We thank Professors Azuma and Raghu for their excellent suggestions and comments on our paper. Our study demonstrates the importance of pulmonary vascular resistance (PVR) as a prognostic factor in the initial evaluation of patients with interstitial lung disease (ILD) and highlights the greater significance of PVR over mPAP in right heart catheterisation (RHC) (1). We acknowledge that there is generally less emphasis on PVR compared to the more commonly discussed mean pulmonary arterial pressure (mPAP), and it was our intention to address this discrepancy with our study.
It is important to clarify that we do not recommend systematic RHC at initial evaluation of ILD. Historically, our approach was to perform RHC more frequently at diagnosis, but in recent years, we have limited this to cases where pulmonary hypertension (PH) is suspected. We recently reported a system for predicting mPAP > 20mmHg using a Pa/Ao ratio ≥ 0.9, PaO2 < 80 Torr, and DLco percent predicted < 50% in patients with idiopathic pulmonary fibrosis (IPF) (2). We propose using this system to screen patients before undergoing RHC, with assessments of both mPAP and PVR.
As Azuma and colleagues pointed out, exercise tolerance tests, including the 6-minute walk test (6MWT), might help in predicting PH. As patients with PH have significantly worse desaturation and walking distance in the 6MWT, those who show significant desaturation and/or reduced walking distance during 6MWT are likely to...
We thank Professors Azuma and Raghu for their excellent suggestions and comments on our paper. Our study demonstrates the importance of pulmonary vascular resistance (PVR) as a prognostic factor in the initial evaluation of patients with interstitial lung disease (ILD) and highlights the greater significance of PVR over mPAP in right heart catheterisation (RHC) (1). We acknowledge that there is generally less emphasis on PVR compared to the more commonly discussed mean pulmonary arterial pressure (mPAP), and it was our intention to address this discrepancy with our study.
It is important to clarify that we do not recommend systematic RHC at initial evaluation of ILD. Historically, our approach was to perform RHC more frequently at diagnosis, but in recent years, we have limited this to cases where pulmonary hypertension (PH) is suspected. We recently reported a system for predicting mPAP > 20mmHg using a Pa/Ao ratio ≥ 0.9, PaO2 < 80 Torr, and DLco percent predicted < 50% in patients with idiopathic pulmonary fibrosis (IPF) (2). We propose using this system to screen patients before undergoing RHC, with assessments of both mPAP and PVR.
As Azuma and colleagues pointed out, exercise tolerance tests, including the 6-minute walk test (6MWT), might help in predicting PH. As patients with PH have significantly worse desaturation and walking distance in the 6MWT, those who show significant desaturation and/or reduced walking distance during 6MWT are likely to have PH. We agree that there is a need for the development of non-invasive tests that can detect PH and elevated PVR in an earlier stage.
1. Thorax. 2024 Apr 15;79(5):422-429.
2. Furukawa T, et al. Eur Respir J. 2018 Jan 18;51(1):1701311.
" We congratulate Sato et al to have undertaken the retrospective stud(y that surfaces clinical significance of pulmonary vascular resistance (PVR) as a predictor of mortality in patients with newly diagnosed ILD with normal mean MAP – i.e., < 30mmhg at rest ( 1) .
While their obsrervation is interesting , are the authors advocating right heart catheterization(RHC) for patients with new onset ILD upfront at the time of initial evaluation undergoing diagnostic interventions for diagnosis of ILD ?
Indeed, RHC is an invasive procedure, and the potential benefits and risks must be weighed in considering RHC for patients with new onset ILD for prognostication and consideration of possible therapeutic interventions. Are the authors recommending RHC for patients with new onset ILD without clues for pulmonary hypertension ?
Do the authors have additional non invasive clinical variables/data that correlate with PVR > 2 wood units with mean PAP < 20 mmHg- such as decreased DLCO corrected for hemoglobin, oxygen desaturation with walking, extent of interstitial lung abnormalities , specific diagnosis in patients with new onset ILD that can be used to screen patients to undergo RHC ?
Perhaps, a noninvasive method using an exercise test as was used in assessing patient's endurance of exercise in patients with IPF treated with pirfenidone for IPF(2) might be a screening test prior to considering RHC as a routine for patients with new ons...
" We congratulate Sato et al to have undertaken the retrospective stud(y that surfaces clinical significance of pulmonary vascular resistance (PVR) as a predictor of mortality in patients with newly diagnosed ILD with normal mean MAP – i.e., < 30mmhg at rest ( 1) .
While their obsrervation is interesting , are the authors advocating right heart catheterization(RHC) for patients with new onset ILD upfront at the time of initial evaluation undergoing diagnostic interventions for diagnosis of ILD ?
Indeed, RHC is an invasive procedure, and the potential benefits and risks must be weighed in considering RHC for patients with new onset ILD for prognostication and consideration of possible therapeutic interventions. Are the authors recommending RHC for patients with new onset ILD without clues for pulmonary hypertension ?
Do the authors have additional non invasive clinical variables/data that correlate with PVR > 2 wood units with mean PAP < 20 mmHg- such as decreased DLCO corrected for hemoglobin, oxygen desaturation with walking, extent of interstitial lung abnormalities , specific diagnosis in patients with new onset ILD that can be used to screen patients to undergo RHC ?
Perhaps, a noninvasive method using an exercise test as was used in assessing patient's endurance of exercise in patients with IPF treated with pirfenidone for IPF(2) might be a screening test prior to considering RHC as a routine for patients with new onset ILD " .
1. Sato T, et al Thorax 2024
2. Azuma A, et al AJRCCM 2005
Dear editor,
I read with interest the state-of-the-art review article by Shah et al1. on the effects of non-invasive ventilation (NIV) on sleep in chronic hypercapnic respiratory failure. However, I wish to delve deeper into the topic of Continuous Positive Airway Pressure (CPAP) especially in patients with Chronic Obstructive Pulmonary Disease-Obstructive Sleep Apnea (COPD-OSA) overlap syndrome and obesity hypoventilation syndrome (OHS).
COPD-OSA overlap syndrome was first described by Professor Flenley2, which is associated with an increased frequency and severity of COPD exacerbations3, hospitalizations3, and mortality4. Current data indicates that CPAP improves these outcomes5.
Similarly, in OHS, OSA is highly prevalent, affecting an estimated 90% of patients with OHS6. CPAP has been demonstrated to offer similar benefits to NIV6 7 and is recommended as the initial treatment for stable OHS patients8. CPAP therapy enhances outcomes by improving ventilation, reducing air-trapping, enhancing diaphragmatic function, improving hypercapnic response, and decreasing CO2 production resulting from excessive respiratory muscle work9. Given its advantages and cost-effectiveness compared to NIV, CPAP devices should be considered the initial treatment option7 for both disease before NIV.
Reference
1. Shah NM, Steier J, Hart N, Kaltsakas G. Effects of non-invasive ventilation on sleep in chronic hypercapnic respiratory failure. Thorax 2023 doi: 10.1136...
Dear editor,
I read with interest the state-of-the-art review article by Shah et al1. on the effects of non-invasive ventilation (NIV) on sleep in chronic hypercapnic respiratory failure. However, I wish to delve deeper into the topic of Continuous Positive Airway Pressure (CPAP) especially in patients with Chronic Obstructive Pulmonary Disease-Obstructive Sleep Apnea (COPD-OSA) overlap syndrome and obesity hypoventilation syndrome (OHS).
COPD-OSA overlap syndrome was first described by Professor Flenley2, which is associated with an increased frequency and severity of COPD exacerbations3, hospitalizations3, and mortality4. Current data indicates that CPAP improves these outcomes5.
Similarly, in OHS, OSA is highly prevalent, affecting an estimated 90% of patients with OHS6. CPAP has been demonstrated to offer similar benefits to NIV6 7 and is recommended as the initial treatment for stable OHS patients8. CPAP therapy enhances outcomes by improving ventilation, reducing air-trapping, enhancing diaphragmatic function, improving hypercapnic response, and decreasing CO2 production resulting from excessive respiratory muscle work9. Given its advantages and cost-effectiveness compared to NIV, CPAP devices should be considered the initial treatment option7 for both disease before NIV.
Reference
1. Shah NM, Steier J, Hart N, Kaltsakas G. Effects of non-invasive ventilation on sleep in chronic hypercapnic respiratory failure. Thorax 2023 doi: 10.1136/thorax-2023-220035 [published Online First: 20231118]
2. Flenley DC. Sleep in chronic obstructive lung disease. Clin Chest Med 1985;6(4):651-61.
3. Brennan M, McDonnell MJ, Walsh SM, et al. Review of the prevalence, pathogenesis and management of OSA-COPD overlap. Sleep Breath 2022;26(4):1551-60. doi: 10.1007/s11325-021-02540-8 [published Online First: 20220116]
4. Marin JM, Soriano JB, Carrizo SJ, et al. Outcomes in patients with chronic obstructive pulmonary disease and obstructive sleep apnea: the overlap syndrome. Am J Respir Crit Care Med 2010;182(3):325-31. doi: 10.1164/rccm.200912-1869OC [published Online First: 20100408]
5. Srivali N, Thongprayoon C, Tangpanithandee S, et al. The use of continuous positive airway pressure in COPD-OSA overlap syndrome: A systematic review. Sleep Med 2023;108:55-60. doi: 10.1016/j.sleep.2023.05.025 [published Online First: 20230608]
6. Masa JF, Corral J, Alonso ML, et al. Efficacy of Different Treatment Alternatives for Obesity Hypoventilation Syndrome. Pickwick Study. Am J Respir Crit Care Med 2015;192(1):86-95. doi: 10.1164/rccm.201410-1900OC
7. Masa JF, Mokhlesi B, Benitez I, et al. Cost-effectiveness of positive airway pressure modalities in obesity hypoventilation syndrome with severe obstructive sleep apnoea. Thorax 2020;75(6):459-67. doi: 10.1136/thoraxjnl-2019-213622 [published Online First: 20200326]
8. Mokhlesi B, Masa JF, Brozek JL, et al. Evaluation and Management of Obesity Hypoventilation Syndrome. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med 2019;200(3):e6-e24. doi: 10.1164/rccm.201905-1071ST
9. McNicholas WT. COPD-OSA Overlap Syndrome: Evolving Evidence Regarding Epidemiology, Clinical Consequences, and Management. Chest 2017;152(6):1318-26. doi: 10.1016/j.chest.2017.04.160 [published Online First: 20170423]
Thank you to the authors for the excellent and very interesting work published.
I would like to ask about the protocol routine follow-up of patients following an acute pulmonary embolus mentioned in the paper: what did this entail, and how did it differ from the protocol implemented as part of the trial?
Secondly, how did the authors select a follow-up telephone at 2 years post acute pulmonary embolus? As is pointed out in the limitations of section of the paper, this could have missed patients with clinically significant CTEPH who did not survive those 2 years. Would an earlier symptom assessment have led to a greater incidence of false positive echocardiograms showing pulmonary hypertension, or would it lead to patients being missed as not enough time would have passed to allow CTEPH to establish?
If a core outcome set (COS) to a global burden of disease is to be globally relevant and applicable, methodological efforts to ensure equal representation of low- and middle-income countries (LMICs) and high-income countries (HICs) at all stages of its development are needed (1, 2). This is due to the differences in disease patterns, healthcare resources, culture, and biomedical beliefs, which may influence outcome priorities (3, 4). A case in point is a study by Van Rijssen et al (5), where participants from Europe, the USA, and Asia did not reach the same consensus on the final patient-reported COS for pancreatic cancer, and Asian participants did not reach a consensus on any outcomes included in the final set.
We read with interest your COS for pulmonary rehabilitation (PR) of patients with COPD in the 2023 September issue of Thorax "(6). We noticed the under-representation of LMICs, especially in Asia and Africa, in your development of the COS. Of the 29 and 27 countries where you recruited participants in the first and second rounds of your Delphi survey, respectively, Asia was represented by only one participant from India, whilst no participant was recruited from Africa. Most participants were from HICs in Europe including the Netherlands, Portugal, United Kingdom, Australia, and Spain.
This underrepresentation of LMICs is noteworthy given that, firstly, the burden of chronic respiratory diseases (including COPD) is greater in LMICs, both in terms...
If a core outcome set (COS) to a global burden of disease is to be globally relevant and applicable, methodological efforts to ensure equal representation of low- and middle-income countries (LMICs) and high-income countries (HICs) at all stages of its development are needed (1, 2). This is due to the differences in disease patterns, healthcare resources, culture, and biomedical beliefs, which may influence outcome priorities (3, 4). A case in point is a study by Van Rijssen et al (5), where participants from Europe, the USA, and Asia did not reach the same consensus on the final patient-reported COS for pancreatic cancer, and Asian participants did not reach a consensus on any outcomes included in the final set.
We read with interest your COS for pulmonary rehabilitation (PR) of patients with COPD in the 2023 September issue of Thorax "(6). We noticed the under-representation of LMICs, especially in Asia and Africa, in your development of the COS. Of the 29 and 27 countries where you recruited participants in the first and second rounds of your Delphi survey, respectively, Asia was represented by only one participant from India, whilst no participant was recruited from Africa. Most participants were from HICs in Europe including the Netherlands, Portugal, United Kingdom, Australia, and Spain.
This underrepresentation of LMICs is noteworthy given that, firstly, the burden of chronic respiratory diseases (including COPD) is greater in LMICs, both in terms of mortality (90%) and disability-adjusted life years (7). Secondly, the unmet needs for PR (such as unavailability of expertise, equipment, access, awareness, low uptake, and lack of training) are more profound in LMICs (8-11). Thirdly, the lack of participation from Africa does not reflect the growing body of PR literature on the continent (12, 13). Fourthly, choosing appropriate outcomes to measure is a topic most important to researchers in LMICs (14). Given these facts, there is a need for greater involvement of LMICS in the development of COS.
You acknowledged the underrepresentation of LMICs in your paper but did not acknowledge limitations in your participant recruitment methods that might have resulted in such underrepresentation. The lack of representation from Africa is of concern to us as Africa-based PR researchers/practitioners. The use of a more rigorous and appropriate methodology in qualitative research has the potential to increase the community’s confidence in COS (15). Your COS was partly informed by two qualitative studies (16, 17) but most of their participants (people with COPD and healthcare professionals) were from HICs in Europe, Pacific/Oceania, and North America. Again, no participant was recruited from Africa despite the existence of PR evidence in the continent as shown in your own systematic review (18) and ours (12, 13).
To explore barriers and enablers to PR in LMICs, Bickton et al interviewed PR professionals from these countries (10). To identify potential participants from these countries, they reviewed papers included in two systematic reviews on PR in LMICs and sent invitation/recruitment emails to their corresponding authors. You should have used a similar purposive sampling approach to ensure participation from Africa. You would then use the PR professionals from Africa identified this way to locally interview (19) patients with spirometry-confirmed COPD and/or their caregivers in their native languages where necessary, for English translation later. Another example is the RECHARGE project, which used consensus meetings between PR researchers from the UK and four LMICs to establish a COS for PR in LMICs (20). Their limitation was not following rigorous methods (21), but they demonstrated the feasibility of HIC–LMIC research partnerships in developing a COS for PR. Finally, on respiratory health matters, Africa is continentally represented by the Pan-African Thoracic Society (PATS; https://panafricanthoracic.org/). Recently, PATS inaugurated its PR Working Group to further give a voice and platform for African PR professionals to promote PR in Africa. Of the 21 societies/associations that you contacted to recruit participants; PATS was not one of them.
Underrepresentation of LMICs in COS development studies has been previously acknowledged (2, 4, 22-24). If we are to attain good health and wellbeing for all (SDG 3) and move towards global health, it is time that COS development researchers start addressing the underrepresentation of LMICs. This is in line with a Core Outcome Measures in Effectiveness Trials (COMET) recommendation (25).
References
1. Davies PA, Davies AK, Kirkham JJ, Young AE. Secondary analysis of data from a core outcome set for burns demonstrated the need for involvement of lower income countries. J Clin Epidemiol. 2022;144:56-71.
2. Davis K, Gorst SL, Harman N, Smith V, Gargon E, Altman DG, et al. Choosing important health outcomes for comparative effectiveness research: An updated systematic review and involvement of low and middle income countries. PLoS One. 2018;13(2):e0190695.
3. Jan RB, Rusham Zahra R, Jamie JK, Louise R, Gina A, Corrado B, et al. Development of a core outcome set for multimorbidity trials in low/middle-income countries (COSMOS): study protocol. BMJ Open. 2022;12(2):e051810.
4. Lee A, Davies A, Young AE. Systematic review of international Delphi surveys for core outcome set development: representation of international patients. BMJ Open. 2020;10(11):e040223.
5. van Rijssen LB, Gerritsen A, Henselmans I, Sprangers MA, Jacobs M, Bassi C, et al. Core Set of Patient-reported Outcomes in Pancreatic Cancer (COPRAC): An International Delphi Study Among Patients and Health Care Providers. Annals of Surgery. 2019;270(1).
6. Souto-Miranda S, Saraiva I, Spruit MA, Marques A. Core outcome set for pulmonary rehabilitation of patients with COPD: results of a modified Delphi survey. Thorax. 2023.
7. Global burden of chronic respiratory diseases and risk factors, 1990-2019: an update from the Global Burden of Disease Study 2019. EClinicalMedicine. 2023;59:101936.
8. Gimigliano F, Negrini S. The World Health Organization "Rehabilitation 2030: a call for action". Eur J Phys Rehabil Med. 2017;53(2):155-68.
9. Singh SJ, Halpin DMG, Salvi S, Kirenga BJ, Mortimer K. Exercise and pulmonary rehabilitation for people with chronic lung disease in LMICs: challenges and opportunities. Lancet Respir Med. 2019;7(12):1002-4.
10. Bickton FM, Shannon H. Barriers and Enablers to Pulmonary Rehabilitation in Low- and Middle-Income Countries: A Qualitative Study of Healthcare Professionals. Int J Chron Obstruct Pulmon Dis. 2022;17:141-53.
11. Bilungula A-MM, Orme MW, Bickton FM, Kirenga B, Rylance J, Pina I, et al. Distinguishing pulmonary rehabilitation from chest physiotherapy in the African context. Journal of the Pan African Thoracic Society.4.
12. Bickton FM, Fombe C, Chisati E, Rylance J. Evidence for pulmonary rehabilitation in chronic respiratory diseases in sub-Saharan Africa: a systematic review. The International Journal of Tuberculosis and Lung Disease. 2020;24(10):991-9.
13. Bilungula AM, Katoto P, Gosselink R, Kayembe JN, Langer D. Pulmonary rehabilitation in Africa: where are we? a multimethod study. Pan Afr Med J. 2022;42:78.
14. Rosala-Hallas A, Bhangu A, Blazeby J, Bowman L, Clarke M, Lang T, et al. Global health trials methodological research agenda: results from a priority setting exercise. Trials. 2018;19(1):48.
15. Keeley T, Williamson P, Callery P, Jones LL, Mathers J, Jones J, et al. The use of qualitative methods to inform Delphi surveys in core outcome set development. Trials. 2016;17(1):230.
16. Souto-Miranda S, Marques A. Triangulated perspectives on outcomes of pulmonary rehabilitation in patients with COPD: a qualitative study to inform a core outcome set. Clin Rehabil. 2019;33(4):805-14.
17. Souto-Miranda S, Vaes AW, Gloeckl R, Grongstad A, Spruit MA, Marques A. International perspectives on outcome measurement in pulmonary rehabilitation of people with COPD: A qualitative study. Respir Med. 2022;201:106936.
18. Souto-Miranda S, Rodrigues G, Spruit MA, Marques A. Pulmonary rehabilitation outcomes in individuals with chronic obstructive pulmonary disease: A systematic review. Ann Phys Rehabil Med. 2022;65(3):101564.
19. Babaji HU, Sulaiman SK, Shittu A, Abubakar Y, Mohammed J. Pulmonary rehabilitation implementation in Northwest Nigeria: A qualitative study of the views of respiratory health-care professionals. Journal of the Pan African Thoracic Society.3.
20. Orme MW, Free RC, Manise A, Jones AV, Akylbekov A, Barton A, et al. Global RECHARGE: Establishing a standard international data set for pulmonary rehabilitation in low- and middle-income countries. J Glob Health. 2020;10(2):020316.
21. Kirkham JJ, Davis K, Altman DG, Blazeby JM, Clarke M, Tunis S, et al. Core Outcome Set-STAndards for Development: The COS-STAD recommendations. PLOS Medicine. 2017;14(11):e1002447.
22. Jamlick K, Sarah LG, David G, Elizabeth G, Bridget Y, Paula RW. Inclusion of participants from low-income and middle-income countries in core outcome sets development: a systematic review. BMJ Open. 2021;11(10):e049981.
23. Susan MS, Emma W, Chris S, Maxime S, Elizabeth B, Martin F. A Core Outcome Set for Multimorbidity Research (COSmm). The Annals of Family Medicine. 2018;16(2):132.
24. Deshmukh SR, Kirkham JJ, Karantana A. Developing a core outcome set for hand fractures and joint injuries in adults. Bone Jt Open. 2023;4(2):87-95.
25. Williamson PR, Altman DG, Bagley H, Barnes KL, Blazeby JM, Brookes ST, et al. The COMET Handbook: version 1.0. Trials. 2017;18(3):280.
We thank Bickton and colleagues for their interest in reading our article and their commentary.
We recognize the need to have a balanced representation of low- and middle-income countries (LMICs) in core outcome sets (COS), specifically in pulmonary rehabilitation (PR) as resources for measurement instruments may vary globally and the burden of COPD and need for pulmonary rehabilitation in these regions are undeniable.
According to the World Bank categories (1), we have included some middle-income countries in our study, from south America (Argentina, Brazil, Colombia, Cuba) and from Asia (not only India, but also the Philippines). Nonetheless, as acknowledged in our COS paper (2), the African and Asian continents were underrepresented.
Although not stated throughout our paper, with the a priori knowledge of the need to include these continents and LMICs, we took some methodological steps to try to ensure their representation. Indeed, we have contacted several professional and patient associations from these regions to help us recruit participants. The Pan African Thoracic Society was contacted directly. Nonetheless, the procedure to contact is a form on a website (https://panafricanthoracic.org/about-us/contact-us), with no other form of contact provided. No response was ever obtained. We congratulate the newly formed PR Working Group, and we look forward to enhancing our communication chan...
We thank Bickton and colleagues for their interest in reading our article and their commentary.
We recognize the need to have a balanced representation of low- and middle-income countries (LMICs) in core outcome sets (COS), specifically in pulmonary rehabilitation (PR) as resources for measurement instruments may vary globally and the burden of COPD and need for pulmonary rehabilitation in these regions are undeniable.
According to the World Bank categories (1), we have included some middle-income countries in our study, from south America (Argentina, Brazil, Colombia, Cuba) and from Asia (not only India, but also the Philippines). Nonetheless, as acknowledged in our COS paper (2), the African and Asian continents were underrepresented.
Although not stated throughout our paper, with the a priori knowledge of the need to include these continents and LMICs, we took some methodological steps to try to ensure their representation. Indeed, we have contacted several professional and patient associations from these regions to help us recruit participants. The Pan African Thoracic Society was contacted directly. Nonetheless, the procedure to contact is a form on a website (https://panafricanthoracic.org/about-us/contact-us), with no other form of contact provided. No response was ever obtained. We congratulate the newly formed PR Working Group, and we look forward to enhancing our communication channels to work more closely with them.
We also contacted the Asian Pacific Society of Respirology (APSR), the Philippine College of Chest Physicians, Alpha-1 Israel, Alpha-1 South Africa, and the Global Allergy and Airways Patient Platform. However, to our knowledge, the only institutions disseminating our project were the Philippine College of Chest Physicians, Alpha-1 South Africa and the Global Allergy and Airways Patient Platform.
Furthermore, we had the two main societies of the field disseminating our study within their working groups, the European Respiratory Society and the American Thoracic Society, which are not exclusive to members of Europe or North America. It would also be beneficial for researchers from LMICs to engage, if not already, with these two societies to increase their representativeness in PR assemblies and studies.
Lastly, to increase the outreach, our study was disseminated on social media, specifically Twitter, which was a great resource for recruitment of participants, especially from North and South America. Hence, we encourage African and Asian researchers, healthcare professionals and PR working groups to connect with internationally known societies and researchers on this platform, as they commonly disseminate studies.
We appreciate the suggestion of including in our recruitment strategy the identification of participants from LMICs in PR papers, which we will follow in the future.
We were not aware of other initiatives aiming to develop a COS for PR such as the RECHARGE project, as this project has not been registered in the COMET initiative database (https://www.comet-initiative.org/Studies), which informs researchers of planned, ongoing, or finished COS. Ours was registered in 2017 and since then only another initiative for post-tuberculosis lung disease has been registered (3). Indeed, if we had previous knowledge, it would have been of great interest for us to collaborate with you. Having different COS, and therefore possible divergent recommendations on outcome measurement within the same intervention and disease, will only perpetuate the heterogeneity in outcome measurement in PR (4).
A stronger engagement of LMICs is imperative in international studies, and communication from both ends (LMICs – HICs) needs to improve. A global PR network is much needed where researchers worldwide can connect and unite efforts into more representative PR studies.
References
1. Bank W. World Bank Country and Lending Groups 2023 [Available from: https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-b....
2. Sara S-M, Isabel S, Martijn AS, et al. Core outcome set for pulmonary rehabilitation of patients with COPD: results of a modified Delphi survey. Thorax 2023:thorax-2023-220522. doi: 10.1136/thorax-2023-220522
3. Migliori GB, Marx FM, Ambrosino N, et al. Clinical standards for the assessment, management and rehabilitation of post-TB lung disease. The International Journal of Tuberculosis and Lung Disease 2021;25(10):797-813. doi: 10.5588/ijtld.21.0425
4. Souto-Miranda S, Rodrigues G, Spruit MA, et al. Pulmonary rehabilitation outcomes in individuals with chronic obstructive pulmonary disease: A systematic review. Ann Phys Rehabil Med 2022;65(3):101564. doi: 10.1016/j.rehab.2021.101564 [published Online First: 20211115]
The systematic review and meta-analysis by Abdullah ALQarni et al. on the effect of positional vibrotactile therapy for positional obstructive sleep apnoea shows that this treatment modality is effective, reducing time in the supine position, severity of obstructive sleep apnoea and daytime sleepiness. (1) It also highlights the lack of patient-centered outcomes beyond daytime sleepiness, which is very important to achieve good adherence to treatment, one of the main limitations of obstructive sleep apnoea treatment to achieve greater health benefits for patients as shown by different clinical trials that have failed to show significant results of continuous airway pressure (CPAP) in the prevention of cardiovascular events in intention-to-treat analyses but did show significant results in patients with good adherence to treatment (2).
Based on this statement, we would like to refer you to our last publication (3), a RCT, which shows high good compliance rates for the active device (mean value of 85% ± 36.6%, defined as device use for more than 4 hours per night and more than 70% of nights per week), values above the usual ones for CPAP treatment, (generally 40%–50% in the long term)(4,5), from the first day and sustained form over time. Patient ́s satisfaction was high and minor side effects were reported.
Our previous research showed their efficacy in terms of reduction of Apnoea-Hypopnoea Index, total sleep time in the supine position; improve oxygen saturati...
The systematic review and meta-analysis by Abdullah ALQarni et al. on the effect of positional vibrotactile therapy for positional obstructive sleep apnoea shows that this treatment modality is effective, reducing time in the supine position, severity of obstructive sleep apnoea and daytime sleepiness. (1) It also highlights the lack of patient-centered outcomes beyond daytime sleepiness, which is very important to achieve good adherence to treatment, one of the main limitations of obstructive sleep apnoea treatment to achieve greater health benefits for patients as shown by different clinical trials that have failed to show significant results of continuous airway pressure (CPAP) in the prevention of cardiovascular events in intention-to-treat analyses but did show significant results in patients with good adherence to treatment (2).
Based on this statement, we would like to refer you to our last publication (3), a RCT, which shows high good compliance rates for the active device (mean value of 85% ± 36.6%, defined as device use for more than 4 hours per night and more than 70% of nights per week), values above the usual ones for CPAP treatment, (generally 40%–50% in the long term)(4,5), from the first day and sustained form over time. Patient ́s satisfaction was high and minor side effects were reported.
Our previous research showed their efficacy in terms of reduction of Apnoea-Hypopnoea Index, total sleep time in the supine position; improve oxygen saturation without deteriorating sleep quality. (6,7). This treatment modality could be used as a primary therapy in Positional Obstructive Sleep Apnoea patients (POSA) or as an alternative in patients who cannot tolerate or are not compliant with the standard CPAP treatment. (3)
Thus, we agree with Abdullah ALQarni et al. (1) that it is important to evaluate patient-centered results that favor treatment compliance, in addition to assessing its effectiveness, that help overcome the current limitations of CPAP and thus contribute to improving the health of patients with POSA.
REFERENCES
1. ALQarni AS, Turnbull CD, Morrell MJ, Kelly JL. Efficacy of vibrotactile positional therapy devices on patients with positional obstructive sleep apnoea: a systematic review and meta-analysis. Thorax. 21 de junio de 2023;thoraxjnl-2021-218402.
2. Javaheri S, Martinez-Garcia MA, Campos-Rodriguez F, Muriel A, Peker Y. Continuous Positive Airway Pressure Adherence for Prevention of Major Adverse Cerebrovascular and Cardiovascular Events in Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2020 Mar 1;201(5):607-610. doi: 10.1164/rccm.201908-1593LE. PMID: 31644880.
3. Hidalgo-Armas L, Inglés S, Vaca R, Cordero-Guevara J, Durán-Carro J, Ullate J, et al. Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial. BMJ Open Respir Res. junio de 2023;10(1):e001503.
4. Rotenberg BW, Murariu D, Pang KP. Trends in CPAP adherence over twenty years of data collection: a flattened curve. J Otolaryngol Head Neck Surg 2016;45:43.
5. Barnes H, Edwards BA, Joosten SA, et al. Positional modification techniques for supine obstructive sleep apnea: A systematic review and meta-analysis. Sleep Med Rev 2017;36:107–15.
6. Hidalgo Armas L, Turino C, Cordero-Guevara J, Manjón JL, Durán-Carro J, Barbé F, et al. A new postural device for the treatment of positional obstructive sleep apnea. A pilot study. Respir Med. May 2019;151:111-7.
7. Hidalgo Armas L, Ingles S, Vaca R, Cordero-Guevara J, Duran Carro J, Ullate J, et al. New forehead device in positional obstructive sleep apnoea: a randomised clinical trial. Thorax. Sept 2021;76(9):930-8.
We were interested in the article "Long-term effect of pulmonary rehabilitation in idiopathic pulmonary fibrosis: a randomised controlled trial" by Kataoka K. et al. [1] The effect of pulmonary rehabilitation in patients with idiopathic pulmonary fibrosis (IPF) is a topical theme in this field. We believe that this multicenter randomised controlled trial conducted in Japan will have an enormous impact on the knowledge of pulmonary rehabilitation in patients with IPF.
The authors conducted a 12-week supervised and home-based unsupervised exercise therapy-based pulmonary rehabilitation for 45 outpatients with IPF treated with antifibrotic drugs. In addition, the patients were followed by a 40-week home-based unsupervised exercise therapy-based maintenance program. The pulmonary rehabilitation resulted in a more significant change (week 52 - Baseline) in endurance time measured by a constant workload test using a bicycle ergometer compared to 43 control patients who received only usual care (mean difference: 187 s [95% CI: 34 to 153]). Although endurance time is a secondary outcome in the authors' study design, this result suggests that IPF patients treated with antifibrotic drugs may benefit from pulmonary rehabilitation as a combination therapy to maintain exercise tolerance.
In contrast, the authors found no statistically significant between-group differences in the change in 6-minute walking distance (6MWD) (52 weeks - Baseline), the prima...
We were interested in the article "Long-term effect of pulmonary rehabilitation in idiopathic pulmonary fibrosis: a randomised controlled trial" by Kataoka K. et al. [1] The effect of pulmonary rehabilitation in patients with idiopathic pulmonary fibrosis (IPF) is a topical theme in this field. We believe that this multicenter randomised controlled trial conducted in Japan will have an enormous impact on the knowledge of pulmonary rehabilitation in patients with IPF.
The authors conducted a 12-week supervised and home-based unsupervised exercise therapy-based pulmonary rehabilitation for 45 outpatients with IPF treated with antifibrotic drugs. In addition, the patients were followed by a 40-week home-based unsupervised exercise therapy-based maintenance program. The pulmonary rehabilitation resulted in a more significant change (week 52 - Baseline) in endurance time measured by a constant workload test using a bicycle ergometer compared to 43 control patients who received only usual care (mean difference: 187 s [95% CI: 34 to 153]). Although endurance time is a secondary outcome in the authors' study design, this result suggests that IPF patients treated with antifibrotic drugs may benefit from pulmonary rehabilitation as a combination therapy to maintain exercise tolerance.
In contrast, the authors found no statistically significant between-group differences in the change in 6-minute walking distance (6MWD) (52 weeks - Baseline), the primary outcome of the study (mean difference: 21 m [95 %CI: -25 to 66]). The authors attributed this result to differences in compliance with pulmonary rehabilitation. Indeed, the supplemental results showed that, among the intervention group, 6MWD changed by -8m (95%CI: -47 to 31) in patients with good adherence, while 6MWD changed by -106 m (95%CI: -172 to -40) in those with poor adherence. These results are significant in pulmonary rehabilitation because active patient engagement is critical to benefit from pulmonary rehabilitation. Thus, future studies are warranted to establish effective interventions to enhance active engagement in pulmonary rehabilitation for patients with poor adherence. Moreover, the present results can also be interpreted from the minimal clinical important difference (MCID). Nathan S. et al. reported that MCIDs of the 6MWD were 29.2 m using a distribution-based approach and 21.7 m using a composite outcome (health events of hospitalisation or death) as an anchor in patients with interstitial lung disease (ILD) [2]. The present trial reported a mean change from baseline to week 52 of -53 m (95% CI: -86 to -21) in the control group. The result means that 6MWD decreased by more than the MCID in almost patients. In contrast, the mean change in the pulmonary rehabilitation group was -33 m (95% CI: -65 to -1), implying that approximately 30 to 40% of patients had a decrease in 6MWD smaller than the MCID. This result suggests that pulmonary rehabilitation may effectively maintain 6MWD after about one year in patients with IPF who received long-term pulmonary rehabilitation compared to patients who did not. We believe that these results can be used to facilitate shared decision-making in introducing pulmonary rehabilitation.
In summary, long-term pulmonary rehabilitation improved endurance time measured by a constant workload test using a bicycle ergometer compared to usual care. Moreover, the current study showed that patients with IPF treated with antifibrotic drugs and long-term pulmonary rehabilitation were less likely to have clinically significant reductions in 6MWD after 52 weeks, whereas most patients treated with antifibrotic drugs alone experienced clinically significant reductions in 6MWD. This result is a novel point of the study. We fully agree with the authors that improving adherence through closer maintenance programs, such as remote programs, is necessary. Previous studies have also reported that participation in pulmonary rehabilitation is associated with lower mortality [3].
We look forward to new efforts by the FITNESS study collaborators.
1 Kataoka K, Nishiyama O, Ogura T, et al. Long-term effect of pulmonary rehabilitation in idiopathic pulmonary fibrosis: a randomised controlled trial. Thorax Published Online First: 3 April 2023. doi:10.1136/thorax-2022-219792
2 Nathan SD, du Bois RM, Albera C, et al. Validation of test performance characteristics and minimal clinically important difference of the 6-minute walk test in patients with idiopathic pulmonary fibrosis. Respir Med 2015;109:914–22.
3 Guler SA, Hur SA, Stickland MK, et al. Survival after inpatient or outpatient pulmonary rehabilitation in patients with fibrotic interstitial lung disease: a multicentre retrospective cohort study. Thorax 2021;:thoraxjnl-2021-217361.
Drs Abul-Ainine and Steer have provided cogent arguments for the use of a 10mg/kg loading dose of intravenous aminophylline to treat acute asthma in children.[1] Their pharmacokinetic evidence for this dose is supported by Yung et al’s randomised placebo controlled trial using this same loading dose.[2] This study recruited 163 children with severe acute asthma unresponsive to three nebulised doses...
Drs Abul-Ainine and Steer have provided cogent arguments for the use of a 10mg/kg loading dose of intravenous aminophylline to treat acute asthma in children.[1] Their pharmacokinetic evidence for this dose is supported by Yung et al’s randomised placebo controlled trial using this same loading dose.[2] This study recruited 163 children with severe acute asthma unresponsive to three nebulised doses of 5mg Salbutamol in an intensive care setting. Those receiving aminophylline did not achieve a significant reduction in hospital stay, which was the primary outcome criteria, but in a sub set of 48 children who were able to perform lung function, there was a mean difference in FEV1% predicted of around 10% favouring aminophylline during the first 24 hours of the study. Oxygen saturations were also improved and, most importantly, 5 subjects in the placebo group were intubated and ventilated with none in the aminophylline group. These data suggest that there is a place for Aminophylline to treat the most severely affected children with acute asthma but its use has to be balanced against risks of toxicity and the high incidence of nausea and vomiting side effects. The latter occured in two thirds of the children in the Yung study and was of such severity that the aminophylline infusions were discontinued in one third of their patients. Such problems are reported less frequently after lower bolus doses.[3]
The use of aminophylline was discussed at length at the BTS – SIGN open meeting in Edingburgh in October 2001. Three important points were emphasized: (i) Frequent doses of nebulised ipratropium in addition to salbutamol, a treatment option not included in the Yung study, are a more preferable first line option with a low risk of side effects, (ii) Early bolus doses of 15mcg/kg of intravenous salbutamol are well tolerated and an effective adjunct in children poorly responsive to initial nebuliser treatment,[4] (iii) Current UK practice for aminophylline dosage as stated in the BNF is for a 5mg/kg bolus.
Unfortunately there is little evidence for the use of continuous intravenous salbutamol in addition to nebuliser treatment,[5] but it was the decision of the evidence review group to recommend bolus IV salbutamol and a subsequent infusion where indicated before the use of aminophylline. Such recommendations cannot be made unreservedly. Good comparative studies are still needed and in particular a randomised controlled trial comparing a bolus of IV salbutamol followed by maintenance infusion with bolus aminophylline and infusion in sufficient doses to achieve therapeutic levels early in the course of treatment. The BTS-SIGN guideline is subject to ongoing review and web based versions will be updated in the light of new evidence as it becomes available. The Yung study has now been included in the updated Cochrane Review of intravenous aminophylline and has upgraded the meta-analysis of evidence in favour of its use.[6] Given that this single study contributes 163 of the 380 children included and is the only study with measurable benefits, it is reasonable to consider revising the recommended aminophylline bolus dose to 10mg/kg given over 1 hour for use in the small number of children with life threatening bronchospasm unresponsive to maximal doses of other bronchodilators and steroids . However, there is insufficient evidence for the use of aminophylline to treat less severe cases and given present evidence no recommendations can be made about the dose of aminophylline if used in addition to intravenous salbutamol.
References
(1) Abul-Ainine A, Steer CR. Aminophylline and the British Asthma Guidelines In Children [electronic response to British Guideline on the Management of Asthma, Chapter 4] thoraxjnl.com 2004http://thorax.bmjjournals.com/cgi/eletters/58/suppl_1/17i#193
(2) Yung M, South M. Randomised controlled trial of aminophylline for severe acute asthma. Arch Dis Child 1998;79:405-410(3)
(3) G Roberts1,2, D Newsom3, K Gomez2, A Raffles4, S Saglani4, J Begent4, P Lachman3, K Sloper5, R Buchdahl6 and A Habel2 On Behalf Of The North West Thames Asthma Study Group Intravenous salbutamol bolus compared with an aminophylline infusion in children with severe asthma: a randomised controlled trial Thorax 2003;58:306-310
(4) Browne GJ, Penna AS, Phung X, et al. Randomised trial of intravenous salbutamol in early management of acute asthma in children. Lancet 1997;349:301–5.
(5) Travers A, Jones AP, Kelly K, Barker SJ, Camargo CA Jr., Rowe BH Intravenous beta2-agonists for acute asthma in the emergency department (Cochrane Review). In: The Cochrane Library, Issue 3, 2003. Oxford: Update Software.
(6) Mitra A, Bassler D, Ducharme FM Intravenous aminophylline for acute severe asthma in children over 2 years using inhaled bronchodilators (Cochrane Review). In: The Cochrane Library, Issue 3, 2003. Oxford: Update Software.
I read with interest the recent publication by Subharta Moitra et al in Thorax.(1) The authors concluded that adult asthmatics have a higher risk of developing obesity than non-asthmatics. An association was found especially in non-atopic asthmatics with longer disease duration and the use of oral corticosteroids (OCS).
Obesity is the strongest risk factor for sleep apnea, and sleep apnea is associated also with asthma.(2) Obesity has been regarded also as a risk factor for developing asthma,(3) but the reverse association is still not clear. Both asthma and obesity begin often in early childhood, and they may share a common background.(3)
The relationships between smoking, physical activity, use of OCS and lung function were discussed in the paper. But why would asthma per se increase weight? Obesity may be considered also as a central nervous system disorder. Obesity and sleep apnea are associated with asthma. Short night sleep, sleep deprivation and chronic insomnia are associated with the development of obesity.(4) Studies have also shown an association between anxiety, depressive symptoms and the development of obesity.(4)
The ECHRS cohort was initiated in 1990. The study was focused on asthma, and unfortunately the original questionnaires did not include questions on sleep, sleep disorders or mental health. Also, no sleep studies or psychological testing were done. This explains the lack of information on anxiety, depres...
I read with interest the recent publication by Subharta Moitra et al in Thorax.(1) The authors concluded that adult asthmatics have a higher risk of developing obesity than non-asthmatics. An association was found especially in non-atopic asthmatics with longer disease duration and the use of oral corticosteroids (OCS).
Obesity is the strongest risk factor for sleep apnea, and sleep apnea is associated also with asthma.(2) Obesity has been regarded also as a risk factor for developing asthma,(3) but the reverse association is still not clear. Both asthma and obesity begin often in early childhood, and they may share a common background.(3)
The relationships between smoking, physical activity, use of OCS and lung function were discussed in the paper. But why would asthma per se increase weight? Obesity may be considered also as a central nervous system disorder. Obesity and sleep apnea are associated with asthma. Short night sleep, sleep deprivation and chronic insomnia are associated with the development of obesity.(4) Studies have also shown an association between anxiety, depressive symptoms and the development of obesity.(4)
The ECHRS cohort was initiated in 1990. The study was focused on asthma, and unfortunately the original questionnaires did not include questions on sleep, sleep disorders or mental health. Also, no sleep studies or psychological testing were done. This explains the lack of information on anxiety, depression, sleep duration, sleep deprivation, snoring and sleep apnea. As these factors are linked to both asthma and obesity, it is difficult to conclude that asthma would be directly related to the development of obesity. A minor problem in this prospective study is also that only 30% of the original members in the cohort (collected 1990-1994) were included in the ECHRS III. Altogether 10,681 subjects were lost to follow-up leaving 5,901 subjects in the third phase. Did those with missing information differ in characteristics from the remaining study subjects?
In sum, obesity is a huge problem, and asthma is an important disease. Understanding the associations between obesity and asthma is important. Could the association be explained by shared associations with sleep-disordered breathing and/or insomnia and/or sleep deprivation and/or anxiety and/or depression, or other common risk factors for both asthma and obesity?
REFERENCES
1. Moitra S, Carsin AE, Abramson MJ, Accordini S, Amaral AFS, Anto J, . . . Garcia-Aymerich J. Long-term effect of asthma on the development of obesity among adults: an international cohort study, ECRHS. Thorax 2022. 10.1136/thoraxjnl-2021-217867
2. Thompson C, Legault J, Moullec G, Baltzan M, Cross N, Dang-Vu TT, . . . Gosselin N. A portrait of obstructive sleep apnea risk factors in 27,210 middle-aged and older adults in the Canadian Longitudinal Study on Aging. Scientific Reports 2022;12. 10.1038/s41598-022-08164-6
3. Litonjua AA, Gold DR. Asthma and obesity: common early-life influences in the inception of disease. J Allergy Clin Immunol 2008;121:1075-84; quiz 85-6. 10.1016/j.jaci.2008.03.005
4. Sivertsen B, Lallukka T, Salo P, Pallesen S, Hysing M, Krokstad S, Simon O. Insomnia as a risk factor for ill health: results from the large population-based prospective HUNT Study in Norway. J Sleep Res 2014;23:124-32. 10.1111/jsr.12102
We thank Professors Azuma and Raghu for their excellent suggestions and comments on our paper. Our study demonstrates the importance of pulmonary vascular resistance (PVR) as a prognostic factor in the initial evaluation of patients with interstitial lung disease (ILD) and highlights the greater significance of PVR over mPAP in right heart catheterisation (RHC) (1). We acknowledge that there is generally less emphasis on PVR compared to the more commonly discussed mean pulmonary arterial pressure (mPAP), and it was our intention to address this discrepancy with our study.
Show MoreIt is important to clarify that we do not recommend systematic RHC at initial evaluation of ILD. Historically, our approach was to perform RHC more frequently at diagnosis, but in recent years, we have limited this to cases where pulmonary hypertension (PH) is suspected. We recently reported a system for predicting mPAP > 20mmHg using a Pa/Ao ratio ≥ 0.9, PaO2 < 80 Torr, and DLco percent predicted < 50% in patients with idiopathic pulmonary fibrosis (IPF) (2). We propose using this system to screen patients before undergoing RHC, with assessments of both mPAP and PVR.
As Azuma and colleagues pointed out, exercise tolerance tests, including the 6-minute walk test (6MWT), might help in predicting PH. As patients with PH have significantly worse desaturation and walking distance in the 6MWT, those who show significant desaturation and/or reduced walking distance during 6MWT are likely to...
" We congratulate Sato et al to have undertaken the retrospective stud(y that surfaces clinical significance of pulmonary vascular resistance (PVR) as a predictor of mortality in patients with newly diagnosed ILD with normal mean MAP – i.e., < 30mmhg at rest ( 1) .
While their obsrervation is interesting , are the authors advocating right heart catheterization(RHC) for patients with new onset ILD upfront at the time of initial evaluation undergoing diagnostic interventions for diagnosis of ILD ?
Indeed, RHC is an invasive procedure, and the potential benefits and risks must be weighed in considering RHC for patients with new onset ILD for prognostication and consideration of possible therapeutic interventions. Are the authors recommending RHC for patients with new onset ILD without clues for pulmonary hypertension ?
Show MoreDo the authors have additional non invasive clinical variables/data that correlate with PVR > 2 wood units with mean PAP < 20 mmHg- such as decreased DLCO corrected for hemoglobin, oxygen desaturation with walking, extent of interstitial lung abnormalities , specific diagnosis in patients with new onset ILD that can be used to screen patients to undergo RHC ?
Perhaps, a noninvasive method using an exercise test as was used in assessing patient's endurance of exercise in patients with IPF treated with pirfenidone for IPF(2) might be a screening test prior to considering RHC as a routine for patients with new ons...
Dear editor,
I read with interest the state-of-the-art review article by Shah et al1. on the effects of non-invasive ventilation (NIV) on sleep in chronic hypercapnic respiratory failure. However, I wish to delve deeper into the topic of Continuous Positive Airway Pressure (CPAP) especially in patients with Chronic Obstructive Pulmonary Disease-Obstructive Sleep Apnea (COPD-OSA) overlap syndrome and obesity hypoventilation syndrome (OHS).
COPD-OSA overlap syndrome was first described by Professor Flenley2, which is associated with an increased frequency and severity of COPD exacerbations3, hospitalizations3, and mortality4. Current data indicates that CPAP improves these outcomes5.
Similarly, in OHS, OSA is highly prevalent, affecting an estimated 90% of patients with OHS6. CPAP has been demonstrated to offer similar benefits to NIV6 7 and is recommended as the initial treatment for stable OHS patients8. CPAP therapy enhances outcomes by improving ventilation, reducing air-trapping, enhancing diaphragmatic function, improving hypercapnic response, and decreasing CO2 production resulting from excessive respiratory muscle work9. Given its advantages and cost-effectiveness compared to NIV, CPAP devices should be considered the initial treatment option7 for both disease before NIV.
Reference
Show More1. Shah NM, Steier J, Hart N, Kaltsakas G. Effects of non-invasive ventilation on sleep in chronic hypercapnic respiratory failure. Thorax 2023 doi: 10.1136...
Thank you to the authors for the excellent and very interesting work published.
I would like to ask about the protocol routine follow-up of patients following an acute pulmonary embolus mentioned in the paper: what did this entail, and how did it differ from the protocol implemented as part of the trial?
Secondly, how did the authors select a follow-up telephone at 2 years post acute pulmonary embolus? As is pointed out in the limitations of section of the paper, this could have missed patients with clinically significant CTEPH who did not survive those 2 years. Would an earlier symptom assessment have led to a greater incidence of false positive echocardiograms showing pulmonary hypertension, or would it lead to patients being missed as not enough time would have passed to allow CTEPH to establish?
Thank you in advance for your clarifications
If a core outcome set (COS) to a global burden of disease is to be globally relevant and applicable, methodological efforts to ensure equal representation of low- and middle-income countries (LMICs) and high-income countries (HICs) at all stages of its development are needed (1, 2). This is due to the differences in disease patterns, healthcare resources, culture, and biomedical beliefs, which may influence outcome priorities (3, 4). A case in point is a study by Van Rijssen et al (5), where participants from Europe, the USA, and Asia did not reach the same consensus on the final patient-reported COS for pancreatic cancer, and Asian participants did not reach a consensus on any outcomes included in the final set.
We read with interest your COS for pulmonary rehabilitation (PR) of patients with COPD in the 2023 September issue of Thorax "(6). We noticed the under-representation of LMICs, especially in Asia and Africa, in your development of the COS. Of the 29 and 27 countries where you recruited participants in the first and second rounds of your Delphi survey, respectively, Asia was represented by only one participant from India, whilst no participant was recruited from Africa. Most participants were from HICs in Europe including the Netherlands, Portugal, United Kingdom, Australia, and Spain.
This underrepresentation of LMICs is noteworthy given that, firstly, the burden of chronic respiratory diseases (including COPD) is greater in LMICs, both in terms...
Show MoreWe thank Bickton and colleagues for their interest in reading our article and their commentary.
Show MoreWe recognize the need to have a balanced representation of low- and middle-income countries (LMICs) in core outcome sets (COS), specifically in pulmonary rehabilitation (PR) as resources for measurement instruments may vary globally and the burden of COPD and need for pulmonary rehabilitation in these regions are undeniable.
According to the World Bank categories (1), we have included some middle-income countries in our study, from south America (Argentina, Brazil, Colombia, Cuba) and from Asia (not only India, but also the Philippines). Nonetheless, as acknowledged in our COS paper (2), the African and Asian continents were underrepresented.
Although not stated throughout our paper, with the a priori knowledge of the need to include these continents and LMICs, we took some methodological steps to try to ensure their representation. Indeed, we have contacted several professional and patient associations from these regions to help us recruit participants. The Pan African Thoracic Society was contacted directly. Nonetheless, the procedure to contact is a form on a website (https://panafricanthoracic.org/about-us/contact-us), with no other form of contact provided. No response was ever obtained. We congratulate the newly formed PR Working Group, and we look forward to enhancing our communication chan...
The systematic review and meta-analysis by Abdullah ALQarni et al. on the effect of positional vibrotactile therapy for positional obstructive sleep apnoea shows that this treatment modality is effective, reducing time in the supine position, severity of obstructive sleep apnoea and daytime sleepiness. (1) It also highlights the lack of patient-centered outcomes beyond daytime sleepiness, which is very important to achieve good adherence to treatment, one of the main limitations of obstructive sleep apnoea treatment to achieve greater health benefits for patients as shown by different clinical trials that have failed to show significant results of continuous airway pressure (CPAP) in the prevention of cardiovascular events in intention-to-treat analyses but did show significant results in patients with good adherence to treatment (2).
Show MoreBased on this statement, we would like to refer you to our last publication (3), a RCT, which shows high good compliance rates for the active device (mean value of 85% ± 36.6%, defined as device use for more than 4 hours per night and more than 70% of nights per week), values above the usual ones for CPAP treatment, (generally 40%–50% in the long term)(4,5), from the first day and sustained form over time. Patient ́s satisfaction was high and minor side effects were reported.
Our previous research showed their efficacy in terms of reduction of Apnoea-Hypopnoea Index, total sleep time in the supine position; improve oxygen saturati...
We were interested in the article "Long-term effect of pulmonary rehabilitation in idiopathic pulmonary fibrosis: a randomised controlled trial" by Kataoka K. et al. [1] The effect of pulmonary rehabilitation in patients with idiopathic pulmonary fibrosis (IPF) is a topical theme in this field. We believe that this multicenter randomised controlled trial conducted in Japan will have an enormous impact on the knowledge of pulmonary rehabilitation in patients with IPF.
Show MoreThe authors conducted a 12-week supervised and home-based unsupervised exercise therapy-based pulmonary rehabilitation for 45 outpatients with IPF treated with antifibrotic drugs. In addition, the patients were followed by a 40-week home-based unsupervised exercise therapy-based maintenance program. The pulmonary rehabilitation resulted in a more significant change (week 52 - Baseline) in endurance time measured by a constant workload test using a bicycle ergometer compared to 43 control patients who received only usual care (mean difference: 187 s [95% CI: 34 to 153]). Although endurance time is a secondary outcome in the authors' study design, this result suggests that IPF patients treated with antifibrotic drugs may benefit from pulmonary rehabilitation as a combination therapy to maintain exercise tolerance.
In contrast, the authors found no statistically significant between-group differences in the change in 6-minute walking distance (6MWD) (52 weeks - Baseline), the prima...
Dear Editor
Drs Abul-Ainine and Steer have provided cogent arguments for the use of a 10mg/kg loading dose of intravenous aminophylline to treat acute asthma in children.[1] Their pharmacokinetic evidence for this dose is supported by Yung et al’s randomised placebo controlled trial using this same loading dose.[2] This study recruited 163 children with severe acute asthma unresponsive to three nebulised doses...
Dear Editor,
I read with interest the recent publication by Subharta Moitra et al in Thorax.(1) The authors concluded that adult asthmatics have a higher risk of developing obesity than non-asthmatics. An association was found especially in non-atopic asthmatics with longer disease duration and the use of oral corticosteroids (OCS).
Obesity is the strongest risk factor for sleep apnea, and sleep apnea is associated also with asthma.(2) Obesity has been regarded also as a risk factor for developing asthma,(3) but the reverse association is still not clear. Both asthma and obesity begin often in early childhood, and they may share a common background.(3)
The relationships between smoking, physical activity, use of OCS and lung function were discussed in the paper. But why would asthma per se increase weight? Obesity may be considered also as a central nervous system disorder. Obesity and sleep apnea are associated with asthma. Short night sleep, sleep deprivation and chronic insomnia are associated with the development of obesity.(4) Studies have also shown an association between anxiety, depressive symptoms and the development of obesity.(4)
The ECHRS cohort was initiated in 1990. The study was focused on asthma, and unfortunately the original questionnaires did not include questions on sleep, sleep disorders or mental health. Also, no sleep studies or psychological testing were done. This explains the lack of information on anxiety, depres...
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