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Systematic review (protocol) of clinical effectiveness and models of care of low-resource pulmonary rehabilitation

Systematic review (protocol) of clinical effectiveness and models of care of low-resource... www.nature.com/npjpcrm PROTOCOL OPEN Systematic review (protocol) of clinical effectiveness and models of care of low-resource pulmonary rehabilitation 1,2 3 4 2,5 6 7 8 GM Monsur Habib , Roberto Rabinovich , Kalyani Divgi , Salahuddin Ahmed , Samir Kumar Saha , Sally Singh , Aftab Uddin and Hilary Pinnock More than half of the people with chronic respiratory diseases (CRDs) live in low- and middle-income countries (LMICs). The increasing disability, reduced productivity, associated anxiety and depression from CRDs result in social isolation and economic hardship for patients and their families. Pulmonary rehabilitation (PR) is a guideline-recommended multidisciplinary and multifaceted intervention that improves the physical and psychological condition of people with CRD. However, PR services are underprovided and uptake is poor in LMICs, especially in low-resourced setting. We aim to systematically assess the effectiveness, applicable components and mode of delivery of PR. We will search MEDLINE, EMBASE, CABI, AMED and CENTRAL from January 1990 using a PICOS search strategy (Population: adults with CRD (including chronic obstructive pulmonary disease, post-tuberculosis, remodelled asthma); Intervention: PR; Comparator: usual care; Outcomes: functional exercise capacity and Health-Related Quality- of-Life; Setting: low-resource settings). Two reviewers will independently screen titles/abstracts and full texts for eligibility and extract data from included papers. We will use the Cochrane Risk-of-Bias tool, rating the quality of evidence using GRADE. We will use narrative synthesis to answer our three objectives: What is the effectiveness of PR in low-resource settings? What components are used in effective studies? What models of service delivery are used? This systematic review will inform the potential impact and practical models of low-resource PR for the betterment of patients with CRDs to improve their substantial health-care burden and address poor quality of life. npj Primary Care Respiratory Medicine (2019) 29:10 ; https://doi.org/10.1038/s41533-019-0122-1 INTRODUCTION productivity, associated anxiety and depression result in social isolation and economic hardship for patients and their families. The World Health Organisation (WHO) estimates that ‘hundreds of Pulmonary rehabilitation (PR) is a guideline-recommended millions’ of people worldwide are affected by chronic respiratory multidisciplinary and multifaceted intervention that reduces the diseases (CRDs), including chronic obstructive pulmonary disease 10,11 burden of chronic respiratory symptoms for people with CRDs. (COPD) (64 million), asthma (235 million), post-tuberculosis (TB) PR is defined as a ‘comprehensive intervention based on a sequelae, bronchiectasis, occupational lung diseases and other thorough patient assessment followed by patient-tailored thera- often-underdiagnosed conditions responsible for chronic respira- 1 pies that include, but are not limited to, exercise training, tory symptoms. More than half of those affected are living in low- education and behaviour change designed to improve the and middle-income countries (LMICs), reflecting the influence of physical and psychological condition of people with CRD and to major preventable risk factors (especially tobacco smoke, poor promote the long-term adherence to health-enhancing beha- environmental air quality, endemic TB) in these countries. For 12 viours’. PR improves shortness of breath, exercise tolerance, example, the prevalence of moderate/severe COPD modelled with 13 14 muscular reconditioning and HRQoL, and reduces the number data from 12 south-east Asian countries has been estimated at 15 and duration of hospital admissions due to exacerbations. 6.3%. In contrast, a more recent study estimated a COPD Although comprehensive programmes of PR offers patient prevalence of 10.6% in LMICs globally. COPD, TB and asthma education with provision of self-management plans, psychological are all within the top 30 conditions responsible for high rates of therapies to manage anxiety and breathlessness and other disability-adjusted life-years. CRDs, particularly COPD, are asso- elements (potentially including optimisation of treatment in some 16,17 ciated with breathlessness and fatigue, which together with health-care settings), the cornerstone of PR is an individually muscle dysfunction/wasting contribute to reduced exercise tailored physical exercise programme. The physiological capacity and physical activity levels. This functional impairment changes produced by aerobic exercise in the muscle contribute is associated with reduced Health-Related Quality-of-Life (HRQoL), to reduced breathlessness and increased endurance exercise increased exacerbation rates and mortality independent of the capacity. Although most studies are conducted in well-resourced 8,9 degree of airway obstruction. The increasing disability, reduced settings, there is some evidence that less equipped ‘cheaper’ 1 2 Bangladesh Primary Care Respiratory Society, Khulna, Bangladesh; NIHR Global Health Research Unit on Respiratory Health (RESPIRE), Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Edinburgh, UK; ELEGI/Colt laboratory, Centre for Inflammation Research, QMRI, The University of Edinburgh and 4 5 Respiratory Department, Royal Infirmary Edinburgh, Edinburgh, UK; Chest Research Foundation, Pune, India; Johns Hopkins University-Bangladesh, Projahnmo, Dhaka, 6 7 Bangladesh; Dhaka Shishu Hospital, Dhaka, Bangladesh; Pulmonary and Cardiac Rehabilitation, Department of Respiratory Medicine (Acute Division), University Hospitals of Leicester NHS Trust, Leicester, UK and International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh Correspondence: Hilary Pinnock (hilary.pinnock@ed.ac.uk) Received: 11 January 2019 Accepted: 8 March 2019 Published in partnership with Primary Care Respiratory Society UK GMM. Habib et al. exercise programmes (e.g., walking with increased speed, using 3. Describe the service models employed to enable low-cost, resistant rubber bands for exercise) are feasible and may have sustainable delivery of PR (e.g., duration/frequency of similar effects to programmes delivered in well-equipped programmes, personnel, venues, equipment, remote access, centres. To be effective, exercise programmes needs to be target population, tele-rehabilitation. etc.) tailored to an individual in terms of intensity, duration, frequency of sessions, and duration of the total programme. Sustainability is challenging as stopping exercise after initial success results in METHODOLOGY loss of benefits over months. We will follow Cochrane methodology, and PRISMA reporting Although the effectiveness of PR in reducing the burden of standards to report findings. The review is registered with 13,15 CRDs is well established, PR services are underprovided even PROSPERO [ID: CRD42019125326]; any changes to the published 22–24 in high-income countries and uptake is poor in LMICs, protocol will be reported. especially in rural communities. Lack of trained health profes- sionals to conduct PR, patients’ limited confidence in the Search strategy effectiveness of PR, and the financial load on the patient and 26,27 We will develop a comprehensive search strategy using Ovid health-care system are barriers to effective programmes. interface for MEDLINE and EMBASE (Appendix 1), which will be Despite potential cost-effectiveness, lack of funds for service 29–31 adapted for searching Global Health (CABI), AMED, PubMed, and development precludes implementation in LMICs. There is no the Cochrane Database of Controlled Trials (CENTRAL). The systematic review that has rigorously evaluated the effectiveness strategy will search for ‘Pulmonary Rehabilitation’ AND ‘COPD or of a PR service for the (sometimes undifferentiated) range of CRDs other CRD’ AND ‘LMIC or low-resource settings’ from 1990 (the seen in LMICs (as opposed to just COPD ) designed and date when global COPD guidelines first recommended PR ) with implemented within the constraints of resource poor commu- a filter for randomised controlled trials (RCTs) and controlled nities. We therefore aimed to systematically search the literature clinical trials (CCTs). We will undertake forward citation on to assess the effectiveness of PR delivered in low-resource included studies, and check reference lists for relevant studies. settings, the components and the models of care used. We will search clinical trial registers for ongoing trials and search for publications of any abstracts that we identify. We do not plan OBJECTIVES to undertake hand searching unless we find a journal that regularly publishes relevant PR papers. We are interested in In the context of comprehensive PR (see Table 1 for definition) studies from LMICs and will, therefore, not impose a language delivered in low-resource settings, we will: restriction, aiming to arrange translation if the English abstract 1. Assess the impact of PR on symptoms, HRQoL, exercise 36 suggests it may be relevant. capacity, psychological well-being, rate of exacerbation or We will export all the searched literature to EndNote for de- hospitalisation, and productivity duplication, screening processes and overall data management. 2. Identify the components of PR associated with effective low- resource interventions (e.g., minimally equipped exercise Selection process programme, type of training, optimisation of cost-effective Our PICOS strategy is detailed in Table 1. In summary, we will therapy, education and self-management support, energy select papers that compare a PR intervention delivered in a low- conservation training, peer group formation etc.) resource setting for people with COPD/other CRDs with usual care. Table 1. PICOS table for the search strategy Population Adults with chronic respiratory disease (CRD), including undiagnosed conditions that cause chronic respiratory symptoms. Although most literature from high-income countries is disease specific (typically COPD) in low-resource settings we anticipate a broader range of diseases and potentially undifferentiated CRD (e.g., COPD, post TB, remodelled asthma, bronchiectasis, interstitial lung disease ) Comorbidity will not be an exclusion criterion Intervention Pulmonary rehabilitation (PR), which includes exercise training (typically aerobic, resistance, and reconditioning, though local resources and 42 16,43 preferences may include other exercise modalities, ) and at least one of the following components: patient education, breathing exercises, energy conservation training, peer group interaction, self-management skill development or other recognised PR interventions along with optimisation of pharmacotherapy Studies of cardio-pulmonary rehabilitation will be included only if data relating to patients with respiratory disease can be extracted Comparator Population who are not given PR—typically ‘usual care’ Outcomes of interest Primary outcomes will be: • Functional exercise capacity (e.g., 6-Minute Walk Test, Incremental Shuttle Walking Test, Endurance Shuttle Walking Test) • Health-Related Quality of Life (HRQoL) (e.g., St. Georges Respiratory Questionnaire (SGRQ), Chronic Respiratory Questionnaire (CRQ) Secondary outcomes will be • Symptom control: e.g., CCQ; including measures of breathlessness: e.g., MRC Dyspneoa Score, Borg scale • Psychological status, e.g., HADS, PHQ-9 • Health-care burden, e.g., exacerbation rates, hospitalisation etc. • Uptake of the service, completion rates • Adverse effects Setting Low-resource settings typically characterised by lack of funds to cover health-care costs, on individual or societal basis, which leads to one or all of the following: • Limited access to medication, equipment, supplies, devices • Less‐developed infrastructure (electrical power, transportation, controlled environment/buildings) • Fewer or less‐trained personnel • Limited access to maintenance and parts • Limited availability of equipment, supplies and medication While low-resource settings will often be in LMICs, we will specifically exclude PR delivered in a well-resourced context (e.g., a tertiary care hospital) in an LMIC, and may include interventions in high-income countries if the context is low resource (e.g., remote, deprived community) Study designs Randomised control trials (RCTs) and clinical controlled trials npj Primary Care Respiratory Medicine (2019) 10 Published in partnership with Primary Care Respiratory Society UK 1234567890():,; GMM. Habib et al. Following training, two reviewers (M.H. and S.A. or K.D.) will screen journal. In addition, we will use the researchers’ professional titles and abstracts and identify potentially eligible studies. networks and the innovative dissemination strategies of the NIHR Global Health Research Unit on Respiratory Health (RESPIRE), Disagreements will be resolved by discussion between reviewers, including social media. involving H.P. or R.R. as necessary. After the retrieval of the full-text of potentially eligible studies, two reviewers (M.H. and S.A. or K.D.) will independently screen the studies against the selection criteria CONCLUSION (see Table 1). Disagreements will be resolved by discussion with PR is an integral component of the management of people with the team (H.P., R.R., S.S. and A.U.) to determine rules for CRDs, particularly for patients with COPD. This is a major challenge operationalising the inclusion/exclusion criteria. If anything, for LMICs who bear a disproportionate burden of CRD but without remains unclear, the authors will be contacted and if this fails, the resources to develop effective PR services. There is an unmet the study will be listed as ‘potentially relevant study’. We will 34 need to implement PR in these countries with a model that is report all the processes in a PRISMA flow diagram, and tabulate effective, deliverable and sustainable in low-resource settings. excluded full-text papers with reasons for exclusion. Indeed, locally delivered low-cost PR may be more sustainable in some health-care economies than unaffordable long-term med- Outcome measurement ication. The findings of this review may inform the potential Our primary outcomes will be functional exercise capacity and impact and practical models of low-resource PR for the better- HRQoL. For details and description of secondary outcomes see ment of patients with CRDs in order to improve their substantial Table 1. health-care burden, and address poor quality of life. Data management and extraction ACKNOWLEDGEMENTS Based on the Cochrane EPOC guidance, we will develop a We acknowledge the contribution of Marshall Dozier, academic librarian of The customised data extraction form, which will be piloted to ensure University of Edinburgh in helping develop the search strategy. We also acknowledge its easy and consistent interpretation and capture of all relevant the logistic support provided by Sebastien George, Postgraduate Research information, including PICOS criteria, definitions used and out- Administrator, Usher Institute of Population Health Sciences and Informatics of The University of Edinburgh. M.H. and S.A. are supported by Ph.D studentships from the come measurements. We will collate multiple reports of the same NIHR Global Health Research Unit on Respiratory Health (RESPIRE). RESPIRE is funded study so that each study, rather than each report, is the unit of by the National Institute of Health Research using Official Development Assistance interest in the review. (ODA) funding. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Risk of bias assessment Two reviewers (M.H. and S.A. or K.D.) will independently assess the AUTHOR CONTRIBUTIONS methodological quality of all included articles according to the M.H. brought the idea of pulmonary rehabilitation in low-resource settings from his Cochrane Risk of Bias’ tool. We will assess the papers for selection, experience of providing a P.R. service in Bangladesh and H.P., R.R., S.K.S. and A.U. performance, detection, attrition, reporting and other sources of bias, supported development of the first draft to which K.D. and S.S. contributed. All and assess the overall risk of bias. A summary of the assessment will authors reviewed and approved the final paper. be recorded and tabulated with the overall judgement. ADDITIONAL INFORMATION Data analysis Supplementary information accompanies the paper on the npj Primary Care The analysis will address our three objectives as follows: Respiratory Medicine website (https://doi.org/10.1038/s41533-019-0122-1). 1. Effectiveness of PR in low-resource settings: On the basis of Competing interests: Neither the funder nor the sponsor (University of Edinburgh) our initial scoping, we anticipate that our included studies contributed to protocol development. M.H. owns a pulmonary rehabilitation clinic in will have substantial clinical, methodological and statistical Bangladesh. All other authors declare no competing interests. heterogeneity, and meta-analysis will not be appropriate. If so, we will conduct a narrative synthesis potentially using Publisher’s note: Springer Nature remains neutral with regard to jurisdictional claims graphical techniques (e.g., Harvest plots ) to illustrate the in published maps and institutional affiliations. key outcomes and their relationships. 2. Components used in effective studies: We will identify the components included in the PR service (exercise training REFERENCES and other components ). 1. World Health Organization. About Chronic Respiratory Diseases. https://www.who. 3. Models of care used in the PR interventions. We will describe int/respiratory/about_topic/en/. Accessed Nov 2018. the models of care used, including personnel and their 2. Bousquet, J., Dahl, R. & Khaltaev, N. 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Guideline-based COPD management in a resource-limited Commons license, and indicate if changes were made. The images or other third party setting-physicians’ understanding, adherence and barriers: a cross-sectional material in this article are included in the article’s Creative Commons license, unless survey of internal and family medicine hospital-based physicians in Nigeria. Prim. indicated otherwise in a credit line to the material. If material is not included in the Care. Respir. J. 22,79–85 (2013). article’s Creative Commons license and your intended use is not permitted by statutory 26. Alsubaiei, M. E. et al. Barriers for setting up a pulmonary rehabilitation program in regulation or exceeds the permitted use, you will need to obtain permission directly the Eastern Province of Saudi Arabia. Ann. Thorac. Med. 11, 121–127 (2016). from the copyright holder. To view a copy of this license, visit http://creativecommons. 27. Cox, N. S., Oliveira, C. C., Lahham, A. & Holland, A. E. Pulmonary rehabilitation org/licenses/by/4.0/. referral and participation are commonly influenced by environment, knowledge, and beliefs about consequences: a systematic review using the Theoretical © The Author(s) 2019 Domains Framework. J. Physiother. 63,84–93 (2017). npj Primary Care Respiratory Medicine (2019) 10 Published in partnership with Primary Care Respiratory Society UK http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png npj Primary Care Respiratory Medicine Springer Journals

Systematic review (protocol) of clinical effectiveness and models of care of low-resource pulmonary rehabilitation

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Medicine & Public Health; Medicine/Public Health, general; Primary Care Medicine; Internal Medicine; Pneumology/Respiratory System; Thoracic Surgery
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www.nature.com/npjpcrm PROTOCOL OPEN Systematic review (protocol) of clinical effectiveness and models of care of low-resource pulmonary rehabilitation 1,2 3 4 2,5 6 7 8 GM Monsur Habib , Roberto Rabinovich , Kalyani Divgi , Salahuddin Ahmed , Samir Kumar Saha , Sally Singh , Aftab Uddin and Hilary Pinnock More than half of the people with chronic respiratory diseases (CRDs) live in low- and middle-income countries (LMICs). The increasing disability, reduced productivity, associated anxiety and depression from CRDs result in social isolation and economic hardship for patients and their families. Pulmonary rehabilitation (PR) is a guideline-recommended multidisciplinary and multifaceted intervention that improves the physical and psychological condition of people with CRD. However, PR services are underprovided and uptake is poor in LMICs, especially in low-resourced setting. We aim to systematically assess the effectiveness, applicable components and mode of delivery of PR. We will search MEDLINE, EMBASE, CABI, AMED and CENTRAL from January 1990 using a PICOS search strategy (Population: adults with CRD (including chronic obstructive pulmonary disease, post-tuberculosis, remodelled asthma); Intervention: PR; Comparator: usual care; Outcomes: functional exercise capacity and Health-Related Quality- of-Life; Setting: low-resource settings). Two reviewers will independently screen titles/abstracts and full texts for eligibility and extract data from included papers. We will use the Cochrane Risk-of-Bias tool, rating the quality of evidence using GRADE. We will use narrative synthesis to answer our three objectives: What is the effectiveness of PR in low-resource settings? What components are used in effective studies? What models of service delivery are used? This systematic review will inform the potential impact and practical models of low-resource PR for the betterment of patients with CRDs to improve their substantial health-care burden and address poor quality of life. npj Primary Care Respiratory Medicine (2019) 29:10 ; https://doi.org/10.1038/s41533-019-0122-1 INTRODUCTION productivity, associated anxiety and depression result in social isolation and economic hardship for patients and their families. The World Health Organisation (WHO) estimates that ‘hundreds of Pulmonary rehabilitation (PR) is a guideline-recommended millions’ of people worldwide are affected by chronic respiratory multidisciplinary and multifaceted intervention that reduces the diseases (CRDs), including chronic obstructive pulmonary disease 10,11 burden of chronic respiratory symptoms for people with CRDs. (COPD) (64 million), asthma (235 million), post-tuberculosis (TB) PR is defined as a ‘comprehensive intervention based on a sequelae, bronchiectasis, occupational lung diseases and other thorough patient assessment followed by patient-tailored thera- often-underdiagnosed conditions responsible for chronic respira- 1 pies that include, but are not limited to, exercise training, tory symptoms. More than half of those affected are living in low- education and behaviour change designed to improve the and middle-income countries (LMICs), reflecting the influence of physical and psychological condition of people with CRD and to major preventable risk factors (especially tobacco smoke, poor promote the long-term adherence to health-enhancing beha- environmental air quality, endemic TB) in these countries. For 12 viours’. PR improves shortness of breath, exercise tolerance, example, the prevalence of moderate/severe COPD modelled with 13 14 muscular reconditioning and HRQoL, and reduces the number data from 12 south-east Asian countries has been estimated at 15 and duration of hospital admissions due to exacerbations. 6.3%. In contrast, a more recent study estimated a COPD Although comprehensive programmes of PR offers patient prevalence of 10.6% in LMICs globally. COPD, TB and asthma education with provision of self-management plans, psychological are all within the top 30 conditions responsible for high rates of therapies to manage anxiety and breathlessness and other disability-adjusted life-years. CRDs, particularly COPD, are asso- elements (potentially including optimisation of treatment in some 16,17 ciated with breathlessness and fatigue, which together with health-care settings), the cornerstone of PR is an individually muscle dysfunction/wasting contribute to reduced exercise tailored physical exercise programme. The physiological capacity and physical activity levels. This functional impairment changes produced by aerobic exercise in the muscle contribute is associated with reduced Health-Related Quality-of-Life (HRQoL), to reduced breathlessness and increased endurance exercise increased exacerbation rates and mortality independent of the capacity. Although most studies are conducted in well-resourced 8,9 degree of airway obstruction. The increasing disability, reduced settings, there is some evidence that less equipped ‘cheaper’ 1 2 Bangladesh Primary Care Respiratory Society, Khulna, Bangladesh; NIHR Global Health Research Unit on Respiratory Health (RESPIRE), Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Edinburgh, UK; ELEGI/Colt laboratory, Centre for Inflammation Research, QMRI, The University of Edinburgh and 4 5 Respiratory Department, Royal Infirmary Edinburgh, Edinburgh, UK; Chest Research Foundation, Pune, India; Johns Hopkins University-Bangladesh, Projahnmo, Dhaka, 6 7 Bangladesh; Dhaka Shishu Hospital, Dhaka, Bangladesh; Pulmonary and Cardiac Rehabilitation, Department of Respiratory Medicine (Acute Division), University Hospitals of Leicester NHS Trust, Leicester, UK and International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh Correspondence: Hilary Pinnock (hilary.pinnock@ed.ac.uk) Received: 11 January 2019 Accepted: 8 March 2019 Published in partnership with Primary Care Respiratory Society UK GMM. Habib et al. exercise programmes (e.g., walking with increased speed, using 3. Describe the service models employed to enable low-cost, resistant rubber bands for exercise) are feasible and may have sustainable delivery of PR (e.g., duration/frequency of similar effects to programmes delivered in well-equipped programmes, personnel, venues, equipment, remote access, centres. To be effective, exercise programmes needs to be target population, tele-rehabilitation. etc.) tailored to an individual in terms of intensity, duration, frequency of sessions, and duration of the total programme. Sustainability is challenging as stopping exercise after initial success results in METHODOLOGY loss of benefits over months. We will follow Cochrane methodology, and PRISMA reporting Although the effectiveness of PR in reducing the burden of standards to report findings. The review is registered with 13,15 CRDs is well established, PR services are underprovided even PROSPERO [ID: CRD42019125326]; any changes to the published 22–24 in high-income countries and uptake is poor in LMICs, protocol will be reported. especially in rural communities. Lack of trained health profes- sionals to conduct PR, patients’ limited confidence in the Search strategy effectiveness of PR, and the financial load on the patient and 26,27 We will develop a comprehensive search strategy using Ovid health-care system are barriers to effective programmes. interface for MEDLINE and EMBASE (Appendix 1), which will be Despite potential cost-effectiveness, lack of funds for service 29–31 adapted for searching Global Health (CABI), AMED, PubMed, and development precludes implementation in LMICs. There is no the Cochrane Database of Controlled Trials (CENTRAL). The systematic review that has rigorously evaluated the effectiveness strategy will search for ‘Pulmonary Rehabilitation’ AND ‘COPD or of a PR service for the (sometimes undifferentiated) range of CRDs other CRD’ AND ‘LMIC or low-resource settings’ from 1990 (the seen in LMICs (as opposed to just COPD ) designed and date when global COPD guidelines first recommended PR ) with implemented within the constraints of resource poor commu- a filter for randomised controlled trials (RCTs) and controlled nities. We therefore aimed to systematically search the literature clinical trials (CCTs). We will undertake forward citation on to assess the effectiveness of PR delivered in low-resource included studies, and check reference lists for relevant studies. settings, the components and the models of care used. We will search clinical trial registers for ongoing trials and search for publications of any abstracts that we identify. We do not plan OBJECTIVES to undertake hand searching unless we find a journal that regularly publishes relevant PR papers. We are interested in In the context of comprehensive PR (see Table 1 for definition) studies from LMICs and will, therefore, not impose a language delivered in low-resource settings, we will: restriction, aiming to arrange translation if the English abstract 1. Assess the impact of PR on symptoms, HRQoL, exercise 36 suggests it may be relevant. capacity, psychological well-being, rate of exacerbation or We will export all the searched literature to EndNote for de- hospitalisation, and productivity duplication, screening processes and overall data management. 2. Identify the components of PR associated with effective low- resource interventions (e.g., minimally equipped exercise Selection process programme, type of training, optimisation of cost-effective Our PICOS strategy is detailed in Table 1. In summary, we will therapy, education and self-management support, energy select papers that compare a PR intervention delivered in a low- conservation training, peer group formation etc.) resource setting for people with COPD/other CRDs with usual care. Table 1. PICOS table for the search strategy Population Adults with chronic respiratory disease (CRD), including undiagnosed conditions that cause chronic respiratory symptoms. Although most literature from high-income countries is disease specific (typically COPD) in low-resource settings we anticipate a broader range of diseases and potentially undifferentiated CRD (e.g., COPD, post TB, remodelled asthma, bronchiectasis, interstitial lung disease ) Comorbidity will not be an exclusion criterion Intervention Pulmonary rehabilitation (PR), which includes exercise training (typically aerobic, resistance, and reconditioning, though local resources and 42 16,43 preferences may include other exercise modalities, ) and at least one of the following components: patient education, breathing exercises, energy conservation training, peer group interaction, self-management skill development or other recognised PR interventions along with optimisation of pharmacotherapy Studies of cardio-pulmonary rehabilitation will be included only if data relating to patients with respiratory disease can be extracted Comparator Population who are not given PR—typically ‘usual care’ Outcomes of interest Primary outcomes will be: • Functional exercise capacity (e.g., 6-Minute Walk Test, Incremental Shuttle Walking Test, Endurance Shuttle Walking Test) • Health-Related Quality of Life (HRQoL) (e.g., St. Georges Respiratory Questionnaire (SGRQ), Chronic Respiratory Questionnaire (CRQ) Secondary outcomes will be • Symptom control: e.g., CCQ; including measures of breathlessness: e.g., MRC Dyspneoa Score, Borg scale • Psychological status, e.g., HADS, PHQ-9 • Health-care burden, e.g., exacerbation rates, hospitalisation etc. • Uptake of the service, completion rates • Adverse effects Setting Low-resource settings typically characterised by lack of funds to cover health-care costs, on individual or societal basis, which leads to one or all of the following: • Limited access to medication, equipment, supplies, devices • Less‐developed infrastructure (electrical power, transportation, controlled environment/buildings) • Fewer or less‐trained personnel • Limited access to maintenance and parts • Limited availability of equipment, supplies and medication While low-resource settings will often be in LMICs, we will specifically exclude PR delivered in a well-resourced context (e.g., a tertiary care hospital) in an LMIC, and may include interventions in high-income countries if the context is low resource (e.g., remote, deprived community) Study designs Randomised control trials (RCTs) and clinical controlled trials npj Primary Care Respiratory Medicine (2019) 10 Published in partnership with Primary Care Respiratory Society UK 1234567890():,; GMM. Habib et al. Following training, two reviewers (M.H. and S.A. or K.D.) will screen journal. In addition, we will use the researchers’ professional titles and abstracts and identify potentially eligible studies. networks and the innovative dissemination strategies of the NIHR Global Health Research Unit on Respiratory Health (RESPIRE), Disagreements will be resolved by discussion between reviewers, including social media. involving H.P. or R.R. as necessary. After the retrieval of the full-text of potentially eligible studies, two reviewers (M.H. and S.A. or K.D.) will independently screen the studies against the selection criteria CONCLUSION (see Table 1). Disagreements will be resolved by discussion with PR is an integral component of the management of people with the team (H.P., R.R., S.S. and A.U.) to determine rules for CRDs, particularly for patients with COPD. This is a major challenge operationalising the inclusion/exclusion criteria. If anything, for LMICs who bear a disproportionate burden of CRD but without remains unclear, the authors will be contacted and if this fails, the resources to develop effective PR services. There is an unmet the study will be listed as ‘potentially relevant study’. We will 34 need to implement PR in these countries with a model that is report all the processes in a PRISMA flow diagram, and tabulate effective, deliverable and sustainable in low-resource settings. excluded full-text papers with reasons for exclusion. Indeed, locally delivered low-cost PR may be more sustainable in some health-care economies than unaffordable long-term med- Outcome measurement ication. The findings of this review may inform the potential Our primary outcomes will be functional exercise capacity and impact and practical models of low-resource PR for the better- HRQoL. For details and description of secondary outcomes see ment of patients with CRDs in order to improve their substantial Table 1. health-care burden, and address poor quality of life. Data management and extraction ACKNOWLEDGEMENTS Based on the Cochrane EPOC guidance, we will develop a We acknowledge the contribution of Marshall Dozier, academic librarian of The customised data extraction form, which will be piloted to ensure University of Edinburgh in helping develop the search strategy. We also acknowledge its easy and consistent interpretation and capture of all relevant the logistic support provided by Sebastien George, Postgraduate Research information, including PICOS criteria, definitions used and out- Administrator, Usher Institute of Population Health Sciences and Informatics of The University of Edinburgh. M.H. and S.A. are supported by Ph.D studentships from the come measurements. We will collate multiple reports of the same NIHR Global Health Research Unit on Respiratory Health (RESPIRE). RESPIRE is funded study so that each study, rather than each report, is the unit of by the National Institute of Health Research using Official Development Assistance interest in the review. (ODA) funding. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Risk of bias assessment Two reviewers (M.H. and S.A. or K.D.) will independently assess the AUTHOR CONTRIBUTIONS methodological quality of all included articles according to the M.H. brought the idea of pulmonary rehabilitation in low-resource settings from his Cochrane Risk of Bias’ tool. We will assess the papers for selection, experience of providing a P.R. service in Bangladesh and H.P., R.R., S.K.S. and A.U. performance, detection, attrition, reporting and other sources of bias, supported development of the first draft to which K.D. and S.S. contributed. All and assess the overall risk of bias. A summary of the assessment will authors reviewed and approved the final paper. be recorded and tabulated with the overall judgement. ADDITIONAL INFORMATION Data analysis Supplementary information accompanies the paper on the npj Primary Care The analysis will address our three objectives as follows: Respiratory Medicine website (https://doi.org/10.1038/s41533-019-0122-1). 1. Effectiveness of PR in low-resource settings: On the basis of Competing interests: Neither the funder nor the sponsor (University of Edinburgh) our initial scoping, we anticipate that our included studies contributed to protocol development. M.H. owns a pulmonary rehabilitation clinic in will have substantial clinical, methodological and statistical Bangladesh. All other authors declare no competing interests. heterogeneity, and meta-analysis will not be appropriate. If so, we will conduct a narrative synthesis potentially using Publisher’s note: Springer Nature remains neutral with regard to jurisdictional claims graphical techniques (e.g., Harvest plots ) to illustrate the in published maps and institutional affiliations. key outcomes and their relationships. 2. Components used in effective studies: We will identify the components included in the PR service (exercise training REFERENCES and other components ). 1. World Health Organization. About Chronic Respiratory Diseases. https://www.who. 3. Models of care used in the PR interventions. We will describe int/respiratory/about_topic/en/. Accessed Nov 2018. the models of care used, including personnel and their 2. Bousquet, J., Dahl, R. & Khaltaev, N. 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Guideline-based COPD management in a resource-limited Commons license, and indicate if changes were made. The images or other third party setting-physicians’ understanding, adherence and barriers: a cross-sectional material in this article are included in the article’s Creative Commons license, unless survey of internal and family medicine hospital-based physicians in Nigeria. Prim. indicated otherwise in a credit line to the material. If material is not included in the Care. Respir. J. 22,79–85 (2013). article’s Creative Commons license and your intended use is not permitted by statutory 26. Alsubaiei, M. E. et al. Barriers for setting up a pulmonary rehabilitation program in regulation or exceeds the permitted use, you will need to obtain permission directly the Eastern Province of Saudi Arabia. Ann. Thorac. Med. 11, 121–127 (2016). from the copyright holder. To view a copy of this license, visit http://creativecommons. 27. Cox, N. S., Oliveira, C. C., Lahham, A. & Holland, A. E. Pulmonary rehabilitation org/licenses/by/4.0/. referral and participation are commonly influenced by environment, knowledge, and beliefs about consequences: a systematic review using the Theoretical © The Author(s) 2019 Domains Framework. J. Physiother. 63,84–93 (2017). npj Primary Care Respiratory Medicine (2019) 10 Published in partnership with Primary Care Respiratory Society UK

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