- Email: [email protected]
Telemedicine and remote management of heart failure
Correspondence
Telemedicine and remote management of heart failure “Everything works” or “nothing works”: clinicians often grapple with these dichotomous and non-qualified conclusions in systematic reviews.1 Seldom does this occur in the same paper. Thus Stefan Anker and colleagues (Aug 20, p 731)2 conclude, from a small number of inconsistent trial results, that the effectiveness of telemedicine interventions in heart failure is “not established” but will “become proven and efficient” in time. The conclusions will foster some immediate consternation. Reasonable concerns relate to the lack of selfcare components in the telemedicine interventions. Less reasonably, the results of the non-supportive trials cited could be selectively dismissed, with past meta-analyses cited as incontrovertible counter evidence.3 The Review2 and these responses miss two vital points: the interventions are complex and their effectiveness is neither dichotomous nor universal. As the Review2 shows, interventions with the same label are not the same interventions. Differences between non-pharmacological interventions for heart failure are numerous, lie deep in the components of components, and are not sufficiently explored in meta-analyses.4 Also, effectiveness is not a dichotomous and universally applicable variable. To categorise these complex interventions as inherently “proven” or “effective” now or as a possibility for the future is wrong.5 Rather, effectiveness is a continuum that varies across time and place.1 At best, particular types of these interventions will work sometimes for some populations.5 Research is needed to understand why telemedicine interventions work when they do work, and should take account of the myriad factors that can affect outcomes. We declare that we have no conflicts of interest.
www.thelancet.com Vol 378 November 26, 2011
*Alexander M Clark, David R Thompson [email protected] University of Alberta, Edmonton, AB T63 2G3, Canada (AMC); and Australia Catholic University, Melbourne, VIC, Australia (DRT) 1 2
3
4
5
Pawson R. Evidence-based policy: a realist perspective. London: Sage, 2006. Anker SDK, Koehler F, Abraham WT. Telemedicine and remote management of patients with heart failure. Lancet 2011; 378: 731–39. Clark R, Inglis S, McAlister F, Cleland J, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ 2007; 334: 942. Savard LA, Thompson DR, Clark AM. A metareview of evidence on heart failure disease management programs: the challenges of describing and synthesizing evidence on complex interventions. Trials 2011; 12: 194. Clark AM, Thompson DR. The future of heart failure disease management programs. Lancet 2008; 372: 784–86.
We commend Stefan Anker and colleagues1 on their excellent Review of telemonitoring in chronic heart failure (CHF) and on their proposed classification of telemedical remote management systems according to the type of data transfer, decision ability, and level of integration. However, several points require clarification in relation to our Cochrane review of telemonitoring and structured telephone support.2 Anker and colleagues describe the study that we included by Kielblock and colleagues3 as a cohort study. We corresponded directly with the Kielblock team specifically to find out whether or not this was a randomised trial and were informed that it was a randomised trial, albeit by date of birth. We have clearly documented in our published review,2 within the risk of bias table for this study, precise acknowledgment of the method used for randomisation and denoted this method to have a high risk of bias. Post-hoc meta-analyses without these data show no substantial change to the effect estimates for all-cause mortality (original risk ratio [RR] 0·66, 95% CI 0·54–0·81, p<0·0001; revised RR 0·72, 0·57–0·92, p=0·008), all-cause hospital admission (original
RR 0·91, 0·84–0·99, p=0·02; revised RR 0·92, 0·84–1·02, p=0·10) or CHFrelated hospital admission (original RR 0·79, 0·67–0·94, p=0·008; revised RR 0·75, 0·60–0·94, p=0·01). Second, we would classify the TeleHF study4,5 as structured telephone support, rather than telemonitoring. Again, inclusion of these data alters the point estimate but not the overall result of the meta-analyses.4 Finally, our review2 does not include invasive telemonitoring, since the search strategy was not designed to capture these studies. Therefore direct comparison of our review findings with recent studies of these interventions is not recommended. JGFC has received funds from Philips and Bosch, which have a commercial interest in telemonitoring, for research, staff, and fees for consulting, and has acted as a paid adviser on the subject of this Correspondence. The other authors declare that they have no conflicts of interest.
*Sally C Inglis, Robyn A Clark, Finlay A McAlister, Simon Stewart, John G F Cleland [email protected] Faculty of Nursing, Midwifery and Health, University of Technology Sydney, Sydney, NSW 2007, Australia (SCI); School of Nursing and Midwifery, Queensland University of Technology, Brisbane, QLD, Australia (RAC); Division of General Internal Medicine, University of Alberta, Edmonton, AB, Canada (FAM); Preventative Health, Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia (SS); and Academic Unit of Cardiology, Castle Hill Hospital, Cottingham, UK (JGFC) 1
2
3
4
5
Anker SD, Koehler F, Abraham WT. Telemedicine and remote management of patients with heart failure. Lancet 2011; 378: 731–39. Inglis SC, Clark RA, McAlister FA, et al. Structured telephone support or telemonitoring programs for patients with chronic heart failure. Cochrane Database Syst Rev 2010; 8: CD007228. Kielblock B, Frye C, Kottmair S, Hudler T, Siegmund-Schultze E, Middeke M. Impact of telemetric management on overall treatment costs and mortality rate among patients with chronic heart failure. Deutsche Medizinische Wochenschrift 2007; 132: 417–22. Inglis SC, Clark RA, Cleland JGF. Telemonitoring in patients with heart failure. N Engl J Med 2011; 364: 1078–79. Chaudhry SI, Mattera JA, Curtis JP, et al. Telemonitoring in patients with heart failure. N Engl J Med 2010; 363: 2301–09.
Submissions should be made via our electronic submission system at http://ees.elsevier.com/ thelancet/
e9
Telemedicine and remote management of heart failure “Everything works” or “nothing works”: clinicians often grapple with these dichotomous and non-qualified conclusions in systematic reviews.1 Seldom does this occur in the same paper. Thus Stefan Anker and colleagues (Aug 20, p 731)2 conclude, from a small number of inconsistent trial results, that the effectiveness of telemedicine interventions in heart failure is “not established” but will “become proven and efficient” in time. The conclusions will foster some immediate consternation. Reasonable concerns relate to the lack of selfcare components in the telemedicine interventions. Less reasonably, the results of the non-supportive trials cited could be selectively dismissed, with past meta-analyses cited as incontrovertible counter evidence.3 The Review2 and these responses miss two vital points: the interventions are complex and their effectiveness is neither dichotomous nor universal. As the Review2 shows, interventions with the same label are not the same interventions. Differences between non-pharmacological interventions for heart failure are numerous, lie deep in the components of components, and are not sufficiently explored in meta-analyses.4 Also, effectiveness is not a dichotomous and universally applicable variable. To categorise these complex interventions as inherently “proven” or “effective” now or as a possibility for the future is wrong.5 Rather, effectiveness is a continuum that varies across time and place.1 At best, particular types of these interventions will work sometimes for some populations.5 Research is needed to understand why telemedicine interventions work when they do work, and should take account of the myriad factors that can affect outcomes. We declare that we have no conflicts of interest.
www.thelancet.com Vol 378 November 26, 2011
*Alexander M Clark, David R Thompson [email protected] University of Alberta, Edmonton, AB T63 2G3, Canada (AMC); and Australia Catholic University, Melbourne, VIC, Australia (DRT) 1 2
3
4
5
Pawson R. Evidence-based policy: a realist perspective. London: Sage, 2006. Anker SDK, Koehler F, Abraham WT. Telemedicine and remote management of patients with heart failure. Lancet 2011; 378: 731–39. Clark R, Inglis S, McAlister F, Cleland J, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ 2007; 334: 942. Savard LA, Thompson DR, Clark AM. A metareview of evidence on heart failure disease management programs: the challenges of describing and synthesizing evidence on complex interventions. Trials 2011; 12: 194. Clark AM, Thompson DR. The future of heart failure disease management programs. Lancet 2008; 372: 784–86.
We commend Stefan Anker and colleagues1 on their excellent Review of telemonitoring in chronic heart failure (CHF) and on their proposed classification of telemedical remote management systems according to the type of data transfer, decision ability, and level of integration. However, several points require clarification in relation to our Cochrane review of telemonitoring and structured telephone support.2 Anker and colleagues describe the study that we included by Kielblock and colleagues3 as a cohort study. We corresponded directly with the Kielblock team specifically to find out whether or not this was a randomised trial and were informed that it was a randomised trial, albeit by date of birth. We have clearly documented in our published review,2 within the risk of bias table for this study, precise acknowledgment of the method used for randomisation and denoted this method to have a high risk of bias. Post-hoc meta-analyses without these data show no substantial change to the effect estimates for all-cause mortality (original risk ratio [RR] 0·66, 95% CI 0·54–0·81, p<0·0001; revised RR 0·72, 0·57–0·92, p=0·008), all-cause hospital admission (original
RR 0·91, 0·84–0·99, p=0·02; revised RR 0·92, 0·84–1·02, p=0·10) or CHFrelated hospital admission (original RR 0·79, 0·67–0·94, p=0·008; revised RR 0·75, 0·60–0·94, p=0·01). Second, we would classify the TeleHF study4,5 as structured telephone support, rather than telemonitoring. Again, inclusion of these data alters the point estimate but not the overall result of the meta-analyses.4 Finally, our review2 does not include invasive telemonitoring, since the search strategy was not designed to capture these studies. Therefore direct comparison of our review findings with recent studies of these interventions is not recommended. JGFC has received funds from Philips and Bosch, which have a commercial interest in telemonitoring, for research, staff, and fees for consulting, and has acted as a paid adviser on the subject of this Correspondence. The other authors declare that they have no conflicts of interest.
*Sally C Inglis, Robyn A Clark, Finlay A McAlister, Simon Stewart, John G F Cleland [email protected] Faculty of Nursing, Midwifery and Health, University of Technology Sydney, Sydney, NSW 2007, Australia (SCI); School of Nursing and Midwifery, Queensland University of Technology, Brisbane, QLD, Australia (RAC); Division of General Internal Medicine, University of Alberta, Edmonton, AB, Canada (FAM); Preventative Health, Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia (SS); and Academic Unit of Cardiology, Castle Hill Hospital, Cottingham, UK (JGFC) 1
2
3
4
5
Anker SD, Koehler F, Abraham WT. Telemedicine and remote management of patients with heart failure. Lancet 2011; 378: 731–39. Inglis SC, Clark RA, McAlister FA, et al. Structured telephone support or telemonitoring programs for patients with chronic heart failure. Cochrane Database Syst Rev 2010; 8: CD007228. Kielblock B, Frye C, Kottmair S, Hudler T, Siegmund-Schultze E, Middeke M. Impact of telemetric management on overall treatment costs and mortality rate among patients with chronic heart failure. Deutsche Medizinische Wochenschrift 2007; 132: 417–22. Inglis SC, Clark RA, Cleland JGF. Telemonitoring in patients with heart failure. N Engl J Med 2011; 364: 1078–79. Chaudhry SI, Mattera JA, Curtis JP, et al. Telemonitoring in patients with heart failure. N Engl J Med 2010; 363: 2301–09.
Submissions should be made via our electronic submission system at http://ees.elsevier.com/ thelancet/
e9