Tailored psychological intervention for anxiety or depression in COPD (TANDEM): a randomised controlled trial.

BACKGROUND: The TANDEM multicentre, pragmatic, randomised controlled trial evaluated whether a tailored psychological intervention based on a cognitive behavioural approach for people with COPD and symptoms of anxiety and/or depression improved anxiety or depression compared with usual care (control). METHODS: People with COPD and moderate to very severe airways obstruction and Hospital Anxiety and Depression Scale subscale scores indicating mild to moderate anxiety (HADS-A) and/or depression (HADS-D) were randomised 1.25:1 (242 intervention and 181 control). Respiratory health professionals delivered the intervention face-to-face over 6-8 weeks. Co-primary outcomes were HADS-A and HADS-D measured 6 months post-randomisation. Secondary outcomes at 6 and 12 months included: HADS-A and HADS-D (12 months), Beck Depression Inventory II, Beck Anxiety Inventory, St George's Respiratory Questionnaire, social engagement, the EuroQol instrument five-level version (EQ-5D-5L), smoking status, completion of pulmonary rehabilitation, and health and social care resource use. RESULTS: The intervention did not improve anxiety (HADS-A mean difference -0.60, 95% CI -1.40-0.21) or depression (HADS-D mean difference -0.66, 95% CI -1.39-0.07) at 6 months. The intervention did not improve any secondary outcomes at either time-point, nor did it influence completion of pulmonary rehabilitation or healthcare resource use. Deaths in the intervention arm (13/242; 5%) exceeded those in the control arm (3/181; 2%), but none were associated with the intervention. Health economic analysis found the intervention highly unlikely to be cost-effective. CONCLUSION: This trial has shown, beyond reasonable doubt, that this cognitive behavioural intervention delivered by trained and supervised respiratory health professionals does not improve psychological comorbidity in people with advanced COPD and depression or anxiety.

STOP- a training intervention to optimise treatment for smoking cessation in community pharmacies: cluster randomised controlled trial.

BACKGROUND: Community pharmacies serve people with high levels of tobacco-related illness, but throughput in NHS Stop Smoking Services in pharmacies remains relatively low. We investigated the effectiveness of a complex intervention to increase service uptake and retention. METHODS: We randomised 60 pharmacies in England and Wales to the STOP intervention or usual practice in a pragmatic, parallel-group, controlled trial over 11 months. Smokers were blind to the allocation. The intervention was theory-based consultation skills training for pharmacy staff with environmental prompts (badges, calendars and behavioural cues). The primary outcome was the number of smokers attending an initial consultation and setting a quit date. RESULTS: The intervention made no significant difference in setting a quit date, retention or quit rate. A total of 631 adult smokers (service users) enrolled and set a quit date in intervention pharmacies compared to 641 in usual practice pharmacies, a rate ratio of 0.75 (95% CI 0.46 to 1.23) adjusted for site and number of prescriptions. A total of 432 (68%) service users were retained at 4 weeks in intervention and 500 (78%) in usual practice pharmacies (odds ratio 0.80, 0.41 to 1.55). A total of 265 (42%) service users quit smoking at 4 weeks in intervention and 276 (43%) in usual practice pharmacies (0.96, 0.65 to 1.43). The pharmacy staff were positive about the intervention with 90% (56/62) stating that it had improved their skills. Sixty-eight per cent would strongly recommend the training to others although there was no difference in self-efficacy for service delivery between arms. Seventy of 131 (53%) service users did not complete the 6-month follow-up assessment. However, 55/61 (90%) service users who completed follow-up were satisfied or very satisfied with the service. All usual practice arm service users (n = 33) and all but one in the intervention arm (n = 27) would recommend the service to smokers. CONCLUSIONS: We found high levels of retention and acceptable quit rates in the NHS pharmacy stop smoking service. Despite pharmacy staff providing positive feedback on the STOP intervention, it made no difference to service throughput. Thus, other factors may currently limit service capacity to help smokers to quit. TRIAL REGISTRATION: ISRCTN, ISRCTN16351033 . Retrospectively registered.

Generational perspective on asthma self-management in the Bangladeshi and Pakistani community in the United Kingdom: A qualitative study.

BACKGROUND: Self-management strategies improve asthma outcomes, although interventions for South Asian populations have been less effective than in White populations. Both self-management and culture are dynamic, and factors such as acculturation and generation have not always been adequately reflected in existing cultural interventions. We aimed to explore the perspectives of Bangladeshi and Pakistani people in the United Kingdom, across multiple generations (first, second and third/fourth), on how they self-manage their asthma, with a view to suggesting recommendations for cultural interventions. METHODS: We purposively recruited Bangladeshi and Pakistani participants, with an active diagnosis of asthma from healthcare settings. Semi-structured interviews in the participants' choice of language (English, Sylheti, Standard Bengali or Urdu) were conducted, and data were analysed thematically. RESULTS: Twenty-seven participants (13 Bangladeshi and 14 Pakistani) were interviewed. There were generational differences in self-management, influenced by complex cultural processes experienced by South Asians as part of being an ethnic minority group. Individuals from the first generation used self-management strategies congruent to traditional beliefs such as 'sweating' and often chose to travel to South Asian countries. Generations born and raised in the United Kingdom learnt and experimented with self-management based on their fused identities and modified their approach depending on whether they were in familial or peer settings. Acculturative stress, which was typically higher in first generations who had migration-related stressors, influenced the priority given to asthma self-management throughout generations. The amount and type of available asthma information as well as social discussions within the community and with healthcare professionals also shaped asthma self-management. CONCLUSIONS: Recognizing cultural diversity and its influence of asthma self-management can help develop effective interventions tailored to the lives of South Asian people. PATIENT OR PUBLIC CONTRIBUTION: Patient and Public Involvement colleagues were consulted throughout to ensure that the study and its materials were fit for purpose.

Towards implementing exercise into the prostate cancer care pathway: development of a theory and evidence-based intervention to train community-based exercise professionals to support change in patient exercise behaviour (The STAMINA trial).

BACKGROUND: The National Institute for Health and Care Excellence (NICE) recommend that men on androgen deprivation therapy (ADT) for prostate cancer should receive supervised exercise to manage the side-effects of treatment. However, these recommendations are rarely implemented into practice. Community-based exercise professionals (CBEPs) represent an important target group to deliver the recommendations nationally, yet their standard training does not address the core competencies required to work with clinical populations, highlighting a need for further professional training. This paper describes the development of a training package to support CBEPs to deliver NICE recommendations. METHODS: Development of the intervention was guided by the Medical Research Council guidance for complex interventions and the Behaviour Change Wheel. In step one, target behaviours, together with their barriers and facilitators were identified from a literature review and focus groups with CBEPs (n = 22) and men on androgen deprivation therapy (n = 26). Focus group outputs were mapped onto the Theoretical Domains Framework (TDF) to identify theoretical constructs for change. In step two, behaviour change techniques and their mode of delivery were selected based on psychological theories and evidence to inform intervention content. In step three, the intervention was refined following delivery and subsequent feedback from intervention recipients and stakeholders. RESULTS: Six modifiable CBEPs target behaviours were identified to support the delivery of the NICE recommendations. Nine domains of the TDF were identified as key determinants of change, including: improving knowledge and skills and changing beliefs about consequences. To target the domains, we included 20 BCTs across 8 training modules and took a blended learning approach to accommodate different learning styles and preferences. Following test delivery to 11 CBEPs and feedback from 28 stakeholders, the training package was refined. CONCLUSION: Established intervention development approaches provided a structured and transparent guide to intervention development. A training package for CBEPs was developed and should increase trust amongst patients and health care professionals when implementing exercise into prostate cancer care. Furthermore, if proven effective, the development and approach taken may provide a blueprint for replication in other clinical populations where exercise has proven efficacy but is insufficiently implemented.

The development of a theory and evidence-based intervention to aid implementation of exercise into the prostate cancer care pathway with a focus on healthcare professional behaviour, the STAMINA trial.

BACKGROUND: Twice-weekly supervised aerobic and resistance exercise for 12 weeks reduces fatigue and improves quality of life in men on Androgen Deprivation Therapy for prostate cancer. Despite the National Institute for Health and Care Excellence (NICE) proposing this as standard of care, it does not routinely take place in practice. Healthcare professionals are in a prime position to deliver and integrate these recommendations. A change in the behaviour of clinical teams is therefore required. In this paper, we describe the development of a training package for healthcare professionals using theory and evidence to promote delivery of such recommendations as standard care. METHODS: The intervention development process was guided by the Medical Research Council guidance for complex interventions and the Behaviour Change Wheel. Target behaviours were identified from the literature and thirty-five prostate cancer care healthcare professionals (including oncologists, consultant urologists, clinical nurse specialists, physiotherapists, general practitioners and commissioners) were interviewed to understand influences on these behaviours. The Theoretical Domains Framework was used to identify theoretical constructs for change. Behaviour change techniques were selected based on theory and evidence and were translated into intervention content. The intervention was refined with the input of stakeholders including healthcare professionals, patients, and exercise professionals in the form of rehearsal deliveries, focus groups and a workshop. RESULTS: Seven modifiable healthcare professional target behaviours were identified to support the delivery of the NICE recommendations including identifying eligible patients suitable for exercise, recommending exercise, providing information, exercise referral, providing support and interpret and feedback on progress. Ten domains from the Theoretical Domain's Framework were identified as necessary for change, including improving knowledge and skills, addressing beliefs about consequences, and targeting social influences. These were targeted through twenty-two behaviour change techniques delivered in a half-day, interactive training package. Based on initial feedback from stakeholders, the intervention was refined in preparation for evaluation. CONCLUSIONS: We designed an intervention based on theory, evidence, and stakeholder feedback to promote and support the delivery of NICE recommendations. Future work will aim to test this training package in a multi-centre randomised trial. If proven effective, the development and training package will provide a template for replication in other clinical populations, where exercise has proven efficacy but is insufficiently implemented.

Community pharmacy interventions for health promotion: effects on professional practice and health outcomes.

BACKGROUND: Community pharmacies are an easily accessible and cost-effective platform for delivering health care worldwide, and the range of services provided has undergone rapid expansion in recent years. Thus, in addition to dispensing medication, pharmacy workers within community pharmacies now give advice on a range of health-promoting behaviours that aim to improve health and to optimise the management of long-term conditions. However, it remains uncertain whether these health-promotion interventions can change the professional practice of pharmacy workers, improve health behaviours and outcomes for pharmacy users and have the potential to address health inequalities. OBJECTIVES: To assess the effectiveness and safety of health-promotion interventions to change community pharmacy workers' professional practice and improve outcomes for users of community pharmacies. SEARCH METHODS: We searched MEDLINE, Embase, CENTRAL, six other databases and two trials registers to 6 February 2018. We also conducted reference checking, citation searches and contacted study authors to identify any additional studies. SELECTION CRITERIA: We included randomised trials of health-promotion interventions in community pharmacies targeted at, or delivered by, pharmacy workers that aimed to improve the health-related behaviour of people attending the pharmacy compared to no treatment, or usual treatment received in the community pharmacy. We excluded interventions where there was no interaction between pharmacy workers and pharmacy users, and those that focused on medication use only. DATA COLLECTION AND ANALYSIS: We used standard procedures recommended by Cochrane and the Effective Practice and Organisation of Care review group for both data collection and analysis. We compared intervention to no intervention or to usual treatment using standardised mean differences (SMD) and 95% confidence intervals (95% CI) (higher scores represent better outcomes for pharmacy user health-related behaviour and quality of life, and lower scores represent better outcomes for clinical outcomes, costs and adverse events). Interpretation of effect sizes (SMD) was in line with Cochrane recommendations. MAIN RESULTS: We included 57 randomised trials with 16,220 participants, described in 83 reports. Forty-nine studies were conducted in high-income countries, and eight in middle-income countries. We found no studies that had been conducted in low-income countries. Most interventions were educational, or incorporated skills training. Interventions were directed at pharmacy workers (n = 8), pharmacy users (n = 13), or both (n = 36). The clinical areas most frequently studied were diabetes, hypertension, asthma, and modification of cardiovascular risk. Duration of follow-up of interventions was often unclear. Only five studies gave details about the theoretical basis for the intervention, and studies did not provide sufficient data to comment on health inequalities. The most common sources of bias were lack of protection against contamination - mainly in individually randomised studies - and inadequate blinding of participants. The certainty of the evidence for all outcomes was moderate. We downgraded the certainty because of the heterogeneity across studies and evidence of potential publication bias. Professional practice outcomes We conducted a narrative analysis for pharmacy worker behaviour due to high heterogeneity in the results. Health-promotion interventions probably improve pharmacy workers' behaviour (2944 participants; 9 studies; moderate-certainty evidence) when compared to no intervention. These studies typically assessed behaviour using a simulated patient (mystery shopper) methodology. Pharmacy user outcomes Health-promotion interventions probably lead to a slight improvement in health-related behaviours of pharmacy users when compared to usual treatment (SMD 0.43, 95% CI 0.14 to 0.72; I2 = 89%; 10 trials; 2138 participants; moderate-certainty evidence). These interventions probably also lead to a slight improvement in intermediate clinical outcomes, such as levels of cholesterol or glycated haemoglobin, for pharmacy users (SMD -0.43, 95% CI -0.65 to -0.21; I2 = 90%; 20 trials; 3971 participants; moderate-certainty evidence). We identified no studies that evaluated the impact of health-promotion interventions on event-based clinical outcomes, such as stroke or myocardial infarction, or the psychological well-being of pharmacy users. Health-promotion interventions probably lead to a slight improvement in quality of life for pharmacy users (SMD 0.29, 95% CI 0.08 to 0.50; I2= 82%; 10 trials, 2687 participants; moderate-certainty evidence). Adverse events No studies reported adverse events for either pharmacy workers or pharmacy users. Costs We found that health-promotion interventions are likely to be cost-effective, based on moderate-certainty evidence from five of seven studies that reported an economic evaluation. AUTHORS' CONCLUSIONS: Health-promotion interventions in the community pharmacy context probably improve pharmacy workers' behaviour and probably have a slight beneficial effect on health-related behaviour, intermediate clinical outcomes, and quality of life for pharmacy users. Such interventions are likely to be cost-effective and the effects are seen across a range of clinical conditions and health-related behaviours. Nevertheless the magnitude of the effects varies between conditions, and more effective interventions might be developed if greater consideration were given to the theoretical basis of the intervention and mechanisms for effecting behaviour change.

Interventions for promoting habitual exercise in people living with and beyond cancer.

BACKGROUND: This is an updated version of the original Cochrane Review published in the Cochrane Library 2013, Issue 9. Despite good evidence for the health benefits of regular exercise for people living with or beyond cancer, understanding how to promote sustainable exercise behaviour change in sedentary cancer survivors, particularly over the long term, is not as well understood. A large majority of people living with or recovering from cancer do not meet current exercise recommendations. Hence, reviewing the evidence on how to promote and sustain exercise behaviour is important for understanding the most effective strategies to ensure benefit in the patient population and identify research gaps. OBJECTIVES: To assess the effects of interventions designed to promote exercise behaviour in sedentary people living with and beyond cancer and to address the following secondary questions: Which interventions are most effective in improving aerobic fitness and skeletal muscle strength and endurance? Which interventions are most effective in improving exercise behaviour amongst patients with different cancers? Which interventions are most likely to promote long-term (12 months or longer) exercise behaviour? What frequency of contact with exercise professionals and/or healthcare professionals is associated with increased exercise behaviour? What theoretical basis is most often associated with better behavioural outcomes? What behaviour change techniques (BCTs) are most often associated with increased exercise behaviour? What adverse effects are attributed to different exercise interventions? SEARCH METHODS: We used standard methodological procedures expected by Cochrane. We updated our 2013 Cochrane systematic review by updating the searches of the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, Embase, AMED, CINAHL, PsycLIT/PsycINFO, SportDiscus and PEDro up to May 2018. We also searched the grey literature, trial registries, wrote to leading experts in the field and searched reference lists of included studies and other related recent systematic reviews. SELECTION CRITERIA: We included only randomised controlled trials (RCTs) that compared an exercise intervention with usual care or 'waiting list' control in sedentary people over the age of 18 with a homogenous primary cancer diagnosis. DATA COLLECTION AND ANALYSIS: In the update, review authors independently screened all titles and abstracts to identify studies that might meet the inclusion criteria, or that could not be safely excluded without assessment of the full text (e.g. when no abstract is available). We extracted data from all eligible papers with at least two members of the author team working independently (RT, LS and RG). We coded BCTs according to the CALO-RE taxonomy. Risk of bias was assessed using the Cochrane's tool for assessing risk of bias. When possible, and if appropriate, we performed a fixed-effect meta-analysis of study outcomes. If statistical heterogeneity was noted, a meta-analysis was performed using a random-effects model. For continuous outcomes (e.g. cardiorespiratory fitness), we extracted the final value, the standard deviation (SD) of the outcome of interest and the number of participants assessed at follow-up in each treatment arm, to estimate the standardised mean difference (SMD) between treatment arms. SMD was used, as investigators used heterogeneous methods to assess individual outcomes. If a meta-analysis was not possible or was not appropriate, we narratively synthesised studies. The quality of the evidence was assessed using the GRADE approach with the GRADE profiler. MAIN RESULTS: We included 23 studies in this review, involving a total of 1372 participants (an addition of 10 studies, 724 participants from the original review); 227 full texts were screened in the update and 377 full texts were screened in the original review leaving 35 publications from a total of 23 unique studies included in the review. We planned to include all cancers, but only studies involving breast, prostate, colorectal and lung cancer met the inclusion criteria. Thirteen studies incorporated a target level of exercise that could meet current recommendations for moderate-intensity aerobic exercise (i.e.150 minutes per week); or resistance exercise (i.e. strength training exercises at least two days per week).Adherence to exercise interventions, which is crucial for understanding treatment dose, is still reported inconsistently. Eight studies reported intervention adherence of 75% or greater to an exercise prescription that met current guidelines. These studies all included a component of supervision: in our analysis of BCTs we designated these studies as 'Tier 1 trials'. Six studies reported intervention adherence of 75% or greater to an aerobic exercise goal that was less than the current guideline recommendations: in our analysis of BCTs we designated these studies as 'Tier 2 trials.' A hierarchy of BCTs was developed for Tier 1 and Tier 2 trials, with programme goal setting, setting of graded tasks and instruction of how to perform behaviour being amongst the most frequent BCTs. Despite the uncertainty surrounding adherence in some of the included studies, interventions resulted in improvements in aerobic exercise tolerance at eight to 12 weeks (SMD 0.54, 95% CI 0.37 to 0.70; 604 participants, 10 studies; low-quality evidence) versus usual care. At six months, aerobic exercise tolerance was also improved (SMD 0.56, 95% CI 0.39 to 0.72; 591 participants; 7 studies; low-quality evidence). AUTHORS' CONCLUSIONS: Since the last version of this review, none of the new relevant studies have provided additional information to change the conclusions. We have found some improved understanding of how to encourage previously inactive cancer survivors to achieve international physical activity guidelines. Goal setting, setting of graded tasks and instruction of how to perform behaviour, feature in interventions that meet recommendations targets and report adherence of 75% or more. However, long-term follow-up data are still limited, and the majority of studies are in white women with breast cancer. There are still a considerable number of published studies with numerous and varied issues related to high risk of bias and poor reporting standards. Additionally, the meta-analyses were often graded as consisting of low- to very low-certainty evidence. A very small number of serious adverse effects were reported amongst the studies, providing reassurance exercise is safe for this population.

Helpful advice and hidden expertize: pharmacy users' experiences of community pharmacy accessibility.

Background: In recent years community pharmacies have emerged as strategically important settings to deliver services aimed at promoting public health. In order to develop evidence-based approaches to public health interventions that exploit the unique accessibility of community pharmacies, it is important to determine how people experience care in this context. This study, therefore, aimed to describe how care is perceived and experienced in community pharmacies with particular focus on community pharmacy access. Methods: In-depth semi-structured interviews were used to explore the perceptions and experiences' of people using community pharmacies. Results: A total of 30 participants were interviewed. Themes specifically emerged in relation to community pharmacy access; these fell into four main categories: relationships; time; lack of awareness; and empowerment. Conclusions: The experience of developing a trusting relationship with the pharmacist is an important consideration in the context of community pharmacy accessibility. This could be an important consideration when a person uses a community pharmacy to access a public health service. There is also a perceived lack of awareness among the general public about the extended role of community pharmacy; this is a potential barrier toward people using them.

What works for whom in pharmacist-led smoking cessation support: realist review.

BACKGROUND: New models of primary care are needed to address funding and staffing pressures. We addressed the research question "what works for whom in what circumstances in relation to the role of community pharmacies in providing lifestyle interventions to support smoking cessation?" METHODS: This is a realist review conducted according to RAMESES standards. We began with a sample of 103 papers included in a quantitative review of community pharmacy intervention trials identified through systematic searching of seven databases. We supplemented this with additional papers: studies that had been excluded from the quantitative review but which provided rigorous and relevant additional data for realist theorising; citation chaining (pursuing reference lists and Google Scholar forward tracking of key papers); the 'search similar citations' function on PubMed. After mapping what research questions had been addressed by these studies and how, we undertook a realist analysis to identify and refine candidate theories about context-mechanism-outcome configurations. RESULTS: Our final sample consisted of 66 papers describing 74 studies (12 systematic reviews, 6 narrative reviews, 18 RCTs, 1 process detail of a RCT, 1 cost-effectiveness study, 12 evaluations of training, 10 surveys, 8 qualitative studies, 2 case studies, 2 business models, 1 development of complex intervention). Most studies had been undertaken in the field of pharmacy practice (pharmacists studying what pharmacists do) and demonstrated the success of pharmacist training in improving confidence, knowledge and (in many but not all studies) patient outcomes. Whilst a few empirical studies had applied psychological theories to account for behaviour change in pharmacists or people attempting to quit, we found no studies that had either developed or tested specific theoretical models to explore how pharmacists' behaviour may be affected by organisational context. Because of the nature of the empirical data, only a provisional realist analysis was possible, consisting of five mechanisms (pharmacist identity, pharmacist capability, pharmacist motivation and clinician confidence and public trust). We offer hypotheses about how these mechanisms might play out differently in different contexts to account for the success, failure or partial success of pharmacy-based smoking cessation efforts. CONCLUSION: Smoking cessation support from community pharmacists and their staff has been extensively studied, but few policy-relevant conclusions are possible. We recommend that further research should avoid duplicating existing literature on individual behaviour change; seek to study the organisational and system context and how this may shape, enable and constrain pharmacists' extended role; and develop and test theory.

How does change occur following a theoretically based self-management intervention for type 2 diabetes.

The purpose of this study was to test the extent that constructs from two theoretical models (self-regulatory theory and social cognitive theory) mediated change in outcomes following a self-management intervention. One hundred and twenty four individuals with type 2 diabetes who had participated in a randomised controlled trial of a diabetes self-management programme were analysed for the extent that illness beliefs and self-efficacy mediated change in self-management behaviours and illness specific quality of life. Exercise specific self-efficacy significantly mediated change in exercise at three months (B = .03; .01, p < .05) while monitoring specific self-efficacy mediated change in monitoring behaviour at both three (B = .04; .01, p < .01) and nine months follow-up (B = 5.97; 1.01, p < .01). Belief in control over diabetes mediated change in illness specific quality of life at three months (B = -.07; .28, p < .05) and nine months (B = .79; .28, p < .01) follow-ups, as well as change in exercise behaviour at immediately post-intervention (B = -.12; .17, p < .05). Behaviour-specific self-efficacy may have a stronger role in mediating self-management behaviours than illness beliefs; however, belief in control over diabetes may be important to manipulate for change in quality of life. This suggests different theoretical constructs may mediate change dependent on outcome.

Exploring the perspectives of healthcare professionals on providing supported asthma self-management for Bangladeshi and Pakistani people in the UK.

BACKGROUND: Self-management support improves asthma outcomes and is widely recommended in guidelines, yet it is poorly implemented in routine practice. There may be additional challenges in the context of ethnic minority groups, where making sense of culture may be necessary. This study aimed to explore the perspectives of healthcare professionals on supporting UK Bangladeshi and Pakistani patients to self-manage their asthma. METHODS: One-to-one semi-structured interviews with professionals (primary and secondary care; medical and nursing) who routinely provide asthma care to Bangladeshi or Pakistani patients. Topics addressed included perceptions of professionals in supporting patients with asthma self-management and ideas for improving culturally competent care. Data were analysed thematically. RESULTS: Nine professionals, from a range of ethnic backgrounds, with considerable experience of treating patients from these communities were interviewed. Despite organisational restrictions (language and time/resources) and expressed gaps in cultural knowledge and training, all interviewees reported attempting to tailor support according to culture. They used their perception of the patient's culture (e.g., big families and family involvement), integrated with their perception of patients' ability to self-manage (e.g., degree of responsibility taken for asthma), to formulate theories about how to culturally adapt their approach to supported self-management, e.g., supporting barriers in understanding asthma. There was consensus that gaps in cultural knowledge of professionals needed to be addressed through training or information. Interventions recommended for patients included basic education, group meetings, and culturally relevant action plans. CONCLUSION: In the absence of formal training and constrained by organisational limitations, self-management support was adapted based on personal and professional perception of culture. These ideas were based on experience and formulated a chain of reasoning. Professionals recognised the limitations of this approach and potential to overgeneralise their perceptions of culture and adaptations of supported self-management. Interventions were desired and need to address professional training in cultural competence and the provision of culturally relevant materials.

Development of theoretically informed audit and feedback: An exemplar from a complex implementation strategy to improve asthma self-management in UK primary care.

RATIONALE: Audit and feedback is an evidence-based implementation strategy, but studies reporting the use of theory to guide design elements are limited. AIMS AND OBJECTIVES: Within the context of a programme of research aiming to improve the implementation of supported asthma self-management in UK primary care (IMPlementing IMProved Asthma self-management as RouTine [IMP2 ART]), we aimed to design and develop theoretically-informed audit and feedback that highlighted supported asthma self-management provision and areas for improvement in primary care general practices. METHOD: Aligned with the Medical Research Council (MRC) complex intervention framework, the audit and feedback was developed in three phases: (1) Development: literature and theory exploration, and prototype audit and feedback design; (2) Feasibility: eliciting feedback on the audit and feedback from general practice staff (n = 9); (3) Prepiloting: delivering the audit and feedback within the IMP2 ART implementation strategy (incorporating patient and professional resources and an asthma review template) and eliciting clinician feedback (n = 9). RESULTS: Audit and feedback design was guided by and mapped to existing literature suggestions and theory (e.g., Theoretical Domains Framework, Behaviour Change Technique Taxonomy). Feedback on the prototype audit and feedback confirmed feasibility but identified some refinements (a need to highlight supporting self-management and importance of asthma action plans). Prepiloting informed integration with other IMP2 ART programme strategies (e.g., patient resources and professional education). CONCLUSION: We conclude that a multistage development process including theory exploration and mapping, contributed to the design and delivery of the audit and feedback. Aligned with the MRC framework, the IMP2 ART strategy (incorporating the audit and feedback) is now being tested in a UK-wide cluster randomised controlled trial.

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.

Interventions for promoting habitual exercise in people living with and beyond cancer.

BACKGROUND: The beneficial effects of regular exercise for people living with or beyond cancer are becoming apparent. However, how to promote exercise behaviour in sedentary cancer cohorts is not as well understood. A large majority of people living with or recovering from cancer do not meet exercise recommendations. Hence, reviewing the evidence on how to promote and sustain exercise behaviour is important. OBJECTIVES: To assess the effects of interventions to promote exercise behaviour in sedentary people living with and beyond cancer and to address the following questions: Which interventions are most effective in improving aerobic fitness and skeletal muscle strength and endurance? What adverse effects are attributed to different exercise interventions? Which interventions are most effective in improving exercise behaviour amongst patients with different cancers? Which interventions are most likely to promote long-term (12 months or longer) exercise behaviour? What frequency of contact with exercise professionals is associated with increased exercise behaviour? What theoretical basis is most often associated with increased exercise behaviour? What behaviour change techniques are most often associated with increased exercise behaviour? SEARCH METHODS: We searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 8, 2012), MEDLINE, EMBASE, AMED, CINAHL, PsycLIT/PsycINFO, SportDiscus and PEDro from inception to August 2012. We also searched the grey literature, wrote to leading experts in the field, wrote to charities and searched reference lists of other recent systematic reviews. SELECTION CRITERIA: We included only randomised controlled trials (RCTs) that compared an exercise intervention with a usual care approach in sedentary people over the age of 18 with a homogenous primary cancer diagnosis. DATA COLLECTION AND ANALYSIS: Two review authors working independently (LB and KH) screened all titles and abstracts to identify studies that might meet the inclusion criteria, or that cannot be safely excluded without assessment of the full text (e.g. when no abstract is available). All eligible papers were formally abstracted by at least two members of the review author team working independently (LB and KH) and using the data collection form. When possible, and if appropriate, we performed a fixed-effect meta-analysis of study outcomes. For continuous outcomes (e.g. cardiorespiratory fitness), we extracted the final value, the standard deviation of the outcome of interest and the number of participants assessed at follow-up in each treatment arm, to estimate standardised mean difference (SMD) between treatment arms. SMD was used, as investigators used heterogeneous methods to assess individual outcomes. If a meta-analysis was not possible or was not appropriate, we synthesised studies as a narrative. MAIN RESULTS: Fourteen trials were included in this review, involving a total of 648 participants. Only studies involving breast, prostate or colorectal cancer were identified as eligible. Just six trials incorporated a target level of exercise that could meet current recommendations. Only three trials were identified that attempted to objectively validate independent exercise behaviour with accelerometers or heart rate monitoring. Adherence to exercise interventions, which is crucial for understanding treatment dose, is often poorly reported. It is important to note that the fundamental metrics of exercise behaviour (i.e. frequency, intensity and duration, repetitions, sets and intensity of resistance training), although easy to devise and report, are seldom included in published clinical trials.None of the included trials reported that 75% or greater adherence (the stated primary outcome for this review) of the intervention group met current aerobic exercise recommendations at any given follow-up. Just two trials reported six weeks of resistance exercise behaviour that would meet the guideline recommendations. However, three trials reported adherence of 75% or greater to an aerobic exercise goal that was less than the current guideline recommendation of 150 minutes per week. All three incorporated both supervised and independent exercise components as part of the intervention, and none placed restrictions on the control group in terms of exercise behaviour. These three trials shared programme set goals and the following behaviour change techniques: generalisation of a target behaviour; prompting of self-monitoring of behaviour; and prompting of practise. Despite the uncertainty surrounding adherence in many of the included trials, interventions caused improvements in aerobic exercise tolerance at 8 to 12 weeks (from 7 studies, SMD 0.73, 95% confidence interval (CI) 0.51 to 0.95) in intervention participants compared with controls. At six months, aerobic exercise tolerance was also improved (from 5 studies, SMD 0.70, 95% CI 0.45 to 0.94), but it should be noted that four of the five trials used in this analysis had a high risk of bias, hence caution is warranted in interpretation of results. Attrition over the course of these interventions is typically low (median 6%). AUTHORS' CONCLUSIONS: Interventions to promote exercise in cancer survivors who report better levels of adherence share some common behaviour change techniques. These involve setting programme goals, prompting practise and self-monitoring and encouraging participants to attempt to generalise behaviours learned in supervised exercise environments to other, non-supervised contexts. However, expecting most sedentary survivors to achieve current guideline recommendations of at least 150 minutes per week of aerobic exercise is likely to be unrealistic. As with all well-designed exercise programmes in any context, prescriptions should be designed around individual capabilities, and frequency, duration and intensity or sets, repetitions, intensity or resistance training should be generated on this basis.

Understanding interventions delivered in the emergency department targeting improved asthma outcomes beyond the emergency department: an integrative review.

OBJECTIVES: The emergency department (ED) represents a place and moment of opportunity to provide interventions to improve long-term asthma outcomes, but feasibility, effectiveness and mechanisms of impact are poorly understood. We aimed to review the existing literature on interventions that are delivered in the ED for adults and adolescents, targeting asthma outcomes beyond the ED, and to code the interventions according to theory used, and to understand the barriers and facilitators to their implementation. METHODS: We systematically searched seven electronic databases and research registers, and manually searched reference lists of included studies and relevant reviews. Both quantitative and qualitative studies that reported on interventions delivered in the ED which aimed to improve asthma outcomes beyond management of the acute exacerbation, for adolescents or adults were included. Methodological quality was assessed using the Mixed Methods Appraisal Tool and informed study interpretation. Theory was coded using the Theoretical Domains Framework. Findings were summarised by narrative synthesis. RESULTS: 12 articles were included, representing 10 unique interventions, including educational and medication-based changes (6 randomised controlled trials and 4 non-randomised studies). Six trials reported statistically significant improvements in one or more outcome measures relating to long-term asthma control, including unscheduled healthcare, asthma control, asthma knowledge or quality of life. We identified limited use of theory in the intervention designs with only one intervention explicitly underpinned by theory. There was little reporting on facilitators or barriers, although brief interventions appeared more feasible. CONCLUSION: The results of this review suggest that ED-based asthma interventions may be capable of improving long-term outcomes. However, there was significant variation in the range of interventions, reported outcomes and duration of follow-up. Future interventions would benefit from using behaviour change theory, such as constructs from the Theoretical Domains Framework. PROSPERO REGISTRATION NUMBER: CRD 42020223058.

Development of a patient-centred electronic review template to support self-management in primary care: a mixed-methods study.

BACKGROUND: Electronic templates are frequently used in long-term condition (LTC) reviews (for example, asthma) to act as reminders and improve documentation; however, they can restrict patient-centred care and opportunities for patients to discuss concerns and self-management. AIM: The IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) programme aimed to develop a patient-centred asthma review template that encourages supported self-management. DESIGN & SETTING: This was a mixed-methods study, which integrated qualitative and systematic review data, primary care Professional Advisory Group feedback, and qualitative data from clinician interviews. METHOD: Aligned with the Medical Research Council complex intervention framework, a template was developed in the following three phases: (1) development phase, which consisted of a qualitative exploration with clinicians and patients, a systematic review, and prototype template development; (2) feasibility pilot phase, which involved feedback from clinicians (n = 7); and (3) pre-piloting phase, which consisted of delivering the template within the IMP2ART implementation strategy (incorporating the template with patient and professional resources) and eliciting clinician feedback (n = 6). RESULTS: Template development was guided by the preliminary qualitative work and the systematic review. A prototype template was developed with an opening question to establish patient agendas, and a closing prompt to confirm agendas have been addressed and an asthma action plan provided. The feasibility pilot identified refinements needed, including focusing the opening question on asthma. Pre-piloting ensured integration with the IMP2ART strategy. CONCLUSION: Following the multi-stage development process, the implementation strategy, including the asthma review template, is now being tested in a cluster randomised controlled trial.

IMP2ART: development of a multi-level programme theory integrating the COM-B model and the iPARIHS framework, to enhance implementation of supported self-management of asthma in primary care.

BACKGROUND: Supported asthma self-management, incorporating an asthma action plan and annual clinical review, has been recommended by UK/global guidelines for over three decades. However, implementation remains poor, as only around a third of individuals receive basic asthma care, according to the UKs leading respiratory charity Asthma and Lung UK. A systematic review of implementation studies recommended that a whole systems approach targeting patients, healthcare professional education, and organisations is needed to improve implementation of supported asthma self-management in primary care. The IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) is a national Hybrid-II implementation cluster randomised controlled trial that aims to evaluate such an approach. This paper describes the development of the implementation strategy for IMP2ART with particular focus on the integration of multiple level theories. METHODS: The Medical Research Council design and evaluation of complex interventions framework and the Person-Based Approach to intervention development were used as guidance for stages of strategy development. Specifically, we (i) set up a multidisciplinary team (including practicing and academic clinicians, health psychologists, public health and patient colleagues), (ii) reviewed and integrated evidence and theory, (iii) developed guiding principles, (iv) developed prototype materials, and (v) conducted a pre-pilot study before final refinement. RESULTS: The implementation strategy included resources for patients, team-based and individual healthcare professional education, practice audit and feedback, and an asthma review template, as well as a facilitator role accessible to primary care practices for 12 months. The synthesis of the integrated Promoting Action on Research Implementation in Health Services (iPARIHS) and Capability, Opportunity, Motivation and Behaviour (COM-B) frameworks led to an evolved framework bringing together important implementation and behaviour change elements which will be used as a basis for the study process evaluation. CONCLUSIONS: A description of rigorous implementation strategy development for the IMP2ART study is provided along with newly theorised integration of implementation and behaviour change science which may be of benefit to others targeting implementation in primary care. TRIAL REGISTRATION: ISRCTN15448074. Registered on 2nd December 2019.

Complex interventions for aggressive challenging behaviour in adults with intellectual disability: A rapid realist review informed by multiple populations.

OBJECTIVES: Approximately 10% of people with intellectual disability display aggressive challenging behaviour, usually due to unmet needs. There are a variety of interventions available, yet a scarcity of understanding about what mechanisms contribute to successful interventions. We explored how complex interventions for aggressive challenging behaviour work in practice and what works for whom by developing programme theories through contexts-mechanism-outcome configurations. METHODS: This review followed modified rapid realist review methodology and RAMESES-II standards. Eligible papers reported on a range of population groups (intellectual disability, mental health, dementia, young people and adults) and settings (community and inpatient) to broaden the scope and available data for review. RESULTS: Five databases and grey literature were searched and a total of 59 studies were included. We developed three overarching domains comprising of 11 contexts-mechanism-outcome configurations; 1. Working with the person displaying aggressive challenging behaviour, 2. Relationships and team focused approaches and 3. Sustaining and embedding facilitating factors at team and systems levels. Mechanisms underlying the successful application of interventions included improving understanding, addressing unmet need, developing positive skills, enhancing carer compassion, and boosting staff self-efficacy and motivation. CONCLUSION: The review emphasises how interventions for aggressive challenging behaviour should be personalised and tailored to suit individual needs. Effective communication and trusting relationships between service users, carers, professionals, and within staff teams is essential to facilitate effective intervention delivery. Carer inclusion and service level buy-in supports the attainment of desired outcomes. Implications for policy, clinical practice and future directions are discussed. PROSPERO REGISTRATION NUMBER: CRD42020203055.

Stakeholder views on the barriers and facilitators of psychosocial interventions to address reduction in aggressive challenging behaviour in adults with intellectual disabilities.

Background: Success of psychosocial interventions in reducing aggressive challenging behaviour is likely to be related not only to mechanistic aspects, but also to therapeutic and system factors. The study aims to examine the facilitators and barriers that influence whether psychosocial interventions for aggressive challenging behaviour in adults with intellectual disabilities lead to positive change. Methods: We conducted 42 semi-structured interviews with adults with intellectual disabilities and aggressive challenging behaviour, family/paid carers, and professionals engaged in or delivering a psychosocial intervention across the UK. Data were analysed thematically using a framework approach. Results: Stakeholders considered therapeutic and supportive relationships and personalised care as facilitating factors of psychosocial interventions to address aggressive challenging behaviour. The operational structure of community intellectual disability services and conflicting expectations of professionals and carers were the main contextual barriers that impeded the implementation of psychosocial interventions addressing aggressive challenging behaviour in adults with intellectual disabilities. Conclusions: Findings highlight the valued components that maximise positive change in adults with intellectual disabilities who display aggressive challenging behaviour. Several operational adjustments including referral criteria, roles of professionals and workforce issues need to be addressed in services to maximise the implementation of psychosocial interventions to reduce aggressive challenging behaviour in adults with intellectual disabilities.

The current study looked at what factors that lead to good outcomes from therapies that aim to reduce aggressive challenging behaviour in adults with learning disabilities. We also looked at the factors that may prevent positive change ( i.e., reduction in aggressive challenging behaviour). We interviewed 42 people including 14 adults with learning disabilities, 13 carers (6 family; 7 paid) and 13 professionals across the UK. All stakeholders agreed that supportive relationships between the person with a learning disability and their therapist, staff consistent, personalised therapy and involvement of the person with a learning disability and their carer(s) in care planning facilitate the reduction of aggressive challenging behaviour. On the other hand, differences in expectations between professionals and carers, personal reasons ( e.g. being the right timing for a person), and the way community learning disability services currently run may stop people from having the opportunity to take part in therapy are barriers to positive change such as reduction of aggressive challenging behaviour. The study findings highlight the valued components that maximise the positive change in adults with intellectual disabilities who display aggressive challenging behaviour. Several operational adjustments including referral criteria, roles of professionals and workforce issues need to be addressed in services to maximise the implementation of psychosocial interventions to reduce aggressive challenging behaviour in adults with intellectual disabilities.