Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial

Abstract

Background: Benefits to patients from reduced depression have been shown from monitoring progress with patientreported outcome measures (PROMs) in psychological therapy and mental health settings. This approach has not yet been researched in the United Kingdom for primary care, which is where most people with depression are treated in the United Kingdom. Methods: This is a parallel-group cluster randomised trial with 1:1 allocation to intervention and control. Patients who are age 18+ years, with a new episode of depressive disorder/symptoms, meet the inclusion criteria. Patients with current depression treatment, comorbid dementia/psychosis/substance misuse/suicidal ideas are excluded. The intervention includes the Administration of Patient Health Questionnaire (PHQ-9) as a PROM within 2 weeks of diagnosis and at follow-up 4 weeks later. General practitioners are trained in interpreting scores and asked to take them into account in their treatment decisions. Patients are given written feedback on scores and suggested treatments. The primary outcome measure is Depression on the Beck Depression Inventory BDI-II at 12 weeks. Secondary outcomes include BDI-II at 26 weeks, changes in drug treatments and referrals, social functioning (Work & Social Adjustment Scale) and quality of life (EQ-5D) at 12 and 26 weeks, service use over 26 weeks (modified Client Services Receipt Inventory) to calculate NHS costs, and patient satisfaction at 26 weeks (Medical Informant Satisfaction Scale). The sample includes 676 total participants from 113 practices across three centres. Randomisation is achieved by computerised sequence generation. Blinding is impossible given the nature of the intervention (self-report outcome measures prevent rating bias). Differences at 12 and 26 weeks between intervention and controls in depression, social functioning and quality of life are analysed using linear mixed models, adjusted for socio-demographics, baseline depression, anxiety, and clustering, while including practice as a random effect. Patient satisfaction, quality of life (QALYs) and costs over 26 weeks

Do PROMS improve outcomes in patients with depression in primary care?

“…They are all recruiting larger samples of patients, providing more training for practitioners, administering PROMs remotely, and providing automatic feedback of the results to practitioners (see table 2). 151617 These studies would provide better evidence on the use of PROMS for monitoring depression in primary care, and on facilitating its integration into routine practice for busy practitioners. Figure 1 shows an infographic used in the ongoing PROMDEP trial of the PHQ-9 17…”

“…Example of feedback on a PHQ-9 test score. The patient infographic is an adaptation of one developed for the DEPSCREEN-INFO trial18 and is used in the PROMDEP trial17 with permission of the DEPSCREEN-INFO chief investigator, Bernd Löwe.…”

“…We asked a patient and public involvement (PPI) colleague, Bryan Palmer, who is providing advice on the PROMDEP study,17 to comment on this article. He checked the text for its readability for a lay audience and emphasised that the patient infographic should refer to the score rather than the result of the PHQ-9 test, as it is only a score on a questionnaire that suggests a certain level of depression, rather than a definitive result in terms of a diagnosis.…”

“…Competing interests: We have read and understood the BMJ Group policy on declaration of interests and declare the following interests: TK is a member of the guideline update committee for the NICE depression guideline, which recommends the use of valid outcome measures to monitor depression,19 and is the lead applicant on the NIHR Health Technology Assessment Programme funded PROMDEP trial of using the PHQ-9 in depression in primary care 17…”

Construct validity and psychosocial correlates of the Italian version of the 21-item Medical Interview Satisfaction Scale in primary care

“… 8 Recently, it has been included among outcome measures in a cluster-randomised trial on depression. 9 To take into account its worldwide spread and to facilitate comparisons with other studies, we chose to translate and adopt the MISS-21 to assess patients’ satisfaction with the medical interview in a randomised clinical trial on patients with mild-to-moderate depression, carried out in an Italian primary care setting.…”