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

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

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.

Journal Article
Kendrick, Tony
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Stuart, Beth
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Leydon, Geraldine M.
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Geraghty, Adam W.A.
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Yao, Lily
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Ryves, Rachel
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Williams, Samantha
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Zhu, Shihua
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Dowrick, Christopher
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Lewis, Glyn
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Moore, Michael
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Kendrick, Tony
c697a72c-c698-469d-8ac2-f00df40583e5
Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Leydon, Geraldine M.
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Geraghty, Adam W.A.
2c6549fe-9868-4806-b65a-21881c1930af
Yao, Lily
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Ryves, Rachel
7ae70377-352a-4297-9798-a6aed0e1c04b
Williams, Samantha
7cec7c3e-7247-473e-8121-f26b625893e1
Zhu, Shihua
13511f9c-151c-483c-9dfd-2da13421db5c
Dowrick, Christopher
1869ad5e-1959-446c-b2a8-3fcdf3e79667
Lewis, Glyn
11aed8f6-3905-455e-8e89-34147a5e5d26
Moore, Michael
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Kendrick, Tony, Stuart, Beth, Leydon, Geraldine M., Geraghty, Adam W.A., Yao, Lily, Ryves, Rachel, Williams, Samantha, Zhu, Shihua, Dowrick, Christopher, Lewis, Glyn and Moore, Michael (2017) Patient-reported outcome measures for monitoring primary care patients with depression: PROMDEP feasibility randomised trial. BMJ Open, 7 (3), [e015266]. (doi:10.1136/bmjopen-2016-015266).

Record type: Article

Abstract

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.

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More information

Accepted/In Press date: 3 March 2017
e-pub ahead of print date: 30 March 2017
Published date: 30 March 2017
Keywords: Journal Article
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 407425
URI: http://eprints.soton.ac.uk/id/eprint/407425
PURE UUID: ff70eabb-eb12-473f-818a-0ec7cfffa665
ORCID for Tony Kendrick: ORCID iD orcid.org/0000-0003-1618-9381
ORCID for Beth Stuart: ORCID iD orcid.org/0000-0001-5432-7437
ORCID for Geraldine M. Leydon: ORCID iD orcid.org/0000-0001-5986-3300
ORCID for Adam W.A. Geraghty: ORCID iD orcid.org/0000-0001-7984-8351
ORCID for Rachel Ryves: ORCID iD orcid.org/0000-0002-3757-1152
ORCID for Samantha Williams: ORCID iD orcid.org/0000-0001-9505-6485
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509

Catalogue record

Date deposited: 07 Apr 2017 01:03
Last modified: 16 Mar 2024 04:10

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Contributors

Author: Tony Kendrick ORCID iD
Author: Beth Stuart ORCID iD
Author: Lily Yao
Author: Rachel Ryves ORCID iD
Author: Shihua Zhu
Author: Christopher Dowrick
Author: Glyn Lewis
Author: Michael Moore ORCID iD

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