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.

Gender, flexibility and workforce in the NHS: A qualitative study.

Data from the General Medical Council show that the number of female doctors registered to practise in the UK continues to grow at a faster rate than the number of male doctors. Our research critically discusses the impact of this gender-based shift, considering how models of medical training are still ill-suited to supporting equity and inclusivity within the workforce, with particular impacts for women despite this gender shift. Drawing on data from our research project Mapping underdoctored areas: the impact of medical training pathways on NHS workforce distribution and health inequalities, this paper explores the experiences of doctors working in the NHS, considering how policies around workforce and beyond have impacted people's willingness and ability to continue in their chosen career path. There is clear evidence that women are underrepresented in some specialties such as surgery, and at different career stages including in senior leadership roles, and our research focuses on the structural factors that contribute to reinforcing these under-representations. Medical education and training are known to be formative points in doctors' lives, with long-lasting impacts for NHS service provision. By understanding in detail how these pathways inadvertently shape where doctors live and work, we will be able to consider how best to change existing systems to provide patients with timely and appropriate access to healthcare. We take a cross-disciplinary theoretical approach, bringing historical, spatiotemporal and sociological insights to healthcare problems. Here, we draw on our first 50 interviews with practising doctors employed in the NHS in areas that struggle to recruit and retain doctors, and explore the gendered nature of career biographies. We also pay attention to the ways in which doctors carve their own career pathways out of, or despite of, personal and professional disruptions.

Health professionals interface with cultural conflict in the delivery of type 2 diabetes care.

OBJECTIVE: This study explored the knowledge and experiences of health professionals (HPs) caring for South Asian patients with type 2 diabetes (T2D). DESIGN: Fourteen HPs, who supported patients with T2D, were interviewed. The recruitment strategy employed purposeful and theoretical sampling methods to recruit HPs who worked across primary and secondary care settings. MAIN OUTCOME MEASURES: Grounded Theory (GT) methodology and analysis generated a theoretical framework that explored HP's perceptions and experiences of providing diabetes care for South Asian patients. RESULTS: A GT, presenting a core category of Cultural Conflict in T2D care, explores the influences of HP's interactions and delivery of care for South Asian patients. This analysis is informed by four categories: (1) Patient Comparisons: South Asian vs White; (2) Recognising the Heterogeneous Nature of South Asian Patients; (3) Language and Communication; (4) HPs' Training and Experience. CONCLUSIONS: The findings consider how the role of social comparison, social norms, and diminished responsibility in patient self-management behaviours influence HPs' perceptions, implicit and explicit bias towards the delivery of care for South Asian patients. There was a clear call for further support and training to help HPs recognise the cultural-ethnic needs of their patients.

Cultural Identity Conflict Informs Engagement with Self-Management Behaviours for South Asian Patients Living with Type-2 Diabetes: A Critical Interpretative Synthesis of Qualitative Research Studies.

The prevalence of type-2 diabetes (T2D) is increasing, particularly among South Asian (SA) communities. Previous research has highlighted the heterogeneous nature of SA ethnicity and the need to consider culture in SA patients' self-management of T2D. We conducted a critical interpretative synthesis (CIS) which aimed to a) develop a new and comprehensive insight into the psychology which underpins SA patients' T2D self-management behaviours and b) present a conceptual model to inform future T2D interventions. A systematic search of the literature retrieved 19 articles, including 536 participants. These were reviewed using established CIS procedures. Analysis identified seven constructs, from which an overarching synthesizing argument 'Cultural Conflict' was derived. Our findings suggest that patients reconstruct knowledge to manage their psychological, behavioural, and cultural conflicts, impacting decisional conflicts associated with T2D self-management and health professional advice (un)consciously. Those unable to resolve this conflict were more likely to default towards cultural identity, continue to align with cultural preferences rather than health professional guidance, and reduce engagement with self-management. Our synthesis and supporting model promote novel ideas for self-management of T2D care for SA patients. Specifically, health professionals should be trained and supported to explore and mitigate negative health beliefs to enable patients to manage social-cultural influences that impact their self-management behaviours.

A grounded theory of type 2 diabetes prevention and risk perception.

OBJECTIVE: Type 2 diabetes (T2D) prevention programmes should target high-risk groups. Previous research has highlighted minimal engagement in such services from South Asian (SA) people. Given SA's elevated risk of T2D, there is a need to understand their perceptions, risks, and beliefs about T2D. DESIGN: This study aimed to assess T2D risk perception within a community sample of SA people using Grounded Theory methodology. Specifically, health beliefs were assessed, and we explored how these beliefs affected their T2D risk perceptions. METHOD: Twenty SA participants (mean age = 38 years) without a diagnosis of T2D were recruited from community and religious settings across the North West of England. In line with grounded theory (Strauss & Corbin, 1990, Basics of qualitative research: Grounded theory procedures and techniques. Newbury Park: Sage Publications), data collection and analysis coincided. RESULTS: The superordinate category of Culturally Situated Risk Perception incorporated a complex psychological understanding of the formation of T2D risk perception, which takes into account the social, cultural, and community-based environmental factors. This superordinate category was explained via two core categories (1) Diminished Responsibility, informed by sub-categories of Destiny and Heredity, and (2) Influencing Healthy Lifestyle Behaviours, informed by sub-categories of Socio-cultural and Environmental. CONCLUSION: This study investigated risk perception of T2D within the SA community. When considering health prevention in the context of an individual's culture, we need to consider the social context in which they live. Failure to acknowledge the cultural-situated T2D risk perception relevant to health promotion and illness messages may account for the issues identified with health care engagement in the SA population.