Dr Sally C Inglis, PhD, NFESC. Baker IDI Heart and Diabetes Institute, Melbourne, Australia and the Cochrane Collaboration Heart Group

Transcription

1 Benefits of structured telephone support or telemonitoring in heart failure on mortality, hospitalisation and cost: a meta-analysis of 8,323 heart failure patients Dr Sally C Inglis, PhD, NFESC Baker IDI Heart and Diabetes Institute, Melbourne, Australia and the Cochrane Collaboration Heart Group RA Clark, University of South Australia, Adelaide, Australia and the Cochrane Collaboration Heart Group FA McAlister, University of Alberta, Alberta Canada and the Cochrane Collaboration Heart Group J Ball, Baker IDI Heart and Diabetes Institute, Melbourne, Australia and the Cochrane Collaboration Heart Group C Lewinter University of Hull, Hull, United Kingdom and Cochrane Collaboration Heart Group D Cullington University of Hull, Hull, United Kingdom and Cochrane Collaboration Heart Group S Stewart Baker IDI Heart and Diabetes Institute, Melbourne, Australia and the Cochrane Collaboration Heart Group JGF Cleland University of Hull, Hull, United Kingdom and Cochrane Collaboration Heart Group Conflicts of interest: I do not have any conflicts of interest. Co-authors conflicts of interest: JGFC has received funds from Philips for research, staff and consulting fees and has acted as a paid advisor on this topic. JGFC, RAC and SS were involved in the design, conduct and publication of studies included in this review.

2 Purpose Review and summarise the evidence for the use of telemonitoring and structured telephone support for patients with chronic heart failure (CHF). To update a previous systematic review and meta-analysis on this topic published in 2007 (Clark, Inglis et al).

3 British Medical Journal. 2007;334(7600):942.

4 Telemonitoring and structured telephone support Telemonitoring (TM) is digital/broadband/satellite/wireless or blue-tooth transmission of physiologic data e.g. electrocardiograph (ECG), blood pressure (BP), weight, pulse oximetry, respiratory rate) and other data (self-care, education, lifestyle modification and medicine administration). Structured telephone support (STS) is monitoring and/or selfcare management delivered using simple telephone technology (data may have been collected and stored by a computer).

5 Usual care We defined usual care as post-discharge care without intensified attendance at cardiology clinics or clinic-based CHF disease management programme or home visiting.

6 Inclusion criteria Study type Randomised controlled trials. Publication Participants Intervention Comparison Outcomes Full peer-reviewed publication (primary meta-analysis of primary outcomes) Participants with a definitive diagnosis of heart failure, aged 18 years. Structured scheduled telephone support or telemonitoring (daily, weekly, monthly). Initiated by a healthcare professional (medical, nursing, social work, pharmacist). Delivered as the only heart failure disease management intervention, without homevisits or intensified clinic follow-up. Targeted towards the patient, and not caregivers. Did not include any visits at home by a specialised CHF healthcare professional or study personnel for the purpose of education or clinical assessment other than an initial visit to set-up equipment. Consisted of standard post-discharge care without intensified attendance at cardiology clinics or clinic-based CHF disease management programme or homevisits. All-cause mortality, CHF-related or all-cause hospitalisations, length of stay, cost of the intervention or cost reductions, quality of life, acceptability, and adherence. Exclusion criteria No primary or secondary outcomes of interest reported or available from the study authors. Not specific to heart failure. Studies could not include any home visits by specialised CHF health professionals or study personnel for the purpose of education or clinical assessment or include intensified clinic follow-up.

7 Methods: Search strategy This systematic review and meta-analysis was undertaken as a Cochrane review (Inglis et al, 2010) and followed Cochrane methodology according to a previously published protocol (Inglis et al, 2008). Fifteen electronic databases were searched (January 2006 to November 2008). Bibliographies of relevant studies and systematic reviews were handsearched. Abstracts from European, American and Australasian cardiology conferences were hand-searched for the years Keywords included: heart failure, cardiac failure, telehealth, telephone, telemonitoring and disease-management. Language restrictions were not applied.

8 Overall, 322 publications from 9,952 citations were identified as potentially relevant and full copies were retrieved and assessed. Two reviewers independently determined inclusion/exclusion and extracted data. We included RCTs in our metaanalysis of the primary outcomes if they were published in full in a peer-reviewed journal. Studies published as abstracts were included in sensitivity analyses of these outcomes.

9 Methods: Statistical analysis Meta-analyses of the primary outcomes (all-cause mortality, CHF-related and all-cause hospitalisations) were performed according to Mantel-Haenzel methods, using a fixed effects model, risk ratios, intention-to-treat, and assessment of statistical heterogeneity using Cochrane's Q test and I² statistic. All analyses were performed using Review Manager (RevMan) Version 5.0 (Copenhagen: The Nordic Cochrane Centre, Cochrane Collaboration, 2008).

10 Included studies Our review includes 30 RCTs of structured telephone support or telemonitoring. 16 RCTs of structured telephone support (+2 abstracts) 11 RCTs of telemonitoring (+3 abstracts) 25 of these RCTs were available as full, peer-reviewed publications and were included in the primary meta-analysis of mortality and hospitalisation rates (STS n=5,613; TM n=2,710). The other five studies were only published as abstracts at the time of our review and we have included these findings in sensitivity analyses of these primary outcomes.

11 Included studies Trials ranged in size: 34 to 1,518 patients in structured telephone support; 10 to 502 patients in telemonitoring. Mean age ranged from 44.5 to 78 years. Mean percent males was 64% (range: 35% to 99%). Only four studies recruited more women than men. The majority (47%) were from the USA; the remainder were from EU countries and one each from India, Argentina and Australia. Length of follow-up (range: 3 to 18 months). Most of the included studies included participants with symptomatic heart failure, although the definition and inclusion criteria differed amongst the studies, with some studies reporting few details of the diagnostic criteria for heart failure.

12 All-cause mortality Structured telephone support RR 0.88 [95% CI ] P=0.08 I 2 =0%

13 All-cause mortality - Telemonitoring RR 0.66 [95% CI ] P< I 2 =0%

14 CHF-related hospitalisation Structured telephone support RR 0.77 [95% CI ] P< I 2 =7%

15 CHF-related hospitalisation - Telemonitoring RR 0.79 [95% CI ] P=0.008 I 2 =39%

16 All-cause hospitalisation Structured telephone support RR 0.92 [95% CI ] P=0.02 I 2 =24%

17 All-cause hospitalisation - Telemonitoring RR 0.91 [95% CI ] P=0.02 I 2 =78%

18 Cost Twelve studies (nine STS and three TM) provided details of cost of the intervention or cost-reductions associated with the intervention. The cost of the interventions varied according to the type of the intervention, in particular the technologies used and the intensity at which it was delivered. Of the eleven studies which reported the effect of the intervention on the cost of care all but three reported reductions in cost (either cost per admission or overall reduction in healthcare costs) ranging between 35% and 86%.

19 Summary of findings Both TM and STS have a broad range of benefits for patients with CHF Telemonitoring: 34% reduction in risk of all-cause mortality (p<0.0001) 21% reduction in the proportion of pts hospitalised due to CHF (p=0.008) 9% reduction in the proportion of pts hospitalised for any cause (p=0.02) Structured telephone support: 12% reduction* in all-cause mortality (p=0.08) 23% reduction in the proportion of pts hospitalised due to CHF (p<0.0001) 8% reduction in the proportion of pts hospitalised for any cause (0.02)

20 Implications of these findings The findings of this review are highly relevant to the future planning and implementation of CHF disease-management globally. This review provides strong evidence that these technologies reduce mortality and hospitalisations as well as improving measures such as quality of life. There may be benefits of using these technologies to manage patients with CHF which relate to human or financial resources, but perhaps the biggest advantage can be gained from utilising these technologies to reach patients with CHF who are without access to home or clinic-based CHF-management programmes (Jaarsma et al, 2006; Clark et al, 2007).

21 Limitations We were limited by the format of published results. The heterogeneity is large for some of the meta-analyses of the primary outcomes (this heterogeneity within methodology but also the types and intensity of applied technologies). There was evidence of publication bias. It is likely that many small studies are never published. There is a dearth of evidence about how long patients should be supported by TM or STS. It is possible that the greatest benefit in terms of education and medication patterns is accrued within a few weeks and that long-term monitoring is redundant.

22 Future There is a dearth of evidence about how long patients should be supported by TM or STS. It is possible that the greatest benefit in terms of education and medication patterns is accrued within a few weeks and that long-term monitoring is redundant. The main issues to resolve with these interventions, in particular telemonitoring revolve around service organisation and costeffectiveness.

23 Conclusion Exciting new evidence to support the use of telemonitoring and structured telephone support in the management of patients with heart failure. Significant benefits with telemonitoring on reducing all-cause mortality and both heart failure and all-cause hospitalisations. Significant benefits with structured telephone support on reducing both heart failure and all-cause hospitalisations. Promising benefits on other outcomes such as functional ability, self-care and evidenced-based prescribing.

24 References Jaarsma T, et al. Heart failure management programmes in Europe. Eur J Cardiovasc Nurs 2006;5: Clark RA, et al. Inequitable provision of optimal services for patients with chronic heart failure: a national geo-mapping study. MJA 2007;186: Clark RA, Inglis SC, et al. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ 2007;334: Inglis SC, et al. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev 2010, Issue 8. CD DOI: / CD pub2. Inglis SC, et al. Structured telephone support or telemonitoring programs for patients with chronic heart failure. Cochrane Database Syst Rev 2008, Issue 3. Art. No.: CD DOI: / CD

25 Thank-you to the following individuals who assisted with our review: Dr Joey Kwong, Managing Editor, and Miss Claire Williams, Assistant Managing Editor, Cochrane Collaboration Heart Review Group. Ms Monika Winterstein, Mr Horst Winterstein, Mrs Erika Winterstein and Ms Andrea Horsky for their assistance with German translations. Ms Margaret Burke (Cochrane Heart Review Group Trial Search Coordinator), Dr Helen Marlborough (Medical Science Librarian, University of Glasgow); Ms Margaret Goedhart (Health Sciences Librarian, University of South Australia). Thank-you to all of the authors of the included studies who provided additional data or clarification: CE Angermann, K Blum; DA DeWalt; M Blasius; P Brocki; S Kottmair; WA Gattis; LR Goldberg; A Laramee; A Mortarra; G Parati; B Riegel; RT Tsuyuki; BJ Wakefield; R Cebola and D Schellberg. Dr Sally Inglis is supported by the Heart Foundation of Australia and the National Health and Medical Research Council of Australia.

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