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.

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.

A Charter to Fundamentally Change the Role of Oral Corticosteroids in the Management of Asthma.

Asthma affects 339 million people worldwide, with an estimated 5-10% experiencing severe asthma. In emergency settings, oral corticosteroids (OCS) can be lifesaving, but acute and long-term treatment can produce clinically important adverse outcomes and increase the risk of mortality. Therefore, global guidelines recommend limiting the use of OCS. Despite the risks, research indicates that 40-60% of people with severe asthma are receiving or have received long-term OCS treatment. Although often perceived as a low-cost option, long-term OCS use can result in significant health impairments and costs owing to adverse outcomes and increased utilization of healthcare resources. Alternative treatment methods, such as biologics, may produce cost-saving benefits with a better safety profile. A comprehensive and concerted effort is necessary to tackle the continued reliance on OCS. Accordingly, a threshold for OCS use should be established to help identify patients at risk of OCS-related adverse outcomes. Receiving a total dose of more than 500 mg per year should trigger a review and specialist referral. Changes to national and local policies, following examples from other chronic diseases, will be crucial to achieving this goal. Globally, multiple barriers to change still exist, but specific steps have been identified to help clinicians reduce reliance on OCS. Implementing these changes will result in positive health outcomes for patients and social and economic benefits for societies.

IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) in primary care: study protocol for a cluster randomised controlled implementation trial.

BACKGROUND: Asthma is a common long-term condition and major public health problem. Supported self-management for asthma that includes a written personalised asthma action plan, supported by regular professional review, reduces unscheduled consultations and improves asthma outcomes and quality of life. However, despite unequivocal inter/national guideline recommendations, supported self-management is poorly implemented in practice. The IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) implementation strategy has been developed to address this challenge. The aim of this implementation trial is to determine whether facilitated delivery of the IMP2ART strategy increases the provision of asthma action plans and reduces unscheduled care in the context of routine UK primary care. METHODS: IMP2ART is a parallel group, cluster randomised controlled hybrid II implementation trial. One hundred forty-four general practices will be randomly assigned to either the IMP2ART implementation strategy or control group. Following a facilitation workshop, implementation group practices will receive organisational resources to help them prioritise supported self-management (including audit and feedback; an IMP2ART asthma review template), training for professionals and resources to support patients to self-manage their asthma. The control group will continue with usual asthma care. The primary clinical outcome is the between-group difference in unscheduled care in the second year after randomisation (i.e. between 12 and 24 months post-randomisation) assessed from routine data. Additionally, a primary implementation outcome of asthma action plan ownership at 12 months will be assessed by questionnaire to a random sub-group of people with asthma. Secondary outcomes include the number of asthma reviews conducted, prescribing outcomes (reliever medication and oral steroids), asthma symptom control, patients' confidence in self-management and professional support and resource use. A health economic analysis will assess cost-effectiveness, and a mixed methods process evaluation will explore implementation, fidelity and adaptation. DISCUSSION: The evidence for supported asthma self-management is overwhelming. This study will add to the literature regarding strategies that can effectively implement supported self-management in primary care to reduce unscheduled consultations and improve asthma outcomes and quality of life. TRIAL REGISTRATION: ISRCTN15448074. Registered on 2 December 2019.

Comparison of COPD primary care in England, Scotland, Wales, and Northern Ireland.

Currently the National Asthma and COPD audit programme (NACAP) only undertakes audit of COPD primary care in Wales due to its near complete data coverage. We aimed to determine if the quality of COPD primary care in the other UK nations is comparable with Wales. We found that English, Scottish, and Northern Irish practices were significantly worse than Welsh practices at recording coded lung function parameters used in COPD diagnosis (ORs: 0.51 [0.43-0.59], 0.29 [0.23-0.36], 0.42 [0.31-0.58], respectively) and referring appropriate patients for pulmonary rehabilitation (ORs: 0.10 [0.09-0.11], 0.12 [0.11-0.14], 0.22 [0.19-0.25], respectively). Completing national audits of primary care in Wales only may have led to improvements in care, or at least improvements in the recording of care in Wales that are not occurring elsewhere in the UK. This highlights the potential importance of audit in improving care quality and accurate recording of that care.

A Renewed Charter: Key Principles to Improve Patient Care in Severe Asthma.

Asthma is a heterogenous respiratory disease, usually associated with chronic airway inflammation and hyper-responsiveness, which affects an estimated 339 million people worldwide. Severe asthma affects approximately 5-10% of patients with asthma, approximately 17-34 million people globally, more than half of whom have uncontrolled disease. Severe asthma carries a substantial burden of disease, including unpredictable symptoms and potentially life-threatening flare-ups. Furthermore, severe asthma has a substantial burden on health care systems and economies worldwide. In 2018, a group of experts from the clinical community, patient support groups, and professional organisations joined together to develop the Severe Asthma Patient Charter, which set out six principles to define what patients should expect for the management of their severe asthma and what should constitute a basic standard of care. Since the publication of that original Charter in 2018, several important changes have occurred, including an improved understanding of asthma and effective asthma management; several new therapies have become available; and finally, the COVID-19 pandemic has placed a spotlight on respiratory conditions, the workforces that treat them, and the fundamental importance of health care system resilience. With those developments in mind, we, representatives of the academic, clinical, and patient advocacy group communities, have updated the Charter to Improve Patient Care in Severe Asthma with a focus on six principles: (1) I deserve a timely, comprehensive assessment of my asthma and its severity; (2) I deserve a timely, straightforward referral to an appropriate specialist for my asthma when it is not well controlled; (3) I deserve to understand what makes my asthma worse; (4) I deserve access to treatment and care that reduces the impact of asthma on my daily life; (5) I deserve not to be reliant on systemic corticosteroids; (6) I deserve to be involved in decisions about my treatment and care.

Unmet needs in the management of immune-mediated thrombotic thrombocytopenic purpura and the potential role of caplacizumab in the UK-A modified-Delphi study.

Immune-mediated thrombotic thrombocytopenic purpura (iTTP) is an ultra-rare, blood-clotting disorder. Management historically relies on plasma exchange and immunosuppression; however, a 10%-20% mortality rate is still observed. Caplacizumab binds to von Willebrand factor and directly inhibits platelet aggregation; addition of caplacizumab to historical treatment induced faster resolution of platelet count in clinical trials. In 2019, a modified-Delphi study was conducted with UK experts, to develop consensus statements on management of acute TTP and the potential role of caplacizumab. An unmet need was acknowledged, and areas requiring improvement included: time to diagnosis and treatment initiation; time to platelet normalisation (TTPN) during which patients remain at risk of persistent microvascular thrombosis and organ damage; and incidence of subsequent exacerbations and relapses. Caplacizumab addition to historical treatment within 24 h (after confirmatory ADAMTS13 [a disintegrin and metalloproteinase with thrombospondin type 1 motif, member 13] assay) would significantly reduce TTPN, which directly influences acute outcomes, with manageable bleeding risk and reduced burden on healthcare systems. Expert panellists agree that poor outcomes in iTTP largely result from failure to rapidly control microvascular thrombosis. Use of caplacizumab during a confirmed iTTP episode could offer better control and may plausibly improve long-term outcomes. However, this consensus must be validated with further clinical trials and robust real-world evidence.

Developing a theoretically informed education programme within the context of a complex implementation strategy in UK primary care: an exemplar from the IMP2ART trial.

BACKGROUND: IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) is a programme of work developing and evaluating a strategy for implementing supported asthma self-management in UK primary care. The strategy encompasses patient-facing resources, professional education, and organisational approaches to embed supported self-management. This paper reports the development of a theoretically informed interprofessional education programme which aims to raise awareness of and enable healthcare professionals to deliver effective supported self-management. METHODS: Aligned with the Medical Research Council (MRC) Complex Intervention Framework, the multidisciplinary team developed educational content in three phases: (1) developmental phase, identifying educational and behaviour change theory to guide development, in consultation with a professional advisory group; (2) feasibility pilot phase, testing the education using a 'think-aloud' method; and (3) pre-pilot phase, delivering the education within the IMP2ART strategy. RESULTS: The developmental phase identified educational and behaviour change theory and the need to provide two education modules: (1) a team module to raise awareness of supported asthma self-management for the whole team and (2) an individual study module for those who conduct asthma reviews with patients. The feasibility pilot highlighted content and design features in need of refinement and the pre-pilot identified substantial changes to the delivery strategy for the education modules. CONCLUSIONS: A multi-stage development process, aligned with the MRC Framework, contributed to the module design and delivery. Prior explorative work, multi-disciplinary team discussions, and professional advisory group consultation, informed the initial development, and in-practice testing and pre-pilot stages enabled refinement. In our experience, there were important benefits of working together as an educationalist/researcher team. The education programme, a core component of the implementation strategy, is now being tested in the IMP2ART UK-wide cluster randomised controlled trial.

The Importance of Self-Management in the Context of Personalized Care in COPD.

Despite current guidelines and decades of evidence on the benefits of a self-management approach, self-management of COPD remains relatively under-utilized in clinical care compared with other chronic diseases. However, self-management interventions can play a valuable role in supporting people with COPD to respond to changing symptoms, and thereby make appropriate decisions regarding the management of their own chronic condition. In this review, we discuss the history and evolution of the concept of self-management, assess current multidisciplinary support programs and clinical interactions designed to optimize self-management, and reflect on how effective these are in terms of clinical and humanistic outcomes. We also evaluate the mechanisms for encouraging change from protocol-based care towards a more personalized care approach, and discuss the role of digital self-management interventions and the importance of addressing health inequalities in COPD treatment, which have been accelerated by the COVID-19 pandemic. Reflecting on the importance of self-management in the context of symptom monitoring and provision of educational support, including information from patient organizations and charities, we discuss the ideal components of a self-management plan for COPD and provide six key recommendations for its implementation: 1) better education for healthcare professionals on disease management and consultation skills; 2) new targets and priorities for patient-focused outcomes; 3) skills gap audits to identify barriers to self-management; 4) best practice sharing within primary care networks and ongoing professional development; 5) enhanced initial consultations to establish optimal self-management from the outset; and 6) negotiation and sharing of self-management plans at the point of diagnosis.

Overcoming Therapeutic Inertia to Reduce the Risk of COPD Exacerbations: Four Action Points for Healthcare Professionals.

BACKGROUND: Therapeutic inertia, defined as failure to escalate or initiate adequate therapy when treatment goals are not met, contributes to poor management of COPD exacerbations. METHODS: A multidisciplinary panel of five expert clinicians actively managing COPD and representative of UK practice developed action points to reduce exacerbation risk, based on evidence, clinical expertise, and experience. The action points are applicable despite changing circumstances (eg, virtual clinics). The panel agreed areas where further evidence is needed. RESULTS: The four action points were (1) an experienced HCP, such as a GP or member of the multi-professional COPD team should review patients within one month of every exacerbation that requires oral steroids, antibiotics, or hospitalization to address modifiable risk factors, optimize non-pharmacological measures, and evaluate pharmacological therapy. (2) Presenting to hospital with an exacerbation defines an important window of opportunity to reduce the risk of further exacerbations. Follow-up by a GP, or member of the multi-professional specialist COPD team within one month of discharge with a full management review and appropriate escalation of pharmacological treatment is essential. (3) Healthcare professionals (HCPs) in all healthcare settings should be able to recognize COPD exacerbations, refer as appropriate and document the episode accurately in medical records across service boundaries. HCPs should support patients to recognize and report exacerbations. (4) HCPs should intervene proactively based on risk assessments, disease activity and any treatable traits at or as soon as possible after diagnosis and annually thereafter. Delivering these action points needs coordinated action with policymakers, funders, and service providers. CONCLUSION: These action points should be a fundamental part of clinical practice to determine if a change in management is necessary to reduce the risk of exacerbations. Policymakers should use these action points to develop systems and initiatives that reduce the risk of further exacerbations.

Survival after acute episodes of immune-mediated thrombotic thrombocytopenic purpura (iTTP) - cognitive functioning and health-related quality of life impact: a descriptive cross-sectional survey of adults living with iTTP in the United Kingdom.

OBJECTIVES: Immune-mediated thrombotic thrombocytopenic purpura (iTTP) is an ultra-rare life-threatening thrombotic microangiopathy affecting adults with unpredictable disease onset and acute presentation. This study aimed to describe the health-related quality of life (HRQoL), cognitive functioning and work productivity of survivors following acute episode(s) of iTTP in the United Kingdom (UK). METHODS: An online survey was developed in collaboration with the TTP Network. Descriptive statistics were calculated for the health questionnaire Short Form Survey-36 Version 2 (SF-36v2), the Hospital Anxiety and Depression Score (HADS), the PROMIS Cognitive Function Abilities Subset - Short Form 6a (PROMIS CFAS - SF6a), and the Work Productivity and Activity Index: Specific Health Problem (WPAI-SHP), along with several iTTP-specific bespoke questions. RESULTS: Fifty participants were recruited between July-November 2019. The mean (standard deviation [SD]) standardized SF-36v2 physical and mental component scores were 42.16 (9.59) and 33.61 (12.34), lower than population norms. The mean (SD) standardized PROMIS CFAS - SF6a score was 39.69 (7.86), lower than population norms. HADS mean (SD) scores of 12.18 (3.14) and 11.78 (2.36) indicated moderate levels of anxiety and depression, respectively. Of those employed (58%), approximately 42.73% of participants reported work productivity loss due to their iTTP. Participants also reported experiencing flashbacks, fatigue interference in family, social and intimate life, and fears of relapse. DISCUSSION AND CONCLUSION: Regardless of recency of the last acute episode, participant scores signified impairments in all domains. Remission from an acute episode of disease does not signify the conclusion of care, but rather the requirement for long-term healthcare particularly focused on psychological support.

Targeting human plasmacytoid dendritic cells through BDCA2 prevents skin inflammation and fibrosis in a novel xenotransplant mouse model of scleroderma.

OBJECTIVES: Plasmacytoid dendritic cells (pDC) have been implicated in the pathogenesis of autoimmune diseases, such as scleroderma (SSc). However, this has been derived from indirect evidence using ex vivo human samples or mouse pDC in vivo. We have developed human-specific pDC models to directly identify their role in inflammation and fibrosis, as well as attenuation of pDC function with BDCA2-targeting to determine its therapeutic application. METHODS: RNAseq of human pDC with TLR9 agonist ODN2216 and humanised monoclonal BDCA2 antibody, CBS004. Organotypic skin rafts consisting of fibroblasts and keratinocytes were stimulated with supernatant from TLR9-stimulated pDC and with CBS004. Human pDC were xenotransplanted into Nonobese diabetic/severe combined immunodeficiency (NOD SCID) mice treated with Aldara (inflammatory model), or bleomycin (fibrotic model) with CBS004 or human IgG control. Skin punch biopsies were used to assess gene and protein expression. RESULTS: RNAseq shows TLR9-induced activation of human pDC goes beyond type I interferon (IFN) secretion, which is functionally inactivated by BDCA2-targeting. Consistent with these findings, we show that BDCA2-targeting of pDC can completely suppress in vitro skin IFN-induced response. Most importantly, xenotransplantation of human pDC significantly increased in vivo skin IFN-induced response to TLR agonist and strongly enhanced fibrotic and immune response to bleomycin compared with controls. In these contexts, BDCA2-targeting suppressed human pDC-specific pathological responses. CONCLUSIONS: Our data indicate that human pDC play a key role in inflammation and immune-driven skin fibrosis, which can be effectively blocked by BDCA2-targeting, providing direct evidence supporting the development of attenuation of pDC function as a therapeutic application for SSc.

Management of Fracture Risk in Patients with Chronic Obstructive Pulmonary Disease (COPD): Building a UK Consensus Through Healthcare Professional and Patient Engagement.

Introduction: Osteoporosis and bone fractures are common in chronic obstructive pulmonary disease (COPD) and contribute significantly to morbidity and mortality. Current national guidance on COPD management recommends addressing bone health in patients, however, does not detail how. This consensus outlines key elements of a structured approach to managing bone health and fracture risk in patients with COPD. Methods: A systematic approach incorporating multifaceted methodologies included detailed patient and healthcare professional (HCP) surveys followed by a roundtable meeting to reach a consensus on what a pathway would look like. Results: The surveys revealed that fracture risk was not always assessed despite being recognised as an important aspect of COPD management by HCPs. The majority of the patients also stated they would be receptive to discussing treatment options if found to be at risk of osteoporotic fractures. Limited time and resource allocation were identified as barriers to addressing bone health during consultations. The consensus from the roundtable meeting was that a proactive systematic approach to assessing bone health should be adopted. This should involve using fracture risk assessment tools to identify individuals at risk, investigating secondary causes of osteoporosis if a diagnosis is made and reinforcing non-pharmacological and preventative measures such as smoking cessation, keeping active and pharmacological management of osteoporosis and medicines management of corticosteroid use. Practically, prioritising patients with important additional risk factors, such as previous fragility fractures, older age and long-term oral corticosteroid use for an assessment, was felt required. Conclusion: There is a need for integrating fracture risk assessment into the COPD pathway. Developing a systematic and holistic approach to addressing bone health is key to achieving this. In tandem, opportunities to disseminate the information and educational resources are also required.

Global Quality Standard for Identification and Management of Severe Asthma.

INTRODUCTION: Severe asthma is a debilitating, life-threatening disease associated with substantial global morbidity, mortality, and health care resource utilization. Patients may not receive guideline-directed medical care for severe asthma. Moreover, viable precision-based assessment tools and newer preventive therapies that can reduce the frequency of exacerbations and associated functional impact are underused. As a result, high rates of poorly controlled severe asthma persist, and patient health-related quality of life suffers. METHODS: In 2019, the Improve Access to Better Care Task Force of the PRECISION Steering Committee set out to develop a global template on quality standards for severe asthma care to support improved access to and delivery of quality care. This Quality Standard is grounded in the vast body of published evidence available for severe asthma care, published clinical guidelines (i.e., from the Global Initiative for Asthma in 2019 and the European Respiratory Society/American Thoracic Society in 2014), and the 2018 PRECISION-supported Charter to Improve Patient Care in Severe Asthma. RESULTS: The Quality Standard developed emphasizes four key elements aimed at optimizing clinical care and outcomes in severe asthma: (1) organization of services, (2) timely identification and referral for suspected severe asthma, (3) specialized assessment and management of severe asthma to optimize outcomes, and (4) patient-centric care and shared decision-making that is reflective of the patient's expectations, priorities, and values. Four key Quality Statements are provided, along with quality metrics and strategies for local adaptation to optimize implementation. CONCLUSION: This Global Quality Standard is intended to mobilize policymakers, health care providers, and patient advocacy groups to build consensus on the definition and expectations of quality care in severe asthma, to promote patient-centric care, to identify gaps in care and areas for improvement, and systematically implement improvement measures and outcomes and to reduce the burden of illness for patients with severe asthma.

Although only 10% of patients with asthma have severe disease, these patients use up to half of all health care resources used to treat asthma. For the patient, severe asthma is associated with substantial morbidity, increased risk of death, and poor quality of life. Effective treatments for severe asthma are available, yet access to these treatments varies for many patients around the globe, and they are not always used effectively when available. A task force of leading global asthma experts was recently assembled to develop global standards to support improved access and delivery of quality care for patients with severe asthma. The task force identified four key elements to optimize management and outcomes: (1) coordination of services, (2) timely detection and referral of patients with severe asthma, (3) use of guideline-recommended assessments and therapies, and (4) integration of patient expectations and values when making treatment decisions. This Quality Standard details each of these elements by providing supporting rationale, ways to measure improvements in each area, and strategies to implement these elements at local clinics around the world. Ultimately, this Quality Standard is intended to help policymakers, health care providers, patient advocacy groups, and other key stakeholders build consensus on the requirements for quality care in severe asthma to improve patient care while also reducing the overall global burden of severe asthma.

BTS guideline for the investigation and management of malignant pleural mesothelioma.

The full guideline for the investigation and management of malignant pleural mesothelioma is published in Thorax. The following is a summary of the recommendations and good practice points. The sections referred to in the summary refer to the full guideline.