Development of a conceptual framework for defining trial efficiency.

BACKGROUND: Globally, there is a growing focus on efficient trials, yet numerous interpretations have emerged, suggesting a significant heterogeneity in understanding "efficiency" within the trial context. Therefore in this study, we aimed to dissect the multifaceted nature of trial efficiency by establishing a comprehensive conceptual framework for its definition. OBJECTIVES: To collate diverse perspectives regarding trial efficiency and to achieve consensus on a conceptual framework for defining trial efficiency. METHODS: From July 2022 to July 2023, we undertook a literature review to identify various terms that have been used to define trial efficiency. We then conducted a modified e-Delphi study, comprising an exploratory open round and a subsequent scoring round to refine and validate the identified items. We recruited a wide range of experts in the global trial community including trialists, funders, sponsors, journal editors and members of the public. Consensus was defined as items rated "without disagreement", measured by the inter-percentile range adjusted for symmetry through the UCLA/RAND approach. RESULTS: Seventy-eight studies were identified from a literature review, from which we extracted nine terms related to trial efficiency. We then used review findings as exemplars in the Delphi open round. Forty-nine international experts were recruited to the e-Delphi panel. Open round responses resulted in the refinement of the initial nine terms, which were consequently included in the scoring round. We obtained consensus on all nine items: 1) four constructs that collectively define trial efficiency containing scientific efficiency, operational efficiency, statistical efficiency and economic efficiency; and 2) five essential building blocks for efficient trial comprising trial design, trial process, infrastructure, superstructure, and stakeholders. CONCLUSIONS: This is the first attempt to dissect the concept of trial efficiency into theoretical constructs. Having an agreed definition will allow better trial implementation and facilitate effective communication and decision-making across stakeholders. We also identified essential building blocks that are the cornerstones of an efficient trial. In this pursuit of understanding, we are not only unravelling the complexities of trial efficiency but also laying the groundwork for evaluating the efficiency of an individual trial or a trial system in the future.

DIGIPREDICT: physiological, behavioural and environmental predictors of asthma attacks-a prospective observational study using digital markers and artificial intelligence-study protocol.

INTRODUCTION: Asthma attacks are a leading cause of morbidity and mortality but are preventable in most if detected and treated promptly. However, the changes that occur physiologically and behaviourally in the days and weeks preceding an attack are not always recognised, highlighting a potential role for technology. The aim of this study 'DIGIPREDICT' is to identify early digital markers of asthma attacks using sensors embedded in smart devices including watches and inhalers, and leverage health and environmental datasets and artificial intelligence, to develop a risk prediction model to provide an early, personalised warning of asthma attacks. METHODS AND ANALYSIS: A prospective sample of 300 people, 12 years or older, with a history of a moderate or severe asthma attack in the last 12 months will be recruited in New Zealand. Each participant will be given a smart watch (to assess physiological measures such as heart and respiratory rate), peak flow meter, smart inhaler (to assess adherence and inhalation) and a cough monitoring application to use regularly over 6 months with fortnightly questionnaires on asthma control and well-being. Data on sociodemographics, asthma control, lung function, dietary intake, medical history and technology acceptance will be collected at baseline and at 6 months. Asthma attacks will be measured by self-report and confirmed with clinical records. The collected data, along with environmental data on weather and air quality, will be analysed using machine learning to develop a risk prediction model for asthma attacks. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the New Zealand Health and Disability Ethics Committee (2023 FULL 13541). Enrolment began in August 2023. Results will be presented at local, national and international meetings, including dissemination via community groups, and submission for publication to peer-reviewed journals. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry ACTRN12623000764639; Australian New Zealand Clinical Trials Registry.

Lung-function trajectories: relevance and implementation in clinical practice.

Lung development starts in utero and continues during childhood through to adolescence, reaching its peak in early adulthood. This growth is followed by gradual decline due to physiological lung ageing. Lung-function development can be altered by several host and environmental factors during the life course. As a result, a range of lung-function trajectories exist in the population. Below average trajectories are associated with respiratory, cardiovascular, metabolic, and mental health comorbidities, as well as with premature death. This Review presents progressive research into lung-function trajectories and assists the implementation of this knowledge in clinical practice as an innovative approach to detect poor lung health early, monitor respiratory disease progression, and promote lung health. Specifically, we propose that, similar to paediatric height and weight charts used globally to monitor children's growth, lung-function charts could be used for both children and adults to monitor lung health status across the life course. To achieve this proposal, we introduce our free online Lung Function Tracker tool. Finally, we discuss challenges and opportunities for effective implementation of the trajectory concept at population level and outline an agenda for crucial research needed to support such implementation.

The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE).

INTRODUCTION: The Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies (RIMES) was developed to improve the quality of reporting of risk minimization program evaluations. In light of continued inadequacies in study reporting, and high-profile program implementation failures, we updated the RIMES Checklist to incorporate additional concepts from the Standards for Reporting of Implementation studies (StaRI). METHODS: The development of the updated checklist, the RIMES-StaRI Extension (RIMES-SE), entailed developing a study protocol and drafting an initial pool of items based on a mapping of the RIMES against the StaRI checklist. A modified e-Delphi exercise was then conducted to determine the importance and understandability of items for checklist inclusion. An expert workshop and an online commentary period for additional feedback followed. RESULTS: The RIMES-SE contains 27 items. It includes two signature features of the StaRI Checklist: 1) a dual strand of items (represented in two columns) describing the risk minimization program (the 'intervention') and the corresponding implementation strategy; and 2) applicable to an array of different research methodologies. CONCLUSIONS: The RIMES-SE Statement and Checklist extends the reporting guidelines set forth in the original RIMES Checklist via inclusion of key implementation science concepts. It is intended to improve the quality and transparency of reporting of risk minimization evaluation studies so as to advance drug safety science.

Assessing catastrophic health expenditure and impoverishment in adult asthma care: a cross-sectional study of patients attending six public health clinics in Klang District, Malaysia.

BACKGROUND: In Malaysia, asthma is a common chronic respiratory illness. Poor asthma control may increase out-of-pocket payment for asthma care, leading to financial hardships Malaysia provides Universal Health Coverage for the population with low user fees in the public health system to reduce financial hardship. We aimed to determine out-of-pocket expenditure on outpatient care for adult patients with asthma visiting government-funded public health clinics. We examined the catastrophic impact and medical impoverishment of these expenses on patients and households in Klang District, Malaysia. METHODS: This is a cross-sectional face-to-face questionnaire survey carried out in six government-funded public health clinics in Klang District, Malaysia. We collected demographic, socio-economic profile, and outpatient asthma-related out-of-pocket payments from 1003 adult patients between July 2019 and January 2020. Incidence of catastrophic health expenditure was estimated as the proportion of patients whose monthly out-of-pocket payments exceeded 10% of their monthly household income. Incidence of poverty was calculated as the proportion of patients whose monthly household income fell below the poverty line stratified for the population of the Klang District. The incidence of medical impoverishment was estimated by the change in the incidence of poverty after out-of-pocket payments were deducted from household income. Predictors of catastrophic health expenditure were determined using multivariate regression analysis. RESULTS: We found the majority (80%) of the public health clinic attendees were from low-income groups, with 41.6% of households living below the poverty line. About two-thirds of the attendees reported personal savings as the main source of health payment. The cost of transportation and complementary-alternative medicine for asthma were the main costs incurred. The incidences of catastrophic expenditure and impoverishment were 1.69% and 0.34% respectively. The only significant predictor of catastrophic health expenditure was household income. Patients in the higher income quintiles (Q2, Q3, Q4) had lower odds of catastrophic risk than the lowest quintile (Q1). Age, gender, ethnicity, and poor asthma control were not significant predictors. CONCLUSION: The public health system in Malaysia provides financial risk protection for adult patients with asthma. Although patients benefited from the heavily subsidised public health services, this study highlighted those in the lowest income quintile still experienced financial catastrophe and impoverishment, and the risk of financial catastrophe was significantly greater in this group. It is crucial to ensure health equity and protect patients of low socio-economic groups from financial hardship.

Outdoor air pollution and near-fatal/fatal asthma attacks in children: A systematic review.

BACKGROUND: Globally, observational studies have demonstrated an association between high levels of air pollution and asthma attacks in children. It remains unclear whether and to what extent exposure may be associated with increased near-fatal/fatal attacks. OBJECTIVE: To systematically review the evidence for an association between ambient outdoor air pollution and fatal and/or near-fatal asthma (NFA). METHODS: Following Cochrane methodology, we searched MEDLINE, EMBASE, Web of Science, Scopus, and Open Grey electronic databases for studies reporting the association of fatal/NFA and air pollution (particulate matter [PM], sulfur dioxide, nitrogen dioxide, black carbon and ozone [O3]) in children. NFA was defined as requiring intensive care unit (ICU) management. RESULTS: Two reviewers independently screened 1358 papers. A total of 276 studies identified asthma attacks related to air pollution, 272 did not meet inclusion criteria after full-text review. Four observational studies described fatal/NFA, of which three addressed NFA. PM2.5 (per 12.5 µg/m3 increase) and O3 (per 22 ppb increase) were associated with NFA in one study (PM2.5, relative risk: 1.26, confidence interval [CI] [1.10-1.44]), O3 (1.19 [1.01-1.40]). PM10 was associated with ICU admission in the context of thunderstorm asthma. Elemental carbon was associated equally with NFA that did not require an ICU admission (p = 0.67). Studies of fatal asthma including children did not demarcate age within the analysis. CONCLUSIONS: Ozone and PM2.5 have been associated with NFA in children but synthesis is limited by the paucity of studies and methodological heterogeneity. Poor reporting of severities of asthma attacks hinders the assessment of whether outdoor air pollution is associated with an increased number of NFA/fatal attacks in children.

Exploring the perceptions of patients with chronic respiratory diseases and their insights into pulmonary rehabilitation in Bangladesh.

Background: Chronic respiratory diseases (CRDs) require holistic management which considers patients' preferences, appropriate pharmacotherapy, pulmonary rehabilitation, and integrated care. We aimed to understand the perceptions of people with CRDs about their condition and pulmonary rehabilitation in Bangladesh. Methods: We conducted semi-structured interviews with a maximum variation sample of people with CRDs who had participated in a feasibility study of pulmonary rehabilitation in 2021/2022. A multidisciplinary team transcribed the interviews verbatim and analysed them in Bengali using a grounded theory approach. Results: We interviewed 15 participants with chronic obstructive pulmonary disease, asthma, or post-tuberculosis. The analysis revealed three themes. The first encompassed understanding CRDs: Patients characterised their condition by the symptoms (e.g. 'Hapani' meaning 'breathlessness') rather than describing a disease entity. Some believed occupation, previous infection, or family history to be a cause. The second theme included perceptions of pulmonary rehabilitation: Exercise was counterintuitive, as it exacerbated the breathlessness symptom that defined their disease. Views varied, though many acknowledged the benefits after a few sessions. Even with home-based programmes, participants described practical barriers to finding time for the sessions and adopted strategies to overcome the challenges. The third theme focused on implementation: Participants highlighted the need for raising awareness of CRDs and the potential of pulmonary rehabilitation in the community, adapting to the local context, and establishing an accessible resourced service. Conclusions: Understanding how patients and their communities perceive their condition and the barriers (both conceptual and logistical) to acceptance is the first step to embedding this highly effective intervention into routine health care services in Bangladesh with potential benefits for the increasing number of people living with CRDs in low- and middle-income countries.

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.

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.

Clinician views on how clinical decision support systems can help diagnose asthma in primary care: a qualitative study.

OBJECTIVE: Asthma can be difficult to diagnose in primary care. Clinical decision support systems (CDSS) can assist clinicians when making diagnostic decisions, but the perspectives of intended users need to be incorporated into the software if the CDSS is to be clinically useful. Therefore, we aimed to understand health professional views on the value of an asthma diagnosis CDSS and the barriers and facilitators for use in UK primary care. METHODS: We recruited doctors and nurses working in UK primary care who had experience of assessing respiratory symptoms and diagnosing asthma. Qualitative interviews were used to explore clinicians' experiences of making a diagnosis of asthma and understand views on a CDSS to support asthma diagnosis. Interviews were audio-recorded, transcribed verbatim and analyzed thematically. RESULTS: 16 clinicians (nine doctors, seven nurses) including 13 participants with over 10 years experience, contributed interviews. Participants saw the potential for a CDSS to support asthma diagnosis in primary care by structuring consultations, identifying relevant information from health records, and having visuals to communicate findings to patients. Being evidence based, regularly updated, integrated with software, quick and easy to use were considered important for a CDSS to be successfully implemented. Experienced clinicians were unsure a CDSS would help their routine practice, particularly in straightforward diagnostic scenarios, but thought a CDSS would be useful for trainees or less experienced colleagues. CONCLUSIONS: To be adopted into clinical practice, clinicians were clear that a CDSS must be validated, integrated with existing software, and quick and easy to use.

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.

Near-fatal and fatal asthma and air pollution: are we missing an opportunity to ask key questions?

There is an increasing body of evidence supporting the link between asthma attacks and air pollution in children. To our knowledge, there has only been one reported case of a fatal asthma attack in a child associated with air pollution and this was in the UK. This article considers why there is a lack of evidence on fatal/near-fatal asthma and air pollution. We also explore three challenges. First, fatal and near-fatal asthma events are rare and not yet well understood. Second, measuring and interpreting personal exposure to air pollution with sufficient temporal and spatial detail are challenging to interpret in the context of individual fatal or near-fatal asthma attacks. Third, current studies are not designed to answer the question of whether or to what extent air pollution is associated with fatal/near-fatal asthma attacks in children. Conclusive evidence is not yet available and systems of data collection for both air pollution and fatal and near-fatal asthma attacks should be enhanced to ensure risk can be determined and impact minimised.

Deriving and validating an asthma diagnosis prediction model for children and young people in primary care.

Introduction: Accurately diagnosing asthma can be challenging. We aimed to derive and validate a prediction model to support primary care clinicians assess the probability of an asthma diagnosis in children and young people. Methods: The derivation dataset was created from the Avon Longitudinal Study of Parents and Children (ALSPAC) linked to electronic health records. Participants with at least three inhaled corticosteroid prescriptions in 12-months and a coded asthma diagnosis were designated as having asthma. Demographics, symptoms, past medical/family history, exposures, investigations, and prescriptions were considered as candidate predictors. Potential candidate predictors were included if data were available in ≥60% of participants. Multiple imputation was used to handle remaining missing data. The prediction model was derived using logistic regression. Internal validation was completed using bootstrap re-sampling. External validation was conducted using health records from the Optimum Patient Care Research Database (OPCRD). Results: Predictors included in the final model were wheeze, cough, breathlessness, hay-fever, eczema, food allergy, social class, maternal asthma, childhood exposure to cigarette smoke, prescription of a short acting beta agonist and the past recording of lung function/reversibility testing. In the derivation dataset, which comprised 11,972 participants aged <25 years (49% female, 8% asthma), model performance as indicated by the C-statistic and calibration slope was 0.86, 95% confidence interval (CI) 0.85-0.87 and 1.00, 95% CI 0.95-1.05 respectively. In the external validation dataset, which included 2,670 participants aged <25 years (50% female, 10% asthma), the C-statistic was 0.85, 95% CI 0.83-0.88, and calibration slope 1.22, 95% CI 1.09-1.35. Conclusions: We derived and validated a prediction model for clinicians to calculate the probability of asthma diagnosis for a child or young person up to 25 years of age presenting to primary care. Following further evaluation of clinical effectiveness, the prediction model could be implemented as a decision support software.

Use of routine healthcare data in randomised implementation trials: a methodological mixed-methods systematic review.

BACKGROUND: Routine data are increasingly used in randomised controlled trials evaluating healthcare interventions. They can aid participant identification, outcome assessment, and intervention delivery. Randomised implementation trials evaluate the effect of implementation strategies on implementation outcomes. Implementation strategies, such as reminders, are used to increase the uptake of evidence-based interventions into practice, while implementation outcomes, such as adoption, are key measures of the implementation process. The use of routine data in effectiveness trials has been explored; however, there are no reviews on implementation trials. We therefore aimed to describe how routine data have been used in randomised implementation trials and the design characteristics of these trials. METHODS: We searched MEDLINE (Ovid) and Cochrane Central Register of Controlled Trials from Jan 2000 to Dec 2021 and manually searched protocols from trial registers. We included implementation trials and type II and type III hybrid effectiveness-implementation trials conducted using routine data. We extracted quantitative and qualitative data and narratively synthesised findings. RESULTS: From 4206 titles, we included 80 trials, of which 22.5% targeted implementation of evidence-based clinical guidelines. Multicomponent implementation strategies were more commonly evaluated (70.0%) than single strategies. Most trials assessed adoption as the primary outcome (65.0%). The majority of trials extracted data from electronic health records (EHRs) (62.5%), and 91.3% used routine data for outcome ascertainment. Reported reasons for using routine data were increasing efficiency, assessing outcomes, reducing research burden, improving quality of care, identifying study samples, confirming findings, and assessing representativeness. Data quality, the EHR system, research governance, and external factors such as government policy could act either as facilitators or barriers. CONCLUSIONS: Adherence to guidance on designing and reporting implementation studies, and specifically to harmonise the language used in describing implementation strategies and implementation outcomes, would aid identification of studies and data extraction. Routine healthcare data are widely used for participant identification, outcome assessment and intervention delivery. Researchers should familiarise themselves with the barriers and facilitators to using routine data, and efforts could be made to improve data quality to overcome some of the barriers. REGISTRATION: PROSPERO CRD42022292321.

Developing a home-based pulmonary rehabilitation programme for patients with chronic respiratory diseases in Malaysia: A mixed-method feasibility study.

Background: The COVID-19 pandemic has underscored the importance of remote healthcare and home-based interventions, including pulmonary rehabilitation, for patients with chronic respiratory diseases (CRDs). It has also heightened the vulnerability of individuals with underlying respiratory conditions to severe illness from COVID-19, necessitating exploration and assessment of the feasibility of delivering home - pulmonary rehabilitation (home-PR) programmes for CRD management in Malaysia and other countries. Home-based programmes offer a safer alternative to in-person rehabilitation during outbreaks like COVID-19 and can serve as a valuable resource for patients who may be hesitant to visit healthcare facilities during such times. We aimed to assess the feasibility of delivering a home-PR programme for patients with CRDs in Malaysia. Methods: We recruited patients with CRDs from two hospitals in Klang Valley, Malaysia to a home-PR programme. Following centre-based assessment, patients performed the exercises at home (five sessions/week for eight weeks (total 40 sessions)). We monitored the patients via weekly telephone calls and asked about adherence to the programme. We measured functional exercise capacity (6-Minutes Walking Test (6MWT) and Health-Related Quality-of-Life (HRQoL) (COPD Assessment Test (CAT)) at baseline and post-PR at nine weeks. We conducted semi-structured interviews with 12 purposively sampled participants to explore views and feedback on the home-PR programme. The interviews were audio recorded, transcribed verbatim, and analysed thematically. Results: We included 30 participants; two withdrew due to hospitalisation. Although 28 (93%) adhered to the full programme, only 11 (37%) attended the post-PR assessment because COVID-19 movement restrictions in Malaysia at that time prevented attendance at the centre. Four themes emerged from the qualitative analysis: involvement of family and caregivers, barriers to home-PR programme, interactions with peers and health care professionals, and programme enhancement. Conclusion: Despite the COVID-19 pandemic, the home-PR programme proved feasible for remote delivery, although centre-based post-PR assessments were not possible. Family involvement played an important role in the home-PR programme. The delivery of this programme can be further improved to maximise the benefit for patients.

A self-management app to improve asthma control in adults with limited health literacy: a mixed-method feasibility study.

BACKGROUND: Digital technology tailored for those with limited health literacy has the potential to reduce health inequalities. Although mobile apps can support self-management in chronic diseases, there is little evidence that this approach applies to people with limited health literacy. We aimed to determine the acceptability of a self-management app in adults living with asthma and have limited health literacy and the feasibility of delivering the intervention and assessing outcomes. METHODS: We recruited eligible adults from the Klang Asthma Cohort registry in primary care for a 3-month mixed-method study plus a 2-month extended observation. We collected baseline data on socio-demography, health literacy and asthma control level. The outcomes of the intervention were assessed at 1- and 3-month: i) adoption (app download and usage), ii) adherence (app usage), iii) retention (app usage in the observation period), iv) health outcomes (e.g., severe asthma attacks) and v) process outcomes (e.g., ownership and use of action plans). At 1-month, participants were purposively sampled for in-depth interviews, which were audio-recorded, transcribed verbatim, and analysed deductively. RESULTS: We recruited 48 participants; 35 participants (23 Female; median age = 43 years; median HLS score = 28) completed the 3 months study. Of these, 14 participants (10 Female; median age = 48 years; median HLS score = 28) provided interviews. Thirty-seven (77%) participants adopted the app (downloaded and used it in the first month of the study). The main factor reported as influencing adoption was the ease of using the app. A total of 950 app usage were captured during the 3-month feasibility study. App usage increased gradually, peaking at month 2 (355 total log-ins) accounting for 78% of users. In month 5, 51.4% of the participants used the app at least once. The main factors influencing continued use included adherence features (e.g., prompts and reminders), familiarity with app function and support from family members. CONCLUSIONS: An asthma self-management app intervention was acceptable for adults with limited health literacy and it was feasible to collect the desired outcomes at different time points during the study. A future trial is warranted to estimate the clinical and cost-effectiveness of the intervention and to explore implementation strategies.

Psychological impact of the COVID-19 pandemic on people with asthma: a co-produced mixed-methods study.

OBJECTIVE: When COVID-19 was declared a pandemic there was concern that people living with asthma were at high-risk of poor outcomes. We aimed to explore the psychological impact of living with asthma in the United Kingdom during the pandemic. METHODS AND MEASURES: Our mixed methods study, co-designed with patient and public involvement colleagues, included an online survey to detect anxiety/depression/post-traumatic stress disorder (PTSD) and health beliefs; and qualitative interviews. We recruited 849 participants for the survey and interviewed 26 between May and June 2020. Audio-recorded interviews were transcribed verbatim, and analysed thematically. RESULTS: The survey identified that 77% of respondents were experiencing symptoms of anxiety, 77% were experiencing symptoms of depression, and PTSD was of concern for 61%. Two-thirds of respondents felt the pandemic had changed how they managed their asthma (n = 568, 66.9%), and over half felt that they had not been given adequate health information about COVID-19 (n = 495, 58.3%). Qualitative interviews identified five themes (1) health communication, (2) interaction with healthcare, (3) COVID-19-related concerns, (4) impact on mental health, and (5) behaviour change. CONCLUSION: Psychological distress was prevalent in people with asthma during the early stage of the pandemic. Understanding this may be useful to inform future healthcare/policy planning.