Implementing psychological interventions delivered by respiratory professionals for people with COPD. A stakeholder interview study.

Implementing psychological interventions in healthcare services requires an understanding of the organisational context. We conducted an interview study with UK National Health Service stakeholders to understand the barriers and facilitators for implementing psychological interventions for people with chronic obstructive pulmonary disorder (COPD). We used TANDEM as an exemplar intervention; a psychological intervention recently evaluated in a randomised controlled trial. Twenty participants providing care and/or services to people with COPD were purposively sampled from NHS primary/secondary care, and commissioning organisations. Participants were recruited via professional networks and referrals. Verbatim transcripts of semi-structured interviews were analysed using thematic analysis. Four themes were identified: (1) Living with COPD and emotional distress affects engagement with physical and psychological services; (2) Resource limitations affects service provision in COPD; (3) Provision of integrated care is important for patient well-being; and (4) Healthcare communication can be an enabler or a barrier to patient engagement. People need support with physical and psychological symptoms inherent with COPD and healthcare should be provided holistically. Respiratory healthcare professionals are considered able to provide psychologically informed approaches, but resources must be available for training, staff supervision and service integration. Communication between professionals is vital for clear understanding of an intervention's aims and content, to facilitate referrals and uptake. There was widespread commitment to integrating psychological and physical care, and support of respiratory healthcare professionals' role in delivering psychological interventions but significant barriers to implementation due to concerns around resources and cost efficiency. The current study informs future intervention development and implementation

Pharmacist-led adherence support in general practice: a qualitative interview study of adults with asthma.

OBJECTIVES: The National Health Service (NHS) in England recently introduced general practice pharmacists (GPPs) to provide medication-focused support to both patients and the general practice team. This healthcare model may benefit people with asthma, who currently receive suboptimal care and demonstrate low medication adherence. This study aimed to explore the perspectives of adults with asthma on the potential for pharmacist-led adherence support delivered in general practice, with a focus on how these perspectives are formed. DESIGN AND SETTING: The study was conducted in the United Kingdom (UK) utilising a qualitative interview methodology. Participants were invited to partake in a telephone-based semistructured interview, followed by an online questionnaire for demographic details and asthma history. Qualitative data were analysed using thematic analysis. PARTICIPANTS: Participants (n=17) were adults with asthma in the UK with a prescription for an inhaled corticosteroid. Participants did not have previous experience with GPPs and were asked to provide their views on a proposed GPP-led service. RESULTS: Participant perspectives of GPPs were determined by trust in pharmacists, perceived gaps in asthma care and the perceived strain on the NHS. Trust was based on pharmacists' perceived clinical competency, established over time, and gauged through a 'benchmarking' process. GPP's fit in current asthma care was assessed based on potential role overlap with other healthcare professionals, continuity of care and medication-related support needs. Participants navigated the NHS based on a perceived hierarchy of healthcare professionals (general practitioners on top, nurses, then pharmacists), and this influenced their perspectives of GPPs. CONCLUSION: While the GPP scheme shows promise based on the perspectives of people with asthma, the identified barriers to optimal patient engagement and service implementation will need to be addressed for the service to be effective.The research was funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care North Thames at Barts Health NHS Trust

Health psychology interventions to improve adherence to maintenance therapies in asthma

© 2018 The Cochrane Collaboration. This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: Main objectives To determine the effectiveness of theory-based and non-theory based health psychology interventions for improving adherence to maintenance therapy in adults with asthma Secondary objectives To compare the effectiveness of adherence interventions which are based on theory, as defined by the Theory Coding Scheme (TCS), to interventions which are not theory-based To identify and describe, using the TSC and Theoretical Domain Framework (TDF), the different health psychology theories which have been used in interventions to improve adherence to maintenance therapy in adults with asthma To evaluate the extent to which health psychology theory has been applied to the development of adherence interventions in asthm

The TANDEM trial: protocol for the process evaluation of a randomised trial of a complex intervention for anxiety and/or depression in people living with chronic obstructive pulmonary disease (COPD)

Background: TANDEM is a randomised controlled trial of a complex healthcare intervention to improve the psychological and physical health of people living with chronic obstructive pulmonary disease (COPD) and anxiety and/or depression. Based on health psychology theory set out in a logic model, respiratory health professionals were recruited and trained to deliver a cognitive behavioural approach intervention (The TANDEM intervention) under the supervision of senior cognitive behavioural practitioners. Here, we describe the protocol for the process evaluation commissioned alongside the trial. A realist approach that includes attention to describing contexts and mechanisms has been adopted. Methods: We set up a multi-disciplinary team to develop and deliver the process evaluation. The mixed-methods design incorporates quantitative process data; monitoring of intervention fidelity; qualitative interviews with patients, carers, health professionals (facilitators) and clinical supervisors about their perspectives on acceptability of the intervention; and exploration with all stakeholders (including management/policy-makers) on future implementation. Normalisation process theory (NPT) will inform data collection and interpretation with a focus on implementation. Quantitative process data will be analysed descriptively. Qualitative interview data will be analysed before the trial outcomes are known using analytic induction and constant comparison to develop themes. Findings from the different elements will be reported separately and then integrated. Conclusion: Detailed description and analysis of study processes in a research trial such as TANDEM enables research teams to describe study contexts and mechanisms and to examine the relationship with outcomes. In this way, learning from the trial goes beyond the randomised control trial (RCT) model where effectiveness is prioritised and makes it possible to explore issues arising for post-trial study implementation. Trial registration: ISRCTN ISRCTN59537391. Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018. Process evaluation protocol version 4.0, 1 November 2020

The development of a new measure of quality of life in the management of gastro-oesophageal reflux disease: the Reflux Questionnaire.

INTRODUCTION This paper reports on the development of a new measure of health-related quality of life for use among patients with gastro-oesophageal reflux disease (GORD), funded as part of the REFLUX trial. This is a large UK multi centre trial that aims to compare the clinical and cost effectiveness of minimal access surgery with best medical treatment for patients with GORD within the NHS. Method Potential items were identified via a series of interviews and focus groups carried out with patients who were receiving/had received medical or surgical treatment for GORD. The final measure consisted of 31 items covering 7 categories (Heartburn; Acid reflux; Wind; Eating and swallowing; Bowel movements; Sleep; Work, physical and social activities). The measure produced two outputs: a quality of life score (RQLS) and five Reflux symptom scores. Reliability (internal consistency), criterion validity with the SF-36 and, sensitivity to change in terms of relationship with reported change in prescribed medication were assessed amongst a sample of 794 patients recruited into the trial. RESULTS The measure was shown to be internally consistent, to show criterion validity with the SF-36 and sensitive to changes in patients use of prescribed medication at baseline and 3 month follow-up. DISCUSSION The Reflux questionnaire is a new self-administered questionnaire for use amongst patients with GORD. Initial findings suggest that the new measure is valid, reliable, acceptable to respondents and simple to administer in both a clinical and research context

PRimary care rEsponse to domestic violence and abuse in the COvid-19 panDEmic (PRECODE): protocol of a rapid mixed-methods study in the UK

BACKGROUND: The implementation of lockdowns in the UK during the COVID-19 pandemic resulted in a system switch to remote primary care consulting at the same time as the incidence of domestic violence and abuse (DVA) increased. Lockdown-specific barriers to disclosure of DVA reduced the opportunity for DVA detection and referral. The PRECODE (PRimary care rEsponse to domestic violence and abuse in the COvid-19 panDEmic) study will comprise quantitative analysis of the impact of the pandemic on referrals from IRIS (Identification and Referral to Improve Safety) trained general practices to DVA agencies in the UK and qualitative analysis of the experiences of clinicians responding to patients affected by DVA and adaptations they have made transitioning to remote DVA training and patient support. METHODS/DESIGN: Using a rapid mixed method design, PRECODE will explore and explain the dynamics of DVA referrals and support before and during the pandemic on a national scale using qualitative data and over four years of referrals time series data. We will undertake interrupted-time series and non-linear regression analysis, including sensitivity analyses, on time series of referrals to DVA services from routinely collected data to evaluate the impact of the pandemic and associated lockdowns on referrals to the IRIS Programme, and analyse key determinants associated with changes in referrals. We will also conduct an interview- and observation-based qualitative study to understand the variation, relevance and feasibility of primary care responses to DVA before and during the pandemic and its aftermath. The triangulation of quantitative and qualitative findings using rapid analysis and synthesis will enable the articulation of multiscale trends in primary care responses to DVA and complex mechanisms by which these responses have changed during the pandemic. DISCUSSION: Our findings will inform the implementation of remote primary care and DVA service responses as services re-configure. Understanding the adaptation of clinical and service responses to DVA during the pandemic is crucial for the development of evidence-based, effective remote support and referral beyond the pandemic. TRIAL REGISTRATION: PRECODE is an observational epidemiologic study, not an intervention evaluation or trial. We will not be reporting results of an intervention on human participants

Adapting domestic abuse training to remote delivery during the COVID-19 pandemic: perspectives from general practice and support services

BACKGROUND: Identifying and responding to patients affected by domestic violence and abuse (DVA) is vital in primary care. There may have been a rise in the reporting of DVA cases during the COVID-19 pandemic and associated lockdown measures. Concurrently general practice adopted remote working that extended to training and education. IRIS (Identification and Referral to Improve Safety) is an example of an evidence-based UK healthcare training support and referral programme, focusing on DVA. IRIS transitioned to remote delivery during the pandemic. AIM: To understand the adaptations and impact of remote DVA training in IRIS-trained general practices by exploring perspectives of those delivering and receiving training. DESIGN AND SETTING: Qualitative interviews and observation of remote training of general practice teams in England were undertaken. METHOD: Semi-structured interviews were conducted with 21 participants (three practice managers, three reception and administrative staff, eight general practice clinicians, and seven specialist DVA staff), alongside observation of eight remote training sessions. Analysis was conducted using a framework approach. RESULTS: Remote DVA training in UK general practice widened access to learners. However, it may have reduced learner engagement compared with face-to-face training and may challenge safeguarding of remote learners who are domestic abuse survivors. DVA training is integral to the partnership between general practice and specialist DVA services, and reduced engagement risks weakening this partnership. CONCLUSION: The authors recommend a hybrid DVA training model for general practice, including remote information delivery alongside a structured face-to-face element. This has broader relevance for other specialist services providing training and education in primary care

Patient involvement in questionnaire design: tackling response error and burden.

Questionnaires capture patient perspectives succinctly and at relatively low cost, making them a popular data collection tool for health researchers. However, questionnaire data can be affected by response error and response burden. Patient involvement during questionnaire design can help reduce the effect of response error and burden. This paper describes a novel approach for patient involvement during questionnaire design, combining methods from cognitive interviewing (Think Aloud Tasks) with an open-ended follow-up discussion to collate and act on patient feedback, while also taking account of the common challenges in questionnaire design (i.e. response error and burden). The strengths and limitations of this approach are discussed, and recommendations are made for future use

LAP-like non-canonical autophagy and evolution of endocytic vacuoles in pancreatic acinar cells

Activation of trypsinogen (formation of trypsin) inside the pancreas is an early pathological event in the development of acute pancreatitis. In our previous studies we identified the activation of trypsinogen within endocytic vacuoles (EVs), cellular organelles that appear in pancreatic acinar cells treated with the inducers of acute pancreatitis. EVs are formed as a result of aberrant compound exocytosis and subsequent internalization of post-exocytic structures. These organelles can be up to 12 μm in diameter and can be actinated (i.e. coated with F-actin). Notably, EVs can undergo intracellular rupture and fusion with the plasma membrane, providing trypsin with access to cytoplasmic and extracellular targets. Unraveling the mechanisms involved in cellular processing of EVs is an interesting cell biological challenge with potential benefits for understanding acute pancreatitis. In this study we have investigated autophagy of EVs and discovered that it involves a non-canonical LC3-conjugation mechanism, reminiscent in its properties to LC3-associated phagocytosis (LAP); in both processes LC3 was recruited to single, outer organellar membranes. Trypsinogen activation peptide was observed in approximately 55% of LC3-coated EVs indicating the relevance of the described process to the early cellular events of acute pancreatitis. We also investigated relationships between actination and non-canonical autophagy of EVs and concluded that these processes represent sequential steps in the evolution of EVs. Our study expands the known roles of LAP and indicates that, in addition to its well-established functions in phagocytosis and macropinocytosis, LAP is also involved in the processing of post-exocytic organelles in exocrine secretory cells. Abbreviations: AP: acute pancreatitis; CCK: cholecystokinin; CLEM: correlative light and electron microscopy; DPI: diphenyleneiodonium; EV: endocytic vacuole; LAP: LC3-associate phagocytosis; MAP1LC3/LC3: microtubule-associated protein 1 light chain 3; PACs: pancreatic acinar cells; PFA: paraformaldehyde; PtdIns3K: phosphatidylinositol 3-kinase; PtdIns3P: phosphatidylinositol 3-phosphate; Res: resveratrol; TAP: trypsinogen activation peptide; TEM: transmission electron microscopy; TLC-S: taurolithocholic acid 3-sulfate; TRD: Dextran Texas Red 3000 MW Neutral; ZGs: zymogen granules