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Patient-reported outcome measures for monitoring primary care patients with depression: PROMDEP feasibility randomised trial

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posted on 30.08.2019, 13:51 by T Kendrick, B Stuart, GM Leydon, AWA Geraghty, L Yao, R Ryves, S Williams, S Zhu, C Dowrick, G Lewis, M Moore
Objectives To determine the feasibility of a trial of patient-reported outcome measures (PROMs) for monitoring primary care patients with depression. Design Partly individually randomised, partly cluster-randomised controlled trial. Setting Nine general practices in Southern England. Participants 47 adults with new episodes of depression: 22 intervention, 25 control. Randomisation Remote computerised sequence generation and allocation. Interventions 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. Blinding Non-blinded, using self-completed measures. Primary outcome Beck Depression Inventory (BDI-II). Secondary outcome measures 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. Results 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. Conclusions 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.

Funding

Funding National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) Programme (grant number PB-PG-0613-31004).

History

Citation

BMJ Open 2017;7:e015266.

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Department of Health Sciences

Version

VoR (Version of Record)

Published in

BMJ Open 2017;7:e015266.

Publisher

BMJ Publishing Group

issn

2044-6055

eissn

2044-6055

Acceptance date

03/03/2017

Copyright date

2017

Available date

30/08/2019

Publisher version

https://bmjopen.bmj.com/content/7/3/e015266

Notes

Data sharing statement We agree to make the relevant anonymised patient-level data available on reasonable request.

Language

en

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