A tailored psychological intervention for anxiety and depression management in people with chronic obstructive pulmonary disease: TANDEM RCT and process evaluation.

Background: People with chronic obstructive pulmonary disease have high levels of anxiety and depression, which is associated with increased morbidity and poor uptake of effective treatments, such as pulmonary rehabilitation. Cognitive-behavioural therapy improves mental health of people with long-term conditions and could potentially increase uptake of pulmonary rehabilitation, enabling synergies that could enhance the mental health of people with chronic obstructive pulmonary disease. Aim: Our aim was to develop and evaluate the clinical effectiveness and cost effectiveness of a tailored cognitive-behavioural approach intervention, which links into, and optimises the benefits of, routine pulmonary rehabilitation. Design: We carried out a pragmatic multicentre randomised controlled trial using a 1.25 : 1 ratio (intervention : control) with a parallel process evaluation, including assessment of fidelity. Setting: Twelve NHS trusts and five Clinical Commissioning Groups in England were recruited into the study. The intervention was delivered in participant's own home or at a local NHS facility, and by telephone. Participants: Between July 2017 and March 2020 we recruited adults with moderate/very severe chronic obstructive pulmonary disease and mild/moderate anxiety and/or depression, meeting eligibility criteria for assessment for pulmonary rehabilitation. Carers of participants were invited to participate. Intervention: The cognitive-behavioural approach intervention (i.e. six to eight 40- to 60-minute sessions plus telephone support throughout pulmonary rehabilitation) was delivered by 31 trained respiratory healthcare professionals to participants prior to commencing pulmonary rehabilitation. Usual care included routine pulmonary rehabilitation referral. Main outcome measures: Co-primary outcomes were Hospital Anxiety and Depression Scale - anxiety and Hospital Anxiety and Depression Scale - depression at 6 months post randomisation. Secondary outcomes at 6 and 12 months included health-related quality of life, smoking status, uptake of pulmonary rehabilitation and healthcare use. Results: We analysed results from 423 randomised participants (intervention, n = 242; control, n = 181). Forty-three carers participated. Follow-up at 6 and 12 months was 93% and 82%, respectively. Despite good fidelity for intervention delivery, mean between-group differences in Hospital Anxiety and Depression Scale at 6 months ruled out clinically important effects (Hospital Anxiety and Depression Scale - anxiety mean difference -0.60, 95% confidence interval -1.40 to 0.21; Hospital Anxiety and Depression Scale - depression mean difference -0.66, 95% confidence interval -1.39 to 0.07), with similar results at 12 months. There were no between-group differences in any of the secondary outcomes. Sensitivity analyses did not alter these conclusions. More adverse events were reported for intervention participants than for control participants, but none related to the trial. The intervention did not generate quality-of-life improvements to justify the additional cost (adjusted mean difference £770.24, 95% confidence interval -£27.91 to £1568.39) to the NHS. The intervention was well received and many participants described positive affects on their quality of life. Facilitators highlighted the complexity of participants' lives and considered the intervention to be of potential valuable; however, the intervention would be difficult to integrate within routine clinical services. Our well-powered trial delivered a theoretically designed intervention with good fidelity. The respiratory-experienced facilitators were trained to deliver a low-intensity cognitive-behavioural approach intervention, but high-intensity cognitive-behavioural therapy might have been more effective. Our broad inclusion criteria specified objectively assessed anxiety and/or depression, but participants were likely to favour talking therapies. Randomisation was concealed and blinding of outcome assessment was breached in only 15 participants. Conclusions: The tailored cognitive-behavioural approach intervention delivered with fidelity by trained respiratory healthcare professionals to people with chronic obstructive pulmonary disease was neither clinically effective nor cost-effective. Alternative approaches that are integrated with routine long-term condition care are needed to address the unmet, complex clinical and psychosocial needs of this group of patients. Trial registration: This trial is registered as ISRCTN59537391. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/146/02) and is published in full in Health Technology Assessment; Vol. 28, No. 1. See the NIHR Funding and Awards website for further award information.

People with long-standing lung problems, such as chronic obstructive pulmonary disease, often also have anxiety and depression, which further reduces their quality of life. Two existing treatments could help. Pulmonary rehabilitation (a programme of exercise and education) improves both the physical and mental health of people with chronic obstructive pulmonary disease. Cognitive­behavioural therapy (a talking therapy) may reduce anxiety and depression. The TANDEM [Tailored intervention for Anxiety and Depression Management in chronic obstructive pulmonary disease (COPD)] intervention linked these two treatments by providing talking therapy based on cognitive­behavioural therapy during the waiting time following referral for pulmonary rehabilitation. The TANDEM treatment was delivered by respiratory healthcare professionals (e.g. nurses or physiotherapists) trained to deliver the talking therapy in six to eight weekly sessions. The sessions were conducted in the participant's home (or another convenient location), with brief telephone support during the pulmonary rehabilitation. Of 423 participants recruited to the study, 242 participants received TANDEM talking therapy and 181 participants received usual care (including a referral to pulmonary rehabilitation). We measured mental health, quality of life, social life, attendance at pulmonary rehabilitation and healthcare use in both groups at 6 and 12 months. Forty-three carers joined the study and we assessed their mental well-being. We interviewed patients, carers and health professionals to find out their views and experience of the TANDEM treatment. We also examined whether or not the TANDEM treatment was good value for money. The TANDEM treatment did not improve the mental or the physical health of people with chronic obstructive pulmonary disease. In addition, the TANDEM treatment cost the NHS an extra £770 per patient, which was not good value for money. The TANDEM treatment was well received, and many participants told us how it had helped them. Heath-care professionals noted how participants did not just have chronic obstructive pulmonary disease, but were coping with many physical, mental and social problems. The TANDEM intervention was not effective and, therefore, other strategies will be needed to help people with chronic obstructive pulmonary disease and mental health problems live with their condition.

Tailored, psychological intervention for anxiety or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): protocol for a randomised controlled trial.

BACKGROUND: People with chronic obstructive pulmonary disease (COPD) are at increased risk of depression and anxiety, which greatly reduces their quality of life and is associated with worse outcomes; but these psychological co-morbidities are under-recognised and undertreated in COPD patients. Pulmonary rehabilitation (PR) improves mood for up to 6 months but health practitioners under-refer, and patients commonly fail to attend/complete PR. Research suggests that complex non-pharmacological interventions, including both psychological and exercise components, may reduce anxiety and depression in COPD. We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression ('TANDEM'), which precedes and optimises the benefits of currently offered PR. We hypothesise that such a psychological intervention, delivered by supervised, trained respiratory healthcare professionals, will improve mood in patients with mild to moderate anxiety and/or depression and encourage uptake and completion of PR. METHODS: We will conduct a multi-centre, pragmatic, randomised controlled trial of the TANDEM intervention compared to usual care across the Midlands, London, the South East and Bristol, UK. We will train healthcare professionals familiar with COPD to deliver the manualised, tailored, face-to-face, one-to-one intervention weekly for 6-8 weeks. We will recruit 430 participants from primary, community and secondary care with confirmed COPD and moderate to very severe airflow limitation, who are eligible for assessment for PR, and who screen positive for symptoms of mild/moderate depression and/or anxiety using the Hospital Anxiety and Depression scale (HADS). Participants will be randomised 1.25:1 (intervention: usual care). The co-primary outcomes are the HADS anxiety and depression subscale scores at 6 months; participants will be followed up to 12 months. Secondary outcomes include uptake and completion of PR and healthcare resource use. There will be a parallel process evaluation and a health economic evaluation. DISCUSSION: The TANDEM intervention has the potential to optimise the unrealised synergy between a psychological intervention and PR. The CBA sessions will precede PR and target individuals' cognitions, behaviours and symptoms associated with anxiety and depression to decrease psychological morbidity and increase effective self-management amongst patients with COPD. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN59537391. Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.

Teaching sociology to undergraduate medical students.

Understanding the social basis of health and medicine and the contexts of clinical care are essential components of good medical practice. This includes the ways in which social factors such as class, ethnicity, and gender influence health outcomes and how people experience health, illness, and health care. In our Guide we describe what sociology is and what it brings to medicine, beginning with the nature of the "sociological imagination." Sociological theory and methods are reviewed to explain and illustrate the role of sociology in the context of undergraduate medical education. Reference is made to the 2016 report, A Core Curriculum for Sociology in UK Undergraduate Medical Education by Collett et al. Teaching and student learning are discussed in terms of organization and delivery, with an emphasis on practice. Sections are also included on assessment, evaluation, opportunities, and challenges and the value of a "community of practice" for sociology teachers in medical education.

Teaching diversity to medical undergraduates: Curriculum development, delivery and assessment. AMEE GUIDE No. 103.

The aim of this Guide is to support teacher with the responsibility of designing, delivering and/or assessing diversity education. Although, the focus is on medical education, the guidance is relevant to all healthcare professionals. The Guide begins by providing an overview of the definitions used and the principles that underpin the teaching of diversity as advocated by Diversity and Medicine in Health (DIMAH). Following an outline of these principles we highlight the difference between equality and diversity education. The Guide then covers diversity education throughout the educational process from the philosophical stance of educators and how this influences the approaches used through to curriculum development, delivery and assessment. Appendices contain practical examples from across the UK, covering lesson plans and specific exercises to deliver teaching. Although, diversity education remains variable and fragmented there is now some momentum to ensure that the principles of good educational practice are applied to diversity education. The nature of this topic means that there are a range of different professions and medical disciplines involved which leads to a great necessity for greater collaboration and sharing of effective practice.

Ethical principles and the rationing of health care: a qualitative study in general practice.

BACKGROUND: Researching sensitive topics, such as the rationing of treatments and denial of care, raises a number of ethical and methodological problems. AIM: To describe the methods and findings from a number of focus group discussions that examined how GPs apply ethical principles when allocating scarce resources. DESIGN OF STUDY: A small-scale qualitative study involving purposive sampling, semi-structured interviews and focus groups. SETTING: Twenty-four GPs from two contrasting areas of London: one relatively affluent and one relatively deprived. METHOD: Initial interviews asked GPs to identify key resource allocation issues. The interviews were transcribed and themes were identified. A number of case studies, each illustrative of an ethical issue related to rationing, were written up in the form of vignettes. In focus group discussions, GPs were given a number of these vignettes to debate. RESULTS: With respect to the ethical basis for decision making, the findings from this part of the study emphasised the role of social and psychological factors, the influence of the quality of the relationship between GPs and patients and confusion among GPs about their role in decision making. CONCLUSION: The use of vignettes developed from prior interviews with GPs creates a non-threatening environment to discuss sensitive or controversial issues. The acceptance by GPs of general moral principles does not entail clarity of coherence of the application of these principles in practice.

Is patient involvement possible when decisions involve scarce resources? A qualitative study of decision-making in primary care.

Greater patient involvement has become a key goal of health care provision. This study explored the way in which general practitioners (GPs) in the UK manage the dual responsibilities of treating individual patients and making the most equitable use of National Health Service (NHS) resources in the context of the policy of greater patient involvement in decision-making. We undertook a qualitative study incorporating a series of interviews and focus groups with a sample of 24 GPs. We analysed GP accounts of decision-making by relating these to substantive ethical principles and the key procedural principle of explicitness in decision-making. GPs saw patient involvement in positive terms but for some GPs involvement served an instrumental purpose, for instance improving patient 'compliance'. GPs identified strongly with the role of patient advocate but experienced role tensions particularly with respect to wider responsibilities for budgets, populations, and society in general. GPs had an implicit understanding of the key ethical principle of explicitness and of other substantive ethical principles but there was incongruence between these and their interpretation in practice. Limited availability of GP time played an important role in this theory/practice gap. GPs engaged in implicit categorisation of patients, legitimating this process by reference to the diversity and complexity of general practice. If patient involvement in health care decision-making is to be increased, then questions of scarcity of resources, including time, will need to be taken into account. If strategies for greater patient involvement are to be pursued then this will have significant implications for funding primary care, particularly in terms of addressing the demands made on consultation time. Good ethics and good professional practice cost money and must be budgeted for. More explicit decision-making in primary care will need to be accompanied by greater explicitness at the national level about roles and responsibilities. Increased patient involvement has consequences for GP training and ways of addressing rationing dilemmas will need to be an important part of this training. Further research is needed to understand micro-decision-making, in particular the spaces in which processes of implicit categorisation lead to distorted communication between doctor and patient.