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Mental health
Research
Patient-reported outcome measures for monitoring primary care patients with depression: PROMDEP feasibility randomised trial
  1. Tony Kendrick1,
  2. Beth Stuart1,
  3. Geraldine M Leydon1,
  4. Adam W A Geraghty1,
  5. Lily Yao1,
  6. Rachel Ryves1,
  7. Samantha Williams1,
  8. Shihua Zhu1,
  9. Christopher Dowrick2,
  10. Glyn Lewis3,
  11. Michael Moore1
  1. 1Primary Care and Population Sciences, University of Southampton, Southampton, UK
  2. 2Institute of Psychology Health and Society, University of Liverpool, Liverpool, UK
  3. 3Institute of Epidemiology and Health Care, University College London, London, UK
  1. Correspondence to Professor Tony Kendrick; ark1{at}soton.ac.uk

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.

  • depression
  • PRIMARY CARE
  • Patient reported outcome measures

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2016-015266

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    Footnotes

    • Twitter Follow Rachel Ryves @rachelryves, Christopher Dowrick @cfd1951 and Tony Kendric k@tony_kendrick

    • Contributors TK, BS, GML, AWAG, LY, CD, GL and MM made substantial contributions to the conception or design of the work. RR, SW and SZ made substantial contributions to the acquisition, analysis and interpretation of data. All authors contributed to drafting the work and revising it critically for important intellectual content, and all approved the final version submitted. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

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

    • Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

    • Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: all authors had financial support from the NIHR Research for Patient Benefit Programme for the submitted work.

    • Ethics approval The study was approved by the NHS Research Ethics Committee (REC) South Central—Oxford A on 28 July 2014 (reference number 14/SC/1067).

    • Provenance and peer review Not commissioned; externally peer reviewed.

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