Engaging stakeholders to level up COPD care in LMICs: lessons learned from the "Breathe Well" programme in Brazil, China, Georgia, and North Macedonia.

BACKGROUND: Effective stakeholder engagement in health research is increasingly being recognised and promoted as an important pathway to closing the gap between knowledge production and its use in health systems. However, little is known about its process and impacts, particularly in low-and middle-income countries. This opinion piece draws on the stakeholder engagement experiences from a global health research programme on Chronic Obstructive Pulmonary Disease (COPD) led by clinician researchers in Brazil, China, Georgia and North Macedonia, and presents the process, outcomes and lessons learned. MAIN BODY: Each country team was supported with an overarching engagement protocol and mentored to develop a tailored plan. Patient involvement in research was previously limited in all countries, requiring intensive efforts through personal communication, meetings, advisory groups and social media. Accredited training programmes were effective incentives for participation from healthcare providers; and aligning research findings with competing policy priorities enabled interest and dialogue with decision-makers. The COVID-19 pandemic severely limited possibilities for planned engagement, although remote methods were used where possible. Planned and persistent engagement contributed to shared knowledge and commitment to change, including raised patient and public awareness about COPD, improved skills and practice of healthcare providers, increased interest and support from clinical leaders, and dialogue for integrating COPD services into national policy and practice. CONCLUSION: Stakeholder engagement enabled relevant local actors to produce and utilise knowledge for small wins such as improving day-to-day practice and for long-term goals of equitable access to COPD care. For it to be successful and sustained, stakeholder engagement needs to be valued and integrated throughout the research and knowledge generation process, complete with dedicated resources, contextualised and flexible planning, and commitment.

Randomised controlled trial testing effectiveness of feedback about lung age or exhaled CO combined with very brief advice for smoking cessation compared to very brief advice alone in North Macedonia: findings from the Breathe Well group.

INTRODUCTION: In 2019, smoking prevalence in North Macedonia was one of the world's highest at around 46% in adults. However, access to smoking cessation treatment is limited and no co-ordinated smoking cessation programmes are provided in primary care. METHODS: We conducted a three parallel-armed randomised controlled trial (n = 1368) to investigate effectiveness and cost-effectiveness of lung age (LA) or exhaled carbon monoxide (CO) feedback combined with very brief advice (VBA) to prompt smoking cessation compared with VBA alone, delivered by GPs in primary care in North Macedonia. All participants who decided to attempt to quit smoking were advised about accessing smoking cessation medications and were also offered behavioural support as part of the "ACT" component of VBA. Participants were aged ≥ 35 years, smoked ≥ 10 cigarettes per day, were recruited from 31 GP practices regardless of motivation to quit and were randomised (1:1:1) using a sequence generated before the start of recruitment. The primary outcome was biochemically validated 7-day point prevalence abstinence at 4 weeks (wks). Participants and GPs were not blinded to allocation after randomisation, however outcome assessors were blind to treatment allocation. RESULTS: There was no evidence of a difference in biochemically confirmed quitting between intervention and control at 4wks (VBA + LA RR 0.90 (97.5%CI: 0.35, 2.27); VBA + CO RR 1.04 (97.5%CI: 0.44, 2.44)), however the absolute number of quitters was small (VBA + LA 1.6%, VBA + CO 1.8%, VBA 1.8%). A similar lack of effect was observed at 12 and 26wks, apart from in the VBA + LA arm where the point estimate was significant but the confidence intervals were very wide. In both treatment arms, a larger proportion reported a reduction in cigarettes smoked per day at 4wks (VBA + LA 1.30 (1.10, 1.54); VBA + CO 1.23 (1.03, 1.49)) compared with VBA. The point estimates indicated a similar direction of effect at 12wks and 26wks, but differences were not statistically significant. Quantitative process measures indicated high fidelity to the intervention delivery protocols, but low uptake of behavioural and pharmacological support. VBA was the dominant intervention in the health economic analyses. CONCLUSION: Overall, there was no evidence that adding LA or CO to VBA increased quit rates. However, a small effect cannot be ruled out as the proportion quitting was low and therefore estimates were imprecise. There was some evidence that participants in the intervention arms were more likely to reduce the amount smoked, at least in the short term. More research is needed to find effective ways to support quitting in settings like North Macedonia where a strong smoking culture persists. TRIAL REGISTRATION: The trial was registered at http://www.isrctn.com (ISRCTN54228638) on the 07/09/2018.

BREATHLEssness in INDIA (BREATHE-INDIA)-Study protocol for the co-design of a community breathlessness intervention in India using realist methods and intervention mapping.

BACKGROUND: Breathlessness that persists despite treatment of causal disease(s) is disabling, associated with high therapy-related costs and poor socioeconomic outcomes. Low resource countries bear a disproportionate burden of respiratory problems, often characterised by disabling breathlessness. Low-cost self-management breathlessness-targeted interventions are effective and deliverable in community settings but have been developed in high-income countries. We aim to understand how breathlessness self-management works in 'real life' populations and cultural contexts, to develop programme theory and co-design a prototype intervention to improve persistent breathlessness management in India. METHODS AND ANALYSIS: Using a Realist approach, Intervention Mapping and the Medical Research Council Complex Intervention Framework we will undertake two phases of work supported by our Expert Group (of respiratory, primary, palliative care physicians) and key stakeholder groups (opinion leader clinicians, community health workers and people with lived experiences of breathlessness). 1) Realist review and evaluation to identify and refine evidence and theory for breathlessness self-management, producing intervention and implementation programme theory. We will identify literature through our Expert Group, scoping searches and systematic searches (Medline, Ebscohost, CINAHL, Scopus, Psychinfo). We will map intervention components to 'what works, for whom, and where.' 2) Intervention development using Intervention Mapping to map intervention and implementation programme theory to intervention components, develop materials to support intervention delivery, and co-design a prototype educational intervention ready for early acceptability and delivery-feasibility testing and evaluation planning in India. Use of stakeholder groups is to allow people with experience of breathlessness and/or its management to contribute their views on content developed by our team based upon review of secondary data sources. Experts and Stakeholders are therefore not research subjects but are included as extended members of the study team and will not follow informed consent procedures. Experts and stakeholders will be acknowledge in outputs arising from our project if they wish to be. Our review conduct will be consistent with RAMESES quality standards. DISCUSSION: At the conclusion of our study, we will have co-designed a breathlessness intervention for use in the community setting in India ready for further evaluation of: effectiveness, socioeconomic outcomes, acceptability and transferability to other low resource settings.

Remote consultations in primary care across low-, middle- and high-income countries: Implications for policy and care delivery.

The COVID-19 pandemic mandated a substantial switch in primary health care delivery from an in-person to a mainly remote telephone or video service. As the COVID-19 pandemic approaches its third year, limited progress appears to have been made in terms of policy development around consultation methods for the post-acute phase of the pandemic. In September 2020, the International Primary Care Respiratory Group convened a global panel of primary care clinicians - including family physicians, paediatricians, pharmacists, academics and patients - to consider the policy and health management implications of the move to remote consultations in the primary care setting. The group gave special consideration to how and how far remote consultations should be integrated into routine primary health care delivery. Remote consultations can be a useful alternative to in-person consultations in primary care not only in situations where there is a need for viral infection control but also for the routine delivery of chronic disease management. However, they may not be more time efficient for the clinician, and they can add to the workload and work-related stress for primary care practitioners if they remain the dominant consultation mode. Remote consultations are also less appropriate than in-person consultations for new disease diagnosis, dealing with multiple issues and providing complex care. Ensuring health care professionals have the appropriate skill set to effectively deliver remote consultations, administrative and/or IT support and appropriate reimbursement will be key to achieving optimal integration of remote consultations into routine clinical practice. Addressing digital access and digital literacy issues at a societal level will also be essential to ensure individuals have fair and equitable access to the internet and sufficient security for exchange of personal and health-related data.

Prioritising the respiratory research needs of primary care: the International Primary Care Respiratory Group (IPCRG) e-Delphi exercise.

BACKGROUND: Community-based care, underpinned by relevant primary care research, is an important component of the global fight against non-communicable diseases. The International Primary Care Research Group's (IPCRG's) Research Needs Statement identified 145 research questions within five domains (asthma, rhinitis, chronic obstructive pulmonary disease (COPD), smoking, respiratory infections). AIMS: To use an e-mail Delphi process to prioritise the research questions. METHODS: An international panel of primary care clinicians scored the clinical importance, feasibility, and international relevance of each question on a scale of 1-5 (5 = most important). In subsequent rounds, informed by the Group's median scores, participants scored overall priority. Consensus was defined as 80% agreement for priority scores 4 or 5. RESULTS: Twenty-three experts from 21 countries completed all three rounds. Sixty-two questions were prioritised across the five domains. A recurring theme was for 'simple tools' (e.g. questionnaires) enabling diagnosis and assessment in community settings, often with limited access to investigations. Seven questions recorded 100% agreement: these involved pragmatic approaches to the diagnosis of COPD and rhinitis, assessment of asthma and respiratory infections, management of rhinitis, and implementing asthma self-management. CONCLUSIONS: Evidence to underpin the primary care approach to diagnosis and assessment and broad management strategies were overarching priorities. If primary care is to contribute to the global challenge of managing respiratory non-communicable diseases, policymakers, funders, and researchers need to prioritise these questions.

Prioritising primary care respiratory research needs: results from the 2020 International Primary Care Respiratory Group (IPCRG) global e-Delphi exercise.

Respiratory diseases remain a significant cause of global morbidity and mortality and primary care plays a central role in their prevention, diagnosis and management. An e-Delphi process was employed to identify and prioritise the current respiratory research needs of primary care health professionals worldwide. One hundred and twelve community-based physicians, nurses and other healthcare professionals from 27 high-, middle- and low-income countries suggested 608 initial research questions, reduced after evidence review by 27 academic experts to 176 questions covering diagnosis, management, monitoring, self-management and prognosis of asthma, COPD and other respiratory conditions (including infections, lung cancer, tobacco control, sleep apnoea). Forty-nine questions reached 80% consensus for importance. Cross-cutting themes identified were: a need for more effective training of primary care clinicians; evidence and guidelines specifically relevant to primary care, adaption for local and low-resource settings; empowerment of patients to improve self-management; and the role of the multidisciplinary healthcare team.

Managing asthma in primary healthcare.

Asthma brings considerable challenges for family doctors because of its variety of shapes, different levels of severity, a wide age range, and the fact that in the last decades clinicians are able to offer much better treatment options with a better level of disease control and a higher quality of life. The objectives of the current review article are to provide an up-to-date review by primary care respiratory leaders from different countries of the most significant challenges regarding asthma diagnosis and management, the importance of team work and the problems in recognizing and dealing with difficult-to-manage and severe asthma in primary care. The article provides a short review of the main challenges faced by family physicians and other primary health care professionals in supporting their patients in the management of asthma, such as asthma diagnosis, promoting access to spirometry, the importance of a multiprofessional team for the management of asthma, how to organize an asthma review, the promotion of patient autonomy and shared decision-making, improving the use of inhalers, the importance of the personalized asthma action plan, dealing with difficult-to-manage and severe asthma in primary care and choosing when, where and how to refer patients with severe asthma. The article also discusses the development of an integrated approach to asthma care in the community and the promotion of Asthma Right Care.

Strategies for the prevention, diagnosis and treatment of COPD in low- and middle- income countries: the importance of primary care.

INTRODUCTION: Low- and middle-income countries (LMICs) bear a high proportion of the global morbidity and mortality caused by COPD. Increased exposure to risk factors throughout life (e.g. malnutrition, indoor and outdoor air pollution, and smoking) is associated with higher COPD prevalence in LMICs and the lack of treatment availability increases avoidable harm. AREAS COVERED: This review covers the epidemiology and burden of COPD in LMICs, and challenges and recommendations related to health-care systems, prevention, diagnosis, and treatment. Main challenges are related to under-resourced health-care systems (such as limited availability of spirometry, rehabilitation, and medicines). Lack of policy and practical local guidelines on COPD diagnosis and management further contribute to the low diagnostic and treatment rates. In the absence of, or limited number of respiratory specialists, primary care practitioners (general practitioners, nurses, pharmacists, physiotherapists, and community health workers) play an even more pivotal role in COPD management in LMICs. EXPERT OPINION: Raising awareness on COPD, educating health-care workers, patients, and communities on cost-effective preventive measures as well as improving availability, affordability and proper use of diagnostic and pharmacological and non-pharmacologic treatment in primary care are the key interventions needed to improve COPD prevention, diagnosis, and care in LMICs.

Challenges in the Implementation of Chronic Obstructive Pulmonary Disease Guidelines in Low- and Middle-Income Countries: An Official American Thoracic Society Workshop Report.

There is a substantial burden of chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD), in low- and middle-income countries (LMICs). LMICs have particular challenges in delivering cost-effective prevention, diagnosis, and management of COPD. Optimal care can be supported by effective implementation of guidelines. This American Thoracic Society workshop considered challenges to implementation of COPD guidelines in LMICs. We make 10 specific recommendations: 1) relevant organizations should provide LMIC-specific COPD management guidance; 2) patient and professional organizations must persuade policy-makers of the importance of lung function testing programs in LMICs; 3) healthcare education and training should emphasize the early-life origins of COPD; 4) urgent action is required by governments to reduce airborne exposures, including exposures to tobacco smoke and indoor and outdoor air pollution; 5) guidance for COPD in LMICs should explicitly link across Essential Medicine Lists and the World Health Organization package of essential noncommunicable disease interventions for primary health care in low-resource settings and should consider availability, affordability, sustainability, and cost-effective use of medicines; 6) the pharmaceutical industry should work to make effective COPD and tobacco-dependence medicines globally accessible and affordable; 7) implementation of locally adapted, cost-effective pulmonary rehabilitation programs should be an international priority; 8) the World Health Organization Global Action Plan for the Prevention and Control of Noncommunicable Diseases should specify how improvements in respiratory health will be achieved; 9) research funders should increase the proportion of funding allocated to COPD in LMICs; and 10) the respiratory community should leverage the skills and enthusiasm of earlier-career clinicians and researchers to improve global respiratory health.

The International Primary Care Respiratory Group (IPCRG) Research Needs Statement 2010.

AIM: Respiratory diseases are a public health issue throughout the world, with high prevalence and morbidity. This Research Needs Statement from the International Primary Care Respiratory Group (IPCRG) aims to highlight unanswered questions on the management of respiratory diseases that are of importance to practising primary care clinicians. METHODS: An informal but inclusive consultation process was instigated in 2009. Draft statements in asthma, rhinitis, COPD, tobacco dependence, and respiratory infections were circulated widely to IPCRG members, other recognised experts, and representatives from a range of economic and healthcare backgrounds. An iterative process was used to generate, prioritise and refine research questions in each section. RESULTS: Two overarching themes emerged. Firstly, there is a real need for research to be undertaken within primary care, which recruits patients representative of primary care populations, evaluates interventions realistically delivered within primary care, and draws conclusions that will be meaningful to professionals working within primary care. Secondly, international and national guidelines exist, but there is little evidence on the best strategies for implementing recommendations. Disease-specific research questions focus on effective and cost-effective ways to prevent disease, confirm the diagnosis, assess control, manage treatment, and empower selfmanagement. Practical questions about how to deliver this comprehensive agenda in diverse primary care settings are highlighted. CONCLUSIONS: We hope that this Research Needs Statement will be used by clinicians and patients campaigning for answers to relevant questions, by researchers seeking funding to provide answers to these questions, and by funding bodies to enable them to prioritise research agendas.

Can an online exercise prescription tool improve adherence to home exercise programmes in children with cerebral palsy and other neurodevelopmental disabilities? A randomised controlled trial.

OBJECTIVE: Determine the adherence to and effectiveness of an 8-week home exercise programme for children with disabilities delivered using Physitrack, an online exercise prescription tool, compared with traditional paper-based methods. DESIGN: Single-blinded, parallel-groups, randomised controlled trial (RCT). SETTING: Intervention took place in participants' homes in Western Australia. PARTICIPANTS: Children aged 6 to 17 years, with neurodevelopmental disabilities including cerebral palsy (CP), receiving community therapy services. INTERVENTION: All participants completed an individualised home exercise programme, which was delivered to the intervention group using Physitrack and conventional paper-based methods for the control group. PRIMARY OUTCOME MEASURES: Adherence to exercise programme, goal achievement and exercise performance. SECONDARY OUTCOME MEASURES: Enjoyment, confidence and usability of Physitrack. RESULTS: Fifty-four participants with CP (n=37) or other neurodevelopmental disabilities (n=17) were recruited. Fifty-three were randomised after one early withdrawal. Forty-six completed the 8-week programme, with 24 in the intervention group and 22 in the control group. There was no difference between the two groups for percentage of exercises completed (intervention (n=22): 62.8% (SD 27.7), control (n=22): 55.8% (SD 19.4), between group mean difference -7.0% (95% CI: -21.6 to 7.5, p=0.34)). Both groups showed significant improvement in their self-rated performance of individualised goal activities, however there was no statistically significant difference between groups for goal achievement, quality of exercise performance, enjoyment, confidence or preferred method of delivery. There were no adverse events. CONCLUSION: Physitrack provides a therapist with a new means of providing an exercise programme with online tools such as exercise videos, but our preliminary findings indicate that it may be no better than a traditional paper-based method for improving exercise adherence or the other outcomes measured. Exercise programmes remain an intervention supported by evidence, but a larger RCT is required to fully evaluate online delivery methods. TRIAL REGISTRATION DETAILS: Australian New Zealand Clinical Trials Registry; ACTRN12616000743460.

A worldwide charter for all children with asthma.

Childhood asthma is a huge global health burden. The spectrum of disease, diagnosis, and management vary depending on where children live in the world and how their community can care for them. Global improvement in diagnosis and management has been unsatisfactory, despite ever more evidence-based guidelines. Guidelines alone are insufficient and need supplementing by government support, changes in policy, access to diagnosis and effective therapy for all children, with research to improve implementation. We propose a worldwide charter for all children with asthma, a roadmap to better education and training which can be adapted for local use. It includes access to effective basic asthma medications. It is not about new expensive medications and biologics as much can be achieved without these. If implemented carefully, the overall cost of care is likely to fall and the global future health and life chance of children with asthma will greatly improve. The key to success will be community involvement together with the local and national development of asthma champions. We call on governments, institutions, and healthcare services to support its implementation.

Spirometry in primary care case-identification, diagnosis and management of COPD.

Chronic obstructive pulmonary disease (COPD) is an important cause of morbidity and mortality worldwide, yet it remains significantly under-diagnosed. Systematic and opportunistic case-identification efforts in primary care, using questionnaires, careful assessment to identify symptoms, and follow-up spirometry, might improve diagnosis rates and enable earlier detection and management of COPD. The aims of spirometry performed for case-identification purposes are to exclude those patients with symptoms but normal lung function and identify those who require more complete investigation for COPD, including 'diagnostic standard' spirometry. Among patients with a confirmed diagnosis of COPD, spirometry monitoring is useful in identifying those with rapid deterioration in lung function who require further assessment. Spirometry in primary care can also support patient education and may encourage smoking cessation and treatment adherence.

Competency domains in an undergraduate Objective Structured Clinical Examination: their impact on compensatory standard setting.

CONTEXT: Following a 15-week attachment in paediatrics and child health, general practice and dermatology medical students in their second clinical year at this medical school undertake a high-stakes assessment including an objective structured clinical examination (OSCE). There were 2 hypotheses. Firstly, groups of similar stations map to competency domains identifiable by factor analysis. Secondly, poor performance in individual domains is compensated for by achieving the required standard of performance across the whole assessment. METHODS: A total of 647 medical students were assessed by an OSCE during 5 individual examination sittings (diets) over 2 years. Ten scoring stations in the OSCE were analysed and confirmatory factor analysis performed comparing a 1-factor model (where all the stations are discrete entities related to one underlying domain) with a 3-factor model (where the stations load onto 3 domains from a previously reported exploratory factor analysis). RESULTS: The 3-factor model yielded a significantly better fit to the data (chi(2 )=( )15.3, P < 0.01). Assessing the compensation data of 1 diet, 29 of 127 students failed in 1 or more domains described, whereas only 5 failed if compensation was allowed across all domains. DISCUSSION: Confirmatory factor analysis showed a significant fit of the data to previously described competency domains for a high-stakes undergraduate OSCE. Compensation within but not between competency domains would provide a more robust standard, improve validity, and substantially reduce the pass rate.

Transfer of care - a randomised control trial investigating the effect of sending the details of patients' discharge medication to their community pharmacist on discharge from hospital.

OBJECTIVE: There is substantial evidence demonstrating that transferring patients between care providers is a high-risk area for medicines management. This study aimed to investigate the effect of sending patients' hospital discharge letters to their nominated community pharmacists on the number of discrepancies between the patient's general practitioner (GP) records and the discharge letter and between the patient's self-described medication regime and the discharge letter. METHODS: In a randomised, controlled trial, 33 participants in two groups, control and intervention, had their discharge letter sent to either their GP only or their GP and nominated community pharmacy after hospital discharge. At least 3 weeks after hospital discharge, the participant's current GP's medication record and their self-described medication regime was obtained. Discrepancies between their GP medication record and their discharge letter and between the participant's self-described medication regime and their discharge letter were counted. The number of discrepancies (relative to the number of drugs prescribed) in the intervention group was compared with the control group for each of the above two categories, using the chi-squared test to determine the statistical significance of any differences between the two groups. RESULTS: The intervention group had statistically fewer discrepancies than the control group for both data sets: GP records compared with the discharge letters (P < 0.0005); participants' self-described medication regimes compared with the discharge letters (P < 0.00005). CONCLUSIONS: Sending a copy of patients' discharge letters to their community pharmacists could be beneficial in reducing post-discharge prescribing discrepancies and improving patient understanding of the changes made to their medicines.

National guidelines for smoking cessation in primary care: a literature review and evidence analysis.

National guidelines for smoking cessation in primary care can be effective in improving clinical practice. This study assessed which parties are involved in the development of such guidelines worldwide, which national guidelines address primary care, what recommendations are made for primary care settings, and how these recommendations correlate with each other and with current evidence. We identified national guidelines using an online resource. Only the most recent version of a guideline was included. If an English version was not available, we requested a translation or summary of the recommendations from the authors. Two researchers independently extracted data on funding sources, development methodologies, involved parties, and recommendations made within the guidelines. These recommendations were categorised using the pile-sort method. Each recommendation was cross-checked with the latest evidence and was awarded an evidence-rating. We identified 43 guidelines from 39 countries and after exclusion, we analysed 26 guidelines (22 targeting general population, 4 targeted subpopulations). Twelve categories of recommendations for primary care were identified. There was almost universal agreement regarding the need to identify smokers, advice them to quit and offer behavioural and pharmacological quit smoking support. Discrepancies were greatest for specific recommendations regarding behavioural and pharmacological support, which are likely to be due to different interpretations of evidence and/or differences in contextual health environments. Based on these findings, we developed a universal checklist of guideline recommendations as a practice tool for primary care professionals and future guideline developers. SMOKING CESSATION SUPPORT IN PRIMARY CARE: UNIVERSAL GUIDELINES SOUGHT: An international team call for a universal guideline for primary-care practitioners who help patients to stop smoking. Although many nations have such guidelines, no studies have examined whether these guidelines are consistent with the current evidence. Marjolein Verbiest at the National Institute for Health Innovation, The University of Auckland, New Zealand, and co-workers of the International Primary Care Respiratory Group and the National Centre for Smoking Cessation and Training reviewed, evaluated and compared 26 national guidelines. Almost all guidelines place importance on identifying smokers, advising them to quit and providing behavioural and medication-based support. However, there were discrepancies in the support offered, which could be due to different interpretations of evidence, costs of medication and cultural differences. The authors offer a checklist for primary care that can inform future universal guidelines suitable for primary care.