- Email: [email protected]
Telemedicine for management of patients with COPD?
Comment
*Richard Beasley, Mark Weatherall, Justin Travers, Philippa Shirtcliffe Medical Research Institute of New Zealand, Wellington 6143, New Zealand (RB, JT, PS); Capital and Coast District Health Board, Wellington, New Zealand (RB, MW, PS); and University of Otago Wellington, Wellington, New Zealand (MW) [email protected] The Medical Research Institute of New Zealand has received research grants from AstraZeneca, GlaxoSmithKline, and Novartis. RB has received fees for consulting and speaking, and reimbursement for attending symposia, from AstraZeneca, GlaxoSmithKline, and Novartis. MW, JT, and PS declare that they have no conflicts of interest. 1
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Global Initiative for the Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of COPD. December, 2008. http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=989 (accessed May 4, 2009). Global Initiative for Asthma. Global strategy for asthma management and prevention 2008. http://www.ginasthma.com/Guidelineitem. asp??l1=2&l2=1&intId=60 (accessed May 4, 2009). Calverley PM, Burge PS, Spencer S, Anderson JA, Jones PW. Bronchodilator reversibility testing in chronic obstructive pulmonary disease. Thorax 2003; 58: 659–64. Vonk JM, Jongepier H, Panhuysen CIM, Schouten JP, Bleecker ER, Postma DS. Risk factors associated with the presence of irreversible airflow limitation and reduced transfer coefficient in patients with asthma after 26 years of follow up. Thorax 2003; 58: 322–37.
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Calverley PM, Rennard SI. What have we learned from large drug treatment trials in COPD? Lancet 2007; 370: 774–85. Travers J, Marsh S, Shirtcliffe P, Beasley R. External validity of pharmaceutical trials in asthma and chronic obstructive pulmonary disease. In: Rothwell PM, ed. Treating individuals: from randomised trials to personalised medicine. Oxford: Elsevier, 2007: 131–35. National Emphysema Treatment Trial Research Group. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med 2003; 348: 2059–73. Brightling CE, Monteiro W, Ward R, et al. Sputum eosinophilia and short-term responses to prednisolone in chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 2000; 356: 1480–85. Marsh SE, Travers J, Weatherall M, et al. Proportional classifications of COPD phenotypes. Thorax 2008; 63: 761–67. Lapperre TS, Snoeck-Stroband JB, Gosman MM, et al. Dissociation of lung function and airway inflammation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2004; 170: 499–504. Fabbri LM, Rabe KF. From COPD to chronic systemic inflammatory syndrome? Lancet 2007; 370: 797–99. Weatherall M, Travers J, Shirtcliffe PM, et al. Distinct clinical phenotypes of airways disease defined by cluster analysis. Eur Respir J 2009; published online April 8. DOI:10.1183/09031936.00174408. Wardlaw AJ, Silverman M, Siva R, Pavord ID, Green R. Multi-dimensional phenotyping: towards a new taxonomy for airway disease. Clin Exp Allergy 2005; 35: 1254–62. The Lancet. A plea to abandon asthma as a disease concept. Lancet 2006; 368: 705.
Telemedicine for management of patients with COPD?
Photolibrary
The European Commission Communication on telemedicine1 highlighted not only the potential of telehealth in the management of chronic obstructive pulmonary disease (COPD), but also the pressing need for good-quality research in this field. COPD affects about 210 million people globally and causes some 3 million
672
deaths annually.2 The disease is a major drain on healthcare budgets with 50% of costs accounted for by hospital admissions, much of which could be avoided through development of more responsive models of care that allow earlier recognition and treatment of exacerbations.3 Telehealth, delivered through landline, broadband, or, increasingly, wireless (wi-fi) or cell-phone technology, seems ideally suited to enable real-time remote monitoring and management of patients from their homes. Telehealth has the potential to transform the way care is delivered for the increasing numbers of people with COPD. However, potential benefits do not equate with effectiveness and the evidence for the effectiveness of telemedicine in COPD compared with, for example, cardiac failure remains weak.4 The uncritical rollout of telehealth for COPD that is taking place in parts of the UK and internationally is hence problematic, because this technology is expensive, might require disruptive reorganisation of care and infrastructure support,5 and is, furthermore, not without risk.6 The rollout of these technologies throughout the National Health Service has the support of the UK Government,7 and there is thus a great deal of pressure for early implementation from enthusiasts. However, we www.thelancet.com Vol 374 August 29, 2009
Comment
believe that the European Commission offers a sounder and strategically considered approach. The European Commission1 rightly exhorts member states to ensure that the potential of telehealth is fully realised by seeking to integrate it into all aspects of care, in an evidence-informed manner. In so doing, the Commission recognises the essential need for new deployments to contribute towards clarifying the currently limited evidence base underlying the use of telehealth in COPD. Although existing effectiveness studies have been promising,8 they have typically been small scale and too heterogeneous in outcome measures to allow any overarching conclusions to be drawn through meta-analysis. The European Commission has therefore rightly called for effectiveness trials in this area, with a scientifically sound methodology that is agreed across different countries and health-care systems. Additionally, the Commission has called for a central core set of clinical, quality of life, and economic endpoints that researchers should measure, when possible, to facilitate metaanalysis. For COPD these endpoints need to include: an agreed definition of what constitutes an exacerbation; physiological measures such as lung function, oxygen saturation, and exercise capacity; internationally validated general and health-related quality of life questionnaires (eg, the St George’s Respiratory Questionnaire9 and EuroQol 5D10); comparable economic outcomes such as service use (eg, hospital bed-days); and cost per quality-adjusted life-year. With our experience from several completed and ongoing telehealth trials, we feel it important that such trials consider not only clinical, quality of life, and economic endpoints, but also detailed analysis of the process changes that might have contributed to success or failure. In particular, this analysis needs to include a description of the underpinning clinical service, which is crucial to the successful implementation of telehealth projects. This information is important because such consideration of process measures will allow causal mechanisms to be understood and inform an assessment of the generalisability of a telehealth-based approach to other disease areas and service configurations. There is also a need for legislative and professional regulatory perspectives to evolve such that these recognise the importance of, and facilitate provision of, safe remote models of care, which are still viewed rather www.thelancet.com Vol 374 August 29, 2009
negatively.11 Finally, the European Union has a role in ensuring that the bewildering array of devices licensed for use in telehealth are interoperable, to reduce the risk of health-care providers buying into expensive technological dead-ends. Telehealth has great potential in COPD, but there are also risks associated with investment and deployment in this area. The European Union Communication1 provides a strategy to build an evidence base, without which we will never know if the current unquestioning enthusiasm of current UK policy is an act of considerable foresight or an expensive mistake. *Brian McKinstry, Hilary Pinnock, Aziz Sheikh General Practice Section (BM) and E-health Group, Centre for Population Health Sciences (HP, AZ), University of Edinburgh, Edinburgh EH8 9DR, UK [email protected] BM, HP, and AS have been funded by the Chief Scientist Office of the Scottish Government for a programme of randomised trials in telehealth (the TeleScot trials). BM has received funding from the BUPA Foundation, Scottish Centre for Telehealth, Intel Corporation, and NHS Lothian for telehealth research. AS and HP have received funding for telehealth-related work from the NHS Connecting for Health Evaluation Programme, NHS Lothian, and the CYMPLA trial funded by Asthma UK. 1
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Commission of the European Communities. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on telemedicine for the benefit of patients, healthcare systems and society. Nov 4, 2008. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do? uri=COM:2008:0689:FIN:EN:PDF (accessed June 6, 2009). Halbert RJ, Isonaka S, George D, Iqbal A. Interpreting COPD prevalence estimates: what is the true burden of disease? Chest 2003; 123: 1684–92. Wilkinson TM, Donaldson GC, Hurst JR, Seemungal TA, Wedzicha JA. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2004; 169: 1298–303. Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ 2007; published online April 10. DOI:10.1136/bmj.39156.536968.55. Jennett P, Yeo M, Pauls M. Graham J. Organizational readiness for telemedicine: implications for success and failure. J Telemed Telecare 2003; 9: 27–30. Car J, Black A, Anandan C, et al. The impact of ehealth on the quality & safety of healthcare: a systematic overview & synthesis of the literature. Report for the NHS connecting for health evaluation programme. March, 2008. http:// www.pcpoh.bham.ac.uk/publichealth/cfhep/documents/NHS_CFHEP_001_ Final_Report.pdf (accessed June 6, 2009). Darzi A. High quality care for all: NHS Next Stage Review final report. June 30, 2008. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/ PublicationsPolicyAndGuidance/DH_085825 (accessed June 6, 2009). Casas A, Troosters T, Garcia-Aymerich J, et al. Integrated care prevents hospitalisations for exacerbations in COPD patients. Eur Respir J 2006; 28: 123–30. Jones PW, Quirk FH, Baveystock CM. The St George’s Respiratory Questionnaire. Respir Med 1991; 85: 25–31. Cheung K, Oemar M, Oppe M, Rabin R, on behalf of the EuroQol Group. User guide: basic information on how to use the EQ-5D. 2003. http://www. euroqol.org/fileadmin/user_upload/Documenten/PDF/User_Guide_v2_ March_2009.pdf (accessed June 17, 2009). McKinstry B, Watson P, Pinnock H, Heaney D, Sheikh A. Telephone consulting in primary care: a triangulated qualitative study of patients and providers. Br J Gen Pract 2009; 59: 433–41.
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*Richard Beasley, Mark Weatherall, Justin Travers, Philippa Shirtcliffe Medical Research Institute of New Zealand, Wellington 6143, New Zealand (RB, JT, PS); Capital and Coast District Health Board, Wellington, New Zealand (RB, MW, PS); and University of Otago Wellington, Wellington, New Zealand (MW) [email protected] The Medical Research Institute of New Zealand has received research grants from AstraZeneca, GlaxoSmithKline, and Novartis. RB has received fees for consulting and speaking, and reimbursement for attending symposia, from AstraZeneca, GlaxoSmithKline, and Novartis. MW, JT, and PS declare that they have no conflicts of interest. 1
2
3
4
Global Initiative for the Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of COPD. December, 2008. http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=989 (accessed May 4, 2009). Global Initiative for Asthma. Global strategy for asthma management and prevention 2008. http://www.ginasthma.com/Guidelineitem. asp??l1=2&l2=1&intId=60 (accessed May 4, 2009). Calverley PM, Burge PS, Spencer S, Anderson JA, Jones PW. Bronchodilator reversibility testing in chronic obstructive pulmonary disease. Thorax 2003; 58: 659–64. Vonk JM, Jongepier H, Panhuysen CIM, Schouten JP, Bleecker ER, Postma DS. Risk factors associated with the presence of irreversible airflow limitation and reduced transfer coefficient in patients with asthma after 26 years of follow up. Thorax 2003; 58: 322–37.
5 6
7
8
9 10
11 12
13
14
Calverley PM, Rennard SI. What have we learned from large drug treatment trials in COPD? Lancet 2007; 370: 774–85. Travers J, Marsh S, Shirtcliffe P, Beasley R. External validity of pharmaceutical trials in asthma and chronic obstructive pulmonary disease. In: Rothwell PM, ed. Treating individuals: from randomised trials to personalised medicine. Oxford: Elsevier, 2007: 131–35. National Emphysema Treatment Trial Research Group. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med 2003; 348: 2059–73. Brightling CE, Monteiro W, Ward R, et al. Sputum eosinophilia and short-term responses to prednisolone in chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 2000; 356: 1480–85. Marsh SE, Travers J, Weatherall M, et al. Proportional classifications of COPD phenotypes. Thorax 2008; 63: 761–67. Lapperre TS, Snoeck-Stroband JB, Gosman MM, et al. Dissociation of lung function and airway inflammation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2004; 170: 499–504. Fabbri LM, Rabe KF. From COPD to chronic systemic inflammatory syndrome? Lancet 2007; 370: 797–99. Weatherall M, Travers J, Shirtcliffe PM, et al. Distinct clinical phenotypes of airways disease defined by cluster analysis. Eur Respir J 2009; published online April 8. DOI:10.1183/09031936.00174408. Wardlaw AJ, Silverman M, Siva R, Pavord ID, Green R. Multi-dimensional phenotyping: towards a new taxonomy for airway disease. Clin Exp Allergy 2005; 35: 1254–62. The Lancet. A plea to abandon asthma as a disease concept. Lancet 2006; 368: 705.
Telemedicine for management of patients with COPD?
Photolibrary
The European Commission Communication on telemedicine1 highlighted not only the potential of telehealth in the management of chronic obstructive pulmonary disease (COPD), but also the pressing need for good-quality research in this field. COPD affects about 210 million people globally and causes some 3 million
672
deaths annually.2 The disease is a major drain on healthcare budgets with 50% of costs accounted for by hospital admissions, much of which could be avoided through development of more responsive models of care that allow earlier recognition and treatment of exacerbations.3 Telehealth, delivered through landline, broadband, or, increasingly, wireless (wi-fi) or cell-phone technology, seems ideally suited to enable real-time remote monitoring and management of patients from their homes. Telehealth has the potential to transform the way care is delivered for the increasing numbers of people with COPD. However, potential benefits do not equate with effectiveness and the evidence for the effectiveness of telemedicine in COPD compared with, for example, cardiac failure remains weak.4 The uncritical rollout of telehealth for COPD that is taking place in parts of the UK and internationally is hence problematic, because this technology is expensive, might require disruptive reorganisation of care and infrastructure support,5 and is, furthermore, not without risk.6 The rollout of these technologies throughout the National Health Service has the support of the UK Government,7 and there is thus a great deal of pressure for early implementation from enthusiasts. However, we www.thelancet.com Vol 374 August 29, 2009
Comment
believe that the European Commission offers a sounder and strategically considered approach. The European Commission1 rightly exhorts member states to ensure that the potential of telehealth is fully realised by seeking to integrate it into all aspects of care, in an evidence-informed manner. In so doing, the Commission recognises the essential need for new deployments to contribute towards clarifying the currently limited evidence base underlying the use of telehealth in COPD. Although existing effectiveness studies have been promising,8 they have typically been small scale and too heterogeneous in outcome measures to allow any overarching conclusions to be drawn through meta-analysis. The European Commission has therefore rightly called for effectiveness trials in this area, with a scientifically sound methodology that is agreed across different countries and health-care systems. Additionally, the Commission has called for a central core set of clinical, quality of life, and economic endpoints that researchers should measure, when possible, to facilitate metaanalysis. For COPD these endpoints need to include: an agreed definition of what constitutes an exacerbation; physiological measures such as lung function, oxygen saturation, and exercise capacity; internationally validated general and health-related quality of life questionnaires (eg, the St George’s Respiratory Questionnaire9 and EuroQol 5D10); comparable economic outcomes such as service use (eg, hospital bed-days); and cost per quality-adjusted life-year. With our experience from several completed and ongoing telehealth trials, we feel it important that such trials consider not only clinical, quality of life, and economic endpoints, but also detailed analysis of the process changes that might have contributed to success or failure. In particular, this analysis needs to include a description of the underpinning clinical service, which is crucial to the successful implementation of telehealth projects. This information is important because such consideration of process measures will allow causal mechanisms to be understood and inform an assessment of the generalisability of a telehealth-based approach to other disease areas and service configurations. There is also a need for legislative and professional regulatory perspectives to evolve such that these recognise the importance of, and facilitate provision of, safe remote models of care, which are still viewed rather www.thelancet.com Vol 374 August 29, 2009
negatively.11 Finally, the European Union has a role in ensuring that the bewildering array of devices licensed for use in telehealth are interoperable, to reduce the risk of health-care providers buying into expensive technological dead-ends. Telehealth has great potential in COPD, but there are also risks associated with investment and deployment in this area. The European Union Communication1 provides a strategy to build an evidence base, without which we will never know if the current unquestioning enthusiasm of current UK policy is an act of considerable foresight or an expensive mistake. *Brian McKinstry, Hilary Pinnock, Aziz Sheikh General Practice Section (BM) and E-health Group, Centre for Population Health Sciences (HP, AZ), University of Edinburgh, Edinburgh EH8 9DR, UK [email protected] BM, HP, and AS have been funded by the Chief Scientist Office of the Scottish Government for a programme of randomised trials in telehealth (the TeleScot trials). BM has received funding from the BUPA Foundation, Scottish Centre for Telehealth, Intel Corporation, and NHS Lothian for telehealth research. AS and HP have received funding for telehealth-related work from the NHS Connecting for Health Evaluation Programme, NHS Lothian, and the CYMPLA trial funded by Asthma UK. 1
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Commission of the European Communities. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on telemedicine for the benefit of patients, healthcare systems and society. Nov 4, 2008. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do? uri=COM:2008:0689:FIN:EN:PDF (accessed June 6, 2009). Halbert RJ, Isonaka S, George D, Iqbal A. Interpreting COPD prevalence estimates: what is the true burden of disease? Chest 2003; 123: 1684–92. Wilkinson TM, Donaldson GC, Hurst JR, Seemungal TA, Wedzicha JA. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2004; 169: 1298–303. Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ 2007; published online April 10. DOI:10.1136/bmj.39156.536968.55. Jennett P, Yeo M, Pauls M. Graham J. Organizational readiness for telemedicine: implications for success and failure. J Telemed Telecare 2003; 9: 27–30. Car J, Black A, Anandan C, et al. The impact of ehealth on the quality & safety of healthcare: a systematic overview & synthesis of the literature. Report for the NHS connecting for health evaluation programme. March, 2008. http:// www.pcpoh.bham.ac.uk/publichealth/cfhep/documents/NHS_CFHEP_001_ Final_Report.pdf (accessed June 6, 2009). Darzi A. High quality care for all: NHS Next Stage Review final report. June 30, 2008. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/ PublicationsPolicyAndGuidance/DH_085825 (accessed June 6, 2009). Casas A, Troosters T, Garcia-Aymerich J, et al. Integrated care prevents hospitalisations for exacerbations in COPD patients. Eur Respir J 2006; 28: 123–30. Jones PW, Quirk FH, Baveystock CM. The St George’s Respiratory Questionnaire. Respir Med 1991; 85: 25–31. Cheung K, Oemar M, Oppe M, Rabin R, on behalf of the EuroQol Group. User guide: basic information on how to use the EQ-5D. 2003. http://www. euroqol.org/fileadmin/user_upload/Documenten/PDF/User_Guide_v2_ March_2009.pdf (accessed June 17, 2009). McKinstry B, Watson P, Pinnock H, Heaney D, Sheikh A. Telephone consulting in primary care: a triangulated qualitative study of patients and providers. Br J Gen Pract 2009; 59: 433–41.
673