{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T01:48:24Z","timestamp":1790732904737,"version":"4.1.0"},"reference-count":66,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2024,3,1]],"date-time":"2024-03-01T00:00:00Z","timestamp":1709251200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["17\/42\/02"],"award-info":[{"award-number":["17\/42\/02"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"\n Background<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n Parallel-group, cluster-randomised superiority trial; 1 : 1 allocation to intervention and control.<\/jats:p>\n <\/jats:sec>\n \n Setting<\/jats:title>\n UK primary care (141 group general practices in England and Wales).<\/jats:p>\n <\/jats:sec>\n \n Inclusion criteria<\/jats:title>\n Patients aged \u2265\u200918 years with a new episode of depressive disorder or symptoms, recruited mainly through medical record searches, plus opportunistically in consultations.<\/jats:p>\n <\/jats:sec>\n \n Exclusions<\/jats:title>\n Current depression treatment, dementia, psychosis, substance misuse and risk of suicide.<\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n Administration of the Patient Health Questionnaire-9 questionnaire with patient feedback soon after diagnosis, and at follow-up 10\u201335 days later, compared with usual care.<\/jats:p>\n <\/jats:sec>\n \n Primary outcome<\/jats:title>\n Beck Depression Inventory, 2nd edition, symptom scores at 12 weeks.<\/jats:p>\n <\/jats:sec>\n \n Secondary outcomes<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Sample size<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Randomisation<\/jats:title>\n Remote computerised randomisation with minimisation by recruiting university, small\/large practice and urban\/rural location.<\/jats:p>\n <\/jats:sec>\n \n Blinding<\/jats:title>\n Blinding of participants was impossible given the open cluster design, but self-report outcome measures prevented observer bias. Analysis was blind to allocation.<\/jats:p>\n <\/jats:sec>\n \n Analysis<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Qualitative interviews<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n 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 \u20130.46, 95% confidence interval \u20132.16 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 \u20130.0157 to 0.0182). Costs were lower in the intervention arm but, again, not significantly (\u2013\u00a3163, 95% confidence interval \u2013\u00a3349 to \u00a328). Cost-effectiveness and cost\u2013utility 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.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n We found no evidence of improved depression management or outcome at 12 weeks from using the Patient Health Questionnaire-9, but patients\u2019 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.<\/jats:p>\n <\/jats:sec>\n \n Study registration<\/jats:title>\n This study is registered as IRAS250225 and ISRCTN17299295.<\/jats:p>\n <\/jats:sec>\n \n Funding<\/jats:title>\n \n 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\n Health Technology Assessment<\/jats:italic>\n ; Vol. 28, No. 17. See the NIHR Funding and Awards website for further award information.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.3310\/plrq4216","type":"journal-article","created":{"date-parts":[[2023,7,27]],"date-time":"2023-07-27T03:01:22Z","timestamp":1690426882000},"page":"1-95","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":34,"title":["Patient-reported outcome measures for monitoring primary care patients with depression: the PROMDEP cluster RCT and economic evaluation"],"prefix":"10.3310","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1618-9381","authenticated-orcid":true,"given":"Tony","family":"Kendrick","sequence":"first","affiliation":[{"name":"School of Primary Care, Population Health and Medical Education, University of Southampton, Southampton, 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