UK.
authors.forename: Lily
authors.initials: L
authors.lastname: Yao
authors.affiliation: Primary Care and Population Sciences, University of Southampton, Southampton, UK.
authors.forename: Rachel
authors.initials: R
authors.lastname: Ryves
authors.affiliation: Primary Care and Population Sciences, University of Southampton, Southampton, UK.
authors.forename: Samantha
authors.initials: S
authors.lastname: Williams
authors.affiliation: Primary Care and Population Sciences, University of Southampton, Southampton, UK.
authors.forename: Shihua
authors.initials: S
authors.lastname: Zhu
authors.affiliation: Institute of Psychology Health and Society, University of Liverpool, Liverpool, UK.
authors.forename: Christopher
authors.initials: C
authors.lastname: Dowrick
authors.affiliation: Institute of Epidemiology and Health Care, University College London, London, UK.
authors.forename: Glyn
authors.initials: G
authors.lastname: Lewis
authors.affiliation: Primary Care and Population Sciences, University of Southampton, Southampton, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Moore
mesh_terms: D000328:Adult; D001291:Attitude of Health Personnel; D001294:Attitude to Health; D016000:Cluster Analysis; D003866:Depressive Disorder / Q000628:therapy*; D004739:England; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D016896:Treatment Outcome
keywords: PRIMARY CARE; Patient reported outcome measures; depression