Patient-reported outcome measures for monitoring primary care patients with depression: the PROMDEP cluster RCT and economic evaluation.

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.

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.

Depression follow-up monitoring with the PHQ-9: open cluster-randomised controlled trial.

BACKGROUND: Outcome monitoring of depression is recommended but lacks evidence of patient benefit in primary care. AIM: To test monitoring depression using the PHQ-9 questionnaire with patient feedback. DESIGN AND SETTING: Open cluster-randomised controlled trial in 141 group practices. METHOD: Adults with new depressive episodes were recruited through records searches and opportunistically. EXCLUSION CRITERIA: dementia, psychosis, substance misuse, suicide risk. The PHQ-9 questionnaire was to be administered soon after diagnosis, and 10-35 days later. PRIMARY OUTCOME: Beck Depression Inventory (BDI-II) score at 12 weeks. SECONDARY OUTCOMES: BDI-II at 26 weeks; Work and Social Adjustment Scale and EuroQol EQ-5D-5L quality of life at 12 and 26 weeks; antidepressant treatment, mental health service use, adverse events, and Medical Informant Satisfaction Scale over 26 weeks. RESULTS: 302 intervention arm patients were recruited and 227 controls. At 12 weeks 252 (83.4%) and 195 (85.9%) were followed-up respectively. Only 41% of intervention arm patients had a GP follow-up PHQ-9 recorded. There was no significant difference in BDI-II score at 12 weeks (mean difference -0.46; 95% CI -2.16,1.26), adjusted for baseline depression, baseline anxiety, sociodemographic factors, and clustering by practice). EQ-5D-5L quality of life scores were higher in the intervention arm at 26 weeks (adjusted mean difference 0.053; 95% CI 0.093,0.013). A clinically significant difference in depression at 26 weeks could not be ruled out. No significant differences were found in social functioning, adverse events, or satisfaction. In a per-protocol analysis, antidepressant use and mental health contacts were significantly greater in intervention arm patients with a recorded follow-up PHQ-9. CONCLUSIONS: No evidence was found of improved depression outcome at 12 weeks from monitoring. The findings of possible benefits over 26 weeks warrant replication, investigating possible mechanisms, preferably with automated delivery of monitoring and more instructive feedback.

Explaining how and why social support groups in hospice day services benefit palliative care patients, for whom, and in what circumstances.

Background: Palliative care aims to provide holistic support for people with life-limiting illness, responding to psychological, social and spiritual needs, as well as to clinical and physical. In the United Kingdom, hospice day services (including day care, group interventions, group activities, and social events for palliative care outpatients) aim to provide opportunities for patients to gain social support, which is thought to improve their quality of life. Objectives: This research explored social support within hospice day services, to explain in detail how and why social support obtained within a hospice day service could be beneficial to palliative care patients. Design: Qualitative research using observations of hospice day services and interviews with service providers. Methods: Data collection involved nineteen interviews with hospice service providers (n = 19) and researcher observations of hospice day services. The findings detail how patient and hospice context interact to produce mechanisms that lead to outcomes beyond the hospice day service. Results: Practical, clinical and social aspects of the hospice day service are important for patients feeling welcome and safe in the setting. The opportunity to connect with other people and work towards personal goals can boost self-confidence for patients who have lost access to meaningful activity. New friendships between patients encourages reciprocal support and feelings of belonging. It is beneficial to have permission to speak freely about topics deemed inappropriate elsewhere, because honest communication is helpful in accepting and adapting to their circumstances. Conclusion: Hospice day services facilitate group settings for reciprocal social support. This research proposes an initial programme theory that can be further developed and tested. It explains how and why, in some contexts, social support increases personal and practical resources to cope with illness and death, leading to changes outside of the hospice (to mood, interpersonal interactions and behaviour) that could improve quality of life.

Social support in hospice day services Hospices provide specialist palliative care to patients with life-limiting illness, offering both clinical and non-clinical support. Some hospices include social settings within their outpatient services which provide palliative care patients with opportunities to meet other people who might have similar experiences ('in the same boat'). Social support gained within these groups is thought to be beneficial, but there isn't much research on how and why this might be the case, and in what situations. We carried out observations of hospice day services and research interviews with hospice service providers. We focused on understanding the need for social support, the social support interactions between group members, and the consequences of these. The research suggests five processes through which social support within hospice day services could have positive outcomes for patients. These are:1. Choosing to be there2. Gaining confidence through new or adapted activity3. Building familiarity and reciprocity with other patients4. Honest conversations about illness and mortality5. Becoming a part of the club The findings propose how and why, in some situations, social support could lead to improvements in mood, behaviour and relationships. This will be useful to guide the development and evaluation of hospice day services.

'My cousin said to me . . .' Patients' use of third-party references to facilitate shared decision-making during naturally occurring primary care consultations.

In this paper, we explore the ways in which patients invoke third parties to gain decision-making influence in clinical consultations. The patients' role in decision-making processes is often overlooked, and this interactional practice has rarely been systematically studied. Through a contextual narrative exploration of 42 naturally occurring consultations between patients (aged 22-84) and general practitioners (GPs) in England, we seek to fill this gap. By exploring how and why patients invoke third parties during discussions about medical treatments, who they refer to, what kind of knowledge their referents possess, and how GPs respond, our main aim is to capture the functions and implications of this interactional practice in relation to decision-making processes. Patients refer to third parties during decision-making processes in most of the consultations, usually to argue for and against certain treatment options, and the GPs recognise these utterances as pro-and-contra arguments. This enables patients to counter the GPs' professional knowledge through various knowledge-sources and encourage the GPs to target their specific concerns. By attributing arguments to third parties, patients claim decision-making influence without threatening the GPs' authority and expertise, which their disadvantaged epistemic position demands. Thereby, patients become able to negotiate their role and their epistemic position, to influence the agenda-setting, and to take part in the decision-making process, without being directly confrontational. Invoking third parties is a non-confrontational way of proposing and opposing treatment options that might facilitate successful patient participation in decision-making processes, and so limit the risk of patients being wronged in their capacity as knowers.

'It feels like my metabolism has shut down'. Negotiating interactional roles and epistemic positions in a primary care consultation.

INTRODUCTION: Our aim is to explore the ways in which a patient and a general practitioner (GP) negotiate knowledge claims stemming from different epistemic domains while dealing with a mismatch between experiential and biomedical knowledge during the clinical consultation. We interpret their interaction in relation to the sociocultural context in which their negotiation is embedded and identify factors facilitating their successful negotiation (a medical error is avoided). METHODS: Based on a narrative analysis of a verbatim transcript of a complete naturally occurring primary care consultation, we explore the moment-to-moment unfolding of talk between the patient and the GP (two women). FINDINGS: The patient experiences symptoms of what she interprets as a thyroid condition, and indirectly asks for medication. She presents her case by drawing on experiential knowledge ('it feels like my metabolism has shut down') and biomedical knowledge (while suggesting a diagnosis and a diagnostic test). The GP informs her that her thyroid blood tests are normal and uses biomedical knowledge to explain why she turns down the patient's request. This stages a potential conflict between the patient's embodied experiential knowledge and the doctor's biomedical knowledge. However, during their encounter, the patient and the GP manage to co-construct the patient's illness story and make shared decisions about further actions. CONCLUSION: The transition from potential conflict to consensus is a result of the mutual efforts of two parties: a patient who persistently claims experiential as well as biomedical knowledge while at the same time deferring to the GP's professional knowledge, and a GP who maintains her epistemic authority while also acknowledging the patient's experiential and biomedical knowledge. PATIENT AND PUBLIC CONTRIBUTION: Our empirical data are sourced from a data archive and patients were not involved in the design or conduct of the study, but our study is based on a naturally occurring clinical consultation with a patient.

The first consultation with a depressed patient: A qualitative study of GPs' approaches to diagnosis.

Background: The first consultation with a depressed patient is important because many patients do not return for subsequent visits. Therefore, the first consultation provides a unique opportunity for diagnosis (if required) and treatment, but there are risks of both under and over-diagnosis. Aim: To understand how general practitioners utilize diagnosis when patients present with a new episode of depression. Method: We approached a random selection of twenty-one general practitioners (GPs) in Auckland, New Zealand and asked them to participate in a semi-structured telephone interview. The interviews explored "the first consultation for a depressed/distressed patient" were undertaken to theme saturation. Interviews were hand-written and later transcribed. Results: We identified three major themes in GPs' approach to diagnosis. The issue of diagnosis was underpinned by a complex understanding of depression and the GP role. GPs did not always make a formal diagnosis, but the experience of a patient's distress/depression was understood by drawing on a range of factors and resources. These included time, screening tools, clinician experience, and patient affect. GPs were careful about how they communicated a diagnosis, both in their documentation and in their conversations with patients. Conclusion: At an initial appointment, the distressed/depressed patient can present to their GP with various symptoms and differing degrees of distress. GPs draw upon a variety of skills and resources to negotiate these complexities. The value of a diagnosis was questioned and issues such as impairment may be more useful concepts for GPs. This is the first study to report the findings of the first visit.

Feasibility of Patient Reported Outcome Measures in Psychosocial Palliative Care: Observational Cohort Study of Hospice Day Care and Social Support Groups.

Palliative care patients can be at risk of social isolation or loneliness. Interventions that can provide effective social support, and particularly emotional support, could facilitate healthy coping that bolsters quality of life and reduces depression in palliative care patients. This is an observational cohort study which recruited thirty patients (n = 30) from the day services of four independent hospices in England. Participants completed patient reported outcome measures in perceived social support, loneliness, and depression, at up to three time points. Age range was 56-91 years, males and females were equally represented, and the sample was 93% white British. In participants that provided two or more timepoints, perceived social support increased, and loneliness and depression decreased. Largest changes with the least variation between participants was in emotional support (p = 0.165) and loneliness (p = 0.104). These results suggest that the psychosocial patient reported outcome measures used (MOS-SS, UCLA, BEDS) could be sensitive to change aligned with the goals of this intervention in palliative care. Participants in this study were observed to derive psychosocial benefit from attending the hospice day service.

Treatment of depression in the first primary care consultation: A qualitative study.

Introduction: The first primary care consultation for patients with depression can have long-term consequences for patients, but little is known about treatment decisions at this visit. The aim of this study was to explore the treatment of patients presenting in primary care with a new episode of depression and the drivers behind GPs' treatment decisions at the initial consultation. Materials and Methods: A random sample of GPs in Auckland was invited to participate. A qualitative study was undertaken using semi-structured interviews. Interview transcripts were analyzed using a general inductive approach. Results: Twenty-one GPs were interviewed. We identified three themes as drivers of treatment decisions at the first visit: characteristics of GPs, characteristics of patients, and characteristics of treatment options. Drivers for prescribing were severe depression and time constraints. A driver for non-pharmacological treatment was a strong doctor-patient relationship. Limited time, skill, and training were associated with low confidence using talking therapies. Access to counseling was reported as poor. There was a very wide range of approaches taken. GPs described preferring antidepressants less and talking therapies more with Maori patients. Behavioral activation was used least despite its ease of use and it being one of the most effective treatments for depression. Conclusion: Treatment of depression at the first visit varies widely between practitioners. GPs report multiple barriers to the provision of talking therapies. A move to a more standardized approach may lead to more equitable care. This is the first study to report findings about the initial primary care consultation for depression.

Six Action Steps to Address Global Disparities in Parkinson Disease: A World Health Organization Priority.

Importance: The Global Burden of Disease study conducted between 1990 and 2016, based on a global study of 195 countries and territories, identified Parkinson disease (PD) as the fastest growing neurological disorder when measured using death and disability. Most people affected by PD live in low- and middle-income countries (LMICs) and experience large inequalities in access to neurological care and essential medicines. This Special Communication describes 6 actions steps that are urgently needed to address global disparities in PD. Observations: The adoption by the 73rd World Health Assembly (WHA) of resolution 73.10 to develop an intersectoral global action plan on epilepsy and other neurological disorders in consultation with member states was the stimulus to coordinate efforts and leverage momentum to advance the agenda of neurological conditions, such as PD. In April 2021, the Brain Health Unit at the World Health Organization convened a multidisciplinary, sex-balanced, international consultation workshop, which identified 6 workable avenues for action within the domains of disease burden; advocacy and awareness; prevention and risk reduction; diagnosis, treatment, and care; caregiver support; and research. Conclusions and Relevance: The dramatic increase of PD cases in many world regions and the potential costs of PD-associated treatment will need to be addressed to prevent possible health service strain. Across the board, governments, multilateral agencies, donors, public health organizations, and health care professionals constitute potential stakeholders who are urged to make this a priority.

Economic evaluation of the Target-D platform to match depression management to severity prognosis in primary care: A within-trial cost-utility analysis.

BACKGROUND: Target-D, a new person-centred e-health platform matching depression care to symptom severity prognosis (minimal/mild, moderate or severe) has demonstrated greater improvement in depressive symptoms than usual care plus attention control. The aim of this study was to evaluate the cost-effectiveness of Target-D compared to usual care from a health sector and partial societal perspective across 3-month and 12-month follow-up. METHODS AND FINDINGS: A cost-utility analysis was conducted alongside the Target-D randomised controlled trial; which involved 1,868 participants attending 14 general practices in metropolitan Melbourne, Australia. Data on costs were collected using a resource use questionnaire administered concurrently with all other outcome measures at baseline, 3-month and 12-month follow-up. Intervention costs were assessed using financial records compiled during the trial. All costs were expressed in Australian dollars (A$) for the 2018-19 financial year. QALY outcomes were derived using the Assessment of Quality of Life-8D (AQoL-8D) questionnaire. On a per person basis, the Target-D intervention cost between $14 (minimal/mild prognostic group) and $676 (severe group). Health sector and societal costs were not significantly different between trial arms at both 3 and 12 months. Relative to a A$50,000 per QALY willingness-to-pay threshold, the probability of Target-D being cost-effective under a health sector perspective was 81% at 3 months and 96% at 12 months. From a societal perspective, the probability of cost-effectiveness was 30% at 3 months and 80% at 12 months. CONCLUSIONS: Target-D is likely to represent good value for money for health care decision makers. Further evaluation of QALY outcomes should accompany any routine roll-out to assess comparability of results to those observed in the trial. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616000537459).

Health and social care services for people with dementia at home at the end of life: A qualitative study of bereaved informal caregivers' experiences.

BACKGROUND: More people are dying at home with dementia and Alzheimer's disease. While informal caregivers are the main providers of care for people with dementia dying at home, they require support from health and social care services. However, little is known about how they experience these services. AIM: To explore informal caregivers' views and experiences of health and social care services when looking after a person with dementia at home at the end-of-life. DESIGN: A qualitative interview study. Data were analysed using thematic analysis. SETTING/PARTICIPANTS: Twenty-nine bereaved informal caregivers who had looked after a person with dementia at home during the last 6 months of life. RESULTS: Specialist palliative care for people with dementia dying at home is rare and care is mostly managed by General Practitioners and domiciliary care workers. Four overarching themes were identified: Poor continuity of care; Lack of expertise; Limited advance care planning; and Loss of autonomy. CONCLUSIONS: End-of-life care at home for people with dementia must be proactively planned with an emphasis on advance care planning. Policy makers should recognise the critical role of domiciliary care services in end-of-life care and ensure that they are adequately qualified and trained.

The Craft of Generalism clinical skills and attitudes for whole person care.

RATIONALE, AIMS AND OBJECTIVES: Generalists manage a broad range of biomedical and biographical knowledge as part of each clinical encounter, often in multiple encounters over time. The sophistication of this broad integrative work is often misunderstood by those schooled in reductionist or constructivist approaches to evidence. There is a need to describe the practical and philosophically robust ways that understanding about the whole person is formed. In this paper we describe first principles of generalist approaches to knowledge formation in clinical practice. We name the Craft of Generalism. METHODS: The newly described methodology of Transdisciplinary Generalism is examined by skilled generalist clinicians and translated into skills and attitudes useful for everyday generalist person-centred practice and research. RESULTS: The Craft of Generalism defines the required scope, process, priorities, and knowledge management skills of all generalists seeking to care for the whole person. These principles are Whole Person Scope, Relational Process, Healing Orientation, and Integrative Wisdom. These skills and attitudes are required for whole person care. If any element of these first principles is left out, the resultant knowledge is incomplete and philosophically incoherent. CONCLUSIONS: Naming the Craft of Generalism defines the generalist gaze and protects generalism from the colonization of a narrowed medical gaze that excludes all but reductionist evidence or constructivist experience. Defining the Craft of Generalism enables clear teaching of the sophisticated skills and attitudes of the generalist clinician. These philosophically robust principles encourage and defend the use of generalist approaches to knowledge in settings across the community - including health policy, education, and research.

"I'm not the doctor; I'm just the patient": Patient agency and shared decision-making in naturally occurring primary care consultations.

OBJECTIVES: To explore interactional processes in which clinical decisions are made in situ during medical consultations, particularly the ways in which patients show agency in decision-making processes by proposing and opposing actions, and which normative dimensions and role-expectations their engagement entail. METHODS: Narrative analysis of verbatim transcripts of 22 naturally occurring consultations, sourced from a corpus of 212 consultations between general practitioners and patients in England. After thematically coding the whole dataset, we selected 22 consultations with particularly engaged patients for in-depth analysis. RESULTS: Patients oppose further actions more often than they propose actions, and they oppose more directly than they propose. When they explain why they propose and oppose something, they reveal their values. Patients' role-performance changes throughout the consultations. CONCLUSION: Assertive patients claim - and probably also achieve - most influence when they oppose actions directly and elaborate why. Patients display ambiguous role-expectations. In final concluding stages of decision-making processes, patients usually defer to GPs' authority. PRACTICE IMPLICATIONS: Clinicians should be attentive to the ways in which patients want to engage in decision-making throughout the whole consultation, with awareness of normative dimensions of both process and content, and the ways in which patient's actions are constrained by their institutional position.