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Background 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. Objective 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. Design Parallel-group, cluster-randomised superiority trial; 1 : 1 allocation to intervention and control. Setting UK primary care (141 group general practices in England and Wales). Inclusion criteria Patients aged ≥ 18 years with a new episode of depressive disorder or symptoms, recruited mainly through medical record searches, plus opportunistically in consultations. Exclusions Current depression treatment, dementia, psychosis, substance misuse and risk of suicide. Intervention Administration of the Patient Health Questionnaire-9 questionnaire with patient feedback soon after diagnosis, and at follow-up 10–35 days later, compared with usual care. Primary outcome Beck Depression Inventory, 2nd edition, symptom scores at 12 weeks. Secondary outcomes 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. Sample size 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. Randomisation Remote computerised randomisation with minimisation by recruiting university, small/large practice and urban/rural location. Blinding Blinding of participants was impossible given the open cluster design, but self-report outcome measures prevented observer bias. Analysis was blind to allocation. Analysis 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. Qualitative interviews 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. Results 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 –0.46, 95% confidence interval –2.16 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 –0.0157 to 0.0182). Costs were lower in the intervention arm but, again, not significantly (–£163, 95% confidence interval –£349 to £28). Cost-effectiveness and cost–utility 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. Conclusions We found no evidence of improved depression management or outcome at 12 weeks from using the Patient Health Questionnaire-9, but patients’ 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. Study registration This study is registered as IRAS250225 and ISRCTN17299295. Funding 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 Health Technology Assessment; Vol. 28, No. 17. See the NIHR Funding and Awards website for further award information. Plain language summary Depression is common, can be disabling and costs the nation billions. The National Health Service recommends general practitioners who treat people with depression use symptom questionnaires to help assess whether those people are getting better over time. A symptom questionnaire is one type of patient-reported outcome measure. Patient-reported outcome measures appear to benefit people having therapy and mental health care, but this approach has not been tested thoroughly in general practice. Most people with depression are treated in general practice, so it is important to test patient-reported outcome measures there, too. In this study, we tested whether using a patient-reported outcome measure helps people with depression get better more quickly. The study was a ‘randomised controlled trial’ in general practices, split into two groups. In one group, people with depression completed the Patient Health Questionnaire, or ‘PHQ-9’, patient-reported outcome measure, which measures nine symptoms of depression. In the other group, people with depression were treated as usual without the Patient Health Questionnaire-9. We fed the results of the Patient Health Questionnaire-9 back to the people with depression themselves to show them how severe their depression was and asked them to discuss the results with the practitioners looking after them. We found no differences between the patient-reported outcome measure group and the control group in their level of depression; their work or social life; their satisfaction with care from their practice; or their use of medicines, therapy or specialist care for depression. However, we did find that their quality of life was improved at 6 months, and the costs of the National Health Service services they used were lower. Using the Patient Health Questionnaire-9 can improve patients’ quality of life, perhaps by making them more aware of improvement in their depression symptoms, and less anxious as a result. Future research should test using a patient-reported outcome measure that includes anxiety and processing the answers through a computer to give practitioners clearer advice on possible changes to treatment for depression. Scientific summary Some text in this chapter has been adapted from the study protocol published as: Kendrick T, Moore M, Leydon G, et al. Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial. Trials 2020;21:441. https://doi.org/10.1186/s13063-020-04344-9. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article unless otherwise stated. Background Depression is common and costly. It can lead to chronic disability, poor quality of life, suicide, and high service use and costs. National Institute for Health and Care Excellence guidelines recommend different treatments for more severe and less severe depression, but general practitioners, who treat more the majority of people with depression in primary care, are often inaccurate in their global clinical assessments of depression severity, and treatment is not targeted to patients most likely to benefit. The National Institute for Health and Care Excellence recommends that practitioners consider using validated patient-reported outcome measures to inform treatment at diagnosis and follow-up of people with depression, but there is insufficient evidence that these measures improve depression management and outcomes for patients in primary care. Aim and objectives The aim of the study was to answer the research question: What is the effectiveness and cost-effectiveness of assessing primary care patients with depression or low mood soon after diagnosis and again at follow-up 10–35 days later, using the Patient Health Questionnaire-9 combined with patient feedback and practitioner guidance on treatment? The objectives were to (1) carry out a cluster-randomised controlled trial to compare the intervention with usual care; (2) provide intervention arm patients with written feedback on their Patient Health Questionnaire-9 scores, indicating evidence-based treatments relevant to the level of severity of depression to discuss with practitioners; (3) train practitioners to interpret Patient Health Questionnaire-9 scores and their implications for choice of treatment, taking into account contextual factors; (4) follow up participants for 26 weeks, with research assessments at 12 and 26 weeks; (5) determine the primary outcome of depressive symptoms on the Beck Depression Inventory, 2nd edition, at 12-week follow-up; (6) examine secondary outcomes, including depressive symptoms on the Beck Depression Inventory, 2nd edition, at 26 weeks, and social functioning and quality of life at both 12- and 26-week follow-ups; (7) measure patient satisfaction, adverse events, antidepressant treatment, secondary care contacts, service use, and costs over 26 weeks’ follow-up, and perform cost-effectiveness and cost–utility analyses; and (8) carry out a qualitative process analysis to explore participants’ reflections on the use of the Patient Health Questionnaire-9 and the potential for implementing it in practice. Methods The study design was a parallel-group, cluster-randomised superiority trial with 1 : 1 allocation to intervention and control arms. The setting was UK primary care (141 group general practices in England and Wales). Inclusion criteria were age ≥ 18 years with a new episode of depressive disorder or symptoms. Patients were recruited mainly through regular medical records searches but also opportunistically at consultations for new episodes of depression. Exclusion criteria were current treatment for depression; dementia; psychosis; substance misuse; or a significant risk of suicide. The intervention was administration of the Patient Health Questionnaire-9 questionnaire as a PROM soon after diagnosis and at follow-up 10–35 days later. Patients were given written feedback on their Patient Health Questionnaire-9 scores and potential treatments to discuss with their general practitioners. Practitioners were trained in interpreting Patient Health Questionnaire-9 scores and taking them into account in treatment decisions. The primary outcome was depressive symptoms on the Beck Depression Inventory, 2nd edition, at 12 weeks. Secondary outcomes were Beck Depression Inventory, 2nd edition, scores at 26 weeks; social functioning (on the Work and Social Adjustment Scale) and quality of life (on the EuroQol-5 Dimensions, five-level) at 12 and 26 weeks; service use including antidepressant treatment and primary and secondary care contacts over 26 weeks to calculate NHS costs; and patient satisfaction at 26 weeks (on the Medical Informant Satisfaction Scale). For our sample size calculation, we assumed a baseline mean Beck Depression Inventory, 2nd edition, score of 24.0 with a standard deviation of 10.0 (derived from a feasibility study), and mean scores at 12-week follow-up of 14.0 in the intervention arm and 17.0 in the control arm. The anticipated difference of 3.0 points (effect size of 0.3) represented the minimum clinically important difference on the Beck Depression Inventory, 2nd edition. At the 5% level of significance, to have 90% power to detect that difference we calculated we needed 235 patients analysed per arm. We aimed to recruit a mean of six patients per practice and assumed an intracluster correlation coefficient of 0.03 (from the feasibility study), which gave a cluster design effect of 1.15, meaning we needed 270 per arm. We assumed a 20% loss to follow-up at 12 weeks, so the total sample size needed was 270 × 2/0.8 and our original target sample size was a total of 676 patients recruited, from 113 practices, by three recruitment centres (the University of Southampton, the University of Liverpool and University College London). We subsequently revised the target sample size on finding a significant correlation coefficient of > 0.5 between baseline and follow-up values for the primary outcome, which meant that we needed only 222 patients analysed per arm and, therefore, a target sample size of 554 patients recruited (revised 10 June 2021). Cluster randomisation of practices to intervention and control arms was carried out remotely by a Clinical Trials Unit statistician using computerised sequence generation, with minimisation by recruiting centre, size of practice and urban or rural location. Blinding of participating practitioners and patients to allocation was impossible given the nature of the intervention and the cluster-randomised design, but self-report outcome measures were used to prevent researcher rating bias, and statistical analysis was blind to allocation. Differences between intervention and control arms in the outcomes of depressive symptoms, social functioning and quality of life measured at 12- and 26-week follow-up were analysed using linear mixed models, adjusting for baseline depression; duration of depression; history of depression; baseline anxiety; sociodemographic factors (gender, age, socioeconomic position, housing, education, marital status and dependants), and clustering including a random effect for practice. Patient satisfaction, quality of life (quality-adjusted life-years) and costs were compared between the arms over the 26 weeks’ study follow-up period. Differences between the arms in the process of care for depression were also analysed, including patients’ self-reported use of antidepressants at the 12- and 26-week follow-up points, and medication and contacts with mental health services (community mental health nurses, counsellors, psychologists, psychiatrists, other therapists and social workers) recorded in practice medical records over the 26 weeks’ follow-up. A health economic evaluation was undertaken from an NHS and Personal Social Services perspective. The outcomes were expressed as incremental cost per point improvement in the Beck Depression Inventory, 2nd edition, clinical outcome (cost-effectiveness analysis), and incremental cost per quality-adjusted life-year gained (cost–utility analysis). The primary analysis at 26 weeks used a generalised linear mixed model to estimate the differences in costs and quality-adjusted life-years (using the EuroQol-5 Dimensions, five-level to calculate patient utilities), adjusted for baseline quality of life; baseline anxiety; sociodemographic factors; and practice as a random effect. Incremental cost-effectiveness ratios and a cost-effectiveness acceptability curve were generated using non-parametric bootstrapping. Qualitative interviews with participating practitioners and patients in both arms were conducted to reflect on their involvement in the trial and analysed using reflexive thematic analysis. Intervention arm participants were asked about barriers, facilitators, benefits and problems related to using the Patient Health Questionnaire-9, including questions derived from the normalisation process theory framework. Results Practices and patients As the number of patients recruited per practice was smaller than anticipated, we recruited significantly more than our target of 113 practices, eventually reaching a total of 189, but 48 practices subsequently withdrew (24 in each arm), so the final number of active practices was 141: 72 intervention and 69 control (28 above our original target). Practice characteristics were well balanced by arm. Of 11,468 patients approached in consultations or through mailed invitations, 1058 (9.2%) returned reply slips about the study: 574 (10.6% of those approached) in the intervention arm and 484 (8.0% of those approached) in the control arm. After the exclusion of patients declining to participate, ineligible at screening or uncontactable, 529 patients were assessed at baseline: 302 (5.5% of those approached) in the intervention arm and 227 (3.8% of those approached) in the control arm. The ratio of intervention to control arm patients recruited was, therefore, 1.3 to 1, which may have reflected lower motivation to take part among control arm practices. Of 529 patients recruited, 453 (85.6%) were followed up at 12 weeks: 254 intervention arm (84.1%) and 199 control arm (87.7%) patients. At the 26-week point, 414 patients (78.3%) were followed up: 230 intervention arm (76.2%) and 184 control arm (81.1%). Medical records data were collected for 259 intervention arm patients (85.8%) and 201 control arm patients (88.5%). The mean BDI-II score for depressive symptoms at baseline was higher in the intervention arm, at 24.1 (standard deviation 8.89) than in the control arm, at 22.4 (standard deviation 9.52). Baseline anxiety and quality-of-life scores were also worse in the intervention arm. Control arm patients were more likely to have had two or more previous depressive episodes. Demographic characteristics were relatively well balanced. Clinical outcomes At the 12-week follow-up, the mean Beck Depression Inventory, 2nd edition, score was 18.5 (standard deviation 10.2) in the intervention arm and 16.9 (standard deviation 10.3) in the control arm. The adjusted mean score was slightly lower in the intervention arm, but this was not statistically significant (mean adjusted difference –0.46, 95% confidence interval –2.16 to 1.26; p = 0.60). At 26 weeks, the mean Beck Depression Inventory, 2nd edition, scores were 15.1 (standard deviation 10.8) in the intervention arm and 14.7 (standard deviation 10.6) in the control arm (mean adjusted difference –1.63, 95% confidence interval –3.48 to 0.21; p = 0.08). Social functioning on the Work and Social Adjustment Scale and Medical Informant Satisfaction Scale satisfaction with care scores favoured the intervention, but the differences found were not statistically significant. A post hoc analysis at 26 weeks showed similar proportions improving by ≥ 50% on the Beck Depression Inventory, 2nd edition, in the intervention and control arms (45.1% vs. 37.3%), but the proportion remitting to a score of

Introduction Effective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in primary care. This paper presents the protocol for determining the effectiveness and cost-effectiveness of a rigorously developed brief eLearning tool, EMPathicO, among patients with and without musculoskeletal pain.Methods and analysis A cluster randomised controlled trial in general practitioner (GP) surgeries in England and Wales serving patients from diverse geographic, socioeconomic and ethnic backgrounds. GP surgeries are randomised (1:1) to receive EMPathicO e-learning immediately, or at trial end. Eligible practitioners (eg, GPs, physiotherapists and nurse practitioners) are involved in managing primary care patients with musculoskeletal pain. Patient recruitment is managed by practice staff and researchers. Target recruitment is 840 adults with and 840 without musculoskeletal pain consulting face-to-face, by telephone or video. Patients complete web-based questionnaires at preconsultation baseline, 1 week and 1, 3 and 6 months later. There are two patient-reported primary outcomes: pain intensity and patient enablement. Cost-effectiveness is considered from the National Health Service and societal perspectives. Secondary and process measures include practitioner patterns of use of EMPathicO, practitioner-reported self-efficacy and intentions, patient-reported symptom severity, quality of life, satisfaction, perceptions of practitioner empathy and optimism, treatment expectancies, anxiety, depression and continuity of care. Purposive subsamples of patients, practitioners and practice staff take part in up to two qualitative, semistructured interviews.Ethics approval and dissemination Approved by the South Central Hampshire B Research Ethics Committee on 1 July 2022 and the Health Research Authority and Health and Care Research Wales on 6 July 2022 (REC reference 22/SC/0145; IRAS project ID 312208). Results will be disseminated via peer-reviewed academic publications, conference presentations and patient and practitioner outlets. If successful, EMPathicO could quickly be made available at a low cost to primary care practices across the country.Trial registration number ISRCTN18010240.

Abstract Background The UK Scientific Advisory Group for Emergencies (SAGE) emphasises the need for high levels of engagement with communities and individuals to ensure the effectiveness of any COVID-19 testing programme. A novel pilot health surveillance programme to assess the feasibility of weekly community RT-LAMP (Reverse transcription loop-mediated isothermal amplification) testing for the SARS-CoV-2 virus using saliva samples collected at home was developed and piloted by the University of Southampton and Southampton City Council. Methods Rapid qualitative evaluation was conducted to explore experiences of those who took part in the programme, of those who declined and of those in the educational and healthcare organisations involved in the pilot testing who were responsible for roll-out. This included 77 interviews and 20 focus groups with 223 staff, students, pupils and household members from four schools, one university, and one community healthcare NHS trust. The insights generated and informed the design and modification of the Southampton COVID-19 Saliva Testing Programme and the next phase of community-testing. Results Discussions revealed that high levels of communication, trust and convenience were necessary to ensure people’s engagement with the programme. Participants felt reassured by and pride in taking part in this novel programme. They suggested modifications to reduce the programme’s environmental impact and overcome cultural barriers to participation. Conclusions Participants’ and stakeholders’ motivations, challenges and concerns need to be understood and these insights used to modify the programme in a continuous, real-time process to ensure and sustain engagement with testing over the extended period necessary. Community leaders and stakeholder organisations should be involved throughout programme development and implementation to optimise engagement.

Abstract Background Benefits to patients from reduced depression have been shown from monitoring progress with patient-reported 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 will be compared between arms. Qualitative process analysis includes interviews with 15–20 GP/NPs and 15–20 patients per arm to reflect trial results and implementation issues, using Normalization Process Theory as a theoretical framework. Discussion If PROMs are helpful in improving patient outcomes for depression even to a small extent, then they are likely to be good value for money, given their low cost. The benefits could be considerable, given that depression is common, disabling, and costly. Trial registration ISRCTN no: 17299295 . Registered 1st October 2018.

Abstract Background Around one in ten adults take antidepressants for depression in England, and their long-term use is increasing. Some need them to prevent relapse, but 30–50% could possibly stop them without relapsing and avoid adverse effects and complications of long-term use. However, stopping is not always easy due to withdrawal symptoms and a fear of relapse of depression. When general practitioners review patients on long-term antidepressants and recommend to those who are suitable to stop the medication, only 6–8% are able to stop. The Reviewing long-term antidepressant use by careful monitoring in everyday practice (REDUCE) research programme aims to identify safe and cost-effective ways of helping patients taking long-term antidepressants taper off treatment when appropriate. Methods Design: REDUCE is a two-arm, 1:1 parallel group randomised controlled trial, with randomisation clustered by participating family practices. Setting: England and north Wales. Population: patients taking antidepressants for longer than 1 year for a first episode of depression or longer than 2 years for repeated episodes of depression who are no longer depressed and want to try to taper off their antidepressant use. Intervention: provision of ‘ADvisor’ internet programmes to general practitioners or nurse practitioners and to patients designed to support antidepressant withdrawal, plus three patient telephone calls from a psychological wellbeing practitioner. The control arm receives usual care. Blinding of patients, practitioners and researchers is not possible in an open pragmatic trial, but statistical and health economic data analysts will remain blind to allocation. Outcome measures: the primary outcome is self-reported nine-item Patient Health Questionnaire at 6 months for depressive symptoms. Secondary outcomes: depressive symptoms at other follow-up time points, anxiety, discontinuation of antidepressants, social functioning, wellbeing, enablement, quality of life, satisfaction, and use of health services for costs. Sample size: 402 patients (201 intervention and 201 controls) from 134 general practices recruited over 15–18 months, and followed-up at 3, 6, 9 and 12 months. A qualitative process evaluation will be conducted through interviews with 15–20 patients and 15–20 practitioners in each arm to explore why the interventions were effective or not, depending on the results. Discussion Helping patients reduce and stop antidepressants is often challenging for practitioners and time-consuming for very busy primary care practices. If REDUCE provides evidence showing that access to internet and telephone support enables more patients to stop treatment without increasing depression we will try to implement the intervention throughout the National Health Service, publishing practical guidance for professionals and advice for patients to follow, publicised through patient support groups. Trial registration ISRCTN:12417565 . Registered on 7 October 2019.